the regulation of research involving human embryos and

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The Regulation of Research Involving Human Embryos

and Cloning in the United Kingdom and Australia

Sonia Marie Allan

Submitted in total fulfilment of the requirements

of the degree of Doctor of Philosophy

April, 2009

Faculty of Law

University of Melbourne

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Abstract

This thesis analyses the nature, rationale, and implementation of

United Kingdom and Australian regulation of research involving

human embryos and cloning using legal materials, other

documents and qualitative interviews with researchers,

practitioners and regulators. It considers how law-makers have

decided upon what to regulate and where to draw the line

between permissible and prohibited activities, and the type of

regulatory design strategies and enforcement approaches

adopted in each jurisdiction (the ‘how to regulate’ question). It is

argued that both jurisdictions have effectively decided upon

permissible and prohibited activities as a result of thorough

public consultation, research, reviews and the parliamentary

process, and have appropriately balanced competing rationales

for regulation. However, the type of regulation used in relation

to those who are licensed to research in this area is unsuitable

due to an over-emphasis on deterrence and the authoritarian

approach taken by the regulatory bureaucracies. The central

thesis is that a responsive regulatory system for licence-holders

should be adopted. It is proposed that such a system would

maintain the top level ‘command and control’ design strategies

and deterrence approaches present in the current regulatory

systems for breaches of legislation by non-licence holders and

serious breaches by licence holders. However, greater use of co-

regulatory design strategies and cooperative, educative and

persuasive enforcement approaches should be used for

regulating licensed research activities.

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Declaration

This is to certify that

(i) the thesis comprises only my original work towards the PhD except where

indicated in the Preface,

(ii) due acknowledgement has been made in the text to all other material used,

(iii) the thesis is less than 100,000 words in length, exclusive of tables, maps, bibliographies and appendices.

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Acknowledgments

Associate Professor Christine Parker. I cannot thank you enough for ‘coming on board’ and being an amazing Supervisor. You facilitated my research trips, and made so many things possible. You kept encouraging me whilst I worked, fell ill, had babies, and lived life’s vicissitudes. You kept pointing me towards relevant material and raising the bar. I have learnt so much and can only thank you again. You are the best!!! Professor Loane Skene. I am grateful for you having accepted me as your PhD student, and being there at the beginning of my journey to welcome me with your very kind, hospitable manner. I thank you for taking the time to read my thesis and giving me valuable advice and feedback about how to improve my arguments, your comments led to greater clarity and a better thesis. Most of all I thank you for encouraging me! Thank you to Professor Gerry Simpson and Associate Professor Jacqueline Peel, my completion seminar assessment panel, who gave very positive feedback and invaluable advice on filling in the gaps and tying up the ‘loose ends’. Thank you to the women who work and have worked in the research office at the University of Melbourne: Margherita Matera, Lucy O’Brien, Sophie Garrett, Mas Generis. You are all stars! (Special thanks to Lucy who lent me her own funds to support a research trip. You are so generous and kind!!!) Associate Professor Carolyn Evans, Associate Dean (Research) for keeping the research higher degree program running at Melbourne Law School, and for introducing initiatives to enhance the quality of Melbourne Law School HDR graduate programme. Dr. Kate Foord (friend and former VLRC colleague) another superstar. University of Melbourne friends and colleagues – especially Michael Bryan, Christian Witting, Ian Malkin, Paula O’Brian, Amir Kordvani, Rachel Carson, Carrie McDougall. University of Melbourne – scholarship, postgraduate association (UMPA). University of Melbourne – My undergraduate, Masters and Juris Doctorate students 2003-2008. Victorian Law Reform Commission – where my writing and research skills were developed and I learnt many skills working on their reference on Assisted Reproductive Technology. Deakin University School of Law, where as a full-time staff member I was able to work solidly on my PhD in second semester 2008. I am extremely grateful for this block of time, which I believe has enabled me to finish. A special thank you to Professor Anne Rees who made this possible.

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This thesis is dedicated to

my husband, Geoffrey Damien Allan,

my daughter, Mahalia Rose Allan, born 14 May 2007 and

my son, Gabriel Jackson Allan, born 14 May 2009:

you are so beautiful, and I love you!

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The law stated in this thesis is the law at March 2009

Citation style: Melbourne University Law Review Association Inc, Australian Guide to Legal Citation (2002)

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TABLE OF CONTENTS

Chapter One:

INTRODUCTION __________________________________________________ 1

I. Introduction: Technology and the Law, a Call for Regulation ________________________ 1

II. Statement of the Research Problem ____________________________________________ 4

III. The Scope of the Research ____________________________________________________ 4

IV. Summary of Research Methodology ____________________________________________ 6

V. Thesis Outline and Organisation _______________________________________________ 7

VI. Conclusion ________________________________________________________________ 15

Chapter Two:

RATIONALES FOR REGULATION: THE BASIS FOR MAKING DECISIONS ABOUT WHAT TO REGULATE AND WHERE TO DRAW THE LINE _________________ 17

I. Introduction ______________________________________________________________ 17

II. Early Philosophical, Religious and Scientific Views of the Embryo and When Life Begins _ 20 A. Hippocrates ____________________________________________________________________ 20 B. Aristotle ______________________________________________________________________ 21 C. Religious Philosophies ___________________________________________________________ 22 D. Developmental Biology and Embryology _____________________________________________ 27

III. Current Scientific Views on the Beginning of Life _________________________________ 30

IV. Formal Regulation of Research Involving Human Embryos _________________________ 32 A. Assisted Reproductive Technologies: Beyond the Moral Status of the Embryo _______________ 32 B. United Kingdom ________________________________________________________________ 32 C. Australia ______________________________________________________________________ 36

V. Reproductive Cloning _______________________________________________________ 42

VI. Stem Cell Research _________________________________________________________ 43

VII. The Use of Cloning Technology in Stem Cell Research _____________________________ 44

VIII. A Shift in the Regulation Debate: Regulating all Research Involving Human Embryos and Cloning __________________________________________________________________ 45

A. Old Debate, New Issues __________________________________________________________ 45 B. Further Rationales for Regulation __________________________________________________ 46

IX. Conclusion ________________________________________________________________ 51

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Chapter Three:

AN INTRODUCTION TO REGULATORY THEORY, DESIGN STRATEGIES AND ENFORCEMENT APPROACHES ______________________________________ 53

I. Introduction ______________________________________________________________ 53

II. Introduction to Theories of Punishment ________________________________________ 55 A. Deterrence Theory ______________________________________________________________ 55 B. Incapacitation Theory ____________________________________________________________ 58 C. Rehabilitation Theory ____________________________________________________________ 59 D. Restorative Justice Theory ________________________________________________________ 60 E. Retribution Theory ______________________________________________________________ 63 F. The Five Theories in the Context of Regulating Research Involving Human Embryos and Cloning 64

III. Regulatory Design Strategies _________________________________________________ 65 A. Command and Control ___________________________________________________________ 66 B. Self-Regulation and Enforced Self-Regulation _________________________________________ 71 C. Co-Regulation __________________________________________________________________ 75

IV. Enforcing Regulation _______________________________________________________ 78 A. Deterrence Approach ____________________________________________________________ 79 B. Cooperative, Persuasive and Educative Approach ______________________________________ 82 C. Progression through Various Approaches ____________________________________________ 84

V. Conclusion ________________________________________________________________ 90

Chapter Four:

REGULATION OF RESEARCH INVOLVING HUMAN EMBRYOS AND CLONING IN THE UNITED KINGDOM AND AUSTRALIA _____________________________ 92

I. Introduction ______________________________________________________________ 92

II. The United Kingdom: Decisions About What to Regulate and Where to Draw the Line Between Permissible and Prohibited Research __________________________________ 94

A. Research Involving Human Embryos: Delineating the First Boundaries ‘Beyond Which Science Should Not Go’ ______________________________________________________________________ 94 B. Stem Cell Research and Cloning – Public Consultation and Moving the Line _________________ 96 C. Stem Cell Research and Cloning – Further Judicial and Committee Review _________________ 102

III. The United Kingdom: Addressing the ‘How to Regulate’ Question __________________ 107 A. Enforcement Mechanisms and Compliance Strategies _________________________________ 107 B. Other Legislation and Recommendations: A Shift in Regulatory Approach but not Design Strategy _ ____________________________________________________________________________ 112

IV. Australia: Decisions About What to Regulate and Where to Draw the Line Between Permissible and Prohibited Research _________________________________________ 118

A. A Call for National Regulation, Regulatory Issues and Rationales _________________________ 118 B. Enactment of Legislation ________________________________________________________ 122

V. Australia: Addressing the ‘How to Regulate’ Question ___________________________ 126 A. Enforcement Mechanisms and Compliance Strategies _________________________________ 126

VI. Independent Review of the Australian Acts ____________________________________ 129 A. Lockhart Recommendations Concerning the Boundaries for Treatment and Use of Embryos __ 133

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B. Lockhart Concerns and Recommendations Regarding the Australian Regulatory System ______ 134 C. Legislative Review ______________________________________________________________ 139

VII. The Regulatory Models Adopted in the United Kingdom and Australia ______________ 146 A. Achieving Regulatory Goals and Meeting Rationales of Regulation _______________________ 147 B. The Regulatory Approach Adopted in the United Kingdom and Australia __________________ 149

VIII. Conclusion _______________________________________________________________ 162

Chapter Five:

RESEARCH SCIENTISTS’ AND PRACTITIONERS’ PERCEPTIONS OF THE REGULATORY REGIMES __________________________________________ 164

I. Introduction _____________________________________________________________ 164

II. Research Method _________________________________________________________ 166 A. The Sample Selection Criteria_____________________________________________________ 166 B. Research Methodology __________________________________________________________ 167 C. Interview Process ______________________________________________________________ 174

III. Analysis Process __________________________________________________________ 176

IV. Qualitative Research Findings _______________________________________________ 178

United Kingdom _______________________________________________________________ 178 A. Profile of Interview Participants ___________________________________________________ 178 B. Within Case-Analysis ___________________________________________________________ 182 C. Cross-Case Analysis _____________________________________________________________ 182

Australia _____________________________________________________________________ 194 A. Profile of Interview Participants ___________________________________________________ 194 B. Within Case-Analysis ___________________________________________________________ 197 C. Cross-Case Analysis _____________________________________________________________ 198

V. Conclusion _______________________________________________________________ 207

Chapter Six:

A BROADER EVALUATION OF SCIENTISTS’ VALUES AND ETHICS AND THE PUBLIC CALL FOR REGULATION ___________________________________ 213

I. Introduction _____________________________________________________________ 213

II. Scientific Values and Ethics _________________________________________________ 216 A. Is there a Personality ‘Type’ that is Attracted to Science? ______________________________ 216 B. Particular Values within Science and in the Broader Community _________________________ 222

III. Why Do People Fear Scientists? _____________________________________________ 227 A. Stereotypes in the Media and Society ______________________________________________ 227 B. ‘Good’ People can do ‘Bad’ Things _________________________________________________ 231

IV. Risk Perception, ‘Regulatory Spirals’ and the Need to Avoid Over-Regulation ________ 241 A. Risk Perception ________________________________________________________________ 241 B. Avoiding Regulatory Spirals and Over-Regulation _____________________________________ 244

V. Conclusion _______________________________________________________________ 250

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Chapter Seven:

ADDRESSING REGULATORY INADEQUACIES: RESPONSIVE REGULATION __ 253

I. Introduction _____________________________________________________________ 253

THE UNITED KINGDOM _________________________________________________________ 255

I. Current Regulation and Proposals for Reform __________________________________ 255

II. Keeping the HFEA: Support by Researchers and Practitioners _____________________ 260

III. HFEA Act Amendments: The Opportunity to Increase Co-Regulatory Strategies _______ 260

IV. Better Regulation: An Opportunity to Address Researcher/Practitioner Concerns _____ 264

V. Better Regulation: The HFEA Response ________________________________________ 266 A. Drafting the Eighth Edition of the HFEA Code of Practice _______________________________ 266 B. ‘Decreasing the Burden’ of Licensing and Inspection Processes __________________________ 267 C. Improving the use of Regulatory Sanctions __________________________________________ 269 D. Ongoing Public Consultation, Policy Review and Cost Reduction _________________________ 274

VI. Recommendations for the Future ____________________________________________ 276

AUSTRALIA ___________________________________________________________________ 281

VII. One Step Forward, Two Steps Behind? ________________________________________ 281

VIII. The Cost of the Australian Regulatory System __________________________________ 287

IX. The Australian System, A Call for Change ______________________________________ 292 A. Changing the Australian Regulatory System to Suit the Australian Context _________________ 295 B. The Regulatory Strategy of Choice _________________________________________________ 297

X. Proposed Models for Revising the Australian Regulatory System __________________ 300 A. Model 1: Co-Regulation Using RTAC, the NHMRC and Legislative Framework _______________ 300 B. Model 2: Modifying the NHMRC Licensing System ____________________________________ 310 C. The Models and ‘Responsive Regulation’ ___________________________________________ 313

XI. Conclusion _______________________________________________________________ 316

Chapter Eight:

CONCLUSION __________________________________________________ 318

I. Introduction _____________________________________________________________ 318

II. Summary of Arguments and Research Findings _________________________________ 318

III. Implications for Theory, Policy and Practice in Relation to Regulating Emerging Technologies _____________________________________________________________ 324

IV. Limitations ______________________________________________________________ 326 A. Fieldwork – Limitations Regarding Sample Size and Self-Report __________________________ 326 B. Difficulties in Obtaining Information from NHMRC and RTAC ____________________________ 327

V. Further Research _________________________________________________________ 328

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BIBLIOGRAPHY

ARTICLES/BOOKS/REPORTS _____________________________________________________ 330

CASE LAW ____________________________________________________________________ 352

LEGISLATION _________________________________________________________________ 352

OTHER SOURCES ______________________________________________________________ 354 Budget Statements __________________________________________________________________ 354 Code of Practice/Guidelines/Schemes ___________________________________________________ 355 Directives _________________________________________________________________________ 356 Editorial Statement _________________________________________________________________ 356 Emails ____________________________________________________________________________ 356 Evidence/Testimonies _______________________________________________________________ 357 Explanatory Memoranda _____________________________________________________________ 358 Interviews _________________________________________________________________________ 358 News Articles ______________________________________________________________________ 358 Other ____________________________________________________________________________ 359 Papers/Speeches ___________________________________________________________________ 359 Parliamentary Debates _______________________________________________________________ 360 Press Releases _____________________________________________________________________ 360 Websites __________________________________________________________________________ 361

APPENDIX 1 ___________________________________________________ 362

APPENDIX 2 ___________________________________________________ 373

APPENDIX 3 ___________________________________________________ 374

APPENDIX 4 ___________________________________________________ 375

APPENDIX 5 ___________________________________________________ 378

APPENDIX 6 ___________________________________________________ 380

APPENDIX 7 ___________________________________________________ 385

APPENDIX 8 ___________________________________________________ 387

APPENDIX 9 ___________________________________________________ 390

APPENDIX 10 __________________________________________________ 394

APPENDIX 11 __________________________________________________ 397

APPENDIX 12 __________________________________________________ 401

APPENDIX 13 __________________________________________________ 403

APPENDIX 14 __________________________________________________ 407

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ABBREVIATIONS

AHEC Australian Health Ethics Committee ART Assisted Reproduction Technology BFS British Fertility Society CNR Cell Nuclear Replacement COAG Council of Australian Governments ES Cells Embryonic Stem Cells FSA Fertility Society of Australia HFEA Human Fertilisation and Embryology Authority HFE Act Human Fertilisation and Embryology Act 1990 (UK) HGAC Human Genetics Advisory Committee HTA Human Tissue Authority ITA Infertility Treatment Authority (Victoria) IVF In vitro Fertilisation KAE Key Areas of Investigation NHMRC National Health and Medical Research Council PHC Act Prohibition of Human Cloning Act 2002 (Cth) PHCR Act Prohibition of Human Cloning for Reproduction Act 2002 (Cth) RES Act Regulatory Enforcement and Sanctions Act 2008 (UK) RIHE Act Research Involving Human Embryos Act 2002 (Cth) RATE Regulatory Authority for Tissue and Embryos

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RTAC Reproductive Technology Accreditation Committee RTAC Code Reproductive Technology Accreditation Committee Code of Practice for

Assisted Reproductive Technology Units SAB Science Advisory Board SCNT Somatic Cell Nuclear Transfer SPA Scientists Personality Assessment VLA Voluntary Licensing Authority for Human in vitro Fertilisation and Embryology

Chapter One: Introduction

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Chapter One:

INTRODUCTION

I. INTRODUCTION: TECHNOLOGY AND THE LAW, A CALL FOR REGULATION

In recent decades there has been tremendous progress in the biological sciences,

particularly in the areas of research involving human embryos and cloning. Such advances

coincide with an era in which science and technology are seen as particularly valuable in

promoting political, social and economic concerns, and are increasingly accorded a special

status by governments.1 Yet despite this special status, legal, ethical and policy dilemmas

are apparent. There is debate regarding whether regulation of science and technology is

necessary, and if so, what form it should take. There is also concern about how the law can

keep pace with rapidly changing technologies.2 Speaking in 1984 of biotechnological

advances in human reproduction, Sir Zelman Cowen3

[I]t is demonstrably the case that the technology outstrips the law, …the time cushion between scientific and technological change, and the need for governmental and social reactions, is now greatly diminished, if it has not completely disappeared.

said:

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1 Better Regulation Task Force, Scientific Research: Innovation with Controls (UK) (2003). 2 Diane Nicol, Donald Chalmers & Brendan Gogarty, ‘Regulating Biomedical Advances: Embryonic Stem Cell Research’ (2002) 2 Macquarie Law Journal 31. 3 The Rt. Hon. Sir Zelman Cowen was Provost of Oriel College, Oxford, and former Governor-General of Australia. 4 Sir Zelman Cowen, Reflections on Medicine, Biotechnology and the Law (1985) 33.

In the same year the United Kingdom’s Warnock Committee5 drew attention to

social and legal considerations surrounding research involving human embryos. They

recognised ‘a wide diversity of moral feelings’ arising from religious, philosophical or

humanist beliefs. However they stated there was commonality amongst all perspectives in

that all ‘people general[ly] want some principles or other to govern the development and

use of the new techniques’. The Warnock Committee concluded ‘there must be some

barriers that are not to be crossed, some limits fixed beyond which people must not be

allowed to go’.6

This thesis focuses on two jurisdictions that have comprehensive regulatory systems

which govern research involving human embryos and cloning. It analyses the United

Kingdom’s and Australia’s approaches to the regulation of research involving human

embryos and cloning using a variety of legal materials, other documents and qualitative

research with researchers, practitioners and regulators. These jurisdictions were chosen as

in 2002 Australia adopted a similar regulatory system to that which had been in place in the

United Kingdom since 1990. However, the United Kingdom system has recently been subject

to extensive review in relation to how it regulates, which emphasises the need for better

regulatory design strategies and enforcement approaches. It is helpful therefore to contrast

Such words resonate in the twenty-first century. Fears of human cloning

and concern about destruction of human embryos for research purposes resound. Protests

about science knowing no bounds have been heard. Governments worldwide face the

dilemma of how to weigh potential benefits of research involving human embryos against

the moral, ethical and legal concerns associated with it.

5 The UK Government convened the Warnock Committee shortly after the first IVF baby was born in 1978. Its purpose was to consider recent and potential developments in medicine and science related to human fertilisation and embryology; to consider what policies and safeguards should be applied, including consideration of the social, ethical and legal implications of these developments; and to make recommendations: Mary Warnock, Report of the Committee of Inquiry into Human Fertilisation and Embryology (1984). (The Warnock Report). 6 Ibid, 2.


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the United Kingdom and Australia to evaluate whether the United Kingdom has made

significant improvements to the older regulatory system, and whether Australia should

‘follow suit’.

Both jurisdictions provide excellent examples of how public consultation,

parliamentary debate and ongoing research can contribute to decisions about what to

regulate and where to draw the line between permissible and prohibited research. The legal

regulation of such practices is problematic. Regulation is required to balance competing

interests—enabling science to progress, but only in a manner that is deemed socially

acceptable. Despite the difficulty of doing it well, the thesis argues that both jurisdictions

have in fact managed to balance sensitivity to the moral and ethical issues with other

rationales for regulation in deciding what to regulate and what to prohibit. The thesis does

not call for changes regarding what is regulated in either jurisdiction or where the line has

been drawn (other than via ordinary ongoing policy and legislative review practices as

technology and/or social attitudes towards the research change).

Rather, this thesis finds that it is the how the regulation of research involving human

embryos and cloning is designed and implemented, not its basic content, that should be

improved in both the United Kingdom and Australia. How regulation of research involving

human embryos and cloning is implemented and the model of regulation adopted is of just

as great importance as content. The thesis argues that the best mode of regulation is one

that is responsive to those being regulated, employs a level of co-regulatory strategies and

increases cooperative, educative and persuasive enforcement approaches when dealing

with licensed researchers and practitioners. It is proposed that such a system would

maintain the top level ‘command and control’ design strategies and deterrence approaches

present in the current regulatory systems for breaches of legislation by non-licence holders

and serious breaches by licence holders. Both the United Kingdom’s and especially

Australia’s regulatory systems can be significantly improved in this regard. It is this issue

with which the bulk of the thesis is concerned.

II. STATEMENT OF THE RESEARCH PROBLEM

There is a need to address the debate regarding whether regulation of research

involving human embryos and cloning is necessary, and if so, what form it should take. The

research problem in its simplest form therefore concerns what to regulate and where to

draw the line between permissible and prohibited practices, and how to regulate in this

context.

III. THE SCOPE OF THE RESEARCH

The scope of this research is to explore the current law regulating research involving

human embryos and cloning in the United Kingdom and Australia, to analyse the regulatory

systems in each jurisdiction, and to assess whether each system has adopted the most

suitable regulatory model. It is purposefully limited to these two jurisdictions for the

reasons stated above.

A brief summary of some other jurisdictions’ laws and regulatory systems may be

found in Appendix 1.7

7 See Appendix 1 for an overview of a number of countries throughout the world, what they permit/prohibit, and information about the regulatory systems/oversight required (where such oversight exists).

The inclusion of this summary serves to recognise that the regulation

of research involving human embryos and/or cloning is a worldwide issue, and highlights

other jurisdictions that have taken either similar (for example, Belgium and Canada) or

radically different regulatory approaches (for example, Germany, Italy, the United States).

However, the specificity and depth enabled by limiting this inquiry to the two jurisdictions


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chosen was seen as preferable to a study which may have provided a broader overview of

more jurisdictions’ laws but would have less scope to discuss and evaluate the particular

regulatory regimes in detail. Limiting the scope of this research to the United Kingdom’s

and Australia’s regulatory systems for research involving human embryos and cloning also

enables the making of practical recommendations for both of these jurisdictions.

The thesis considers what the rationales for regulating research involving human

embryos and cloning are, and the regulatory theory that underpins how these rationales

should be put into place. A review of the existing laws and procedures for regulating

research involving human embryos and cloning, and how they arose, is also provided. Such

discussion forms the baseline for evaluation of the United Kingdom’s and Australia’s

decisions about what is regulated, where the line has been drawn between permissible and

prohibited activities, and how to regulate in this context. It leads to recommendations that

propose legislative and regulatory changes in each jurisdiction. Ultimately of course, these

are up to law-makers to decide whether to implement.

The way in which the law should be enforced is also addressed. The focus is upon the

implementation of the law by regulatory bodies set up by government or by industry itself.

This thesis does not consider the role of the court system in properly upholding the legal

framework, other than by reference to disputes that have previously determined how

legislation should be interpreted when deciding where boundaries should be drawn. The

scope of discussion therefore extends to decisions relating to boundary setting and choice

of regulatory model and method, rather than anticipation of any role the Courts might play

in the future interpretation of the suggested legal framework or regulation of research

involving human embryos and cloning.

The thesis also does not analyse other modes of legal and/or non-legal regulation

that may operate to ‘regulate’ research practice outside of the specific legislative schemes

set up to regulate research involving human embryos and cloning in the United Kingdom

and Australia. Whilst these forms of ‘regulation’ are acknowledged within the discussion

where relevant, the aim and focus of this thesis is to consider the primary form of regulation

that exists in the United Kingdom and Australia—that is, the legislative framework that

governs research involving human embryos and cloning and the operation of the regulatory

bureaucracies that have been established to conduct licensing, oversight and monitoring

functions. In further research it may be fruitful to look at contract law, internal disciplinary

action within hospitals and research institutes, professional registration, reputation, peer

review, and internal ethics committee reviews.

The aim is to propose a legal regime which is flexible, responsive and operates in a

way that is clearly understood. Most importantly, it is to suggest a regulatory model that will

command the respect of those regulated, and all members of the community, so that the

system is accepted by everyone. That such things should be the goals of regulation

generally, and in this area in particular, is explained and justified by considering regulatory

theory. The proposed ‘successful’ new model will enable the regulatory system to resolve

disputes and doubts, and be able to respond (at least to initial ‘wrongdoing’) without resort

to the courts.

IV. SUMMARY OF RESEARCH METHODOLOGY

This thesis analyses the nature, rationale for, and implementation of the United

Kingdom’s and Australia’s regulation of research involving human embryos and cloning. Two


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primary modes of analysis are used: review of legal materials and other scholarly articles

and documents; and qualitative interviews with researchers, practitioners and regulators.

The documentary and secondary resources used concerned history, philosophy,

psychology, social science, regulatory theory and/or the law. They were drawn upon to

understand the complicated factors involved in the regulation of an area of science that has

raised many varied dilemmas. In analysing such resources weight was given to public and

political debates and subsequent reports concerning the regulation of research involving

human embryos and cloning.

The qualitative interviews enabled the views of those subject to the regulation to be

utilised. These interviews are of fundamental importance as researchers and practitioners

are the only people who can tell us how they perceive the regulatory system that governs

them. They are also crucial to evaluation of the regulatory systems in relation to regulatory

theory. Being able to consider, compare and/or contrast regulators’ views on the regulation

in place provided further insight into the regulatory systems.

V. THESIS OUTLINE AND ORGANISATION

The order in which this thesis is set out reflects the evolution of debate and

regulation regarding research involving human embryos and cloning.

Chapter Two sets the scene for the arguments presented in this thesis by introducing

rationales for regulating research involving human embryos and cloning. It begins with a

brief overview of the history of philosophical, theological and scientific views of when life

begins and the moral status of human embryos. The discussion highlights that early

regulation relating to how human embryos should be treated was broad and based on

informal and non-state (including church) processes. The chapter goes on to discuss the

emergence of developmental biology and embryology as separate branches of science, and

subsequent advances in technology that led to the birth of the first IVF baby. The latter is

the beginning of the ‘new age of research’ that spawned numerous government inquiries

and a shift in regulatory responses to both reproductive technology and research involving

human embryos. A ‘narrow’ form of regulation was introduced in which specific legislation

and regulatory bodies were developed to define what was permissible and to monitor

research and practice. The main rationale for such regulation was to address the issue of the

moral status of the human embryo by according it some level of respect, whilst

simultaneously allowing the progress of research. A number of other rationales for

regulation are also introduced. It is argued that each of these rationales play an important

role in making decisions about what to regulate and where to draw the line between

permissible and prohibited research. It is important to understand such rationales and

decisions before moving to a consideration of the way in which regulation is occurring in the

United Kingdom and Australia. Only if these issues have been addressed appropriately can

the best mode of regulation be chosen and implemented.

Chapter Three moves to the question of how to regulate. It provides a review of

modern regulatory theory, which is concerned with design and implementation of

regulatory regimes rather than content. The purpose of this review is to enable the

evaluation in later chapters of current regulatory design strategies and enforcement

approaches in the United Kingdom and Australia, and the development of a theory

concerning what would be best practice for the regulation of research involving human

embryos and cloning. Theories of punishment, regulatory design strategies and the

approach to enforcement that regulatory agencies may take are introduced. Of the three


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regulatory design strategies discussed—‘command and control’; ‘self-regulation/enforced

self-regulation’; and ‘co-regulation’—Chapter Three shows that co-regulation addresses

many of the flaws and concerns raised in relation to the other two strategies. It is also

demonstrated to work very well in areas that have raised significant moral and ethical

concerns. Chapter Three also shows that Ayres’ and Braithwaite’s theory of ‘responsive

regulation’,8

Chapter Four outlines the public debate and political responses in the late 20th and

early 21st Centuries concerning research involving human embryos and cloning in the United

Kingdom and Australia. It focuses on the United Kingdom’s Human Fertilisation and

Embryology Act 1991 and Australia’s Research Involving Human Embryos Act 2002 (Cth) and

Prohibition of Human Cloning Act 2002 (Cth) (later renamed the Prohibition of Human

Cloning for Reproduction Act 2002 (Cth)). Reviews of the Acts are also considered. The

chapter evaluates how each jurisdiction has addressed questions of what to regulate and

where to draw the line between permissible and prohibited research. It is argued that

which proposes utilising a combination of cooperative, persuasive, educative

and deterrent enforcement approaches is more effective at achieving compliance and being

seen as legitimate than using only, or predominantly, one approach. A responsive approach

to enforcement is very consistent with co-regulation.

Together Chapters Two and Three provide the basis for evaluating how the United

Kingdom’s and Australia’s regulatory systems have addressed what to regulate, where to

draw the line between permissible and prohibited research, and how to regulate in the

context of research involving human embryos and cloning. Chapters Four, Five and Six move

on to detailing and evaluating the respective regulatory systems.

8 Ian Ayres and John Braithwaite, Responsive Regulation: Transcending the Deregulation Debate (1992); John Braithwaite, Restorative Justice and Responsive Regulation (2002).

although balancing sensitive issues is very difficult, both regulatory systems have done an

excellent job at this task. Following extensive public consultation, reviews, reports and

parliamentary debate, the processes adopted in each jurisdiction have enabled a clear

legislative approach to be taken. This allows us to move on to the next issue which is how

each jurisdiction has addressed the way that research involving human embryos and cloning

are being regulated.

Although most attention by commentators and policy makers has been paid to the

difficult moral and ethical issues associated with deciding what to regulate, there are

equally difficult and nuanced considerations to be taken into account in deciding how to

regulate. Chapter Four therefore also explores how each jurisdiction has chosen to regulate.

The types of regulatory design strategy and enforcement approaches adopted in each

jurisdiction are analysed. It is argued that both jurisdictions have adopted a ‘command and

control’ design strategy which has emphasised deterrence as a primary enforcement

approach. This is contrasted with Ayres and Braithwaite’s recognition that ‘...the regulatory

agencies that do the best at achieving their goals are those that strike some sort of balance

between [deterrence and cooperative] models’ of regulation.9

9 Ayres and Braithwaite, above n8, 21.

Chapter Four demonstrates

that whilst both jurisdictions have incorporated cooperative, persuasive and educative

approaches to a small degree in their regulatory systems, a balance with deterrence has not

been achieved—the latter being utilised to a greater degree. However, recent legislative

changes and a wider governmental push for better regulation in the United Kingdom has

been the impetus for a move towards an improved regulatory model in that jurisdiction. It is

recognised that before drawing any solid conclusions about best regulatory practice, it is


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also necessary to explore how these systems are viewed and responded to by researchers

and practitioners.

Chapter Five thus reports the results of fieldwork conducted in both the United

Kingdom and Australia in which leading researchers and practitioners in the field of research

involving human embryos and cloning, and regulators were interviewed. In analysing the

results, arguments that neither jurisdiction has adopted the best regulatory strategies or

enforcement approaches are again supported. Whilst researchers and practitioners showed

acceptance of regulation as a means of quelling public fears, the results in both jurisdictions

highlight dissatisfaction with issues of bureaucracy and the authoritarian approaches taken

by regulatory agencies. In both jurisdictions participants reported that compliance had little,

if anything, to do with the threat of criminal prosecution and/or imprisonment. Researchers

and practitioners emphasised that they did not like being viewed or treated as though they

were ‘baddies’ or as though they could not be trusted. They also reported their perception

that regulators often did not have the scientific knowledge to fully understand what the

researchers and practitioners were doing (or wanted to do) and that they did not show a

willingness to draw upon researchers’ and practitioners’ expertise. The strong sense of

Australian researchers and practitioners in particular that the regulatory system adopted

affects the conduct of science and progress of research in a negative way is also noted.

Finally Chapter Five reports the finding that in the United Kingdom, despite the

shortcomings, researchers and practitioners were happy with the regulatory model but

wanted to address the shortcomings. On the other hand, there was a general preference in

Australia amongst researchers and practitioners for an enforced self-regulatory model

rather than what was seen as an authoritative oversight model. Regulators views on the

regulatory systems are compared and contrasted.

Limitations of the results reported in Chapter Five are recognised and addressed in

Chapter Six. That is, the results reported in Chapter Five are based on a small sample size

and so require further validation. Additionally, drawing conclusions based on self-report of

participants alone might be vulnerable to the criticism that participants would not admit to

wrongdoing or wanting to do things prohibited by law. Chapter Six therefore explores and

responds to the results presented in Chapter Five by analysing the following questions in a

broader context:

1. What are the values and ethics of scientists?

2. What fears do people have about scientists and are they valid?

3. How do these issues affect the regulation of research involving human embryos and

cloning?

After exploring whether there are particular ‘types’ of people attracted to science, and the

values and ethics found within the field and the community, it is argued that researchers

and practitioners generally share and reflect the same ethics and values as those of the

wider communities in which they live. However, a consideration of what makes people fear

scientists, and the fact that in certain situations ‘good’ people can do (and have done) ‘bad’

things, leads to the argument that in areas of risk some Government oversight and

regulation is warranted. Nonetheless, Chapter Six shows that there is a danger of a

‘regulatory spiral’ if the regulatory approach is based only upon heightened risk perception

and public demand for the government to ‘do something’, rather than a tempered approach

to regulation. The arguments presented in Chapter Six support the central thesis that a

‘responsive regulatory’ system should be adopted.

Chapter Seven moves to the question of how to respond to the inadequacies of the

regulatory systems as identified in the evaluation of the two regulatory regimes presented


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in Chapters Four to Six. It uses the theoretical framework set out in Chapters Two and

Three, as well as the specific evaluative conclusions in Chapters Four to Six as the basis for

proposals for change. It specifically considers what has been done in the United Kingdom

and Australia to address regulatory inadequacies, and whether it would be possible to

improve the respective regulatory systems.

It is argued that a level of ‘command and control’ design and deterrence approaches

should be retained for breaches of legislation by non-licence holders and serious breaches

by licence holders. However, adopting a level of co-regulatory design strategies and

increased co-operative, educative and persuasive enforcement approaches to regulate

compliant licence holders, would enable regulation to satisfy moral, political, economic and

social rationales, and would result in regulatory systems that are responsive to regulatees

rather than focused on punishment or the threat of punishment. It is shown that such a

system would ensure government boundary setting and oversight, whilst encouraging

dialogue between regulators, regulatees and the community to discuss risk perceptions,

avoid stereotyping, and enable a system of regulation in which all such parties play a

significant role in the regulation of licensed research activity. Such interaction would also

help to avoid institutional insularity, or pressures that have the potential to lead to an

environment where wrongdoing might occur, whilst fostering trust and co-operation with

those regulated.

Chapter Seven shows that the United Kingdom is successfully moving towards such a

‘responsive regulatory regime’. Such a move satisfactorily includes the maintenance of the

United Kingdom’s regulatory bureaucracy, the Human Fertilisation and Embryology

Authority (HFEA). Suggestions for further improvement and co-regulatory strategies are

made. It is argued that Australia is not achieving similar goals and has not begun to

adequately question the regulatory structure in place. Proposals are made for two alternate

models that would serve to address the problems with the type of regulation adopted in

Australia. The first model suggests utilising an established self-regulatory body to take over

the licensing and oversight functions currently conducted by the National Health and

Medical Research Council (NHMRC) Licensing Committee and Inspectorate, whilst

maintaining the possibility that the NHMRC play a role in higher level enforcement

approaches if necessary. This model introduces a level of co-regulation that does not exist in

the current regulatory system, whilst maintaining the framework legislation and higher level

command and control strategies and enforcement for non-compliers and/or those that

might operate contrary to the legislation and licensing system. The second model is one

which more closely reflects the revised United Kingdom regulatory design strategy and

enforcement approaches, and suggests similar modifications to the NHMRC Licensing

System as those made for the United Kingdom. It again also adds proposals for increased co-

regulatory strategies at the base of the regulatory pyramid. It is argued that given the

opportunity for cost recovery, the differences between the United Kingdom and Australia

regulatory bureaucracies remit, and the small scale of licensed research in Australia, the first

model is preferable.

Chapter Eight concludes with a summary of arguments and research findings. It

discusses the consequences of choosing better regulatory design strategies and

enforcement approaches in the context of research involving human embryos and cloning.

The conclusion also explores the implications that the research findings and arguments put

forth in this thesis have for theory, policy and practice more broadly in relation to the

regulation of science. Limitations of the study are discussed and suggestions for further

research made.


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VI. CONCLUSION

The arguments presented in this thesis involve an analysis of the decisions that have

been made in the United Kingdom and Australia about what to regulate and where to draw

the line between permissible and prohibited research. The thesis also analyses the

regulatory models adopted in these jurisdictions when deciding upon how to regulate in the

context of research involving human embryos and cloning. In depth consideration of the

rationales for regulating research involving human embryos and cloning, alongside

regulatory theory and arguments for better regulation are presented.

Decisions concerning what to regulate and where to draw the line between

permissible and prohibited research have involved analysing the potential benefits of an

activity, the level of ethical objections, how widely those objections are spread, and the

level of risk that such research poses.10

However, it is argued in this thesis that the regulatory design strategies and

enforcement approaches chosen in both the United Kingdom and Australia are not (or have

It is shown in this thesis that both the United

Kingdom and Australia have used extensive public consultation; governmental,

departmental and committee reviews; and the parliamentary process to draw boundaries

for permissible and prohibited activities that reflect what is acceptable to the majority of

people in those societies. This is a remarkable and important achievement and there is no

call to challenge where boundaries have been set within either jurisdiction outside of having

effective and efficient review processes.

10 Legislation Review Committee (Australia), Legislation Review: Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002, Reports, Canberra, December 2005.

not been) the most suitable for regulating the majority of researchers and practitioners who

are compliant with the legislation. Whilst serving a valuable purpose in possibly deterring

those who wish to act outside of the licensing system or contrary to the legislative

provisions, they lack the responsiveness required of better regulatory models. It is argued

that including a level of co-regulatory strategies and cooperative, educative and responsive

approaches to enforcement would make ‘it possible to implement the objectives defined by

the legislator through measures carried out by active and recognised parties in the field

concerned’.11 Such a model clearly has the potential to reduce costs, bureaucracy, and

unnecessary regulatory burdens whilst not detracting from decisions about what to regulate

and where to draw the line. It thus accommodates the contentious moral and ethical issues

surrounding such research by maintaining legislative boundaries and oversight, whilst

reflecting Braithwaite’s theory that the best mode of regulation is one which is respected

and accepted by those who are regulated.12

The research findings and discussion presented in this thesis are important and

original noting that the United Kingdom House of Lords, House of Commons, Joint

Committee on the Human Tissue and Embryos (Draft) Bill, Session 2006-2007, (2007) paper

recognised ‘the lack of research undertaken as to the workings of the current regulatory

structure, and improvements that could be made’.

13

11 Commission of the European Communities, Report from the Commission on European Governance (2002), 15. 12 Ayres and Braithwaite, above n8; Braithwaite, Restorative Justice and Responsive Regulation, above n8. 13 House of Lords, House of Commons, Joint Committee on the Human Tissue and Embryos (Draft) Bill, Session 2006-2007 (2007), HL Paper 169-I; HC Paper 630-I, 31.

Similarly, no such study has been

conducted in Australia.

Chapter Two: Rationales for Regulation

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Chapter Two:

RATIONALES FOR REGULATION:

THE BASIS FOR MAKING DECISIONS ABOUT WHAT TO REGULATE AND WHERE TO DRAW THE LINE

I. INTRODUCTION

The term regulation can be defined in numerous ways14 being applied broadly to any

form of behavioural control including informal and non-state processes,15 and narrowly ‘to a

set of authoritative rules accompanied by a mechanism, usually a public agency, for

monitoring and promoting compliance with those rules’.16 Selznick has described the

‘central meaning’ of regulation as being ‘a sustained and focused control exercised by a

public agency over activities that are valued by a community’.17

14 See B.M. Mitnick, The Polictical Economy of Regulation (1980) cited in Anthony Ogus, Regulation: Legal Form and Economic Theory (1994), 1. 15 R Baldwin, L Scott and C Hood (eds), A Reader on Regulation (1998), 3-4. 16Ibid. 17 P. Selznick, ‘Focusing Organizational Research on Regulation’ in R. Noll (ed), Regulatory Policy and the Social Sciences (1985), 363 cited in Ogus, above n14.

Regulation in this sense is

embodied in legislative provisions, or guidelines and/or codes of practice that either wholly

or conditionally allow certain practices, or prohibit them completely. It is with these

intentional, legal, and ‘narrow’ types of regulation in the context of research involving

human embryos and cloning that this thesis is predominantly concerned. As will be shown

below, it is also the narrow form of legal regulation which is now emphasised in the United

Kingdom and Australia by policy-makers.

However, regulation of research involving human embryos historically reflected a

broader form of behavioural control, which included informal and non-state processes such

as the dictates of church authorities. It is thus important to recognise that recent debates on

regulation of research involving human embryos and cloning were preceded by centuries of

philosophical and religious thinking, and research and debate about what life is and when it

begins. The views expressed historically influenced how human embryos were treated, and

most importantly underpin the renewed debate in the late 20th and early 21st centuries

concerning whether or not, and if so how, research involving human embryos and cloning

should be legally regulated. Moral, ethical and philosophical arguments concerning human

embryos and the way in which they should be treated continue to demand sensitivity once

the decision to regulate has been made when deciding upon permissible and prohibited

activities. It is thus imperative to any consideration of the modern ‘narrow’ legal approach

to regulation of research involving human embryos and cloning, to have some

understanding of the relevant history of thinking about embryos and embryo research and

broad informal regulation via religion and community ethics.

This chapter therefore begins with an overview of some influential philosophical and

religious viewpoints from the ages concerning the beginning of life. It then discusses the

emergence of developmental biology and embryology and the views of life contained

therein. Through discussion of the subsequent advances in technology that led to the birth

of the first in vitro fertilisation (IVF) baby in 1978 it is shown that the broad ‘regulation’ of

the past moved toward the ‘narrow approach’. Increasingly authoritative rules accompanied

by a mechanism for monitoring and promoting compliance with those rules (such as the

creation of oversight bodies) were implemented in the United Kingdom and in some state

jurisdictions in Australia as reproductive technologies advanced.


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It will be shown that regulation of research involving human embryos has continued

to develop as technological advances such as stem cell research and cloning technologies

saw the potential outcomes of research involving human embryos grow. Such potential

related to both reproduction technologies and broader applications such as the treatment

of disease. The call for regulation moved away from being based only upon the moral status

of the embryo and drew upon a number of other rationales. Regulators therefore ‘stepped

in’ not to solve questions of when life begins, but rather to provide a framework within

which those wanting to conduct research involving human embryos could work. The other

rationales for regulation that became relevant to making regulatory decisions are therefore

also discussed.

This chapter provides a background to the technology and regulation of research

involving human embryos and cloning. It places the ‘modern issues’ concerning legal

regulation of research involving human embryos and cloning in their broader context of

earlier regulation by community ethics. It also ‘sets the stage’ for the evaluation of the

regulatory systems adopted in the United Kingdom and Australia in Chapters Four to Six by

introducing the principled arguments that underpin the way in which these jurisdictions

have answered the questions of what to regulate and where to draw the line between

permissible and prohibited research and practice. It is important to understand the

rationales for regulation before moving to a consideration of the boundaries that have been

drawn, the way in which regulation is occurring in the United Kingdom and Australia, and an

evaluation of whether the best regulatory strategies and enforcement approaches have

been adopted.

II. EARLY PHILOSOPHICAL, RELIGIOUS AND SCIENTIFIC VIEWS OF THE

EMBRYO AND WHEN LIFE BEGINS

A. Hippocrates

Early theorising regarding how an embryo is formed and develops may be found in

the Hippocratic treatise on The Seed and the Nature of the Child.18

In The Seed,

19 it was posited that both males and females produced sperm, and that

in order for a woman to conceive both their sperm had to come together (through

intercourse) and be retained in the woman’s womb.20

The Nature of the Child

21 addressed how the embryo was thought to breathe,

develop and be nourished. Here it was said that ‘if the seed which comes from both parents

remains in the womb of the woman, it is …mixed together… and gathers into one mass…’22

The seed was said to next acquire breath, before a membrane formed around it and flesh

began to form.23 In describing a six day old aborted embryo, the conclusion was drawn that

the embryo respired through the ‘umbilicus’ and grew because of ‘its mother’s blood which

descends to the womb [and coagulates] caus[ing] the increase of what is to become a living

thing’.24 It was said that the foetus was formed at maximum ‘for a female at forty-two

days... and for the male, in thirty days...’25

18 G.E.R. Lloyd (ed), Hippocratic Writings (1978). The Hippocratic collection of some 60 or so medical works is ascribed to various authors and was probably not written by Hippocrates himself. The treatise The Seed and The Nature of the Child, together with the work known as Diseases IV are believed to have been written by the same author. 19 Ibid, 320-321. 20 Ibid, 320. 21 Ibid, 324-346. 22 Ibid, 324. 23 Ibid, 324-325. 24 Ibid, 326. 25 Ibid, 329.

Hippocrates is said to have believed that


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conception marked the beginning of a human life, and that this was reflected by his clear

disapproval of practices that terminated life such as abortion.26

B. Aristotle

Aristotle, born in 384BC the son of a physician, was one of the most noted

philosophers and scientists of the ancient world.27 The significant influence of Aristotle on

modern thought cannot be denied, as it was he that expanded upon the Hippocratic treatise

through active observation and deduction.28 In his treatise On the Generation of Animals29

Aristotle explored and responded to pre-Socratic views that a tiny fully formed individual

(Latin: homunculus) already exists in genetic material prior to conception. That is, Aristotle

asked the question of whether the embryo always existed (that is, in some pre-formed

state), or whether it was brought into being by the reproductive process. In order to answer

such questions, some of the earliest research on animal embryos may be found.30 For

example, using hen’s eggs, Aristotle observed the progress of embryo development and

then made generalisations.31

Rejecting the idea of the homunculus,

32

26 L.Tribe, Abortion the Clash of the Absolutes (1990). 27 Otfried Hoffe, Aristotle (2003). It has in fact been said that ‘no one living before Darwin has made a contribution to our understanding of the living world as great as that made by Aristotle…[and] the history of biology needs to begin with Aristotle’: E.Mayr, Die Entwicklung der biologischen Gedankenwel (1984) 73, cited in Otfried Hoffe, Aristotle (2003), 86. 28 Ibid, 86. 29 Aristotle, On the Generation of Animals – translated by Arthur Platt (2007).

Aristotle concluded that life occurred via the

material contribution of female menstrual blood and the coming together of male and

female fluids (which enabled the form and animal to come into being). Of importance to this

discussion is that according to Aristotle life did not occur at this point, but rather the crucial

30 W. Ogle, Aristotle on the Parts of Animals (first published 1882, reprint 1912), accessed via University of Adelaide ebooks, http://ebooks.adelaide.edu.au/a/aristotle/parts/complete.html at 20 January 2006. 31 Ibid. 32 The idea that an embryo is simply a small version of an adult, with all its organs and body parts being preformed.

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factor was the point at which a human gained its soul.33 For Aristotle it was ‘ensoulment’—

which occurred at around forty days for males and at eighty days for females34—that

actualised the potential life that was materially there.35

The notion of ‘ensoulment’ was picked up by later philosophers and theologians and

viewed as the discrete event at which life began and moral status was bestowed upon an

embryo.

36 However, Aristotle’s theory in fact could be categorised as what would later be

referred to by scientists as an epigenetic approach in that his emphasis was on gradual,

emergent processes.37

C. Religious Philosophies

Similarly, many theologians and religious philosophies reflected the belief that

human life begins some time after conception. For example, according to Professor Laurie

Zoloth, Professor of Ethics and Director of the Program in Jewish Studies at San Francisco

State University, ‘central to the understanding of embryology in the Talmud,38 and

subsequent to the halachic response’ is the position that a foetus goes through a number of

stages before becoming a human being.39

33 Aristotle, On the Soul - English translation by W. S. Hett (1964), 4-5.

Jewish understanding is therefore epigenetic in

positing that although something begins at the moment of conception, this occurrence is

followed by many more significant developmental stages. In addition, whilst the Jewish faith

recognises the beginning of ‘life’ at some time after the 40th day, full moral status is not

34 Ibid. 35 Jane Maienschein, Whose View of Life: Embryos, Cloning and Stem Cells (2003) 14. 36 Ibid. 37 Hoffe, above n27, 90. 38 The Talmud being the book of religious teachings and rules followed by members of the Jewish religion. 39 Laurie Zoloth in J.L. Atkin, ‘Cellular Division’ in Science and Spirit, http://www.science-spirit.org/webextras/zoloth.html, at 20 March 2004.

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conferred on the foetus until birth.40 That is, the foetus is only considered to be a human

being when it is born and can live as a separate entity outside the womb.41 Jewish teachings

on this matter have been consistent over time. Such a view has modern day ramifications

for research involving human embryos: Zoloth has said ‘it is not murder when the 100-cell

blastocyst, created by artificial, non-coital, extracorporeal means is destroyed to recover the

inner cellular mass that will be stem cells. Rather, it is the life that, if it could be saved by

stem cells, must be saved that is of concern’.42

The Islamic view is similar in its epigenetic approach. The creation of human

individuality and foetal development are referred to ‘in several dozen verses of the Qur’an

in various contexts’,

43 and also in prophetic sayings (known as hadith). Here the embryonic

journey is seen developmentally, comprising the four stages known as the ‘Nutfah’,44

‘Alaqa’,45 ‘Mudghah’46 and the ‘Puer’.47 The Prophet Muhammad (said to be the ultimate

interpreter of the Qur’an) is reported to have said two hadiths relating to the physical

development of the embryo and the time of ensoulment.48

Verily your creation is on this wise. The constituents of one of you are collected for forty days in his mother’s womb; it becomes something that

These are:

40 This differs slightly in the rabbinical writings and also in what can be inferred from the Torah’s views on abortion. Nonetheless, all three sources appear to place this at some time after conception and/or birth: see I. Jakobovits, ‘Jewish Views on Abortion’ in D. Walbert and J. Butler (eds) Abortion Society and Law (1973), 103-121. 41 Zoloth in Atkin, above n39; Laurie Zoloth, ‘The Ethics of the Eighth Day: Jewish Bioethics and Research on Human Embryonic Stem Cells’ in S Holland, K Lebacqz and L Zoloth (eds) The Human Embryonic Stem Cell Debate: Science, Ethics, and Public Policy (2001). 42 Zoloth in Atkin, above n39 at 25 September 2004. 43 The Noble Qur’an. As-Sajdah 32, 8–9; Al-Mu’minun 23,13–14; Nuh 71,14; An-Nahl 16, 4; Al-Qiyamah 75, 37–9; At-Tariq 86, 6; Al-Mursalat 77 ,20–1; Al-Insan 76, 2; Al-Hajj 22, 5; Al-‘Alaq 96,1–2; Ghafir 40, 67; . Az-Zumer 39, 6; An-Najm 53, 45–6; Fatir 35,11; Al-‘Imran 3, 6; Al-Infitar 82, 68 as cited in S Aksoy, ‘Making regulations and drawing up legislation in Islamic countries under conditions of uncertainty, with special reference to embryonic stem cell research’ (2005) 31 Journal of Medical Ethics399, 400. 44 Nutfah: mixed drops of the male and female sexual discharge lodged in a safe lodging. 45 Alaqa: a piece of thick coagulated blood. 46 Mudgah: a little lump of flesh. 47 Puer bones clothed with flesh brought forth as another creation. 48 S Aksoy, ‘Making Regulations and Drawing up Legislation in Islamic Countries under Conditions of Uncertainty, with Special Reference to Embryonic Stem Cell Research’ (2005) 31 Journal of Medical Ethics 399, 400.

clings (alaqa) in the same (period) (mithla dhalik), then it becomes a chewed lump of flesh (mudgha) in the same (period) (mithla dhalik). And the angel is sent to him with instructions concerning four things, so the angel writes down his provision (sustenance), his death, his deeds, and whether he will be wretched or fortunate. Then the soul is breathed into him. And; After the zygote (nutfa) has been established in the womb for forty or forty five nights, the angel comes and says: ‘‘My Lord, will he be wretched or fortunate?’’ And both these things would be written. Then the angel says: ‘‘My Lord, would he be male or female?’’ And both these things are written. And his deeds and actions, his death, his livelihood; these are also recorded. Then his document of destiny is rolled and there is no addition to and subtraction from it.

According to Askoy,49 ‘there are different versions (narrations) of both hadiths with very

minor differences’. He concludes however, in accordance with ‘some ancient scholars, as

well as some contemporary researchers’ that the most accepted view is that, ‘the

completion of certain physical forms and ensoulment take place after the 40th day of

conception’.50 Askoy states, ‘from the information derived from [the] verses [in the Qua’ran]

and hadiths and on the basis of current embryological knowledge we can say that the soul

meets with body at the beginning of eight weeks’ gestation, around day 50, and forms a

‘‘full human person’’.’51 He continues, ‘according to many Muslim scholars, terminating the

life of an embryo before ensoulment is regarded as something to be disliked (makruh), while

it is considered as forbidden (haram), after this stage.’ 52 This view is confirmed when

considering Islamic legal rulings, in which ‘causing a fetus [sic] to die before forty days has

not quite been considered homicide, as it is after that time’.53

49 Dr S Aksoy, Harran University, Faculty of Medicine, Department of Medical Ethics and History of Medicine, Morfoloji Binasi, 63300 Sanliurfa, Turkey. 50 Aksoy, above n48. 51 Ibid. 52 Ibid. 53 Maienschein, above n35,14.


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According to some early Muslim doctors,54 such an account may be seen to have its

origins in the writings of the Greek physician Galen55 who taught that the embryo

developed in four stages.56 It has also been said that the ‘Nutfah’, ‘Alaqa’, ‘Mudghah’ and

the ‘Puer’ are ‘a seventh-century echo of Aristotle and the Ayer-veda’,57

Unlike Judaism and Islam, Catholic views on the beginning of life have changed over

time. Although there has never been a unanimous position put forward by the Catholic

Church, many early Catholic views on the beginning of life, (and the status that should be

accorded human embryos), emphasised the point at which a life came into existence as the

gaining of a soul or ‘fructification’. This occurred at some point after the foetus had begun

to grow.

in other words a

mixture of Greek and ancient Indian teachings. This is important as we consider how

philosophies and religions have influenced thought over time, crossing cultures and the

ages.

58 The point at which a developing embryo became a human being—known as

hominisation—was therefore delayed.59

54 Including Ibn-Qayyim & Basim Musallam, Director of the Centre of Middle Eastern Studies at the University of Cambridge who states:

“The stages of development which the Qur'an and Hadith established for believers agreed perfectly with Galen's scientific account ... There is no doubt that medieval thought appreciated this agreement between the Qur'an and Galen, for Arabic science employed the same Qur'anic terms to describe the Galenic stages”.

See B. Musallam Sex and Society in Islam. (1983), 54. 55 Claudius Galenus of Pergamum (131-201 AD), better known as ‘Galen’, was an antique Greek physician. His views dominated European medicine for over a thousand years. From 162 he lived in Rome where he wrote extensively, lectured and publicly demonstrated his knowledge of anatomy. 56 The first is that in which… ‘the form of the semen prevails’; the second, ‘when the semen is filled with blood, and heart, brain and liver are still unarticulated and unshaped’; the third…was when … ‘it is possible to see the three ruling parts clearly, … the stomach more dimly, and much more still, that of the limbs’. The fourth and final period is at ‘the stage when all the parts in the limbs have been differentiated, the object no longer being called an embryo only, but already a child, which jerks and moves as an animal now fully formed’: Phillip de Lacy (ed & translator), Galen: On Semen (1992) 1-10, 92-95, 101. 57 J. Needham A History of Embryology (2nd edition, 1959) 82.

Although penance was still required for the

intentional death of an unborn child, it was not deemed murder if a ‘child’ was killed before

58 Charles Hoole, The Didache – or Teachings of the Twelve Apostles, http://www.earlychristianwritings.com/text/didache-hoole.html at 2 April 2004. The Didache meaning ‘The Teachings of the Twelve Apostles’ was written circa 70 – 100 CE and was one of the earliest church documents. 59 Maienschein, above n35.

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the fortieth day of development.’60 This view fell out of favour with Pope Sixtus V who

declared that excommunication—the penalty designated for homicide—applied at any stage

of pregnancy.61 Whilst his successor Gregory XIV, did not accept this view,62 subsequent

successors did and by the time of Pope Pius XI, Pope Sixtus V’s view was ingrained in

Catholic teachings.63 Modern Catholic views posit that life begins at conception. In both

Gaudium et Spes64 and the Declaration on Procured Abortion65

Buddhism also reflects a discrete moment theory in its teachings that individual

human life begins at conception. Moreover, by virtue of its distinctive belief in rebirth, ‘it

regards the new embryo as the bearer of a karmic identity and therefore entitled to the

same moral respect as an adult’.

the church has declared that

life must be protected ‘from the moment of conception’ and as such embryo research is not

allowed.

66 Buddhist philosophy places great importance on the

principle of ahimsa, or non-harming, and therefore demonstrates grave reservations about

any scientific technique or procedure that involves the destruction of life, whether human

or animal. Such actions are prohibited by the First Precept of Buddhism, which prohibits

causing death or injury to living creatures.67 However, Buddhism has no central authority

competent to pronounce on these ethical dilemmas, and different sects and groups will

typically discuss and resolve such matters at a local level.68

60 John T. McNeill and Helena M. Gamer, Medieval Handbooks of Penance (1974) 119-120; Joseph F Donceel, ‘Immediate Animation and Delayed Hominization,’ Theological Studies, Vols. 1 & 2 (1970), 86-88.

61 Scott F Gilbert, DevBio: A Companion to Developmental Biology (8th Ed, 2006), Chapter 2. http://8e.devbio.com/article.php?id=162 at 8 June 2007; John L Allen Jr. ‘Under Vatican Ruling Abortion Triggers Automatic Excommunication’, National Catholic Reporter. 17 January, 2003. 62 Ibid. 63 In his encyclical Casti Connubii (Of Chaste Spouses); see Acta Apostolicae Sedis, 22:539-92. 64 Issued by the Second Vatican Council. 65 Issued by the Sacred Congregation for he Doctrine of Faith. 66 Damien Keown, Reader in Buddhism at Goldsmiths College in London, United Kingdom, and editor of the online Journal of Buddhist Ethics, http://www.science-spirit.org/webextras/keown.html at 10 April 2004. 67 Ibid. 68 Ibid.

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Non-governmental regulation of the treatment of embryos and/or foetuses—

primarily in relation to whether abortion was acceptable—therefore existed under the

various religious doctrines depending on their view of when life began and how life should

be treated. In Western culture historically, Christian religious beliefs affected formal legal

opinion on the treatment of embryos/foetuses in the context of abortion. For example,

from 1307 to 1803, abortion was not punished under English common law provided it

occurred before quickening (that is, before the foetus could be felt to move) and abortions

performed after quickening were generally considered as only misdemeanours.69 This

coincides with the Christian religious views of the time. In 1803 however, a criminal abortion

law was codified in which the abortion of a ‘quick’ foetus became a capital offence, while

abortions performed prior to quickening incurred lesser penalties.70

D. Developmental Biology and Embryology

Whilst religious philosophers continued arguing about when life begins in the

context of the abortion debate, research on embryos was not reported for almost 2000

years after Aristotle. The scientific revolution of the 16th and 17th Centuries brought new

enthusiasm for the empirical study of nature.71 During the early 16th century, anatomical

drawings of foetuses were made, including those of Leonardo Da Vinci72 (although not

published for some time) and the Italian anatomist, Andreas Vesalius.73

69 Samuel J. Behrman and Robert William Kistner, Progress in Infertility (2nd Ed. 1975), 985. 70Ibid. 71 Maienschein, above n35, 19. 72 See E. MacCurdy The Notebooks of Leonardo da Vinci. Vols 1-3 (London: Reprint Society, 1954). 73 Andreas Vesalius was the author of the first complete textbook of anatomy, De Humani Corporis Fabrica (On the Fabric of the Human Body) 1543 (held at the United States National Library of Medicine, National Institutes of Health).

However there was

no documentation of the very earliest periods of development as ‘researchers simply did

not know how to look inside the pregnant female at [the] earliest stages [of pregnancy] nor

follow the processes of development over time’.74 Maienschein notes that ‘without

knowledge of the earliest parts of the developmental process, researchers had little reason

to move beyond Aristotle’s interpretation of life’s beginning…’75

Views of embryonic development significantly changed in the latter 17th century as

studies on animal development were conducted. Specifically, in 1651, William Harvey

concluded from his research, mainly on chick eggs, that all animals came from eggs in a

manner in which complexity of form gradually appears.

76 From here and with the advent of

the microscope, interest and advances in developmental biology grew and in 1672 Marcello

Malpighi published the first microscopic account of chick development.77 Malpighi however,

took a preformation view having shown that the unincubated chick egg already had a great

deal of structure. Malpighi’s questioning of the epigenetic views of Aristotle and Harvey

reignited debate about whether the organs of the embryo are formed ‘from scratch’ at each

generation, or whether embryonic development merely required the growth of existing

structures.78 This debate was to continue until the 1820s, when ‘a combination of new

staining techniques, improved microscopes, and institutional reforms in German universities

created a revolution in descriptive embryology’.79

In 1839 Mattias Schleiden and Theodor Schwann

Embryology was born as a discrete field of

science.

80

74 Maienschein, above n35, 23. 75 Ibid. 76 William Harvey, Exercitationes de Generatione Animalium, 1651 cited in Maienschein, above n35, 23. 77 Howard B. Adelmann, Marcello Malpighi and Evolution of Embryology. Volumes 1 & 2. (1966).

each proposed what is known as

the ‘cell theory’ that all living things are made of cells. In 1855, Rudolf Virchow extended the

78 Scott F. Gilbert, Developmental Biology (6th Ed. 2000), http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=dbio.section.36 at 15 January 2005. 79 Ibid. Note particularly the work of Christian Pander, Karl Ernst von Baer, and Heinrich Rathke. 80 The former in relation to plants and the latter regarding animals.

http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=dbio.section.36�


Page 29

theory positing that all living cells come from pre-existing cells.81

• Gametogenesis—in which the germ cells (or gametes) that will produce the embryo

are formed;

This theory led to the

realisation that the embryo developed from a single cell, the zygote, which underwent many

cell divisions as the tissues and organs were formed. It is from this and continuing work in

the fields of developmental biology and embryology that science now views development as

moving through a number of stages. These include:

• Fertilisation—in which the male and female germ cells unite to form a zygote (the

zygote is complex, but undifferentiated);

• Cleavage—which occurs in the ampulla of the oviduct and involves a series of very

rapid mitotic divisions that divide the large zygote into many smaller cells. At this

stage the zygote is termed a blastocyst. The in utero development of the blastocyst

then proceeds as follows:

o By the fourth day of development, the blastocyst is free in the uterus.

o By the fifth to sixth day, the blastocyst hatches and begins implanting.

o During the next few days, the blastocyst is fully implanted and by the

thirteenth or fourteenth day, the primary stem villi as well as the primitive

streak appear.

• Gastrulation—which results in the formation of the three germ layers - ectoderm,

mesoderm, and endoderm.

81 R. Virchow, Cellular-Pathologie, Arch. Pathol. Anat. 8 (1855), 3–39, cited in Ralp Dahm, ‘Freiderich Miescher and the Discovery of DNA’ (2005) 248(2) Developmental Biology, 274.

• Organogenesis—in which the layers and tissues form organs such as the heart, brain,

liver.82

The human embryo has been defined as the developing organism between implantation

until approximately the end of the eighth week.

83 Developmental stages from this time to

birth are commonly designated as foetal.84

III. CURRENT SCIENTIFIC VIEWS ON THE BEGINNING OF LIFE

In DevBio: A companion to developmental biology,85 Scott F. Gilbert considers in

some detail the different perspectives of philosophers, religious bodies and science on when

life begins. With respect to current scientific views on the beginning of life he highlights that

there are many.86

The following table summarises the perspectives presented by Gilbert:

Table 1: Current Scientific Views on the Beginning of Life

VIEW

PERSPECTIVE

Metabolic View 1

• There is no single developmental moment marking the beginning of human life.

• As gametes (that is, sperm and egg cells) are individual units of life in the same respect

as any other single or multicellular organism, neither the union of two gametes nor

any developmental point thereafter should be designated as the beginning of new life.

Metabolic View 2

• The argument over when a new human life begins is irrelevant because the

development of a child is a smoothly continuous process.

• Marking points such as the fourteen day dividing line between a zygote and an embryo

82 Keith L. Moore & T.V.N. Persaud, The Developing Human: Clinically Oriented Embryology (7th Ed. 2003); William J Larson, Human Embryology (3rd Ed. 2001). 83 Ibid, 7. 84 Ibid, 8. 85 Gilbert, DevBio: A Companion to Developmental Biology, above n61. 86 Ibid, Ch 2.1.


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are artificial constructions of biologists and doctors in order to better categorise

development for academic purposes.

Genetic View

• Life begins at the moment a genetically unique individual is formed, that is,

fertilisation.

• NB. This view is contradicted by more recent evidence that there is no moment of

fertilisation, the process itself taking between 12-24 hours. It is also contradicted by

natural twinning, which takes place up until 14-15 days after fertilisation.

Embryological View

• Human life begins at gastrulation, the point at which the zygote is an ontological

individual and can no longer separate into twins. (This occurs at about 12-14 days).

Neurological View

• The beginning of human life begins at the time a foetus acquires a recognizable EEG

pattern (that is, brain activity can be seen). This occurs approximately 24-27 weeks

after conception. The view accords with the view that life ends when no such pattern

can be recognised.

Ecological/

technological view

• Human life begins when a foetus can exist separately from its maternal biological

environment.

It can be seen from Table 1 that even within science, there continues to be a variety of

attitudes and theories concerning human development and when human life begins. Again,

they diverge and reflect the values (scientific and/or otherwise) of the people propounding

them. It is quite logical to conclude that any such view, or combination of views, could

significantly determine what is or is not permitted in relation to embryo research and

therefore the regulatory responses to such research. However, it was not until the late 20th

and early 21st centuries that the ‘narrow’ type of regulation discussed in the introduction to

this section (that is, ‘a set of authoritative rules accompanied by a mechanism, usually a

public agency, for monitoring and promoting compliance with those rules’)87

IV. FORMAL REGULATION OF RESEARCH INVOLVING HUMAN EMBRYOS

was adopted in

relation to research involving human embryos rather than the moral/religious based

regulation that existed previously.

A. Assisted Reproductive Technologies: Beyond the Moral Status of

the Embryo

At the end of the 19th century, the possibility of culturing oocytes was recognised,

but it was not until the 1930s that studies using animal models began to be published.88

These studies formed the basis for subsequent experimental research and advances in the

field of assisted reproduction.89 The first human pregnancy resulting from in vitro

fertilisation (IVF) occurred in Victoria, Australia in 1973.90 Then in 1978, in the United

Kingdom, the first full-term IVF pregnancy was achieved, and a child was born.91

B. United Kingdom

The

emergence of these technologies led to the concurrent development of regulatory regimes

as debate about the moral, ethical and legal use of human embryos was re-ignited.

In 1982 the UK Government set up the Committee of Inquiry into Human

Fertilisation and Embryology, under the chairmanship of philosopher, Dame Mary Warnock

87Ibid, 3-4. 88For example see: G. Pincus and E V Enzmann. ‘The Growth, Maturation and Atresia of Ovarian Eggs in the Rabbit’ (1937) Journal of Morphology, 351-383; R. Yanaginachi and M C Chang, ‘Fertilization of Hamster Eggs in Vitro’ (1963) Nature 281-282. 89 For example see: R G Edwards, ‘Maturation In Vitro of Human Ovarian Oocytes’ (1965) 2 Lancet, 926-929; R G Edwards, RP Donahue, TA Baranki and HW Jones, ‘Preliminary Attempts to Fertilise Oocytes Matured inVitro’ (1966) 96 American Journal of Obstetrics and Gynaecology 192-200. 90 Monash IVF, Fertility Update, December 2003. 91 P.C. Steptoe and R.G. Edwards, ‘Birth After Reimplantation of Human Embryo’, 2 Lancet 366.


Page 33

(The Warnock Committee). Scientists and health professionals dominated the fifteen-

member committee, (although only one - Professor Malcolm MacNaughton - had

professional involvement in assisted reproduction).92

to consider recent and potential developments in medicine and science related to human fertilization and embryology; to consider what policies and safeguards should be applied, including consideration of the social, ethical and legal implications of their developments; and to make recommendations.

The Committee's terms of reference

were:

93

The Warnock Committee published its report (The Warnock Report) in July 1984.

94

The question was not…whether the embryo was alive and human, or whether if implanted, it might eventually become a full human being. We concluded that all these things were true. We nevertheless argued that, in practical terms, a collection of four or sixteen cells was so different from a full human being, from a new human baby or a fully formed human foetus, that it might legitimately be treated differently.

It

recommended new legislation setting out legal limits on assisted reproduction and research

involving human embryos and the setting up of a licensing authority. Of note is the majority

view expressed in the report that:

95

Specifically the majority of the Warnock Committee took the view that although a human

embryo had a special status entitling it to ‘some protection in the law’, it still might be used

(at its very earliest stages of development) as a means to an end that was good for other

humans.

96

92 Warnock, above n

There was strong support from the majority for the use of unused human

embryos from IVF in research, and a slim majority favoured the generation of embryos for

research purposes in extraordinary circumstances. This illustrates a shift away from the

centuries of debate about when life began and what was acceptable in terms of treatment

of human embryos based on this ‘yard-stick’, to a recognition that viewing an embryo as a

5, iv-v. 93 Ibid 4. 94 Ibid. 95 Ibid, xv. 96 Ibid.

life did not necessarily preclude its use in experimentation. Similarly, there was movement

in the values that underpinned modern regulation of research involving human embryos. It

became acceptable to treat a human embryo differently (albeit with respect) and use it for

research in order to serve another socially desirable outcome—specifically encouraging the

potential of science to develop ways to assist those who were unable to have children.

With this shift in attitude came a cautiousness that led to systems of regulation that

demanded research involving human embryos was not conducted without oversight. The

Warnock Committee thus also recommended the establishment of a government licensing

authority to oversee both clinical IVF and research involving human embryos. The

objectives of a stricter regulatory regime were not to prevent research involving human

embryos, but rather to allow it within certain parameters including those that satisfied the

call for some level of ‘respect’.

In March 1985, the Medical Research Council and Royal College of Obstetricians and

Gynaecologists founded the Voluntary Licensing Authority for Human in vitro Fertilisation

and Embryology (VLA) (an interim body established as a result of the view that the setting

up of a statutory body would take some time).97 The VLA carried out the licence inspections

and issued licences to centres based on written applications to the VLA describing the

particulars of the treatment services or research on embryos that such centres wished to

undertake or were already providing. There followed a green paper in 1986, a white paper

in 198798 and finally a bill in November 1989.99

Six years after the Warnock report, virtually all of the Warnock Committee's

recommendations were translated into the Human Fertilisation and Embryology Act 1990

97 The United Kingdom Parliament, Select Committee on Science and Technology: Fifth Report 2005. 98 Department of Health and Social Security (UK), Human Fertilisation and Embryology: A Framework for Legislation (1987) (Cm 259). 99 Human Fertilisation and Embryology Bill 1989 (UK).


Page 35

(UK) (the HFE Act). The Bill received Royal Assent on 1 November 1990, and the Human

Fertilisation and Embryology Authority (HFEA) was established.100

the granting of licences ‘authorising activities in the course of providing

treatment services’;

While the HFE Act

contained a number of prohibitions on the uses of human embryos, it gave wide powers of

interpretation to the HFEA. The HFE Act sets out the duties of the HFEA, including:

101

the requirement that the Authority maintain ‘a code of practice giving guidance

about the proper conduct of activities carried out in pursuance of a licence’;

102

the requirement that they maintain a register of those receiving treatment and

born as a result of treatment.

and

103

From 1991 to the present, official licensing authorities have reviewed all research involving

human embryos proposals in the United Kingdom. They have also kept detailed records on

the number of embryos used in research and published annual reports on approved

projects.

104

100 The Human Fertilisation and Embryology Authority took up its full statutory responsibilities in August 1991. Human Fertilisation and Embryology Act 1990 (UK) s5. 101 ‘Treatment services’ are defined as ‘medical, surgical or obstetric services provided to the public or a section of the public for the purpose of assisting women to carry children’: Human Fertilisation and Embryology Act 1990 (UK) s2. A licence regarding the provision of treatment services may authorise: the creation of embryos in vitro, keeping embryos, using gametes, practices designed to ensure that embryos are in a suitable condition, placing any embryo in a woman, and such other practices as are permitted under the regulations: para 1 sch 2. 102 Human Fertilisation and Embryology Act 1990 (UK) s25(1). 103 Human Fertilisation and Embryology Act 1990 (UK) s31.

Whilst there have been a number of revisions and legal challenges to the HFE

Act since its inception (see examples in Appendices 2 and 3) the approach taken in the UK

has been permissive and facilitative, allowing researchers to use human embryos subject to

licensing conditions. In January 2001, regulations adopted by the British Parliament

expanded the list of permissible goals for research involving human embryos and, explicitly

104 See Human Fertilisation and Embryology Website: http://212.49.193.187/cps/rde/xchg/SID-3F57D79B-907F604D/hfea/hs.xsl/421.html at 1 April 2009.

http://212.49.193.187/cps/rde/xchg/SID-3F57D79B-907F604D/hfea/hs.xsl/421.html�


gave permission for the creation of human embryos for research by means of nuclear

transfer, and in 2008 revisions to the HFE Act furthered permissible activities. The specifics

of the regulatory system in relation to research involving human embryos, cloning and other

research activities are further discussed in Chapter Four.

C. Australia

The position differed in Australia to that of the United Kingdom due to Australia

being a federation105 in which the Commonwealth has power to regulate only on certain

matters set out in the Australian constitution.106 Other regulatory powers fall to the

individual states. As such it was not (and remains not) within the legislative power of the

Commonwealth of Australia to legislate directly on the subject of assisted reproductive

technology (ART).107 Each state and territory is responsible for designing and implementing

its own regulatory regime if it chooses to do so. Some appointed a specialist committee

and/or commissioned an official inquiry into the use of reproductive technologies108

105 A federation is a state comprised of a number of self-governing regions (‘states’ or ‘territories’) united by a central (‘federal’) government. In a federation, the self-governing status of the component states is constitutionally entrenched and may not be altered by a unilateral decision of the central government. 106 Australian Constitution, ss51-52. 107 Noting that the states can choose to refer power to the Commonwealth. 108 D Chalmers, Final Report: Committee to Investigate Artificial Conception and Related Matters (Hobart, June, 1985); Committee to Consider the Social, Ethical and Legal Issues Arising from In Vitro Fertilization (Waller Committee) Report on Donor Gametes in IVF (advance copy, Victoria, August 1983); Committee to Consider the Social, Ethical and Legal Issues Arising from In Vitro Fertilization (Waller Committee) Report on the Disposition of Embryos Produced by In Vitro Fertilization (Vic Govt Printer, August 1984); A.F. Connor and P. Kelly, Report of the Working Party on In Vitro Fertilization and Artificial Insemination by Donor (South Australia, January 1984); J. Demack, Report of the Special Committee Appointed by the Queensland Government to Enquire into the Laws Relating to Artificial Insemination, In Vitro Fertilization and Other Related Matters (Queensland, March 1984); Medical Research Ethics Committee, Embryo Donation by Uterine Flushing. Interim report on Ethical Considerations (Canberra, ACT, NHMRC, 1985); New South Wales Advisory Committee on Human Artificial Insemination, Australian Attitudes to Human Artificial Insemination, prepared by G Rawson (NSW Govt Printer, 1984); New South Wales Law Reform Commission, Human Artificial Insemination (Discussion paper 11, NSW Govt Printer, 1984); WA Parliamentary Committee, Report of the Committee Appointed by the Western Australian Government to Enquire into the Social, Legal and Ethical Issues Relating to In Vitro Fertilisation and its Supervision (Perth, WA, 1986).

whilst


Page 37

the federal government considered overarching guidelines.109 Only three states—Victoria,

Western Australia and South Australia developed legislation that governed research

involving human embryos.110 Some of the states preferred regulation by non-legislative

guidelines.111

Victoria was the first common law jurisdiction in the world to pass laws regulating

reproductive technologies.

112 Similar to the United Kingdom, a committee was established

in 1982 to conduct an inquiry into the wide-ranging implications (social, ethical and legal) of

the new technology of IVF in the state of Victoria.113 Headed by Professor Louis Waller, the

then Victorian Law Reform Commissioner, the ‘Waller Committee’ produced three

reports.114 In the third report the Waller Committee recommended that a standing review

and advisory body should evaluate all proposed embryo research.115

Victoria was quick to enact legislation, and in 1984, the Victorian Government

passed the Infertility (Medical Procedures) Act. Under this Act a Standing Review and

Advisory Committee on Infertility (SRACI) was established, its major functions being ‘to

109 National Health and Medical Research Council (NHMRC), Statement on Human Embryo Experimentation (Canberra, ACT, NHMRC 1982); National Health and Medical Research Council (NHMRC), Ethics in Medical Research Involving the Human Foetus and Human Foetal Tissue (Canberra, ACT, NHMRC 1983). 110 Infertility Treatment Act 1995 (Vic), amended by Health Legislation (Research Involving Human Embryos and Prohibition of Human Cloning) Act 2003; Reproductive Technology (Clinical Practices) Act 1988 (SA), amended by Research Involving Human Embryos Act 2003 (SA); Human Reproductive Technology Act 1991 (WA), amended by Human Reproductive Technology Amendment Act 2004. NB Whilst there is no specific reproductive technology legislation in the Northern Territory, reproductive medicine services in the territory are provided by South Australian clinicians operating under guidelines consistent with the South Australian legislation. 111 NHMRC, National Statement on Ethical Conduct in Research Involving Humans (1999) and NHMRC, Ethical Guidelines on Assisted Reproductive Technology (1996). 112 Helen Szoke, Social Regulation, Reproductive Technology and Public Interest. Policy and Process in Pioneering Jurisditions (Phd Thesis, University of Melbourne, 2004), 2. 113 Committee to Consider the Social, Ethical and Legal Issues Arising from In Vitro Fertilization, Report on the Disposition of Embryos Produced by In Vitro Fertilization, above n108. 114 Committee to Consider the Social, Ethical and Legal Issues Arising from In Vitro Fertilization, Interim Report (1982); Committee to Consider the Social, Ethical and Legal Issues Arising from In Vitro Fertilization, Report on Donor Gametes in IVF, above n108; Committee to Consider the Social, Ethical and Legal Issues Arising from In Vitro Fertilization, Report on the Disposition of Embryos Produced by In Vitro Fertilization above n108. 115 Committee to Consider the Social, Ethical and Legal Issues Arising from In Vitro Fertilization (Waller Committee) Report on the Disposition of Embryos Produced by In Vitro Fertilization, above n108.

consider, and if appropriate, approve proposals for experiments on embryos, and to advise

the Minister for Health in relation to infertility and on procedures for its alleviation’.116

Similar oversight and licensing systems were adopted in South Australia and Western

Australia. The South Australian Council on Reproductive Technology was established under

the Reproductive Technology (Clinical Practices) Act 1988 (SA). The Act empowered the

Council to formulate a code of ethical practice to govern the use of artificial fertilisation

procedures.

This

Act was later repealed by the Infertility Treatment Act 1995 (Vic). The Infertility Treatment

Act 1995 (Vic), continued to regulate research by providing that only licensed persons who

met certain criteria could conduct research. The Act also replaced SRACI by establishing the

Infertility Treatment Authority (ITA), which became the licensing and oversight body in

Victoria.

117

The Victorian, South Australian and Western Australian legislation stipulated who

may receive treatment, and rules about the use of human embryos for research. Each

imposed strict limitations on research involving human embryos, prohibiting any research

that would destroy a human embryo.

The Human Reproductive Technology Act 1991 (WA) established the Western

Australian Reproductive Technology Council.

118 Such prohibitions reflected the principle that

human embryos (even if not human beings) should be accorded respect.119

116 Standing Review and Advisory Committee on Infertility, Annual Report 1996 (1996) 39. 117 ‘Artificial fertilisation procedure’ means any medical procedure directed at fertilisation of a human ovum by artificial means and includes an in-vitro fertilisation procedure: Reproductive Technology (Clinical Practices) Act 1988 (SA) s3. The code is set out as a schedule to the Reproductive Technology (Code of Ethical Clinical Practice) Regulations 1995 (SA). 118 Sonia Magri, ‘Research Involving Human Embryos and Cloning: Difficulties of Legislating in a Changing Environment and Model Approaches to Regulation’ (2005) 12(4) Journal of Law and Medicine 483, 486. 119 House of Representatives Standing Committee on Legal and Constitutional Affairs, Human Cloning: Scientific, Ethical and Regulatory Aspects of Human Cloning and Stem Cell Research (August 2001) at [8.42].

However the

scope of restriction varied from state to state, depending on the definition of embryo in the


Page 39

respective Acts.120 For example, the Victorian Act defined an ‘embryo’ as ‘any stage of

human embryonic development at and from syngamy’,121 whilst Western Australia defined

‘embryo’ as ‘a live human embryo, in the stage of development which occurs from the

completion of the fertilisation of the egg; or the initiation of parthenogenesis, to the time

when [seven] completed weeks of the development have occurred’.122 Such differences in

definition meant that within the same country, the boundaries of when, and what kind of,

research was permissible depended upon where in Australia, the research was to be

conducted.123

New South Wales, Queensland, Tasmania and the Australian Capital Territory did not

enact legislation. Rather, they opted to follow federal government guidelines published by

the National Health and Medical Research Council (NHMRC).

124 In October 1982 the NHMRC

issued guidelines on the ethical aspects of research related to the use of assisted

reproductive technology (ART), in vitro fertilisation and embryo transfer as a supplementary

note to the NHMRC Statement on Human Experimentation. In 1993 the Australian Health

Ethics Committee (AHEC) commenced a review of these guidelines, leading to the release in

June 1996 of Ethical Guidelines on Assisted Reproductive Technology.125

120 Ibid, [8.17]-[8.36], [8.41]-[8.67]. 121 Infertility Treatment Act 1995 (Vic), amended by amended by Health Legislation (Research Involving Human Embryos and Prohibition of Human Cloning) Act 2003, s3. 122 Human Reproductive Technology Act 1991 (WA) s 3, amended by Human Reproductive Technology Amendment Act 2004, s3. 123 Magri, above n118, 486.

The Guidelines

described a range of prohibited or unacceptable practices. On the issue of research

124 The National Health and Medical Research Council (NHMRC) is ‘Australia's peak body for supporting health and medical research; for developing health advice for the Australian community, health professionals and governments; and for providing advice on ethical behaviour in health care and in the conduct of health and medical research.’ See http://www.nhmrc.gov.au/ at 1 April 2009. 125 National Health and Medical Research Council, Ethical Guidelines on Assisted Reproductive Technology (1996). The Australian Health Ethics Committee rescinded the 1996 NHMRC Ethical Guidelines on Assisted Reproductive Technology in 2004. Reference to this document is included here for historical purposes.

http://www.nhmrc.gov.au/�

involving excess126 ART embryos the Guidelines allowed the use of excess ART embryos for

research that may damage or destroy the embryo, under exceptional circumstances.127 In

releasing these guidelines, AHEC identified the need for all States and Territories to

introduce comprehensive ART legislation and recommended to the Commonwealth Minister

for Health that ART legislation be enacted in those States and Territories that had not

introduced such legislation.128

The position regarding all states and territories was altered in 2002 when the federal

government introduced legislation governing research involving human embryos and

cloning.

129 The Research Involving Human Embryos Act 2002 (the RIHE Act) and the

Prohibition of Human Cloning Act 2002 (the PHC Act) received Royal Assent on 22 December

2003, with a majority of provisions coming into force on the 16 January 2003.130 States and

Territories enacted empowering or mirror legislation in order to give full effect to the

Commonwealth legislation countrywide.131

126 That is embryos ‘excess’ to the needs of the people for whom they were created during assisted reproductive treatments. 127 John Seymour and Sonia Magri, ART, Surrogacy and Legal Parentage: A Comparative Legislative Review (Victorian Law Reform Commission, 2004). 128 In 2007 NSW enacted the Assisted Reproductive Technology Act 2007 (NSW). This Act regulates certain things relating to the provision of Assisted Reproductive services, including identification and record keeping of donors of gametes for ART, surrogacy, and use of gametes. (It does not regulate research involving human embryos or cloning, and does not set up a similar licensing authority for ART to that in Victoria, S.A. or W.A). 129 Research Involving Human Embryos Act 2002 (Cth); Prohibition on Human Cloning and other Prohibited Practices Act 2002 (Cth). 130 Research Involving Human Embryos Act 2002 (Cth), s2; Prohibition on Human Cloning Act 2002 (Cth), s2. 131 Research Involving Human Embryos (New South Wales) Act 2003; Prohibition on Human Cloning and other Prohibited Practices (New South Wales) Act 2003; Health Legislation (Research involving human embryos and prohibition of cloning) Act 2003 (Victoria); Research Involving Human Embryos Act 2003 (South Australia); Prohibition of human cloning Act 2003 (South Australia); Human Embryonic Research Regulation Act 2003 (Tas); Human Cloning and Other Prohibited Practices Act 2003 (Tas); Research Involving Human Embryos and Prohibition of Human Cloning Act 2003 (Qld); Human Reproductive Technology Amendment Act 2004 (WA); Human Embryo (Research) Act 2004 (ACT); Human Cloning (Prohibition) Act 2004 (ACT); the Northern Territory follows South Australian legislation.

This was necessary as the Commonwealth

legislation was susceptible to constitutional challenge if individuals were prosecuted for an


Page 41

offence and the legislation could not govern state government organisations and non-

trading corporations.132

The NHMRC Guidelines were also reviewed in 2004.

133

[w]hile there are different views in our community about the moral status of a human embryo, one that is very widely shared is that embryos are not to be treated as mere tissue. Research involving human embryos must comply with the guidelines and with the Research Involving Human Embryos Act 2002 (RIHE Act), which was passed by the Australian Parliament in 2002 to limit research involving human embryos to specific situations. Under this legislation, any research, training or quality assurance activities using excess assisted reproductive technology (ART) embryos require a licence…

The new guidelines stated:

134

132 The mirrored legislation in each state/territory served the purpose of ensuring regulation governed not only those over whom the Commonwealth has power to regulate (pursuant to the Australian Constitution, s51-52) but also individuals, state government organisations and non—trading corporations which fall under the auspices of individual state/territory powers. For further discussion of this point see below, Chapter Four. 133 National Health and Medical Research Council (NHMRC), Ethical Guidelines on the use of Assisted Reproductive Technology in Clinical Practice and Research, 2004. 134 Ibid, 45.

Moral views about research involving human embryos were recognised. However, the

NHMRC Guidelines took the position that it was impossible to reflect all such views in the

regulation of research involving human embryos. Rather they adopted the ‘widely shared’

position that embryos were to be treated differently to ‘mere’ tissue.

Significantly, a marked change in the regulation of research involving human

embryos may be seen in that it was increasingly falling under narrower and more formal

forms of regulatory responses. That is, increasingly authoritative rules accompanied by a

mechanism for monitoring and promoting compliance with those rules, such as the creation

of oversight bodies, were being implemented. The impetus to these changes occurred as

further technological advances meant that the potential for research involving human

embryos grew both in relation to reproduction technologies and to research that had

broader applications.

V. REPRODUCTIVE CLONING

In February 1997, another breakthrough in the world of reproductive medicine was

announced: the cloning of Dolly the sheep.135 The technique that allowed the reproduction

of a sheep without fertilisation of an egg with sperm—somatic cell nuclear transfer (SCNT)

(also referred to as cell nuclear replacement)136—required the nucleus from the somatic cell

of one sheep to be fused with an enucleated egg cell of another. The cell that resulted was

then implanted into the uterus of a ‘mother’, where it multiplied and grew into Dolly the

sheep. Dolly was a ‘clone’ of the sheep from which the cell nucleus was taken. Whilst, in

fact, the researchers involved in this cloning were trying to produce a genetically uniform

line of farm animals that might have some future use as living ‘factories’ for pharmaceutical

products,137

135 Ian Wilmut, et al. ‘Viable Offspring Derived from Fetal and Adult Mammalian Cells’ (1997) Nature 385, 810-813. 136 This term is particularly used in the United Kingdom. Within this document I have used ‘CNR’ when discussing direct findings of United Kingdom authorities and/or views expressed toward research in that country. 137 Ibid.

the implications of Dolly for human reproduction were clear – many asked how

long it would be before human cloning took place. This coupled with breakthroughs in stem

cell research (discussed below) reignited ethical, social, philosophical and legal debate and

opened the way to further regulation. In particular it reaffirmed the call for uniform

legislation—at least in relation to research involving human embryos and cloning

technologies. Similarly advances in ‘stem cell research’ influenced the debate and impacted

upon later regulatory responses.


Page 43

VI. STEM CELL RESEARCH

In November 1998, James Thomson and his team of researchers at the University of

Wisconsin announced they had produced human embryonic stem (ES) cell lines.138 As yet

undifferentiated, but with the potential to differentiate into almost any body tissue (that is,

‘pluripotent’), and able to reproduce indefinitely in culture, they promised to revolutionise

medicine. Research on stem cells offered the potential to aid in the understanding, and

ultimate prevention, of cell abnormalities (and related diseases) by enabling the

investigation of cell development.139 It also offered the potential for a more effective way of

testing drugs.140 Most heralded however, was its potential to lead to the creation of a

renewable source of replacement cells and/or tissue, which would enable the treatment of

a myriad of diseases, conditions, and disabilities.141 The significance of such research was

unquestionable despite the observation of the Australian National Health and Medical

Research Council (NHMRC) that ‘further basic research [was] required to clarify its

potential.’142

In order to produce the pluripotent ES cell lines, the process implemented by

Thomson and his team involved the destruction of human embryos gathered from those

138 James A Thomson, Joseph Itskovitz-Eldor, Sander S Shapiro, Michelle A Waknitz, Jennifer J Swiergiel, Vivienne S Marshall, and Jeffrey M Jones, ‘Embryonic Stem Cell Lines Derived from Human Blastocysts’ (1998) 282 Science 1145-1147. Such research took place in the United States and was legal. 139 National Institutes of General Medical Sciences, ‘Workshop on the Basic Biology of Mammalian Stem Cells’, 9-10 June 2002, Maryland, < http://www.nigms.nih.gov/news/reports/stemcellworkshop.html> at 11 October 2005. 140 Drugs could first be tested on cell lines and only those found to be safe and appearing to have beneficial effects would graduate to further laboratory testing on animals and human subjects. 141 Dr. Allen Spiegel and Dr. Gerald Fischbach, ‘Testimony on the Promise of Human Pluripotent Stem Cell Research’ before the United States Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies, April 26, 2000 <http://www.hhs.gov/asl/testify/t000426a.html> at 10 October 2002. In this testimony stem cell research was heralded as having the potential to one day treat diseases and/or injuries ranging from Parkinson’s and Alzheimer’s diseases, Motor Neurone Disease, heart disease, diabetes, osteoarthritis, rheumatoid arthritis to spinal cord injury, stroke and/or burns. 142 National Health & Medical Research Council: Stem Cells Derived from Human Embryos (29 August 2002) at http://www.nhmrc.gov.au/issues/stem_cell.htm at 15 September 2004.

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deemed ‘surplus’ (or ‘excess’) to the needs of people undergoing assisted reproductive

treatment.143 This was highly controversial. Some argued that an embryo is a person or a

potential person, and therefore deserves the same protection from harm as that given to

human subjects in general.144 Others argued that as fertility clinics only stored excess

embryos for a limited time before their inevitable destruction, there was nothing wrong

with using those ‘surplus embryos’ for developing new stem cell lines that could be used for

research that may be of value—directly or indirectly—in the treatment of human disease

and ailments.145

VII. THE USE OF CLONING TECHNOLOGY IN STEM CELL RESEARCH

In addition to the above controversy, it soon became apparent that human embryos

created via the cloning techniques used to create Dolly the sheep, might also be a source of

embryonic stem cells.146 A distinction was made between ‘reproductive’ cloning, (that is,

cloning to create a whole organism), and ‘therapeutic’ cloning, (that is, cloning for the

purposes of finding therapies for the human race.)147

143 Thomson et al, above n138, 1145-1147.

Whilst both forms of cloning involve

the creation of an embryo using SCNT, in ‘therapeutic’ cloning the transplantation of the

embryo into a uterus would not occur. (Note: The term ‘therapeutic cloning’ has since fallen

out of favour. In this thesis I refer to SCNT and specify whether the creation of an embryo

via SCNT is for research or reproductive purposes where necessary).

144 See for example Submissions 667, 868, 1003, 1036 to the Senate Community Affairs Committee, Inquiry into Research Involving Human Embryos and Prohibition of Human Cloning Bill 2002 (2002). (Available at http://www.aph.gov.au/SENATE/COMMITTEE/clac_ctte/completed_inquiries/2002-04/emb_cloning/submissions/sublist.htm at 1 April 2009). 145 Ms Royles, Coalition for the Advancement of Medical Research in ‘Community Affairs Legislation Committee: Research Involving Embryos and Prohibition of Human Cloning Bill 2002: Discussion’, < http://search.aph.gov.au/search/ParlInfo.ASP?action=view&item=102&resultsID=ZAULe> at 17 September 2002. 146 The Royal Society (UK) Stem Cell Research and Therapeutic Cloning: An Update No.4 (Nov. 2000), < http://www.royalsoc.ac.uk/templates/statements/StatementDetails.cfm?statementid=123> at 10 October 2002. 147 This differs from previous views and definitions of ‘therapeutic’ treatment of embryos in which the benefit is derived for the embryo and not (as in this case) for the benefit of another.

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Some argued that SCNT is acceptable arguing for example, that an embryo created

outside of the human body has no potential for growth into a human unless implanted and

as such should be viewed differently to embryos in utero. Others saw the creation of human

embryos specifically so that they may be destroyed as even more controversial than the use

of excess ART embryos already in existence.148 This was coupled with the fear that creating

embryos using SCNT for stem cell research was just a step closer to cloning human

beings.149

VIII. A SHIFT IN THE REGULATION DEBATE: REGULATING ALL RESEARCH

INVOLVING HUMAN EMBRYOS AND CLONING

A. Old Debate, New Issues

In light of such emerging technologies, further debate on research involving human

embryos, which now also included the new technologies of cloning and embryonic stem cell

research, ensued. Such debate again reflected the history of thoughts, arguments and

beliefs about the beginning of life and moral status of the human embryo. It included

consideration of the regulatory responses to research aimed initially at understanding life

itself and later at assisting in the formation of embryos for reproductive technologies.

However, whilst a clear progression can be seen from philosophical and religious viewpoints

of early times and scientific theories concerning the beginning of life, to the regulation of

new sciences relating to reproductive technology, and concerns about research involving

human embryos and cloning generally, new issues were also relevant. For example, whether

it was acceptable to use research involving human embryos as a means to investigate

and/or develop potential treatments, or cures, for illnesses suffered by other living humans;

148 For further discussion of both sides of the debate see for example House of Representatives Standing Committee on Legal and Constitutional Affairs, above n119. 149 Ibid.

whether just because technology exists it should be used (for example, reproductive

cloning); the potential applications of such research and its related economic benefits to the

countries in which the research was taking place; and the political and/or economic

consequences of allowing or denying such research.150

B. Further Rationales for Regulation

As with earlier debates on the moral status of the human embryo, the current debates

proved no consensus could be reached concerning the ‘beginning of life’ or the value to be

placed on a human embryo. Rather regulators ‘stepped in’, not to solve questions of when

life begins, but rather to provide a framework within which those wanting to conduct

research could work whilst striking an arguable balance between opposing views. The

regulatory models adopted in the United Kingdom and Australia are discussed in detail in

Chapter Four, but first it must be recognised that the regulatory responses to these new

issues illustrate that decisions were motivated by numerous other rationales in addition to

the moral and ethical dilemmas discussed.

Regulation can be politically or economically motivated or technically justified,151 and ‘in

any one sector or industry the case for regulating may well be based…on a combination of

rationales’.152 Such further rationales cannot be ignored in the context of research involving

human embryos and cloning. Baldwin and Cave set out twelve potential rationales for

regulating in the context of market environments,153

150 Ibid. 151 Robert Baldwin and Martin Cave, Understanding Regulation: Theory, Strategy and Practice (1999), 9. 152 Ibid, 16.

some of which suit the context of

science.

153 Monopolies and natural monopolies, windfall profits, externalities, information inadequacies, continuity and availability of services, anti-competitive and behaviour predatory pricing, public goods and moral hazard,


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The first, an ‘information inadequacies’ justification, relates to the public demand to

be informed about general research practice, and any hazards or deficiencies associated

therewith. Just as ‘competitive markets can only function properly if consumers are

sufficiently well informed to evaluate competing products’,154

For example, such risks include the potential for exploitation of ‘excess’ human

embryos left over from assisted reproductive treatments for research purposes. That is, if

there are no control mechanisms or consent requirements human embryos that are

considered excess to the needs of those persons undergoing assisted reproduction might be

used unnecessarily for research purposes or not treated with the level of respect that

society deems suitable.

the information inadequacies

justification is relevant in other contexts, including science. The public are concerned with

what is permissible in society and as possible consumers of the end products of scientific

research they demand to be informed about potential risks, research practices, reliability

and validity of studies, outcomes of any trials, and any other significant issues that might

arise.

The need for information is particularly relevant in the context of research involving

human embryos and cloning. As discussed above, there has throughout the ages been a

concern about the moral status of the human embryo, how they are to be perceived and

what should or should not be permitted in relation to research involving human embryos

and/or treatment. In addition, there are other perceived risks associated with research

involving human embryos and cloning (for the creation of embryos for research and/or for

reproduction) about which the public might wish to, and arguably should, be informed.

unequal bargaining power, scarcity and rationing, distributive justice and social policy, rationalisation and coordination, and planning. 154 F.Hayek, ‘The Use of Knowledge in Society’ (1945) 35 American Economic Review 519; S. Breyer Regulation and its Reform (1982); and Ogus, above n14 cited in Baldwin and Cave, above n151, 12.

There are also risks associated with collecting ova from women for somatic cell

nuclear transfer which include but are not limited to risks to their health.155 For example,

because many eggs are needed for cloning attempts, women could be subject to health risks

associated with high levels of hormones used to stimulate egg production. Egg donation also

involves surgery which has its own inherent risks.156 Risks concerning commodification,

deception, coercion, and exploitation also exist,157

Another risk is the use of animal ova as a substitute for human ova in somatic cell

nuclear transfer

as do risks associated with the difficulties

or impossibility in obtaining fully informed consent where critical information is lacking

concerning the extent of the possible health risks to women.

158 in which the resultant ‘human’ embryo would contain traces of animal

DNA , albeit argued to be small (approximately 0.01%).159

In relation to human reproductive cloning, risks to women, foetus and the newborn

need also be recognised noting that data from experiments which have used sheep, cattle,

pigs, goats, and mice ‘clearly illustrate the problems involved and are quite compelling’.

160

Very few cloning attempts are successful, many clones die in utero (including up to the late

stages of pregnancy) or soon after birth, and those that have survived have frequently

exhibited severe birth defects.161

155 Donna Dickenson and Itziar Alkortar Idiakez, ‘Ova Donation for Stem Cell Research: An International Perspective’, 1(2) International Journal of Feminist Approaches to Bioethics 125. 156 National Research Council (US), Scientific and Medical Aspects of Human Reproductive Cloning (2003). 157 Dickenson and Alkortar Idiakez, above n155.

In addition, female animals carrying cloned foetuses have

158 Two research teams in the United Kingdom (The University of Newcastle and Kings College, London) are currently licensed to utilise this technique. On 1 April 2008 the team at Newcastle University announced via media release that it had successfully generated ‘admixed embryos’ by adding human DNA to empty cow eggs in the first experiment of its kind in Britain. Such results are yet to be published in a peer-reviewed journal. See Mark Henderson, ‘We have Created Human-Animal Embryos Already’, The Times, April 2 2008 (also at http://www.timesonline.co.uk/tol/life_and_style/health/article3663033.ece at 11 October 2008). 159 Mitochondrial DNA remains in the egg used and therefore the resulting embryo, although containing the majority of human DNA in the nucleus, is not absent of other (that is, animal) genetic material. 160 National Research Council (US), above n156. 161 Ibid.

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been found to face serious risks, including death from cloning-related complications.162 It

has been said that ‘human reproductive cloning is likely to have similar negative

outcomes’.163

There is also a need to be mindful of associated or potential risks and hazards

concerning the end products (treatments, therapeutic goods, pharmaceuticals) of such

research. For example, early research using embryonic stem cell lines as potential

treatments for diseases indicated that the inability to control pluripotent cell production

might lead to cancer, and more recent research using adult stem cell reprogramming still

carried with it some concern that the insertion of viruses and outside genes could change

the way a cell's native genes behave, turning on a harmful process or turning off a beneficial

one.

164

The next rationale for regulation is that it may be required to encourage the

production of ‘public goods’. For example, the commodities of science may bring shared

benefits and be generally desired. However, such encouragement must arguably be

Such hazards and risks may over time be reduced or eliminated by further research

and/or alternative methods, and new hazards and risks might become apparent. As such,

the public need to be informed not only about what is or is not permitted, for example the

extent to which research involving human embryos is allowed or that there are bans on

reproductive cloning, but also about the progress of the research and the end products that

result. Only then can the public form proper opinions in relation to such technology and

make informed decisions about whether they agree with research and whether they will

accept any potential treatments and products that may result from research in the future.

162 Ibid. 163 Ibid. 164 Nikhil Swaminathan, ‘Stem Cells-This Time without Cancer’, Scientific American, 30 November 2007, http://www.sciam.com/article.cfm?id=stem-cells-without-cancer at 11 October 2008.

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balanced with the ‘moral hazards’ presented by the research, for example by placing

constraints on exploitative or controversial research.165

These rationales are important in the context of research involving human embryos

and cloning. They are considered again in Chapter Four in relation to whether the United

Kingdom and Australian regulatory systems meet such objectives, and in Chapter Seven

when considering how to achieve better regulation in this area of science. The following

The above description of some of

the potential hazards and risks associated with research involving human embryos and

cloning and the promise of therapeutic treatments for a myriad of diseases is again relevant

here. That is, it is clear that regulation in this field needs not only to inform the public of

what is occurring in relation to these new technologies and research areas, but that it must

balance the encouragement of research aimed at developing treatments and understanding

disease (the ‘production of public goods’) with the above mentioned risks.

Finally, distributive justice and social policy justifications are relevant to scientific

enterprises that are controversial in nature such as embryo research and cloning. As a

matter of policy society may decide to overrule individual preferences on some issues and

regulate. We have already seen that many different views concerning the status of embryos

exist. As we shall see in Chapter Four such differences continue to be illustrated in the more

recent public debate that took place concerning research involving human embryos and

cloning and are reflected in the vast difference in individual preferences concerning whether

such research should be permitted and if so the extent to which it should be permitted.

Whilst individual scientists or members of the public may wholeheartedly wish to proceed

with such research, others are equally against it. Balancing such preferences often involves

coming to some sort of public/social policy decision and then regulating accordingly.

165 Hayek, above n154; Breyer above n154; and Ogus, above n14 cited in Baldwin and Cave, above n151, 12.


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chapter however turns to an introduction to the types of mechanisms, strategies and

enforcement approaches that may be used within legislation and broader regulatory

systems as a means to meet such goals and get those who are regulated to comply with the

law.

IX. CONCLUSION This chapter has illustrated a fundamental rationale that underpins the regulation of

research involving human embryos and cloning technologies. That is, the moral status of the

embryo. The associated dilemma of where to draw the line regarding research that involves

the destruction and/or creation of human embryos was demonstrated. It was shown that

moral and ethical arguments concerning the status to be accorded a human embryo have

existed throughout the ages. Such arguments are closely linked to the debate about when

human life begins. Both have influenced research aimed initially at understanding life itself,

later at assisting in the formation of embryos and most recently in an attempt to find

treatments and/or cures for illnesses suffered by the living.

It was also shown that debates concerning the moral status of the embryo, when life

begins, and the ethical dilemmas faced by those wishing to conduct research involving

human embryos, were re-ignited as advances in reproductive technologies were made.

Along with these advances came the introduction of formal regulation of research involving

human embryos which moved beyond being based purely on the moral status of the

embryo or trying to define the point at which life begins. In fact, it was shown that no

consensus could be reached concerning these questions but regulators ‘stepped in’ to

provide a framework within which those wanting to conduct research involving human

embryos could work. The chapter detailed how regulatory models adopted in the United

Kingdom and Australia involved increasingly authoritative rules accompanied by a

mechanism for monitoring and promoting compliance with those rules (such as the creation

of oversight bodies) as such technologies advanced.

The discussion concluded with an introduction to the further technological advances

in research involving human embryos, including embryonic stem cell research and cloning

technologies, which meant the potential for research involving human embryos grew. It

was shown that new issues and other rationales for regulation have become increasingly

relevant. These other rationales for regulation were introduced, demonstrating how they

too play a fundamental role in determining laws that should govern research involving

human embryos and cloning. It was shown that decisions about what to regulate and where

to draw the line between permissible and prohibited research include meeting demands to

keep the public informed about general research practice and any hazards or deficiencies

associated with the research; encouraging the production of ‘public goods’ whilst balancing

such encouragement with the ‘moral hazards’ presented by the research; and reflect

‘distributive justice and social policy justifications’.

The analysis in this chapter of the rationales for regulation of research involving

human embryos and cloning will form the basis for the evaluation in Chapters Four to Six of

how the United Kingdom and Australia have addressed the questions of what to regulate

and where to draw the line regarding permissible and prohibited research and practice. But,

before moving to such evaluation, it is necessary to first lay down a framework for

evaluating how these jurisdictions have addressed the how to regulate question. Chapter

Three concerns this.

Chapter Three: Regulatory Theory, Design Strategies and Enforcement Approaches

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Chapter Three:

AN INTRODUCTION TO REGULATORY THEORY, DESIGN STRATEGIES AND ENFORCEMENT APPROACHES

I. INTRODUCTION

This chapter provides a review of modern regulatory theory, the purpose of which is

to enable the evaluation in Chapters Four to Six of current regulatory design strategies and

enforcement approaches in the United Kingdom and Australia, and to enable development

of recommendations in Chapter Seven that may address regulatory inadequacies and lead

to better regulation of research involving human embryos and cloning.

Five primary theories of punishment—deterrence, incapacitation, rehabilitation,

restoration and retribution—are introduced. These theories are separate from the

rationales discussed in Chapter Two. The rationales discussed in Chapter Two form the basis

for decision making concerning questions of what to regulate and where to draw the line

for permissible and prohibited research and practices. The theories of punishment address

the separate and subsequent issue of how to regulate, and provide a foundation for

choosing the sorts of regulatory design strategies and enforcement approaches to be

adopted within any given regulatory system. Chapter Four will argue that the United

Kingdom and Australia have dealt adequately with the rationales for regulation but not so

well on regulatory design strategy or enforcement approaches.

The five theories of punishment are introduced with brief examples of how they are

or could be applied in the regulation of research involving human embryos and cloning. The

chapter then goes on to introduce regulatory design strategies and enforcement approaches

that instantiate these theories of punishment in different ways. Specifically, three regulatory

design strategies which are relevant as possible modes of regulation in the context of

research involving human embryos and cloning—1) ‘command and control’; 2) ‘self-

regulation/enforced self-regulation’; and 3) ‘co-regulation’—are introduced. Three major

enforcement approaches that regulatory bodies can take in order to achieve compliance are

also considered—1) a deterrent approach, 2) a cooperative, persuasive and educative

approach and 3) Braithwaite’s model of ‘responsive regulation’ which proposes a

combination of, and progression through, the first two approaches. All three approaches

diverge as to which theory, or combination of theories, of punishment they emphasise, and

how they try to achieve compliance with regulation. It is argued that it is best to take a

responsive regulatory approach to enforcement, and to incorporate co-regulatory design

strategies where possible.

This framework for understanding what design strategies and enforcement

approaches are available, and when they are most suitably used, forms the foundation for

analysing and evaluating the way the United Kingdom and Australia have addressed the how

to regulate question in Chapters Four, Five and Six, and proposed changes to the current

models in Chapter Seven.


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II. INTRODUCTION TO THEORIES OF PUNISHMENT

There are five primary theories of punishment - deterrence, incapacitation,

rehabilitation, restoration and retribution—that may underpin regulation.166 Such theories

are generally divided into two general philosophies: utilitarian and retributive.167

A. Deterrence Theory

Broadly

speaking, the utilitarian theory of punishment seeks to ‘punish’ offenders to discourage

future wrongdoing. This would include deterrence, incapacitation, rehabilitation and

restorative approaches. The retributive theory seeks to punish offenders in response to

offences they have committed in the past and because they ‘deserve’ to be punished. The

five theories of punishment are summarised as follows:

Deterrence theory posits that enforcement provisions should be used that have the

effect of deterring people from committing an offence.168 The theory assumes that potential

offenders make a rational decision before they act and will consider whether the estimated

benefits of so acting will exceed the estimated costs of engaging in the act.169 The larger the

size of the penalty, the increased potential cost to the offender, and in turn the greater

deterrent incentive to comply with the law.170 People are thus deterred from actions

because they refrain from carrying them out due to an aversion to the possible

consequences of those actions.171

166 Peter Cartwright, Consumer Protection and the Criminal Law - Law, Theory and Policy in the UK (2001), 214. 167 Cyndi Banks, Criminal Justice Ethics (2004), 115. 168 Cartwright, above n166, 75. 169 K. Yeung, Securing Compliance: A Principled Approach (2004), 64. 170 Ibid. 171 Banks, above n167, 106.

The aim is to achieve individual deterrence by punishing

an offender in order to deter personal recidivism and also general deterrence. That is

deterring all people from committing crimes in the future.

Different approaches to deterrence may be found to date back as early 621BC

where, for example, the laws promulgated by Draco for Athens incorporated such severe

(‘draconian’) penalties as to put rational people off committing crimes, even with only a

remote possibility of being caught and punished.172 For example, the laws of Dracos

included the death penalty for most offences—from stealing a cabbage to murder.173 In

1764, Cesare Becarria174 proposed a graduated system of penalties which were to ‘fit’ the

crime.175 Similarly, the English jurist and utilitarian philosopher Jeremy Bentham, who is

considered to be the major proponent of using punishment as a deterrent,

176

Pain and pleasure are the great springs of human action. When a man perceives or supposes pain to be the consequence of an act he is acted on in a certain manner as tends with a certain force to withdraw him as it were from the commission of the act. If the apparent magnitude be greater than the magnitude of the pleasure expected he will be absolutely prevented from performing it.

conceptualised deterrence as follows:

177

172 Barbara Hudson, Understanding Justice an Introduction to Ideas, Perspectives and Controversies in Modern Penal Theory (2003).

173 Plutarch, Solon (75ACE) Translated by John Dryden, http://classics.mit.edu/Plutarch/solon.html at 30 October 2008. ‘…Draco himself…being asked why he made death the penalty for most offences, replied that in his opinion the lesser ones deserved it, and for the greater ones no heavier penalty could be found.’ This comment therefore also illustrates that some punishments may incorporate more than one aim. Here Draconian penalties are used to illustrate the concept of deterrence but also note penalties were intended by Draco as retributive. 174 Cesare Becarria (1738-1794) was born in Italy the eldest son in an aristocratic family and educated at a Jesuit school. In his mid twenties Beccaria became close friends with Pietro and Alessandro Verri, two brothers who formed an intellectual circle called ‘the academy of fists’ which focused on reforming the criminal justice system. Through this group Beccaria became acquainted with French and British political philosophers, such as Hobbes, Hume, Diderot, Helvetius, Montesquieu, and Hume. At the encouragement of Pietro Verri, Beccaria wrote On Crimes and Punishments (1764). This book led him to be known as ‘the first major penologist of the constitutional state.’ 175 Cesare Becarria On Crimes and Punishment (1764) as cited in Hudson, above n172, 19. 176 Banks, above n167, 107. 177 Jeremy Bentham as cited in Banks, above n167.

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Bentham’s philosophy was that punishment is a means to an end, and not an end in itself.178

1. Taking away the physical power to reoffend;

Note that in relation to individual deterrence, Bentham saw three strategies to deter an

individual from re-offending:

2. Taking away the desire to reoffend; and

3. Making the individual afraid to reoffend.179

As such, one might include the two ‘theories’ discussed below – incapacitation and

rehabilitation - as forming part of a subset of enforcement provisions that aim to achieve

individual deterrence. Whilst in relation to general deterrence Bentham stated:

The punishment suffered by the offender presents to everyone an example of what he himself would have to suffer, if he is guilty of the same offense [sic].180

An example of a penalty that is underpinned by deterrence theory in relation to

human embryos is the 1803 criminal abortion law discussed in Chapter Two in which the

abortion of a ‘quick’ foetus became a capital offence.

In this sense the public needs to be made aware of both the penalties for committing

certain crimes and that those penalties are actually being enforced.

181 Such laws were intended to prevent

abortion after a certain stage of pregnancy. Current laws on research involving human

embryos and cloning in the United Kingdom and Australia may also serve, or be intended to

deter both individuals and the general public from engaging in certain practices. For

example, the law in the United Kingdom provides for penalties that impose terms of

imprisonment ranging from 6 months to 10 years, and/or fines for breaching the HFE Act.182

178 Banks, above n167, 107. 179 Jeremy Bentham cited in Hudson, above n172, 19. 180 Ibid.

181 Childbirth by Choice Trust, Abortion Law, History & Religion, http://www.cbctrust.com/history_law_religion.php#80 at 11 April 2006. 182 Human Fertilisation and Embryology Act 1990 (UK), s41.

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For example, a person is guilty of an offence and liable on conviction to imprisonment for up

to ten years and/or a fine if they place in a woman a live embryo other than a human

embryo or live gametes other than human gametes.183 Similarly, in Australia current

legislation provides for up to 15 years imprisonment if a person intentionally places a

human embryo clone in the body of a human or the body of an animal.184

B. Incapacitation Theory

Incapacitation theory suggests that after a person has broken the law, penalties

should be implemented that have the consequence of making the offender incapable, or at

least less capable, of re-offending.185 To the extent that the penalty is intended to

incapacitate, the offender is controlled so as to preclude his/her opportunity for further

similar behaviour.186 Generally, incapacitation mechanisms include terms of imprisonment

or, in some jurisdictions, the death penalty. Large fines and licence revocation may also in

some circumstances be incapacitating as they may serve to put the offender out of business

or prevent them from practising. Generally the punishment must render it impossible or

very difficult to re-offend.187

The same examples used above in relation to deterrence theory may again be used

here to illustrate incapacitation theory. That is, current laws in both the United Kingdom

188

and Australia, 189

183 Human Fertilisation and Embryology Act 1990 (UK), s41(1). 184 See for example, Prohibition of Human Cloning for Reproduction Act 2002 (Cth), sections 9-23C. 185 Cartwright, above n166, 77-78. 186 Don M. Gottfredson, Decision Making in Criminal Justice: Toward the Rational Exercise of Discretion (1988), 142. 187 Hudson, above n172, 32. 188 Human Fertilisation and Embryology Act 1990 (UK), s41. 189 Prohibition of Human Cloning for Reproduction Act 2002 (Cth), s9.

provide for lengthy prison sentences and/or fines if one commits an

offence which is established under each jurisdiction’s legislation. Loss of licence in both

jurisdictions for conducting research may also serve to incapacitate researchers and/or


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practitioners if they were to act against any relevant laws, codes of practice, regulations

and/or guidelines in each jurisdiction.

C. Rehabilitation Theory

In one form, rehabilitation theory is based on the notion that punishment is to be

inflicted on offenders so as to reform them, or rehabilitate them. It may as such be linked to

a number of different types of penalties—for example, fines, imprisonment, community

service, probation—which are intended to lead the offender to recognise they have

committed a wrong and/or to feel publicly shamed.190 This may in turn prompt a person to

change their behaviour and more importantly their values so that he or she will refrain from

committing further offences, now believing such behaviour is wrong.191 Such change can be

distinguished from deterrence in which the offender simply abstains from criminal acts

because of fear of being caught and punished again. 192

Rehabilitation theory may also underlie strategies that operate prior to offences

occurring. That is, rehabilitation can operate outside of the punishment paradigm, as an

alternative to punishment.

Punishment that leads to reform or

rehabilitation is therefore seen as a tool that enables the offender to re-integrate into

society through actual change in the offender.

193 An example of this would be a strategy that is intended to

educate those regulated so that they do not offend. Such a strategy ‘would attempt to

persuade offenders to comply with [the] law in the future, not through fear of punishment,

but by creating in the offender the capacity for social participation and responsibility’.194

190 Banks, above n167, 116. 191 Ibid. 192 Ibid. 193 Ibid. 194 Cartwright, above n166, 78.

When applied in this way, offenders or potential offenders may decide not to offend when

educated, for example, in relation to avoiding the careless commission of offences.195

D. Restorative Justice Theory

In

relation to research involving human embryos and cloning, educating researchers and

practitioners about the requirements and boundaries set by the law (with respect to how

they can meet their legal obligations and what is or is not permitted) might be one way to

utilise ‘educative deterrence’ and rehabilitation theory in order to avoid offences.

A restorative justice theory offers an alternative to the view that crime is an act against

the state—a position which largely does not address the consequences on victims and the

community but rather focuses on punishing offenders without forcing them to face the

impact of their crimes.196 Restorative justice mechanisms of regulation are thus aimed at

more inclusive processes and seek to involve all ‘stakeholders’—including, but not limited

to, those directly affected by the offence, family members, and members of the affected

community.197

i. Crime is an offense against human relationships;

The aim is to provide opportunities for those directly affected by crime to be

involved in the process of responding to any harm caused. The guiding principles of

restorative justice are thus summarised:

ii. Victims and the community are central to justice processes; iii. The first priority of justice processes is to assist victims; iv. The second priority is to restore the community, to the degree possible; v. The offender has personal responsibility to victims and to the community for crimes committed;

vi. Stakeholders share responsibilities for restorative justice through partnerships for action; and vii. The offender will develop improved competency and understanding as a result of the restorative

justice experience.198

195 Ibid, 79.

196 US Department of Justice, National Institute of Justice, Restorative Justice (Nov 26, 2007), http://www.ojp.usdoj.gov/nij/topics/courts/restorative-justice/welcome.htm at 20 October 2008. 197 Michelle Maiese, ‘Restorative Justice’ in Guy Burgess and Heidi Burgess (eds) Beyond Intractability: Conflict Research Consortium, University of Colorado, Boulder. Posted: October 2003 http://www.beyondintractability.org/essay/restorative_justice/, at 17 July 2008. 198 US Department of Justice, above n196.

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Based on these principles, restorative justice is a ‘forward-looking, preventive response

that strives to understand crime in its social context’.199 As such, Marshall states that a

commonly accepted international definition of restorative justice is that it is ‘a process

whereby parties with a stake in a specific offence collectively resolve how to deal with the

aftermath of the offence and its implications for the future.’ 200 Inherent to this restorative

process for resolving how to deal with offences, and to the general theory of restorative

justice itself, is the assumption that crime has its origins in social conditions. Therefore

communities must both take some responsibility for remedying conditions that contribute

to crime and work toward promoting healing.201

In addition, healing is crucial not only for victims, but also for offenders.

202 Both the

rehabilitation of offenders and their integration into the community are thus vital aspects of

restorative justice.203 Offenders should be treated respectfully and their needs addressed.

Removing them from the community, or imposing any other severe restrictions, is a last

resort. Rather the view is that the best way to prevent re-offending is re-integration.204

Restorative justice theory however differs from rehabilitation theory in that ‘restorative

justice sees social support and social control as the means to rehabilitation’. 205

Examples of sentencing tools used within a restorative justice approach include

requiring the offender to engage in some sort of restoration (for example repairing

damaged property, or by way of compensation), community service programs, and victim-

199 Maiese, above n197. 200 Tony F. Marshall, Restorative Justice an Overview (1999), 5. 201 Ibid. 202 Gordon Bazemore and Mara Shiff (eds), Restorative Community Justice: Repairing Harm and Transforming Communities (2001), 17. 203 Howard Zehr and Harry Mika, ‘Fundamental Concepts of Restorative Justice’ (1998) 1(1) Contemporary Justice Review: Issues in Criminal, Social, and Restorative Justice 47-56. 204 Ibid. 205 Banks, above n167, 118.

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offender mediation programs.206 Such programs have been utilised in some criminal and

juvenile courts since the 1970s. However there has been some criticism that in spite of

some success within these programs, no clear principles have been formulated for restoring

the harm done by offenders to community standards and the precise meaning of restorative

justice remains ambiguous.207 Restorative justice has also been criticised by some as

minimising the impact of crime on victims and ignoring their feelings by avoiding the rituals

and ceremonies found in other approaches used within the criminal law (that is Court

processes, the imposition of prison sentences, etc).208 On the other hand, proponents of

restorative justice such as Braithwaite argue that the justice system in fact fails to recognise

victim’s voices and the view that social harmony is restored simply by ‘justice being done’

within the criminal context is inadequate.209

206 Bazemore and Shiff (eds), above n202, 25. 207 Andrew Von Hirsch, et al. (eds) Restorative Justice and Criminal Justice: Competing or reconcilable paradigms? (2002); Elmar G M Weitekampe and Hans Jurgen Kerner (eds), Restorative Justice: Theoretical Foundations (2002), 92. 208 Banks, above n167, 119. 209 John Braithwaite, ‘Restorative Justice’ in M. Tonry (ed), The Handbook of Crime and Punishment (1998), 323.

In the context of research involving human embryos and/or cloning, theoretically

restorative justice could play a role in moving the [hypothetical] offender out of the lab and

having them face the public, or exposing them to the people to whom such research has

affected negatively. In doing so there may also be an educative process required and/or

mediation with the aforementioned people in order to shift researcher attitudes and

promote compliance.


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E. Retribution Theory

The fifth theory of punishment is retribution theory. This theory involves a ‘just

desserts’ approach to punishment.210 That is, in taking a retribution approach, wrongdoers

are punished because of the offence they committed. This theory posits that punishment is

justified because it is deserved.211

However, it has been argued that the censure expressed through criminal law can

have the effect of deterring third party behaviour anyway,

Retribution theory is the only one of the five theories discussed that is not utilitarian

in its approach. Unlike the other theories of punishment mentioned so far, retributivism

sees punishing those who deserve it is something good in itself, rather than good because it

causes something else such as the prevention of future crime. In the context of research

involving human embryos and cloning, such a theory would engage the use of criminal

penalties and/or fines simply to punish a person who has committed an offence because

they deserve it. For example, a prison sentence of 15 years for a person who attempted

reproductive cloning might be imposed for no other reason than the offence was deemed

repugnant, and the offender deserving of a lengthy prison sentence.

212

210Cartwright, above n166, 80. 211 Banks, above n167, 109. 212 Banks, above n167, 109.

even if the actual penalties

imposed on the wrongdoer are aimed at punishing them relative to the crime they have

committed.

F. The Five Theories in the Context of Regulating Research Involving

Human Embryos and Cloning

The five theories of punishment discussed above underlie various regulatory

approaches that may be chosen to govern a particular group or activity. In the discussion

above brief examples of how each theory might translate into the use of various penalties or

approaches to treating offenders/potential offenders in the context of research involving

human embryos and cloning have been given.

Whilst the various theories are most often used in order to justify the imposition of

punishment in the context of criminal offences, they are directly relevant to the justification

of punishment for regulatory offences also.213 The United Kingdom and Australia both have

regulatory and criminal offences available to sanction breaches of regulation concerning

research involving human embryos and cloning. Whilst the use of criminal offences may

carry greater connotations of moral improbity, ‘both types of offence may invoke the

coercive power of the state in visiting some form of hard treatment on the offender’.214

213 Karen Yeung, ‘Quantifying Regulatory Penalties: Australian Competition Law Penalties in Perspective’ (1999) Melbourne University Law Review 18. 214 Ibid.

As

will be seen in Chapter Four, such an approach in fact is fundamental to the ‘command and

control’ strategies each jurisdiction has adopted. However, before moving on to the

evaluation of the United Kingdom and Australian regulatory systems and the development

of this paper’s central thesis concerning better regulatory strategies, it is first necessary to

introduce the relevant regulatory design strategies, and approaches to enforcement that

have been developed to put these theories of punishment into action.


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III. REGULATORY DESIGN STRATEGIES

In its most straight-forward sense, regulation refers to a set of authoritative rules accompanied by a mechanism, usually administered by a public agency, for monitoring and promoting compliance with those rules. A broader understanding of regulation sees government strategies going beyond the creation and enforcement of rules, and includes taxation measures, subsidies and other incentives or disclosure requirements. The broader definitions of regulation recognise that non-government actors/agencies, including corporations, professional firms, international stakeholders, other community groups and private citizens can be involved in regulation.215

The above quote illustrates that regulation may take different forms. Whilst there are many

regulatory design strategies that may be adopted to achieve regulation,

216

1. ‘command and control’ (the regulatory design strategy that has been adopted in

both the United Kingdom and Australia—as illustrated in Chapter Four),

relevant to the

discussion of regulation of research involving human embryos and cloning, are those known

as:

2. ‘self regulation and enforced self-regulation’ (the regulatory design strategy

preferred by research scientists and practitioners—as illustrated in Chapter Five) and

3. ‘co-regulation’ (the regulatory design strategy shown by this thesis to be the most

fitting in relation to the regulation of those licensed to conduct research involving

human embryos and cloning (for research purposes)—as discussed in Chapter

Seven).

The following discussion introduces these design strategies.

215 Toni Makkai (Acting Director, Australian Institute of Criminology) ‘Foreword’ in Richard Johnstone and Rick Sarre (eds), Regulation: Enforcement and Compliance (2004), v. 216 Including (but not limited to) command and control, self regulation, enforced self-regulation, incentive based regimes, market-harnessing controls, disclosure regulation, direct action, rights and liabilities, and public compensation/social insurance schemes.

A. Command and Control

Command and control regulatory design strategies generally impose standards

backed by criminal sanctions.217 Formerly referred to by some as ‘direct regulation’,218 the

idea that lies behind command and control design strategies is that the force of the law is

used to prohibit certain activities, to demand some sort of positive action, and/or to

prescribe conditions for entry into a certain sector.219 Regulatory bureaucracies are

established to enforce the command and control approach.220 Rules are usually contained

in primary or secondary legislation which are then enforced by the regulatory

bureaucracies,221

Command and control approaches often involve some sort of licensing process to

screen entry into a certain activity, and may also set out such things as expected standards,

the manner of conducting the activity, the allocation of resources, or any other thing

deemed necessary to control.

noting that at times the regulatory agency may be granted some rule or

decision making power.

222

The strengths of the command and control approach are that the force of the law

may be used to fix standards with immediacy and to prohibit activities that do not conform

to such standards.

223 The words of the Warnock Committee discussed in Chapter One that

‘there must be some barriers that are not to be crossed, some limits fixed beyond which

people must not be allowed to go’,224

217Baldwin and Cave, above n151, 35. 218 Neil Gunningham, Peter Grabosky and Darren Sinclair, Smart Regulation: Designing Environmental Policy (1998), 39. 219Baldwin and Cave, above n151, 35. 220 Ibid. 221Ibid. 222 Ibid. 223Ibid.

are illustrative of such an approach. Baldwin and Cave

highlight the fact that when this approach is adopted ‘the government is seen as acting

224 Warnock, above n5, 2.


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forcefully and to be taking a clear stand: by designating some forms of behaviour as

unacceptable; by excluding dangerous parties from certain areas; by protecting the public;

and establishing penalties for those engaging in offensive conduct’.225

• concern that ‘capture’ may occur. Regulatory capture occurs when officials

inappropriately identify with the interests of a client or industry and may as a

result fail, or be reluctant to enforce penalties, or even adopt an advocacy

role for the regulated;

Criticisms of command and control strategies include, but are not limited to:

226

• concern that such an approach leads to the unnecessary development of

complex and inflexible rules.

227

• concern that such a system promulgates so many rules over time that the

result is over-regulation, legalism, delay, intrusion and the strangling of

competition and enterprise;

The consequence of this being that rules are

hard to comply with or unfair or (particularly in the context of science) may

prevent activities unnecessarily;

228

• using bodies of officials and inspectorates to enforce the many rules is often

very expensive;

229

• the techniques for enforcement often give rise to contention;

230

• the effects of enforcement are said to be uncertain.

and

231

225 Baldwin and Cave, above n151, 35. 226 Gary Adams, et al. ‘Regulatory Capture: Managing the Risk’ (2007), paper presented at the Australian Public Sector Anti-Corruption Conference, 24 October 2007 – Sydney (Government regulators – the environment and the corruption risks stream). 227 Eugene Bardach and Robert A. Kagan, Going By the Book: The Problem of Regulatory Unreasonableness (2002), 94-120. 228 Ibid. 229 Ogus, above n14. 230 Ibid. 231 Ibid.

Baldwin and Cave state on the latter point that ‘rules in [command and control] systems

may be too narrow or too broad in scope. They may, accordingly, fail to cover conduct that

should be controlled or else may constrain activity that should be unrestricted.’232 They add

that command and control systems may lead to problems of ‘creative compliance’ in order

to ‘avoid the intention of the law without breaking the terms of the law’.233

Such issues have clearly been illustrated in the context of research involving human

embryos and cloning. For example, in his paper ‘Banning human cloning: a study in the

difficulties of defining science’

234

1) that legislation should be written using the best possible definitions in light of present

knowledge;

Professor Henry Greely of Stanford University, discusses the

difficulties of legislating in relation to cloning. He notes that good definitions need to meet

two goals. First, they must regulate the practices that are of concern without regulating the

kinds of medical or research techniques that the legislature does not want to ban. This, he

says, requires determining which are which. Secondly, it requires terms to be defined in both

their current context, and also in a way that anticipates new technologies. This means that it

is necessary to use language that does not in the future become too restrictive, not

restrictive enough, or both. Greely suggests three possible legislative approaches:

2) that terms should be left undefined (that is, abandon precision in favour of general

regulations – for example, a ban on ‘human cloning’); and

232 Baldwin and Cave, above n151, 38. 233 Ibid. 234 Professor Henry Greely, ‘Banning Human Cloning: a Study in the Difficulties of Defining Science’ (1998) 8 Southern California Interdisciplinary Law Journal 131.


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3) that an ongoing regulatory authority be appointed with the explicit authority to pass

regulations and/or change definitions as new technologies are discovered and/or

current legislative provisions are found to be inadequate.235

The problem with the first suggested approach is that ‘the best possible definitions

in light of present knowledge’ may not always be similar, or stand up to technological

change – and therefore the approach is inadequate. This has been an ongoing problem in

Australian state and commonwealth legislation regarding research involving human

embryos and cloning. It was, for example, evident in Chapter Two regarding the different

definitions of ‘embryo’ found in early state legislation in Victoria

236 and Western

Australia237 which in turn meant that what kind of research was permissible depended upon

where in Australia the research was to be conducted.238

Finally, Greely’s last suggested solution would only work if the overseeing authority

actually has such powers -- that is, the explicit authority to pass regulations and/or change

The problem with the second approach is that leaving terms undefined or

abandoning precision in favour of broad regulations leaves those governed by the legislation

unsure of what they may or may not do. This in turn may lead to them, or their legal

representatives, having to either decide whether their activities fall within the broad

regulation without regulatory input or having to ‘argue it out’. Where people have to decide

for themselves whether their activities fall within the regulation then no real regulation

exists. ‘Arguing it out’ raises problems of cost, for example, through litigation to get

authorative input, and timeliness of deciding whether something is allowed or not.

235 Ibid, at 147. 236 Infertility Treatment Act 1995 (Vic), amended by amended by Health Legislation (Research Involving Human Embryos and Prohibition of Human Cloning) Act 2003, s 3. 237 Human Reproductive Technology Act 1991 (WA) s 3, amended by Human Reproductive Technology Amendment Act 2004, s 3. 238 Magri, above n118, 486.

definitions as new technologies are discovered and/or current legislative provisions are found

to be inadequate. As will be seen in the discussion of regulatory systems adopted in the

United Kingdom and Australia presented in Chapter Four, neither the HFEA nor the NHMRC

Licensing Committee has such powers. The United Kingdom HFEA does however have the

power and ability to pass a Code of Practice which includes the settings of standards and

guidance for compliance with the governing legislation, conducts ongoing policy reviews, and

has prompted the promulgation of regulations as changes regarding the legislation needed to

occur. The Australian NHMRC Licensing Committee does not have similar functions.

Even if the oversight authorities were given direct powers to pass regulations and/or

change definitions, Greely’s suggestion is also still problematic because the concern that

‘such a system promulgates so many rules over time that the result is over-regulation,

legalism, delay, intrusion and the strangling of competition and enterprise’239 still exists.

Similarly, it does not address the concern that using bodies of officials and inspectorates to

enforce the many rules is often very expensive.240

Other problems with ‘command and control’ strategies also exist. Bardach and Kagan

warn that whilst expressions of regulatory toughness, often fundamental to the ‘command

and control’ approach, might be good in ‘dealing with the few bad apples, they may be self

defeating in dealing with the majority of good apples’.

241 Such approaches may result in

resentment and resistance, a system in which information sharing is undermined, and one

that diverts the energies of both sides into ‘pointless legal routines and conflicts’.242

239 Bardach and Kagan, above n227, 94-120. 240 Ogus, above n14. 241Bardach and Kagan, above n227, 119. 242 Ibid.

In light


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of such difficulties some regulators advocate moving away from command and control

models toward less restrictive forms of control.243

B. Self-Regulation and Enforced Self-Regulation

Later chapters will show that the criticisms of ‘command and control’ strategies are

borne out in practice within the regulatory systems adopted in both the United Kingdom and

Australia when regulating licence holders. Indeed, this thesis argues that whilst the

‘command and control’ design strategy may be usefully maintained to address breaches of

legislation by non-licence holders and serious breaches by licence holders, greater use of co-

regulatory design strategies and cooperative, educative and persuasive enforcement

approaches should be used in the context of regulating licensed research involving human

embryos and cloning.

Self-regulation in its most basic form involves an organisation or association

developing a system of rules that it monitors and enforces against its members.244 In this

sense, the rules are self-made and self-administered without government oversight.245

When it is subject to some sort of government oversight or structuring, self-regulation can

be classified as ‘enforced’. Thus ‘enforced’ self-regulation may be a regime that is mandated

by government but implemented by the organisation or association itself, or legislation

might subject self-regulation to scrutiny and approval by a government department.246

The strengths of enforced self-regulation regimes are said to include the high level of

commitment of associations to ‘their own’ rules; well informed rule making; low costs to

governments; a close fit between rules and standards that the association accepts as

243 Baldwin and Cave, above n151, 39. 244 Ibid. 245 Ibid. 246 Ibid.

realistically attainable; greater detection of violations and in securing convictions where

prosecutions are necessary; greater comprehensiveness of rules; the ability of self-

regulatory rules for rapid adjustment to circumstances; and more effective complaints

procedures.247

This type of regulation has however been criticised on a number of bases, particularly in

relation to the danger that rules will often prove to be self-serving; the potential that rule

setting procedures might lack openness, transparency, accountability and acceptance by the

public and consumers; the difficulty associated with some compliance units within

associations always retaining their independence; lack of trust from the public regarding

internal compliance units in being able to apply rules in the public or consumer interest; and

the fact that the public may demand that the government take responsibility for a sector or

community rather than relying on self-regulation.

248

An example of self-regulation is the position taken by some states in Australia

regarding the regulation of assisted reproductive technologies. As outlined in Chapter Two,

New South Wales, Queensland, Tasmania and the Australian Capital Territory have not

enacted legislation regarding the regulation of assisted reproduction technologies per se.

Rather, they opt to follow federal government guidelines published by the National Health

and Medical Research Council (NHMRC) which describe a range of prohibited or

unacceptable practices, in conjunction with industry self regulation through a body known

as the Reproductive Technology Accreditation Committee (RTAC).

In addition, self-regulation may prove

inadequate when the consequences of non-compliance are severe and stronger

mechanisms for dealing with non-compliance, such as legislated penalty provisions, are

required.

247 Ibid, 40. 248Ibid, 40-41.


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RTAC was established in 1987, by the Fertility Society of Australia.249 Its primary

responsibility is accreditation of Assisted Reproductive Technology (ART) Units (that is,

clinics etc. that provide assisted reproduction services) against a code of practice developed

by the industry, The Code of Practice for Assisted Reproductive Technology Units250 (RTAC

Code). The current edition of the RTAC Code (revised in May 2008) states that its purpose is

to ‘promote continuous improvement in the quality of care offered to people accessing

fertility treatment; provide a framework and set criteria for the auditing process that leads

to accreditation of organisations that deliver fertility services; and to ensure the auditing

process is carried out in an independent, non-adversarial and constructive manner’.251

The RTAC Code dictates critical criteria for ART organisations that are audited

annually by RTAC in accordance with their ‘RTAC Certification Scheme’

252

249 The Fertility Society of Australia is the peak body representing scientists, doctors, researchers, nurses, consumers and counsellors in reproductive medicine in Australia & New Zealand. 250 Fertility Society of Australia and Reproductive Technology Accreditation Committee, The Code of Practice for Assisted Reproductive Technology Units, Revised May 2008. 251 Ibid, 4. 252 Fertility Society of Australia, Reproductive Technology Accreditation Committee Certification Scheme (RTAC Scheme), August 2008. In 2007, the FSA decided to introduce independent (third-party) certification of ART units as the basis for considering the RTAC licence, and asked the Joint Accreditation System of Australia and New Zealand (JAS-ANZ) to assist in the development and delivery of an RTAC Scheme. The RTAC Scheme consists of a detailed Management Manual developed by RTAC and the RTAC Code of Practice and was developed by the RTAC Technical Committee and JAS-ANZ.

and ‘Good Practice

Criteria’ which are audited every three years. The full details of these criteria are

reproduced in Appendices 11 and 12, and discussed in relation to their potential application

to governing research involving human embryos and cloning in Chapter Seven. Suffice to say

here, that this self-regulatory body provides extensive self-made and self-administered rules

to which its members must adhere (and agree to do so voluntarily in some states). RTAC

also requires that the current facilities it accredits comply with all legislative and regulatory

requirements including state based legislation, NHMRC guidelines, and HREC requirements.

As a self-regulatory body, RTAC has been recognised in Australia as functioning in a

way that meets all of the above mentioned benefits of a self-regulatory system. For

example, in its submission to the Lockhart Committee Review,253

RTAC accreditation and requirements to comply with the NHMRC Ethical Guidelines provide a rigorous framework to ensure excellence in the provision of ART services. … There is no evidence to suggest that such accreditation and ethical oversight has been lacking or has enabled ART practitioners to engage in inappropriate practices.

the Queensland

government stated:

254

Despite the initial scepticism of the government, RTAC has demonstrated that self-regulation can work … Benefits of self regulation include its flexibility as it is more able to respond to emerging scientific advances, reflect developing social expectations and allow for a greater degree of autonomy for consumers in the decision making process. Importantly RTAC is not restricted to rigid legislation but using the Code of Practice requirements as a minimum standard, seeks to continually improve practice. This is crucial to improving the quality of care as needs are identified.

Similarly, community groups have expressed satisfaction with a self-regulatory approach in

the ART context, particularly in relationship to its flexibility and ability to respond to

emerging scientific advances:

255

In contrast, concerns about the negative aspects of self-regulation may also be cited. For

example, the Committee of the St Thomas More Society in their submission to the Lockhart

Committee did not support the self-regulatory approach particularly because of their

concern that ‘legislation would ensure the industry operates in accordance with established

ethical standards, including transparency and full disclosure of risk’.

256

253 The Lockhart Committee was established in accordance with section 25(3) of the Prohibition of Human Cloning Act 2002 and section 47(3) of the Research Involving Human Embryos Act 2002 which required the review of the Acts after three years of them being enacted). See Legislation Review Committee (Australia), above n10. 254 Legislation Review Committee (Australia), above n10: Queensland Government (Submission LRC930) 255 Ibid: ACCESS (Australia’s National Infertility Network) (Submission LRC899) 256 Ibid: St Thomas More Society (Submission LRC397)

An area like research

involving human embryos and cloning raises such public concern and potential risks as seen

in Chapter Two, that some government oversight is necessary.


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C. Co-Regulation

Co-regulation is an approach in which various methods of regulation are brought to

bear on a specific problem. It may be seen as the middle ground between traditional

statutory regulation and private self-regulation257—the two approaches described above.

Typically co-regulation involves both primary legislation and self-regulation or, if not self-

regulation, at least some form of direct participation of bodies that represent stakeholders

in the regulatory decision-making process.258 This reflects a regulatory design strategy which

combines the elements of legislation, more especially in its predictable and binding nature,

with the more flexible regime of self-regulation.259 It thus involves self-regulation and

legislative action working together in a manner that mutually reinforces one another.260

Importantly, it ‘makes it possible to implement the objectives defined by the legislator

through measures carried out by active and recognised parties in the field concerned’.261

Notably, the RTAC system used as an example of a ‘self-regulatory’ strategy above, is

also a good illustration of a ‘co-regulatory strategy’. Some states in Australia have chosen to

govern assisted reproductive technologies by utilising both legislation and RTAC oversight.

For example, Western Australia mandates RTAC accreditation under their ART legislation.

262

257 Kelley Lee and Jeff Collin, Global Change and Health (2005), 192.

Similarly, the Infertility Treatment Authority established under the Infertility Treatment Act

1995 (Vic), works closely with RTAC in regulating Assisted Reproduction Clinics. The benefits

258 P. Eijlander, ‘Possibilities and Constraints in the use of Self-Regulation and Co-Regulation in Legislative Policy: Experience in the Netherlands – Lessons to be Learned for the EU?’ (2005) 9(1) Electronic Journal of Comparative Law, http://www.ejcl.org/ at 24 October 2008. 259 Opinion of the European Economic and Social Committee on Simplification (2002) Official Journal of the European Communities, 2002/c48/28, http://eur-lex.europa.eu/LexUriServ/site/en/oj/2002/c_048/c_04820020221en01300141.pdf at 1 April 2009. 260 Eijlander, above n258. 261 Commission of the European Communities, Report from the Commission on European Governance, above n11, 15. 262 Human Reproductive Technology Act 1991 (WA), s29(5)(aa)(i);

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of utilising such a system are illustrated by the following statements. Ms Louise Johnson,

CEO of the Victorian Infertility Treatment Authority (ITA):

I think one of the important processes is not only is there a checking that various requirements are met in all areas of ART practice and the legislation as far as the ITA is concerned, but as well as quality assurance, quality improvement is also looked at as well. And there is quite a strong team that is put together by RTAC that visits various licensed places and clinics. We have representatives from the Infertility Treatment Authority that are involved as well and observe the RTAC practices as well as asking our own questions where they need to be asked to ensure that legislation is being complied with under the Infertility Treatment Act.263

… we rely absolutely on the expertise of RTAC to give accreditation for the clinical practices of the units that we license … we’re very satisfied with the RTAC process as we see it in Victoria. We think it’s very thorough, very professional and we certainly rely on it for their part of it.

Similarly, Professor Jock Findlay, Chair of the Victorian ITA, has said:

264

A co-regulatory approach therefore enables the legislature to first set the essential

legal framework, the stakeholders or parties concerned can then fill in the details, and the

public authorities are able to then monitor the outcome.

The essential element of a co-regulatory approach that is highlighted by these examples is

that in working together, cooperation between the government (and its agencies) with

those subject to the regulation is achieved and, reportedly, works very well in governing an

area which has raised significant moral and ethical concerns.

265

263 Ms Louise Johnson, representing the Victorian ITA (Melbourne hearings) in Legislation Review Committee (Australia), above n10, 124. 264 Professor Jock Findlay, representing the Victorian ITA (Melbourne hearings) in Legislation Review Committee (Australia), above n10, 124.

In ‘filling in the details’ it

enables cooperative and educative dialogue to occur between the law-makers, those

subject to the regulation, and the public. The legislature might then validate the more

detailed rules developed by turning them into binding legislation. It implies taking self-

regulation one step further in a cooperative approach to governance. Rather than mere co-

existence of self-regulation and regulation, it involves the sharing of responsibilities

265 Linda Senden, ‘Soft Law, Self-Regulation and Co-Regulation in European Law: Where do they Meet?’ (2005) 9(1) Electronic Journal of Comparative Law, http://www.ejcl.org/ at 24 October 2008.

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between public and private partners.266 Noting that ‘[t]he exact shape of co-regulation, the

way in which legal and non-legal instruments are combined and who launches the initiative

– stakeholders or the [Government]– will vary from sector to sector’267

The European Union commission (EU commission) states that ‘co-regulation implies

that a framework of overall objectives, basic rights, enforcement and appeal mechanisms,

and conditions for monitoring compliance [are] set in the legislation… [T]he organisations

participating must be representative, accountable and capable of following open

procedures in formulating and applying agreed rules.’

— and arguably

situation to situation.

268 They state the latter is ‘a key factor

in deciding the added value of a co-regulatory approach in a given case’.269

Most importantly however is that ‘where co-regulation fails to deliver the desired

results or where certain private actors do not commit to the agreed rules, it will always

remain possible for public authorities to intervene by establishing the specific rules

needed.’

270

266 Opinion of the European Economic and Social Committee on Simplification, above n259. 267 Commission of the European Communities, European Governance: A White Paper (2001), 21. 268 Ibid. 269 Ibid. 270 Ibid.

It is therefore most appropriate where there is good reason to have government

involvement and formal laws contained within legislation, for example providing a

framework for activity, and in instances where self-regulation would not be satisfactory

alone. Such an approach therefore has increasingly been favoured in the European Union

(EU) as a suitable regulatory approach to be taken in areas where the expertise of those

being regulated can inform the regulatory process, but where risk dictates that government

oversight is also necessary.271

Co-regulation combines binding legislative and regulatory action with actions taken by the actors most concerned, drawing on their practical expertise. The result is wider ownership of the policies in question by involving those most affected by implementing rules in their preparation and enforcement. This often achieves better compliance, even where the detailed rules are non-binding.

It has also been recognised as effective in achieving better

compliance:

272

IV. ENFORCING REGULATION

Co-regulation therefore also addresses the shortfalls of both command and control and self-

regulation.

However, a good co-regulatory design strategy will often in fact involve different

layers. There may be a cooperative, co-regulatory design as the main ‘on-the-ground’

strategy, but the potential for command and control where that fails. This will be discussed

further below in relation to ‘responsive regulation’, which recommends this sort of layered

approach. It is based on these factors along with the evaluation of the current regulatory

design strategies and enforcement approaches adopted in the United Kingdom, that

Chapter Seven will argue that a layered approach which emphasises co-regulatory design on

the ground level, but maintains higher level command and control design strategies, is most

suitable to the regulation of research involving human embryos and cloning. However,

before moving to such arguments, various approaches to enforcing these regulatory

strategies are introduced.

Operating in conjunction with the chosen regulatory design strategy are the rules

that dictate how the system is to operate (for example, whether there will be a licensing

271 Ibid. 272 Ibid.


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authority), and how breaches or non-compliance are to be dealt with (for example,

imprisonment, fines, compensation, loss of licence). The strategies and mechanisms decided

upon will again often reflect some (or all) of the theories of punishment discussed above.

The main factor becomes how a particular system operates and is enforced in order to

achieve compliance with the rules that have been set.

It is relevant to this discussion to consider the two major approaches that

enforcement agencies may take in order to achieve compliance with them—deterrence or a

cooperative, persuasive and educative approach.273

A. Deterrence Approach

In addition, Braithwaite’s model of

‘responsive regulation’, which sees enforcement as involving progression through such

approaches, is discussed. Such approaches diverge in their emphasis on the underlying

theories of punishment, or a combination thereof, as catalysts for compliance in regulatory

schemes. It is Braithwaite’s model that is argued to be the most effective in achieving

compliance and operating in a manner that promotes better regulation. Similar to the

conclusions drawn regarding co-regulation, it will be shown that a mixture of punishment

(or the threat thereof) and persuasion is preferable to approaches that adopt deterrence or

cooperation, persuasion and education alone.

As discussed above, deterrence involves securing compliance with the law by way of

both detecting breaches and penalising those who have offended, and by having penalties

in place about which the public can make rational decisions concerning the costs of

engaging in certain acts and whether they outweigh the benefits. Both in turn are seen as

273 Cartwright, above n166, 214.

tools to achieve the main goal of preventing future crime by way of deterrence.274

The most significant strengths of a deterrence approach are that it is ‘theoretically

capable of generating a specific quantum of penalty... [and i]t provides a non-arbitrary,

principled and systematic approach to the practical problem of penalty setting.’

A

deterrence approach might also include the use of incapacitation and/or rehabilitation

mechanisms—the elements of which have already been discussed—in order to deter

behaviour in the future.

275

Bilmes and Woodbury claim that a deterrence approach is also particularly valuable

in acknowledging the need to factor the probability of detection into the calculation of

appropriate penalties.

That is, it

can lead to a consistent approach to enforcement as penalties are quantifiable, and

regulatory agencies adopt a policy of always taking action when they discover a breach. As

such the adoption of such an approach reduces the likelihood of unfairness and/or

arbitrariness in that penalties are implemented based on the offence itself in a fairly

uniform manner.

276

Factoring the probability of detection into the penalty setting equation does not, however, inexorably lead to the acceptance of the deterrence model of penalty setting. For example, it could plausibly be argued that the probability of detection is related to the ‘seriousness’ of the violation, which is a factor relevant to determining the penalty level under the desert model. Thus, the more covert the behaviour involved (and, therefore, the smaller the probability of detection), the greater the seriousness of the contravention, thereby justifying an escalation in the level of the penalty.

That is, where violations of the law are difficult to detect, an

increase in penalty would be justified.

However, as Yeung points out

277

274 Banks, above n167, 105. 275 Yeung, ‘Quantifying Regulatory Penalties: Australian Competition Law Penalties in Perspective’, above n213. 276 Jack Bilmes and John Woodbury, ‘Deterrence and Justice: Setting Civil Penalties in the Federal Trade Commission’ (1991) 14 Research in Law and Economics 191, 202. 277 Yeung, ‘Quantifying Regulatory Penalties: Australian Competition Law Penalties in Perspective’, above n213, 18.


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In this sense the greater penalty reflects a retribution theory rather than a deterrence

approach.

This is not the main failing of a deterrence approach. Deterrence approaches have

been greatly criticised for numerous other reasons.278 Criticisms exist in relation to the cost

of taking prosecution action which can be very high, if not prohibitive;279 the lack of

empirical evidence showing that such an approach does in fact prevent crime;280

...there exists no scientific basis for expecting that a general deterrence policy, which does not involve an unacceptable interference with human rights, will do anything to control the crime rate. The sort of information needed to base a morally acceptable general policy is lacking. There is some convincing evidence in some areas that some legal deterrents have exerted deterrent effects. These findings are not, however, generalizable [sic] beyond the conditions that were investigated. Given the present state of knowledge, implementing an official deterrence policy can be no more than a shot in the dark, or a political decision to pacify “public sentiment”.

and the

difficulties with determining which penalties to use.

After conducting a comprehensive review of studies that have considered the

deterrent effects of punishment Beyleveld concluded:

281

Similarly, in relation to determining which penalties to use Hudson argues that a

deterrence approach is inevitably flawed. She notes that ‘the immediate obvious difficulty

This is not to say that setting, for example, legislative prohibitions and/or penalties for

certain activities (such as human reproductive cloning) that assuage community concerns

and ‘set limits’ should not occur. The criticism is that adopting a general deterrence

approach as a mode of enforcement when such an approach is based on nothing more than

‘a shot in the dark’ or a ‘political decision to pacify public sentiment’ is unsatisfactory.

278 Braithwaite, Restorative Justice and Responsive Regulation, above n8, 102. 279 Cartwright, above n166, 214. 280 Deryck Beyleveld, 'Deterrence Research as a Basis for Deterrence Policies' (1979) 18 Howard Journal of Penology and Crime Prevention, 135-149. 281 Ibid.

with deterrence is how we can know how severe penalties have to be to make people

decide against crime’.282

...even if some sort of ‘deterrence calculus’ were possible for at least the crimes of material gain that seem to arise from rational deliberation...any consequent deterrent effect would be difficult to measure.

She also states that:

283

In this sense the deterrence approach is again problematic as there is a potential difficulty in

measuring whether the penalties are actually serving to deter behaviour. In addition, it is

difficult to determine how much crime is actually being committed as crime rates are only

based on reported crimes and/or convictions. Even if such rates could be properly

established, this does not necessarily mean that one could determine how effective

penalties were in deterring such behaviour.

284

B. Cooperative, Persuasive and Educative Approach

Finally, it is apparent that in some

circumstances, even the most severe penalties (for example the death penalty) do not

prevent people from committing crimes in certain circumstances. Yet, deterrence

approaches are still popular with governments and policy makers, and, continue to be used

despite these important criticisms.

The second major approach that regulatory agencies may take in order to achieve

compliance is an approach that emphasises co-operation, persuasion and education. Such

an approach involves an ‘efficient, cost-conscious use of resources and ...can be justified as

economically rational’.285 In addition, selective use of less formal mechanisms of

enforcement may produce a higher level of compliance than routine prosecutions.286

282 Hudson, above n172, 22. 283 Ibid. 284 Ibid. 285 Baldwin and Cave, above n151, 98. 286 Ibid.


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A cooperative, persuasive and educative approach is based on the assumption that

compliance is best secured by cooperation rather than adversarial or punitive

approaches.287 This approach recognises that those being regulated are amenable to good

faith negotiation (cooperation) and are willing to follow the advice of regulators

(persuasion).288 Educative processes are thus important. This may entail regulators ‘giving

advice and education for accomplishing compliance by publishing best practice guides,

running seminars, setting up networks and seminars for compliance professionals, and being

involved in developing voluntary management system standards’.289 Such systems ‘seek to

prevent harm by disseminating knowledge about the risks of misconduct and extant

regulatory standards by ensuring businesses are competent to operate and act in a socially

desirable manner and by creating cooperative relationships with those regulated’.290

On the other hand, such approaches have been criticised, particularly by proponents

of deterrence strategies, as prone to ‘capture’—that is the regulators and regulatees having

so much to do with each other through shared experience, exchanges, contacts and/or

familiarity as to make prosecution unthinkable.

291 In addition, if used as the only mode of

enforcement approach, cooperation, persuasion and education can lead to a fairly benign

form of regulation if sanctioning powers are absent or regulators are unable to respond to

non-compliance.292

287 Sally Simpson, Corporate Crime, Law and Social Control (2002), 99. 288 John Braithwaite, To Punish or Persuade: Enforcement of Coal Mine Safety (1985), 118. 289 Christine Parker, The Open Corporation: Effective Self-Regulation and Democracy (2002), 269. 290 Simpson, above n287, 95. 291 Richard Brown, ‘Theory and Practice of Regulatory Enforcement: Occupational Health and Safety Regulation in British Columbia’ (1994) 16(1) Law and Policy 63, 83-86. 292 Simpson, above n287, 95.

C. Progression through Various Approaches

Instead of drawing a stark contrast between deterrence and cooperative, persuasive

and educative approaches, it is possible to see enforcement as something that involves a

progression through different compliance seeking approaches.293

Here Ayres and Braithwaite’s theory of ‘responsive regulation’

294—which is ‘a

leading approach to describing and prescribing how regulatory enforcement action best

promotes compliance’295—is relevant. This approach provides the most influential

formulation of the idea that governments and regulators should be responsive to the

conduct of those they seek to regulate in deciding whether a more or less interventionist

response is needed.296 In particular, Braithwaite has posited that law enforcers should be

responsive to how effectively citizens or corporations are regulating themselves before

deciding whether to escalate intervention.297

Ayres and Braithwaite also note that ‘increasingly within both scholarly and

regulatory communities there is a feeling that the regulatory agencies that do the best at

achieving their goals are those that strike some sort of balance between [deterrence and

293 Ibid, 99. 294 Ayres and Braithwaite, above n8; Braithwaite, Restorative Justice and Responsive Regulation, above n8. 295 Vibeke Lehmann Nielsen and Christine Parker, ‘Testing Responsive Regulation in Regulatory Enforcement’ (Paper presented at Law and Society Association Annual Meeting, Denver, United States, 30 May 2008), 2. 296 Ibid. (Nielsen and Parker note that literature on regulatory enforcement includes a range of alternative formulations that incorporate similar ideas, such as ‘flexible enforcement’ (Robert A. Kagan, ‘Regulatory Enforcement’ in D. Rosenbloom and R.Schwartz (eds) Handbook of Regulation and Administrative Law 1994, 383-422; Joseph Rees, Reforming the Workplace: A Study of Self-Regulation in Occupational Safety 1988), ‘tit for tat’ regulatory enforcement (John T. Scholz, ‘Cooperation, Deterrence, and the Ecology of Regulatory Enforcement’ (1984), 18 Law & Society Review 179-224; Raymond J. Burby and Robert G. Paterson, ‘Improving Compliance with State Environmental Regulations’ (1993) 12 Journal of Policy Analysis and Management 753-772), and ‘creative’ enforcement strategy (Peter J. May and Raymond J. Burby, ‘Making Sense Out of Regulatory Enforcement’ (1998) 20 Law & Policy 157-182) and that there are also a profusion of attempts to elaborate, tweak, or develop Ayres and Braithwaite’s original ideas about responsive regulation (eg N. Gunningham and P Grabosky, Smart Regulation: Designing Environmental Policy (1998); Neil Gunningham and Richard Johnstone, Regulating Workplace Safety: Systems and Sanctions (1999)114-133; Parker, above n289; Sally Simpson, above n287) including by Braithwaite himself (John Braithwaite, Toni Makkai and Valerie Braithwaite, Regulating Aged Care: Ritualism and the New Pyramid (2007)). 297 Braithwaite, Restorative Justice and Responsive Regulation, above n8, 29.


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cooperative/persuasive/educative] models’ of regulation.298 In this sense, the enforcement

approach suggested generally involves a combination of both punishment and persuasive

techniques. That is, this type of approach aims to prevent harm and persuade actors to

comply, rather than focusing solely on punishing wrongdoing.299

In rejecting a regulatory system based totally on either persuasion or punishment,

300

Braithwaite concludes that actors will exploit an approach based only on persuasion and

self-regulation when they are motivated by things such as economic rationality. However he

also warns that adopting an approach based mostly on punishment will undermine the good

will of actors when they are motivated by a sense of responsibility.301 Ayres and Braithwaite

note ‘a crucial danger of a punitive posture that projects negative expectations of the

regulated actor is that it inhibits self-regulation’.302 They further state ‘individual rebellion

against being stigmatized as controllable only by punishment is aggregated ...into collective

forms of resistance’.303 They state that the crucial question is when to punish and when to

persuade.304

According to Braithwaite, once citizens see the legal system as a responsive

regulatory system they know they have the opportunity to argue about unjust laws, rather

than being forced into strict punishment regimes in the first instance.

305

298 Ayres and Braithwaite, above n8, 21. 299 Cartwright, above n166, 214. 300 Ayres and Braithwaite, above n8, 24-25. 301 Ibid. 302Ibid, 25. 303 Ibid. 304 Ibid. 305 Braithwaite, Restorative Justice and Responsive Regulation, above n8, 34.

However, they will

also see that ‘game playing in order to avoid legal obligations, failure to listen to persuasive

arguments about the harm their behaviour is doing and what must be done to repair it, will

inexorably lead to regulatory escalation’. 306 In this way, the forces of law are seen as fair

and legitimate but also invincible by those being regulated. 307

Braithwaite suggests that enforcement agencies are most likely to achieve

compliance with their legislation when a mixture of persuasion and punishment techniques

can be used.

308 The most distinctive feature of Braithwaite’s ‘responsive regulation’ is the

‘regulatory pyramid’ in which enforcement agencies employ a hierarchy of sanctions,

commencing with persuasion and culminating in a severe penalty such as imprisonment or

licence revocation.309 That is, more cooperative strategies are deployed at the base of the

pyramid and progressively more punitive approaches utilised only if, and when, cooperative

strategies fail.310

The argument that ‘responsive regulation’ encapsulates is that regulators should

start with the presumption of being cooperative ‘however serious the crime.’

311 This

involves beginning with ‘the most restorative dialogue-based approach we can craft for

securing compliance with a just law’.312 Whilst recognising that it might be appropriate

when there are ‘compelling reasons to do so’ to abandon the presumption of starting at the

base of the pyramid, Braithwaite states that usually with ‘even the most serious matters...it

is better to start with a dialogue at the base of the pyramid’.313 From here, regulatory

enforcement agencies should react responsively to compliant or non-compliant behaviour

of each regulatee.314

306 Ibid. 307Ibid. 308 Ibid, 35. 309 Ibid. 310Ibid, 32. 311 Ibid, 30. 312 Ibid. 313Ibid. 314 Nielsen and Parker, above n295, 2.

Moving up the pyramid to somewhat punitive approaches should


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occur reluctantly and only when dialogue fails.315 An escalation to the most punitive

approaches should only occur when the modest forms of punishment fail.316

The crucial point of the ‘responsive regulation’ theory is that it ‘is a dynamic model.

It is not about specifying in advance which are the types of matters that should be dealt

with at the base of the pyramid, which are the more serious ones that should be in the

middle, and which are the most egregious ones for the peak of the pyramid’.

317 The move

up the pyramid is a response not to the seriousness of the harm done but to the failure to

elicit reform and repair at the base with restorative justice processes. This process, argues

Braithwaite, not only favours less coercive and costly state intervention where possible, but

also makes more coercive measures more legitimate when escalation up the pyramid is

necessary. Braithwaite states that ‘when regulation is seen as more legitimate, more

procedurally fair, compliance with the law is more likely’.318 Accordingly he posits that

cooperation and kindness breed cooperation and kindness, and treating people in an open

minded and respectful manner makes them more willing to listen and cooperate.319

Non-compliance is less attractive for those regulated by the regime if the

enforcement agency is able to escalate the sanction should persuasion be ineffective or

inappropriate given the nature of the breach. Given this, Ayres and Braithwaite argue that

regulatory enforcement agents are only able to utilize responsive regulation to best effect

where they do in fact have a suite of investigation and enforcement options available to

315 Braithwaite, Restorative Justice and Responsive Regulation, above n8, 30. 316 Ibid. 317Ibid. 318 Ibid, 33. 319Ibid. Although the aim in this section is to introduce and explain theories of effective regulation, this view is very important to the discussion that takes place in Chapter Four which moves to a consideration and evaluation of the regulatory system that Australia has put into place regarding research involving human embryos and cloning.

them at all levels of the pyramid, including sufficient punishment at the top.320 The more

options available in the middle of the pyramid between cooperative compliance and the

most serious punishment and incapacitation, the better the theory predicts that responsive

regulation will work.321 Figure 1 reproduces the enforcement pyramid diagram argued by

Braithwaite to depict the enforcement approach of an effective enforcement agency.322

Figure 1: Example of an Enforcement Pyramid

323

Although different agencies have different sanctions available to them, the basic premise of

the enforcement pyramid remains the same. The most frequently used and least severe

sanctions should be found at the bottom of the pyramid while the most severe and least

frequently used sanctions should be found at the peak.324

320 Ayres and Braithwaite, above n8, 44-47; Nielsen and Parker, above n295, 4. 321 Ayres and Braithwaite, above n8, 44-47. 322 Ibid, 39. 323 Ibid. 324 Ibid.

Persuasion

Warning Letter Warning Letter

Civil Penalty

Criminal Penalty

Licence Suspension

Licence Revocation


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With regards to the theories of punishment discussed above, Braithwaite contends

that ‘restorative justice, deterrence and incapacitation are all limited and flawed theories of

compliance’.325 Each needs to be understood and applied in a model that includes all three.

In his figure entitled ‘Toward an Integration of Restorative, Deterrent and Incapacitative

Justice,’326

Enforcement Approaches

Braithwaite hierarchically orders these concepts and places restorative justice at

the base of the pyramid, moving up to deterrence and then incapacitation. As with the

above pyramid, the tools/strategies at the base of the pyramid should be used most

frequently and those at the top least frequently and only as necessary.

Finally, the ‘responsive regulatory’ approach may utilise different enforcement

approaches. An example of this is included in Figure 2.

Figure 2: Example of a Pyramid of Regulatory Design Strategies and 327

325 Braithwaite, Restorative Justice and Responsive Regulation, above n8, 32. 326 Ibid. 327 Ayres and Braithwaite, above n8, 39.

Self-Regulation

Command Regulation with Non-Discretionary Punishment

Command Regulation with Discretionary Punishment

Enforced Self-Regulation

Again, the key contention is that most regulatory action will be channelled to the base of

the pyramid—in its realms of persuasion and self-regulation. Noting the above pyramid is

just one example of the various regulatory design strategies and enforcement approaches

that might be employed within the pyramid, co-regulation might for example replace the

enforced self-regulation and self-regulatory base at the bottom. The aim in all instances

would be to avoid implementing approaches that are adversarial and interventionist, unless

proven to be necessary after all other strategies have failed.328 The signalling of the

capacity to ‘get tough’ is still important as it can encourage a regulatory climate that is more

non-litigious and voluntary than is possible when the state rules out adversarial and punitive

approaches as an option.329 Again, the perception that prosecution is a last resort is an

important factor. If compliance with legislation can be ensured by informal measures then

the prime purpose of the legislation can be achieved cost effectively—‘punishment is

expensive; persuasion is cheap’.330

V. CONCLUSION

The type of model adopted greatly influences the types of punishment mechanisms

chosen, the level of compliance, and the level to which the regulatory system works as a

whole. This chapter has provided the theoretical framework in which Chapters Four to Six will

evaluate current regulatory design strategies and enforcement approaches in the United

Kingdom and Australia regarding research involving human embryos and cloning. The

theoretical framework in this chapter will also provide the basis for proposals in Chapter

Seven to change the Australian and United Kingdom models to include a more responsive

328 Ibid. 329 Ibid. 330 Ibid, 41.


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regulatory approach by maintaining the top level ‘command and control’ design strategies

and deterrence approaches for breaches of legislation by non-licence holders and serious

breaches by licence holders, but implementing greater use of co-regulatory design strategies

and cooperative, educative and persuasive enforcement approaches when regulating

licensed research activities.

The next chapter considers both the objectives and the mechanics of the United

Kingdom and Australian regulatory regimes governing research involving human embryos

and cloning. It looks at how each jurisdiction has addressed the questions of what to

regulate, where to draw the line between permissible and prohibited activities, and how to

regulate. It concludes with an analysis of the type of regulatory design strategy and

enforcement approaches each of the two regulatory systems reflect.

Chapter Four:

REGULATION OF RESEARCH INVOLVING HUMAN EMBRYOS AND CLONING IN THE UNITED KINGDOM AND AUSTRALIA

I. INTRODUCTION

In the previous two chapters we have examined the rationales for regulating

research involving human embryos and cloning (Chapter Two) and the different regulatory

design strategies and enforcement approaches to do so (Chapter Three). In this chapter we

turn specifically to the United Kingdom’s Human Fertilisation and Embryology Act 1990 and

Australia’s Research Involving Human Embryos Act 2002 (Cth) and Prohibition of Human

Cloning Act 2002 (Cth) (later renamed the Prohibition of Human Cloning for Reproduction

Act 2002 (Cth)). Reviews of the Acts are also considered.

This chapter uses the theoretical framework laid out in Chapters Two and Three

respectively to evaluate how each jurisdiction has addressed questions of what to regulate

and where to draw the line between permissible and prohibited research. In order to do

this, the chapter lays out what the United Kingdom and Australian Acts each address and

the public debates and political responses that led to their enactment in the late 20th and

early 21st centuries. It also evaluates how each jurisdiction has chosen to regulate by

considering each jurisdiction’s regulatory design strategy and enforcement approach in

relation to the principles introduced in Chapter Three.

It shows that the rationales discussed in Chapter Two have been met. It will be

argued that each jurisdiction has adopted a clear legislative approach successfully setting

Chapter Four: Regulation of Research Involving Human Embryos and Cloning in the United Kingdom and Australia

Page 93

boundaries for research involving human embryos and prohibiting human reproductive

cloning and certain other practices. However, having satisfactorily addressed what to

regulate and where to draw the line does not indicate that the ‘best mode of regulation’ has

been chosen. The way each jurisdiction has decided how to regulate is therefore analysed.

Of the three regulatory design strategies discussed in Chapter Three—‘self-

regulation/enforced self-regulation’; ‘command and control’; and ‘co-regulation’—it is

argued that both jurisdictions have adopted a ‘command and control’ design strategy. This

is contrasted with Ayres and Braithwaite’s recognition that ‘...the regulatory agencies that

do the best at achieving their goals are those that strike some sort of balance between

[deterrence and cooperative/responsive/educative] models’ of regulation.331


It is argued

that whilst both jurisdictions have to a small degree incorporated cooperative, persuasive

and educative approaches in their regulatory systems, a responsive ‘balance’ with

deterrence approaches has not been achieved.

The analysis presented in this chapter therefore suggests that the mode of

regulation chosen in each jurisdiction does not reflect best regulatory practice. Chapters

Five and Six will further develop this argument by reference to how these systems are

viewed and whether they are accepted by researchers and practitioners (Chapter Five), and

a broader analysis of issues pertaining to scientific values in the research context, and the

regulation of risk in the context of emerging technologies (Chapter Six). Chapter Seven will

set out proposals for regulatory reform.

II. THE UNITED KINGDOM: DECISIONS ABOUT WHAT TO REGULATE AND

WHERE TO DRAW THE LINE BETWEEN PERMISSIBLE AND PROHIBITED

RESEARCH

A. Research Involving Human Embryos: Delineating the First

Boundaries ‘Beyond Which Science Should Not Go’

In making decisions about what to regulate and where to draw the line between

permissible and prohibited research regarding research involving human embryos and

cloning, the United Kingdom relied heavily upon the findings of ‘the Warnock Committee’

inquiry discussed in Chapter Two, into the ethical, social and legal issues raised by advances

in human fertilisation and embryology.332 It was shown that the majority of the Warnock

Committee took the view that although a human embryo had a special status entitling it to

‘some protection in the law’ (underpinned by the ethical, moral and philosophical views

discussed in Chapter Two), an embryo might be used at its very earliest stages of

development as a means to an end that was good for other humans.333 This accords with

the rationale that regulation may be required to encourage the production of ‘public

goods’ whilst being balanced with the ‘moral hazards’ presented by the research.334

However, deciding upon whether human embryos could be used for research at all

was only the first issue for which this ‘balancing’ was to occur. Where such embryos could

or should be obtained was also of issue. In answering this question, there was strong

support from the majority of the Warnock Committee for the use of unused embryos from

332 Warnock, above n5. 333 Warnock, above n5. 334 Hayek, above n151; Breyer, above n151; and Ogus, above n14 cited in Baldwin and Cave, above n151, 12.


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IVF in research, whilst there was greater division amongst the Committee concerning the

generation of embryos specifically for research purposes.335

The Warnock Committee recognised ‘a clear moral distinction between the research

use of embryos available by chance, which were not needed for the purposes of treatment,

and …the generation of embryos brought into being for the purposes of research alone’.

336

However, a slim majority favoured permitting the generation of embryos for research

purposes. They argued that ‘if research involving human embryos is to be permitted…it

makes no difference whether these embryos happen to be available or were brought into

existence for the sake of research’.337

The members of the committee that were opposed to the deliberate generation of

embryos for research also recognised that it might slow down the pace, and/or limit the

possible types of research. However their emphasis was on the ‘moral hazards’ that allowing

embryos to be created for research might pose. They adhered to the view that, ‘whatever

the handicap to scientific progress, it would be morally wrong to bring human embryos into

The majority view was that in neither case would the

embryos have the potential for life, because in neither case were they to be transferred to a

uterus. Further, the members that held this view gave a great deal of weight to the

consideration that ‘to prohibit the generation of embryos specifically for research would

severely curtail the range and scientific validity of research involving human embryos’

[particularly because] inevitably ‘spare embryos’ from IVF treatment ‘tend to be less good’

which, they argued, could affect the findings of any research project. Here, in the balancing

exercise, the majority emphasised the rationale that encourages the production of ‘public

goods’.

335 See expression of dissent by TSG Baker, Professor Dyson, Mrs Edwards and Doctor Greengross in Warnock, above n5, 94. 336 Warnock, above n5, 67. 337Ibid, 68.

being solely for the purpose of research’.338 A further argument put forward in dissent was

that once it was ‘permissible to allow embryos to come into being with the sole intention

they be used for research, this would open the way for an ever-increasing use of human

embryos for routine and less valid research’.339

promoting advances in the treatment of infertility

The majority view was accepted, and since the subsequent enactment of the HFE

Act, research involving human embryos has been permitted in the United Kingdom for

strictly defined purposes. These purposes were:

increasing knowledge about the causes of miscarriage

increasing knowledge about the causes of congenital disease

developing more effective techniques of contraception

developing methods for detecting the presence of gene or chromosome

abnormalities in embryos before implantation, or

for such other purposes as may be specified in regulations. 340

Such activities all related to work associated with assisted reproductive technology including

research that could improve understanding or treatment of congenital diseases.

B. Stem Cell Research and Cloning – Public Consultation and

Moving the Line

The debate about what to regulate and where to draw the line continued as technology

progressed. In 1998, in response to the developments surrounding embryonic stem cell

338 Ibid, 67. 339 Ibid. 340 Human Fertilisation and Embryology Act 1990 (UK), Schedule 2, 3(2).


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research and cloning, the HFEA and Human Genetics Advisory Committee341 (HGAC)

undertook a joint public consultation on cloning. They released a consultation paper

‘Cloning Issues in Reproduction, Science and Medicine’,342 which asked a number of

questions pertaining to both the use of cell nuclear replacement technology for research

and for reproductive purposes. Amongst the questions asked was whether research using

cell nuclear replacement technology would raise any new ethical issues in relation to what

was already permitted when working with embryos in the 14-day period; and whether there

were any medical or scientific areas that might benefit from research involving human cell

nuclear replacement.343 Nearly 200 responses were received—‘about 40% from individual

members of the public and the rest from a wide range of constituencies, including

professional bodies, religious organisations and lay groups, many of whom had organised

their own discussion groups or otherwise canvassed views’.344

such safeguards be recognised as wholly adequate to forbid human reproductive

cloning in the United Kingdom (however, the report also suggested the Government

should consider the possibility of introducing legislation that would explicitly ban

human reproductive cloning regardless of the technique used);

The report concluded that

the HFE Act had proved effective in dealing with new developments relating to human

cloning. It recommended that:

341 The HGAC was established in December 1996 as a non-statutory advisory body. It provides independent advice to UK Health and Industry Ministers on issues arising from developments in human genetics that have social, ethical and/or economic consequences. 342 Human Genetics Advisory Committee (HGAC) Papers, Cloning Issues in Reproduction, Science and Medicine (1998), http://www.advisorybodies.doh.gov.uk/hgac/papers/papers_c.htm at 12 June 2006. 343 Ibid. 344 Human Fertilisation and Embryology Authority, HFEA/HGAC Welcome Government Response to Cloning Report (Press release, 24 May 1999), http://www.hfea.gov.uk/PressOffice/Archive/HFEAHGACwelcomeGovernmentresponsetohumancloningreport at 12 June 2006.

http://www.advisorybodies.doh.gov.uk/hgac/papers/papers_c.htm�

http://www.hfea.gov.uk/PressOffice/Archive/HFEAHGACwelcomeGovernmentresponsetohumancloningreport�

the Secretary of State for Health should consider specifying in regulations

two further purposes for which the HFEA might issue licences for research: the

development of methods of therapy for mitochondrial disease; and the development

of therapeutic treatments for diseased or damaged tissues or organs; and,

the issues be examined again in five years time in the light of developments and

public attitudes towards them.345

In response to the report, the UK Government stated:

The Government reaffirms its policy that human reproductive cloning is ethically unacceptable and cannot take place in this country. However, we recognise that regulations to allow therapeutic research should be very carefully considered. It has been suggested that therapeutic cloning techniques might be able to provide immunologically compatible tissue for the treatment of degenerative diseases of the heart, liver, kidneys and cerebral tissue, or repair damage to skin or bone. We believe that more evidence is required of the need for such research, its potential benefits and risks and that account should be taken of alternative approaches that might achieve the same ends.346

In September 1999, the United Kingdom government set up an expert group under

the chairmanship of the Chief Medical Officer, Professor Sir Liam Donaldson (the Donaldson

Committee). The terms of reference for the Donaldson Committee were ‘to undertake an

assessment of the anticipated benefits of new areas of research using human embryos, the

risks, and the alternatives; to advise whether these new areas of research should be

permitted; and to advise whether regulations needed to be made under the 1990 Act to

extend the purposes for which the HFEA might issue licences for research involving human

345 Ibid. 346 Department of Health, Government Response to the HFEA/HGAC Report on Cloning (Press release, 24 June 1999) http://www.dh.gov.uk/PublicationsAndStatistics/PressReleases/PressReleasesNotices/fs/en?CONTENT_ID=4025446&chk=0zNabK at 12 June 2006.

http://www.dh.gov.uk/PublicationsAndStatistics/PressReleases/PressReleasesNotices/fs/en?CONTENT_ID=4025446&chk=0zNabK�

http://www.dh.gov.uk/PublicationsAndStatistics/PressReleases/PressReleasesNotices/fs/en?CONTENT_ID=4025446&chk=0zNabK�


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embryos’.347 In its report,348

With respect to ethical considerations the Donaldson Committee emphasised that

the then current restrictions and controls on embryo research reflected the belief that the

embryo has a special status as a potential human being, but that ‘the respect due to the

embryo increases as it develops, and that this respect, in the early stages in particular, may

properly be weighed against the potential benefits arising from the proposed research’.

the Donaldson Committee noted that research involving the

creation of an embryo from cell nuclear replacement was not prohibited under the HFE Act,

provided it was for one of the existing specified purposes. However, the HFE Act as it was

did not permit ‘the creation or use of embryos for research to improve understanding or

treatment of non-congenital diseases’—noting that there was scope for additional research

purposes to be added through Regulations.

349

They also stated that although the creation of embryos via cell nuclear replacement may

raise concerns about embryos being created simply as ‘a means to an end’, the potential

benefits of such research needed to be weighed against these concerns. Finally, they

concluded that concerns about allowing research involving human embryos created by cell

nuclear replacement being the first step toward enabling human reproductive cloning were

not a realistic prospect because of the stringent controls operated in the United Kingdom by

the HFEA.350

The principal recommendation of the Donaldson Committee was that ‘research using

embryos (whether created by IVF or cell nuclear replacement) to increase understanding

347 House of Lords, Select Committee Appointed to Consider and Report on the Issues Connected with Human Cloning and Stem Cell Research Arising from the Human Fertilisation (Research Purposes) Regulations 2001, Stem Cell Research Report (13 February 2002). 348 Department of Health (UK), Stem Cell Research: Medical Progress with Responsibility: A Report from the Chief Medical Officer’s Expert Group Reviewing the Potential of Developments in Stem Cell Research and Cell Nuclear Replacement to Benefit Human Health (June 2000), 7. 349 Ibid, 7. 350 Ibid, 7.

about human disease and disorders and their cell-based treatments should be permitted’,

subject to the controls in the HFE Act.351

In light of the report, the United Kingdom government brought forward draft

regulations extending the purposes for which research involving human embryos could be

lawfully conducted. In January 2001, following large majorities in both Houses of

Parliament,

352

increasing knowledge about the development of embryos;

the Human Fertilisation and Embryology (Research Purposes) Regulations

were enacted. These extended the purposes for which embryo research could take place,

adding to the above:

increasing knowledge about serious disease; and

enabling any such knowledge to be applied in developing treatments for

serious disease.353

These additional provisions allowed for embryos to be developed using SCNT,

noting that embryos can be created for research purposes only, kept only up to 14 days

(when the primitive streak appears) and, the genetic make-up of any cell cannot be altered

while it forms part of an embryo.

When evaluating the ongoing process of revising the regulation in terms of

permissible and prohibited activities, it is again apparent that the underlying rationales for

regulation discussed in Chapter Two are all manifest. As the technology evolved and

regulatory decisions about where to draw the line (or in fact, whether to shift the earlier line

that had been drawn) were called for, consideration of the moral and ethical dilemmas

351 Ibid, 10. 352 The regulations were debated and passed by the House of Commons on 19 December 2000 and by the House of Lords on 22 January 2001. In the House of Commons the vote was 366 to 174 (majority 192) in favour of the regulations. In the House of Lords the Peers voted in favour of the regulations and rejected a delaying amendment by 212 votes to 92 (a majority of 120). 353 Human Fertilisation and Embryology Act 1990 (UK), Schedule 2, 3(2); Human Fertilisation and Embryology (Research Purposes) Regulations 2001 (UK).


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associated with such research can be seen. The weighing of potential benefits against the

moral hazards posed by the development of technologies within the area is then illustrated

through consultation and committee processes. In addition, the ongoing process of

addressing the public demand to be informed about general research practice, and any

hazards or deficiencies associated therewith is seen. Distributive justice and social policy

justifications are also apparent in that, whilst taking into account submissions made to the

inquiries, individual preferences did not form the basis of decisions about where to draw the

line—rather they reflected a considered decision making process which included reference

to public opinion, the potential scientific outcomes, and the potential risks involved with

such research.

What is clearly apparent is that the regulation of research involving human embryos,

and later cloning, in the United Kingdom was, and continues to be, responsive to

technological changes and flexible in terms of being able to be reviewed in relation to

permissible and prohibited activities. This occurred within a relatively short period of time in

a legal regulatory sense and was facilitated by the enactment of regulations rather than full

legislative review. However, although the Human Fertilisation and Embryology (Research

Purposes) Regulations (the regulations) were passed by a significant majority of both United

Kingdom Houses of Parliament, and the consultation and committee processes reflect

fundamental rationales for regulation, such reviews—and boundary shifting—were not

without controversy. This is illustrated in the next section, and is important in recognising

that deciding upon what to regulate and where to draw the line between permissible and

prohibited research’ has involved ongoing legal as well as political and public processes.

C. Stem Cell Research and Cloning – Further Judicial and Committee

Review

Prior to the passing of the regulations the Pro-Life Alliance applied to the United

Kingdom the High Court of Justice for judicial review of the legislation354

(b) references to an embryo include an egg in the process of fertilisation, and, for this purpose, fertilisation is not complete until the appearance of a two cell zygote.

arguing that an

embryo created by cell nuclear replacement did not fall within the HFE Act’s definition of

embryo and therefore should not be allowed. The HFE Act provided:

(1) In this Act, except where otherwise stated -- (a) embryo means a live human embryo where fertilisation is complete, and

355

In November 2001, Crane J ruled in favour of the Pro-Life Alliance, indicating that it was

common ground that cell nuclear replacement did not involve fertilisation and as such, the

HFE Act (or any additions to it) did not cover embryos created in this way.

356 This judgment,

contrary to the intent of the Pro-Life alliance, left human cloning unregulated in the United

Kingdom. The United Kingdom government immediately announced that it would introduce

legislation to prohibit reproductive cloning. The Human Reproductive Cloning Act 2001 (UK),

which provides that ‘a person who places in a woman a human embryo which has been

created otherwise than by fertilisation is guilty of an offence’,357

354 R v Secretary of State for Health, ex parte Bruno Quintavalle (on behalf of Pro-Life Alliance) [2001], EWHC Admin 918. 355 Human Fertilisation and Embryology Act 1990 (UK), s1. 356 R v Secretary of State for Health, ex parte Bruno Quintavalle (on behalf of Pro-Life Alliance) [2001], EWHC Admin 918. 357 s1(1).

became law on 4 December

2001. The United Kingdom government also lodged an appeal against the judgment to try to

bring the use of cell nuclear replacement for research back within the scope of the HFE


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Act.358 The Court of Appeal ruled in favour of the Government. An appeal by the Pro-Life

Alliance to the House of Lords was dismissed in 2003.359

Secondly, some members of the House of Lords expressed concern that the

proposed changes in the regulations were being rushed through parliament and should be

left unchanged until they had been fully considered by a Lords committee.

360 There was

particular concern about the ethical implications of stem cell research on embryos produced

by cloning. Whilst the House of Lords rejected delaying the amendment, it agreed a motion

appointing a Committee (the Select Committee) ‘to consider and report on the issues

connected with human cloning and stem cell research arising from the Human Fertilisation

and Embryology (Research Purposes) Regulations’.361

The Select Committee issued a call for evidence on 5 April 2001 and distributed it

widely,

Thus whilst allowing the regulation to

be responsive in a reasonable timeframe given the rapidity with which technological

advances are made, caution was still able to be exercised and further investigations made

without delaying scientific progress.

362

358 R (Quintavalle) v Secretary of State for Health [2002] EWCA, Civ. 29. 359 R (on the application of Quintavalle on behalf of Pro-Life Alliance) v Secretary of State for Health ([2003] UKHL 13.

stating that as these were ‘profound issues which touch many people very deeply

360 ‘In the Lords an amendment was tabled by Lord Alton of Liverpool inviting the House to decline to approve the draft regulations until a Select Committee had reported on the issues connected with human cloning and stem cell research. This amendment was rejected (by 212 votes to 92). An alternative amendment was then proposed by Lord Walton of Detchant calling on the Government to support the appointment of a Select Committee to report on the issues connected with human cloning and stem cell research, and to undertake to review the Regulations following the report of that Committee. This amendment was passed without a division, and the Regulations duly came into effect on 31 January 2001.’ House of Lords, Select Committee appointed to consider and report on the issues connected with human cloning and stem cell research arising from the Human Fertilisation and Embryology (Research Purposes) Regulations 2001 (UK). 361 The motion was agreed on 7 March 2001: Ibid. 362 The call for evidence was distributed to scientific and research organisations, the churches, medical charities, patients’ support groups, pro-life groups and others with a close interest in the issues, and organisations representing sections of the general public, such as the National Association of Citizens Advice Bureaux, the Townswomen’s Guild, the Trades Union Congress and the National Federation of Women’s Institutes.

[they] wanted to hear from as broad a cross section of society as possible’.363 Again, the

recognition of the longstanding ethical, moral and philosophical arguments discussed in

Chapter Two, alongside the desire of many to facilitate research that had the potential to

cure diseases was apparent. The Select Committee received 52 submissions from

representative organisations and 57 from individuals. It also held 12 sessions of oral

evidence at which 42 people364 appeared. In order to reach a broader range of opinion they

also commissioned the Hansard Society to conduct an internet debate over a period of four

weeks in September and October 2001. One hundred and ninety six people registered to

take part in the debate, 110 users logged on to the site and 330 messages were posted. The

Select Committee reported that the ‘nature of the submissions …received varied

considerably, consisting of both technical evidence about scientific developments and

expressions of opinion and argument on the ethical aspects’.365

The central question for the Select Committee was whether the extension of the

purposes in the Human Fertilisation and Embryology (Research Purposes) Regulations was

justified. In addressing this question it detailed its conclusions and recommendations in

relation to stem cell research, the status of the early embryo, CNR and cloning, and

legislation and regulation.

366

Specifically, the Select Committee concluded that both adult and human embryonic

stem cell research appeared to have great therapeutic potential for the treatment of many

363 House of Lords, Select Committee Appointed to Consider and Report on the Issues Connected with Human Cloning and Stem Cell Research Arising from the Human Fertilisation (Research Purposes) Regulations 2001, above n347. 364 Representing 17 organisations (or in some cases giving evidence on their own account). 365 House of Lords, Select Committee Appointed to Consider and Report on the Issues Connected with Human Cloning and Stem Cell Research Arising from the Human Fertilisation (Research Purposes) Regulations 2001, above n347. 366 Ibid.


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disorders and for the repair of damaged tissue.367 They concluded that in order to ensure

maximum medical benefit it was necessary to keep both routes open, and saw a ‘strong

scientific and medical case for continued research on human ES cells’.368 Again—in terms of

regulatory rationales—we see the balancing of potential public benefits of research against

the moral hazards. Whilst recognising the ‘deeply held views of those who regard any

research involving the destruction of a human embryo as wrong’, the Select Committee ‘was

not persuaded that all research on early human embryos should be prohibited’.369

Distributive justice and social policy justifications are again apparent. Decisions

about whether to extend the purposes in the Human Fertilisation and Embryology (Research

Purposes) Regulations did not reflect individual points of view. Rather they reflect balancing

social policy justifications, which saw the potential public benefits as justifying permitting

certain research involving human embryos and cloning (for research purposes), with the

moral, ethical and philosophical concerns discussed in Chapter Two. The Select Committee

noted that the number of embryos created for research was much smaller than the number

of ‘surplus’ IVF embryos used. They expressed the view that such research could continue

but that embryos should not be created specifically for research purposes unless there was

a demonstrable and exceptional need that could not be met by the use of surplus

embryos.

This

conclusion was drawn by reference to the context of current law and social attitudes, in

particular that the HFE Act had permitted research on both surplus IVF embryos and

embryos created for research since its inception.

370

367 Ibid. 368 Ibid. 369 Ibid. 370 Ibid.

The Select Committee also concluded that the use of CNR to create embryos for

research was acceptable provided again that there was ‘demonstrable and exceptional

need’ that could not be met by the use of ‘surplus’ embryos. They noted their view that

there was no ethical difference between the use of surplus embryos and CNR created

embryos for research purposes up to the 14-day limit. They also reiterated strong

opposition to human reproductive cloning and endorsed the legislation that prohibited it.

Ultimately, it was the conclusion of the Select Committee that the extension of the purposes

in the Human Fertilisation and Embryology (Research Purposes) Regulations was justified.

Research involving human embryos has thus been permitted by legislation in the

United Kingdom since 1990 and the boundaries relating to such research have shifted as

science has advanced. The HFEA have kept detailed records on the number of embryos used

in research and published annual reports on approved projects.371 ‘Some 48,000 embryos

which were no longer needed for in vitro fertilisation were used in research between August

1991 and March 1998 and 118 embryos were created in the course of research in the same

period’.372

Again it is argued that the ongoing process of line drawing in relation to what is or is

not permissible with regards to research involving human embryos and cloning, reflects and

incorporates the underlying rationales for regulation discussed in Chapter Two (and above).

The United Kingdom has adequately addressed what to regulate and where to draw the line

between permissible and prohibited activities questions. In doing so, the position they have

adopted has led to a legislative framework that allows research involving human embryos to

progress whilst prohibiting activities that are seen as unacceptable. Given the extensive

In February 2009 thirty-six research projects held HFEA licenses. A summary of

the details of such licences can be found at Appendix 4.

371 See Human Fertilisation and Embryology Website: http://212.49.193.187/cps/rde/xchg/SID-3F57D79B-907F604D/hfea/hs.xsl/421.html. 372 Department of Health (UK), Stem Cell Research: Medical Progress with Responsibility: A report from the Chief Medical Officer’s Expert Group Reviewing the Potential of Developments in Stem Cell Research and Cell Nuclear Replacement to Benefit Human Health, above n348.




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public consultation, inquiries, reviews, reports and parliamentary debate that have been

conducted, there is no need to challenge such boundaries beyond ensuring review

processes are maintained and continued revision occurs in an area that is constantly

changing and advancing.

However, this does not indicate that the type of regulation chosen is the most

suitable for the context of research involving human embryos and cloning.

III. THE UNITED KINGDOM: ADDRESSING THE ‘HOW TO REGULATE’ QUESTION

A. Enforcement Mechanisms and Compliance Strategies

The Human Fertilisation and Embryology Authority (HFEA) was established with the

enactment of the 1990 HFE Act.373 As stated in Chapter Two, it is a regulatory bureaucracy

that has the primary duties of granting of licences ‘authorising activities in the course of

providing treatment services’;374 maintaining ‘a code of practice giving guidance about the

proper conduct of activities carried out in pursuance of a licence’;375 and maintaining a

register of those receiving treatment and born as a result of treatment.376 In addition, the

HFEA carries out oversight activities and is required to report publicly on the services it

provides and its licensing activities377 and, pursuant to the HFE Act, the HFEA has a statutory

duty to produce a Code of Practice that sets standards and gives guidance about the proper

conduct of HFEA-licensed activities.378

373 The Human Fertilisation and Embryology Authority took up its full statutory responsibilities in August 1991. Human Fertilisation and Embryology Act 1990 (UK) s5. 374 Human Fertilisation and Embryology Act 1990 (UK) s2. See also above n101. 375 Human Fertilisation and Embryology Act 1990 (UK) s25(1). 376 Human Fertilisation and Embryology Act 1990 (UK) s31. 377 Human Fertilisation and Embryology Act 1990 (UK) ss7-8.

378 The HFEA Code of Practice (7th Edition) came into force in July 2007. This edition is made up of two parts; ‘Standards’ and ‘Guidance’. The Standards contain a set of agreed, common specifications for relevant aspects of ART or research projects involving the use of human embryos. Conformity to standards is mandatory insofar as they express a legal requirement or a condition of licence. Evidence of conformity with the standards is

Anybody wishing to conduct research involving human embryos and/or cloning in

the United Kingdom must therefore adhere to the HFE Act, the HFEA licensing system, and

the HFEA Code of Practice. As such, the regulatory system in place in the United Kingdom

provides a framework within which research scientists and practitioners are required to

work including that all those wanting to do certain research must obtain a licence and are

subject to ongoing oversight and inspections. Since the inception of these provisions all

research in the United Kingdom has been conducted under the aegis of the HFE Act and

HFEA licensing system.

There are also severe criminal penalties, fines and the potential for licence

revocation, if a person commits certain ‘offences’ under the HFE Act. That is, with the

introduction of the 1990 HFE Act prohibitions and corresponding criminal sanctions were

also enacted. Section 41 of the HFE Act provides for numerous offences and penalties that

impose terms of imprisonment ranging from 6 months to 10 years, and/or fines. Specific

examples of offences pertaining to research involving human embryos and treatment

include that:

1) section 41(1) of the HFE Act 1990 (UK) provides that a person who places in a

woman a live embryo other than a human embryo, or any live gametes other than human

gametes; uses gametes in any way prohibited by the regulations; keeps or uses an embryo

after the appearance of the primitive streak; places an embryo in any animal; keeps or uses

an embryo in any circumstances in which regulations prohibit its keeping or use; or replaces

sought during an HFEA inspection and is considered by HFEA licence committees in considering whether to grant, renew, vary or revoke a licence. The Guidance, gives further information concerning the manner in which licensable activities are to be carried out, and the functions and responsibilities of licensees. On 17 November 2008 the HFEA announced its public consultation on the draft of the eight edition of the HFEA Code of Practice. This consultation will end on 18 February 2009. Following Ministerial approval, the eight edition of the HFEA Code of Practice will be published in July 2009 and come into force on 1 October 2009: Human Fertilisation and Embryology Authority, ‘FAQ-Draft Eight edition of the HFEA Code of Practice’, http://www.hfea.gov.uk/en/1744.html at 20 November 2008.

http://www.hfea.gov.uk/en/1744.html�


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a nucleus of a cell of an embryo with a nucleus taken from a cell of any person, embryo or

subsequent development of an embryo, is guilty of an offence and liable on conviction on

indictment to imprisonment for a term not exceeding ten years or a fine or both;379

2) a person is guilty of an offence and liable on conviction to imprisonment for up to

two years and/or a fine under the Act if they bring about the creation of an embryo, or keep

or use an embryo, except in pursuance of a licence.

and

380 (Similar penalties apply to a person

who provides false or misleading information for the purposes of a grant of a licence.)381

Pursuant to section 1(1) of the Human Reproductive Cloning Act 2001 (UK) it is also a

criminal offence to implant an embryo which has been created otherwise than by

fertilisation in a woman. A person who is guilty of the offence is liable on conviction on

indictment to imprisonment for a term not exceeding 10 years or a fine or both.

382

a) any information given for the purposes of the application for the grant of the

licence was in any material respect false or misleading,

In addition to the criminal sanctions available under the HFE Act, the HFEA licence

committee may revoke a licence if it is satisfied that:

b) the premises to which the licence relates are no longer suitable for the activities

authorised by the licence,

c) the person responsible has failed to comply with directions given in connection

with any discharge of licence, or is unable because of incapacity to discharge, the

duty under section 17 of the Act to ensure that the other persons to whom the

licence applies are of such character, and are so qualified by training and

experience, as to be suitable persons to participate in the activities authorised by

379 Human Fertilisation and Embryology Act 1990 (UK), s41(1). 380 Human Fertilisation and Embryology Act 1990 (UK), s41(2). 381 Human Fertilisation and Embryology Act 1990 (UK), s41(3). 382 Human Reproductive Cloning Act 2001 (UK), s1(2).

the licence, proper equipment is used, proper arrangements are made for the

keeping of gametes and embryos and for the disposal of gametes or embryos

that have been allowed to perish, suitable practices are used in the course of the

activities, and the conditions of the licence are complied with, or

d) there has been any other material change of circumstances since the licence was

granted.383

A licence committee may also revoke a licence if it ceases to be satisfied that the character

of the person responsible is such as is required for the supervision of those activities or that

the nominal licensee is a suitable person to hold a licence, or the person responsible dies or

is convicted of an offence under this Act.

A number of underlying theories of punishment (and corresponding mechanisms for

enforcement) introduced in Chapter Three are reflected within the United Kingdom regime.

The threat of financial penalties, and imprisonment in relation to deemed offences

and/or loss of licence as penalties that can be used if researchers and/or practitioners do

not comply with the legislation, regulations and/or Code of Practice could, in theory, serve

to deter behaviour. That is, although the penalties exist, they may not need to be used for

the legislation to be effective as a regulatory tool. As such, the threat of the enforcement

provisions may (theoretically) in itself secure compliance and therefore act as a deterrent in

most instances.

The above described penalties are also forms of incapacitation. In instances where

there is a breach of the legislation (that is, the commission of an offence), the heavy

penalties would incapacitate the offender(s) from acting further.

383 Human Fertilisation and Embryology Act 1990 (UK), s18(1).


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Rehabilitation also theoretically has a place within the licensing and oversight system

adopted in the United Kingdom. For example, the financial or jail penalties may serve to

lead offenders to recognise they have committed a wrong and/or to feel publicly shamed,

which in turn may prompt changes to behaviour in the future. Educative deterrence may

also exist through a dialogue between the regulators and regulatees (that is, the research

scientists and practitioners).

Finally, retribution by way of a ‘just deserts’ approach to punishment is also arguably

existent in that the deterrent and incapacitation methods discussed above are clearly linked

to the types of offences that may be committed. More information is needed regarding

what lies behind how and why the penalties in the Act were decided upon, however they

may arguably reflect a view that if one committed an offence under the Act they ‘deserve’

to be punished.

In addition to the underlying theories of punishment, of the three regulatory

approaches discussed in Chapter Three, it is apparent that with the inception of the HFE Act

the United Kingdom adopted a ‘command and control’ regulatory design strategy. A

regulatory bureaucracy, the HFEA, was set up whose influence is exercised by imposing

standards backed by criminal sanctions. The force of the law is used to prohibit certain

activities, to demand some sort of positive action, and to prescribe conditions for entry into

conducting research involving human embryos via a licensing system. The HFEA is granted

some decision making power via its publication of a code of practice. The licensing process

operates to screen entry into certain activities, and also set out such things as expected

standards, the manner of conducting the activity (for example, in making decisions about

how many embryos may be used), and to oversee and carry out inspections of the licensed

facilities.

The regulatory mechanisms and strategies adopted by the United Kingdom are

further discussed and evaluated below, after the Australian regulatory system has been

described. Before moving to consideration of the Australian system however a number of

other significant occurrences in the United Kingdom that will ultimately impact on the

regulatory system they have adopted are noted. These will also be the subject of further

discussion in Chapter Seven when arguing that the best mode of regulation for the United

Kingdom is one that incorporates co-regulatory strategies.

B. Other Legislation and Recommendations: A Shift in Regulatory

Approach but not Design Strategy

At around the same time as the Human Fertilisation and Embryology (Research

Purposes) Regulations were being passed, there were also significant developments in the

United Kingdom and European Union regarding the law on human tissue. Following a 2002

Department of Health review of the law on human organs and tissues, the Human Tissue Act

2004 (UK) established another regulatory authority called ‘the Human Tissue Authority’

(HTA). In 2004, the European Union Tissue Directive also set EU-wide standards of quality

and safety for the donation, procurement, testing, processing, preservation, storage and

distribution of human tissue and cells.384

At approximately the same time, but separate from this legislative process, the

United Kingdom Department of Health undertook a review of its 'arm's length bodies' (the

Arms Length Review) in an effort to improve efficiency and cut bureaucracy.

385

384 Directive 2004/23/EC of the European Parliament and the Council of the European Union. Secondary legislation implementing the Directive was passed in April 2007.

It

subsequently proposed to replace, by April 2008, the HFEA and the HTA with a single body

385 Department of Health (UK), Report on Reconfiguring the Department of Health's Arm's Length Bodies, July 2004.


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with responsibilities across the range of human tissue and cells, to be known as the

‘Regulatory Authority for Tissue and Embryos’ (RATE).386 However, six months earlier, in

January 2004, the United Kingdom government had announced a review of the 1990 HFE

Act citing developments in reproductive medicine since the passage of the original

legislation. They conducted a public consultation during the latter half of 2005, and

published the White Paper: Review of the Human Fertilisation and Embryology Act:

Proposals for revised legislation (including establishment of the Regulatory Authority for

Tissue and Embryos) in December 2006. The Human Tissue and Embryos (Draft) Bill was

published in May 2007 for scrutiny by a Joint Committee of both Houses, which rejected the

government’s proposals to merge the HFEA and HTA into RATE. 387

We have found the evidence against establishing RATE overwhelming and convincing and we recommend that the Government abandons the proposals in Part 1 of the draft Bill. We consider that the regulatory oversight provided by the HFEA and the HTA is better than the oversight that could be provided by RATE and we recommend that the HFEA and the HTA ...should be retained as separate authorities.

In particular, the Joint

Committee noted:

388

The Joint Committee did however note ‘the lack of research undertaken as to the workings

of the current regulatory structure, and improvements that could be made’.

389 They

recognised that ‘greater savings, consistency, efficiency and co-operation might be achieved

both within and between the two organisations’ and recommended that the Government,

in consultation with the HFEA, HTA and their stakeholders, ‘look at ways to achieve such

improvements’. They also called for further amendment to the bill ‘to provide a clear

framework based on the principles of devolved regulation.’390

386 Ibid, 37. 387 House of Lords, House of Commons, above n13. 388 Ibid, 31. 389 Ibid. 390 Ibid, 23.

It was their view that:

..Legislation should devolve regulatory authority and decision making to the regulators, who in turn should be given the power in legislation to define areas of ‘exemption’ within their regulatory remit. This would provide a framework of ‘permitted regulation’ and give greater freedom and authority to the regulator and clinicians except where there is good reason to do otherwise. ... 391

In accordance with their recommendation about a framework of permissive regulations, the

Joint Committee suggested that the draft Bill ‘should be amended to give the regulator

statutory power to define areas of exemption from the current regulatory remit where

appropriate.’

392 They stated their support for a ‘lighter touch’ and urged the regulators to

investigate ways in which the unnecessary duplication of regulation could be eliminated.393

The United Kingdom government however did not agree with pursuing a system of

‘devolved regulation’ stating that they believed ‘that such a framework would introduce a

lack of accountability’.

394 They further stated that giving the HFEA the power to make

exemptions from regulation would cause uncertainty about the scope of the regulation,

would be confusing and open up the HFEA to the possibility of increased litigation and

judicial review.395

Policy proposals from the 2006 White Paper, as updated following the pre-legislative

scrutiny by the Joint Committee and the government’s response to this scrutiny, were given

form in the Human Fertilisation and Embryology Act 2008 (UK).

396 The purpose of this Act

was to ‘amend the law relating to assisted reproduction treatment and embryo research’.397

391 Ibid. 392 Ibid. 392 Ibid, 78. 393 Ibid, 23. 393 Ibid, 78. 394 Department of Health (UK), Government Response to the Report from the Joint Committee on the Human Tissue and Embryos (Draft) Bill (2007), 5. 395 Ibid. 396 The new legislation received Royal Assent on 13 November 2008. 397 The Act is in three Parts. The first Part comprises amendments to the 1990 Act, the second Part makes provision about who is to be treated, after the coming into force of the Part, as the parent of a child who has been born as a result of assisted reproduction treatments, and the third Part makes miscellaneous and general provision. This discussion therefore is focused upon the first part only.


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Regarding what to regulate and where to draw the line between permissible and

prohibited research, it was considered whether the boundaries should again be shifted in

relation to inter-species embryos. The Joint Committee asked the Government to revisit its

approach to such embryos, and suggested that revised legislation should provide a general

definition regarding the creation and use of inter-species embryos for research that the

HFEA could interpret and apply to individual research applications.398 This recommendation

reflected what was already happening in practice under the HFE Act 1990 in the absence of

a general definition regarding the creation and use of inter-species embryos.399 The United

Kingdom government agreed that the HFEA be given more flexibility to make licensing

decisions with respect to a list of inter-species embryos to be defined in the Act and stated

that it would give the HFEA the remit to license research in this area, subject to the usual

requirements of the research being ‘necessary or desirable’.400

Large parts of the amended HFE Act have seen the United Kingdom Parliament bring

into law the HFEA policies that had developed as technology advanced since the 1990 Act’s

inception. Of particular importance to this discussion is that the definition of embryo has

been amended to ensure that the creation and use of all human embryos outside the

body—whatever the process used in their creation—are subject to regulation;

401

398 House of Lords, House of Commons, above n13, 51. 399 That is, in January 2007, the Human Fertilisation and Embryology Authority conducted a public consultation with regards to the question of creating human-animal (‘admixed’) embryos for research. Such consultation was a direct result of two licence applications to create stem cells from embryos created by Somatic Cell Nuclear Transfer using animal eggs. In September 2007 the HFEA concluded that ‘such research legally falls within the HFEA’s remit and having looked at all the evidence, …there was no fundamental reason to prevent cytoplasmic hybrid research’. Whilst recognising that public opinion was ‘finely divided’, they decided that individual research teams could conduct such research provided they satisfied the HFEA that the research was both ‘necessary and desirable’, and met the overall research standards required by the HFEA for any embryo research. See Human Fertilisation and Embryology Authority, Hybrids and Chimeras: A Report on the Findings of the Consultation (2007). 400 Department of Health (UK), Government Response to the Report from the Joint Committee on the Human Tissue and Embryos (Draft) Bill (2007), above n394, 6. 401 Human Fertilisation and Embryology Act 1990 (UK), s1(1).

restrictions

on the use of HFEA-collected data have been altered to make it easier to do follow-up

research;402 and provisions that increase the scope of legitimate embryo research activities,

including regulation of inter-species/’admixed’ embryos have been added.403

In relation to how to regulate, the Government stated their support for ‘the move

towards lighter touch regulation, as indicated by section 8ZA of the revised HFE Act. Section

8ZA provides that the HFEA must carry out its functions effectively, efficiently and

economically and with regard to the principles of best regulatory practice.’

Pre-empting

changes to the HFE Act, applications from Kings College London and Newcastle University to

carry out research using human animal cytoplasmic hybrid embryos (also referred to as

inter-species/admixed embryos) were respectively approved by the HFEA in November 2007

and January 2008 and subsequently offered one-year research licences.

404 Such a

position is underpinned by the United Kingdom government’s ‘Better Regulation’ agenda,

which builds on the recommendations of two major policy reviews commissioned by the

Government in 2005: The Hampton Review of regulation and inspection405 and the Better

Regulation Taskforce report Less is More.406

The Hampton Review set out a vision of regulatory systems based around risk and

proportionality.

407 The Less is More report concluded that the regulatory burden on

business could be considerably reduced by decreasing administrative costs, prioritising new

regulations, and simplifying and removing existing regulations.408

402 Human Fertilisation and Embryology Act 1990 (UK), s31. 403 Human Fertilisation and Embryology Act 1990 (UK), s3(3). 404 Human Fertilisation and Embryology Act 1990 (UK), s8ZA(1). 405 Philip Hampton, Reducing Administrative Burdens: Effective Inspection and Enforcement (2005).

These reviews and their

impact on the HFEA regulatory system are discussed in more detail in Chapter Seven. For

now, it is noted that in relation to regulating research involving human embryos and

406 Better Regulation Task Force, Regulation - Less is More, Reducing Burdens Improving Outcomes, A BRTF Report to the Prime Minister (March 2005). 407 Hampton, above n405. 408 Better Regulation Task Force, Regulation - Less is More, Reducing Burdens Improving Outcomes, A BRTF Report to the Prime Minister, above n406, 3.


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cloning, the main features of the existing regulatory model are retained. That is, the

framework legislation backed by the HFEA licensing and oversight function has been

maintained.

However, additional provisions have been implemented which reflect an increased

emphasis on a cooperative, persuasive and educative approach. As mentioned above the

Act requires that the HFEA ‘provide, to such extent as it considers appropriate, advice and

information for persons to whom licences apply or who are receiving treatment services or

providing gametes or embryos for use for the purposes of activities governed by the HFE

Act, or may wish to do so.’409

• maintain a statement of the general principles which it considers should be

followed –

There are also provisions that require the HFEA to:

(i) in the carrying-on of activities governed by the HFE Act, and

(ii) in the carrying-out of its functions in relation to such activities;410

• promote, in relation to activities governed by the HFE Act, compliance with –

(i) requirements imposed by or under the Act, and

(ii) the code of practice under section 25 of this Act.411

The amendments to the HFE Act also require that the HFEA ‘must, so far as relevant, have

regard to the principles of best regulatory practice (including the principles under which

regulatory activities should be transparent, accountable, proportionate, consistent and

targeted only at cases in which action is needed).

412

Recommendations for how this might

be achieved are made in Chapter Seven of this paper.

409 Human Fertilisation and Embryology Act 1990 (UK), s8(1)(c). 410 Human Fertilisation and Embryology Act 1990 (UK), s8(1)(ca). 411 Human Fertilisation and Embryology Act 1990 (UK), s8(1)(ca). 412 Human Fertilisation and Embryology Act 1990 (UK), s8ZA(2).

IV. AUSTRALIA: DECISIONS ABOUT WHAT TO REGULATE AND WHERE TO

DRAW THE LINE BETWEEN PERMISSIBLE AND PROHIBITED RESEARCH

A. A Call for National Regulation, Regulatory Issues and Rationales

As detailed in Chapter Two, Australia did not have uniform regulation of issues

relating to embryo research or cloning up until 2002. Although some states had legislation

regulating assisted reproductive technology and associated research,413 other states and

territories were regulated only by NHMRC guidelines, adherence to which might affect

funding for projects, but which was not then required by law. Although there had been a

number of reports and inquiries since the 1980s in relation to human cloning and research

involving excess ART embryos,414 in 2001 there was no uniform regulation governing either.

The primary reason for the lack of uniform national regulation was the uncertainty as to

whether the Australian Federal Government had the necessary constitutional power to

support the introduction of Commonwealth legislation.415 However, the Standing

Committee on Legal and Constitutional Affairs’ (Andrews Committee) Report,416 and digests

prepared for debate,417

413 See Chapter 2. 414 See for example, Senate Select Committee on the Human Embryo Experimentation Bill 1985, Human Embryo Experimentation in Australia (1986); Committee to Consider the Social Ethical and Legal Issues Arising from In Vitro Fertilization, Report on the Disposition of Embryos Produced by in vitro Fertilization above n108; Queensland Government, Report of the Special Committee by the Appointed Queensland Government to Inquire into the Laws relating to Artificial Insemination, In -Vitro Fertilization and Other Related Matters (Brisbane 1984). 415 The question was whether the Commonwealth has the power to pass legislation concerning matters regarding research involving human embryos and cloning given it was not within the legislative power of the Commonwealth of Australia to legislate on the subject of ART, and each state and territory was responsible for designing and implementing its own regulatory regime. 416 House of Representatives Standing Committee on Legal and Constitutional Affairs, above n119.

concluded that the Commonwealth did in fact possess legislative

417 Parliament of Australia, Bills Digest No. 17 2002-03: Research Involving Embryos and Prohibition of Human Cloning Bill 2002, Department of the Parliamentary Library at http://www.aph.gov.au/library/pubs/bd/2002-03/03bd017.htm at 11 August 2005.

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power ‘in many areas that impinge upon the use of cloning [and related research such as

that involving human embryos]’.418

As public debate surged over these issues, the Australian Federal Government was

met with their next, rather large, challenge: having had its power to legislate recognised it

had to consider how it could implement two opposing policies. As a conservative

government, the then ‘Howard Cabinet’

419 had adopted a traditional ethical view on the

moral status of the embryo and had been proactive in its protection.420 Simultaneously, the

Government was proactive in maintaining Australia’s position at the forefront of biomedical

research—including embryonic stem cell research. It was argued that Australia housed

‘some of the world’s best researchers, and as such [was obliged] to keep them here so [its]

citizens [could be some] of the first to actually benefit from new therapies as they

…developed.’421

418 House of Representatives Standing Committee on Legal and Constitutional Affairs, above n119, 12; The relevant powers are those relating to import and export of human material, patenting, trade and commerce, corporations and external affairs (see Commonwealth of Australia Constitution Act (1900) ss51(i), (xviii), (xx), (xxix)). Later advice from the Australian Government Solicitor raised serious doubts about the constitutionality of the legislation particularly that the legislation would be open to challenge if individuals were prosecuted for an offence under the Commonwealth legislation (as there is no head of power for the Commonwealth to pass such laws to govern individuals acting within Australia). Consequently, States needed to enact empowering or mirror legislation in order to give full effect to the Commonwealth legislation. 419 That is the government in power at the time, headed by John Howard. 420 Gene Technology Act 2000 (Cth), s 192b; M Metherell and D Smith, ‘Stemming the tide’, The Sydney Morning Herald, 02 March 2002. 421 Ibid.

The two positions were difficult to reconcile and had therefore played a

large part in the lack of comprehensive national legislation governing embryo research and

cloning. However, as demand for regulation grew, the need to balance rationales for

regulation such as weighing of potential benefits of research involving human embryos

against the moral hazards such research posed was apparent. Again, the rationales

discussed in Chapter Two may be seen to underpin the decisions that were made regarding

what should be regulated and where to draw the line between permissible and prohibited

activities in this jurisdiction.

On 5 April 2002 the Council of Australian Governments (COAG) proceeded to call for

the Government to introduce ‘nationally consistent legislation’ to:

a) prohibit certain practices associated with reproductive technologies, including cloning of human beings; and

b) regulate activities involving the use of certain human embryos created by ART.422

The Research Involving Embryos and Prohibition of Human Cloning Bill 2002 was

subsequently introduced in the House of Representatives on 27 June 2002. The House

debated the Bill during August and on 29th August 2002 members used a free vote423 to split

it in two, arguing that issues pertaining to research involving embryos and the prohibition of

human cloning should be addressed separately.424

On 21 August 2002, the Senate

The two bills did not amend the

provisions of the original bill in any way. Rather they separated the regulation of research

involving human embryos and the setting up of a licensing authority from the activities

which were deemed unacceptable (such as reproductive cloning), or only acceptable

pursuant to meeting licensing conditions.

425 referred the provisions of the original Bill426

422 Explanatory Memorandum, Research Involving Embryos and Prohibition of Human Cloning Bill 2002. 423 Also known as a ‘conscience vote’ in which members are not required to vote upon party lines.

to the

Committee for report by 24 October 2002, in order to ‘consult widely with various

stakeholders in the community to inform the Senate in its deliberations on the Bill’. The

inquiry was advertised in a major Australian newspaper (The Australian) on 28 August and

11 September 2002 and over the internet. Submissions were also invited from a large range

of groups and individuals, including representatives from the medical science research

424 See National Health & Medical Research Council, Splitting of the Research Involving Embryos and Prohibition of Human Cloning Act 2002, http://www.nhmrc.gov.au at 7 September 2002. 425 On the recommendation of the Selection of Bills Committee: Report No. 6 of 2002. 426 As the provisions in the original bill were not amended by it having been split in the lower house, the Senate Committee addressed its report to the original provisions.

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community (domestic and international, private and public); consumer and other health

care groups; ethics groups and other community organisations.427

The Senate Committee received 1851 submissions during its inquiry. In addition, the

Senate Committee held public hearings involving some 52 witnesses.

428 Of the 1851

submissions made to the Senate Committee, although 289 submissions were recognised to

be ‘form letters’, the vast majority of submissions did not support the position taken in the

bills. One thousand eight hundred and three (1803) submissions opposed research involving

human embryos, whilst only forty-eight (48) supported it.429

427 The Senate, Community Affairs Legislation Committee, Provisions of the Research Involving Human Embryos & Prohibition on Human Cloning Bill 2002, Commonwealth of Australia, October 2002.

The large proportion of

submissions against the position taken in the bills must however be treated with caution.

The call for submissions in consultation differs from a referendum or vote conducted across

the country. People who feel passionately about a subject are more likely to make a

submission than those who do not. Additionally, people who are not concerned about the

passing of certain laws are unlikely to write in and say they are not concerned—they are

more likely simply to let the law pass. The major purpose of a call for submissions is to

gather information and give people a voice in the process. Submissions received can then be

used as a guide when considering issues of concern and developing understanding, and an

alert to anything that is contentious or needs further discussion, change or regulation.

Regulatory rationales such as distributive justice and social policy justifications are relevant

when making regulatory decisions about research involving human embryos and cloning.

That is, as a matter of policy society may decide to overrule individual preferences on some

issues and regulate. The submissions reflected the vast difference in individual preferences

428 Submissions that were received electronically and the Hansard record of the public hearings are publicly available on the Committee’s website:.http://www.aph.gov.au/senate_ca at 26 June 2004. 429 The Senate, Community Affairs Legislation Committee, above n427, 231.

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concerning whether such research should be permitted and if so the extent to which it

should be permitted. Whilst many individual scientists and members of the public

wholeheartedly wished to proceed with such research, others were equally against it.

Balancing such preferences therefore involved coming to some sort of public/social policy

decision and then regulating accordingly.

The Senate Committee Report stated that as the inquiry was undertaken in

circumstances where the political parties had given their Senators a ‘free vote’ on the Bill,

the purpose of the inquiry was primarily to gather information to assist Senators make an

informed decision on the Bill when it was to be considered in the Senate. As such, the report

did not attempt to ‘formulate conclusions or recommendations that the Committee

consider[ed] should be the prerogative of individual Senators in a ‘free vote’’.430

B. Enactment of Legislation

Both Acts were passed with significant majorities in both houses—the Lower House

voted 99 to 33 in favour of the Acts, and the Upper House 43 to 26.

The Research Involving Human Embryos Act 2002 (the RIHE Act) and the Prohibition

of Human Cloning Act 2002 (the PHC Act) received Royal Assent on 22 December 2003, with

a majority of provisions coming into force on the 16 January 2003.431 States and Territories

enacted empowering or mirror legislation in order to give full effect to the Commonwealth

legislation countrywide.432

430 Ibid, [1.5]. 431 Research Involving Human Embryos Act 2002 (Cth), s2; Prohibition on Human Cloning Act 2002 (Cth), s2.

This was necessary as the Commonwealth legislation was

432 Research Involving Human Embryos (New South Wales) Act 2003; Prohibition on Human Cloning and other Prohibited Practices (New South Wales) Act 2003; Health Legislation (Research involving human embryos and prohibition of cloning) Act 2003 (Victoria); Research Involving Human Embryos Act 2003 (South Australia); Prohibition of human cloning Act 2003 (South Australia); Human Embryonic Research Regulation Act 2003 (Tas); Human Cloning and Other Prohibited Practices Act 2003 (Tas); Research Involving Human Embryos and Prohibition of Human Cloning Act 2003 (Qld); Human Reproductive Technology Amendment Act 2004


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susceptible to constitutional challenge if individuals were prosecuted for an offence,433

In terms of deciding what to regulate and where to draw the line, the RIHE Act 2002

was introduced to govern the use of ‘excess’ ART embryos by both publicly and privately

funded researchers. An embryo was considered to be ‘excess’ if the embryo was created, by

ART, for use in the assisted reproductive technology treatment of a woman and was excess

to the needs of the woman for whom it was created and her spouse (if any) at the time the

embryo was created.

and

the legislation could not govern state government organisations and non-trading

corporations. Uniform State and Territory legislation was thus passed to ensure full

regulation of all those that may wish to conduct such research. The Commonwealth Acts are

discussed here, keeping in mind that the initial provisions of the state and territory acts

mirrored such legislation.

434

a) given written authority for use of the embryo for a purpose other than a purpose relating to the assisted reproductive technology treatment of the woman concerned, and the authority is in force at that time; or

Consent requirements provided that in order for an embryo to be

considered excess, the woman for whom the ART embryo was created and her spouse at

the time must have either:

b) have determined in writing that the embryo is excess to their needs, and the determination is in force at that time.435

The Act defined ‘proper consent’ as that obtained in accordance with the then NHMRC

Ethical Guidelines on Assisted Reproductive Technology. Regulation 2.1A of the Research

Involving Human Embryos Regulations 2003, which was added in 2005 and amended in

2007, now prescribes the NHMRC Ethical guidelines on the use of assisted reproductive

(WA); Human Embryo (Research) Act 2004 (ACT); Human Cloning (Prohibition) Act 2004 (ACT); the Northern Territory government is follows South Australian legislation. 433 This is so because there is no head of power under the Australian Constitution for the Commonwealth to pass such laws to govern individuals acting within Australia. See above n132, above n415-418 and accompanying discussion in text. 434 Research Involving Human Embryos Act 2002 (Cth), s9. 435 Research Involving Human Embryos Act 2002(Cth), s24 (2)(a) & (b).

technology in clinical practice and research as the document in which the definition of

‘proper consent’ should be found. Many ART clinics have since implemented additional

measures to meet the consent requirements.436

Once an embryo was declared to be excess, the RIHE Act allowed research to be

conducted provided strict licensing conditions were met.

437 That is, the RIHE Act allowed

research on excess human embryos only by those people who were licensed unless a

particular use falls under one of the exceptions in the legislation.438

The object of the PHC Act 2002 (Cth) was to ‘address concerns, including ethical

concerns, about scientific developments in relation to human reproduction and the

utilisation of human embryos by prohibiting certain practices.’

The licensing system is

detailed below in the section regarding the type of regulation adopted by Australia.

439 In particular the PHC Act

2002 (Cth) expressly prohibited the creation of a human embryo clone for any purpose.440

• creating a human embryo other than by fertilisation, or developing such an

embryo;

Other practices that were strictly prohibited included:

441

• creating a human embryo for a purpose other than achieving pregnancy in a

woman;

442

436 Monash IVF at

http://www.monashivf.edu.au at 4 January 2004; The Reproductive Medical Unit at University of Adelaide, http://www.repromed.com.au/DONOR_SPERM.html at 4 January 2004; IVF Australia - NSW http://www.ivf.com.au/htmlpages/calendar.html at 4 January 2004. Various clinics have introduced comprehensive consent forms, provide information by way of fact sheets, require a potential donor to undertake counselling sessions concerning the personal, social and legal aspects of donation, run information evenings about IVF in general and/or refer to NHMRC guidelines. For example, The Reproductive Medicine Unit at the University of Adelaide requires two counselling sessions about such issues prior to giving consent to donate embryos for research purposes. 437 Research Involving Human Embryos Act 2002 (Cth), ss20-28. 438 Research Involving Human Embryos Act 2002 (Cth) s10(1)(b); and s10(2) (which list the exceptions). 439 Prohibition of Human Cloning Act 2002 (Cth), s3. 440 Prohibition of Human Cloning Act 2002 (Cth), s9. 441 Prohibition of Human Cloning Act 2002 (Cth), s13. 442 Prohibition of Human Cloning Act 2002 (Cth), s14.

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• creating or developing a human embryo containing genetic material provided by

more than 2 persons;443

• developing a human embryo outside the body of a woman for more than 14

days;

444

• using precursor cells from a human embryo or a human fetus to create a human

embryo, or developing such an embryo;

445

• heritable alterations to genome;

446

• collecting a viable human embryo from the body of a woman;

447

• creating a chimeric or hybrid embryo.

and

448

The implementation of such legislative prohibitions via the PHC Act therefore served to

draw the line for permissible and prohibited research.

The moral and ethical objections to certain types of research, recognition of the risks

associated with such research, and the other rationales for regulation outlined in Chapter

Two can therefore be seen to take form in both Acts. What to regulate and where to draw

the line questions are substantially addressed. Whilst the PHC Act prohibited activities that

were considered unacceptable for moral, ethical, or the level of risk reasons, the RIHE Act

permitted activities provided certain criteria was met – including licensing. The RIHE Act also

served to put into place the type of regulatory design strategies to be used within the

Australian regulatory system to govern research activities. Both Acts contain enforcement

provisions for offences against what is prohibited or for not meeting the criteria stipulated

in the Acts.

443 Prohibition of Human Cloning Act 2002 (Cth), s15. 444 Prohibition of Human Cloning Act 2002 (Cth), s16. 445 Prohibition of Human Cloning Act 2002 (Cth), s17. 446 Prohibition of Human Cloning Act 2002 (Cth), s18. 447 Prohibition of Human Cloning Act 2002 (Cth), s19. 448 Prohibition of Human Cloning Act 2002 (Cth), s20.

V. AUSTRALIA: ADDRESSING THE ‘HOW TO REGULATE’ QUESTION

A. Enforcement Mechanisms and Compliance Strategies

Australia—like the United Kingdom—adopted a ‘command and control’ design

strategy when deciding upon how to regulate research involving human embryos and

cloning. Section 13 of the RIHE Act 2002 established the NHMRC Licensing Committee,449

To obtain a licence to conduct research involving human embryos, a person must

apply to the NHMRC Licensing Committee.

a

regulatory bureaucracy whose influence is exercised by imposing standards backed by

criminal sanctions.

450 When applying for a licence that authorises

use of an excess ART embryo that may damage or destroy the embryo, the Licensing

Committee must be satisfied that appropriate protocols are in place (i) to enable proper

consent to be obtained before an excess ART embryo is used under the licence; and (ii) to

enable compliance with any restrictions on such consent.451

• the HREC’s approval,

In determining an application

the Licensing Committee must consider:

• compliance with the NHMRC guidelines,

• the number of excess ART embryos likely to be necessary to achieve the goals of the

activity or project proposed in the application;

• the likelihood of significant advance in knowledge, or improvement in technologies

for treatment, as a result of the use of excess ART embryos proposed in the

application, which could not reasonably be achieved by other means; and

449 Research Involving Human Embryos Act 2002 (Cth) s13 (also see s15 for the details of the persons who make up the NHMRC Licensing Committee). 450 Research Involving Human Embryos Act 2002 (Cth) s20. 451 Research Involving Human Embryos Act 2002 (Cth) s21.


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• any other additional matters (if any) prescribed by the regulations.452

The licensing committee was given the power to grant licences for a wide variety of

research including, but not necessarily limited to, research which promises cures for

diseases; examines the effectiveness of a new culture medium used in ART practice; trains

clinicians in micro-surgical ART techniques; is aimed at improving ART techniques; and

research for toxicology and other drug experimentation. In 2009, ten licenses for research

were operative (See Appendix 5).

In Australia, the sanctions for committing offences are stipulated in both Acts as

maximum terms of imprisonment453 noting however that section 4B of the Crimes Act 1914

(Cth) allows for a pecuniary penalty instead of, or in addition to, a term of imprisonment.

The RIHE Act created offences and imposed penalties for breaching its provisions including

that anyone who uses an excess embryo without a licence may face imprisonment of up to

five years.454

• creating a human embryo clone,

Criminal penalties were also stipulated for breaches of the provisions of the

PHC Act 2002 (Cth). Within the original 2002 Act, the penalties include imprisonment for up

to 15 years for:

455

• placing a human embryo clone in the body of a human or animal,

456

• importing or exporting a human embryo clone.

or

457

A person also faces imprisonment for up to 10 years for creating a human embryo other

than by fertilisation or developing such an embryo,

458

452 Research Involving Human Embryos Act 2002 (Cth) s21(4). 453 See Prohibition of Human Cloning for Reproduction Act 2002 (Cth), ss9-23C and Research Involving Human Embryos Act 2002 (Cth), ss10-12A. 454 Research Involving Human Embryos Act 2002 (Cth), s11, s12, s26(1). 455 Prohibition of Human Cloning Act 2002 (Cth), s9. 456 Prohibition of Human Cloning Act 2002 (Cth), s10. 457 Prohibition of Human Cloning Act 2002 (Cth), s11. 458 Prohibition of Human Cloning Act 2002 (Cth), s13.

creating a human embryo other than

for the purposes of achieving pregnancy in a woman,459 creating or developing a human

embryo containing genetic material produced by more than two persons,460 developing a

human embryo outside the body of a woman for more than 14 days,461 using precursor cells

from a human embryo or foetus to create a human embryo or developing such an

embryo,462 creating heritable alterations to the genome,463 collecting a viable human

embryo from a woman,464 creating a chimeric or hybrid embryo,465 placing a human embryo

in an animal,466 placing a human embryo in the body of a human other than in a woman’s

reproductive tract,467 placing an animal embryo in the body of a human,468 importing or

exporting a ‘prohibited’469 embryo,470and trading in human eggs, sperm or embryos for

commercial gain.471

It is therefore argued that the same underlying theories of punishment (and

corresponding mechanisms for enforcement) introduced in Chapter Three and discussed in

In addition, a licence holder who breaches the conditions of an issued licence could have

their licence varied, suspended or revoked pursuant to sections 25, 26 and 28 of the RIHE

Act 2002 (Cth).

459 Prohibition of Human Cloning Act 2002 (Cth), s14. 460 Prohibition of Human Cloning Act 2002 (Cth), s15. 461 Prohibition of Human Cloning Act 2002 (Cth), s16. 462 Prohibition of Human Cloning Act 2002 (Cth), s17. 463 Prohibition of Human Cloning Act 2002 (Cth), s18. 464 Prohibition of Human Cloning Act 2002 (Cth), s19. 465 Prohibition of Human Cloning Act 2002 (Cth), s20. 466 Prohibition of Human Cloning Act 2002 (Cth), s21(1). 467 Prohibition of Human Cloning Act 2002 (Cth), s21(2). 468 Prohibition of Human Cloning Act 2002 (Cth), s21(3). 469 A ‘prohibited’ embryo includes a human embryo created by a process other than the fertilisation of a human egg by human sperm; a human embryo created outside the body of a woman, unless the intention of the person who created the embryo was to attempt to achieve pregnancy in a particular woman; a human embryo that contains genetic material provided by more than 2 persons; a human embryo that has been developing outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended; a human embryo created using precursor cells taken from a human embryo or a human fetus; a human embryo that contains a human cell (within the meaning of section 18) whose genome has been altered in such a way that the alteration is heritable by human descendants of the human whose cell was altered; a human embryo that was removed from the body of a woman by a person intending to collect a viable human embryo; a chimeric embryo or a hybrid embryo. Prohibition of Human Cloning Act 2002 (Cth), s22(4). 470 Prohibition of Human Cloning Act 2002 (Cth), s22. 471 Prohibition of Human Cloning Act 2002 (Cth), s23.


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relation to the United Kingdom regulatory system, are also reflected within the Australian

regulatory system. Whilst decisions about what to regulate and where to draw the line

between permissible and prohibited research differed to the United Kingdom in that

boundaries were drawn in different places, the regulatory design strategy adopted in

Australia was the same as that adopted in the United Kingdom in 1990. Enforcement

approaches again reflect underlying deterrence, incapacitation, rehabilitation, and

retribution theories.

The regulatory mechanisms and design strategies adopted by Australia are further

discussed and evaluated below, comparing them with Braithwaite’s theory of ‘responsive

regulation’ and evaluating them alongside the United Kingdom. However, before moving to

deeper evaluation of the regulatory design strategies, further reviews and amendments to

the Australian system are discussed. This illustrates how the regulation of research involving

human embryos and cloning requires constant review as advances in technology are made

and public opinion shifts. It also ‘paints a picture’ of the shortfalls of the regulatory system

which will be considered in later chapters.

VI. INDEPENDENT REVIEW OF THE AUSTRALIAN ACTS

A review of the Prohibition of Human Cloning Act 2002 and the Research Involving

Human Embryos Act 2002 was required by legislation to commence as soon as possible after

19 December 2004. On 17 June 2005, the then Minister for Ageing472

472 The Hon Julie Bishop, MP.

appointed an

independent committee to review the Acts. The review was intended to ‘directly inform the

development of Australian Government policy on human cloning, research involving human

embryos, and related matters’.473

• the scope and operation of the two Acts;

It was required that the following issues be taken into

account:

• developments in technology in relation to assisted reproductive technology;

• developments in medical research and scientific research and the potential

therapeutic applications of such research;

• community standards; and

• the applicability of establishing a National Stem Cell Bank.

The review, headed by The Hon John S Lockhart,474

473 National Health and Medical Research Council, Embryo Research: Legislative Review,

and later by Professor Loane

Skene, involved consultation with the Australian, State and Territory governments, relevant

agencies and a broad range of persons with expertise in, or experience of, relevant

disciplines and an extensive public consultation phase. The main issues grappled with by the

Committee (as set out in the foreword of its report) were:

• When does human life begin?

• How far should society allow research involving human embryos?

• What safeguards should surround the research?

• Should human embryos be accorded the same rights as human beings after

birth?

• How should ‘human embryo’ be defined?

• What safeguards should be provided to protect the rights of women?

• Can common ground be found between the widely varying, indeed

divergent, views of morality held by members of our society?

http://nhmrc.gov.au/embryo/issues.htm at 15 January 2005. 474 The former Federal Court Judge died in Sydney on 13January 2006, aged 70.

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• Should society declare activities to be illegal, with all the attendant

consequences of criminal conduct, when there is a wide range of ethical

views on those activities?

• What are the limits of the use of in vitro fertilisation (IVF) and related

methods (collectively known as assisted reproductive technology, or ART)

and research involving human embryos?

• Should excess ART embryos continue to be available for research, with

permission under licence?

• Should the creation of human embryos for research purposes be

permitted?

• Should the creation of human embryo clones by somatic cell nuclear

transfer be permitted, under licence, for research, training and clinical

applications?

• Should an Australian stem cell bank be established?475

The Lockhart Committee received 1035 submissions, held public hearings in all state

and territory capitals,

These all reflect questions concerning what to regulate and where to draw the line.

476

despite the divergent views received by the Committee during the reviews, both proponents and opponents of embryo research agreed that the current system of legislation is valuable. Therefore, the Committee recommended a continuation of national legislation imposing prohibitions on human reproductive cloning and some other ART practices, as well as strict control and monitoring, under licence, of research involving human embryos.

and conducted a series of facilitated consultation meetings in

Sydney, Brisbane and Melbourne. The Committee’s reports were presented to the Minister

for Ageing on 19 December 2005.

The Lockhart Committee stated:

477

475 Legislation Review Committee (Australia), above n10, iv. 476 The hearings in Tasmania were by video-conference. 477 Legislation Review Committee (Australia), above n10, xiv.

This statement pre-empts what the Lockhart Committee went on to recommend. Their

recommendations primarily focussed on issues of what to regulate and where the line

should be drawn or rather, shifted to regarding research involving human embryos and

cloning. The Lockhart Committee only touched upon the how to regulate question, and then

only to the extent of discussing the need to make sure the boundaries drawn by the

legislation were clear, and the possibility of giving the NHMRC more power. They did not

review the type of regulation that had been adopted. In fact, the above quoted statement

that ‘strict control and monitoring under licence’ was necessary reflects the view that the

‘command and control’ approach was satisfactory.

The Lockhart Committee made 54 recommendations, which are reproduced in full at

Appendix 6. In summary, the first recommendation was that ‘[c]linical practice and

scientific research involving assisted reproductive technologies (ART) and the creation and

use of human embryos for research purposes should continue to be subject to specific

national legislation’478

478 Ibid, xxii.

—that is, the regulatory system should be maintained.

Recommendations 2 to 27 address the treatment and use of embryos (including

recommendations concerning what should/should not be permissible in research).

Recommendation 28 suggests how the term embryo should be [re]defined.

Recommendations 29-49 deal with consent, licensing and monitoring of approved bodies,

import and export of embryos, biotechnology and commercialisation; and the establishment of

a National Stem Cell Bank. Recommendations 50-54 contain specific recommendations about

legislation, licensing and a call for continued public education.


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A. Lockhart Recommendations Concerning the Boundaries for

Treatment and Use of Embryos

The Lockhart Committee recommended that the law continue to provide that only

embryos created by the fertilisation of an egg by sperm can be implanted in a woman.479

They also recommended the continued prohibition of implanting into a woman a cloned

embryo,480 a human-animal hybrid or chimeric embryo,481 an embryo formed from the

genetic material of more than two people,482 an embryo created using precursor cells from

a human embryo or a human foetus,483 or an embryo that carries genetic alterations that

can be inherited by subsequent generations.484

In relation to research involving human embryos, the report states that the use of

excess ART embryos in research should continue to be permitted, under licence, as under

the 2002 RIHE Act.

The continued prohibition of implanting a

human embryo into an animal was also recommended.

485 It also proposed that research should be permitted on fresh embryos

which are unsuitable for use486

• human somatic cell nuclear transfer;

and that pursuant to licensing the following be permitted:

487

• the creation of human embryos and human embryo clones by means other

than fertilisation of an egg by a sperm such as nuclear or pronuclear transfer

and parthenogenesis),

488

479 Ibid, xxii. (Recommendation 3). 480 Ibid. Recommendation 2. 481 Ibid. Recommendation 5. 482 Ibid. Recommendation 8. 483 Ibid. Recommendation 9. 484 Ibid. Recommendation 10. 485 Ibid. Recommendation 14. 486 Ibid. Recommendations 20-22. 487 Ibid. Recommendation 23. 488 Ibid. Recommendation 25.

• the creation of human embryos using the genetic material from more than

two people, or including heritable genetic alterations,489

• creation of embryos using precursor cells from a human embryo or a human

foetus.

490

The recommendations were that the above only be permitted for research, training and

clinical applications, including production of human embryonic stem cells, provided the

research satisfies all the criteria outlined in the amended Act and these embryos are not

implanted into the body of a woman or allowed to develop for more than 14 days. These

recommendations mirrored what was permissible (under licence) in the United Kingdom at

the time.

B. Lockhart Concerns and Recommendations Regarding the

Australian Regulatory System

In relation to the regulatory system in place, the Lockhart Committee considered

how the then current legislative approach dealt with the ‘complex and changing

biotechnology involved’, other regulatory models, and the comments received in the

submissions and hearings in relation to this issue. The Committee identified ‘three areas of

concern about the development and application of prescriptive legislation in this area’,491

• difficulties associated with drafting legislation in areas of rapid technological

and scientific advance;

being:

• difficulties in the interpretation of legislation; and

489 Ibid. Recommendation 26. 490 Ibid. Recommendation 27. 491 Ibid, 153.


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• lack of legal protection for researchers.

Firstly, they identified that in this complex and changing area of biotechnology,

legislative provisions may prohibit activities that, if considered ‘in light of new knowledge’ or

with proper understanding of the science involved, should not be prohibited.492 Conversely

they state that the legislation may ‘accidentally’ allow activities that should be prohibited.493

1) section 20(2) of the PHC Act which states that it is an offence to create a hybrid

embryo,

Examples given by the Lockhart Committee of the legislation acting to prohibit activities that

might arguably be allowed include the following:

494 prevents a clinical test routinely undertaken in other countries, which

involves testing for the viability of human sperm on a hamster egg rather than a

human oocyte. The Committee suggests that underlying this prohibition was the

aim to ‘assuage community concern that new technologies might be used to make

half-human, half-animal hybrids’;495

2) the current provisions of the Acts have also prevented work to develop safer and

improved methods of egg collection, development and storage for use in ART

treatment.

and

496

With respect to activities that were intended to be prohibited which may ‘accidentally’ be

allowed, the Lockhart Committee gave the example that whilst the PHC Act prohibits various

types of research involving human embryos, the definition of embryo which contains the

492 Ibid. 493 Ibid. 494 Defined as ‘an embryo created by the fertilisation of an animal egg by human sperm’: Prohibition of Human Cloning Act 2002 (Cth), s8(1). 495 Legislation Review Committee (Australia), above n10, 153. 496 Ibid.

word ‘live’ may in fact allow research on embryos that have been left to ‘succumb’.497

One might question whether people would agree that embryos that have been left to ‘succumb’ should then be available for unregulated research on the basis that they are no longer ‘live’. Certainly, many people believe that such embryos, if left to succumb, should be disposed of respectfully and not used for other purposes without ethical approval and proper consent. Yet this is not the effect of the legislation.

They

state,

498

This accords with the views presented in a paper published by the author, who in 2005

identified this problem and stated ‘if the legislature intended to protect the dignity of

human embryos, the limits on their use should extend beyond death’.

499

[I]f legislation is unclear or ambiguous, it is possible that scientists may undertake research that is prohibited, believing it is lawful, and then face a potential fine and prison sentence. Similarly, a researcher may face criminal prosecution if they do research that requires a licence, but they do not obtain a licence because they do not believe it is necessary.

It is also apparent

that such a provision simultaneously provides an example of the Lockhart Committee’s

second concern, that there were difficulties in interpreting some provisions of the

legislation.

The Lockhart Committee also expressed concern about the lack of legal protection

for researchers, stating:

500

Such a lack of clarity may prevent research from being undertaken and/or funded for fear of

prosecution. Moreover, the Committee noted the prescriptive nature of the 2002 Acts did

not provide the Licensing Committee discretion in applying and interpreting it and as such,

497 The use of the word ‘succumb’ reflects that used by previous legislation and guidelines. It refers to when embryos are taken out of cryopreservation and left to thaw (this makes them unviable and results in their ‘death’). 498Legislation Review Committee (Australia), above n10, 154. 499 Magri, above n118. 500 Legislation Review Committee (Australia), above n10, 154.


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‘if it grants a licence for research that is later ruled by a court to contravene the Act, it will

be no defence to the researcher that he or she obtained a licence’.501

in the cases of both the PHC Act and the RIHE Act, a combination of legislation, regulations, guidelines and Licensing Committee rulings, together with rigorous parliamentary and community reporting, could provide an accountable and flexible system in line with the expectations of the government, researchers and the community. This may also avoid the need for further reviews of the legislation outside the usual parliamentary process of amendment.

In considering these shortcomings, the Lockhart Committee recommended a more

flexible approach to the regulation of this area, stating that

502

• regulations are more flexible than legislation because they can be made without

passing through the full parliamentary process, while being subjected to

parliamentary scrutiny by being tabled in parliament for consideration for the

required period;

In calling for such a combination of regulatory tools, the Lockhart Committee noted that:

• guidelines published by a regulatory agency may increase the flexibility and

responsiveness of a regulatory scheme, as they may be readily altered in the light of

new research and knowledge;

• giving the Licensing Committee the power to give ‘rulings’ about the interpretation

of the Acts, would enable further flexibility in this rapidly developing area and could

be backed by a legislative provision that researchers who act on the basis of such

rulings be protected from potential prosecution;503

• as all of the above would operate under a system in which reporting back to the

NHMRC and Parliament, adequate checks and responses could be made by the

and

501 Ibid. 502 Ibid, 158; xxvi 50-53. 503 Legislation Review Committee (Australia), above n10, 155; xxvi (Recommendations 50-52).

Government with respect to the legislation’s operation and interpretation when

needed.504

In addition to the above, the Lockhart Committee recommended that ‘in view of the

fast-moving developments in the field, and the range of amendments proposed [by the

Lockhart Committee], the two Acts should be subject to a further review either six years

after royal assent of the current Acts or three years after royal assent to any amended

legislation’;

505 and finally that ‘there should be ongoing public education and consultation

programs in the areas of science that are relevant to the Acts.506

The Lockhart Committee failed however to recognise some of the major shortfalls

and criticisms of a command and control system to which their recommendations might

give rise (or at the very least they did not address such shortfalls). For example, whilst

recognising the need for flexibility as new research and knowledge occurred in this rapidly

developing area, the Lockhart Committee suggested that the oversight authority be given

‘the explicit authority to pass regulations and/or change definitions as new technologies are

discovered and/or current legislative provisions are found to be inadequate’.

507 However

such a suggestion does not address the concern that ‘such a system promulgates so many

rules over time that the result is over-regulation, legalism, delay, intrusion and the

strangling of competition and enterprise’.508 Similarly, it does not address the concern that

using bodies of officials and inspectorates to enforce the many rules is often very

expensive;509

504 Ibid, 154-156. 505 Ibid, xxvi (Recommendation 53). 506 Ibid, xxvi (Recommendation 54). 507 Which reflects Greely’s third recommendation discussed in Chapter Three. Greely, above n234. 508Bardach and Kagan, above n224, 94-120. 509 Ogus, above n14.

or the other problems outlined in Chapter Three regarding how such a system

may be perceived by those being regulated. These shortfalls are again addressed in Chapter


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Seven when making recommendations for the implementation of a level of co-regulatory

design strategies and cooperative, educative and persuasive enforcement approaches which

would encourage dialogue between regulators, regulatees and the public, avoid such

authoritarian approaches when dealing compliant license holders, and would enable

regulatees to participate in their own regulation.

Nonetheless, it is noted that the Lockhart Committee did at least suggest that

greater flexibility was required in the regulatory system. Such suggestions were not

considered when their report and subsequent bills proposing changes to the legislation

were considered by Parliament. The chapter now turns to the legislative changes that

followed the Lockhart Committee review.

C. Legislative Review

In 2006, Senator the Honourable Kay Patterson introduced a private members bill—

the Prohibition of Human Cloning for Reproduction and the Regulation of Research involving

human embryos Amendment Bill 2006—into parliament which proposed changes to the

Research Involving Human Embryos Act 2002 (Cth) and Prohibition of Human Cloning Act

2002 (Cth). This bill was based predominantly on the Lockhart Committee recommendations

concerning what to regulate and where to draw/shift the line with regards to permissible

and prohibited activities for research involving human embryos and cloning.

The bill was referred to the Senate Community Affairs Committee on 14 September

2006. The ‘Inquiry into Legislative Responses to Recommendations of the Lockhart

Committee’ received four hundred and ninety four submissions.510

510 Senate Community Affairs Committee, Inquiry into the Legislative Responses to Recommendations of the Lockhart Review: Submissions Received by the Committee as at 30 October 2006,

Public hearings were

http://www.aph.gov.au/senate/committee/clac_ctte/completed_inquiries/2004-07/leg_response_lockhart_review/submissions/sublist.htm at 15 March 2009.

http://www.aph.gov.au/senate/committee/clac_ctte/completed_inquiries/2004-07/leg_response_lockhart_review/submissions/sublist.htm�


also conducted in Canberra, Sydney and Melbourne respectively on the 20th, 23rd and 24th

October 2006. In both the submissions and the hearings the focus was clearly on questions

of what to regulate and where the line should be drawn/shifted for permissible and

prohibited research activities (particularly in relation to whether the creation of embryos for

research using SCNT should be permitted), as well as the maintenance of strict prohibitions

for certain practices such as human reproductive cloning.511

The focus on what to regulate and where to draw the line questions during the

Senate Committee inquiry, and by the Lockhart Committee members, is illustrated in

testimony made by Professor Loane Skene

512

We support broad national legislation of the current type. We believe that there should be prohibitions on certain types of conduct that everybody seems to regard as being morally wrong. ...[O]ur first and most basic recommendation was that the current legislation should stay in place and that most of the current prohibitions should also remain, in order to reassure the community that things that they object to will not be allowed to be done and, if those things are done, there are very heavy penalties—15 years imprisonment for the most serious of them. ...[T]hat is the underpinning of all of our recommendations.

at the hearings. She emphasised the

Committee’s support for the maintenance of prohibitions regarded by ‘everybody’ as

morally wrong, and highlighted that the type of regulation in place was not being

questioned:

513

Associate Professor Kerridge

514

511 Ibid; Senate Community Affairs Committee, Inquiry into the Legislative Responses to Recommendations of the Lockhart Review: Public Hearings and Transcripts,

also testified as to the Lockhart Committee’s process

of deciding upon what should be permitted or prohibited. The following statement

illustrates that balancing the rationales for regulation discussed in Chapter Two has played

http://www.aph.gov.au/senate/committee/clac_ctte/completed_inquiries/2004-07/leg_response_lockhart_review/hearings/index.htm at 14 March 2009. 512 Professor of Law at the University of Melbourne and was Deputy Chair of the Lockhart committee. 513 Evidence to Senate Community Affairs Committee, Inquiry into the Legislative responses to Recommendations of the Lockhart Review, Parliament of Australia, Canberra, 20 October 2006, CA2 (Professor Loane Skene). 514 A previous member of the Lockhart committee and Associate Professor in Bioethics at the University of Sydney.

http://www.aph.gov.au/senate/committee/clac_ctte/completed_inquiries/2004-07/leg_response_lockhart_review/hearings/index.htm�

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an important role in deciding upon where to draw the line for research involving human

embryos and cloning:

We did not seek to dissolve moral disagreement about the status of the embryo. That has not been possible in 2000 years. We thought it was very unlikely we would do it in six months. What we did try to do, though, was to come up with recommendations regarding the process of developing policy where there is significant moral disagreement ... We did that in a series of ways. We did it through considering respectfully...the written and verbal submissions. We did it by reviewing evidence, because we believed that making good ethical recommendations was as much an issue of evidence as it was of considered reflection on values, and we did it by trying to identify those things that might be shared across the community. We thought that these were not just respect for life but also things like care for those who are ill, care for vulnerable people, compassion, social justice and those sorts of things that were shared across religious viewpoints or across the philosophical divides.515

The subsequent report published by the Senate Community Affairs Committee

largely focused on the issue of whether or not SCNT should be permitted to create human

embryos for research purposes.

Such testimony indicates that conclusions drawn by the Committee were based upon a

process of consultation, public submissions, review of evidence and an attempt to balance

competing interests and values.

516

515 Evidence to Senate Community Affairs Committee, Inquiry into the Legislative responses to Recommendations of the Lockhart Review, Parliament of Australia, Canberra, 20 October 2006, CA2 (Associate Professor Ian Kerridge). 516 Senate Community Affairs Committee, Inquiry into the Legislative responses to Recommendations of the Lockhart Review, 26 October 2006.

The Lockhart Committee recommendations 50-52,

concerning the regulatory approach to legislation, although limited to giving the NHMRC

Licensing Committee the power to give binding rulings on the interpretation of the PHCR

and RIHE Acts and protection of scientists who act in accordance with such rulings, were not

addressed. In additional comments made by Senator Natasha Stott Despoja and Senator

Webber, recommendations for amending the bill to include provisions which would

continue to set the overarching prohibitions ‘but allow the NHMRC Licensing Committee

some flexibility in awarding licences’ were made.517

After some further parliamentary debate and amendments, the bill passed the

Senate by two votes on 7 November 2006 and the House of Representatives on 6 December

2006 by 82 votes to 62.

Again such recommendations appear to

have been ‘lost’ amidst the focus on what to regulate and where to draw the line.

518

Under the amended PHCR Act, it is no longer an offence to create a human embryo

clone provided it is done so under licence,

The Prohibition of Human Cloning for Reproduction and the

Regulation of Research involving human embryos Amendment Act 2006 (the Amendment

Act) came into operation on 12 June 2007. The resulting amendments to the RIHE Act and

the PHC Act (now titled the Prohibition of Human Cloning for Reproduction Act 2002 (PHCR

Act)) shifted the previous boundaries by altering definitions and broadening the scope of

activities permitted under the Acts.

Specifically, the definition of human embryo found in the earlier PHC Act was repealed.

Section 8(1) of the PHCR Act now provides that:

human embryo means a discrete entity that has arisen from either: (a) the first mitotic division when fertilisation of a human oocyte by a human sperm is complete; or (b) any other process that initiates organised development of a biological entity with a human nuclear genome or altered human nuclear genome that has the potential to develop up to, or beyond, the stage at which the primitive streak appears; and has not yet reached 8 weeks of development since the first mitotic division.

This definitional change accords with the Lockhart committee’s recommendation 28.

519

517 Senate Community Affairs Committee, Inquiry into the Legislative Responses to Recommendations of the Lockhart Review, 26 October 2006, (Additonal Comments by Senator Natasha Stott Despoja and Senator Webber), 78. 518 Again noting that in both Houses a ‘free vote’ was given in which members were not required to vote along party lines. 519 Prohibition of Human Cloning for Reproduction Act 2002 (Cth), s22.

however a person commits an offence if they

intentionally place a human embryo clone in the body of a human or the body of an


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animal.520 A person also commits an offence if they intentionally place any human embryo

in an animal or anywhere other than a woman’s reproductive tract; or an animal embryo in

a human.521

It remains an offence to import or export a human embryo clone in or out of

Australia.

522 Section 12 provides that it is an offence to create a human embryo by the

process of fertilisation of a human egg by a human sperm outside of the body of a woman,

unless the person’s intention in creating the embryo is to achieve a pregnancy. It is also an

offence to create or develop a human embryo by fertilisation that contains the genetic

material provided by more than two persons,523 and to develop an embryo outside of the

human body for more than 14 days.524 It remains an offence to alter the genome of a

human cell in such a way that the alteration is intentionally heritable by descendants of the

human whose cell was altered,525 to collect a viable human embryo from the body of a

woman,526 and to create a chimeric embryo.527 The PHCR Act has been amended so that it is

no longer an offence to create a hybrid embryo. Rather it is an offence if a person

intentionally develops a hybrid embryo for a period of more than 14 days (excluding any

period where the development is suspended).528

The new legislation continues the preference for a command and control system,

retains national focus, and maintains the federal licensing body which licenses and monitors

research involving human embryos and cloning (amongst other functions). It is noted that a

clear distinction between the PHCR Act as a prohibition act and the RIHE Act as the enabling

520 Prohibition of Human Cloning for Reproduction Act 2002 (Cth), s9. 521 Prohibition of Human Cloning for Reproduction Act 2002 (Cth), s19(a)-(c). 522 Prohibition of Human Cloning for Reproduction Act 2002 (Cth), s10. 523 Prohibition of Human Cloning for Reproduction Act 2002 (Cth), s13. 524 Prohibition of Human Cloning for Reproduction Act 2002 (Cth), s14. 525 Prohibition of Human Cloning for Reproduction Act 2002 (Cth), s15. 526 Prohibition of Human Cloning for Reproduction Act 2002 (Cth), s16. 527 Prohibition of Human Cloning for Reproduction Act 2002 (Cth), s17. 528 Prohibition of Human Cloning for Reproduction Act 2002 (Cth), s18.

act pursuant to licensing provisions is not possible given that subsequent to changes in

legislation in 2006 – the PHCR Act prohibits some things (for example, reproductive cloning)

completely, and others unless authorised by a licence.529

At the COAG meeting on 13 April 2007, all jurisdictions

There is a significant link therefore

between the two Acts.

530 restated their commitment

to introduce nationally consistent legislation signing a notice of variation to the

intergovernmental agreement. It was stated that the ‘commitment follows amendments

enacted by the Prohibition of Human Cloning for Reproduction and the Regulation of

Research involving human embryos Amendment Act 2006 (Cth) to the Prohibition of Human

Cloning Act 2002 (Cth) and the Research involving Human Embryos Act 2002 (Cth).’ COAG

recognised that the changes were to give effect to the majority of the recommendations of

the Lockhart Review report released in December 2005. The States and the Australian

Capital Territory undertook ‘to use their best endeavours to introduce corresponding

legislation into their legislatures by 12 June 2008 and for all parties to maintain nationally-

consistent arrangements over time’.531 Interestingly, this has not been the case. Whilst

some states and territories did pass corresponding legislation,532

The rejection of corresponding legislation by Western Australia occurred after a

team led by Shinya Yamanaka at Kyoto University published a paper in November 2007

which reported that differentiated human skin cells could be reprogrammed to an embryo-

Western Australia has not

followed suit.

529 Prohibition of Human Cloning for Reproduction Act 2002 (Cth). See generally Division 2. 530 With the exception of the Northern Territory which follows South Australian legislation. 531 Council of Australian Governments, Council of Australian Governments’ meeting Canberra 13 April 2007, Communique, http://www.coag.gov.au/coag_meeting_outcomes/2007-04-13/index.cfm#Lockhart at 12 August 2008. 532 Infertility Treatment Amendment Act 2007 (Vic); Assisted Reproduction Treatment Act 2008 (Vic); Human Cloning and Other Prohibited Practices Amendment Act 2007 (NSW); Human Cloning and Other Prohibited Practices Amendment Bill 2007(Tas); Research Involving Human Embryos and Prohibition of Human Cloning Amendment Act 2007 (Qld); Human Cloning and Embryo Research Amendment Act 2008 (ACT).

http://www.coag.gov.au/coag_meeting_outcomes/2007-04-13/index.cfm#Lockhart�


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like state.533 The resulting cells are referred to as ‘induced pluripotent stem’ (iPS) cells. In

December 2007 the success of a similar approach was reported by a University of Wisconsin

team led by James Thomson and Junying Yu.534

As such, the legal position in Western Australia differs. Section 42 of the RHE Act

(Cth) provides the Act is not intended to exclude the operation of any law of a state, to the

extent that the law is capable of operating concurrently with the RHE Act (Cth). The WA

legislation, which maintains the position described in Chapter Four, is capable of operating

concurrently with the RHE Act (Cth). The dilemma however is that because of the

Commonwealth powers to legislate on matters concerning the importation and exportation

of human material, patenting, trade and commerce, corporations and external affairs,

Both the Japanese and US research called

into doubt the need for human embryonic stem cell research and, as such, the need for

permitting the use (and inevitable destruction) of embryos created using cloning

technologies or excess to ART for the purposes of obtaining stem cells.

535

The Licensing Committee does not have an "official view" on the relationship between the Commonwealth Act and WA following the defeat of the legislation in WA. There are currently no licences issued to organisations in WA so there is no immediate need to address the issue. If a licence application is submitted by an organisation from WA, the Licensing Committee will consider it on its merits and will

corporations may arguably apply for licenses under the Commonwealth Acts to do research

not permitted under the State Act, which governs individuals. The difficulty thus arises that

what might be prohibited and subject to sanctions with regards to individual behaviour

might not be so if the ‘person’ acting is a corporation.

In asking the NHMRC Licensing Committee about their view regarding the Western

Australian position, the author received the following response:

533 K Takahashi et al. ‘Induction of Pluripotent Stem Cells from Adult Human Fibroblasts by Defined Factors’ (Nov, 2007) 131(5) Cell 861 – 872. 534 J. Yu et al. ‘Induced Pluripotent Stem Cell Lines Derived from Human Somatic Cells’ (21 December 2007) 318(5858) Science. [Originally published in Science Express on 20 November 2007]. 535 That is, sections 51(i), (xviii), (xx), (xxix)) of the Australian Constitution.

take legal advice at that time about the interaction between the two sets of legislation in relation to the specific licence application. It is the Committee's understanding that the main issue will be the status of the organisation in relation to paragraph 51 of the Constitution and that this will determine which legislation applies. Furthermore, the committee considers it likely that most organisations applying for a licence will be constitutional corporations. However, the committee will be guided by advice from the experts in constitutional law at the Australian Government Solicitor's Office which will be obtained if/when the situation arises.536

VII. THE REGULATORY MODELS ADOPTED IN THE UNITED KINGDOM AND

AUSTRALIA

Such a response suggests that the NHMRC Licensing Committee does not act as a body that

informs the public about its position relating to when it will or will not grant licenses in

advance. This is despite one of its predominant functions being licensing. Again, such

shortfalls indicate that the regulatory system and approaches adopted in Australia are not

the best model for regulating emerging technologies such as those associated with research

on human embryo and cloning.

The regulatory systems in place in both the United Kingdom and Australia govern the

general community, research scientists and practitioners, in relation to what is permitted

and prohibited in relation to human embryos and cloning in each jurisdiction and provide a

licensing framework within which research scientists and practitioners are required to work.

Whilst the United Kingdom and Australian regulatory systems have varied to some extent in

relation to what is or is not permissible in the areas of research involving human embryos

and cloning, their regulatory approaches operate in a similar manner. As such it is possible

to consider the systems together when considering how well they have answered the

questions of what to regulate and where to draw the line between permissible and

536 Email from Melissa Crampton (Director of Licensing NHMRC) to Sonia Allan 27 August 2008.


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prohibited activities and the how to regulate question with regards to the type of strategy

adopted in both jurisdictions—noting differences where they arise.

A. Achieving Regulatory Goals and Meeting Rationales of

Regulation

Having considered the details of the regulatory systems adopted in both the United

Kingdom and Australia it has been shown that both jurisdictions have put into place

regulation that reflects the rationales introduced in Chapter Two and, ‘on the face of it’,

meet the corresponding regulatory goals. Although a difficult task, they have managed to

balance competing rationales and define what to regulate, and where the line between

permissible and prohibited activities is drawn. Both jurisdictions have adopted regulatory

systems which include legislative provisions that provide the framework for what is

permissible and prohibited, and set up oversight bodies whose purpose it is to ensure

compliance with the legislation amongst other functions for those with a licence to conduct

research in this area.

In both jurisdictions the regulatory bureaucracies implement a public reporting

regime in which information about licenses that have been granted is published. In addition,

the HFEA keep detailed records on the number of embryos used in research and publish

annual reports on approved projects,537

537 See Human Fertilisation and Embryology Website:

whilst the NHMRC Licensing Committee in Australia

publishes quarterly reports relating to their inspection activities, licensing applications and

procedures, and any other relevant information regarding regulatory and/or research

http://212.49.193.187/cps/rde/xchg/SID-3F57D79B-907F604D/hfea/hs.xsl/421.html at 1 April 2009.



activity.538

Simultaneously the legislation and regulatory systems in both jurisdictions allows for

research to be conducted within the bounds of the regulatory provisions. Given that the

research has been promoted based on its potential to cure diseases and its potential

usefulness in relation to testing of pharmaceutical products, such permission does

encourage the production of ‘public goods’. This encouragement arguably has been

balanced with the ‘moral hazards’ presented by the research, for example by placing

constraints on exploitative or controversial research.

In this sense there seems to be a clear response to the public demand for

information about general research practice, and any associated hazards or deficiencies.

539

the higher the potential benefits of an activity, the greater the need for ethical objections to be of a high level and widely accepted in order to prevent that activity. Conversely, where benefits are not yet established, or where there is widespread and deeply held community objection, then total prohibition through the legal system may be justified. ...[E]ven though some people think that an activity is unethical, it does not necessarily follow that that activity should be made illegal. ...[T]he wider the range of ethical views on a particular activity, the weaker becomes the case for declaring that activity to be illegal, with all the attendant consequences of criminal conduct.

In their review of the legislation, the

Lockhart Committee noted that this balance to some extent may be met by taking the view

that:

540

Similarly both jurisdictions have successfully balanced the preferences of individuals

who may wholeheartedly wish to proceed with embryo research and/or cloning with those

of others who are equally against it. This is a most difficult task, and one may have expected

there to be more difficulty in achieving some resolution or balance. However, this chapter

has illustrated that the consultation and review processes in both jurisdictions were, and

continue to be, very effective. These processes included interested parties ranging from

It would appear that this is in fact the approach that has been taken in both jurisdictions.

538 See NHMRC Website on Human Embryos and Cloning: http://www.nhmrc.gov.au/research/embryos/index.htm at 1 April 2009. 539Hayek, above n151; Breyer, above n151; and Ogus, above n14 cited in Baldwin and Cave, above n151, 12. 540 Legislation Review Committee (Australia), above n10, xiv.

http://www.nhmrc.gov.au/research/embryos/index.htm�


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research scientists and practitioners, church authorities, ethics groups, academics, members

of the public, people with disabilities or diseases, to government officials. Many different

points of view were considered by way of accepting written and oral submissions,

consultation and debate. This was followed by written reports and recommendations aimed

at coming to some sort of accepted public policy decision, which again were subject to

further comment or review. Finally amendments to legislation via the Parliamentary

process, and codes of practice by the regulatory authorities, which regulate research

involving human embryos and cloning, were highlighted.

Whilst not every individual may be happy with the decision to allow certain practices

or prohibit others, and the debate about the moral status of the human embryo continues,

it does appear that the general population is satisfied with decisions about what to regulate

and where to draw the line. As such, continuing regular review processes, and reassessment

of whether to shift the line (based on further consultation, advances in science, and shifts in

public attitudes) are suitable ways of ensuring that the boundaries continue to be set in a

satisfactory manner, and that effective balancing of rationales for regulation is maintained.

B. The Regulatory Approach Adopted in the United Kingdom and

Australia

Both the United Kingdom and Australia have implemented regulatory systems which

include strict prohibitions that apply to the whole community. The police can be involved if

there is an apparent breach of these prohibitions, and people may be prosecuted through

the court system and punished accordingly. The main focus of the regulatory design strategy

adopted however is upon enabling research within certain bounds, and making sure

research scientists and practitioners working in the area behave appropriately. In both

jurisdictions, this is done by way of a licensing system that enables appropriate research,

provided the researcher has a licence, and prohibits other research where a licence does not

exist or where research takes place outside of the specific terms of a licence if there is one.

In relation to the how to regulate question, the licensing system, and related

regulatory design strategy and enforcement approaches, are the primary focus of this

thesis, rather than enforcement of the boundaries of what is permitted against the general

community.

Nonetheless, a number of mechanisms of punishment introduced in Chapter Three

are reflected within the United Kingdom and Australian regimes in relation to both

enforcing the prohibition on certain types of research and research without a licence in the

wider community and also in relation to those wishing to conduct research involving human

embryos and cloning pursuant to the licensing regime.

It is apparent that in the United Kingdom and Australia the presence of legislation

with strict prohibitions and penalties serves the theoretical purpose of deterrence. Both

jurisdictions have adopted regulatory regimes which contain the threat of financial

penalties, imprisonment in relation to deemed offenses and/or loss of licence as penalties

that can be used if researchers and/or practitioners do not comply which the respective

legislation. Such penalties are also forms of incapacitation punishment.

It was also shown in the above discussion that rehabilitation and retribution theories

are incorporated in the respective jurisdictions enforcement mechanisms. Only restorative

justice seems not to have a place in either regime. The regulatory systems in both

jurisdictions therefore contain to varying degrees many (but not all) of the theories that

were shown to underpin the various enforcement approaches.


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However, returning to the focus upon those who willingly subject themselves to the

licensing system and who wish to work within the regulatory framework to conduct

research involving human embryos and cloning, the particular regulatory design strategies

and enforcement approaches chosen have a big impact on how the system is accepted by

them, and subsequently on compliance. The issue is not whether the different theories of

punishment are all present and accounted for but whether they are appropriate to this

context and whether they are in practice put together in the way most likely to achieve the

best regulatory system possible. The question thus becomes whether the regimes in the

United Kingdom and Australian are of the type that will encourage researchers and

practitioners to comply. To answer this it is first necessary to discuss in more detail the type

of strategy that has been implemented in each jurisdiction.

1. Regulatory Design Strategy Adopted

Of the three regulatory design strategies—‘command and control’; ‘self-regulation

and enforced self-regulation’; and ‘co-regulation’—it is apparent that both jurisdictions have

adopted a ‘command and control’ approach. That is, in both jurisdictions influence is

exercised by imposing standards backed by criminal sanctions. The force of the law is used

to prohibit certain activities, to demand some sort of positive action, and to prescribe

conditions for entry into conducting research involving human embryos via a licensing

system. In both jurisdictions regulatory bureaucracies (the HFEA and NHMRC Licensing

Committee) have been established to enforce the command and control approach. In the

United Kingdom regime, the HFEA is granted some rule/decision making power via its

publication of a code of practice. The licensing process operates to screen entry into certain

activities, and also to set out such things as expected standards, the manner of conducting

the activity (for example, in making decisions about how many embryos may be used), and

to oversee and carry out inspections of the licensed facilities.

2. Enforcement Approach Adopted

Whilst it is very clear that a ‘command and control’ design strategy in both

jurisdictions has been adopted, underlying assumptions about what enforcement approach

is necessary to achieve compliance are a little harder to determine. Deterrence approaches,

cooperative, persuasive and educative approaches, and a combination thereof are

considered in turn.

a) Deterrence

As discussed in Chapter Two, deterrence involves securing compliance with the law

by detecting breaches and penalising those who have offended; and, by having penalties in

place about which the public can make rational decisions concerning the costs of engaging

in certain acts and whether they outweigh the benefits. Both in turn are seen as tools to

achieve the main goal of preventing future crime by way of deterrence.541

541 Banks, above n167, 105.

It is clear that

both the United Kingdom’s and Australia’s systems operate in a way that emphasises

detecting breaches—by way of regular inspections and oversight of licence holders—and

penalising any offenders. In addition, the significance of penalties of up to 10-15 years

imprisonment for either license holders or others who breach the Acts, may also

theoretically serve to place the rational actor in a position in which s/he would decide

against the commission of an offence due to the costs outweighing the benefits.


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If both regulatory systems’ enforcement approaches are conceptualised in a

pyramid, a hierarchy of penalties and regulatory requirements may be seen. For someone

without a licence it is just the tip of a pyramid – that is, criminal sanctions; whilst for those

who are licensed there are some other options. Nonetheless, even for licence holders, it is a

narrow pyramid. It is really just the tip of the sort of pyramid that Ayres and Braithwaite

recommend. Figure 3 depicts this:

Figure 3: The Current Regulatory Systems’ Enforcement Approaches:

The licensing and oversight at the bottom of the pyramid is a way of ‘policing’ research

activities conducted by licence holders, whilst severe penalties, including imprisonment, for

breaching the Act are at the top of the pyramid for those who might not adhere to lower

level regulatory requirements such as licensing. Cooperative, responsive and educative

approaches are largely missing or represented only to a small degree at the base within the

listed activities. These are discussed in the following section.

In terms of punishment and the deterrence approaches present in the pyramid, the

narrow tip might in theory represent the fact that few people will be subject to the penalties

Applying for licences, inspections,

Some ‘information visits’ and education (via information published on websites, etc)

Licence Revocation

Criminal Sanctions (Including imprisonment

and fines)

related to committing offences that would result in imprisonment or licence revocation as

few people will actually commit such crimes. Whether this is in fact the case because the

deterrent approach adopted is effective, or rather because generally researchers and

practitioners would not participate in certain activities anyway, is something that will be

explored in Chapters Five and Six. However, if an offence were to be committed, such

penalties would clearly be aimed at incapacitating the offender, with the possibility of

underlying rehabilitation, and elements of retribution. The threat of penalties might also

serve to deter the general population from engaging in certain behaviours. For example,

somebody wishing to do human reproductive cloning might be deterred by the threat of 10-

15 years in prison. Thus the enforcement approach might act to serve both individual and

general deterrent objectives.

b) Cooperative, persuasive and educative approaches

As the analysis above shows, most ‘command and control’ regimes emphasise

deterrence approaches. However, cooperative, persuasive and educative approaches may

also be seen in each jurisdiction—at least with respect to the licensing and monitoring

regimes at the base of the pyramid.

In Australia’s case, the Australian Lockhart Committee Report states that:

The monitoring and compliance framework used by the inspectors is based on a model of ‘cooperative compliance’, which encourages licence holders and others affected by the legislation to cooperate with the NHMRC to comply with the legislation. Emphasis is placed on education and communication to promote awareness of the responsibilities of both the licence holders and the inspectors. A key mechanism for raising awareness of the legislation is information exchange visits, which are made to researchers, licence holders, human research ethics committee members and other interested organisations. Information is also made available through seminars, workshops, websites and publications.542

542 Legislation Review Committee (Australia), above n10, 111.


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To the extent to which the inspectors act in a persuasive and educative manner in relation

to ‘encouraging licence holders to cooperate with the NHMRC and comply with the

legislation’ then there are less punitive approaches to enforcement at work. However,

whilst persuasive and educative strategies may be found at the bottom of the pyramid, the

impetus is towards the possibility of deterrence of activities that might lead to licence

revocation or criminal sanctions. It is not towards promoting cooperation and co-regulation

where researchers and practitioners participate in their own regulation.

The greater emphasis on deterrence can be seen when considering the Australian

monitoring system a little more closely:

Visits are usually arranged in advance with the licence holder, but unannounced inspections can also occur ... Inspections must take place at reasonable hours. If problems with compliance are identified, the inspectors might conduct additional monitoring inspections. Another form of inspection is the audit of records, which is conducted within a few weeks of the issue of a licence to assist new licence holders to meet the conditions of the licence relating to record keeping. At the time of expiry of the licence, a final inspection is conducted and the inspectors provide advice to the licence holder on preparation of the final report on the licensed activities. Before or during an inspection, licence holders may request advice from the inspectors. The inspectors, under the direction of the Chair of the Licensing Committee, might also provide formal verbal or written advice to bring issues or breaches to the attention of the licence holder. If a serious instance of noncompliance is detected during an inspection, or a formal complaint is received by the Licensing Committee, an investigation may be initiated. This may involve unannounced inspections or audits. If a breach is confirmed, actions available to the Licensing Committee include variation of the licence, suspension or revocation of the licence, or referral of the breach to the Australian Federal Police for possible criminal prosecution. Sanctions and prosecution would only be used for serious breaches where there was a clear intent by an individual or organisation to commit an offence.543

543 Ibid, 111.

There are only a few instances in which the monitoring/inspection system seems to engage

in a ‘dialogue’ with those being regulated according to the above. The first is to arrange an

inspection (although noting that the inspectorate might decide to conduct an inspection

unannounced—a threat and deterrent against wrongful behaviour at any time). The second

is that ‘before or during an inspection, licence holders may request advice from the

inspectors...’. The inspectors may also ‘under the direction of the Chair of the Licensing

Committee ...provide formal verbal or written advice to bring issues or breaches to the

attention of the licence holder’ – but this is not dialogue.

The licensing committee does release further information on compliance and the

operation of the regulatory system on the NHMRC website such as information kits, and

reports. Such tools do serve a communicative and educative purpose, which in turn do at

least theoretically assist with compliance. But again, this is not dialogue or cooperation.

Rather it is one-way communication.

The most cooperative thing is that the NHMRC Licensing Committee engages in

some ‘information exchange visits’ ‘in order to strengthen cooperative compliance of

organisations and persons affected by the legislation through an increased awareness of

legislative requirements.’544

544 National Health and Medical Research Council, NHMRC Licensing Committee Report to the Parliament of Australia for the Period 1 October 2005 to 31 March 2006 (2006). See also Appendix 14 for details of these visits.

They also state that they prefer to conduct such visits to

unlicensed premises rather than formal inspections, and that ‘through these visits, NHMRC

inspectors gain valuable information regarding relevant activities undertaken by


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organisations.’545 In addition, inspectors provide information to assist organisations in the

establishment of appropriate protocols that ensure compliance with the legislation.546

The HFEA has, since 2004, employed what they call a ‘horizon scanning panel’ which

they explain serves as an early warning system to identify, ‘through a rigorous and

systematic appraisal of scientific research, new developments that may impact on the field

of assisted reproduction or embryo research so that the Authority is aware of potential

licence applications and prepared, if necessary, with an Authority policy or position.’

In the United Kingdom some apparent cooperative, persuasive and/or educative

activities also occur at the base of the pyramid. The licensing and monitoring system is

implemented in much the same way as that in Australia. The HFEA, however, has additional

powers in relation to its publication of a Code of Practice, which contains amongst other

relevant things, guidelines which provide further information concerning the manner in

which licensable activities are to be carried out, and the functions and responsibilities of

licensees.

547 In

identifying issues that could impact on ART or embryo research the HFEA draws from issues

identified in journal articles, conferences and/or suggestions from experts. With regards to

the latter, they have set up a panel (the ‘Horizon Scanning Panel) of international experts548

545 National Health and Medical Research Council, NHMRC Licensing Committee Report to the Parliament of Australia for the Period 1 October 2003 to 31 March 2004 (2004). 546 Ibid.

in the field of ART and embryo research to advise them via internet communication,

questionnaires and a meeting once a year. The people on the panel are all professional

researchers and practitioners working in the field. The HFEA then engages in further

information gathering on issues as needed, prioritising of issues, consideration of the issues

547 Human Fertilisation and Embryology Authority, ‘Horizon Scanning Panel’, http://www.hfea.gov.uk/en/1554.html at 29 October 2008. 548 See Appendix 7 for list of experts on panel.


by sub-committees of the HFEA which might entail research and/or policy review, and then

output.549

The 2008 amendments to the HFE Act also require that the HFEA act in a manner

that promotes compliance, and operates ‘effectively, efficiently and economically’.

In addition, the HFEA conducts regular policy reviews and public consultations on

relevant issues. This is an ongoing process which occurs as issues arise. The United

Kingdom’s approach therefore contrasts with Australia in that in Australia, the policy review

and public consultation phase is the work of a specially set up parliamentary committee (like

the Lockhart Committee) that will review the legislation periodically. Of note in relation to

the Australian system of review is that the review of the 2002 legislation took place in late

2005, and amendments to legislation did not come into force until 2007. As such the next

review will not take place until 2010, which means any significant form of public

consultation and review in Australia is occurring about once every five years, and any

legislative changes therefore take between five and seven years. In this sense, the United

Kingdom system seems to engage in more ongoing dialogue and be more responsive than

that in Australia.

550 It

must also have regard to the principles of best regulatory practice including the principles

under which regulatory activities should be transparent, accountable, proportionate,

consistent and targeted only at cases in which action is needed.551

Whilst both jurisdictions employ deterrence approaches that utilise policing

mechanisms and threats of harsh sanctions to control behaviour, the review of the United

Kingdom Act has shown an increasing emphasis on cooperative, persuasive and educative

549 Human Fertilisation and Embryology Authority, ‘Horizon Scanning Panel’, above n547. 550 Human Fertilisation and Embryology Act 1990 (UK), s8ZA(1). 551 Human Fertilisation and Embryology Act 1990 (UK), s8ZA(2).


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approaches and better regulation, albeit still within the ‘command and control’ framework.

Australia on the other hand has only newly introduced its regulatory regime, and despite

the recent review, emphasises deterrent approaches to a greater degree than the

cooperative, persuasive and educative approach described in Chapter Two.

c) A mixture of deterrence, cooperative, persuasive and educative approaches

The third strategy considered in Chapter Two was one in which deterrent and

compliance approaches were mixed, with both punishment and persuasion involved. As is

apparent from the discussion above, although a ‘command and control’ design strategy has

been adopted in both jurisdictions there is a mix of deterrent and, to varying extents,

cooperative, persuasive and educative enforcement approaches. However, one could not

argue that either jurisdiction’s approach fits the Braithwaite ‘responsive regulation’ model.

If the regulatory responses in both jurisdictions are again imagined to be contained

in a pyramid, it can be seen that within the regulatory systems there are different sanctions

available (as illustrated above in Figure 3). Both systems also contain deterrence and

incapacitation mechanisms which, in addition to restorative justice, Braithwaite contends

should all be included in a responsive regulatory scheme. To some extent these

mechanisms are ordered hierarchically in the respective regulatory systems with the

broadest form of mechanisms and interactions between the regulators and those being

regulated —in terms of licensing and monitoring—occurring at the base of the pyramid,

whilst at the top of the pyramid sanctions which would incapacitate are apparent. However,

deterrence approaches as the catalyst to prevent researchers from committing offences by

way of the threat of imprisonment; pecuniary penalties; and/or licence revocation, seem to

be employed extensively, providing a truncated pyramid which is lacking in base level

responsive enforcement mechanisms. The pyramid does not include other options for

securing compliance as in Ayres and Braithwaite’s ideal pyramid.

Another stark inconsistency with Braithwaite’s model is that the regulatory regimes

do not provide for a system in which one would move up the pyramid always starting at the

base. As noted in Chapter Three, in ‘responsive regulation’ there is a presumption in favour

of starting official intervention at the base of the pyramid, moving up the pyramid from

restorative justice to deterrence and then incapacitation. Whilst we do see, to some extent,

that more cooperative strategies are deployed at the base of the pyramid and that

progressively more punitive approaches may be utilised, neither jurisdiction’s regulatory

system encapsulates the notion that regulators should start with the presumption of being

cooperative ‘however serious the crime’.552 There is no ‘restorative dialogue-based

approach... for securing compliance with a just law’.553 Neither the regulatory system in the

United Kingdom or Australia reflects the idea that responses are not to the seriousness of

the harm done but to the failure to elicit reform and repair at the base with restorative

justice processes.554

What in fact occurs is that in both the United Kingdom and Australia there are clear

offences that would lead to imposition of immediate sanctions that lie at the top of the

In fact, the above quote from the Lockhart Committee is illustrative of

how even the lower levels of ‘compliance’ work. Whilst there may be options in terms of

penalties available such as ‘variation of licence, suspension or revocation’ or ‘referral of the

breach to the Australian Federal Police for possible criminal prosecution’ all bar the

variation of licence are some of the most extreme and incapacitating forms of punishment

available.

552 Braithwaite, Restorative Justice and Responsive Regulation, above n8, 30. 553 Ibid. 554Ibid.


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pyramid (obviously after police prosecution and usual criminal processes occurred). The

licensing system deals with the rest but provides few options being predominantly restricted

to variation or revocation. Whilst all the theories of punishment are represented to varying

degrees, the crucial point of the ‘responsive regulation’ theory—that it is a dynamic

model—is missing because clearly, the systems adopted in both the United Kingdom and

Australia have specified in advance which are the types of matters that should be dealt with

at the base of the pyramid, which are the more serious ones that should be in the middle,

and which are the most egregious ones for the peak of the pyramid.

It is noted here however, and will be addressed further in Chapter Seven that in

some instances, such as where strict prohibitions exist, or where people are operating

outside of the licensing system, having a dynamic model would not work. Some breaches

should be dealt with immediately at the top of the pyramid, for example, attempting human

reproductive cloning. By recognising that neither the United Kingdom’s or Australia’s

regulatory systems fit the Braithwaite model of ‘responsive regulation’ perfectly, it is not

suggested that the strict prohibitions that have been decided upon through extensive

consultation and review processes be ignored or removed. What to regulate and where to

draw the line questions have been addressed adequately in both jurisdictions. As stated in

Chapter Three, even Braithwaite recognises that it might be appropriate when there are

‘compelling reasons to do so’ to abandon the presumption of starting at the base of the

pyramid. 555

555Braithwaite, Restorative Justice and Responsive Regulation, above n8, 30.

VIII. CONCLUSION

This chapter has considered in detail the public debate surrounding research

involving human embryos and cloning and the implementation of regulatory regimes in the

United Kingdom and Australia to regulate such activities, including ongoing reviews and

amendments to the respective Acts. It also considered the level to which such systems meet

the underlying rationales for regulation and the mechanisms and strategies utilised in order

to secure compliance.

It was argued that the underlying rationales have been met and adequately reflect

decisions about what to regulate and where to draw the line between permissible and

prohibited research. In considering the how to regulate question, it was illustrated that both

jurisdictions have adopted ‘command and control’ regulatory design strategies. The

‘command and control’ strategies adopted in both the United Kingdom and Australia, whilst

containing some cooperative, persuasive and educative enforcement approaches are

predominantly underpinned by a deterrence approach. Neither reflects Braithwaite’s model

of ‘responsive regulation’ and an appropriate balance between punishment and persuasion

has not yet been achieved in either jurisdiction. However, the United Kingdom has begun

moving towards such a system.

The inquiry into whether the United Kingdom and Australia have drawn appropriate

boundaries and whether they have respectively adopted the best regulatory model does not

stop there. It is necessary to consider how the regulatory systems are viewed by, and

whether they are accepted by, researchers and practitioners. That is, do researchers and

practitioners see the systems as setting clear boundaries, acting in a punitive or cooperative

way, governing research adequately? On what basis do researchers and practitioners


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comply with the regulatory systems in place? These are important questions as the

discussion in Chapter Three highlighted the flaws in adopting regulatory design strategies

that are not respected by those that are regulated. These questions are therefore explored

in the following chapter.

Chapter Five:

RESEARCH SCIENTISTS’ AND PRACTITIONERS’ PERCEPTIONS

OF THE REGULATORY REGIMES

I. INTRODUCTION

This chapter reports on how the regulatory systems are viewed by researchers and

practitioners in the United Kingdom and Australia. This is done by way of qualitative analysis

of fieldwork conducted in both jurisdictions in which researchers and practitioners

specifically in the field of research involving human embryos, cloning and/or ART who were

based at the major universities, hospitals and/or research institutes were interviewed.

Representatives from the regulatory authorities were also interviewed.

Whether researchers and practitioners saw the respective regulatory systems as

impeding their research and/or practice, whether they comply with the regulatory systems

and the basis upon which they comply, and whether the system in place is in fact their

preferred system of regulation, is explored.

In exploring these questions it will be shown that in Australia there was a strong

sense that the regulatory systems affected the conduct of science in a negative way. It will

also be shown that the value placed on the respective regulatory systems by those

interviewed, was predominantly based on recognition that the regulatory systems served to

quell public fears about the research, rather than being related to the view that the

regulatory systems in fact made people comply or prevented unsavoury research. It will be

demonstrated that, in both jurisdictions compliance was reported by researchers and

Chapter Five: Research Scientists’ and Practitioners’ Perceptions of the Regulatory Regimes

Page 165

practitioners to have little, if anything, to do with the threat of criminal prosecution and/or

imprisonment, and that regulators also questioned the need for such sanctions.

It will be seen that the results of the fieldwork conducted initially indicated that

there might be higher respect for the United Kingdom system because it was more

permissive. This is illustrated by the United Kingdom’s researchers being slightly happier in

relation to having a reasonably permissive system in terms of what research was allowed, as

opposed to Australian researchers who saw the system as slow moving and not permissive

enough. However even after legislative changes in Australia, and moves to allowing the

same sort of research as that permitted in the United Kingdom, dissatisfaction with the

Australian regulatory system remained. This indicates that it was the design and

implementation of the system that led to dissatisfaction, rather than what was permitted in

terms of research.

At the time of conducting the fieldwork, the licensing systems in both jurisdictions

were seen by those being regulated as too bureaucratic.

Researchers and practitioners did not like being viewed or treated as though they

were ‘baddies’. This may have important ramifications for the effectiveness of the

regulation, as this chapter will show. The view that the regulators often did not have the

scientific knowledge to fully understand what the researchers and practitioners were doing

(or wanted to do) but that they also did not show a willingness to draw upon researchers’

and practitioners’ expertise (again tied in with the lack of respect shown or distrust of those

who were being regulated) will also be shown.

Finally, the results indicate that, despite its shortcomings, researchers and

practitioners in the United Kingdom are happy with the regulatory model that governs them

(but want to address the shortcomings), whilst there is a general preference in Australia to

move to an enforced self-regulatory model from the current system that is seen as an

authoritative oversight model.

II. RESEARCH METHOD

A. The Sample Selection Criteria

Participants included research scientists and ART practitioners who were conducting

research involving human embryos, cloning and/or related research permissible under the

respective United Kingdom and Australian Acts, and who were current licence holders. One

representative from each of the regulatory authorities (that is, the HFEA and the NHMRC

Licensing Committee) was also interviewed.

Participants were selected using a purposive approach556

The sample size was small. However, the area of interest (that is, research involving

human embryos and cloning) is a highly specialised field with arguably some of the top

scientists in the world working in it. As such, whilst the pool of participants was limited, the

which enabled the

researcher to select specifically for expertise and experience in the field of research

involving human embryos and cloning, and therefore the insight they could provide in

relation to whether and how the regulatory systems might affect them. Selecting

participants involved checking the Human Fertilisation and Embryology Authority’s [HFEA’s]

and the NHMRC Licensing Committee’s public records in order to identify licence holders.

Contact details were obtained by accessing one of the following: publicly available records,

the website of the participant’s organisation, or obtaining contact details from a participant

who had suggested interviewing another participant. All participants were based at major

universities, hospitals and/or research institutes in the United Kingdom or Australia.

556 M Q Patton, Qualitative Evaluation and Research Methods (2002).


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knowledge and expertise of this very select group of practitioners meant that they were the

most important people to interview for this study. In total, nine interviews were conducted

in the United Kingdom: eight research scientists/practitioners and one HFEA representative.

Six interviews were conducted in Australia: five research scientists/practitioners and one

NHMRC Licensing Committee representative.

No comparison or control groups were included in this study as the primary aim of

the interviews was to research expert scientists’ and practitioners’ views and opinions

pertaining to the regulation of research involving human embryos, cloning and related

practices. However, in each jurisdiction one member of the regulatory authority was

interviewed. In addition, Chapters Two and Three discussed the public and political views

and responses to regulation of research involving human embryos and cloning using

alternative sources of information such as parliamentary debates, government white

papers, reviews and other publications, concerning the regulatory system in each

jurisdiction. This discussion provides a point of comparison to the views elicited from

research scientists and practitioners during the interviews and is discussed again in Chapter

Six in relation to the results presented in this chapter.

B. Research Methodology

a) Method Adopted

A qualitative method of collecting and analysing data was chosen. An interview

questionnaire was devised with the intention that each participant would be asked the

same basic questions and that each interview would follow the same general format.

However the methodology chosen was a ‘semi-structured face to face interview’. That is, it

was intended that participants would be permitted to elaborate on answers and discuss

other matters they deemed relevant amidst being asked the interview questions. Being

‘semi-structured’ the methodology allowed the researcher to probe for more details during

the interviews and enabled the use of her knowledge, expertise, and interpersonal skills to

explore interesting or unexpected ideas or themes raised by participants. The methodology

also enabled participants to ask for clarification if they did not understand what was being

asked, and ensured they were interpreting the questions in the way that was intended.

As recommended by Patton,557

This type of qualitative method also has a number of advantages that were deemed

most suitable to the enquiry being made here. Semi-structured face to face interviews

provide a means of understanding the views and intentions of participants in a way that

could not be understood through the use of other evaluative tools.

broad, open-ended questions were used to ensure

that the same basic questions were asked of all participants and that there was a similar

structure in all interviews. The questions were sufficiently non-specific so as to avoid

directing participants.

The design of the interview questionnaire provided enough structure to ensure that

none of the key areas of investigation were missed but allowed for sufficient flexibility in the

event that there were issues raised within the interview that needed to be investigated

further.

558 That is, unlike

multiple choice questionnaires, methods that involve simply counting/tallying responses

(quantitative methods), or even interviews that are strictly structured, such a method

enabled the participants to give their personal perspectives and report on their personal

experiences.559

557 Ibid. 558Ibid. 559Ibid.


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It allowed the participants to describe what was meaningful or important to them

using their own words rather than being restricted to predetermined categories.560

Finally, the reporting of quotes from semi-structured interviews provides high

credibility and face validity (that is, the results ‘ring true’ to participants and make intuitive

sense to lay audiences).

This was

deemed important so that participants felt more relaxed and were more candid in their

responses. It was also deemed important as the author was specifically interested in the

participants’ views and opinions rather than a tally or quantitative interpretation relating to

a set of data.

561 Quotations were also particularly useful as they allowed the

researcher to represent people in their own terms and capture participants’ views of their

experiences in their own words. 562

b) Shortcomings of Method

Shortcomings of this method were also considered. Particularly that this method

may be experienced as more intrusive than quantitative approaches; may be more reactive

to personalities, moods, and interpersonal dynamics between the interviewer and the

participant than methods such as surveys; and participants may say more than they

intended to say, and later regret having done so.563

560 Meg Sewell, The Use of Qualitative Interviews in Evaluation,

In addition, analysing and interpreting

qualitative interviews is much more time-consuming than analysing and interpreting

quantitative interviews; and the method may be more subjective than quantitative

http://ag.arizona.edu/fcs/cyfernet/cyfar/Intervu5.htm at 27 September 2008. 561 Ibid. 562 Patton, above n556. 563 Sewell, above n560.

http://ag.arizona.edu/fcs/cyfernet/cyfar/Intervu5.htm�

interviews because the evaluator/researcher decides which quotes or specific examples to

report. 564

c) Description of Interview Questionnaire

These shortcomings were addressed as much as possible where they may have led to

confusion or misreporting of results. For example, the research purposes were explained to

participants and any queries or concerns they had discussed; and participants were invited

to read transcripts of interviews after they were conducted and were permitted to change

or delete their responses if they had not expressed what they had wanted to. The time

consuming process of transcribing, analysing and interpreting qualitative interviews was

seen to be outweighed by the importance of this research and the benefit of talking face to

face with the researchers and practitioners in the field of embryo research and cloning.

Other shortcomings were also deemed to be outweighed by the benefits discussed above.

Finally, the greatest concern was that this type of methodology carries the risk of

participants giving socially desirable responses rather than reporting on what they really

think and/or do. To address this issue, interview questions were designed with a level of

repetition to enable cross-checking of responses and also in a way that enabled the

participant to comment on what they thought the general perception and conduct of other

researchers and practitioners was, along with their own perceptions, conduct and reasons

for behaviour. This enabled the researcher to again explore any differences between

responses that were ‘personal’ rather than general.

The semi-structured, in depth interview consequently devised for the study consisted of

seventeen questions. Each of the questions was developed by considering what the key

564 Ibid.


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areas of investigation were. This helped to ensure the interviews would all follow a certain

general structure. However, it is reiterated that the main purpose of using the semi-

structured interview format was to enable the researcher to understand and capture the

points of view of the participants without anticipating the specific issues that would be

raised. The pre-prepared interview questions and key areas of exploration (KAE) are

outlined below:

Identification of research/practice area

1. Can you begin by briefly describing the type of research/practice that you do.

KAE: To identify the participant’s research and/or practice area.

Knowledge of regulatory regime

2. Could you describe the formal regulation (for example laws) that governs your research/practice and comment on how it affects your work?

KAE: to determine the participant’s extent of knowledge and familiarity with the regulatory

system governing their research/practice.

Personal assessment of the regulatory system

3. What is your view about the pros and cons of having a formalised licensing system regarding research involving human embryos and cloning?

KAE: to elicit an opinion about the perceived benefits and/or disadvantages of having a

licensing system.

4. Do you think that such regulation sets clear boundaries about what you can/can’t do as a scientific researcher/practitioner?

KAE: to assess whether the participant perceived the regulation as clear.

Perceived effects of regulatory system on scientific and research practice.

5. Do you feel that formal, legalistic regulation hinders your ability to conduct scientific research and/or practice?

KAE: to assess the participant’s response to the regulation and in particular whether s/he

felt it hindered their ability to conduct desired research.

Compliance

6. In your opinion, what are the main reasons why people comply with formal regulation? (For example, fear of losing a licence, belief in the regulation, acceptance of where the boundaries have been set?)

KAE: to elicit the participant’s views on why other people comply with the regulatory

system.

7. Do you think that this is an area of regulation where the strict letter of the law is important, or are there different ways of interpreting the law in this area that give people more latitude and flexibility?

KAE: to assess whether the participant views the law as one that needs to be adhered to

strictly or whether it was open to interpretation.

8. What makes you comply with the legal regulation of your scientific activity/practice?

KAE: to explicitly ask the basis upon which the participant complied with the legislation.

Self-regulation as an alternative

9. Can you now describe the way in which your industry self regulates? (For example, industry standards, scientific and medical self regulatory bodies, etc)

10. What is your view about the pros and cons of having a system of self-regulation regarding research involving human embryos and cloning?

11. Do you think that such regulation would be better or worse than the more formal methods of regulation with regards to setting clear boundaries about what you can/can’t do as a scientific researcher/practitioner?

12. Do you feel that a self-regulatory system would hinder your ability to conduct scientific research and/or practice?

13. In your opinion, what are the main reasons why people comply with self-regulatory regimes? (For example, meeting professional standards; ethics of practice; etc)

14. Do you think professional self-regulation would suffice in the context of research involving human embryos and cloning? Why or why not?


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KAE: Questions 9 to 14 were devised to provide an opportunity to discuss self-regulation

as an alternative to the current regulatory system. The questions mirror the questions and

purposes described above in relation to Questions 2-6 but relate to ‘self-regulation’. They

particularly assess whether the participants were of the opinion that they should be left to

regulate themselves and the participant’s views on compliance to self-regulatory systems.

Participants views on external factors influence research practice.

15. Do you think social norms and informal social disapproval play a role in influencing what research scientists and/or ART practitioners will or won’t do? If so, what is that role and how does it influence what is/isn’t done?

KAE: To assess whether the participant was influenced by social norms and/or informal

social disapproval when considering the type of research/practice they were or would be

involved in.

Other regulatory models and likely compliance.

16. I am going to read (and show you) a list of different types of regulatory approaches that may be applied when regulating research scientists/practitioners in the context of research involving human embryos and cloning. Could you tell me with respect to each one, whether you:

*Perceive it to be a satisfactory mode of regulation in this context (why/why not); *Would be likely to comply with it (why/why not).

a. Formal regulation: Strict legal rules that impose legislative boundaries on what you can/cannot do as a research scientist. (Such rules if broken would be linked to sanctions ranging from fines, to loss of licence to imprisonment). b. Enforced self regulation: where legislation or regulatory action forces research scientists and/or practitioners to introduce self regulatory programmes that meet standards and goals set by the government and that can be publicly enforced. c. Co-regulation: government and self regulatory bodies work together to set and enforce standards. d. Self regulation: in which the professional bodies and associations set the standards and boundaries of what is/isn’t allowed – without government interference. e. No regulation: scientists and/or practitioners are simply left to make their own decisions about what they wish to do in the laboratory

KAE: To allow the participant to consider various approaches to regulation and indicate

which they thought were satisfactory and whether they would be likely to comply with a

particular approach.

Further discussion

17. Would you like to add anything else or make any other comments about the systems of regulation we have discussed?

KAE: The final question was open-ended and served to invite more discussion between

the participant and researcher. It was intended that ending the interview with this question

would provide the opportunity to discuss anything the participant felt had not been covered

and/or was important.

d) Human Research Ethics Requirements

Because the research involved human subjects, pursuant to ethics committee

requirements, consent forms and plain English statements of purpose outlining my research

project were devised and supplied to each participant along with the questionnaires prior to

the interview. (See Appendices 8, 9 and 10).

C. Interview Process

Each interview was conducted face-to-face in a public facility of the participant’s

choosing. Such premises included meeting rooms and private offices at University

departments, public hospitals and other research facilities. Each of the facilities ensured

privacy for the participant and allowed for the interviews to be recorded.

The researcher conducted all interviews, which were audio recorded for later

transcription. The data collection process of the research study extended over three years.


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At the end of 2005 and early 2006 the researcher travelled to the United Kingdom where

interviews were conducted in London, Sheffield, Newcastle, Manchester, Edinburgh and

Glasgow. Interviews were conducted both pre and post legislative change in Melbourne and

Sydney, Australia in 2006 and 2008.

Each interview began with the tape recorder turned off. Participants were reminded

of the purpose of the interview and its estimated duration and structure were discussed. As

stated above participants had been provided with a consent form, plain English statement

of purpose outlining the reasons for the study and a copy of the questions prior to the

interviews. At the interviews, the researcher first read through the plain English statement

with the participants and answered any questions they had about the research. All

participants then signed a consent form before the interview questions were asked.

Participants were given the opportunity to ask questions before the interview commenced

and were reminded that they were free to cease the interview and/or withdraw their

consent at any time.

The interviews ranged in duration from forty-five to ninety minutes. The average

interview time was one hour. Each interview continued as long as the participant chose.

The researcher, when conducting the interview, read a question to the participant

and allowed them sufficient time to respond. Redirection questions and clarification

questions were added occasionally at the researcher’s discretion. This was particularly

because as the interviews progressed and key issues were identified, the interviewer was

able to probe more deeply. Consistent with the views expressed by Minichiello et al,565

565 V. Minichiello, R. Aroni, E. Timewell and L. Alexander, In-Depth Interviewing: Researching People (1990).

the

richness of the data that could be obtained from semi-structured interviews was believed to

offset any concerns about variations in questions asked, and issues probed.

All interviews were audio taped and only brief notes were taken during the

interview. This was done (as recommended by Patton)566

III. ANALYSIS PROCESS

to allow the interviewer to

maintain her focus on the participant, respond appropriately and investigate any new issues

raised in the interviews.

After the interviews had been transcribed they were sent to the participant for their

approval and or clarification.

After the interviews were completed, they were systematically transcribed. Each

transcription was assigned a code (being ‘P’ for ‘participant’ and a number—for example

[P1], [P2] etc). This code served to de-identify the participants, make further analysis more

objective (by reducing researcher bias in selecting answers), and enable later use of quotes

that differentiated between speakers without identifying them specifically.

The data was then reviewed by the researcher, and results analysed to determine

patterns of response. Whilst the aim here was not to build a theory per se, both ‘within-

case’ and ‘cross-case’ analysis were used. ‘Within-case’ analysis was used predominantly to

gain familiarity with the interview data and derive themes and categories from the data in

relation to each interview. An inductive process of coding was used, deriving categories and

themes from the data itself.567 ‘Cross-case’ analysis was then used to group together

responses from different participants to similar questions or issues and identify patterns

across all cases.568

566 Patton, above n556. 567 Ibid. 568 K.M. Eisenhardt, ‘Building Theories from Case Study Research’, 14(4) Academy of Management Review (1989), 532-550.

The aim was to force the researcher to go beyond the initial impressions


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and see evidence through multiple lenses.569

3) divide the data by data source to exploit ’unique insights possible from different

types of data collection’.

As a result, the likelihood of achieving an

accurate and reliable conclusion is improved. Cross case analysis thus provided a more

useful basis of analysis for this research because it focussed on the key themes rather than

the individual participants. Such an approach was essential to ensure that analysis of the

interviews occurred with as little bias as possible, and that the full range of issues could be

identified and discussed.

Coupled with the ‘within case’ analysis identification of categories, Eisenhardt

suggests three possible approaches to cross-case analysis:

1) select categories and look for within-group similarities coupled with intergroup

differences,

2) select pairs of cases and list the similarities and differences between each pair,

and

570

As recommended by Schmerling et al,

For the purposes of this study, the first approach was deemed most suitable. Given the

small sample size a group comparison (rather than pairing cases) enabled similarities and

differences to be identified across categories in a meaningful way, whilst the third approach

did not apply in this context as different data sources did not exist (the only data being

interview data).

571

569 Ibid, 533. 570 Ibid, 540-541. 571 A. Schmerling, P. Schattner, and L. Piterman, ‘Qualitative Research in Medical Practice’, 158 Medical Journal of Australia (1993), 618 - 623.

the data entry and analysis were

undertaken as quickly as possible following the interviews.

IV. QUALITATIVE RESEARCH FINDINGS

UNITED KINGDOM

A. Profile of Interview Participants

Eight research scientists/practitioners and one member of the HFEA agreed to

participate in a qualitative interview. This included research scientists/practitioners that

headed clinical and research departments in hospitals, Universities and government

research and therapeutic clinics. Many of the people interviewed held multiple senior

positions and/or were leaders in their field of research and/or practice. They thus were

responsible for (and arguably represented) numerous research scientists/practitioners that

worked beneath them.

As per the level of identification agreed to by all participants572

POSITION DESCRIPTION

general details of

those interviewed, including a description of their position, the facility they worked for, and

the type of research/treatment they were conducting is contained in Table 2. All of the

participants (except for the HFEA member) were holders of and/or subject to HFEA licenses.

TABLE 2: Profile of United Kingdom Participants

FACILITY TYPE OF RESEARCH/TREATMENT

Scientific Director at St Mary’s Hospital in charge of the IVF labs and the experimental labs at the hospital; Job title: Consultant Clinical Embryologist (a protected term in the NHS in the

St Mary’s Hospital. University of Manchester

Treats about 600 patients a year and is entirely NHS (state) funded, there are no private patients. Supervises a research group which is currently doing some work on cultivating embryonic stem cells.

572 See Appendices 8 & 9 (Consent Form and Plain Language Statement, including discussion of identification).


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United Kingdom). Also a research scientist who holds an honorary position at the University of Manchester and co-supervises a research group there.

‘We hold two licences here, one for embryo research itself, aimed at relieving infertility, and the second licence, to make embryonic stem cells from IVF embryos.’

Director Research Scientist

Centre of Development of Stem Cell Biology at the University of Edinburgh

Looking at the basic properties of different types of stem cell including embryonic stem cells, foetal tissue stem cells and adult stem cells. Research focus on embryonic stem cells and pluripotency, and also a lot of work on neural stem cells. In most cases work with mouse stem cells, but in some cases work with human ES cells and human neural stem cells. Holds a licence to derive human ES cells, the first licence issued under the new regulations in the United Kingdom—but I held a licence prior to the new regulations.

Professor in the Department of Molecular Biology Professor in Obstetrics and Gynaecology. Co-director of the Centre of Stem Cell Biology. I am a reproductive biologist.

University of Sheffield The Centre of Stem Cell Biology

Main area is on the derivation of human embryonic stem cells. I am particularly interested in the derivation of reproductive tissues from embryonic stem cells, so either trophoblasts or germ cells. Looking at derivation of primordial germ cells and whether we can form gametes from those.

A stem cell biologist and co-director of the Centre of Stem Cell Biology

The Centre of Stem Cell Biology

My work involves having gotten some [stem-cell] lines, looking at how they behave.

Professor of Reproductive Science at the College of Medicine and Veterinary Medicine at the University of Edinburgh.

The University of Edinburgh

My research has all been concerned with gametes and embryos. Presently what we are interested in are the mechanisms that change the organization of nuclei and chromatin so that cells change from one type of cell to another type. This is fundamentally interesting but it also has the potential for practical application in the development of new techniques for cell therapies. These techniques may involve nuclear transfer, but hopefully we will get to the stage where we do not need to use cloning to produce the cells that we want to produce.

Consultant gynaecologist.

Newcastle Fertility Centre at Life

As well as general fertility clinics and close involvement of all aspects of fertility treatment, I take responsibility for the fertility preservation service and am the named ‘person responsible’ on the clinic’s licence (issued by the HFEA). This means that I am responsible in terms of the licence for everything that goes on in relation to the clinical operations and practice here at the centre.

Scientific Director Research Scientist

Newcastle Fertility Centre at Life.

Responsible for running the clinical labs at the Newcastle Fertility Centre at Life. ‘I also do research and am about to switch to the University, it’ll be part NHS


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and part University.’

Professor at Kings College London Wolfson Centre for Age Related Diseases (CARD).

Kings College London Wolfson Centre for Age Related Diseases (CARD).

We are a stem cell biology lab and we are primarily interested in the therapeutic applications of stem cells. The work in our lab is focused on the derivation, propagation, characterisation and assessment of the therapeutic potential of a wide range of stem cell population, including those from early embryos, as well as those obtained from foetal and adult tissues. So we have a licence from the human embryology authority to derive stem cells from human embryos and we work primarily on nine embryonic stem cell sources and foetal tissue. Our major interests include brain repair, Parkinson’s disease, cardiac disease, diabetes, and joint and bone repair.

I am a member of the HFEA.

HFEA University of Glasgow

Previously a research scientist for 20 years. I am now Executive Dean of Medicine. I am also the editor of Reproductive Medicine which is where a lot of the articles on this type of research are published.

B. Within Case-Analysis

‘Within-case’ analysis was used predominantly to gain familiarity with the interview

data and derive themes and categories from the data. Four main themes/categories

emerged at the initial stage of qualitative coding.

The first main category of response clearly present in the interviews was the

demonstrated knowledge of, and responses to, the presence of a regulatory system. The

second central theme to appear across interviews related to the researchers’/practitioners’

responses to the licensing system. The third broad category identified was the

researchers’/practitioners’ views on compliance including views regarding penalties. The

fourth emergent category related to self-regulation within science and ART practice. Each of

these categories is discussed below using a cross-case analysis qualitative methodology to

elucidate results.

C. Cross-Case Analysis

1. Knowledge of and Responses to Regulatory Framework

All participants demonstrated extensive knowledge of and familiarity with the HFE Act,

including both specific provisions of the Act and its role in setting up the HFEA (including the

licensing system), giving the HFEA the power to write the HFEA Code of Practice and the

implications such a regulatory system had on their research/practice:

We are governed by the HFE Act, which sets up the licensing system for clinical practice and research. There is also a Code of Practice issued by the Human Fertilisation and Embryology Authority which is very significant in relation to practice generally. [P6] We have the HFEA Act of 1990, we also have an alteration to the Act which took place a number of years ago which increased the range of reasons for allowable research to be carried out in relation to embryo research. [P9]


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One participant outlined the main restrictions under the HFE Act commenting that it was

hard to separate what scientists might/might not do if the legislation did not exist:

There are also restrictions in terms of what you can do. You can’t culture embryos for over 14 days, you can’t take a human embryo and put it into an animal, you can’t make chimeras or hybrid cells. .... But what we find is that these are things we would not do anyway. So in practice, it’s not really that restrictive. I mean it is hard to separate really what we might do in principle if the HFEA Act did not exist, but I would say that at the moment it is not too restrictive. ...[P1]

The main response to the regulatory system that participants had was that they all

commented on the usefulness of having the regulatory system in light of public concerns

and ‘lack of understanding’ of the science:

...[P}ersonally, I would feel quite vulnerable doing the sort of research that we do without the HFEA Act. I am quite strongly in favour of the HFEA system. [P1] ...the United Kingdom system in principle is fine. It is exactly what it should be. I do believe you to have statutory regulation in this area. [P2] I think it’s entirely appropriate that research with human embryos is regulated. I think it’s actually in everybody’s benefit that regulation is in place. [P5] ... it is reassuring. At least with this system you can say that what you are doing is legal, that you have been approved and that you are not some kind of renegade. It really works for the scientists’ protection. [P7] I am actually in favour of the regulations... The regulations foster our work and provide a regulatory framework in which we can work.... I don’t hear any stem cell researchers saying that the regulations are too restrictive. [P8] These are new technologies and the public doesn’t understand them to any great extent and we spend a lot of time trying to inform them, but I think having something like the HFEA provides a certain level of comfort. The HFEA has been around since 1990, and I think people are comfortable that the HFEA is going to protect them in some way. [P8] The other fact is that confers some level of respectability, the HFEA has looked at it, licensing implies that there has been ethical approval from their own ethics committee and our own internal ethics approval, and it proves it’s legal. So taken together, it gives you a bit of protection from someone saying they think the research you are doing is a bit objectionable. I can say ‘well have you checked my research licence?’ [P1] ... I do in fact think it is a very good thing. If anything, it protects us in a certain respect, in that we have a set of rules that we stick to, so you know what the framework is. You can use that—you can say, I have a licence, I am inspected every year, you may disagree with what I am doing but this is all licensed and open to inspection. So you feel at least you have a way of arguing that. If not, people could say they don’t know what a particular scientist is doing. At least you can say the HFEA inspectors know what we are doing, they come and inspect us, and in this way, it is in the public domain, which it should be. [P3]

..I do think the importance of the HFEA is that by regulating it, by licensing it, it helps the public understand that we are ‘goodies’. That is there, but you don’t want to over regulate to prevent things from happening. [P6]

Participants also expressed their views toward other benefits of the regulatory system:

It discourages trivial research. It discourages people in IVF units across the country who don’t have research training, taking embryos and conducting research on them, because you have to have a licence. [P1] I think the regulatory system is good, that [it] needs to be in place. When you are doing research, [even if] you agree that some sort of record system needs to be in place, that’s not what’s important. It’s getting the stem cells and doing the research. If you didn’t have to, you might get on with it and sometime later fill in the records. This is where mistakes would be made. ... [A]nnual inspections... force us to stock-take and just double check everything...[A]t each inspection, we get it a bit smoother about how we are recording and capturing things. It would be totally unacceptable to do this in other areas of science, but here, I think it’s necessary. [P2]

There was less satisfaction evident when discussing whether the legislative provisions set

clear boundaries for the researchers/practitioners. Only one scientist stated that clear

boundaries had been set by the legislation, noting this was qualified with an expression of

minor irritation towards where the line had been drawn:

Yes. I think the statute sets clear boundaries in terms of what you can and can’t do, and what you have to record. There are one or two very irritating things—for example, there’s an expiry date on embryos. An embryo has been donated to research, it has been consented to, but if I keep it a day over the date I’m breaking the law. This is absurd. Often I don’t get the embryo until that day. [P2]

Other participants emphasised the problems that occur as science progresses or ventures

into new technologies:

I don’t know [if it sets clear boundaries] to be honest. The problem comes along when there is something new. I think in a sense cloning illustrates that the Act was not clear. But the difficulty is how you can regulate in advance for things that you can’t see coming. ... [I]t is very difficult, if not impossible, to define things in a way which will be accurate over a long period of time. I’m not sure what that means, there could be two structures: one could be that we set up a body of people who will make the decision, the other is that parliament has to revisit the thing every few years. [P3] The limitations come from the work at the edge really in that it can be incredibly complicated to move things forward... There are also some edges in the sense that you might ask them something and the HFEA are not always sure of how to interpret the Act, or for that matter, sometimes the researchers and clinicians are not sure how the HFEA will interpret it and therefore do not do certain things. [P6]


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I think it’s a mistake to have specifics in the law. I think the definition of an embryo is the perfect example in the Act. ...What they have done is shrunken the vocabulary of embryology and then everything gets pulled into this embryo thing, and classically an embryo was post implantation. I would prefer to see them talking about zygotes, pre-implantation and so on. This would allow them to set points at where things might happen, but also in terms of public perception many people think of an embryo as a small baby and this is just misleading them. [P7] Having a formal regulatory system is not the issue. What is missing is the bit in the middle. If the legislation just provided a framework and then you had a policy maker which acts like the genetic advisory committee type of body which looks at whether the research is desirable rather than having their hands tied by some outdated specific wording. And then if we wanted to change the law, wouldn’t it be better with a body of people with relevant expertise? [P7]

2. Responses to the Licensing System

Again, all participants had extensive knowledge of the licensing system set up under the

HFE Act. Examples of responses that describe how the licensing system works include the

following:

The HFEA regulate everything that is done in the United Kingdom. This includes therapy as well as all research. In order to have permission to carry out research it is necessary to submit an application to the authority to demonstrate that you meet one of their five or six specific objectives. You have to define your research objectives and give reasonable grounds for doing the research you propose to do and that you can do the experiments properly. You have to provide patient information and consent forms which will be used, and as well as all of that, the authority will carry out an inspection of the premises at which the research will be conducted for a number of things including cleanliness but also security. [P5]

There was however strong expression of dissatisfaction concerning the implementation of

the licensing system:

Many participants detailed the bureaucracy involved in applying for licences:

The processes are very bureaucratic in that there are a lot of boxes that you need to tick. So there is a restriction in terms of bureaucracy. [P1] ...the bureaucracy is not always joined up. A few years ago they had a real problem of lack of resources, not enough people, and basically nobody that knew what they were doing in terms of the research side of things. They were a bit better on the clinical side. Now they seem to have a more people, but for example, this form that they send you to fill in is such an antiquated form, it’s so difficult to deal with. They don’t make it easy for you. Everything is cumbersome and takes up a lot of time. And, they are very unresponsive, but then you suddenly get a call out of the blue. So they could still do their job better... I don’t think it’s because there is too much regulation. It’s the bureaucracy; it’s just not efficiently done. They invariably turn up with reports that are out of date or have mistakes in them. They are simply not on top of their job. [P2]

The downside is the sheer amount of paper work involved. However, we’ve had this in our country for a long time with respect to auditing embryos, and a lot of this is necessary. You need to audit where the embryo goes to, what is done with it, consents to the particular use of the embryo, and so on, but I think that is right. [P3] [M]ostly the negatives are that it can be a bit bureaucratic, rather than that it exists at all. For example, we are moving sites and although you could argue that what we are doing in the new building is the same as what we are doing right here, we must apply for a completely new licence. The bottom line is that we don’t have the same postcode. There are things like that, we can do it, fill in a form, but it’s going to cost us 500 pounds for a new licence, a lot of paperwork, it just doesn’t make a lot of sense. [P6] The con is that it is just too inefficient. They need to model themselves more on research councils and how they deal with applications and grant requests. And also just to work together. The project that we were proposing was seen as universally desirable, there was just a technicality in the wording of the Act. I feel that if they come to us in a more collegiate spirit, we could have worked something out before everybody’s money got wasted. [P7] The HFEA are understaffed and really inefficient... [P7]

One participant gave an example of the type of bureaucracy they had faced:

My licence was renewed in May, and they came and reported on this. They said everything was fine except there was one new section and that this new section they didn’t think was properly consistent with the aims of the Act and should be removed. I pointed out to them that this ‘new section’ had been in the licence for four years. But they just ignore this completely and said it’s a new section and it must be removed. So they are not on top of it. Then it’s like any regulatory authority, you know once they’ve written it on paper, you can’t get anywhere with them. Things like that are a bit irritating. [P2]

Another emphasised inefficiency:

I think this is made worse by the fact that the HFEA are understaffed and really inefficient. ..[O]ur last experience was that I sent a licence application in January and in April was told they didn’t have it. It then suddenly showed up. I mean if you put a funding application through the MRC you get an immediate acknowledgment. This just doesn’t happen with the HFEA. You almost need someone who has a full time job to phone the HFEA and keep asking what the progress with the application is and see what stage it’s at. Things just disappear there. [P7]

One participant stressed dissatisfaction with the general approach taken by the HFEA:

I think what the HFEA sees itself as doing is stopping the ‘baddies’. But to be honest, I don’t think there are too many ‘baddies’, if any, in this field. So in that sense, having them is a bit redundant. People would like to do more than they are allowed to do, but I don’t think anybody has the desire to do it in an unreasonable way. [P6]

One participant expressed concern about the HFEA Licensing Committee’s consistency in

granting licences for particular research:

The other problem is probably consistency. The HFEA is often criticised for lack of consistency. They will make a decision on one project, and then a different decision in


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relation to a similar project at another university. So that can be an issue. It depends on the inspection team. You get different teams geographically and so on. [P1]

Some participants mentioned the issue of duplication between applications to ethics

committees and HFEA licence applications:

The cons are the amount of form filling. There can be a lot of duplication. A lot of the information that we have to provide the HFEA we must also provide internally to our ethics committee, in terms of patient information sheets, project information and so on. One of the major criticisms of the HFEA is the amount of duplication. [P1] In addition to that, we have to get ethics approval from the central organization here called COREC, we have to get ethics approval from the University Senate and we also have to get home office approval for any other research we do here. Eventually when tissue banking regulations come in, we will have to meet those requirements as well. [P1] So the licensing procedure is that you put in an application which is reviewed by the HFEA, even though you may already have funding for your research and may have already been through a peer review process by other scientists, so you go through that whole process again. [P7]

The HFEA Committee Member commented on this, stating that ethics committees alone

would not be satisfactory, and that the regulatory system actually enabled relatively liberal

laws:

Many scientists would think that the normal world of science should just be that if they have ethics approval they should just be able to go ahead and do their research, and don’t see why regulation should be required—and certainly don’t see why heavy regulation is required. But, in an area such as this, they don’t see that there could be a public backlash, and in fact our relatively liberal laws in this country are a result of the fact that we do have regulation. We know what has happened in countries that haven’t had regulation... Italy had no regulation and people were doing whatever they liked almost, within the scope of what embryology could achieve, even cloning. And of course, there has been a huge backlash in Italy and they have implemented very restrictive regulation. So we feel that the regulation is a worthwhile way of achieving public confidence, at the frustration of scientists who don’t want to be wasting time as they see it getting licenses and filling in applications. [P9]

There was also some expression of dissatisfaction with the amount of time it took to obtain

a licence:

There is also the delay. It can take the HFEA a number of weeks or months to look at a research application and a lot of groups in the United Kingdom criticise that. [P1] ... [Having a formal licensing system] affects our research in a major way because everything we do we must apply for a licence... The licensing committee is made up of predominantly lay-people. If they don’t grant the licence then you have to go through an appeals process where you appeal to the licence committee, and if that doesn’t work you go to an appeals committee. The effect of this is that it slows everything down. [P7]

The HFEA Committee Member recognised that the time taken to process applications could

impact on the science:

The negative effect is that it slows down the scientists getting on with things. It can certainly take many weeks, sometimes more if there is toing and froing between the committee and the scientists. There is the application to make, which takes time to write it, there’s the wait for the committee to meet, if the committee has any queries it goes back to the researcher, and if those queries are substantial, they will have to wait till the next committee meeting, and so it can take many months whereas the researcher would have liked just to get on with things. [P9]

Another participant noted twice that there were significant costs involved in licence

applications and appeals processes. This participant’s comments were also important in

relation to how such costs and processes affected the research:

I would also say that there is lots of clinical research that doesn’t get done because of the money it costs for licences. [P7] [Going to the appeals committee]. That was extremely expensive.... It held up the research by 18 months and cost a lot of money. [P7]

In addition to the time delays on research and the cost of the appeals process, the

adversarial nature of the appeals process, and the need to hire legal counsel was noted by

one participant who had appealed a licence application refusal:

Our particular experience of it is that we went to the appeals committee. I don’t think this happens very often but when it does it is not pleasant. We initially felt that we were going down there to put our case to the group of people on the authority, but then we received a bundle of documents and it turned out they had three legal people there, and we felt like lambs to the slaughter. It suddenly became very adversarial, we asked for a postponement had to go and get legal advice. When we saw the documents we could see what their objections were but if I’d had that information earlier I could have made a better case to ease their worries. But by the time I got the information, they had already engaged their legal team. I think they could do more to work together with researchers. [P7]

These difficulties were also recognised by another participant:

One that’s been through the news recently is researching mitochondrial diseases. This is a classic example of where the Act has botched it up quite badly and it has taken a lot of time and cost a lot in terms of legal expenses to be able to do what they wanted to do. [P1]


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There were mixed results in relation to how participants viewed the HFEA Licensing

Committee’s membership. Some recommended that the licensing committee be ‘slimmed

down’:

I think what should happen is that there should be a framework which is created by a variety of different people. It should certainly include biologists, scientists, clinician, people with religious faith, people without religious faith, and so on so that it includes people who are within reasonable limits that are representative of society. These people should formulate the set of rules but the aim should then be that these rules or guidelines should be applied by a smaller number of people who are trained and can make decisions quite quickly. [Although] this is the first authority of its kind in the world, and it’s been groundbreaking in its work and very effective...my personal view is that it could usefully be slimmed down and made a more efficient organization without greatly reducing the value and accuracy of the judgments. [P5]

Some participants expressed dissatisfaction with the membership stating that the members

did not possess adequate scientific understanding of ‘what was going on’ and this affected

licensing:

The HFEA is made up of many lay people. It has an effect on the understanding of what is going on and this is the reason that licensing issues can arise. The ideal situation would be that there is more consultation with the people who are actually doing the work. [P6] The licence committee considers that they have ‘expert’ scientific advice, but the fact is that they have an embryologist, or a medical geneticist, that doesn’t do much anymore. If you are active in those fields you can’t afford the time to sit on committees. They rely heavily on legal advice. I think a better model would be to have a panel of experts that they consult when they get difficult cases, rather than having them required to be members of the committee. I think that would work better. [P7] The other major problem is the lack of expertise on the authority. I mean they have scientists on the authority, but they may not be on the team that inspects your application. You might have someone with a PhD, but even that could be out of date or in a different field. You might not have anyone who has expertise in your research area. There can be a real problem in them understanding what you are doing. You have to be very careful that the wording is correct and that the interpretations are correct. [P1] The HFEA is very broad, and there [are] only a couple of scientists. At one stage it was almost all lay-people and there was very little if any scientific input on the committee and it was having an effect. It was holding up everything actually, as the laypeople just didn’t know enough about the science and therefore were just not making a decision. They react they are not ahead of the game they are behind it. And in that sense, that’s my main criticism of them. [P3]

The HFEA Committee Member also commented on the membership of the Committee.

The Committee is served by officers of the authority, including a legal person. It is served by a majority of lay persons, and its makeup would be chaired by a lay person of the authority. But there would be a number of members of the authority with scientific and clinical expertise. I would reckon you are looking at approximately 4 or 5 people making a quota. So you have scientific and clinical expertise, and the lay people will bring other levels of

expertise—they are not just people off the street, they have experience in other fields... the science and clinical advice that they are given by the members present I think the lay people do have a certain understanding of what the project is about. [P9]

3. Compliance

All participants said that the penalties within the HFE Act did not deter their

behaviour and were not the reason for their personal compliance with the regulatory

system. The reason for this was expressed by the participants to be that there were certain

types of research that they simply would not engage in (for example, reproductive cloning).

This is illustrated by a number of participants’ comments:

Criminal penalties do not deter my behaviour. Like other things in life, I don’t steal from people because I think I’m going to get caught and go to jail, but because I think it is wrong. I don’t want to have the guilt hanging over me. Similarly, there is certain type of research that I just wouldn’t do. Loss of licence and the other penalties are the same as well. We know what we are allowed to do and what we are not allowed to do under the Act; it is not the penalties that censure what I do. [P1] Most of us do not work with the fear that if we do something we will go to prison. [P6] I think everybody I know in the field...works within the framework because we want to. We find it very supportive and nurturing, and at the same time work within it because we are all very happy with it. So the fact that there are criminal penalties doesn’t affect what we do. You could remove the criminal penalties and I don’t think it would change anyone’s behaviour. I don’t think it acts as a deterrent because people wouldn’t do it anyway. I mean I have never heard anyone say ‘gee I really want to do reproductive cloning but I can’t because I’ll go to prison’. I think again, it’s a set of guidelines that everyone buys into here and if you don’t want to then you would have moved off to the US years ago. [P8]

Again, the undercurrent of public opinion (that is, keeping the public happy) was a present theme:

In relation to stem cell science (separating that from research involving human embryos), the reason that we would comply is the desire that there is an undercurrent of public opinion which is supportive, and we want to maintain that support, and there are some voices out there that although possibly unfounded or in a distinct minority that would like to see the whole thing shut down. We don’t want that to happen. We want to keep the public on board and on side. I have nothing to hide from the public. The thought is that if the public is not on board and on side, we may end up with laws that restrict what we can do. We don’t need that in relation to stem cell research which is quite different to that on embryos. [P4]

A number of participants also emphasised their professional reputations as being important:

Professional ruin if you didn’t. [P5]


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I guess my self-image really. I wouldn’t want to see myself as doing something to embryos that patients hadn’t consented to. That’s the main thing. It’s not the fact that I may end up in prison. I don’t consider doing the things that would put me in prison. [P7]

Loss of licence was mentioned as a bigger deterrent than prison sentences:

There is a lot of risk if you don’t. I mean you lose your licence if you don’t. We have made three cell lines and we could probably be fine if we couldn’t make any more but we are a high profile lab and losing our licence would be a major blow. And we still want to continue making cell lines with human genetic disorders within them. So losing my licence and the publicity around that would be detrimental to my research. [P8] ...you know that you will lose your licence. The last thing you want is to lose your licence because of some fault in the paper work. I mean, if you were doing some kind of criminal activity, like culturing the embryos beyond 14 days, or research without proper consent, but that’s not what scientists are doing. Mistakes can happen if you don’t have proper recording systems in place, or if you are not on top of the law with things like the expiry date issue, or if they are just bloody awkward to always comply with. That’s what’s irritating, where there’s no sense in it, but you know you have to record everything and show it to them, and if they are not convinced that you are showing them everything, or they find some fault in the records, then you are going to lose your licence. [P2]

When discussing why they thought other people complied with the regulatory system, only

one participant mentioned that the threat of prison was a possible reason for compliance

with the Act (noting that even so, this participant had said that it was not a personal reason

for their compliance):

There are statutory penalties associated with that, you know if you develop an embryo for more than 14 days or engage in reproductive cloning you go to prison. There is a strong chance of going to prison. You know it can be punitive. [P8]

With regards to the penalties included in the HFE Act, many participants regarded the loss

of licence, along with other types of censure, as more appropriate penalties than criminal

sanctions. However, participants did express the view that criminal sanctions may be

necessary where somebody has done something intentionally wrong, and quite extreme.

This was qualified by the ‘fear’ and disapproval that people who were the ‘person

responsible’ on the licence, or people that had made an ‘honest mistake’ might be subject

to these penalties inappropriately:

I think the loss of licence is appropriate, and I think the censure before that—that they can put conditions on a licence—is good. ...But there has been a lot of discussion about the criminal penalties and possible prison sentences that can be imposed on the ‘person

responsible’ on a licence. That’s been really controversial. Often the person responsible is not the person who in practice knows what is really going on. For example, often the person responsible may be a clinician, when it is the scientist in the lab that really knows what is going on, and the clinician has no authority over such a person. A person responsible should not be held responsible criminally for an honest mistake, or for the actions of a person they have no control over. I think if there is real fraud, or an intention to deceive, then that’s OK, but where that doesn’t exist it is hard to accept and I think that needs to be reviewed. ... [P1] I’m not against [the penalties], but I’m not sure that they are entirely necessary. However, I guess for extreme cases for example reproductive cloning. It’s not just unethical, but I have used the term ‘criminally irresponsible’ because of the risks to the woman and children concerned. There I would think it would be reasonable to have a criminal penalty for someone to do that. I think in terms of deterrent, you have to define the community you are thinking of in the first place. Within the United Kingdom, yes, but if you wanted to do it you could go somewhere else that didn’t have regulation. [P5]

One participant agreed that criminal sanctions were appropriate in some circumstances, but

added that they also served to demonstrate to the public that the research taking place in

the United Kingdom was ‘serious business’:

It depends on what you do. Something more serious like taking embryos [where proper consent has not been obtained] when you knew they hadn’t been, or using embryos that have gone beyond 14 days, or making some kind backhand payment to people, then yes. ...I think that sanction has to be there to demonstrate to the public that this is serious business. But also so we can stand up and say, when things like that which has happened recently in Korea occur, we can say ‘that simply could not happen here’. And so you can’t use that to damn all this research... [P2]

The HFEA Committee member stated that criminal sanctions did not generally make that

much difference and that professional reputation and loss of licence were probably enough.

It was however noted that in some instances criminal sanctions were needed:

...in a law abiding country such as this, criminal sanctions generally don’t make that much difference. People would not want their reputations to be ruined, even if they didn’t get a fine or go to jail, there would be enough scandal about them that this might be enough to prevent people from doing what is generally deemed unacceptable. The loss of licence and scandal associated with misconduct is probably enough. But in some contexts I suppose such sanctions may be necessary. In the treatment context there was the example of a person working in the lab was stealing embryos. Both the person responsible (the clinician) and the person who was doing this were brought before the Courts I believe, however only the person who actually committed the offence was sent to jail. [P9]


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4. Self-regulation

Participants described the way in which their industry self-regulates. A couple of

participants emphasised the layers of regulation beneath the HFEA system, all of which was

self-regulatory:

In principle there is a self-regulatory system. Many clinics refer to an external ethics committee, as most research has to go through an ethics approval process. [P6] There are several layers of regulation. There are ethics committees, professional bodies that represent embryologists, and everyone who works as a clinical scientist is registered with the Health Professions Council and there are professional standards within that, there are also professional standards with the Royal College of Pathologists, and the standards of the Association of Clinical Embryologists. [P7]

One practitioner emphasised that as well as professional bodies that draw up standards and

the ‘strong censure if one steps out of line’, that they regulated their own practice in terms

of thinking about the women they were implanting embryos in, and setting standards within

the laboratories:

Clinical treatment is self regulating in the sense that there are professional bodies that draw up standards. They have often been very proactive in how treatment occurs. There is also quite a strong censure if one steps out of line. This can have a strong effect on practitioners. We also regulate ourselves in terms of best practice... [There is] ...professional self regulation above and beyond what’s required of us. [P1]

When considering whether professional self-regulation would suffice in the context of

research involving human embryos and cloning, all but one participant said ‘no’. Most

returned to the emphasis on the public support given by way of having a formal regulatory

system:

No. The problem is that there would be one or two rogues that would go beyond professional regulation. These people could escape censure. The essential problem with self-regulation is that you only need one rogue and the whole system is gone. Their behaviour would reflect on everybody else in the system. Public support for being publicly funded would disappear. [P1] No. You need to get beyond that. You need to get outside the particular community that is involved. [P5] No. I think the added layer of formal regulation is still good, because it protects the scientists and eases public worry. I think having a formal body that says ‘Is that safe, has it been adequately tested?’ is a good thing. It’s just that the emphasis of regulation should be on that. [P7]

The HFEA Committee Member recognised that self-regulation ‘might work’, but said self-

regulation with externally posed sanctions would work better.

Self regulation through professional bodies might be a workable mechanism. It is what some people in the field might like to see. What it couldn’t do is impose any kind of legal sanction against someone who went out on their own. Professional sanctions might not be effective enough. It therefore is less satisfactory, but it is a possible mechanism. It could work in a country like England where society tends generally to behave itself. However, it didn’t work in Italy. Would people comply with it? On the whole, yes, but the people on the edges would have little to stop them from doing whatever it was that they wanted. Unless it’s an official professional body to which one must be a member, they might not have any power to sanction somebody’s behaviour. ...Demanding that there is self regulation in other words. It’s like self regulation but with sanctions. So I suppose it’s more likely to work than self regulation alone. [P9]

The HFEA Committee Member’s preference however was the system in place, noting that

the sanctions within it might not actually be that necessary:

Formal regulation: That’s pretty much what we have in this country, but professional bodies influence it, as I mentioned. [P9]

AUSTRALIA

A. Profile of Interview Participants

Six research scientists/practitioners and one member of the NHMRC Licensing

Committee agreed to participate in qualitative interviews. Participants included research

scientists/practitioners that headed clinical and research departments in hospitals and

Universities, and also two research scientists from private research and therapeutic clinics.

Again, a number of the people interviewed held multiple senior positions and/or were

leaders in their field. They thus were responsible for (and arguably represented) numerous

research scientists/practitioners that worked beneath them.

General details of those interviewed, including a description of their position, the

facility they worked for, and the type of research/treatment they were conducting is


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contained in Table 3.573

POSITION DESCRIPTION

Of the research scientists/practitioners, five were holders of and/or

subject to NHMRC licenses and one was a research scientist and ART Practitioner whose

work was affected by the Commonwealth legislation.

Three research scientists/practitioners were interviewed prior to the legislative

changes in 2007, and three were interviewed after the amendments were enacted.

TABLE 3: Profile of Australian Participants

FACILITY TYPE OF RESEARCH/TREATMENT

Cell Biologist Professor of Stem Cell Sciences Director, Monash Immunology and Stem Cell Laboratories at Monash University; Founder of the National Biotechnology Centre of Excellence – ‘Australian Stem Cell Centre’ Global Scientific Strategy Advisor.

Stem Cell Sciences Monash Immunology and Stem Cell Laboratories, Monash University

Understanding stem cell biology and other related science. Works with stem cells (adult and embryonic), germ cells, and embryos. Research is focused on how to maintain stem cells, how to clone them, how to differentiate to all the different species that we’d be interested in for researching, and maybe eventually clinical applications.

Research Scientist Professor Unit Leader, Embryonic stem cell differentiation group.

Monash Immunology and Stem Cell Laboratories, Monash University

Focuses on understanding the way that embryonic stem cells differentiate into forming other sorts of tissues. Particularly trying to direct embryonic stem cells to become certain sorts of tissues that would be useful eventually for therapeutic purposes. The particular areas that we focus on are blood cell formation and the generation of pancreatic endocrine cells that

573 Again this meets the level of consent given by all participants concerning information that might identify them. See Appendices 8 & 9 (Consent Form and Plain Language Statement, including discussion of identification).

make insulin and therefore would be of value to patients with diabetes. In the past, worked using mouse embryonic stem cells as a model, and in the last three to four years moved increasingly into human embryonic stem cells.

Research Scientist and Coordinator

Sydney IVF

With regards to human embryos coordinates and runs three of the licences held by Sydney IVF. I’ve had to do everything from thawing the embryos to destroying the embryos, using them for experiments which the licences are approved for.

Research Scientist

Sydney IVF

In charge of meeting the regulations, writes the licence applications

Research Scientist Clinician/Practitioner Educator

Royal Women’s Hospital Melbourne Melbourne University

I work in male reproduction research on sperm function treatment of infertility and results of IVF. I also teach students about this area of medicine. I have a small practice and I have had experience with problems of regulation since its inception. Also I have been involved with various issues to do with regulation over the years. Particularly I have been concerned about things that affect male infertility patient’s treatment with pre-implantation genetic diagnosis for male infertility problems, particularly the use of donor sperm, but I am interested in all aspects of regulation in this area.


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Recently retired as Chairman of the R&D Committee of IVF Australia, which is a large private Sydney-based Infertility Clinic An IVF practitioner since 1982. I was also Chair of RTAC for 6 years before retiring several years ago. I am currently on the IVF A Ethics Committee in my role as Emeritus Professor of O&G at Sydney University.

IVF Australia RTAC IVF Ethics Committee Sydney University

My current research chiefly involves follow up of the psychological bonds of IVF Mothers related to maternal age. In another capacity I was involved in the application of IVF A with its Senior Embryologist John Ryan for a licence to use up to 100 embryos (that were surplus to the couples' needs) to establish an embryonic stem cell line with Professor Bernie Tuch of the Juvenile Diabetes Prevention unit at the UNSW for human pancreas cells. Cell lines have now been established.

NHMRC Licensing Committee Chair

NHMRC My contribution, as far as an individual, is because of my research background in reproductive biology. But then of course I also Chair the Committee which means I have extra responsibilities, in terms of running the Committee working with the Secretariat. I actually appoint the Inspectors, under the Act, they can only be Inspectors of the Act if I agree to appoint them and I issue the licences on behalf of the Committee and often consult the Minister.

B. Within Case-Analysis

‘Within-case’ analysis was again used predominantly to gain familiarity with the interview

data and derive themes and categories from the data. Five main themes/categories

emerged at the initial stage of qualitative coding.

Four of the categories were similar to those derived from the United Kingdom

interviews. The first main category of response clearly present in the Australian interviews

was the demonstrated knowledge of, and responses to, the presence of a regulatory

system. The second central theme to appear across interviews related to the

researchers’/practitioners’ responses to the licensing system. The third broad category

identified was the researchers’/practitioners’ views on compliance including views regarding

penalties. The fourth emergent category related to self-regulation within science and ART

practice. Finally, a fifth category featured in the Australian interviews, that of the effect of

the regulatory system on scientific research and/or practice. Each of these categories is

discussed below using a cross-case analysis qualitative methodology to elucidate results.

Where relevant, differences between responses made in relation to pre- and post-

legislative amendments are noted.

C. Cross-Case Analysis

1. Knowledge of and Responses to Regulatory Framework

All participants demonstrated good knowledge of the regulatory framework

governing their research. Clear recognition of the existence of the RHE and PHC/PHCR Acts

respectively, including specific provisions of the Acts, was apparent, however all Australian

participants emphasised the ‘layers of regulation/requirements’ that existed. This was said

to range from requirements concerning gaining informed consent, to having to go through a

number of ethics committee approval processes, to meeting the NHMRC licensing

committee requirements:

I derive embryonic stem cells from left over embryos from patients who have had IVF treatments. So with their consent they are donated for research, specifically in my case for deriving embryonic stem cells. So I have to have a licence for that which means that I have got to have support from at least two ethics committees: hospital ethics committee where the IVF embryos are derived and also the university ethics committee. Then I have to have


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approval by the licensing committee of the National Health and Medical Research Council. Then I have to conform to all the regulations that they impose in keeping records. We have to ensure that we only use embryos that are allowed under the law and under regulation... You almost need a compliance officer to make sure you are compliant with all these [P10] Well we have to meet internal ethics committee approval, and we’re bound by the [RHE] and [PHCR] Acts, and the requirement to get a licence through the NHMRC licensing committee and that pretty much governs what we can and can’t do – our licences are quite specific. I think its effect on us is that it can be quite overbearing. It can also be at times quite a lot of work, doubling up on processes through ethics committee applications and NHRMC Licensing Committee applications, but at the same time we have to comply so we just have to do all of it. [P13]

Differentiation was made between regulation governing research involving human embryos

to derive stem cells, and the regulation once the stem cells had been derived:

In terms of the stem cell work, once the embryonic stem cells are derived there is no particular regulation relating to them apart from those that govern cells grown in the laboratory. So there is advice, recommendations to the NHMRC about what is being used and ethics approval for making different parts of tissues from embryonic stem cells. [P10]

One participant expressed his dissatisfaction with the ‘inflexibility’ of the legislation and

regulatory system:

Well the legislation is incredibly inflexible. I have never been very comfortable about legislation that you can’t change. Clearly even when [you are] supposed to review that legislation after three years, there is no guarantee that they will consistently make sensible recommendations on it. So you can see that that’s a fairly inflexible system. ...Inflexible regulation in this kind of area just doesn’t make sense, there are always going to be cases that are perfectly reasonable but just don’t fit into the legislation or regulatory framework and do we have to wait more than three years every time we want to see something change? [P10]

Another expressed their dissatisfaction with the way they were treated in relation to the

regulation and their input into it:

You have the feeling when you talk to these people that we are always regarded as crooks. You are the subject of this legislation and therefore whatever you say is clearly of much less value or interest to us than somebody else. This has been a feeling that I have that it is distressing to actually have to be looked at in that light and to have to fight all the time for these sort of things... [P11]

However, similar to the United Kingdom interviews, the majority of participants in Australia

commented on the regulatory system being useful in light of public concerns and ‘lack of

understanding’ of the science:

... I think it enables the community to feel that there is an appropriate oversight. In an area where there are the ethical concerns that’s obviously the best way to do things to enable research because the community can believe, or has a comfort that there is an oversight there that things are not being done that they wouldn’t be comfortable with, so that the community tends to relax under those circumstances. Eventually most of these things become more liberal as time goes on. Unless there is any issue ...there is no need to maintain that kind of intensive oversight over activities... We’re in the intensive oversight phase at this stage. ...I recognise that is the only way the Government will allow us to do the research because there is that oversight, so we have to recognise it otherwise we wouldn’t be doing anything. [P10]

I think some of the pros really are that to some people (the public) it’s a nice safeguard for them. They see that it’s not the mad scientist scenario which can sometimes be portrayed in the media. [P13]

One participant who was interviewed after the legislative changes commented on the

boundaries set by the legislation:

I think the legislation does set clear boundaries. The legislation is quite clear, or I think it’s as clear as an Act can be. I think it definitely improved after the review and the changes to the Acts. [P13]

However, the same participant went on to note that although the boundaries were clear,

this did not account for ‘grey areas’ of science, and that although interested in the scientist’s

views, the NHMRC did not really understand what the scientists were doing, nor were they

able to act:

I think however that there will always be a few areas which may be a little bit grey or that the government couldn’t think of in the first instance. You need to be able to give feedback and extend on that. ... [T]hings always come up as you’re developing a new technique or whatever that you haven’t thought of and the review process seems a little long given the rapid movement of technology. I think we (scientists) need a little bit more input, because we really are the ones on the ground doing the research. I think the NHMRC could improve on finding out our views on different things. We like to check with them because it’s better to be safe than sorry and we don’t want to step on the wrong toes or whatever, but you are then faced with other problems: you need people who understand what you are doing, and that are then able to act. [P13]

Another participant noted that the actual legislative provisions and definitions were not

suitable in the context of gradual biological processes:

I think definitions of a gradual biological process are very difficult. Regulations rather than strict laws would give more latitude. [P16]


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2. Responses to the Licensing System

Again, all participants had extensive knowledge of the licensing system set up under the

Australian legislation. In the Australian interviews the scientists questioned the need for a

licensing system given the other layers of regulation that exist in conjunction with the

legislation:

The scientific research is already strictly regulated by the ethics committees and these sorts of things. The additional ethics and licensing and all that sort of thing is just wasted money really. It is highly unnecessary because you already have sufficient oversight of these sorts of activities. [P11]

I think all you need is the legislation and the ethics committees. The added licensing committee and inspectorate seems a bit redundant to me. I can see that it serves to add a sense of assurance to the public, but really, in practice, it does nothing to stop people from doing the wrong thing. ...I understand why they do it in a way but in another way it just amounts to smoke and mirrors to keep the public happy. You know it’s a ‘look we are doing something’ approach, but it doesn’t serve to stop those who want to do bad science. [P13]

One participant noted that a licensing system could be ‘misused’ if the members of the

committee were of a particular view:

It could be dangerous if it’s misused, you know like if the people on the committee were motivated in a particular way they could make things really difficult…that would be very bad. Of course, they would still have to act within the bounds of the legislation... But my point is that if there was some sort of hidden agenda [for example] they’re not there to actually regulate [but rather] to prohibit. That would be bad. ...But I suppose at the moment they’re pretty stable, I think. [P12]

One participant described the inspections by the NHMRC Licensing Committee inspectorate.

Whilst generally being accepting of such inspections some of the issues inspections were

causing on a practical level were noted:

So the licensing committee inspectors are actually coming in and inspecting on a regular basis. We get inspections for every licence. And we get ...between a month and three week’s notice that they’re coming. On the day they will present us with a set of embryos which they would like to look at. We have to be able to account for those embryos and show them how we have processed them. The inspectors do have scientific backgrounds I think, but they’re mainly concerned with checking that the embryos were used for the correct licence and they were used for the way that the licence says they can be used and how they were finally processed. So, they pretty much come in and look at the records. There’s no other way that they could know this information unless they were here when we do our work and saw it for themselves. They have to rely on our records. They also come and look at the facilities and make sure everything is OK and when we moved they did an inspection to make sure that it was all OK. This is all OK, but it also causes some difficulties. Like it can be a bit difficult at times

because we do need to keep on site every single patient file of every embryo that we use so we can’t, realistically we can’t send them off to say storage facilities or somewhere where the files are kept offsite when we are finished with them. The practical consequence of this is that you know we’d need a lot of extra storage here for patient files which is not a big issue, but is still an issue. It can cost a lot of money in the long run to have to store all files permanently on site because they don’t tell us the embryos they want to look at beforehand. It’s all a bit absurd really. [P13]

The same participant noted again that the licensing system and inspectorate, whilst adding

a fair amount of stress, did not necessarily prevent those people who wish to do research

outside of the Acts from doing it:

It’s a very stressful day…. You know you’ve dotted all your ‘i’s and crossed all your‘t’s but you never know what they’re going to come up with. Again, it comes to my mind that if you want to do research that wasn’t in the bounds of legislation, you wouldn’t be doing it here and it wouldn’t be in those records anyway. So in terms of the inspection, it doesn’t really make sense. It’s a bit redundant. In my eyes you know, if you had somebody who wanted to do the research outside of the legislation, they wouldn’t have a licence, so therefore wouldn’t be being inspected. [P13]

Others commented on the Licensing Committee’s membership:

Well you know many people have a general view of committees. People who go on committees are people who don’t have anything else better to do - which is great because in some instances you need the committee process and so those people serve a purpose. But in this area, the people who can understand the science best are not going to be there because they want be in their laboratories doing the science. So what you do is you tend to end up with people who remain on the committee or go on the committee who like that kind of function. And they tend not to be in any way related to the science that is being done. [P10]

In relation to this issue the NHMRC Licensing Committee Member commented that the

committee was made up of a combination of people with scientific or clinical expertise and

other people with expertise in other relevant areas:

Well the Committee sort of breaks into two main expertise groups, I suppose. There is a group that have more expertise on the technology and science; so there is an embryologist, a medical practitioner who works in an IVF unit and me. It turns out one of the consumer reps is also a veterinarian practitioner, so she also has expertise in both. Then there is the other group which has a greater interest in ethics, consumer affairs issues and regulation. [P15]

There was also some expression of dissatisfaction with the amount of time it takes to obtain

or change a licence, or challenge a decision of the Licensing Committee:

The whole implementation of the licensing system here just delays everything. Getting a licence takes time in itself. Then, on top of that, I hope something that hopefully will come up in the next review is really looking at easier or more efficient ways of implementing the system. For example, if I have a licence to do something and then whilst I’m doing that research I realise I need to vary the licence, I


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have to go through the whole process again. This can take months. The licensing system should have a way making it easier to apply for variations. [P13] The licensing issue can take some time, particularly if you want to appeal a decision. If they don’t understand what it is we want to do, they might refuse a licence. That happened here. We had to go to the Tribunal for a review which was successful. But that took months and costs a lot of money. [P12] It is too time consuming for the private sector. This is probably the main reason why IVF A has not applied for another licence. [P16]

The NHMRC Licensing Committee member described their process and the time taken as

follows:

Okay. When a licence application comes in it gets assigned a number and it then comes to me, and if there is a Licensing Committee meeting in the very near future we’ll take it straight to that. What we do then is appoint a working group. If there is not going to be a Licensing Committee meeting for some time then I will do the appointment of the working group in the interim. The working group is normally made up of two members of the Committee, plus the appropriate members of the Secretariat. Those two members of the Committee one will be from the science technology side and the other will be the sort of ethics consumer side. So we’ve always got the two present. That working group, together with the Secretariat, will then go through the application and identify issues, questions, whatever they might have for the applicants. They will then go back to the applicants through email, or preferably by a site visit just to sit around a table and talk about the application and get it straight. Make sure everyone understands what it is. So by the time it actually comes to the Licensing Committee for approval and issuing of a licence, you would hope that everything is pretty well worked out. Nevertheless, it’s always the case that there will be some conditions put on it. It might be still subject to institutional ethics approval or subject to some other thing. Essentially we hope that by the time it goes through the Committee that’s it and we look to try and turn a licence application around within 10 to 15 weeks if possible. [P15]

That participant also added

[T]here is a responsibility on the Committee to decide what is a significant advance in knowledge or an improvement in technology. We spent a long time working that out, so we now have guidelines about that. In fact that slowed down the process of issuing licenses in the beginning, where some applicants got a little bit unhappy and edgy that it was taking so long. The Licensing Committee doesn’t apologise for that, we think we have to make it correct right from the beginning, because we need to assure the community and the Parliament’s that this was being done properly and not just recklessly. [P15]

Six years after the initial legislation was passed, researchers were still stating that the issuing

of licenses and/or variations to licenses was not happening quickly enough and was

impacting on the science.

3. Compliance

All participants were aware of the presence of sanctions including loss of licence, fines

and jail. However, the reasons for complying with the legislation differed.

One participant reported that these sanctions were relevant in determining how

they worked:

Well, in a sense, one has to comply with the legislation simply because the sanctions and penalties are quite significant and one has to take them seriously. It’s not that I’m actually thinking ‘I’m not going to do that because I don’t want to go to jail’ but we’re thinking that we have to be careful if something is at the edge, because if we get it wrong, we could go to jail. So in that sense it is relevant at the boundaries. [P14]

Another was adamant that their compliance was not to do with the sanctions, but

rather because it was the law of the country they chose to live in:

Well when we live in a democracy and they are the rules you have to accept them otherwise you move somewhere else. So if you live and work in Australia you confirm to the laws - so that’s just it. It’s not to do with the penalties it’s to do with respecting the society in which we choose to live [P10]

A similar response was given by a participant who said:

We accept that the boundaries have been set by government so we comply for this reason. [P16]

That participant added:

I do not believe punitive actions are appropriate. Failure of accreditation by RTAC (industry self-regulation) would mean that the IVF Unit would go out of business, which is disincentive enough. [P16]

One participant emphasised the importance of public confidence in keeping their business

running, and therefore the importance of acting ethically:

I think it’s interesting that when they were looking at, you know, creating and implementing legislation, it was so much of a moral and ethical kind of emphasis and argument and trying to balance all of that, but really when you put it in practice our priorities are based not on going to jail, but complying with what’s acceptable or ethical, keeping a good public face in terms of our company, and so therefore profitability and functioning. Our bottom line is that we have patients, and our company relies on them. That is a business. And those patients wouldn’t come to us if they think what we are doing is unethical, you know, I don’t think we could do anything unethical. [P12]


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The NHMRC Licensing Committee Member recognised the question of whether criminal

sanctions were needed:

I think there is a whole argument out there that is worth exploring as to whether or not you need criminal sanctions in something like this. I think from the professional scientific point of view, I’d like to think that they want to do this research because they want to do it properly and after all if you don’t do your research properly your results are suspect anyway. So as a scientist you want to try and do the best you can. ... [P15]

4. Self-regulation

Participants described the way in which their industry self-regulates. A number of

participants emphasised the layers of regulation beneath the legislative and licensing

system in place, all of which was self-regulatory:

We already have ethics committees and professional bodies overseeing what we do. I think this is preferable. [P14] We have quite a bit of self-regulation, definitely through ISO, through our ethics committee. That’s I guess our major self-regulation. To a certain extent there are professional bodies also, but I’d say mostly it would be our ethics committee which regulates most of it. [P13] The scientific research is already strictly regulated by the ethics committees and these sorts of things. The additional ethics and licensing and all that sort of thing is just wasted money really. It is highly unnecessary because you already have sufficient oversight of these sorts of activities. [P11]

When considering whether professional self-regulation would suffice in the context of

research involving human embryos and cloning, a number of participants were in favour of

some mode of self-regulation:

I think self-regulation is very suitable. Probably the enforced self-regulation is probably what the community would feel reasonably comfortable about it if we had regulatory oversight. The industry generally, as far as research has gone in the past has been very good. I mean even in Korea, it was the industry that exposed all those that were doing the wrong thing. It wasn’t somebody else.... We are principled people and I think enforcement is the key. But at least self regulation would enable you to have people who actually knew more about what was going on. I would have thought that has been a major benefit. [P10] I think at least with [enforced self-regulation] there is then the opportunity that the regulation of that sort of licensing is done by people with more of a scientific background and having an interest and stuff in the area. I don’t have any particular problem with that as a model system and I think it’s probably preferable. [P14] The Federal Government recognises (for Medicare funding and research) RTAC. This is an independent committee of the Fertility Society of Australia. All Units are regularly inspected,

and accredited for 3 years (or less), with requirements and suggestions. It acts under a complex Code of Practice which is available for inspection from the FSA website. It already works in NSW and Queensland, where there are no State regulatory authorities. [In addition] all Ethics Committees have to be constituted to reflect community standards and RTAC reviews this. I believe enforced self regulation...is the best model. [P16].

One participant expressed complete dissatisfaction with the presence of the regulation:

I think the Government should show leadership in this area and not kowtow to public fear or conservative values (which are the minority in this area I might add). They should show that we value science and we value progress. They should stand up and say we do these things because this is OK, we trust the people that are involved in these things, trained professionals, you don't need to regulate them they already behave.[P11]

The NHMRC Licensing Committee Member stated that enforced self-regulation might work,

but that in his view, the added layer of requirements ensured that things were being done

properly:

I think it would be very difficult to move to a more flexible system. It might be possible to move to enforced self-regulation. But some of the things that you want in this area, I think, are the knowledge that things really are being done properly and also the reporting systems that come with that and the inspection systems. It does sound a bit overbearing but in fact it’s not really. If it’s set up properly, if it’s set up in cooperation rather than under whatever the alternative is—brute force, authoritarian—if it’s set up cooperatively, I think it works very well. [P15]

5. Impact on the Science

A number of scientists expressed concern about how the regulatory system was impacting

upon the science. In particular it was seen to have a negative impact, slowing down progress

and acting as a barrier to research generally:

[I]t’s having a negative impact because it is slowing us down dramatically in the areas that we want to get on with. We are really interested in making stem cells from patients with cancer, patients with heart disease, motor neurone disease all these complicated diseases which we don’t really have a very good idea of the cause. It’s going to happen somewhere else and then we will have to be clients and will have to buy it back, and the cost of buying it back is enormous with medicine. [P10] It can have a great impact on your research. The whole licensing system can delay it quite a lot and I mean there’s a lot of justification and we understand that we have to justify what we do but it can be quite time consuming. I think it delays [science] significantly. You know without the licensing committee if it didn’t get through our ethics committee, you couldn’t do it anyway. ....It’s pretty heavily regulated in my opinion and it’s quite heavily policed. I think some things are a bit over the top. I mean it really does affect Australia’s progress. [P13] There are two things: one is that the interpretation of the letter of the law is sometimes difficult because it’s sometimes hard to actually draft the words to cover all the available sort of research contingencies accurately, and also to be able to anticipate today what in six


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months or 12 months’ time may become an issue. This can significantly impact on what researchers do if one is not sure if they are operating within the law or if the licensing committee deems what you want to do as outside of the law. Although there is provision in the Act that the legislation can be appropriately renewed and amended at intervals as required to take into account changes within I guess the scientific background or what sort of scientific research tells us are possibilities or are issues and things like that the review process happens every three years, and by time it is complete it can be up to six years before the legislation is changed. For science in this area, that is ridiculous. You can’t wait six years to know if you can do something or not, you are simply left behind. [P14]. Yes we actually went backwards as far as fertilization research went, whereas the stem cell people went forward. Again, that is an indictment on the way things are done. ...Really there should never have been any restriction on doing fertilisation research in the first place and we would be much further forward. [P11] From my point of view, the current process seems very bureaucratic and complex (only because the legislation is such). It requires constant inspections and written communication. It is a great barrier for us to do further research within the private sector. [P16]

V. CONCLUSION The results of the fieldwork illustrate that all participants in both the United Kingdom

and Australia demonstrated extensive knowledge of and familiarity with the respective

regulatory systems. This included knowledge of both specific provisions of the legislation

that governed what they were or were not permitted to do regarding research involving

human embryos and cloning, and the respective licensing systems.

In both jurisdictions the implications the regulatory system had on research and

practice featured heavily. Whilst all researchers and practitioners recognised that having

some form of regulatory system added public confidence in relation to their research and

practice, they all emphasised that the practicalities and implementation of having a licensing

system were bureaucratic, time consuming, and at times, heavily affected the conduct of

scientific research and practice. United Kingdom researchers and practitioners had

experienced this for a long period of time as their system of regulation had been in place

since 1990. Although raising some concerns about the impact regulation was having on

science, they were less vocal on this issue than the Australian researchers and practitioners.

Many United Kingdom participants in fact said that the system actually allowed them to do

the research they wanted to do.

However, delays and frustrations were apparent in both jurisdictions, particularly

when researchers were moving into ‘grey areas’ or areas that were ‘cutting edge’ or on the

boundaries. A major problem reported was that when touching upon ‘grey areas’ or areas

that were ‘cutting edge’ the committee members often lacked the expertise to make

judgements about what the scientists or practitioners wished to do. In the United Kingdom

this had led to instances of lengthy and costly appeals, and complaints that the HFEA went

straight to their lawyers instead of consulting with the scientists. In Australia, there were

also reports of having to appeal to the Administrative Appeals Tribunal574

In Australia, the participants also reported a lag in adjusting legislative definitions,

and what the legislation permitted, when compared to the science that was happening

around the world. Recognising that the review processes were in place, scientists and

practitioners expressed concerned about the impact on research as a result of it taking at

least six years for legislative changes to occur.

when unhappy

with NHMRC Licensing Committee decisions—again this was a time consuming and costly

process. In both jurisdictions the scientists involved in these appeals reported that the

respective committees simply had not understood the science involved in the application.

574 In July 2007, pursuant to section 32 of the Research Involving Human Embryos Act 2002, Sydney IVF Limited appealed to the Administrative Appeals Tribunal (AAT) for a review of NHMRC Licensing Committee’s decision not to vary Licence 309703. Having regard to the additional information provided by the applicant both prior to, and during the hearing, the parties reached an agreement that NHMRC Embryo Research Licensing Committee vary the licence. On 4 January 2008, the Tribunal issued orders which gave effect to this agreement. The AAT stated that there was no criticism of NHMRC Licensing Committee nor of the position it had taken in relation to its original decision. The AAT acknowledged the original decision had been made on the basis of the information provided to the Committee at that time. Under the agreed variation, Sydney IVF Limited is permitted to use an additional 150 excess Assisted Reproductive Technology (ART) embryos to complete a prescribed set of experiments. The licence expiry date has been extended from 16 April 2009 to 16 April 2010. National Health and Medical Research Council, NHMRC Embryo Licensing Committee: Report to the Parliament of Australia for the period 1 October 2007 to 31 March 2008 (2008), 11. (Email from Mary Novello, Administrative Appeals Tribunal to Sonia Allan, 18 March 2009 confirmed that there are no written decisions for the decision. It was given orally to the parties.)


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The members of the HFEA Licensing Committee and the NHMRC Licensing

Committee interviewed recognised the criticism that the whole process took too long, and

that this could impact on the science. However they emphasised having to ‘get things right’

and assure the public and the government that things were being done properly. They, as

opposed to the scientists and practitioners, saw their respective Committees as possessing

the relevant knowledge base to make licensing decisions.

It was also found that all participants were aware of the presence of sanctions

including loss of licence, fines and possible prison sentences. However, the reasons given by

the participants for their compliance with the legislation and regulatory system were

predominantly not these sanctions. In fact, in both the United Kingdom and Australia, the

majority of participants said that the penalties within the respective Acts were not a major

deterrent or reason for their personal compliance with the regulatory system. A number

simply stated that there were certain types of research that they simply would not engage

in (for example, reproductive cloning). Many had a strong sense that some things were

simply wrong and they did not want to do them. Others emphasised that they respected the

laws of the country they lived in. In the United Kingdom only one participant mentioned

that the threat of prison was a possible reason for other people’s compliance with the Act

(noting that even so, it was not a personal reason for their compliance). Similarly in

Australia, only one participant reported that the sanctions were relevant in determining

how they worked.

A number of scientists emphasised that although the legislation is aimed at ‘stopping

the baddies’ that they were not in fact ‘baddies’, emphasising that scientists often shared

the exact same morals as the rest of the society in which they live. Others, along these same

lines, were offended that they are consistently being regulated as though they are not to be

trusted.

The undercurrent of public opinion (that is, keeping the public happy) was a present

theme in many participants’ explanation for compliance. In fact, they seemed to see the

system as creating an undercurrent of public opinion that was supportive of the research

because the public knew that it was regulated under licence and therefore ‘serious

business.’ Complying therefore was actually a way of allowing researchers and practitioners

to continue with the research they wanted to do. This was particularly so in the United

Kingdom.

A number of participants also emphasised their professional reputations as being

important. In considering the sanctions that were in place, researchers and practitioners

said that loss of licence served as a bigger deterrent than prison sentences as this would

compromise the researchers’ ability to work.

In discussing which penalties were appropriate in the context of research involving

human embryos and cloning, there was a general consensus in both jurisdictions that loss of

licence and other types of censure were more appropriate penalties than criminal sanctions.

However, some participants did express the view that criminal sanctions may be necessary

where somebody has done something intentionally wrong, and quite extreme. This was

qualified by the ‘fear’ of the potential that if someone made an ‘honest mistake’ they could

be subject to these penalties inappropriately.

The members of the HFEA Committee and NHMRC Licensing Committee respectively

stated that their view was that criminal sanctions did not generally make that much

difference. They both expressed that consequences regarding loss of professional

reputation and loss of licence were probably enough. The HFEA member however noted


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that in some instances criminal sanctions were needed, whilst the NHMRC member

commented that the argument that there was no need for criminal sanctions was ‘worth

exploring’.

Issues of self-regulation were also explored. It was found that in both jurisdictions

participants described similar layers of self-regulation that existed beneath the respective

legislative frameworks and licensing systems. It was emphasised that this existed by way of

professional bodies, and internal and external ethics committees which considered

everything from practice to any research the participants were interested in doing. It also

extended to the need to self-regulate and ‘do the right thing’ in order to gain public funding

of research, which also required ethics committee approval.

Interestingly the participants’ views on whether such self-regulation would suffice in

the context of research involving human embryos and cloning differed in the United

Kingdom to Australia. All but one participant in the United Kingdom said ‘no’. Most returned

to the emphasis on the public support given by way of having a formal regulatory system

and the fact that although they had a formal regulatory system it had actually allowed them

to have quite a permissive research environment. The participant in the United Kingdom

that saw the HFEA as redundant was of the view that there was not anybody in the United

Kingdom, who wanted to do bad things, however they did see the HFEA as providing public

understanding.

In Australia, the majority of participants were in favour of some mode of self-

regulation – the emphasis being placed on some kind of ‘enforced self-regulation’—rather

than the formal regulatory system that had been put into place. The emphasis again was

that researchers and practitioners are principled people and that the industry does a very

good job at exposing people within it who are not acting properly. The consensus was that

some oversight may be needed so that public confidence could be maintained, but that

heavy burdensome regulation was not necessary. It was also emphasised that in states

where prior to the Commonwealth Acts there had been no regulatory authorities, there had

been successful self-regulation for years.

The HFEA Committee Member recognised that self-regulation ‘might work’, but said

enforced self-regulation (self-regulation with externally posed sanctions) would work better.

However, his final conclusion was that his preference was the system in place. Similarly the

NHMRC Licensing Committee Member stated that enforced self-regulation might work, but

that in his view, the added layer of requirements ensured that things were being done

properly. He also stated that it would be very difficult to move to a more flexible system.

In conclusion, the research conducted raises some important discussion points and

questions which will be explored in the following chapters. The view by scientists that they

are being treated like ‘baddies’ or as if they are ‘not to be trusted’ resounds when

considering the discussion in previous chapters about the best design strategies and

approaches to regulation. This issue is explored in greater detail in the following chapter.

The results indicate a need to increase cooperative, persuasive and educative approaches,

and reduce the bureaucracy associated with the regulatory systems in both jurisdictions.

These results indicate initial support for the central thesis presented in this paper that a

responsive regulatory system should be adopted. That is, the top level ‘command and

control’ design strategies and deterrence approaches present in the current regulatory

systems for breaches of legislation by non-licence holders and serious breaches by licence

holders should be maintained. However, greater use of co-regulatory design strategies and

cooperative, educative and persuasive enforcement approaches should be used in the

context of regulating licensed research activities.

Chapter Six: A Broader Evaluation of Scientists’ Values and Ethics and the Public Call for Regulation

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Chapter Six:

A BROADER EVALUATION OF SCIENTISTS’ VALUES AND ETHICS AND THE PUBLIC CALL FOR REGULATION

I. INTRODUCTION

I think the Government should show leadership in this area and not kowtow to public fear or conservative values (which are the minority in this area I might add). They should show that we value science and we value progress. They should stand up and say we do these things because this is OK, we trust the people that are involved in these things, trained professionals, you don't need to regulate them they already behave.[P11] Yes. I think what the HFEA sees itself as doing is stopping the ‘baddies’. But to be honest, I don’t think there are too many ‘baddies’, if any, in this field. [P6] Criminal penalties do not deter my behaviour. Like other things in life, I don’t steal from people because I think I’m going to get caught and go to jail, but because I think it is wrong. ...Similarly, there is certain type of research that I just wouldn’t do. [P1]

During the fieldwork reported in Chapter Five a number of participants expressed

the view that they were treated like they could not be trusted and as though there were a

number of ‘baddies’ in their field that needed stopping. The research also illustrated that

according to the participants interviewed, what motivates them to act, or refrain from

acting, in certain ways is their general sense of responsibility—that is, they are ‘good

people’, professionals, adhere to internal and external codes of ethics and ethical standards,

and have a conscience—rather than any threat of criminal prosecution or imprisonment.

Participants presented themselves as reflecting the values found in the wider community

about research involving human embryos and cloning, and gave no indications that they

wanted to do research that went against such values.575

575 Noting problems with self-report method are recognised above and below.

They acted within the regulatory

system in place in each jurisdiction, applied for licences and accessed the appeals process if

an issue concerning what was permitted arose.

Such results indicate the ‘good will’ of the researchers and practitioners but, in spite

of this good will, it has been shown that the regulatory strategy implemented in both

jurisdictions is one that places a significant emphasis on punishment and deterrence.

Braithwaite’s warning that ‘a strategy based mostly on punishment will undermine the good

will of actors when they are motivated by a sense of responsibility’576 is therefore very

relevant. Remember also that Ayres and Braithwaite note ‘a crucial danger of a punitive

posture that projects negative expectations of the regulated actor is that it inhibits self-

regulation’577 and ‘individual rebellion against being stigmatized as controllable only by

punishment is aggregated ...into collective forms of resistance’.578

1. What are the ethics and values of scientists?

This again supports the

argument that neither jurisdiction has adopted the best regulatory design strategy or

enforcement approaches when governing licensed researchers and practitioners.

However, the results reported in Chapter Five are based on a small sample size and

so require further validation. Additionally, drawing conclusions based on self-report of

participants alone might be vulnerable to the criticism that participants would not admit to

wrongdoing or wanting to do things prohibited by law. This chapter therefore explores and

responds to the results presented in Chapter Five by analysing the following questions in a

broader context:

2. What fears do other people have about scientists and are they valid?

576 Ayres and Braithwaite, above n8, 24-25. 577Ibid. 578Ibid.


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3. How should these issues affect the regulation of research involving human embryos and

cloning?

After exploring whether there are particular ‘types’ of people attracted to science,

and the values and ethics shown within the field, it will be argued that researchers and

practitioners generally share and reflect the same ethics and values as that shown in the

broader societies in which they live. However, a consideration of what makes people fear

scientists, and the fact that in certain situations ‘good’ people can do (and have done) ‘bad’

things, leads to the argument that in areas of risk some Government oversight/regulation is

warranted. That is although scientists’ ethical values are broadly representative of the

community at large, stringent forms of regulation remain necessary to cater for

‘exceptional’ cases where ‘bad’ things may be done. Nonetheless, it will be shown that there

is a danger of a ‘regulatory spiral’ if the regulatory approach taken is based only upon

heightened public perception of risk and the demand for regulation. Rather, ongoing

assessment of risks and a tempered approach to regulation is needed.

The arguments in this chapter support the thesis that a responsive regulatory system

should be adopted. They highlight that a level of co-regulatory design strategies and

cooperative, educative and persuasive enforcement approaches would best suit the context

of licensed research involving human embryos and cloning due at the bottom of the

regulatory pyramid. Maintaining the top level ‘command and control’ design strategies and

deterrence approaches present in the current regulatory systems should only be done so to

address breaches of legislation by non-licence holders and serious breaches by licence

holders. Such an approach would ensure government boundary setting and oversight and

that strict prohibitions and penalties for certain offences remain in place, whilst

simultaneously respecting the majority of researchers and practitioners who would not

engage in conduct that falls outside of general community values and ethics. Such regulation

would help to avoid institutional insularity, or pressures that have the potential to lead to an

environment where wrongdoing might occur, whilst fostering trust and cooperation with

those regulated. It would also increase the capacity for dialogue between regulators,

regulatees and the community and enable knowledge exchange about the science and the

perceived risks involved in research.

II. SCIENTIFIC VALUES AND ETHICS

A. Is there a Personality ‘Type’ that is Attracted to Science?

In exploring whether scientists do in fact reflect the values and ethics of the broader

community, one place to start is to ask whether people who choose to be scientists display

certain characteristics, and, if so, do these characteristics show them to have, or lack,

particular values or ethics?

Some vocational/organisational psychologists argue there are particular ‘types’ of

person attracted to, or better suited to, particular vocations. For example, one of the most

influential vocational theorists of our time,579 John L Holland,580 proposed that by late high

school most people come to resemble a combination of six vocational personality/interest

types: Realistic (R), Investigative (I), Artistic (A), Social (S), Enterprising (E) or Conventional

(C) which have corresponding environment types.581

579 Mark L Savikas and Gary D Gottfredson, ‘Holland’s Theory (1959-1999): 40 Years of Research and Application’ (1999) 55 Journal of Vocational Behaviour 1.

Holland asserted ‘these types reliably

show characteristic behavioural repertoires, patterns of likes and dislikes, specific values

and unique self descriptions’ and that people choose [work] environments because of their

580 John L. Holland is an American psychologist who spent much of his career at Johns Hopkins University. He received his B.Sc. from the University of Omaha and Ph.D. from the University of Minnesota. 581 J.L. Holland, Making Vocational Choices: A Theory of Vocational Personalities and Work Environments (3rd ed, 1997).

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personalities.582 Individuals suited to their work environment remain there because the

environment encourages them to use their distinctive skills and competencies, is supportive

of their attitudes and values, and permits them to assume agreeable roles.583

According to Holland, a person with a dominant ‘investigative type’ will be attracted

to jobs in the sciences.

584 Holland states that such a person ‘has mathematical and scientific

ability but often lacks leadership ability. They are analytical; independent; rational; cautious;

intellectual; reserved; complex; introspective; retiring; critical; pessimistic; unassuming;

curious; precise; and unpopular’.585 However although describing attributes the typology

does not in fact provide great insight into the values or ethics of scientists.586

Other tests developed specifically to determine ‘the unique aspects of scientists’

interests, values, motives, and opinions’

587 prove questionable. For example, a ‘personality

typology’ developed by The Science Advisory Board (SAB)588

582 Ibid. 583 J.L. Holland, The Psychology of Vocational Choice (1966); Holland, Making Vocational Choices above n555. There are a number of assumptions behind Holland’s theory which deserve discussion but are beyond the scope of this thesis. In summary they include that: the selection of an occupation can be a reflection of a person's personality; an interest inventory can be a personality inventory; vocational stereotypes hold important psychological meaning; there exist six different personality types against which we evaluate ourselves—most people are a combination of types, not a pure type; there exist six distinct working environments—each is dominated by a specific type; people are motivated to seek out jobs that complement their personalities, thereby maximising their individual strengths and minimising their weaknesses; specific career related behaviours, such as success, satisfaction, and job stability, can be reasonably predicted by examining a person's personality/environment fit. 584 Stephen D Brown, Career Development and Counselling: Putting Theory and Research to Work (2004), 26. 585 John L Holland, Amy Powell and Barbara Fritzsche, Self Directed Search Professional User’s Guide (4th Ed, 1994) as cited in Stephen D Brown, Career Development and Counselling: Putting Theory and Research to Work (2004), 26. 586 Holland’s theory is one of the most researched and written about theories in vocational psychology. There is much praise and application of the theory, and also criticisms. It is beyond the scope of this paper to explore these in detail. The point of inclusion is simply to highlight there are theories that say certain ‘types’ of people are attracted to certain professions, but such theories do not shed any light on the values or ethics of scientists.

claimed the questionnaire

developed by them—the Scientific Personality Assessment (SPA)—was ‘the first-ever

587 Tamara R. Zemlo and Robin Rothrock, The Human Side of Science: What is the Archetypal Researcher Personality? (2005), http://scienceboard.net/pdf/personality_screen.pdf_1.pdf at 4 January 2009. 588 The Board is ‘an independent, worldwide panel of life science and medical professionals that convenes electronically to voice their opinions on a wide range of topics. Total membership is greater than 41,000 members from more than 50 countries. The Board's members range from Department Heads and Principal Investigators to Lab Technicians and graduate students from universities, research centers and hospitals’. See http://scienceboard.net/ at 4 January 2009.

http://scienceboard.net/pdf/personality_screen.pdf_1.pdf�

http://scienceboard.net/�

psychological profile of life science researchers’.589 Two thousand nine hundred and fifty

(2950) members of the SAB completed the 76-question SPA to self-assess their personality

based on adjectives provided. They were also asked to describe their behaviour when

making a decision, searching for information, reacting to change, and interacting with

others.590 It is reported that the answers were analysed using a ‘proprietary scoring

system’591 to group them into one of four personality types: leader, explorer, enthusiast and

organiser, which are described in detail in a self-published paper.592

Lead

er

Table 4 summarises the

descriptions given of each type:

Table 4: Summary of Scientist Personality Types Reported by SAB

Disciplined; able to guide and manage other researchers; persistent; assertive; independent; structured; enjoy challenging projects; self-assured and proud of their scientific achievements; excel at multi-tasking; prefer fast-paced research environments; take action immediately. Work best with “big picture” projects that need to be pushed through with aggressiveness or personal resolve. Mandate perfection; are usually easy to get along with—provided others measure up to their high expectations. Sometimes criticised for making decisions too quickly, often relying on their instinct rather than systematic analysis of the facts; extremely competitive, especially when it comes to being the first to uncover significant findings; sometimes lack the diplomacy needed to keep everyone informed and involved when working in a group; concerned with achieving their personal goals and dreams. In a dysfunctional research team, they may be resented or even feared because of their aggressiveness and perceived lack of concern for others’ feelings.

Expl

orer

Visionaries; full of novel ideas; willing to venture into uncharted territories; live life to the fullest; take an idealistic approach to the research process; driven by competition; fascinated with new exciting ideas and technologies. Outgoing; enjoy being the centre of attention; some may view them as socially aggressive. In the lab explorers are the motivators of their research team. Excel at networking with fellow scientists. Confident. Can quickly lose focus and get bored, yearning for the next exciting challenge. Can be disorganized, impulsive and struggle with follow-through and time management, especially when it comes to repeating failed experiments or meeting grant/publication deadlines. Often considered by others to be poor listeners as they monopolize conversations. Opinionated. Tend to attribute successes to their own strengths and may fail to recognise important contributions of lab members and suppliers.

589 Zemlo and Rothrock, above n587. 590 Ibid. 591 Zemlo and Rothrock do not give details concerning the ‘proprietary scoring system’ used or what it entailed. 592 Zemlo and Rothrock, above n587, 2-3.


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Enth

usia

st

Motivated to interact with and please others; sensitive and accommodating individuals; effortlessly make friends with other researchers; easily work on collaborative projects; great listeners; more amiable than other scientific personas; often strive to reach a group consensus when decisions have to be made; easy-going; lack of ego; extremely hard workers; take pride in their strong work ethic. Their role in a research team is usually supportive and cooperative they are viewed by others as dependable, patient, and loyal. Because of their eminent likeability and trustworthiness, enthusiasts both excel at negotiating and are effective advocates for their research and lab. Others may perceive them as being unassertive and conformist. Tend to keep their thoughts and feelings to themselves; in their effort to “get along” sometimes find themselves involved in projects/decisions in which they have little interest/ no personal stake. Resistant to change, steers clear of risk, and avoids conflict with scientific colleagues.

Org

anis

er

Methodical, traditional and pragmatic approach to research; highly intellectual individuals; soft-spoken; refrain from expressing their feelings, not wanting to overtly influence another’s opinion or analysis of experimental results; can be very particular and often judgmental of others, especially when a colleague’s assumption contradicts their own; thrive on facts and data; perfectionists; bothered by careless mistakes; strive for high levels of accuracy and precision in their work, and expect the same from others. Because of the extensive detail they require of any task, prefer to work on only a few research projects at a time. Extremely cautious decision-makers; have a tendency to analyse problems from multiple angles—but their final analysis is routinely based upon very sound judgment. They become frustrated and sometimes procrastinate when sufficient facts are not available, or quality of the available data does not meet their high standards. Other scientific personas may find them too demanding.

The SAB reported that of the scientists that completed the questionnaire, 28% were

leaders, 24% explorers, 32% organisers, and 16% enthusiasts. However, there are glaring

problems with all of the results. The SPA relies on ‘self-report’. There is no evidence that any

of the people who completed the questionnaires in fact possessed any of the qualities

chosen, only that they may have seen themselves that way, or wished others to see them

that way. There is no evidence of statistical validation of the data, nor of the SPA tool. With

regards to the latter, ‘proprietary scoring systems’ have been criticised as they often cannot

be evaluated by independent journals or peer review. Basic information may be withheld

because of its proprietary nature, for example, the identification of clinical variables, values

of normal age-related ranges, as well as the equations relating patient characteristics to

outcome. It has been argued that missing information found in papers that report findings

that may have commercial implications (as with the results of the SPA) make a potentially

useful contribution uninterpretable.593

Whilst the majority of the above criticisms of the SPA are made by the author, as

there has been no researched evaluation of the SAB’s profiling exercise, similar criticisms

have been made of other widely used vocational selection and profiling tools. For example,

the Myers-Briggs Type Indicator (MBTI),

Overall, there are no reported tests of reliability or

validity for the SPA, despite these being fundamental issues concerning the foundation of

any psychological test.

One could also argue that the different ‘personality type’ descriptions the SAB

asserts are found in science, are so broad and so different, appear to be personalities found

everywhere in society, and in all sorts of work environments. In addition, the percentage of

each type reported seems to be fairly evenly spread. There are no statistical data stating

that the results reflect any significant differences between scientists and the general

population, or that science attracts more of one ‘type’ of person than another. Potentially,

what the results do show, if anything, is that scientists are just like anyone in society and in

fact there is no specific ‘type’ of person that becomes a scientist.

594 which posits sixteen personality types and

predicts that ‘INTJs’ (Introverted, intuitive, thinking, judging) people are best suited to

scientific careers, has been criticised widely in research literature because it lacks reliability

and statistical validity.595

593 R.K Kanter, ‘Research Publications Involving Proprietary Products: Science, News or Advertising?’ (1998) 101(3) Paediatrics 468. 594 A widely used commercial tool used to guide people in choosing vocations, or evaluate them for suitability to a particular job, developed by Katharine Cook Briggs and her daughter, Isabel Briggs Myers and based on the typological theories of Carl Jung. See F.W. Saunders, Katherine and Isabel: Mother’s Light, Daughter’s Journey (1991) for a complete history of the development of the MBTI. Se also Paul D Tieger and Barbara Barron-Tieger. ‘Personality Typing: A First Step to a Satisfying Career’ (1993) 53(2) Journal of Career Planning & Employment, 50 for a discussion of the MBTI and 16 personality types.

In reviewing the MBTI in 1991, the US Army Research Institute

595 J. Hunsley, C.M. Lee, J.M. Wood, ‘Controversial and Questionable Assessment Techniques’ in S.O. Lilienfeld, J.M. Lohr and S.J. Lynn (eds.), Science and Pseudoscience in Clinical Psychology (2004), 65; R.R. McCrae and P.T. Costa, ‘Reinterpreting the Myers-Briggs Type Indicator From the Perspective of the Five-Factor Model of Personality’ (1989) 57 Journal of Personality 17; L F Stricker and J. Ross, ‘An Assessment of


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concluded the instrument should not be used for career planning counselling.596 The

Institute's analysis of the available research showed no evidence for the utility of the test

and, with respect to career planning noted ‘the types may simply be an example of

stereotypes.’597 It will be shown below that stereotypes held in the broader community,

although popular, do nothing but amplify the call for regulation and do not relate to the

actual or potential risks associated with research involving human embryos and cloning.

Here it is noted that the popularity of personality profiling tools is often interpreted as an

indication of their accuracy and utility, which then leads to wider use and less inclination to

question the foundations of the test.598

In fact, there are many differing theories about how people choose any given

profession—trait and factor theory;

Such popularity is unrelated to reliability or validity.

Such typologies bring us no closer to answering the question concerning scientific values

and ethics posed above.

599 decision making theory;600 expertise theory601

Some Structural Properties of the Jungian Personality Typology’ (1964), 68 Journal of Abnormal and Social Psychology 62–71. 596 D. Druckman and R. A. Bjork, (eds), In the Mind’s Eye: Enhancing Human Performance (1991). 597 Ibid. 598 David J Pittenger, ‘Measuring the MBTI and Coming Up Short’ (1993), 54(1) Journal of Career Planning & Placement,48. 599 For example, see Frank Parsons, Choosing a Vocation (1909). 600 For example, see D Brown, Career Choice and Development (2002). 601 For example, see K.A. Ericsson and J. Smith, (eds) Toward a General Theory of Expertise: Prospects and Limits (1991).

to

name a few. Much may be said about each of them in relation to the different factors they

posit are relevant to job choice. For the purposes of this discussion it is simply noted that,

like ‘type theories’, none of them suggest that science is a profession that attracts

particularly untrustworthy, unethical, or valueless people. Nor is there any research that

indicates people predisposed to criminal behaviour are more likely to become scientists.

Whilst one may accept or reject the ‘type theories’ touched upon above or adopt another

vocational theory that relates to why people become scientists, none suggest it is a

profession full of ‘baddies’. This supports the argument that regulatory design strategies

which adopt primarily deterrence approaches and emphasise punishment are inadequate in

the context of human embryos and cloning.

B. Particular Values within Science and in the Broader Community

The above discussion demonstrates that it is questionable whether a particular ‘type’

of person becomes a scientist, and that the available research does not show science to

attract particularly untrustworthy or ‘bad’ individuals compared with the rest of the

population. Nonetheless, as this section will show, there is other literature on the particular

values held both within the field of science and by the broader general community with

regards to the conduct of scientific research that is relevant to decisions about how to

regulate areas such as research involving human embryos and cloning.

Allchin posits that ‘the common characterization of science as value-free or value-

neutral can be misleading’.602 He uses the example that scientists ‘strongly disvalue fraud,

error and "pseudoscience"’.603 In addition, the pursuit of science as an activity is itself an

implicit endorsement of the value of developing knowledge of the material world.604

602 D. Allchin, ‘Values in Science: An Educational Perspective.’ (1999) 8 Science & Education 1, 1-12. 603 Ibid. 604 Ibid.

Scientists also value novelty—exemplified in the professional credit given for significant new

discoveries such as prestige among peers, eponymous laws, Nobel Prizes, etc. In considering

the values of science, Allchin emphasises that ‘honesty is as important in science as

elsewhere, and researchers are expected to report authentic results and not withhold


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relevant information.’605 He also recognises that ethics demands proper treatment of

animals and humans, regardless of whether they are subjects of research or not.606

For Allchin, values intersect with science in three primary ways:

607

• First there are values that guide scientific research (epistemic values)—these

include ‘reliability, testability, accuracy, precision, generality, simplicity of

concepts and heuristic power’.

608

Such values tend to make up the ‘objective’ component of science.

• Secondly, the fact that scientific enterprise is unavoidably embedded in the

particular culture of individual practitioners means that scientists bring their

cultural values (consciously or not) to scientific practice.609

• Thirdly, values emerge from science, both as a product and process, and may

be redistributed more broadly in the culture or society.

610

These latter two factors reflect the subjective components of science.

As such, ‘while the pursuit of scientific knowledge implies a certain set of

characteristically ‘scientific’ values, the relevance of other values in the practice of science

are not thereby eclipsed.’611

Similarly, Ruse concludes that subjective values interact with the objective pursuit of

knowledge.

These other values are particularly important in deciding what

research is or is not conducted.

612

605 Ibid. 606 Ibid. 607 Ibid. 608 Ibid. 609 Ibid. 610 Ibid. 611 Ibid. 612 Michael Ruse, Mystery of Mysteries: Is Evolution a Social Construction? (2001), 29-35. (Michael Ruse is a Professor in philosophy at Florida State University. His major research areas are the philosophy of biology (especially Darwinism), Ethics, and the History and Philosophy of Science).

Ruse’s principal conclusion however is that science is largely an objective

enterprise.613 Scientists are rife with subjective values and these values play a role in

motivating scientific work but in ‘real science’ objective epistemic values come to the

fore.614

Here what Daniel Callahan

This statement is important. Although Ruse argues that objective epistemic values

come to the fore once the research is being conducted, it is also apparent in this statement

that cultural values can and do influence (or ‘motivate’) the type of research done in the

first place.

615 refers to as the ‘research imperative’616 is also

relevant. The ‘research imperative’ is ‘the felt drive to use research to gain knowledge for its

own sake or as a motive to achieve a worthy practical end’.617 Callahan argues that it is

valued both within science and the broader community and motivates the desire to conduct

certain types of research. 618 He states that it ‘captures the meaning of such commonly

heard phrases about the necessity of research; or the moral obligation to pursue certain

types of research; or the overpowering promise of research to relieve suffering, a goal not to

be denied...’.619

• the drive to gain scientific knowledge for its own sake (for example, to

understand the human genome)

Deciding upon the types of research that should be conducted therefore

again reflects subjective values linked to the ‘research imperative’. Callahan describes a

continuum of uses and interpretations of which he draws the following examples:

613 Ibid. 614 Ibid. 615 Director of the International Program at the Hastings Center and Senior Fellow at the Harvard Medical School. 616 Daniel Callanhan, What Price Better Health? (2003). 617 Ibid, 3. 618 Ibid, 3. 619 Ibid, 3.


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• a felt moral obligation to relieve pain and suffering (for example, to find a

cure for cancer)

• a rationale for pursuing research goals that are of doubtful human value

or are potentially harmful (for example, as some would argue, research

on human cloning)

• a public relations tool to justify the chase after profit (for example, the

pharmaceutical industry’s defence of high drug prices)

• the pursuit of worthy goals even at the risk of compromising important

moral and social values (for example, hazardous research on competent

human beings without their consent).620

Some of the above examples may seem to be fairly worthy goals, whilst others may be seen

as hazardous or as posing unacceptable risks.

The ‘research imperative’ is clearly illustrated in the field of research involving

human embryos and cloning. Not only do scientists have strong sense that we should ‘value

science’ and ‘value progress’,621

620 Ibid, 3-4. 621 As emphasised by those interviewed during the fieldwork, and illustrated by the one of the quotes that starts this Chapter.

the promise for cures for a myriad of diseases has always

been one of the strongest selling points regarding arguments in favour of this area of

research. Here we have a very good example of that ‘felt moral obligation to relieve pain

and suffering’ as a subjective value that drives research choices in this field. This value also

permeates our society and is seen as important in the sense that there are many diseases

for which such research has potential to assist.622

As discussed in Chapter Two however, it is clear that researchers and practitioners in

different fields or areas of science hold different views about one of the fundamental

rationales for regulating in this field—that is, the moral status of the human embryo and

related issues concerning when life begins. The differing views arguably come from the

Based on the results of the fieldwork reported in Chapter Five however, it may be

argued that the ‘research imperative’ operates in the context of research involving human

embryos only to the extent that it reflects the values and ethics of the broader society. For

example, there was a strong sense in both the United Kingdom and Australia from the

scientific and broader community that human reproductive cloning should not be allowed

simply because it was possible. All of the researchers and practitioners interviewed in this

study reflected the view expressed in the following statement:

I mean I have never heard anyone say ‘gee I really want to do reproductive cloning but I can’t because I’ll go to prison’. I think again, it’s a set of guidelines that everyone buys into here and if you don’t want to then you would have moved off to the US years ago. [P8]

Similarly, strong opposition to reproductive cloning was shown during the public

consultations described in Chapters Three and Four in both the United Kingdom and

Australia. In these jurisdictions, it therefore appears that there is no sense of a ‘research

imperative’ to pursue research goals that are of doubtful human value or are potentially

harmful (noting again that participants interviewed in both jurisdictions were well aware

that they could do this type of research in other countries and yet they stayed where they

were).

622 As shown in Chapters Three and Four when considering the public consultations and discussion of what should be permitted (and why) regarding research involving human embryos and SCNT for research purposes.


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different sub-cultural views of their field, developed through working within certain

paradigms that shape their ‘objective’ approaches. As such, it would be a logical extension

to conclude that individual scientists in the field of research involving human embryos and

cloning are not only influenced by the broader views and values of the society in which they

live, but by the sub-culture(s) of their particular field.

Of course, it is again noted that any conclusions about the values and ethics held by

scientists in the field of research involving human embryos and cloning made on the basis of

the interviews reported in Chapter Five must remain tentative to the extent that they rely

purely on self-reports. Participants may not have revealed things that may have placed

them in a bad light or made their positions as research scientists or practitioners acting

within the boundaries of the respective regulatory regimes questionable. We now turn to

the other side of the picture and an evaluation of why the public may fear scientists and/or

wrongdoing within research and subsequently demand regulation.

III. WHY DO PEOPLE FEAR SCIENTISTS?

A. Stereotypes in the Media and Society

In the discussion above concerning whether there is a certain ‘type’ of person that

becomes a scientist it was seen that vocational theories (and selection tools) that say that

there is have been criticised for reflecting stereotypes.623 Stereotypes influence what

information people seek,624 attend to625 and remember about626

623 Druckman and Bjork, above n596. The term stereotype is here used to mean an image of a given social group, usually based on rough, often negative generalisations. Although stereotypes can be positive as well as negative, they are, in everyday usage, most often understood as irrationally based negative attitudes about certain social groups and their members. 624 Lucy C. Johnston and Neil Macrae, ‘Changing Social Stereotypes: the Case of the Information Seeker’ (1994), 24 European Journal of Psychology 581. 625 S.M. Belmore and M.L. Hubbard, ‘The Role of advance Expectancies in Person Memory’ (1987) 53 Journal

of Personality and Social Psychology, 61-70.

members of a social group.

They also influence how people judge and respond to members of that group.627

Roslyn Haynes states that ‘throughout western culture the master narrative of the

scientist is of an evil and dangerous man... good scientists are in the minority and the

number of recurring stereotypes is small.’

This

section discusses research that shows that predominantly negative stereotypes of scientists

permeate wider society, begin at an early age, and are even found within the field of science

itself. Negative stereotyping of scientists may be one reason people fear science, do not

trust scientists and/or may have a heightened perception of risk in relation to research

involving human embryos. Such stereotyping is explored here as part of the argument that

regulatory decisions need to be based on the rationales discussed in Chapter Two and upon

research regarding better regulatory design strategies and enforcement approaches, rather

than on heightened risk perception, undue attention to isolated incidents, and/or

perceptions about ‘evil scientists’ such as those perpetuated in the media and society

through stereotypes.

628 She identifies seven: ‘the evil alchemist; the

noble scientist as hero or saviour of society; the foolish scientist, whether the gullible,

seventeenth century virtuoso or the absent-minded professor; the inhuman researcher...;

the scientist as adventurer...; the mad, bad, dangerous scientist, unscrupulous in the

exercise of power; and the helpless scientist, unable to control the outcome of his or her

work.’629

626 J. Fyock and C. Stangor, ‘The Role of Memory Biases in Stereotype Maintenance’ (1994) 33 British Journal of Social Psychology 331-344. 627 C. Neil Macrae, Charles Stangor, and Miles Hewstone (eds), Stereotypes and Stereotyping (1996). See this book for a comprehensive consideration of how stereotypes are created, how accurate they are, how they affect interpersonal and intergroup relations, and whether they can be changed. 628 Rosyln Haynes, ‘From Alchemy to Artificial Intelligence: Stereotypes of the Scientist in Western literature’ (2003) 12 Public Understanding of Science 243. 629 Ibid.


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Research has further shown that these stereotypes of scientists are not limited to

the media. They are developed very early in life and are maintained into adulthood.630 Again

the focus appears to be on the ‘mad, bad, dangerous scientist’. This is confirmed by David

Wade Chambers’ ‘draw-a-scientist test’ developed and administered over an eleven year

period to 4,807 school children aged five to eleven (grades K-5).631 The focus of the study

was to determine at which age children reproduced a standard image of a scientist

described by previous research of Margaret Mead.632 Chambers found that by 4th to 5th

grade children drew five/six of seven basic indicators of the standard image of a scientist.

These indicators included lab coat; glasses; beard; symbols of research (scientific and lab

equipment of any kind); symbols of knowledge (books, filing cabinets); technology (the

‘products’ of science) and; relevant captions (formulae, taxonomic classifications, the

‘eureka’ syndrome, etc). Some alternative images appeared in statistically significant

numbers also.633 These included ‘clear representations of the Jekyll/Hyde and Frankenstein

legends, magical portrayals of alchemical laboratories, the frightening visions of clearly

deranged, sometimes labelled ‘mad’, scientists testing for example, new improved versions

of the electric chair’.634 Chambers concluded that the stereotypical images found to exist

with high-school students in earlier studies635

630 Margaret Mead and Rhoda Metraux, ‘Image of the Scientist Amongst High-School Students: A Pilot Study’ (1958), 126(3270) Science 384; David Wade Chambers, ‘Stereotypic Images of the Scientist: the Draw-a-Scientist Test’ (1983) 67(2) Science Education 255; C.R. Barman, ‘Completing the Study: High School Students' Views of Scientists and Science’ (1997) 36(7) Science and Children 16; Mary Wyre, Women, Science, and Technology: A Reader in Feminist Science Studies (2001), 81. 631 Chambers, above n630, 255. 632 Mead and Metraux, above n630, 384. (Here it was found that the standard image of a scientist held by college students was ‘a man who wears a white coat and works in a laboratory. He is elderly or middle aged and wears glasses...he may wear a beard...he is surrounded by equipment: test tubes, Bunsen burners, flasks and bottles...he writes neatly in black notebooks...One day he may straighten up and shout ‘I found it, I found it’...Through his work people will have new and better products...he has to keep dangerous secrets...his work may be dangerous...’.) 633 Chambers, above n630. 634 Ibid. 635 Again, with particular reference to the study by Mead and Metraux, above n630.

were ‘alive and well’ in grade school children

over a quarter of a century later.636 Such results have been repeated over time,637 and

reported in relation to college students638 and adults.639

Similarly, stereotypes can also be propagated by those within scientific fields

themselves. For example, in an editorial piece in Medical Hypotheses, Bruce G. Charlton,

640

Scientists as people do not necessarily have to conform to that stereotype. Since science works by a process of selection, it makes sense to have a wide range of personalities in science. It takes all types.

initially debunks the ‘stereotypical scientist’ as one who is conscientious and self critical,

stating that

641

...Science as a social system needs to be conscientious and self-critical, but the selection pressures within science have changed over recent decades. In the past, a successful scientist often resembled the white-coated, bespectacled and introverted Nutty Professor in Jerry Lewis’s movie of that name. But the modern science superstar is more like the Nutty Professor’s alter ego, nightclub singer ‘Buddy Love’: a sharp-suited, good-looking and charismatic charmer. While Nutty was dull but impartial, Buddy is compelling but self-seeking...

However, Charlton goes on to offer another stereotype—that of the modern day scientist:

642

Charlton warns ‘[o]ur attitude towards public scientific pronouncements should be adjusted

accordingly.’

643

Despite the appeal, saleability in the media of certain stereotypes, and the fact that

they are widespread in the community, they are however stereotypes. Although ‘a small

The editorial offers no researched evidence that ‘Buddy Love’ is any more

present in the laboratory than the ‘Nutty Professor’ however such stereotypes (one or the

other, or both) are again appealing and widespread.

636 Chambers, above n630. 637 For examples see C.R. Barman, ‘Students' Views of Scientists and Science: Results from a National Study’ (1997) 35(1) Science and Children 18; Barman, ‘Completing the Study: High School Students' Views of Scientists and Science’ above n604; DC Fort and HL Varney, ‘How Students See Scientists: Mostly Male, Mostly White and Mostly Benevolent.’ (1989) 26(8) Science and Children 8; J Rahm and P. Charbonneau, ‘Probing Stereotypes Through Students' Drawings of Scientists’ (1997) 65(8) American Journal of Physics 774. 638 Barman, ‘Completing the Study: High School Students' Views of Scientists and Science’ above n630. 639 Wyre, above n630, 81. 640 Bruce G Charlton MD is a medical doctor, Editor in Chief of the journal Medical Hypotheses, and a Reader in evolutionary psychiatry at the Department of Psychology, University of Newcastle-Upon Tyne. 641 Bruce G. Charlton, ‘Editorial: From Nutty Professor to Buddy Love—Personality Types in Modern Science’ (2007) 68 Medical Hypotheses 243. 642 Ibid. 643 Ibid.


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minority of scientists [themselves!] argue that stereotypes are usually accurate and can be

relied upon without reservations, most disagree - and vehemently’.644 In any case, research

agrees on the fact that negative stereotypes often lead to prejudice and discrimination that

has negative effects.645

B. ‘Good’ People can do ‘Bad’ Things

For example, distrust of researchers and practitioners based upon

such prejudice and discrimination may lead to regulatory design strategies and enforcement

approaches that respond to, and/or perpetuate, the view that scientists are not to be

trusted and therefore treat them like ‘baddies’.

This is not the basis to make regulatory decisions.

Based on the discussion presented in this chapter thus far, it could be argued that

there is little risk of scientists undertaking work that offends public sentiment. Researchers

and practitioners reflect the cultural values of the societies in which they live, and negative

images of scientists are based on stereotypes rather than reality. However, this must be

balanced against the knowledge that different people in the same society are driven by

different things, including a variation in their emphasis on different aspects of the ‘research

imperative’ discussed above. There might also be institutional pressures that distort the

‘research imperative’. For example, pressure to get publications or funding in some

circumstances might encourage scientists to ‘push the boundaries’ of community values.

Such things again lead to increased fear that, without regulation, science will know no

bounds. 644 Annie Murphy Paul, ‘Where Bias Begins: The Truth About Stereotypes’ (1998) May/June Psychology Today, http://www.psychologytoday.com/articles/index.php?term=19980501-000029&page=1 at 2 January 2009. 645 Dolores Albarracin, Blair T. Johnson, Mark P. Zanna, The Handbook of Attitudes (2005), 727. Cf Macrae, Stangor and Hewstone, above n627, 445 who argue that there is no a priori reason to assume that stereotyping, prejudice or discrimination is always negative. (However, in the context of science as discussed above it has been shown that they are predominantly negative). In any case, neither position is a basis to make regulatory decisions.

http://www.psychologytoday.com/articles/index.php?term=19980501-000029&page=1�

In addition, one cannot ignore differing views about whether particular research

does in fact pose unreasonable risks and/or hazards. For example, human reproductive

cloning may be seen as a way to treat or offer insights into infertility (a positive), whilst at

the same time posing huge and unnecessary risks to the mother, the foetus and for some,

the very fabric of society (a negative). Thus, despite the general ‘good will’ of most

researchers and practitioners, at least some people continue to fear that some scientists

may act improperly or that research will go beyond what is acceptable.

This fear is legitimate to the extent that despite the general ethical behaviour of the

majority of researchers and practitioners, one does not need to look far to find examples

throughout the history of science in which researchers or practitioners have engaged in

unethical, and in some cases extremely damaging, research. To list them all here is beyond

the scope of this discussion, however, one need only consider the horrific human

experimentation that occurred on large numbers of Jews by the Nazi regime in WWII646 to

illustrate the significant impact wrongdoing can have on public trust of researchers. The

statements made in a 2006 interview with the New York Times by German Nobel laureate

Christiane Nüsslein-Volhard illustrate this.647 She said that much opposition in Germany to

current research proposals such as research involving human embryos was rooted in the

history of such terrible experiments on adults and children as those that took place during

WWII.648 She stated it had contributed to the public's ‘deep distrust in science and also a

fear that you open Pandora's Box and you don't know what's coming out’.649

646 Vivian Spitz, Doctors from Hell: The Horrific Account of Nazi Experiments on Humans (2005).

647 The New York Times, Stem Cell Ethics and the Nazi Past (2006) – Interview, video: http://video.nytimes.com/video/2006/06/28/science/1194817096743/stem-cells-ethics-and-the-nazi-past.html at 22 October 2008. 648 Ibid. 649 Ibid.

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In response to such atrocities comes the public desire to develop codes of ethics for

research, and the desire to regulate all science and medical practice—a legitimate response

to a perceived risk. As such, following the World War Two atrocities650

Table 5: The Nuremberg Code

a set of 10

principles—known as the Nuremberg Code—where developed for physicians to conform to

when carrying out experimentation. Table 5 sets out these principles:

1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.

2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

3. The experiment should be so designed and based on the results of animal experimentation and knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.

4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. 5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury

will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects. 6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the

problem to be solved by the experiment. 7. Proper preparations should be made and adequate facilities provided to protect the experimental subject

against even remote possibilities of injury, disability, or death. 8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care

should be required through all stages of the experiment of those who conduct or engage in the experiment. 9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if

he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.

10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Copied from 2(10) Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, (1949), 181-182.

650 Stemming from the decisions in the ‘Subsequent Nuremberg Trials’, a series of twelve US military tribunals for war crimes against surviving members of the military, political, and economical leadership of Nazi Germany, held in the Palace of Justice, Nuremberg after World War II from 1946 to 1949 following the Trial of the Major War Criminals before the International Military Tribunal.

In addition, in 1964 the World Medical Association developed the International Declaration

of Helsinki which further developed the ten principles first stated in the Nuremberg Code,

and tied them to the Declaration of Geneva (1948), a statement of physician's ethical duties.

The Declaration more specifically addresses clinical research, reflecting changes in medical

practice from the term 'Human Experimentation' used in the Nuremberg Code. The primary

purpose of the accord was to declare individual patient interests before those of society.

However, whilst these principles continue to be of great importance, there have in

fact been further abuses and exploitations of humans in research after their

development.651

In 2004, in a paper published in Science by a South Korean team, headed by Dr Woo

Suk Hwang, it was claimed that a team of researchers had cloned a human blastocyst.

Research and practice associated with the use of human embryos,

therapeutic and human reproductive cloning, has, unfortunately not been free of such

behaviour.

652 A

second paper, published in 2005, reported the first derivations of human ES cells carrying

the genome of patients suffering from disease.653

651 For example in the United States see 1) the Tuskeegee Syphilis Study, 1932-1972 in which 399 poor, and mostly illiterate,

Such results were heralded around the

world. However, shortly after publication, suspicion began to fall on the ethical practices of

Dr Hwang and then the validity of the research itself. On investigation by the Seoul National

University it was found that:

African American sharecroppers were studied to observe the natural progression of the disease if left untreated. Participants in the study were not required to give informed consent and were not informed of their diagnosis. Instead they were told they had ‘bad blood’ and could receive free medical treatment, rides to the clinic, meals and burial insurance in case of death in return for participating; 2) the Willowbrook School Study, 1963-1966 in which healthy children were intentionally inoculated, orally and by injection, with the virus that causes Hepatitus, then monitored to gauge the effects of gamma globulin in combating it; and 3) the Jewish Chronic Disease Hospital Study, 1963 which involved the injection of live cancer cells into patients who were hospitalized with various chronic debilitating diseases without informing them of what was being done, and without their consent. 652 W.S.Hwang, et al. ‘Evidence of a Pluripotent Human Embryonic Stem Cell Line Derived From a Cloned Blastocyst’ (2004) 303(5664) Science; 1669–1674. The article has now been retracted. 653 Ibid.

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[t]aken together, Professor Hwang's research team possesses neither the patient-specific ES cell line described in 2005 publication nor the NT-1 ES cell line, the forerunner cloned cell line described in 2004 publication. The data in 2004 publication are also fabricated as can be seen by the non-match between the donor A and NT-1. Such act is none other than deceiving the scientific community and the public at large. ... Not all the wrongdoing of all the individuals associated with fabricated publications can be revealed by this committee. However, that the publications are fabricated alone mandates a severe penalty by the academia.654

In short the claims were fraudulent and both papers were retracted due to falsification of

results.

655

The studies were also controversial in that the researchers had reported that their

single cell line was the result of 242 attempts with oocytes donated by 16 women,

656

however, shortly after the paper was published, allegations that two junior members of the

lab had donated oocytes for the work were reported in Nature.657 Such a donation, although

not illegal, raised ethical flags because lab members might feel pressure from senior

members or might think they could benefit, for example by being named co-author658—a

potential breach of the principle of voluntariness embedded in the Helsinki Declaration and

the Nuremberg Code.659 The Seoul National University Investigation reported that a total of

2061 eggs from 129 females had been collected from four hospitals and provided to

Professor Hwang's team between 2002 and 2005.660

The exact accounting for the number of eggs used for each of Science articles is impossible as the initiation date for each project is uncertain and laboratory recording is not thorough. However, while the 2005 article claims to have used 185 eggs, laboratory notes indicated that at least 273 eggs have been used from September 17 of 2004 to February 7 of 2005. Regarding the article in 2004, Professor Hwang claimed to have been unaware of the egg donation by the laboratory members. However, the graduate student who donated eggs informed the committee that the act of donation, while

It stated

654 SNU Investigation Committee (Chairman Chung Myung-hee), Summary of the Final Report on Hwang’s Research Allegation’ (October, 2006), http://socrates.berkeley.edu/~scotch/science_policy/snu_report.pdf at 21 October 2008. 655 Science Editorial Statement Concerning Stem Cell Manuscripts by Woo Suk Hwang et al. 12 January 2006, http://www.sciencemag.org/sciext/hwang2005/science_statement.pdf at 11 August 2008 656 Hwang, et al. above n652. The article has now been retracted. 657 David Cyranoski, ‘Korea’s Stem-Cell Stars Dogged by Suspicion of Ethical Breach’ (2004) 429 Nature 3. 658 Gretchen Vogel, ‘Collaborators Split over Ethics Allegations’ (2005) 310 Science 1100. 659 Dickenson and Alkortar Idiakez, above n155. 660 SNU Investigation Committee (Chairman Chung Myung-hee), above n654.

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voluntary, was approved by Professor Hwang. Egg aspiration was carried out by Dr. Sung Il Roh on March 10 of 2003 at MizMedi Hospital, and notably, Professor Hwang accompanied the student to the hospital himself. In May of 2003, Professor Hwang's research team circulated a form asking consent for voluntary egg donation and collected signature from female technicians. This is based on information provided by eight current and former lab members.661

Clearly there was impropriety on many counts. Such actions were given much international

attention in the media, and again led to some public fear of scientists acting improperly or

conducting ‘bad’ research in these areas. Similar fears have been raised in relation to false

claims about human cloning by the religious sect known as the Raelians and their subsidiary

company Clonaid.

662

There is good reason to recognise this call given that when improprieties have

occurred in science the impact and human consequences have been severe. A blind

acceptance of scientists (or any group of people) as ‘good people’, professionals who adhere

to internal and external codes of ethics and ethical standards, and have a conscience,

without recognising that even ‘good’ people can do ‘bad’ things, would be overly simplistic

and naive. There is much research that supports this.

However, although research involving human embryos and cloning have not been

absent of abuses and exploitation, nor is there an abundance of examples of wrongdoing or

of research that offends public opinion. Further, when such improprieties have occurred, it

has been fellow scientists, students, human rights watchers and/or the media that have

found out and reported the misbehaviour—not any regulatory agency. Nonetheless, the call

for regulation resounds.

661 Ibid. 662 See for example, Clonaid website, http://www.clonaid.com/page.php?8 at 3 March 2007; CNN, ‘Raelian Leader says Cloning First Step to Immortality’ (2004), CNN Online: Health News, http://archives.cnn.com/2002/HEALTH/12/27/human.cloning/index.html at 6 October 2008 at 26 October 2008; AFP, ‘Swiss Court Denies Residency to Controversial French Guru’, http://afp.google.com/article/ALeqM5ivrmjO0KlMEuYscKTuQcB2m4LfyQ at 26 October 2008; BioEdge: Bioethics News from Around the World, ‘Raelian Cloning a Fake After All’, http://www.bioedge.org/index.php/bioethics/bioethics_article/8321/ at 26 October 2008.

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For example it is the view of Dr. Philip Zimbardo663 of Stanford University, who has

spent his professional life researching why ‘good people do evil deeds’664 that ‘virtually

anyone could be recruited to engage in evil deeds that deprive other human beings of their

dignity, humanity and life.’665 Zimbardo endorses a ‘situationist perspective’ (that is, all

people are capable of doing good or bad things depending on their environment and other

factors) rather that a ‘dispositional’ point of view (that is, people are either ‘good’ or

‘bad’).666

Zimbardo’s research and subsequent situationist perspective was prompted by

interest in Stanley Milgram’s famous post World War Two experiments on obedience—a

consequence of Milgram’s deep personal concerns about how readily the Nazis had

obediently killed Jews during the Holocaust.

667 In Milgram’s experiments volunteers were

told they were participating in an experiment about the effects of punishment on

learning.668

volt

They were assigned the role of teacher and were directed by a person acting as

the experimenter to administer an electric shock to a ‘learner’ (also an actor), with the

voltage increasing in 15- increments for each wrong answer given in relation to a word

learning task. 669

1. Please continue.

If at any time the subject (teacher) indicated his desire to halt the

experiment, he was given a succession of verbal prods by the experimenter, in this order:

663 Philip Zimbardo has been a professor of psychology at Stanford University since 1968, previously having taught at Yale University, New York University and the University of Columbia. 664 Illustrated for example by his famous ‘Stanford Prison Experiment’ in which middle-class college students were randomly assigned to roles as prisoner or guard. In one description of the experiment it is said: ‘We watch as nice, middle-class young men turn sadistic; the experiment is terminated prematurely due to its character imploding power’. 665 Philip G. Zimbardo, Ph. D ‘A Situationist Perspective on the Psychology of Evil: Understanding How Good People Are Transformed into Perpetrators’ in Arthur Miller (ed) The Social Psychology of Good and Evil: Understanding Our Capacity for Kindness and Cruelty (2004), 21. 666 Ibid. 667 Philip G. Zimbardo, PhD ‘When Good People Do Evil’ (2007) Yale Alumni Magazine 40. 668 Stanley Milgram, ‘Behavioral Study of Obedience’ (1963) 67 Journal of Abnormal and Social Psychology 371. 669 Ibid.

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2. The experiment requires that you continue.

3. It is absolutely essential that you continue.

4. You have no other choice, you must go on.670

If the subject still wished to stop after all four successive verbal prods, the experiment was

halted. Otherwise, it was halted after the subject had given what they thought to be the

maximum 450-volt shock three times in succession.

671

In Milgram’s experiments, two of every three participants gave what they thought

were maximum electric shocks of 450 volts to ‘learners’ when they made an error. The vast

majority of people ‘shocked’ the victim over and over again. Whilst most participants

dissented from time to time, when directed to continue, they returned to administering

shocks that in reality would have killed the people they were shocking.

672

I set up a simple experiment at Yale University to test how much

Milgram wrote:

pain an ordinary citizen would inflict on another person simply because he was ordered to by an experimental scientist. Stark authority was pitted against the subjects' [participants'] strongest moral imperatives against hurting others, and, with the subjects' [participants'] ears ringing with the screams of the victims, authority won more often than not. The extreme willingness of adults to go to almost any lengths on the command of an authority constitutes the chief finding of the study and the fact most urgently demanding explanation. Ordinary people, simply doing their jobs, and without any particular hostility on their part, can become agents in a terrible destructive process. Moreover, even when the destructive effects of their work become patently clear and they are asked to carry out actions incompatible with fundamental standards of morality, relatively few people have the resources needed to resist authority.673

Milgram repeated the experiments in different locations and altering different variables,

finding he could ‘soar to 90 percent of people continuing to the 450-volt maximum or be

reduced to less than 10 percent—by introducing just one crucial variable into the

[Emphasis added].

670 Ibid. 671 Ibid. 672 Philip G. Zimbardo, PhD ‘When Good People Do Evil’ above n667. 673 Stanley Milgram, ‘The Perils of Obedience’, Harpers Magazine (1974), abridged and adapted from Stanley Milgram, Obedience to Authority an Experimental Point of View (1974).

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compliance recipe.’674 One such variation according to Milgram ‘depicts a dilemma that is

more common in everyday life. The subject was not ordered to pull the lever that shocked

the victim, but merely to perform a subsidiary task (administering the word-pair test) while

another person administered the shock’.675 In this situation, thirty-seven of forty adults

continued to the highest level of the shock generator. Milgram stated ‘Predictably, they

excused their behavior [sic] by saying that the responsibility belonged to the man who

actually pulled the switch.’676 He hypothesised that ‘this may illustrate a dangerously typical

arrangement in a complex society: it is easy to ignore responsibility when one is only an

intermediate link in a chain of actions.’677

Such experiments demonstrate vividly that in certain circumstances there is at least

a significant chance that ordinary people with ‘good’ values and ethics may do things that go

against their own, and society’s, core moral beliefs. This has been argued to apply to the

human experimentation and genocide that occurred in Nazi concentration camps in World

War Two

678 and also in a variety of other situations (for example suicide bombers, torturers

and executioners, prison guards, not going to the aid of someone in trouble).679

674 Philip G. Zimbardo, PhD ‘When Good People Do Evil’ above n667. 675 Stanley Milgram, ‘The Perils of Obedience’, above n673. 676 Ibid. 677 Ibid. 678 Christopher Browning, Ordinary Men: Reserve Police Battalion 101 and the Final Solution in Poland (1993). 679 Philip G. Zimbardo, PhD ‘When Good People Do Evil’ above n667.

Arguably

therefore, such a thing could occur in a research laboratory if the right or wrong variables

existed to create a situation in which ‘good’ people might act badly or in ways that might be

considered unethical. For example, the situation in which junior researchers ‘consented’ to

donating eggs for Dr Hwang’s research considered above. In this situation other members of

the research team that were aware of the conduct of Dr Hwang said nothing.

Similar situations might arise where there is pressure to get publications or funding

and, in some circumstances might encourage scientists to ‘push the boundaries’ of

community values—particularly if there is insularity within the research environment. Of

course, this would be tempered by the fact that scientists could not publish material

regarding experiments, nor would they in many instances receive funding, if they were

engaging in activities that were prohibited by law – because it would make their activities

known. In the United Kingdom and Australia, engaging in such activity would lead to

prosecution.

This supports the argument that a responsive regulatory system that includes higher

level command and control strategies and deterrent approaches at the top of the pyramid

and co-regulatory design strategies which encourage cooperative, educative and persuasive

enforcement approaches at the base, rather than self-regulation alone, is the most suitable

for regulating licensed research involving human embryos and cloning. The risk associated

with research and practice warrants clear decisions about what to regulate and where to

draw the line—including that strict prohibition, penalties and enforcement exist for certain

activities. The government needs to set legal boundaries and maintain a level of

independent oversight to ensure that wrongdoing does not occur. However, there is also a

call for a regulatory design strategy that allows the production of public goods, and does not

stifle the progress of research or overemphasise enforcement approaches that are not

needed. Scientists in this area are generally ‘good apples’. The purpose of regulation should

be to avoid situations that might ‘poison the barrel’ or to deter ‘mavericks’ that are

operating outside of the licensing system, but not to treat all researchers and practitioners

as though they are ‘baddies’. Utilising a level of co-regulatory strategies that allows licensed

researchers and practitioners to participate in their own regulation is warranted.


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IV. RISK PERCEPTION, ‘REGULATORY SPIRALS’ AND THE NEED TO AVOID

OVER-REGULATION

Regulatory approaches which fail to recognise scientists’ ethical values are likely to

be broadly representative of the community at large and to treat them accordingly have

been criticised above, as have calls for regulation which may be influenced by negative

stereotypes and ill-founded fears of ‘mad’ scientists. However, the long history of moral

arguments regarding the status of the human embryo and risks associated with research

involving human embryos and cloning (as outlined in Chapter Two), the knowledge that

even ‘good’ people can do ‘bad’ things, and the public call for the government to regulate

research, justify some government regulation of research involving human embryos and

cloning. This section considers the need to balance the call for regulation against the need

to avoid ‘regulatory spirals’ and over-regulation.

A. Risk Perception

Recognition that ‘experts’ and ‘lay’ people often disagree about how risky various

technologies are has led to investigation of various factors that influence risk perception.

Early theorists posited that individuals have exaggerated fears when given inadequate or

incorrect information, and that given additional information they can be helped to

understand the true risk involved in an activity and hence lessen their opinion of danger.680

Latter research, conducted within a psychometric paradigm, however focused upon the

roles of affect, emotion and stigma when considering risk perception.681

680 Chauncey Starr, ‘Social Benefit Versus Technological Risk’ (1969) 165(3899) Science 1232. 681 Paul Slovic (ed), The Perception of Risk (2000).

Such research

found that, contrary to the early theorists’ assumptions that rational decisions about risks

are made based upon the information people are given, people generally see most risks in

society as being unacceptably high.682 However, the greater perceived benefit the greater

the tolerance for risk, and vice versa.683

This calls for recognition that people see risk subjectively and judge it according to its

characteristics and context.

684 Public and professional responses to risk are therefore

intimately bound up with wider values. As a result, it has been shown that isolated ‘facts’

about risks may have little impact on debates about their acceptability and attitudes to risk

depend critically on perceived benefits - or lack thereof.685 Research literature and the

practice of risk communication has therefore seen a move ‘from an original emphasis on

‘public misperceptions of risk’, which tended to treat all deviations from expert estimates as

products of ignorance or stupidity, to approaches which promote risk communication as a

two-way process in which both ‘expert’ and ‘lay’ perspectives should inform each other’.686

Recognition that perceptions of risk are influenced by subjective values does not

however lead to the argument that ‘perceived’ risk or risk analysis should be disregarded

when making regulatory decisions. Recognising public perception of risk and concerns about

the treatment of human embryos was in fact shown to be of fundamental relevance when

discussing rationales for regulation in Chapter Two. It has clearly played an important role in

both the United Kingdom and Australia when making decisions about what to regulate and

where to draw the line. It was also shown that the balancing of the production of public

682 Ibid. 683 Ibid. 684 Simon Thomas and Steve E. Hrudey, Risk of Death in Canada: What We Know and How We Know It (1997). 685 Department of Health (UK), Communicating About Risks to Public Health: Pointers to Good Practice (1997). 686 Department of Health (Australia), Environmental Health Risk Assessment Guidelines for Assessing Human Health Risks from Environmental Hazards, http://www.health.gov.au/internet/main/publishing.nsf/Content/ohp-ehra-2004.htm~ohp-ehra-2004-framework.htm~ohp-ehra-2004-framework-3.htm at 17 March 2009.

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goods against the moral hazards of research was in fact key to deciding upon acceptable

boundaries for research.

It is noted that current risks identified in relation to research involving human

embryos or cloning, or the fear of researchers behaving criminally or unethically, have not

led the wider community to want to stop all research. Nor did participants interviewed in

this research indicate that research involving human embryos and/or the use of SCNT

should be conducted without reference to public sentiment or the potential risks and/or

hazards involved. In fact, the interviews suggested that researchers and practitioners were

amenable to some form of regulation within this context. They want to work within what

the general public sees as acceptable and are happy to take responsibility for themselves

within these parameters.

The balancing of perceived risks against the possible benefits of such research is

again apparent. There is however a danger of promulgating bad regulation if undue

attention is placed on isolated incidents and things that are unlikely to occur, or regulation is

addressed towards heightened risk perception or risk aversion alone.687 Such attention or

emphasis may result in slipping into a cycle of increased regulation to meet the demands of

increased risk aversion688

687 Department of Health (Australia), Environmental Health Risk Assessment Guidelines for Assessing Human Health Risks from Environmental Hazards,

and adopting regulatory design strategies and enforcements

approaches that emphasise fear rather than providing a balanced, responsive approach to

regulation.

http://www.health.gov.au/internet/main/publishing.nsf/Content/ohp-ehra-2004.htm~ohp-ehra-2004-framework.htm~ohp-ehra-2004-framework-3.htm at 17 March 2009. 688 Better Regulation Commission, Risk, Responsibility and Regulation: Whose Risk is it Anyway? (2007), 5.



B. Avoiding Regulatory Spirals and Over-Regulation

The United Kingdom Better Regulation Commission689 warned that slipping into a

cycle of increased regulation to meet the demands of increased risk aversion can lead to the

promulgation of a ‘plethora of rules, regulations and guidelines’.690 This can occur when the

public response, often encouraged by the media, to a perceived risk (be that a risk emerging

over time or a specific incident) is an ever increasing call for regulation.691 The ‘regulatory

spiral’ that follows is summarised in Figure 4.692

Figure 4: Regulatory Response to Risk

689 The Better Regulation Commission (BRC), which operated until January 2008 until replaced with the Risk and Regulation Advisory Council, worked with policy-makers to reduce unnecessary regulatory and administrative burdens. 690 Better Regulation Commission, above n688, 7. 691 Ibid. 692 Ibid, 9.


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Figure 4 illustrates the process of slipping into a regulatory spiral as:

1. The perception of a risk emerges. This can be progressive over time or following a

specific incident.

2. A public debate follows, often based around headlines and incomplete or biased

information, resulting in a call for ‘something to be done’, which is amplified by the

media.

3. Instinctively the public looks to the Government to manage the risk.

4. Responding to this public pressure, the government makes ambitious claims that it

can solve the problem and steps in with a regulatory response, rarely considering the

tradeoffs involved.

5. As a result, the role of the Government as risk manager is reinforced.

6. When the regulations are implemented, they inevitably fail to solve all the problems

and also bring with them unintended consequences.

7. With good implementation, some hazards are prevented, but this does not make

news. Other hazards are not prevented and problems persist, leading to calls for

more government action.

8. As a result of more regulation, people complain that liberties and enterprise are

diminished and criticise the ‘nanny state’.

9. Governments are blamed for interfering and acting unreasonably and, as a result,

the national level of frustration shifts up a notch.

10. If we are not careful, governments may seek to address issues of frustration and

disengagement through more regulation. 693

693 Ibid, 7-9.

Similarly Haines et al694describe the potential for over-regulation to occur in a

cyclical fashion. They describe the cycle to be ‘characterised by oscillation between

demands to regulate and to de-regulate.’ 695 They state that ‘responses to disasters can play

a key role in renewing and reinforcing this cycle’696 describing how a harmful event prompts

inquiries into the circumstances and causes which typically recommend a range of

regulatory and other responses.697 In describing this type of regulation as metaphorical

‘poison ivy’ they state: ‘[r]apid proliferation of these and other regulatory ‘vines’ gives rise

to complaints about enterprise being stifled [and] in response, government taskforces

search for ways to reduce the red tape – for instance, by pruning regulations and

introducing sunset clauses.’698 However the regulatory cycle continues when another

harmful event takes place or another risk is recognised.699 Arguments (made by unions, the

media and other commentators) that relevant parties have been left unprotected are made

and further regulation ensues.700

To continue our metaphor, the more effort that has been put into clearing the regulatory ivy (e.g. following enquiries into over-regulation), the more vigorous the regrowth that can occur.

Haines et al state:

701

Such responses (and arguably the regulatory spiral) can clearly be seen in relation to the

regulation of research involving human embryos and cloning. There was the emergence of

perceived risk(s) in relation to cloning and research involving human embryos. The public

debate was fuelled by sensationalist headlines and media reports which often focused

disproportionately on isolated incidents and things that are unlikely to occur. Fear of science

694 Fiona Haines, Adam Sutton and Chris Platania-Phung, ‘It’s all About Risk Isn’t It? Science, Politics, Public Opinion and Regulatory Reform’ (2007/8) 10 Flinders Journal of Law Reform 435. 695 Ibid, 436. 696 Ibid. 697 Ibid. 698 Ibid. 699 Ibid. 700 Ibid. 701 Ibid.


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and scientists doing ‘bad’ things increased or was reinforced. A call for the Government to

manage the risk ensued. The Government, undoubtedly in response to public pressure,

stepped in with a regulatory response and its role as ‘risk manager’ was reinforced – and so

began the fall into the regulatory spiral.

This decision to regulate and the fall into the regulatory spiral is also influenced by

the precautionary principle—a principle that generally has been used as a reason to regulate

in areas that pose some kind of risk to human health or environment.702

‘Strong precaution’ calls for regulation whenever there is a possible risk to health,

safety, or the environment even if the supporting evidence is uncertain or speculative and

even if the economic costs of regulation are high.

Under the

precautionary principle, the degree to which regulators will interfere is directly related to

the type of precautionary principle adopted—‘strong’ or ‘weak’.

703 The strong precautionary principle

implies that there is a responsibility to intervene and protect the public from exposure to

harm where scientific investigation discovers a plausible risk.704 The protections that

mitigate suspected risks can be relaxed only if further scientific findings emerge that more

robustly support an alternative explanation.705 ‘Weak precaution’ allows preventative

measures to be taken in the face of uncertainty, but does not require them.706

702 Noting that it has been criticised as being ‘no longer a legal principle’ by illustrating a number of notorious cases in which the principle has become politicised in a way to suppress innovation for reasons that have nothing to do with risk. See: Wolfgang van den Daele, ‘Legal Framework and Political Strategy in Dealing with the Risks of New Technology: the Two Faces of the Precautionary Principle’ in Hans Somsen (ed), The Regulatory Challenge of Biotechnology (2007). 703 See for example the oft quoted Wingspread Statement on the Precautionary Principle (made at the 1998 Wingspread Conference on Implementing the Precautionary Principle) that says ‘When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically.’: cited in Carolyn Raffensperger and Joel A. Tickner, Protecting Public Health & the Environment: Implementing the Precautionary Principle (1999). 704 Ibid. 705 Linda Cameran: New Zealand Treasury, Environmental Risk Management in New Zealand—is there Scope to Apply a More Generic Framework? Policy Perspectives Paper (2006). 706 For a collation of several essays that criticise ‘strong precaution’ see Julian Morris (ed), Rethinking Risk and the Precautionary Principle (2000).

To satisfy the

threshold of harm, there must be some evidence relating to both the likelihood of

occurrence and the severity of consequences, and the requirement to justify the need for

action (the burden of proof) generally falls on those advocating precautionary action.707

In either case, there is the potential for over-regulation. Crucial to decisions about

when and how to regulate is whether there is an absolute need to regulate in this area and,

if regulation is implemented, how to avoid the distortion of regulatory priorities.

As discussed in Chapters Two and Three, the recognition of a variety of ethical, moral

and scientific risks or potential hazards was an impetus to implementing legislation and the

regulatory regimes in the United Kingdom and Australia. In both jurisdictions, the legislative

provisions regarding what is permitted or prohibited reflect the ‘weaker’ precautionary

approach. The United Kingdom has in fact been seen to be rather permissive in relation to

the research it has allowed, and Australia has recently followed suit. Both jurisdictions have

permitted more activities as technology has advanced and public attitudes have shifted.

However, to some degree ‘strong precaution’ is also illustrated in the regulatory

systems adopted and the enforcement approach taken by the regulatory authorities. That is,

the respective regulatory bodies (the HFEA and the NHMRC Licensing Committee) were

seen by researchers and practitioners as adopting a strong precautionary approach at the

level of licensing and oversight of research (treating the researchers as though they ‘were

not to be trusted’ or that they were ‘baddies’ and policing activities rather than utilising

more cooperative ways of regulating those that were already compliant).

708

707 Cameran: New Zealand Treasury, above n705; For detailed discussion of the precautionary principle and case studies that reflect its operation see Jacqueline Peel, The Precautionary Principle in Practice: Environmental Decision-making and Scientific Uncertainty (2005). 708Cameran: New Zealand Treasury, above n705.

That is,

how to avoid directing regulation away from plausible hazards to ill-founded ones; stifling

technological innovation and paralysing development; failing to recognise that regulatory


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measures have costs, as well as benefits, and may themselves give rise to risk; and

implementing excessive discretion as to when and how to apply the precautionary

principle.709 These are inherent problems of adopting either precautionary principle.710

The solution is not to totally disregard precaution. Rather, the decision is how to

balance the regulation of risks against the potential benefits of the research. In determining

what to regulate and where to draw the line between permissible and prohibited activity,

separating the actual risks associated with research involving human embryos and cloning

from ill-founded fears or heightened risk perception would be ideal. However, ‘actual’ risks

are often unquantifiable and unknowable

711

709 Ibid. 710 Ibid.

and risk perception should not be totally

disregarded when making regulatory decisions. That is, it is important to respond to

perceived risks by creating an interactive process involving the exchange of information

among individuals, groups, institutions and experts about the nature, severity and

acceptability of risks and then making decisions (regulatory or otherwise) about how to

combat them.

This suggests that a co-regulatory design strategy that employs cooperative,

educative and persuasive enforcement approaches should play a big part in any scheme of

regulation, facilitating scientists, the government and the public to communicate with each

other. Indeed this sort of co-regulatory approach to the how to regulate issue, should then

provide a sound basis for ongoing review of what to regulate and where to draw the line

between permissible and prohibited activities.

711 Department of Health (Australia), Environmental Health Risk Assessment Guidelines for Assessing Human Health Risks from Environmental Hazards, http://www.health.gov.au/internet/main/publishing.nsf/Content/ohp-ehra-2004.htm~ohp-ehra-2004-framework.htm~ohp-ehra-2004-framework-3.htm at 17 March 2009.



V. CONCLUSION

This chapter has explored research and literature that relates to the following

questions:

1. What are the ethics and values of scientists?

2. What fears do people have about scientists and are they valid?

3. How should these issues effect the regulation of emerging technologies such as research

involving human embryos and cloning?

With regards to the first question, a number of vocational theories that proposed

‘typologies’ of people attracted to science were considered, and criticisms of such theories

recognised. It was also recognised that there are many other vocational theories, and the

only thing that can be said with certainty about any of them, is that none proposes that

science is a field that attracts particularly untrustworthy or unethical people. Nor do any of

the theories propose that people with a propensity for criminal behaviour or a complete

disregard for public sentiment are attracted to science related professions. The values and

ethics demonstrated within the field were also considered. It was argued that researchers

and practitioners share and reflect the same ethics and values as those shown in the

broader societies in which they live.

Consideration of the second question—what makes people fear scientists—illustrated

that much fear and prejudice is based on stereotypes that are perpetuated in the media, but

that are unfounded and are not a good basis on which to make regulatory decisions. It was

recognised however that some fear is legitimate and relates to the perception of risks

associated with research involving human embryos and cloning and the knowledge that in


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certain situations ‘good’ people can do (and have done) ‘bad’ things. This led to the

argument that in areas of risk some Government oversight/regulation is warranted.

Nonetheless, discussion of the third question showed that there is a danger of a

‘regulatory spiral’ if the regulatory approach is based on heightened risk perception alone

rather than a tempered approach to regulation.

The arguments in this chapter again support the thesis that introducing a level of co-

regulation, increased cooperation and responsive regulation in the context of licensed

research involving human embryos and cloning is warranted. Co-regulation is a good way to

address inherently unreliable risk perceptions through dialogue and information exchange

rather than either strict regulation based on prejudice or pure self-regulation. It would

ensure government boundary setting and oversight, whilst recognising that scientists are

generally good people who can be trusted, and enabling their expert knowledge about the

science and the associated risks to be recognised. Such regulation would help to avoid

institutional insularity, or pressures that have the potential to lead to an environment where

wrongdoing might occur, whilst fostering trust and co-operation with those regulated. It

would also recognise the support for regulation from both the public and scientific

community,712

Regulation has eased public fear, and the majority of those interviewed emphasised

the importance of research being regulated as a way of demonstrating to the public that

what they are doing is legitimate. Nevertheless, ‘regulatory spirals’ should be avoided.

and political debates that led to the decision to regulate in the first place.

713

712 Although support from the scientific community seems to exist more so in the United Kingdom than Australia. 713 Haines, Sutton and Platania-Phung, above n694, 436.

The consensus from a range of studies is that the key to moving away from regulatory

spirals/cycles is to embrace a ‘responsive regulatory’ approach.714

As was mentioned in

Chapter Four, the United Kingdom is in fact moving towards such an approach. The

possibilities for a responsive regulatory system that includes a level of co-regulation will be

explored further in the context of regulating licensed research involving human embryos

and cloning in the next chapter.

714 Ibid; Ayres and Braithwaite, above n8; Braithwaite, Restorative Justice and Responsive Regulation, above n8.

Chapter Seven: Addressing Regulatory Inadequacies: Responsive Regulation

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Chapter Seven:

ADDRESSING REGULATORY INADEQUACIES:

RESPONSIVE REGULATION

I. INTRODUCTION

This chapter analyses the inadequacies of the regulatory systems for licence holders

highlighted in Chapter Four, and raised by researchers and practitioners during the

fieldwork reported in Chapter Five. It specifically considers what has been done in the

United Kingdom and Australia to address regulatory inadequacies, and whether it would be

possible to change the respective regulatory systems. It is argued that a responsive

regulatory system should be adopted in both the United Kingdom and Australia. It is

proposed that such a system would maintain the top level command and control design

strategies and deterrence approaches present in the current regulatory systems for

breaches of legislation by non-licence holders and serious breaches by licence holders.

However, greater use of co-regulatory design strategies and cooperative, educative and

persuasive enforcement approaches should be used in the context of regulating licensed

research activities. Such a system would enable regulation to satisfy moral, political,

economic and social rationales. It would also lead to systems which are responsive to

regulatees rather than unnecessarily focused on punishment or the threat of punishment.

The arguments in this chapter are underpinned by the conclusions drawn in Chapter

Six. That is, researchers and practitioners generally reflect values held in the wider society in

which they live, but given that ‘good’ people can do ‘bad’ things, and the serious

consequences if this were to occur, some regulation is necessary. However, each jurisdiction

needs to avoid regulatory spirals or over-regulation and adopt a tempered, responsive

approach to regulation. Each jurisdiction is discussed in turn.

It is shown that the United Kingdom is successfully moving towards a ‘responsive

regulatory regime’ for licence holders, which encompasses predominantly cooperative,

persuasive and educative enforcement approaches and better regulation principles. This

includes the maintenance of the ‘command and control’ design strategy and the HFEA, but

ensures the HFEA has an improved role. Suggestions for further improvement are made. In

particular it is proposed that the implementation of co-regulatory strategies at the bottom

of the new pyramid would complement command and control strategies at the top and

serve to meet the better regulation principles more comprehensively.

On the other hand, it is shown that Australia has not begun to adequately question

the regulatory structure in place for licence holders or its suitability to the small number of

institutes conducting research involving human embryos and cloning. The estimated costs of

maintaining such a system in this jurisdiction are also of concern. A different approach for

implementing co-regulation at the base of Australia’s regulatory pyramid is proposed.

Suggestions are made for 1) utilising an already established and well respected self-

regulatory body (that is, the Reproductive Technology Accreditation Committee (RTAC)) for

the licensing and oversight functions and extensively modifying the NHMRC system so that

it complements the RTAC strategy, or 2) extensively modifying the NHMRC system to reduce

the regulatory burdens placed on licensees, bureaucracy and costs associated with the

current licensing regime. It is concluded that creating a system which maintains the top level

‘command and control’ design strategies and deterrence approaches for breaches of


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legislation by non-licence holders and serious breaches by licence holders, but introduces a

level of co-regulatory strategies and cooperative, educative and persuasive enforcement

approaches when dealing with licensed research activities would achieve ‘responsive

regulation’.

THE UNITED KINGDOM

I. CURRENT REGULATION AND PROPOSALS FOR REFORM

Prior to making the final decision to review the HFE Act and maintain the United

Kingdom’s command and control model of regulation,715 the United Kingdom government

considered three regulatory options.716

i. Option One: De-regulation

These options were:

The United Kingdom Department of Health saw this option as meaning ‘essentially

removing the existing regulatory requirements in whole or in part’.717 If they were removed

in part, the Department of Health stated this would have meant ‘retaining certain

prohibitions, but removing some licensing requirements’.718

Under this option it was the view of the Department of Health that the requirements

of the European Tissue Directive relating to quality and safety of blood and blood products,

tissue and cells would still apply. However ‘as these [did] not extend to ‘ethical’ matters or

to research in vitro, a range of activities involving, for example, the use of embryos for

715 (and subsequent to the pre-legislative scrutiny and the report from the Joint Committee discussed in Chapter Three). 716 Department of Health (UK), Impact Assessment on the Human Fertilisation and Embryology Bill (2008) (2007). 717 Ibid, 5. 718 Ibid, 5.

research in vitro including embryonic stem cell research, or donated gametes, [would be

left] without specific regulation beyond quality and safety aspects’. 719

The Department of Health identified two benefits of de-regulation. Firstly ‘the

avoidance of the costs of regulation, which largely fall on licence-holders and generally are

passed on to service users’.

720 Such costs are significant. For example, the direct compliance

costs of current regulation under the HFEA include the following fees paid by ART clinics:

initial treatment licence fees of £500 (£200 for storage only licences), then fees of £105.50

per cycle of in vitro fertilisation, and £52 per donor insemination cycle; and licensing fees

charged to small embryo research projects (£500) and for larger projects (£750). In addition,

indicative costs of compliance with the HFEA’s Code of Practice for licence holders, other

than licence fees, (that is, ‘administrative burden’ costs) have been estimated to be in the

region of £10 million.721

Secondly, the Department recognised that ‘[a]rguably, other benefits could accrue

from fewer constraints on clinical and academic freedom from regulatory intervention’.

722

However, the United Kingdom Health Department also identified some perceived

negatives of de-regulation. In particular they emphasised that it was ‘impossible to quantify

‘costs’ arising from a perceived lack of adequate regulation of activities in this area’,

They did not go on to discuss what these ‘other benefits’ were, but presumably they would

include the ability to pursue clinical and research interests without the interference of a

regulatory authority which might in turn result in more rapid advances in technology.

723

719 Ibid. 720 Ibid, 6. 721 Department of Health (UK) Review of the Human Fertilisation and Embryology Act: Proposals for revised legislation (including establishment of the Regulatory Authority for Tissues and Embryos), December 2006, 40. 722 Department of Health (UK), Impact Assessment on the Human Fertilisation and Embryology Bill (2008), above n716, 6. 723 Ibid, 7.

highlighting that ‘[t]he current regulatory scheme arose from public concern that there was


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a need for active regulation and monitoring, recognised by those who are subject to

regulation.’724 In addition, they identified that ‘risks associated with [de-regulation] included

the opening up of inconsistencies in the way in which specific and closely related cases are

handled.’725 Presumably this might result due to a lack of clarity in the rules to be applied or

a lack of rules on specific issues. The Health Department also noted that deregulation would

not necessarily mean that the administrative burden of £10million would no longer apply as

other statutory requirements may impose similar burdens. For example, the European

Tissue Directive would remain, and compliance with non-statutory regulation and other

professional good practice would still be required. Finally, they cited the point made by the

Better Regulation Task Force, in its 2003 report Scientific Research: Innovation with Controls

that ‘the United Kingdom is seen as a world leader in embryonic stem cell research, and this

is largely due to the effective regulations that control it.’726

ii. Option Two: Do nothing

The Department of Health rejected this option.

This option would have meant retaining the existing (that is, pre 2008 amendments)

regulatory provisions and structures. The Department of Health saw few positives in

maintaining the status quo. In fact, the only benefits stated were that such an option ‘has

the short term merit of temporary avoidance of costs and uncertainty/ disruption associated

with change.’ 727

On the other hand there were a number of negative consequences of maintaining

the existing legislation. It was the Department of Health’s view that adopting this option

‘would risk the law becoming outmoded by, for example, new ethical and/or technological

724 Ibid, 7. 725 Ibid, 5. 726 Ibid, 7. 727 Ibid.

developments, or outdated in relation to ...factors ...that led to the Government’s decision

to review the law in this area.’728 In addition it ‘would threaten the United Kingdom’s

position at the forefront of development of reproductive technology which is, in part,

attributed to robust and transparent regulatory controls.’ 729

iii. Option Three: Update the HFE Act and retain the HFEA

It was also anticipated there

would be costs arising from legal challenges as technological advances overtook the wording

of the Act, and ‘opportunity costs’ as a result of increasing legal uncertainty impacting on,

for example, investment decisions in relation to stem cell research. Finally they emphasised

that embryo research in a number of areas would remain limited to that permitted by the

1990 Act.

This option was also rejected.

As illustrated by the discussion in Chapter Four, this is the option that was adopted

and has led to the passing of the 2008 amendments to the HFE Act. The option considered

most favourable by the Department of Health was to update the law on assisted conception

and embryo research, whilst retaining The Human Fertilisation and Embryology Authority as

the United Kingdom's independent regulator overseeing safe and appropriate practice in

assisted reproduction treatment and embryo research – the command and control model.

Here it is important to keep in mind that the HFEA’s functions and remit include that

it licenses and monitors all United Kingdom clinics that offer ART including IVF and DI (donor

insemination) treatments, and is not limited to regulation of all United Kingdom-based

research into human embryos. They also regulate the storage of eggs, sperm and embryos.

The HFEA 2007/2008 Annual Report reported that their work had included the inspections

of 119 clinics and research establishments, the processing of 43 new licence applications, 49 728 Ibid, 6. 729Ibid, 7.


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licence renewals, 17 applications for Pre-Implantation Genetic Diagnosis, the integration of

services new to regulation under the European Union Tissue and Cells Directive (the EUTCD)

into the regulatory activity of the HFEA, the relicensing of 116 clinics under the EUTCD, the

publication of eleven research inspection reports, three panel meetings with licensed clinics,

three meetings with patient organisations, a ‘fertility view’ panel survey, five public and

stakeholder consultations regarding multiple births and single embryo transfer, dealing with

472 Freedom of Information requests, 65 opening the register requests, sixteen enquiries

regarding the Data Protection Act, one enquiry concerning the Environmental Information

Regulations, nine Authority meetings, 18,118 telephone enquiries from patients and the

public, 4,482 phone and email enquiries from clinics and researchers dealt with by the

inspectors. There were also 449,048 visits to the HFEA website.730

However, the decision to maintain the HFEA was not due to it having extensive

functions. The Department of Health emphasised that ‘retaining the HFEA has the benefit of

maintaining the professional reputation it has earned since 1990, and the respect it has as a

model regulatory environment for embryonic stem cell research.’

731 They also noted that

during pre-legislative scrutiny the option commanded support from professional

organisations including the British Medical Association (BMA).732

730 Human Fertilisation and Embryology Authority, Annual Report and Accounts2007/08, 23 June 2008. 731 Department of Health (UK), Impact Assessment on the Human Fertilisation and Embryology Bill (2008), above n716, 5. 732 Ibid.

The HFEA continues to licence and monitor centres carrying out IVF, donor

insemination and research involving human embryos, and provide a range of detailed

information for patients, professionals and Government.

II. KEEPING THE HFEA: SUPPORT BY RESEARCHERS AND PRACTITIONERS

In the United Kingdom fieldwork it was apparent that the majority of the researchers

and practitioners interviewed were happy with having a regulatory system in which there

was both a legislative framework to work within and an oversight body. For most of them

this approach is in fact the only one they have known throughout their working lives.733

Nonetheless, the acceptance of the command and control regulatory model appeared to be

because the system was perceived as providing public legitimacy and, in many instances, as

fostering the researchers’ and practitioners’ work. It was also seen to discourage trivial

research and encourage good record keeping, as well as fostering input from a variety of

people including scientists, practitioners, and members of the community, patient groups,

companies and any other interested party or group.734

III. HFEA ACT AMENDMENTS: THE OPPORTUNITY TO INCREASE CO-REGULATORY STRATEGIES

Thus, whilst the majority of

participants said that enforced self-regulation might work as an alternative option, they

were in fact in favour of maintaining the current regulatory system – including the HFEA.

Whilst recognising the importance of public acceptance and the comfort the HFEA

might bring, one United Kingdom researcher recognised the risk of over-regulation, the

HFEA being ‘redundant’ and the approach taken by the HFEA as an authority being one in

733 Research using human embryos has been taking place in the United Kingdom since the 1970s, when Patrick Steptoe and Robert Edwards were first exploring the possibility of treating infertility through in vitro fertilisation (IVF). A voluntary licensing system was in place in the UK from the mid 1980s. Embryo research first became subject to statutory regulation in 1991. 734 [P5].


Page 261

which it viewed its role as being to stop the ‘baddies’.735

This has also been recognised to some degree by the new provisions in the United

Kingdom’s HFE Act that require the HFEA to ‘carry out its functions effectively, efficiently

and economically’

Such risks and consequences were

discussed above in Chapter Six.

736 and mandate that the HFEA ‘must, so far as relevant, have regard to

the principles of best regulatory practice including the principles under which regulatory

activities should be transparent, accountable, proportionate, consistent and targeted only at

cases in which action is needed.’737

1. The Regulator’s Compliance Code

These provisions illustrate a move away from the ‘spiral

of regulation’ and the opportunity to reduce the costs of regulation. The potential to reduce

regulatory burdens placed upon licensed researchers and practitioners that are operating

within the system and showing compliance is also apparent. This provides the opportunity

to stop treating everyone like ‘baddies’ and encourages cooperative approaches.

This is reinforced by two other extraneous requirements: the Regulator’s Compliance

Code and the Regulatory Enforcement and Sanctions Act 2008 (UK) (‘the better regulation

requirements’). These create statutory requirements regarding how regulators in the United

Kingdom must regulate, and therefore impact on the regulation of research involving

human embryos and cloning.

From 6 April 2008 regulators in the United Kingdom (including the HFEA) have had to

have regard to the provisions of the Regulators’ Compliance Code. The Regulators’

Compliance Code is a statutory code of practice intended to encourage regulators to

735 [P6]. 736 Human Fertilisation and Embryology Act 1990 (UK), s8ZA(1). 737 Human Fertilisation and Embryology Act 1990 (UK)., s8ZA(2).

achieve their objectives in a way that minimises the burdens on business.738 The Code

applies when regulators determine their general policies or principles about how they

exercise their regulatory functions, and when they set standards or give general guidance. It

does not apply at the regulatory decision-making level – that is, not to individual

enforcement decisions. The Code is based on the seven principles of inspection and

enforcement identified in the Hampton Report.739

1. comprehensive risk assessment should be the foundation of all regulators’

enforcement programmes;

These principles include that:

2. there should be no inspections without a reason, and data requirements for less

risky businesses should be lower than for riskier businesses;

3. resources released from unnecessary inspections should be redirected towards

advice to improve compliance;

4. there should be fewer, simpler forms;

5. data requirements, including the design of forms, should be coordinated across

regulators;

6. when new regulations are being devised, Departments should plan to ensure

enforcement can be as efficient as possible, and follows the principles of this report;

and

7. thirty-one national regulators should be reduced to seven more thematic bodies.740

The purpose of the Code is to embed a risk-based, proportionate, targeted and

flexible approach to regulatory inspection and enforcement among the regulators to which

738 Department for Business Enterprise and Regulatory Reform, Regulators Compliance Code: Statutory Code of Practice for Regulators, 17 December 2007, 7. 739 Hampton, above n405. 740 Ibid, 2.


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it applies. It does not dismantle the ‘command and control’ structure, but it is aimed at

ensuring that ‘regulators are efficient and effective in their work, without imposing

unnecessary burdens on the parties they regulate’741

2. The Regulatory Enforcement and Sanctions Act 2008 (UK)

within that structure.

Having come into operation in July 2008, the Regulatory Enforcement and Sanctions

(RES) Act 2008 (UK) governs the operation of a large number of Government regulators,

including the HFEA. Guidelines to the RES Act state that it was introduced as a result of

regular complaints from businesses, frontline public and third sector workers about the time

they spend on regulation and the many ways in which they find rules frustrating.742 To

address these concerns the United Kingdom government stated it was ‘committed to

pursuing a programme of ambitious and wide-ranging regulatory reform’743

1. Regulating only when necessary and doing so in a light-touch way that is

proportionate to the risk;

and that key to

this is:

2. Setting exacting targets for reducing the cost of administering regulation;

3. Rationalising inspection and enforcement arrangements; and

4. Supporting compliance and tackling businesses that deliberately or

consistently flout their regulatory responsibilities.744

Of particular note for the purposes of this thesis is Part Three of the RES Act which provides

a framework of administrative sanctions that will allow regulators to tackle non-compliance

741 The code refers to ‘regulated entities’ which includes businesses, public sector bodies, charities and voluntary sector organisations that are subject to regulation. 742 Better Regulation Executive, Regulatory Enforcement and Sanctions Act 2008: Guidance to the Act, December 2008, 5. 743 Ibid. 744 Ibid.

in ways that are transparent, flexible, and proportionate to the offence.745

IV. BETTER REGULATION: AN OPPORTUNITY TO ADDRESS

RESEARCHER/PRACTITIONER CONCERNS

Part Four of the

RES Act places a duty on specified regulators to review the burdens they impose, reduce any

that are unnecessary and unjustifiable and report on their progress annually.

These ‘better regulation requirements’ therefore provide the opportunity to address

the issues of bureaucracy, lack of flexibility, redundancy, and authoritarian approach raised

by the researchers and practitioners during the fieldwork reported in Chapter Four. What

the HFEA is doing, and recommendations for how they may further increase cooperative,

persuasive and educative approaches by adopting a form of co-regulation, is discussed

below.

The ‘better regulation requirements’, alongside the amendments to the HFE Act

described above, have led to a requirement for reform of HFEA practices and procedures.

The fact that they have been introduced is positive. Researchers and practitioners regulated

by the HFEA are generally in favour of having such a system, but expressed strong

dissatisfaction concerning the implementation of the regulatory system. The fieldwork

reported in Chapter Five therefore ‘dovetails’ with more general concerns about regulators

and indicates some specific ways in which the HFEA could be improved along these lines.

This is particularly so in relation to the responses given by participants regarding the

bureaucracy involved with HFEA licensing, inspections and general operation. Difficulties

745 Noting that Parts 1 and 2 of the RES Act relate to local authorities and do not concern HFEA, Part 3 gives regulators listed in Schedule 5 to the Act (including the HFEA) an ‘extended tool kit of alternative civil sanctions as a more proportionate and flexible response to cases of regulatory non-compliance normally dealt with in the criminal courts.’


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with outdated and overly complex forms,746 the number of ‘boxes that needed to be

ticked’,747 the sheer amount of paper work involved,748 having to apply for a new licence

when moving premises even though the research being done was the same,749 and general

inefficiency750

In addition, duplication between applications to ethics committees and HFEA licence

applications,

were cited as illustrative of the issues researchers and practitioners faced. A

significant example of inefficiency and bureaucracy is repeated here as it quite markedly

makes the point:

...My licence was renewed in May, and they came and reported on this. They said everything was fine except there was one new section and that this new section they didn’t think was properly consistent with the aims of the Act and should be removed. I pointed out to them that this ‘new section’ had been in the licence for four years. But they just ignored this completely and said it’s a new section and it must be removed. So they are not on top of it. Then it’s like any regulatory authority, you know once they’ve written it on paper, you can’t get anywhere with them. Things like that are a bit irritating. [P2]

751 dissatisfaction with the amount of time it takes to obtain a licence,752 lack of

consistency with granting licenses for particular research,753 and the cost of applications and

appeals processes754

Such research findings are important as the House of Lords, House of Commons,

Joint Committee on the Human Tissue and Embryos (Draft) Bill, Session 2006-2007, (2007)

paper recognised ‘the lack of research undertaken as to the workings of the current

regulatory structure, and improvements that could be made’.

were all issues raised by researchers and practitioners in relation to the

negative experiences they had with the implementation of the regulatory system.

755

746 [P2]. 747 [P1]. 748 [P3]. 749 [P6]. 750 [P7]. 751 [P1], [P7]. 752 [P1], [P7], 753 [P1]. 754 [P7]. 755 House of Lords, House of Commons, above n13, 31.

Whilst the present study

really only represents a beginning to research considering how the regulatory system works

in practice and the improvements that could be made, all of the reported issues need to be

addressed in order to comply with the ‘better regulation requirements’.

V. BETTER REGULATION: THE HFEA RESPONSE

In mid to late 2008 the HFEA recognised the 2008 amendments to the HFE Act would

give rise to the need to implement changes to their functioning once new provisions had

been enacted. They also recognised the need (and obligation) to respond to the new

government better regulation initiatives, including the statutory Regulators´ Compliance

Code and the Regulatory Enforcement & Sanctions Act 2008.

The HFEA has since announced that it is conducting a comprehensive review of its

organisational functions in a programme of work called ‘Programme 2010’.756 They state

they will be involving clinics and other stakeholders in this work as it progresses, to ensure

the organisation’s future ways of working will be as efficient and effective as possible.757 In

undertaking such a review the HFEA has said that the main focus of its regulatory

improvements will be the publication of the eighth edition of the HFEA Code of Practice and

related improvements to their inspection, licensing and processes including better linkage

between their inspection process and the revised code. 758

A. Drafting the Eight Edition of the HFEA Code of Practice

The HFEA states that in drafting their eight edition of the HFEA Code of Practice their

‘objective is to improve the effectiveness and usability of the Code of Practice ...to comply

756 Human Fertilisation and Embryology Authority, Annual Report and Accounts2007/08, above n730, 9. 757 Human Fertilisation and Embryology Authority, The HFEA Improvement Program, http://www.hfea.gov.uk/en/1739.html at 29 October 2008. 758 Ibid.



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with the new requirements of Human Fertilisation and Embryology legislation’.759 Key to

their approach is to help and encourage licensed centres to understand and meet regulatory

requirements more easily; to better differentiate between requirements and guidance; to

remove unnecessary guidance and reduce complexity; and to introduce greater consistency

and alignment to the inspection process. 760

B. ‘Decreasing the Burden’ of Licensing and Inspection Processes

The HFEA has also undertaken to reduce the burden on those regulated under the

HFEA Act in relation to licensing and inspections. This has been an ongoing process.

In their 2007/08 Annual Report, the HFEA stated that there had been ‘further

streamlining of the licensing process for research and treatment through the introduction of

risk-based inspection, using a revised risk assessment tool.’761

This move was confirmed in a speech given at the British Fertility Society’s (BFS)

Summer College 2008 by the Interim Chief Executive of the HFEA, Alan Doran, who outlined

‘where the HFEA were heading’ in relation to inspection.

This equates to a move away

from the ‘regulatory spiral’ discussed above, and toward a regulatory approach that

responds to risks associated with research and practice in an appropriate manner.

762 He stated that the HFEA ‘should

inspect to the degree and at the frequency indicated by three factors: hard edged risk

assessment, statistical analysis or serious adverse incidents, and licensing requirements’.763

759 Ibid. 760 Ibid. 761 Human Fertilisation and Embryology Authority, Annual Report and Accounts2007/08, above n730, 9.

Most importantly, he emphasised ‘a shift towards self-assessment and a presumption that

762 Alan Doran, HFEA CEO, ‘Inspections – Where are we Heading’, Speech delivered at BFS Summer College, 2-5 September 2008, Adelphi Hotel, Ranelagh Place, Liverpool, L3 5UL, 2 September 2008. 763 Ibid.

centres wish to show compliance rather than that it is the HFEA’s role to find failure’.764

This reflects the recommendations made in the Hampton Report and the subsequent ‘better

regulation requirements’.765

Notably, the Hampton Report drew upon Ayres and Braithwaite’s theories,

It also accords with the arguments presented here that a

cooperative, persuasive and educative approach in the first instance would be better than

one in which the HFEA adopts strict authoritarian and ‘deterrent’ approaches from the

beginning and goes in looking for ‘baddies’.

766

recognising that ‘regulatory compliance was best secured by persuasion in the first instance,

with inspection, enforcement notices and penalties being used for more risky businesses

further up the pyramid’.767 In highlighting that this approach has been adopted by many

regulators in the United Kingdom,768 Hampton noted that many large-scale random

inspections of the past had been replaced by more targeted intervention.769 Hampton also

stated that with these developments ‘has come a general acceptance among business and

regulators that inspections are an inefficient enforcement mechanism in lower-risk or high-

performing businesses, and that risk assessments should inform the work programmes of

inspectorates.’ 770

764 Ibid.

Such a move may well be the solution to reducing, or potentially eliminating, the

difficulties highlighted in the fieldwork described in Chapter Five.

765 Department for Business Enterprise and Regulatory Reform, Regulators Compliance Code: Statutory Code of Practice for Regulators, 17 December 2007, 7; Regulatory Enforcement & Sanctions Act 2008 (UK). 766 Ayres and Braithwaite, above n8, 39 in Hampton, above n405, 27. 767 Hampton, above n405, 27. 768 Ibid. 769Ibid. 770Ibid.


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C. Improving the use of Regulatory Sanctions

Integral to adopting a ‘responsive regulatory approach’ and increasing cooperative,

persuasive and educative approaches are the type of sanctions used in relation to

enforcement. The HFEA stated in its 2007/08 Annual Report that ‘preparatory work [had

been] started relating to the potential future increase in regulatory powers arising from the

Regulatory Enforcement and Sanctions [Act], further work on which is planned for

2008/09.’771

In doing this the HFEA is responding to the United Kingdom government’s position

that ‘regulators should have access to effective sanctions that are flexible and proportionate

and that ensure the protection of workers, consumers and the environment when tackling

non-compliance by businesses.’

772 This position is based upon the acceptance in full773 of

recommendations made in the 2006 ‘Macrory Report’ which looked at the effectiveness of

existing sanctioning regimes.774 The Macrory Report, undertaken following the Hampton

Report’s findings that regulators’ penalty regimes were cumbersome and ineffective, set out

a blueprint for transforming the regulatory sanctioning regime in the United Kingdom. It

referred to Braithwaite’s responsive regulatory theory extensively. Macrory found that

many regulatory sanctioning regimes were over reliant on criminal prosecution and lacking

in flexibility.775 He made a number of recommendations to ensure regulators have access to

a flexible set of sanctioning tools that are consistent with the risk-based approach to

enforcement outlined in the Hampton Review.776

771 Human Fertilisation and Embryology Authority, Annual Report and Accounts2007/08, above n730, 9-10. 772 Better Regulation Executive, above n742, 27. 773 Ibid, 27-28. 774 Professor Richard Macrory, Regulatory Justice: Making Justice Effective (2006). 775 Ibid, 7. 776 Ibid.

This included proposing an alternative

system of civil sanctions in order to set up a modern and targeted sanctioning regime that

would enable regulators to match the sanctions to the circumstances of different cases. 777

1. Fixed monetary penalty notices

The RES Act in adopting these principles allows a Minister, by order, to give a

regulator access to four new civil sanctions:

778

2. Discretionary requirements

– under which a regulator will be able to impose

a monetary penalty of a fixed amount;

779

• a variable monetary penalty determined by the regulator;

• a requirement to take specified steps within a stated period to secure that an

offence does not continue or happen again (compliance notice); and

• a requirement to take specified steps within a stated period to secure that the

position is restored, so far as possible, to what it would have been if no offence

had been committed (restoration notice);

– which will enable a regulator to impose, by notice,

one or more of the following:

3. Stop notices780

4. Enforcement undertakings

– which will prevent a business from carrying on an activity described

in the notice until it has taken steps to come back into compliance; and

781

The new powers are an alternative to criminal prosecution and it will be for the regulator to

determine the appropriate response to a particular instance of regulatory noncompliance.

– which will enable a business, which a regulator

reasonably suspects of having committed an offence, to give an undertaking to a

regulator to take one or more corrective actions set out in the undertaking.

777 Ibid. In particular see Chapter 6. 778 Regulatory Enforcement and Sanctions Act 2008 (UK), ss39-41. 779 Regulatory Enforcement and Sanctions Act 2008 (UK), ss42-45. 780 Regulatory Enforcement and Sanctions Act 2008 (UK), ss46-49. 781 Regulatory Enforcement and Sanctions Act 2008 (UK), s50.


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On 17 December 2008 the HFEA Authority Committee recommended that the HFEA

apply for three of these powers: Discretionary Requirements, Stop Notices and Enforcement

Undertakings.782

If the powers are conferred it is noted they may only be applied to criminal offences

and would bear the same burden of proof (beyond reasonable doubt). The HFEA Authority

outlined the activities that constitute criminal offences (under s41 of the HFE Act) and that

would be subject to the powers applied for.

These recommendations will be decided by the HFEA before application is

made for such powers to be conferred upon them.

783

• procuring, creating, distributing and storing embryos except in pursuance of a

licence;

These include:

• creating, keeping or using an embryo or gametes except in pursuance of a licence;

• keeping or using an embryo in circumstances prohibited by Regulations;

• knowingly providing materially false information;

• disclosing patient identifying information or breaches in confidentiality under s33;

• breaching Directions on the giving or receiving of money in respect of supply of

gametes or embryos (2006/1);

• breach of Directions issued by the licence committee under s24(7)(a) requiring

information or materials to be transferred to the authority;

• obstructing an inspection; and/or

• obstructing a warrant. 784

782 Trish Davies and Kristen Veblen (HFEA), Regulatory Enforcement and Sanctions Act, 2008 (2008) (HFEA Authority Paper for Decision). 783 Ibid. 784 Ibid..

The Authority indicated that other offences (such as implanting non-human or admixed

embryos or gametes in a woman; using female germ cells taken or derived from an embryo

or foetus to provide fertility services; creating, keeping or using admixed embryo other than

in pursuance of a licence; putting human or admixed embryos in animals; replacing the

nucleus of an embryo) ‘are presumably circumstances which would warrant immediate

referral to the police to be investigated and possibly prosecuted’.785

Such powers would give the HFEA more power to use coercive force than it currently

has. Currently the powers of the HFEA to encourage compliance are informal or deal directly

with the status of the licence.

786 The Authority ‘may issue directions to those concerned

with the licence, but the only formal means for enforcement of these directions is to modify

the conditions of a licence or to suspend or revoke a licence.’787 To suspend a licence, the

committee must suspect that there are grounds for revoking a licence and must be of the

opinion that immediate action is necessary. The licence committee may revoke a licence

under Section 18 of the HFE Act if information in the application is found to be false or

misleading, the licensed premises are no longer suitable, the person responsible has failed

to carry out their duties or is no longer suitable or there has been a material change of

circumstances since the licence was granted. In the most serious of offences, the Chief

Executive may refer the case to the police.788

The current set of enforcement options is limited to informal actions, direct action in respect of a licence or referral to the police. While these strategies should continue to be exercised where appropriate it would be beneficial for the HFEA to have more flexible powers to be able to exercise enforcement proportionately. The HFEA has not yet developed consistent

The HFEA Authority in suggesting the HFEA apply for the powers of discretionary

requirements, stop notices and enforcement undertakings concludes:

785 Ibid. 786 Ibid. 787 Ibid. 788 Ibid.


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practices of enforcement and the leniency currently exercised in most cases, which may be attributed to an inability to exercise proportionality in sanctioning, runs the risk of undermining the reputation of the HFEA as an effective regulator. These new powers will benefit both the Authority and licence holders by encouraging clear policies and resulting in more robust, flexible and consistent enforcement.789

Here the potential to see Ayres and Braithwaite’s theory of ‘responsive regulation’

Such a conclusion again reflects movement towards regulatory strategies that closely mirror

the Braithwaite model discussed in Chapter Two.

790

being utilised in the context of HFEA regulatory system is apparent. The RES Act and the

Regulators’ Compliance Code791 allow for regulatory bodies to be responsive to the conduct

of those they seek to regulate in deciding whether a more or less interventionist response is

needed.792 Depending on which enforcement sanctions the HFEA applies for (and receives),

and the extent to which they implement cooperative, persuasive and educative approaches,

the potential to be ‘increasingly responsive to how [researchers and practitioners] are

regulating themselves before deciding whether to escalate intervention’793

What this type of approach also allows is the potential for the HFEA to recognise that

‘...regulatory agencies that do the best at achieving their goals are those that strike some

sort of balance between [deterrence and cooperative] models’ of regulation,

is apparent.

794 and

implement strategies accordingly. With the new proposals and better regulation regime, we

are seeing a move towards a strategy which involves a combination of both punishment and

persuasive techniques. That is, ‘this type of strategy aims to prevent harm and persuade

actors to comply, rather than focusing solely on punishing wrongdoing’.795

789 Ibid, 12. 790 Ayres and Braithwaite, above n8; Braithwaite, Restorative Justice and Responsive Regulation, above n8. 791 Department for Business Enterprise and Regulatory Reform, Regulators Compliance Code: Statutory Code of Practice for Regulators, 17 December 2007, 7. 792 Ibid. 793 Braithwaite, Restorative Justice and Responsive Regulation, above n8, 29. 794 Ayres and Braithwaite, above n8, 21. 795 Cartwright, above n166, 214.

This is a far better approach which allows a movement away from what was seen as

a system in which all were being treated as ‘baddies’—a system in which the potential was

that the strategy based mostly on punishment could ‘undermine the good will of actors

when they are [in fact] motivated by a sense of responsibility’.796 By rejecting such a

regulatory system the fear that ‘actors will exploit a strategy of persuasion and self-

regulation when they are motivated by things such as economic rationality’ is also assuaged.

Given Braithwaite’s proposal that ‘enforcement agencies that can employ a hierarchy of

sanctions, commencing with persuasion and culminating in a severe penalty such as

imprisonment or licence revocation, are the most effective at achieving compliance’797 the

move towards such a regime is favourable. It closely mirrors the example given in Figure 1

(Chapter Three) of an enforcement pyramid argued by Braithwaite to depict the

enforcement approach of an effective enforcement agency.798

D. Ongoing Public Consultation, Policy Review and Cost Reduction

Moving toward a better regulatory model does not stop with introducing increased

access to a range of low and mid-level sanctions by the regulatory body, as well as

maintaining high end sanctions in order to find the appropriate balance between co-

operation, persuasion and education approaches and deterrence. The application of

sanctions only applies when there is wrongdoing. This thesis has argued that most

researchers and practitioners in the United Kingdom are unlikely to engage in behaviour

that is contrary to the HFE Act. Therefore emphasis on adequate communication and co-

operation, persuasion and education at the base of the regulatory pyramid are most

796 Ayres and Braithwaite, above n8, 24-25. 797 Ibid. 798 Ibid, 39.


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important for the better operation of the regulatory system. The streamlining of the

licensing and inspection approach discussed above is therefore very important, as is

continued policy review and addressing the issues of bureaucracy that have been raised in

this paper.

We have already seen the extent to which the HFEA has engaged in ongoing policy

review and development, including an ability to make decisions about what falls within or

outside of the Act, since its inception. In the 2007/08 business year the HFEA’s policy on the

use of human eggs in research was completed and published; it also initiated a widespread

public dialogue on the use of hybrid embryos in research and subsequently produced a

public report on this issue, which led to a policy decision on how the HFEA should approach

the licensing of interspecies embryos for research; a new policy to improve witnessing

procedures in embryology laboratories was also implemented. In that year the HFEA also

commenced work in preparation for the review of the HFE Act 1990, providing advice and

starting to plan ahead for changes which will be implemented in the 2008/09 business year

and beyond. This included contributing to the work of the Joint Parliamentary Scrutiny

Committee on the draft Bill and continuing to engage in its annual horizon scanning

activities to identify priority areas of scientific embryology research and practice. The HFEA

published a report summarising the horizon scanning issues identified, prioritised and

considered. In accordance with the Government’s Better Regulation agenda, the HFEA also

developed a model process for conducting impact assessments (including the assessment of

potential equalities impacts for all new major activities and projects), and for costing the

implications of simplification plans. These are all activities that are crucial to a regulatory

system in which the regulatory authority engages in dialogue with the public and those

being regulated, and implements policies and compliance approaches based on an informed

position. Such increasing dialogue can only serve to further validate the HFEA’s role as

regulatory authority in the field of research involving human embryos and cloning.

Fundamental to the United Kingdom Better Regulation strategy and the United

Kingdom Department of Health’s Arms Length Review programme799 is also a reduction in

costs and spending associated for regulatory bodies. The HFEA has clearly worked toward

such a reduction. In 2008 it drew down £2.5 million in Grant-in-Aid as opposed to over £6

million in Grant-in-Aid in 2005/06 and reduced its total expenditure from over £11 million in

2005/06 to £7.9 million in 2007/08. This is important, as moves towards better regulation

should mean a reduction in unnecessary costs associated with things like unnecessary

inspections, paperwork and other bureaucratic processes. It also moves towards meeting

the new HFE Act requirement that the HFEA ‘carry out its functions effectively, efficiently

and economically’.800

VI. RECOMMENDATIONS FOR THE FUTURE

The above is just the beginning of the required changes. The HFEA will, over the next

couple of years, work towards implementing further changes to meet the requirement that

they must, so far as relevant, have regard to the principles of best regulatory practice

(including the principles under which regulatory activities should be transparent,

accountable, proportionate, consistent and targeted only at cases in which action is

needed).801

799 Department of Health (UK), Report on Reconfiguring the Department of Health's Arm's Length Bodies, above n385. 800 Human Fertilisation and Embryology Act 1990 (UK), s8ZA(1). 801 Human Fertilisation and Embryology Act 1990 (UK), s8ZA(2).

In order to achieve the best mode of regulation under the model the United

Kingdom has chosen to adopt, there needs to be continued communication with the

regulated sector to ensure the focus is on information exchange and good levels of


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compliance, as well as good communication with research establishments to ensure that the

regulatory burden is actually being reduced.

All the changes that are in train in the United Kingdom will greatly improve the

responsiveness of the regulation by increasing the options available within the regulatory

pyramid. However, to do this properly, there is a need to go further and introduce co-

regulatory elements at the base.

The acceptance of the HFEA by the community and licensed researchers and

practitioners, and the important role that it plays in the regulation of research involving

human embryos and cloning has been recognised. Introducing a co-regulatory design

strategy at the very base of the regulatory pyramid would enable the potential for those

governed by the regulatory system (the researchers and practitioners) to work together

with the regulatory body (the HFEA) in a manner that mutually reinforces one another.802

Importantly it ‘makes it possible to implement the objectives defined by the legislator

through measures carried out by active and recognised parties in the field concerned’803

One example of working together in this sense might include allowing the ‘low risk’

(in terms of compliance) institutes to undertake, for example, a self-report/assessment

regime in relation to their compliance with licence conditions, which would reduce the need

for frequent inspections. That the HFEA has in fact indicated considering such a move was

noted above. In developing the details of such self-report/assessment, the HFEA could

and

clearly has the potential to further reduce costs, bureaucracy, and reduce unnecessary

regulatory burdens.

802 Ibid. 803 Commission of the European Communities, Report from the Commission on European Governance, above n11, 15.

cooperate with those subject to the regulation in the process of creating the new rules.804

That is, the legislature has set the essential legal framework, but there is room for the

stakeholders or parties concerned to fill in the details, and to then have the HFEA monitor

the outcome. This is a mode of ‘meta-regulation’ in which the ‘role of legal and regulatory

strategies is to add the “triple loop” that forces [regulatees] to evaluate and report on their

own self-regulation strategies so that regulatory agencies can determine that the ultimate

substantive objectives of regulation are being met’.805

Figure 5: The Triple Loop Evaluation of Self-Regulation

Parker depicts this as follows:

806

+

The legislature or HFEA might also in turn validate the more detailed rules developed

by the regulated by including them in future Codes of Practice or introducing them into

binding legislation. In this way co-regulation combines the elements of legislation (especially

its predictable and binding nature), with the more flexible regime of a form of self-

804 Senden, above n265. 805 Parker, above n289, 245. 806 Ibid, 278,

Regulatory Goals & strategies Reporting of corporate self-evaluation

to regulators & stakeholders Allows regulators & stakeholders to evaluate & revise regulatory goals & strategies

Company Corporate management systems, culture & practices Evaluate & revise

Self-regulation Monitor program effects & outcomes Evaluate & revise


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regulation. This is warranted given the recognition that those being regulated are ethical

scientists with values that reflect those of the society within which they live. As stated in

Chapter Two, ‘[i]t implies taking self-regulation one step further in a cooperative approach

to governance. Rather than mere co-existence of self-regulation and regulation, it involves

the sharing of responsibilities between public and private partners’.807

In summary, the final outcome would again reflect the approach suggested by

Braithwaite in which various strategies are employed within a regulatory pyramid. The law

provides a framework for all that goes on both within and outside of the licensing system.

The aim however is to avoid implementing adversarial and interventionist strategies when

regulating those who are predominantly compliant.

Other areas in which the researchers and practitioners could co-regulate could be

determined by further consultation between them and the HFEA. Examples might include

the development of appropriate and less burdensome forms and licence application

processes, the reduction in repetition between information submitted to research ethics

committees and to the HFEA and streamlining the two processes in some way, the reduction

in litigation over contentious or ‘grey’ areas of research by way of increased communication

with researchers and practitioners—including recognition that they are in fact ‘the experts’

and again, are respectable, trustworthy, decent people who share community ethical

values.

808

807 Opinion of the European Economic and Social Committee on Simplification, above n259. 808 Ayres and Braithwaite, above n8, 39.

In keeping with the United Kingdom’s

decision to retain the HFEA, it is proposed that responsive regulation may be achieved by

adopting a co-regulatory approach at the base of the regulatory pyramid, moving up to

‘command and control with discretionary sanctions’, and then finally to ‘command and

control with non-discretionary sanctions’. This is illustrated in Figure 6:

Figure 6: Proposed Regulatory Model

* Note all other self-regulatory mechanisms (for example requirements for human research ethics approval) still exist beneath this level of regulation.

NO

N-C

OM

PLIA

NT

Com

man

d an

d Co

ntro

l

High

Courts; Govt Authorities (eg Police); HFEA

Medium

Courts; Govt Authorities (eg Police); HFEA

Low

HFEA

COMPLIANT

Co-regulation

Researchers; License holders;

Community;

HFEA

Responsive regulation emphasises discretion about which enforcement strategy to use. In relation to licensed research activity, most regulation will occur at the bottom of the pyramid with increased enforcement strategies being used dependant on frequency and severity of non-compliance (and whether lower level compliance strategies are being ignored). Compliance at any stage would lead to return to the bottom of the pyramid. In instances where non-licence holders commit an offence, or where there is serious non-compliance by licence holders, immediate use of higher level sanctions would be warranted.

Criminal Prosecution

Increased use of enforcement techniques: injunctions; licence revocation.

Increased direction: Warning letters; written notices; variation to license; increased monitoring/auditing; cost recovery for increase in compliance strategies

Co-operative compliance strategies: Education, routine monitoring, licensing, self-report on compliance, web-site, information dissemination, communication and dialogue b/w regulators, regulatees and community, feedback from researchers/practitioners; flexibility.

Legi

slat

ive

Fram

ewor

k

Add to new system

Increase in new system

Again, the perception that prosecution is a last resort is an important factor. If compliance

with legislation can be ensured by informal measures then the prime purpose of the

legislation can be achieved cost effectively—‘punishment is expensive; persuasion is

cheap’.809

809 Ibid, 41.

The lower level co-regulatory design strategy proposed for the base of the

pyramid allows scientists to have a dialogue with regulators, and be responsive to

community perceptions. It would facilitate discussion of risk perceptions, avoid

stereotyping, and also to ensure scientists do not become too insular. It would also enable


Page 281

the HFEA and the legislature to continue responding to issues of what to regulate and where

to draw the line, based on increased information exchange and then corresponding revision

of regulation and rules.

Of course, as recognised in Chapter Three, the regulatory design strategy and

enforcement approaches proposed would still allow for imposition of high end sanctions

(such as criminal prosecution) to cater for exceptional cases where ‘bad’ things may happen.

In some instances in the context of research involving human embryos and cloning, such as

where strict prohibitions exist, or where people are operating outside of the licensing

system, having a dynamic model would not work. It is therefore not recommended that the

United Kingdom regulatory system attempt to fit the Braithwaite model of ‘responsive

regulation’ perfectly. It is not suggested that the strict prohibitions that have been decided

upon through extensive consultation and review processes be ignored or removed, or that

offenders should not be prosecuted if the need to address criminal activity arises. Again, it is

recognised that what to regulate and where to draw the line questions have been

addressed adequately and that even Braithwaite recognises that it might be appropriate

when there are ‘compelling reasons to do so’ to abandon the presumption of starting at the

base of the pyramid.810

AUSTRALIA

VII. ONE STEP FORWARD, TWO STEPS BEHIND?

Australia took a great step forward in choosing to adopt a regulatory framework

approach to govern research involving human embryos and cloning rather than imposing a

complete ban or leaving the law in the inconsistent state that previously existed. It is an

810Braithwaite, Restorative Justice and Responsive Regulation, above n8, 30.

area in which there are legitimate risks and concerns, in which the ‘precautionary principle’

is warranted to some degree, and some regulation is called for. Like the United Kingdom,

after extensive public consultation, review and parliamentary debate, Australia addressed

the questions of what to regulate and where to draw the line regarding permissible and

prohibited activities in a systematic and consultative manner. However, it does appear that

Australia is at least two steps behind the United Kingdom in regard to the regulatory system

it has adopted. That is, in answering the how to regulate question, Australia has

implemented the very system that has been extensively reviewed in the United Kingdom,

and is now being reinvented to move towards a ‘responsive regulatory regime’ which

encompasses predominantly cooperative, persuasive and educative approaches and better

regulation principles. The remainder of the chapter summarises the problems and suggests

some solutions.

Unfortunately, whilst the design and implementation of the Australian regulatory

system was briefly considered in the 2005 Lockhart review,811 the main focus of the

Lockhart Committee Report was still upon arguments concerning the question of when life

begins, the moral status of the embryo, how the embryo should be defined within the

legislation, and what to permit or prohibit in relation to research involving human embryos

and cloning.812

Although Australia’s regulatory system is relatively new (only six years old at the

time of writing) a significant amount of dissatisfaction with it was found during the

fieldwork described in Chapter Five. This included the issues discussed above concerning

These are important questions when deciding upon what to regulate and

where to draw the line. However questions regarding how to regulate once the parameters

of acceptable research have been determined are also very important for good regulation.

811 Legislation Review Committee (Australia), above n10, 99-113. 812 Ibid, iv.


Page 283

how researchers and practitioners felt they were being treated as untrustworthy or like

‘mad scientists’ and regulated as a result of fear rather than informed practice. Extensive

issues about the operation of the regulatory system in Australia and the NHMRC licensing

system were also raised.

In particular many saw that the additional licensing system for research involving

human embryos was wasted money given existing strict regulation of all medical research

by ethics committees,813 and redundant because if one wanted to do something that was

not within the bounds of the legislation they simply would not apply for a licence and/or it

would not be in the records the licensing committee inspects.814

The practical consequences, in terms of costs of storage of files onsite, of the way

the licensing system operates and the associated financial impacts on those regulated

815

were also raised as a matter of concern. The time it took to gain a licence816and the fact that

a licence holder had to ‘go through the whole process again’ in relation to any alterations to

a licence once it had been granted817 were also seen as frustrating and bureaucratic

processes that impact upon research in a negative manner.818

Some of the researchers interviewed and a number of other significant stem cell

scientists have since left Australia to pursue their research interests in countries that do not

have such regimes.

819

813 [P11], [P13]. 814 [P13]. 815 [P13]. 816 [P12], [P13], [P16]. 817 [P13]. 818 [P10], [P11], [P13], [P14], [P16]. 819 For example, Alan Trounson moved to California Institute of Regenerative Medicine in late 2007. Martin Pera and Dianna DeVore of the Melbourne-based Australian Stem Cell Centre and Paul Simmons of the Peter MacCallum Cancer Centre left for the United States in 2006.

However one cannot assume that it is the Australian regulatory

system that has led in whole or in part to such departures. Speculation about why scientists

are leaving Australia often attributes the move to offers of greater pay, better research

funding and/or other research opportunities overseas that do not exist in Australia.820

...I understand why they do it in a way but in another way it just amounts to smoke and mirrors to keep the public happy. You know it’s a ‘look we are doing something’ approach, but it doesn’t serve to stop those who want to do bad science.

Further research into the reasons for people leaving is needed to draw firm conclusions.

Nonetheless, there should be concern if the opportunities in Australia, including what is

allowed by the regulatory system and how it is regulated, are not such that the world’s top

researchers wish to remain here.

One of the most resounding comments during the fieldwork conducted in Australia

was when one participant stated:

821

Such research findings were reflected and are therefore validated in submissions

made to the Lockhart Committee review. However, the Lockhart Committee Report stated

that it ‘considers that the Licensing Committee fulfils a valuable role in this process and is

broadly supported by researchers and by the community.’

As argued in Chapter Six, it is not a good enough reason to have an elaborate regulatory

system in place, simply to keep the public happy. Nor is it justified given the discussion

about the type of system adopted and the estimated costs of the system (which are

discussed below) in relation to those being regulated.

822

820 For example, Professor Bob Williamson, chairman of the National Committee for Medicine at the Australian Academy of Science and professor of medical genetics at Melbourne University, said in an interview reported in The Age, 16 September 2007 said ‘...we have now lost three or four of the very best stem cell scientists from Australia... while local research was funded to the tune of $A50 million, it doesn't really match up to their $US3 billion... With the finance and political capacity they have in California, and indeed the leadership they are showing, it was too good an opportunity to miss...’ 821 [P13]. 822 Legislation Review Committee (Australia), above n10, 176.

This statement does not

accord with the findings of the interview research with researchers and practitioners

conducted both pre and post legislative changes for this thesis, in which there was in fact an


Page 285

expression of strong dissatisfaction by those regulated with regards to the NHMRC Licensing

Committee’s operation.

Why was the dissatisfaction so much more pronounced in Australia than that found

in the United Kingdom? One factor may be that the Australian system was implemented

long after weaknesses with pure command and control systems had been identified.823 Even

where such systems are maintained, they are being amended and revised so that they

function in a way that removes or reduces regulatory bureaucracy, over-regulation and an

emphasis on deterrence. This was illustrated in the discussion above regarding the United

Kingdom decision to keep the HFEA but revise its functions and operations. Instead, whilst

utilising cooperative, persuasive and educative approaches to a small degree towards the

bottom of the pyramid,824

Also, as opposed to the United Kingdom situation in which many researchers and

practitioners had never worked within a different regime, many Australian researchers and

practitioners have a long history of working within an ‘ethical guidelines’ framework, and a

system which was predominantly self-regulatory. Researchers who have now had to move

to a more authoritarian system might find it hard to accept. This was supported in the

fieldwork reported in Chapter Five which illustrates a negative reaction by researchers and

practitioners to what they saw as the strong policing approach adopted by the NHMRC

the majority of the work of the NHMRC Licensing Committee was

perceived by compliant researchers and practitioners interviewed during the fieldwork, as

one which emphasises deterrence and is lacking in responsive regulation – the very flaws

the command and control system has been criticised for.

823 Adams, et al. above n225; Bardach.and Kagan, above n226; Stephen G. Breyer, Regulation and its Reform (1982); Ogus, above n14. 824 Such as the NHMRC Licensing committee developing a program of activities for communication with stakeholders [which]... include presentations by members of the Licensing Committee at various meetings, visits to applicants by committee members and secretariat, production of information bulletins about the committee’s activities, and a training workshop for human research ethics committee (HREC) members.

Licensing system, to being treated as though they were ‘not to be trusted’, ‘the last people

to be listened to’, and with general suspicion. Although in the United Kingdom there was a

similar sense of ‘being treated like baddies’, a general move away from such approaches

was apparent in that jurisdiction, but not so in Australia.

Another explanation for the dissatisfaction with the Australian system might have

been that the legislation was more restrictive than the United Kingdom (and other

jurisdictions) in terms of permissible research at the time that some of the interviews were

conducted. This led to a strong view that the regulatory regime was inimical to science.

However, even though this changed with the 2007 amendments to the RIHE Act and PHRC

Act which now put Australia on par with the United Kingdom with regard to permissible

research, the researchers and practitioners interviewed post legislative changes still viewed

the licensing system negatively. It seems the negative view of the licensing enforcement was

based on the higher deterrent element involved in the Australian regulatory design than

that found in the United Kingdom or that existed elsewhere rather than the substance of

what research is permitted.

In addition the system as it stands is less able to respond to changes—legislative

review and subsequent amendments being the only avenue to address what is permitted or

not permitted and taking anywhere up to seven years to come into force.825

It seems the predominant function of the NHMRC Licensing Committee is therefore

to assuage public fears. In doing so it has created an unnecessary bureaucracy. A regulatory

There is a stark

contrast between the Australian review system and the continuous review process and

policy development that occurs in the United Kingdom given the quite different powers of

the HFEA to those of the NHMRC Licensing Committee.

825 See discussion above in Chapters Four and Five.


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system that predominantly serves to assuage public fears is not adequate, particularly if it

leads to over-regulation and adopts the essence of a strong ‘precautionary principle’ despite

fairly permissive legislative boundaries. In the following section, the cost of the Australian

regulatory system is considered, as better regulation also means a cost-effective regime.

VIII. THE COST OF THE AUSTRALIAN REGULATORY SYSTEM

Fundamental to the review of regulatory structures in place in the United Kingdom

was a reduction in costs and spending for regulatory bodies. It was seen that the HFEA has

clearly worked toward such a reduction. It does not however appear that Australia has done

the same. In fact, the estimated or budgeted cost of the Australian licensing system in

relation to whom and what it is regulating appears completely out of proportion to the

number of regulatees in Australia and the risk of wrongdoing. It will also be seen below that

there is no opportunity for cost recovery.

Whilst the Director of Licensing for the NHMRC has indicated that there are ‘no

documents on the public record’ that provide information about the exact costs of the

NHMRC Licensing Committee,826 the 2005 Lockhart Committee Report stated that ‘the costs

of supporting the Licensing Committee and the national compliance system are

significant.’827

826 Email from Melissa Crampton, (Director of Licensing NHMRC Licensing Committee) to Sonia Allan, 18 March 2009 in response to an email from Sonia Allan to Melissa Crompton, 18 March 2009 in which the author asked whether there were any documents or information that detail the cost of the NHMRC Licensing Committee. The author sent this email after having conducted extensive searches of the Australian Government Department of Health and Ageing, Health and Ageing Portfolio Budget Statements, from the 2002-03 financial year to the 2008-09 financial year; NHMRC Annual Reports; NHMRC Licensing Committee Reports; and general web searches trying to find information concerning what the NHMRC Licensing Committee actually costs. 827 Legislation Review Committee (Australia), above n10.

In that report it was stated that the Australian Government Portfolio Budget

Statement for the financial year 2003–04 indicated a total commitment of $3.3 million per

year.828 Whilst it is difficult to discern whether the $3.3 million dollars is in fact spent by the

NHMRC Licensing Committee due to the lack of information on the public record, such an

amount seems completely disproportionate to the NHMRC Licensing Committee’s functions.

Such functions are to consider applications for licences to use excess ART embryos; refuse or

grant licences, subject to conditions; maintain a publicly available database containing

information about licences issued; monitor activities and ensure compliance with the

legislation through appointment of inspectors and take necessary enforcement action, such

as cancelling or suspending licences; and report to the Australian Parliament at six-monthly

intervals on the operation of the RIHE Act and the licences issued under the Act.829

In the six years since the NHMRC Licensing Committee’s inception, this translates in

practice into the NHMRC Licensing Committee and its inspectorate being in charge of

granting licenses to, monitoring and reporting on less than a handful of research institutes.

For example, there were four research institutes that held licenses in 2006.

830

Since the inception of the Acts, the NHMRC Licensing Committee have also reported

on conducting forty-six information exchange visits conducted during five of the twelve

reporting periods.

There are

now only two research institutes in 2009. At January 2009, although there were ten current

licences granted by the NHMRC Licensing Committee, these ten licences were held by only

two institutes: Sydney IVF held eight of these licences; Melbourne IVF two.

831

828 Noting, that one could assume that this figure would have risen each year, however the author not having access to latter figures the $3.3 million figure will be use as the basis for arguments relating to cost. 829 Research Involving Human Embryos Act 2002 (Cth), Part 2 (Divisions 4 and 5). 830 See Appendix 5.

Licensing Committee Meetings are reported to occur on average two

831 National Health and Medical Research Council, NHMRC Licensing Committee Report to the Parliament of Australia for the Period 1 April 2008 to 30 September 2008 (2008); National Health and Medical Research Council, NHMRC Licensing Committee Report to the Parliament of Australia for the Period 1 October 2007 to 31 March 2008 (2008); National Health and Medical Research Council, NHMRC Licensing Committee Report to the Parliament of Australia for the Period 1 April 2007 to 30 September 2007(2007); National Health and Medical Research Council, NHMRC Licensing Committee Report to the Parliament of Australia for the Period 1 October 2006 to 31 March 2007 (2007); National Health and Medical Research Council, NHMRC Licensing


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to three times bi-annually, with an approximate total of twenty three meetings since the

committee was formed.832 Many of these meetings appear to occur over two days.833 There

also has been at least one instance of international travel by the Chair of the NHMRC

Licensing Committee,834

Significant costs were also incurred in 2007 when a decision by the NHMRC Licensing

Committee to reject an application for a variation of licence which was challenged by

Sydney IVF in 2007 in the Administrative Appeals Tribunal.

although this does not appear to be a regular occurrence. Costs

associated with information exchange visits, as well as Committee meetings (which may

include accommodation and travel expenses, as well as payment of committee members),

maintaining a database, reporting bi-annually to the Minister, running a website and any

international travel and associated costs need to be established, but again it is doubtful that

$3.3 million dollars could be justified. If this is the amount that is being spent on the NHMRC

Licensing Committee’s operations, it clearly needs questioning.

835

Committee Report to the Parliament of Australia for the Period 1 April 2006 to 30 September 2006 (2006); National Health and Medical Research Council, NHMRC Licensing Committee Report to the Parliament of Australia for the Period 1 October 2005 to 31 March 2006 (2006); National Health and Medical Research Council, NHMRC Licensing Committee Report to the Parliament of Australia for the Period 1 April 2005 to 30 September 2005 (2005); National Health and Medical Research Council, NHMRC Licensing Committee Report to the Parliament of Australia for the Period 1 October 2004 to 31 March 2005 (2005); National Health and Medical Research Council, NHMRC Licensing Committee Report to the Parliament of Australia for the Period 1 April 2004 to 30 September 2004 (2004); National Health and Medical Research Council, NHMRC Licensing Committee Report to the Parliament of Australia for the Period 1 October 2003 to 31 March 2004 (2004); National Health and Medical Research Council, NHMRC Licensing Committee Report to the Parliament of Australia for the Period 1 April 2003 to 30 September 2003 (2003); National Health and Medical Research Council, NHMRC Licensing Committee Report to the Parliament of Australia for the Period 19 December 2002 to 31 March 2003 (2003). See Appendix 14 for details regarding exchange visits. 832 Ibid. 833Ibid. 834 In June 2005 the Chair of the Embryo Research Licensing Committee, Professor Jock Findlay, and Dr Harry Rothenfluh of the NHMRC, visited the HFEA to ‘discuss topics of mutual interest, including processes for assessing and taking decisions on licence applications, monitoring and compliance strategies’: National Health and Medical Research Council, Annual Report 2005 (2005). 835 See above n575.

The Chair of the NHMRC

Licensing Committee reported that ‘[m]embers agreed the cost and time of the process was

significant however members also agreed the exercise was extremely valuable as an

investment for the future’.836

Further, the Lockhart Review highlighted that to date no cost recovery mechanism

has been applied to the costs of the NHMRC Licensing Committee.

A more cooperative regulatory system would serve to avoid

such costs in all instances other than where criminal activity has occurred. Whilst the focus

here is on costs, it is also noted that allowing such matters to reach Courts or Tribunals

again illustrates the adversarial approach inherent in the current regime.

837 In fact, there is no

opportunity for cost recovery of this or any other figure. Recovering the budgeted $3.3

million cost or any significant cost of the regulatory system in Australia from the licensed

institutes would also be impractical and ultimately not possible. For example, using the $3.3

million figure, split evenly between them on a per annum basis, it would cost $1.65 million

for each institute in 2009. Alternatively, it would cost $330,000 per licence—Sydney IVF

would pay $2.64 million and Melbourne IVF $660,000 in 2009. A more reasonable and

realistic licensing fee on the other hand, would do little to meet the cost of the NHMRC

Licensing Committee. This was again recognised by the Lockhart Committee.838

The Lockhart Committee stated that the Productivity Commission’s review of cost

recovery recommended that ‘cost recovery arrangements that are not justified on grounds

of economic efficiency should not be undertaken solely to raise revenue for government

activities.’

839 It was therefore the view of the Lockhart Committee that ‘considering the

small number of licence applications received, it is unlikely that introducing cost recovery

would be cost-effective or efficient.’840

836 National Health and Medical Research Council, Report of the 168th Session of the National Health and Medical Research Council (13 December 2007). 837 Legislation Review Committee (Australia), above n10. 838 Legislation Review Committee (Australia), above n10. 839 Ibid. 840 Ibid, 101.


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This contrasts with the United Kingdom system in which licence holders are

responsible for many of the costs of the system by way of licensing fees (which amounted to

£5,212,804 in the 2007/08 financial year). However, as stated the HFEA’s function and remit

is far more extensive than the NHMRC Licensing Committee’s. The HFEA regulates all

assisted reproduction clinics, research involving human embryos and the storage of eggs,

sperm and embryos. This amounts to approximately 300 centres licensed by the HFEA

(including licensed clinics and research institutes)841

The Lockhart Committee also recognised that ‘organisations are already meeting the

costs of compliance with the national regulatory scheme and, in relation to compliance with

licensing requirements, these costs may be significant.’

and so the funding of a large proportion

of the operation of the HFEA through licensing fees is possible.

Whilst the Lockhart Committee was correct in recognising that it would not be

efficient to recover the costs of the regulatory system from licensees in Australia, they did

not question or investigate the cost of the system itself (to both government and licence

holders). Such an investigation is warranted given the small number of research facilities

actually conducting such research and the other functions of the NHMRC Licensing

Committee. As stated, it is doubtful that the other limited functions of the Licensing

Committee would or should cost millions of dollars per annum.

842

This is not to detract from the NHMRC’s function as ‘Australia's peak body for

supporting health and medical research; for developing health advice for the Australian

community, health professionals and governments; and for providing advice on ethical

This indicates a recognition that

the current system places significant financial burdens on those being regulated – another

potential reason for the regulatees’ dissatisfaction.

841 Human Fertilisation and Embryology Authority, Annual Report and Accounts2007/08, above n730, 29-33. 842 Legislation Review Committee (Australia), above n10, 101.

behaviour in health care and in the conduct of health and medical research’.843

IX. THE AUSTRALIAN SYSTEM, A CALL FOR CHANGE

Rather it is

to question the costs, both to the public and to the regulatees, of the NHMRC Licensing

Committee (a committee that falls within the overall NHMRC’s functions but is dedicated to

the oversight and implementation of the law regarding research involving human embryos

and cloning). Particularly in a climate of economic uncertainty, downturn and stress, based

on the figure reported in the Lockhart Committee report, one cannot reasonably justify

budgeting for a $3.3 million dollar regulatory system that currently (in 2009) regulates two

research facilities, and has limited other functions. This is particularly so if there are other

regulatory design strategies and enforcement approaches (including prohibiting

unacceptable practices) that will continue to govern research involving human embryos and

cloning well but reduce the regulatory burdens and costs of the system that currently exists.

The call therefore is to consider whether Australia could move to a more flexible,

and potentially less costly, system.

The NHMRC member interviewed for this study, whilst recognising cooperation is

important, stated that ‘it would be very difficult to move to a more flexible system.’844 It

appeared that his view was that the current regulatory model was the only way to do things

properly due to the need for reporting and inspection systems.845

843 NHMRC Website,

However, as illustrated

above in relation to the United Kingdom regulatory system, and argued below, it is possible

to move to a more flexible system and maintain licensing, reporting and inspection. What is

needed is a move away from only being able to see what exists and using cooperative

http://nhmrc.gov.au/about/index.htm at 15 November 2008. 844 [P15]. 845 [P15].

http://nhmrc.gov.au/about/index.htm�


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strategies only to a small degree, and to see better modes of regulation and make

cooperation a significant reality.

Similarly, whilst the Lockhart Committee acknowledged that ‘prescriptive legislation

has a number of disadvantages because it is difficult to anticipate advances in knowledge

and potential new uses of the technologies’,846 it stopped short of considering the type of

regulatory system in place. Rather, it suggested that the NHMRC Licensing Committee be

given powers to make ‘binding rulings... on its interpretation of the legislation’847 which

could be subject to parliamentary scrutiny by ‘a legislative requirement that the Licensing

Committee must report immediately on its rulings to the NHMRC and to parliament and

that the rulings must be tabled in parliament for its consideration.’848

in the cases of both the PHC Act and the RIHE Act, a combination of legislation, regulations, guidelines and Licensing Committee rulings, together with rigorous parliamentary and community reporting, could provide an accountable and flexible system in line with the expectations of the government, researchers and the community.

The Lockhart Committee stated its view as follows:

849

They suggested that ‘this may also avoid the need for further reviews of the legislation

outside the usual parliamentary process of amendment.’

850

846 Legislation Review Committee (Australia), above n10, 159. 847 Ibid. 848 Ibid. 849 Ibid. 850 Ibid.

This may provide for a system

that is able to respond to technological change more rapidly than the one that exists now –

something that must be addressed – but it does not address the problems highlighted here

with regards to the regulatory design strategy or enforcement approaches in place. In fact, it

seems to reflect the view that the NHMRC Licensing Committee is in the best position to

make rulings, interpret legislation, determine any necessary changes and then table such

rulings in Parliament.

The Lockhart Committee may have presumed the NHMRC Licensing Committee would

consult with research scientists, practitioners and the community when making such

‘rulings’. It is not, however, inherent in what they say. This does not accord with the

principles discussed throughout this thesis concerning the best modes of regulation and

enforcement. It certainly does not recognise or consider principles of co-regulation and how

they may serve to enable rule making to be a process in which those regulated and

stakeholders (such as the public) have a greater role in the overall functioning and

implementation of the system. That is, it does not imply information exchange or dialogue

with regulatees or the community to discuss potential risks, risk perceptions, to avoid

stereotyping, and also to ensure scientists do not become too insular.

Secondly, giving further regulatory powers to the NHMRC Licensing Committee may

result in increasing the costs of the regulatory system rather than addressing issues of

better regulation and the need to decrease regulatory burdens. It was already shown above

that on issues of law relating to the disparities between Commonwealth and Western

Australian legislation, the NHMRC Licensing Committee did not take a position and

anticipated seeking legal advice if someone from Western Australia applied for a licence. If

they cannot inform the public about who will or will not be licensed without seeking legal

advice, they are probably not in a position currently to interpret legislation, make regulatory

rulings, or suggest amendments to the law to parliament. At the very least, a legal advisor

would need to be hired and one would imagine extensive public consultations conducted

before rulings made.

Notably changes to give the NHMRC more powers pursuant to the Lockhart

recommendation were not made in the 2007 amendments to the RIHE Act or the PHRC Act.


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Whilst the Lockhart Committee rightly recognised the need to be able to respond

quickly to changes in technology, and commented on the move to a more flexible system,

the Lockhart Committee’s comments did not go far enough. All of the strategies and

arguments that have been made for better regulation in the United Kingdom and that are

discussed above in relation to that jurisdiction equally apply to the Australian regulatory

system. Australia needs to move away from the ‘spiral of regulation’ and the adoption of an

approach that has little or no regard for the costs of regulation or the impact on science, as

well as the over emphasis on deterrence. Australia too, should move towards a compliance

strategy that emphasises ‘responsive regulatory’ principles, and so far as relevant, should

have regard to the principles of best regulatory practice discussed above in relation to the

United Kingdom.

A. Changing the Australian Regulatory System to Suit the Australian

Context

The Australian regulatory system is in need of further review. Australia can learn and

be guided by considering other jurisdictions’ experiences, insights and regulatory design

strategies. This does not however mean that Australia should simply adopt a regulatory

system based exactly on those that exist elsewhere (or in particular that of the United

Kingdom). It must implement a system that is suitable to the Australian context.

What is most notably different about Australia in this context to the United Kingdom

is that at present the Australian NHMRC Licensing Committee appears to have significant

costs associated with its limited functions, yet presently licenses, monitors and oversees

only two research institutes. Whilst actual costs were not available, the NHMRC Licensing

Committee’s further functions (beyond licensing) which are predominantly limited to

information exchange visits, maintaining a database, reporting to government, and

committee meetings, do not seem proportionate to the reported budget of $3.3 million.

Giving the NHMRC Licensing Committee the powers to make ‘rulings’ on

interpretation of legislation as suggested by the Lockhart Committee may in fact increase

the costs of the regulatory system, and allowing such rulings does not address any of the

other issues raised above in relation to the choice of regulatory model and its

implementation.

Further, because the states and territories in Australia are responsible for the

regulation of assisted reproduction, the NHMRC Licensing Committee will never have the

extent of responsibilities that the HFEA has, and so adopting a similar system in relation only

to the comparatively small scale regulation of research involving human embryos and

cloning is questionable. Whilst it was recognised above that the decision to maintain the

HFEA was not due to it having extensive functions but rather ‘the benefit of maintaining the

professional reputation it has earned since 1990, and the respect it has as a model

regulatory environment for embryonic stem cell research,’851

851 Department of Health (UK), Impact Assessment on the Human Fertilisation and Embryology Bill (2008), above n716, 5.

it is doubtful whether the

same rationale may be applied to the NHMRC Licensing Committee. Unlike the support

expressed by regulatees in the United Kingdom for maintaining the HFEA, regulatees in

Australia preferred enforced self-regulation and were critical of the NHMRC licensing

system. Of course, as recognised below in Chapter Eight, further investigation with regards

to what the Australian public would accept is need.

The question therefore is what type of alternative regulatory system should be

adopted?


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B. The Regulatory Strategy of Choice

The majority of the participants interviewed in the Australian fieldwork were in

favour of moving to a self-regulatory system with the preference being some form of

enforced self-regulation.852 They emphasised the presence of ethics committees and

professional bodies that already oversee what they do853 and said that enforced self-

regulation might provide the community with a satisfactory level of comfort.854 They also

emphasised that where there is wrongdoing, it is usually exposed by the industry itself

rather than through any regulatory agency,855 and that some form of enforced self-

regulation would enable people ‘who actually knew more about what was going on’ to

provide checks on other researchers or practitioners.856

However, the major problem with a suggested move towards a self-regulatory

system, even if it involves ‘enforced self-regulation’, is that it does not reflect the public call

for a more formal regulatory system apparent both prior to passing the original RHE and

PHC Acts and during the review of the legislation between 2005-2007. Nor does it recognise

that public acceptance of the regulatory system in place is important, albeit as stated not

the only factor to be considered or used as justification for any chosen regulatory system.

Whilst self-regulatory systems have significant strengths—as outlined in Chapter Three—

these factors outweigh them. Criticisms about the potential that rule setting procedures

These are all valid arguments,

particularly because it seems that the information relied upon by the NHMRC Licensing

Committee is in fact what the researchers or practitioners place in their files anyway, a de

facto form of self-regulation.

852 [P11], [P13], [P14], [P16]. 853 [P11], [P13], [P14], [P16]. 854 [P10]. 855 [P10]. 856 [P10], [P14].

might lack acceptance by the public and consumers; lack of trust from the public regarding

internal compliance units in being able to apply rules in the public or consumer interest; and

that the public has demanded that the government take responsibility for this sector,857

It was seen in Chapter Four that the current regulation may be depicted as

illustrated in Figure 3 – a pyramid in which the licensing and oversight at the bottom of the

pyramid is a way of ‘policing’ research activities conducted by licence holders. Severe

penalties, including imprisonment, for breaching the Act are at the top of the pyramid for

are

also most important. Whilst it has been argued above that scientists are ethical, reflect the

values of society, and that those conducting this type of research are unlikely to breach the

law, in choosing the best mode of regulation the public demand for a more formal system of

regulation than self-regulation cannot be ignored.

As such, neither self-regulation nor enforced self-regulation would suffice. Rather, as

suggested above for the United Kingdom, introducing a level of co-regulation into the

current model would be most suitable. This is because co-regulation allows the legislature

to set the framework rules (the parameters of acceptable research), rather than the

industry itself. This approach is more reflective of what is accepted by the wider community

than a purely self-regulatory approach. It requires scientists to engage with, and be held

accountable to community values, but trusts them to take responsibility to do this. It also

serves to maintain strict prohibitions on certain activities like human reproductive cloning,

and provides for exceptional cases where someone might engage in criminal activity.

A system which employs responsive regulation when governing licensed research

activities and includes a level of co-regulation, would still fit with what those regulated

expressed they would prefer whilst not ignoring other important considerations.

857 Baldwin and Cave, above n151, 40-41.


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those who might not adhere to lower level regulatory requirements such as licensing or

might seek to do research on embryos or cloning outside the system and without a licence.

Whilst it is not argued that the Australian regulatory system should remove these options, it

is argued that it should address the fact that cooperative, educative and persuasive

approaches are largely missing or represented only to a small degree at the base of the

pyramid within the listed activities. The introduction of a co-regulatory approach at the base

of the pyramid to govern licensed research activities would make the system complete.

Such a system would allow for the continued presence of strict prohibitions and

enforcement approaches for those that might commit offences outside of the licensing

system, or licence holders who engage in severe breaches of the regulatory system, whilst

allowing for responsive regulation of licensed activities. The proposed regulatory system

reflects the model suggested by Braithwaite and depicted in Chapter Three, Figure 2.

However, it replaces the lower level ‘enforced-self regulation’ and ‘self-regulation’ in that

figure with co-regulation at the base of the pyramid. This is most appropriate where there is

good reason to have government involvement and formal laws contained within legislation,

for example providing a framework for activity, and in instances where self-regulation would

not be satisfactory alone. It has been shown above that this fits the context of research

involving human embryos and cloning.

The following section proposes two alternative models for how the suggested

regulatory system might be implemented.

X. PROPOSED MODELS FOR REVISING THE AUSTRALIAN REGULATORY

SYSTEM

The legislature cannot ignore the extensive research into better regulation that has

been conducted in the United Kingdom and which has led to direct revision of the

regulatory system upon which the Australian system is modelled. Nor can one ignore the

need to recognise that licensed researchers and practitioners not only indicated that they

want a less onerous scheme of licensing and compliance, but have demonstrated nothing

but compliance since the inception of the RIHE and PHRC Acts and corresponding regulatory

regime. This section therefore considers two possible models for revising the current

regulatory system in Australia. Like the model proposed for the United Kingdom above, both

models allow for greater opportunity for licensed researchers and practitioners to engage in

a dialogue with regulators and the community and would allow for discussion of perceived

risks, avoid stereotyping, and ensure that research scientists do not become too insular.

However the first model differs from the United Kingdom model in regulatory design.

A. Model 1: Co-Regulation Using RTAC, the NHMRC and Legislative

Framework

It is proposed that the most appropriate regulatory system for the Australian context

is one in which researchers and practitioners would still be governed by the RIHE Act and

PHRC Act however, given the small scale of operation in Australia, a different approach to

the licensing and monitoring of such activities would be taken at ground level. In particular,

Australia is in a very good position to draw on self-regulatory bodies already in place and the

expertise of the researchers and practitioners within the field to take over the ‘bottom level’


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of regulating researchers and practitioners conducting research involving human embryos

and cloning (for research purposes) within the licensing system. The first (and preferred)

proposed model is that Australia should maintain the legislative framework, utilise the

Reproductive Technology Accreditation Committee (RTAC) to license, monitor and oversee

research activity, and maintain the NHMRC in a modified form to complement RTAC

functions and provide higher level enforcement if necessary,.

1. Why RTAC?

The functioning of RTAC was detailed in Chapter Three when considering different

types of regulatory design strategies. Its function within those Australian states with self-

regulation and those with co-regulation was illustrated. It was demonstrated that RTAC as

an industry body ensures compliance to standards are met, implements strategies for

monitoring via regular audits and inspections, and reports on facility activities and outcomes

in the context of Assisted Reproductive Treatment/Technology (ART). It also requires that

the current facilities it accredits comply with all legislative and regulatory requirements

including state based legislation, NHMRC guidelines, and HREC requirements (which include

extensive provisions and requirements about what is permissible or prohibited, safety,

ethical conduct, practice, consents and so on). Such oversight would easily translate to the

context of research involving human embryos and cloning.

RTAC is a most relevant industry body that could quite easily take over the functions

of the NHMRC Licensing Committee in relation to licensing and oversight practices. This is

particularly so as in practice this would currently mean oversight of two premises which it

already oversees, licenses, and audits in relation to their ART practices. Utilising RTAC for

licensing and oversight of research involving human embryos and cloning (for research

purposes) as well, would serve to reduce the authoritative approach complained of by

researchers and practitioners, incorporate a form of self-regulation but with more stringent

oversight, and streamline the number of inspections that are currently conducted by the

NHMRC Licensing Committee Inspectors (noting that there are on average five monitoring

inspections being made bi-annually – or approximately 10 per year).858 This is justified given

that 1) currently there are only two licensed research institutes, one holds eight licences and

the other, two; 2) the inspections carried out by the NHMRC Licensing Committee

Inspectors rely on data contained in the research facility’s files anyway; and 3) the result of

all inspections since the NHMRC Licensing Committee’s inception has been to find licence

holders compliant and there have been no breaches of the legislation.859

Noting the discussion in Chapter Three recognised concerns about the RTAC as a

self-regulatory body and that some did not support the self-regulatory approach because of

their concern that ‘legislation would ensure the industry operates in accordance with

established ethical standards, including transparency and full disclosure of risk’,

860 it is

stressed that self-regulation is not what is suggested here. The model proposed here would

require RTAC to operate within the legislative framework and be subject to government

oversight – a co-regulatory design strategy for the base of the pyramid. That this serves to

address fears about transparency and disclosure was illustrated in Chapter Three by

reference to those states that mandate RTAC accreditation under their ART legislation861

858 See Appendix 13 for information regarding the details and number of inspections carried out by the NHMRC Licensing Committee since its inception. 859 Ibid. 860 Legislation Review Committee (Australia), above n10: St Thomas More Society (Submission LRC397) 861 Human Reproductive Technology Act 1991 (WA), s29(5)(aa)(i);

and work closely with RTAC in regulating assisted reproduction clinics. In fact, it was shown

that particularly in these instances the regulation of ART facilities by RTAC has been met


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with great approval by government, review committees, state regulatory bodies and the

public alike.

With respect to concerns about ensuring that the industry operates in accordance

with ethical standards it is again stressed that RTAC not only emphasises but requires

adherence to ethical modes of conduct, guidelines and HREC requirements as well as

ensuring safety and standards are met. RTAC also uses independent auditors to carry out

inspections of regulated facilities which provides an added layer of protection against

concerns about disclosure of non-compliance where self-regulatory bodies are used.

Finally, the Lockhart Committee recognised that ‘the self-regulatory approach of the

RTAC system was seen as a benefit because of its flexibility to respond to changes in

technology, among other things.862

As an industry regulatory body, RTAC would meet a co-regulation strategy perfectly

as it clearly represents those being regulated and encompasses the expertise in the field to

be able to understand what those being regulated are actually doing. Such a regulatory

strategy could quite easily be inserted into the RIHE Act and PHRC Act. At a state level, RTAC

is already mentioned in Western Australian and South Australian legislation, and these

States, as well as Victoria, will not issue ART clinics with a licence unless they are RTAC

accredited. Creating a co-regulatory system utilising RTAC would provide ‘the advantages of

the predictability and binding nature of legislation with the flexibility of self-regulatory

approaches’. Such an approach would also address the cost recovery issue relating to the

current NHMRC Licensing Committee noting that RTAC does in fact collect fees from the ART

Units it governs.

This again is most relevant to the context of research

involving human embryos and cloning—an area of science which is constantly changing.

862 Ibid.

2. Making it Possible

It is suggested that if RTAC were to ‘take over’ the licensing and oversight functions

carried out by the NHMRC, for the purposes of regulating licensed research involving human

embryos and cloning (for research purposes), their current committee would need to be

expanded. This would serve the purpose of assuaging public concern regarding utilising a

self-regulatory body, but more importantly because for the purposes of licensing and

oversight of this technology there is consensus that there is a need to utilise other expertise

(for example an ethicist). The Committee could therefore be structured as the NHMRC

Licensing Committee currently is, to include:

• a member of AHEC;

• a person with expertise in research ethics;

• a person with expertise in a relevant area of research;

• a person with expertise in assisted reproductive technology;

• a person with expertise in a relevant area of law;

• a person with expertise in consumer health issues relating to disability and

disease;

• a person with expertise in consumer issues relating to assisted reproductive

technology;

• a person with expertise in the regulation of assisted reproductive technology;

• a person with expertise in embryology.

Some of these requirements will already be fulfilled by the current professional and

layperson membership of the RTAC Committee, whilst other positions would have to be

appointed accordingly.


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In adding members to the RTAC Committee further investigation into restructuring is

needed. This would include consideration of whether the RTAC Committee would remain a

voluntary one or whether there would be costs involved (such as payment of members). If

there were costs involved, it would also require analysis of whether such costs could be

included in RTACs cost-recovery system or whether it would need to be funded from

elsewhere. In any case, given the current structure and functioning of RTAC it is unlikely that

it would be more costly than the NHMRC Licensing Committee.

3. Suggested Operation

In implementing RTAC licensing and oversight functions, Australia might be guided

by the United Kingdom indication that they will move toward a system of self-report, except

in cases where there appears to be real concern about risk of non-compliance. This would

work in Australia, as the system currently relies on inspection of files held by researchers – a

de-facto form of self-regulation in that it relies on researchers to keep accurate records and

report honestly. It again is suggested that such a system would incorporate Parker’s meta-

regulatory style (see discussion and Figure 5 above that depicts her ‘triple loop evaluation of

self-regulation’).863 This model not only requires internal monitoring and evaluation of

compliance, effects and outcomes, but reporting to regulatory authorities which allows

them to evaluate and revise the licensee’s operations, and assess whether the substantive

objectives of regulation are being met.864

863 Parker, above n289, 278. 864 Ibid, 245.

RTAC’s role therefore would be to monitor

compliance and evaluate and revise licensee’s operations where necessary.

RTAC could also play a role in addressing the bureaucratic redundancy of particular

procedures concerning licence variations about which researchers and practitioners have

expressed dissatisfaction. As illustrated again by one licensee interviewed in the fieldwork

stated:

I hope something that hopefully will come up in the next review is really looking at easier or more efficient ways of implementing the system. For example, if I have a licence to do something and then whilst I’m doing that research I realise I need to vary the licence, I have to go through the whole process again. This can take months. The licensing system should have a way making it easier to apply for variations. [P13]

The model suggested emphasises cooperation where there is compliance. Given the

expertise that RTAC would bring to the process, there most certainly would be room for

developing a different way to address the variation process. Also, given again that licence

holders have proven to be completely compliant with the current regulatory system, there

is clearly an opportunity to address this issue.

In utilising RTAC however, problems with the current functioning of the body must

also be recognised and addressed so that better regulation is in fact the result of the

proposed model. For example, access to good legal advice concerning interpretation and

functioning of the Acts is imperative when directing licensees, licence applicants and the

general public about what is or is not permissible (this is also the case for the NHMRC

Licensing Committee). This is noted as the current 2008 RTAC Code of Practice and RTAC

Scheme documents misstate the law in relation to permissible uses of human embryos and

the need for RTAC licensing.865

865 See Fertility Society of Australia and Reproductive Technology Accreditation Committee, The Code of Practice for Assisted Reproductive Technology Units, above n248, 4; Fertility Society of Australia, Reproductive Technology Accreditation Committee Certification Scheme (RTAC Scheme), above n250, [5.4]. Each cites the Prohibition of Human Cloning for Reproduction and the Regulation of Research involving human embryos Amendment Act 2006 rather than the governing legislation; each incorrectly quotes the law; each states that ‘...it is currently an offence in Australian Commonwealth law to use human embryos in any way without RTAC licensing.’ This statement is incorrect. The Commonwealth law does not mandate RTAC licensing. The RIHE Act and PHRC Act allow research on human embryos in certain circumstances pursuant to NHMRC licensing.

Membership on the committee of someone with legal


Page 307

expertise may go some way to address this. Whether or not RTAC is equipped to facilitate

the reporting system in place; and what enforcement powers RTAC might be able to

exercise also need to be addressed. The latter is particularly important in ensuring that the

role of RTAC does not leave the regulatory system lacking in the capacity for ‘punishment’ in

the event that there was wrongdoing and would need to take into account how ‘responsive’

regulation might be implemented. It is suggested that some of these problems would be

addressed by utilising the NHMRC in a different capacity to that which it serves now.

4. The NHMRC’s Role in this Model

Whilst it is suggested that RTAC take over the licensing, monitoring and oversight

role currently conducted by the NHMRC Licensing Committee, the NHMRC would still play

an important role in the overall regulation of research involving human embryos and cloning

in Australia. For example, RTAC might work with the NHMRC in achieving compliance and/or

where there are issues of non-compliance. The two bodies could work in conjunction to

achieve cooperative compliance by delivering things such as education, seminars and

maintenance of web-site information. The NHMRC could also continue to provide a location

(the NHMRC website) at which reports on licensing, and information about research and

compliance are published, and communication with the public occurs. The NHMRC

‘Information Exchange Visits’ could also form the basis for further educative programs to be

run by RTAC.

The NHMRC could also play a role in delivering enforcement strategies that a self-

regulatory body might not be able to deliver. For example if there was non-compliance, it

might be RTAC’s initial function to issue warning letters, vary licenses and/or to place tighter

control on a research institute’s performance. However, if non-compliance continued,

RTAC’s role might be limited and the NHMRC role increased for issuing directions to comply

with the relevant legislation. This moves into the ‘command and control with discretionary

enforcement approaches’ level of the pyramid as depicted in Figure 2 above, and Figure 7

below. If non-compliance persisted, then further penalties such as loss of licence,

injunctions and/or criminal sanctions might be pursued either giving the NHMRC power to

implement these enforcement strategies – by way of an enforcement officer – or by direct

notification to the relevant authorities and prosecution in the Courts. This reflects moving

up the pyramid again to the tip, where a command and control regulatory design is again

maintained but non-discretionary enforcement approaches employed. Looking at the

United Kingdom as a model for enabling this would be prudent.

Whilst the focus above has been on utilising RTAC to create co-regulation at the very

bottom of the pyramid, it is also important to improve the responsiveness of the whole

system, including by adding middle layers to the pyramid as they have done in the United

Kingdom and doing other sorts of things they have done in the United Kingdom to improve

regulation. It is not here being suggested that Australia try to mirror the exact system in the

United Kingdom due to the differences stated above. However, Australia could benefit from

considering such things as the provisions in the HFE Act which provide that the HFEA ‘carry

out its functions effectively, efficiently and economically’866 and mandate that the HFEA

must, so far as relevant, have regard to the principles of best regulatory practice.867

866 Human Fertilisation and Embryology Act 1990 (UK), s8ZA(1). 867 Human Fertilisation and Embryology Act 1990 (UK)., s8ZA(2).

In

addressing the how to regulate question in Australia, consideration should also be given to

the United Kingdom’s Regulators Compliance Code and the Regulatory Enforcement and

Sanctions Act 2008 (UK)) and how they came about. As stated above, these are relevant to

the enforcement approaches and powers of the regulatory authority. They provide a


Page 309

framework of administrative sanctions that will allow regulators to tackle non-compliance in

ways that are transparent, flexible, and proportionate to the offence,868 and place a duty on

specified regulators to review the burdens they impose, reduce any that are unnecessary

and unjustifiable and report on their progress annually. The recognition by the HFEA that

‘the current set of enforcement options available to them is limited to informal actions,

direct action in respect of a licence or referral to the police,’869 and that ‘while these

strategies should continue to be exercised where appropriate it would be beneficial ...to

have more flexible powers to be able to exercise enforcement proportionately’870

The idea is to allow for the regulatory bodies to be responsive to the conduct of

those they seek to regulate in deciding whether a more or less interventionist response is

needed.

may

equally apply to the NHMRC. Giving the NHMRC the powers of discretionary requirements,

stop notices and enforcement undertakings, again for example by way of having an

enforcement officer, should therefore also be considered.

871

868 Noting that Parts 1 and 2 of the RES Act relate to local authorities and do not concern HFEA, Part 3 gives regulators listed in Schedule 5 to the Act (including the HFEA) an ‘extended tool kit of alternative civil sanctions as a more proportionate and flexible response to cases of regulatory non-compliance normally dealt with in the criminal courts.’ 869 Ibid, 12. 870 Ibid, 12. 871 Ibid.

The focus should not be predominantly on enforcement or non-compliance

particularly as there has not been any wrongdoing in Australia, thus the argument to allow

RTAC to function at the broadest, lower level of the pyramid. We need to recognise the

licensed researchers and practitioners undertaking research involving human embryos and

cloning (for research purposes) are ‘good apples’, and focus upon implementing increased

cooperative, persuasive and educative approaches. There is much potential in reviewing the

NHMRC Licensing system to incorporate co-regulatory strategies using a body like RTAC and

to be ‘increasingly responsive to how [researchers and practitioners] are regulating

themselves before deciding whether to escalate intervention’.872

B. Model 2: Modifying the NHMRC Licensing System

Finally it is noted that

within this model, the NHMRC could continue to play a role where there is risk associated

with research or practice that is contrary to the legislation and occurring outside of the

institutes that carry licences. In such instances it may be the NHMRC that arranges

inspections and/or prosecution where required.

In considering options for addressing issues related to the type of regulatory system

in place in Australia and the enforcement approaches used, it would be remiss to ignore the

possibility that the above suggested model may not be accepted by the community or by

law-makers. As such, as a secondary alternative, it may be possible for Australia to follow

the United Kingdom approach a little more closely and maintain the NHMRC Licensing

Committee in a significantly modified form. This is not the preferred model due to all of the

arguments presented in this thesis that relate to better regulatory practice. However, given

the potential of this model as an alternative, it is necessary to address how the current

regulatory system can move toward incorporating responsive regulation when regulating

licence holders within the NHMRC licensing regime.

Under this model the NHMRC Licensing Committee’s functions, operation and

enforcement approaches still need to be reviewed, costs and bureaucracy reduced, and the

sharing of responsibilities between public and private partners enabled. Like the United

Kingdom, ‘low risk’ (in terms of compliance) institutes may for example, undertake a self-

report/assessment regime in relation to their compliance with licence conditions, which

would reduce the need for frequent inspections. As suggested for the United Kingdom

872 Braithwaite, Restorative Justice and Responsive Regulation, above n8, 29.


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HFEA, in developing the details of such self-report/assessment, the NHMRC Licensing

Committee could cooperate with those subject to the regulation in the process of creating

the new rules.873 This would enable moving away from the apparent view that the NHMRC

Licensing Committee is in the best position to decide upon rules and regulations, what is

needed is recognition that the legislature has set the essential legal framework, but there is

room for the stakeholders or parties concerned to fill in the details. The NHMRC Licensing

Committee’s role should be to monitor the outcome, but only intervene where necessary.

Again, this is a mode of ‘meta-regulation’ in which the ‘role of legal and regulatory

strategies is to add the “triple loop” that forces [regulatees] to evaluate and report on their

own self-regulation strategies so that regulatory agencies can determine that the ultimate

substantive objectives of regulation are being met’.874

All other suggestions made above in relation to Model 1 regarding the NHMRC

Licensing Committee would equally apply under this model. That is, regard should be had to

the provisions in the HFE Act, the United Kingdom’s Regulators Compliance Code and the

Regulatory Enforcement and Sanctions Act 2008 (UK)) and the provision for a framework of

administrative sanctions that will allow regulators to tackle non-compliance in ways that are

transparent, flexible, and proportionate to the offence,

875

873 Senden, above n265. 874 Parker, above n289, 245. 875 Noting that Parts 1 and 2 of the RES Act relate to local authorities and do not concern HFEA, Part 3 gives regulators listed in Schedule 5 to the Act (including the HFEA) an ‘extended tool kit of alternative civil sanctions as a more proportionate and flexible response to cases of regulatory non-compliance normally dealt with in the criminal courts.’

and place a duty on specified

regulators to review the burdens they impose, reduce any that are unnecessary and

unjustifiable and report on their progress annually. Again, recognising that the current set of

enforcement options available to the NHMRC Licensing Committee is limited to informal

actions, direct action in respect of a licence or referral to the police is proposed that it

would be beneficial to have more flexible powers to be able to exercise enforcement

proportionately. Under this model, giving the NHMRC Licensing Committee the powers of

discretionary requirements, stop notices and enforcement undertakings should therefore

again be considered.

Similar to Model 1, the idea is to allow for regulatory bodies to be responsive to the

conduct of those they seek to regulate in deciding whether a more or less interventionist

response is needed.876

The reason why this model is less preferred is firstly the issue of costs and secondly

the way in which this model still emphasises authority over those within the field being

capable and competent of being compliant to legislative provisions and engaging in

responsible research practice. On the issue of costs, giving further regulatory powers to the

NHMRC Licensing Committee may result in increasing the costs of the regulatory system

rather than addressing issues of better regulation and the need to decrease regulatory

burdens. Whilst incorporating RTAC into the regulatory regime may provide for at least

some cost recovery, modifying and utilising the NHMRC Licensing Committee alone does not

provide the same opportunity. On the second issue, there is a need to recognise the

researchers and practitioners undertaking research involving human embryos and cloning

(for research purposes) are ‘good apples’, and focus upon implementing increased

cooperative, persuasive and educative approaches. In any case, there is much to be said for

revising the current regulatory system’s application to licensed researchers.

The focus should not be predominantly on enforcement or non-

compliance as there has not been any wrongdoing in Australia. The difference with Model 1

is that rather than allowing RTAC to function at the broadest, lower level of the pyramid, the

NHMRC Licensing Committee would be responsible for these functions too.

876 Ibid.


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C. The Models and ‘Responsive Regulation’

Figure 7 depicts the proposed model of regulation for Australia:

Figure 7: Proposed Model for Australia

NON-

COM

PLIA

NT

Com

man

d an

d Co

ntro

l

High

Courts; Govt Authorities (eg Police); NHMRC

Medium

Courts; Govt Authorities (eg Police); NHMRC

Low

NHMRC/RTAC

COMPLIANT

Co-regulation

Researchers; License holders;

Community; RTAC

[Model 2: NHMRC]

* Note all other self-regulatory mechanisms (for example requirements for human research ethics approval) still exist beneath this level of regulation.

Responsive regulation emphasises discretion about which enforcement strategy to use. In relation to licensed research activity, most regulation will occur at the bottom of the pyramid with increased enforcement strategies being used dependant on frequency and severity of non-compliance (and whether lower level compliance strategies are being ignored). Compliance at any stage would lead to return to the bottom of the pyramid. In instances where non-licence holders commit an offence, or where there is severe non-compliance by licence holders, immediate use of higher level sanctions would be warranted.

Criminal Prosecution

Increased use of enforcement techniques: injunctions; licence revocation.

Increased direction: Warning letters; written notices; variation to license; increased monitoring/auditing; cost recovery for increase in compliance strategies

Co-operative compliance strategies: Education, routine monitoring, licensing, self-report on compliance, web-site, information dissemination, communication and dialogue b/w regulators, regulatees and community, feedback from researchers/practitioners; flexibility.

Legi

slativ

e Fr

amew

ork

Add to current system

Add to current system

Figure 7 depicts the proposed model of regulation made in this thesis and applicable

whether Model 1 or Model 2 is adopted, noting that if Model 2 were adopted one would

simply remove reference to RTAC. What the above pyramid adds to the current regulatory

system is a defined bottom level which, as shown in Chapter Four and Figure 3, is lacking in

the current regulatory design strategy and enforcement approaches.

As with the original United Kingdom system, the current Australian regime may be

depicted by a pyramid in which the licensing and oversight at the bottom of the pyramid is a

way of ‘policing’ research activities whilst severe penalties (including imprisonment) for

breaching the Act are at the top. As shown in Chapter Four, responsive and educative

approaches are largely missing or represented only to a small degree at the base within the

listed activities. The proposed model(s) instead recognise the different levels of

compliance/non-compliance with which a responsive regulatory system might deal. It adds

the co-regulatory base levels of the pyramid in which licensed researchers and practitioners

who will comply in any event [self-regulation] may be governed within the legislative

framework using cooperative approaches, as discussed for example in relation to self-report

on licences. The second level of the pyramid allows for governance of researchers and

practitioners who have engaged in ‘low-level’ non-compliance by including the ability for

regulators to choose to use appropriate persuasion/educative strategies and therefore

adding to the current system a range of further enforcement options. The top levels of the

pyramid continue to provide strategies for dealing with egregious non-compliers, including

those who are conducting research without an appropriate licence or licence holders who

engage in serious offences, by maintaining strict prohibitions and the ability to pursue heavy

sections and/or criminal penalties for such behaviour.

The entire pyramid reflects the ability to utilise both punishment and persuasion.

The focus should not unnecessarily be on the risk of wrongdoing, but rather it should be on

the fact that instances of wrongdoing will be the exception rather than the rule. That is why

the bottom of the pyramid is broad and the tip narrow. It represents that most researchers

and practitioner will operate at the base of the regulatory system and are not in need of

punitive or deterrent enforcement approaches. It is again noted that of all the inspections

conducted by the NHMRC Licensing Committee to date, there has never been a finding of

non-compliance.


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Ultimately, it is recognised that such a move would require that particular details be

the subject of further inquiry and development to ensure all regulatory requirements and

concerns relating to the regulation of research involving human embryos and cloning are

satisfactorily addressed. However, the model is based upon Ayres’ and Braithwaite’s 1992

formulation of ‘responsive regulation’ in which it was argued that responsive regulation was

concerned not only with how regulators should enforce pre-existing regulatory rules, but

also with promoting policies of enforced self-regulation or co-regulation.877

It is clear from the above discussion that Australia needs to reduce the regulatory

burden placed upon compliant license holders and address the issue of how to reduce the

costs of the regulatory system. It is also apparent that there is room to act in a more

transparent way – for example by making the actual costs of the licensing system publicly

available. Either of the models would allow for this. The most important point in choosing

between options for regulation is that ‘...regulatory agencies that do the best at achieving

their goals are those that strike some sort of balance between [deterrence and cooperative]

models’ of regulation.

A system that

utilises industry knowledge, expertise, and treats those regulated with respect whilst also

setting clear legislative boundaries, undoubtedly results in a better regulatory regime, as has

been argued here. Creating a co-regulatory system utilising 1) RTAC (in a modified form) in

conjunction with a greatly modified NHMRC Licensing system or 2) a comprehensively

revised NHMRC Licensing System alone, would provide ‘the advantages of the predictability

and binding nature of legislation with the flexibility of self-regulatory approaches’ and

achieve ‘responsive regulation’.

878

877 Ayres and Braithwaite, above n8, 101-132. 878 Ayres and Braithwaite, above n8, 21.

The combination between punishment and persuasive techniques

is most suited to the context of research involving human embryos and cloning because it

still recognises the boundaries set when answering questions about what to regulate and

where to draw the line between permissible and prohibited activities, but also answers the

how to regulate question more efficiently than the current regulatory regimes.

XI. CONCLUSION

Based on the discussion of the regulatory systems in the United Kingdom and

Australia, in conjunction with consideration of the views put forward by researchers and

practitioners during the fieldwork reported in Chapter Five and the conclusions drawn in

Chapter Six, this chapter has argued that both jurisdictions need to move toward systems

that include co-regulatory strategies.

Such a move towards a ‘responsive regulatory regime’ which encompasses

predominantly cooperative, persuasive and educative approaches and better regulation

principles is being made successfully in the United Kingdom and satisfactorily includes their

choice to maintain the existence of the HFEA. The argument presented in this chapter was

that whilst maintaining the HFEA as the oversight body, in moving forward the United

Kingdom should be mindful of introducing a co-regulatory strategy at the very base of the

regulatory pyramid which would enable those governed by the regulatory system to work

together with the HFEA in a manner that mutually reinforces one another. Whilst some

possible suggestions for working together were put forward, it is concluded that further

consultation is needed in the United Kingdom to determine how the researchers and

practitioners could participate in regulation and achieve the best regulatory model.

In contrast with the United Kingdom move toward a more responsive regulatory

system, it is here concluded that Australia is ‘two steps behind’ in a regulatory sense, and is


Page 317

not achieving similar goals. In fact, having only recently implemented its regulatory system,

it was seen that Australia has not adequately questioned the structure it has chosen. Such

questioning is however needed given that in six years we have seen what appears to be a

very expensive system given the small scale of operations. In addition, it must be recognised

that the NHMRC Licensing Committee does not operate in the same way as the HFEA, and

will never have the breadth of regulatory responsibilities carried by them due to the

differing legal structure in Australia and state regulation of ART. It is therefore argued that

the regulatory design strategy and enforcement approaches utilised by the NHMRC

Licensing Committee and inspectorate need to be revised. One suggested option (the

preferred Model 1) for this would be to utilise an already established and well respected

self-regulatory body (that is, RTAC) for the licensing, monitoring and inspection functions

required under the RIHE and PHRC Acts and retain the NHMRC Licensing Committee for

assistance with reporting and educative functions, and possibly for higher level enforcement

functions. The second (less preferred) suggested model would be to retain the NHMRC

Licensing System but extensively modify it in a similar way to the changes that have been

made and are recommended here regarding the United Kingdom regulatory system and

HFEA. In either case, creating a co-regulatory system which maintains the RIHE and PHRC

Acts whilst utilising RTAC and/or an extensively revised NHMRC Licensing Committee would

provide ‘the advantages of the predictability and binding nature of legislation with the

flexibility of self-regulatory approaches’. It would certainly address many of the issues raised

in this paper about choosing better regulatory design strategies, taking a tempered

approach to regulation, and moving away from unnecessary emphasis on deterrence.

Chapter Eight:

CONCLUSION

I. INTRODUCTION

This chapter concludes with a summary of arguments and research findings. It discusses

the consequences of choosing better regulatory strategies and enforcement approaches in

the context of research involving human embryos and cloning. The conclusion also explores

the implications that the research findings and arguments put forward in this thesis have for

theory, policy and practice when regulating emerging technologies. Limitations of the study

are discussed and suggestions for further research made.

II. SUMMARY OF ARGUMENTS AND RESEARCH FINDINGS

This thesis recognises the need to address debate regarding whether regulation of

research involving human embryos and cloning is necessary, and if so, what form it should

take. It is therefore concerned with the questions of what to regulate, where to draw the

line between permissible and prohibited research activity, and how to regulate in this

context. The thesis focuses upon the United Kingdom and Australia as they can valuably be

compared in relation to how each jurisdiction has answered such questions, and contrasted

as a result of the recent United Kingdom move towards adopting better regulation

strategies and enforcement approaches that Australia is yet to make.

Chapter Eight: Conclusion

Page 319

The discussion presented in the previous chapters supports the argument that in

relation to research involving human embryos and cloning some regulation is necessary.

Chapter Two introduces rationales for regulation, and shows that the issues

surrounding research involving human embryos and cloning are not new. They are steeped

in a history of philosophical, religious and scientific thought and debate about the beginning

of life and the moral status of the embryo all of which have led to various modes of

regulation (informal and formal, broad and narrow). We need to be aware of, and recognise

such debate and the diversity of views held in relation to the status of the human embryo

and when life begins when making any regulatory decisions concerning research involving

human embryos and cloning. The long history of debate, inability to resolve ongoing

disagreement about the moral status of the human embryo, and general consensus that an

embryo is to be treated differently to other human tissue, results in a strong ethical and

moral rationale for regulating such research. Similarly, the call to recognise perceived risks,

engage in dialogue with the community about such risks, and to regulate in areas of risk

where the consequences of such risk eventuating might be severe, reflect important

rationales for regulation. However other rationales that encourage the production of public

goods demand that regulation balances the recognition of potential hazards with the

potential benefits such research can bring.

By analysing the way in which both the United Kingdom and Australia implemented

legislation after extensive public consultation, inquiries and subsequent reports,

parliamentary debates, and review Chapter Four shows that despite the difficulty of doing it

well, both jurisdictions have in fact managed to balance sensitivity to the moral and ethical

issues with the other rationales for regulation in deciding what to regulate and where to

draw the line between permissible and prohibited research. The legislative boundaries

drawn in each jurisdiction reflect societal attitudes about research involving human

embryos and cloning.

The decisions made in relation to what to regulate and where to draw the line

between permissible and prohibited activities will be subject to ongoing review as

technology and/or attitudes towards research involving human embryos and cloning

change. Apart from the need to address issues concerning the current review system in

Australia, which leads to an excessive time delay in seeing changes to the legislation, the

process of deciding upon what to regulate and where to draw the line has been

comprehensive and commendable.

The thesis argues however, that neither jurisdiction has adopted the best mode of

regulation despite both having excellent approaches to what to regulate and where to draw

the line. The United Kingdom has only recently considered and addressed regulatory design

strategies and enforcement approaches (i.e. how to regulate) and is in the process of

implementing change. There is still scope to include positive co-regulatory strategies and

cooperative enforcement approaches when putting into place the new system. The issue

has not been considered adequately in Australia. The central thesis presented in this paper

therefore is that both the United Kingdom and Australia should look closely at the model of

regulation they have adopted and incorporate a responsive regulatory regime.

In answering the how to regulate question and making suggestions for improving the

regulatory system, we need to be mindful of the underlying rationales set out in Chapter

Two. It is necessary to consider whether any proposed regulatory system is adequate to

meet the ethical and moral concerns that animated the regulatory system in the first place,

but also to adequately address the other rationales discussed. Informing the public about

research practices, encouraging the production of public goods (for example treatments for


Page 321

disease), balancing the potential hazards of the research against the production of public

goods, and ensuring the regulatory system reflects social policy principles of distributive

justice which emphasise broad societal views rather than individual preferences, are all

factors that underpin and help to decide upon how to regulate well.

In addition, understanding regulatory theory, including theories of punishment,

regulatory design strategies and approaches to enforcement is crucial to evaluating the

current regulatory systems in the United Kingdom and Australia, and deciding upon the

ideal mode of regulation. The rationales set out in Chapter Two and the review in Chapter

Three of modern regulatory theory therefore provide the basis for sound assessment of the

respective regimes in Chapter Four, Five and Six, and a foundation to the proposed

suggestions for improvement to the respective regulatory systems in Chapter Seven.

In addition to considering how the United Kingdom and Australia have answered

questions concerning what to regulate and where to draw the line, Chapter Four also draws

upon Chapters Two and Three when analysing the type of regulatory systems chosen in the

United Kingdom and Australia. It is argued that both jurisdictions have adopted a ‘command

and control’ design strategy that emphasises deterrence as a primary enforcement

approach. This is contrasted with Ayres and Braithwaite’s theory that better regulation

involves striking a balance between deterrence and cooperative approaches to

regulation.879


Chapter Four illustrates that such a balance has not been achieved in either

jurisdiction, but recognises that recent legislative changes and a wider governmental push

for better regulation in the United Kingdom has been the impetus for a move towards a

better regulatory model in that jurisdiction. Ultimately Chapter Four indicates that both

jurisdictions need to address the lack of co-regulatory strategies and to increase cooperative

approaches to regulation in order to achieve better regulation.

However, the thesis argues that one cannot form such conclusions or make

proposals for the better regulation, without exploring how regulatees perceive the

regulatory systems they are subject to. Discussing the values and ethics of scientists and in

the wider community towards scientists and science, why people fear scientists, the

perceived risks associated with science, and the call for regulation, are also fundamental to

evaluating the sort of regulatory design strategies and enforcement approaches that should

be adopted. This was the purpose of the fieldwork which is reported in Chapter Five, and

discussion and analysis presented in Chapter Six.

Based upon the results of the fieldwork, and a broader analysis in Chapter Six of

literature on the values and ethics of scientists and in the wider community towards

scientists and science, the thesis argues that researchers and practitioners generally share

and reflect the same ethics and values as those shown in the wider communities in which

they live. However, the fact that in certain situations ‘good’ people can do (and have done)

‘bad’ things and that there are perceived risks associated with research involving human

embryos and cloning leads to the argument that some Government oversight and regulation

is warranted. It was shown however that such regulation should not be based on

unwarranted fear of ‘mad’ or ‘evil’ scientists or the public call for regulation alone. Whilst

ongoing risk analysis is needed, and some regulation is necessary, regulatory spirals and

over-regulation should be avoided. The best way to do this is to encourage increased

dialogue and direct participation in regulation of licensed research activities between

regulators, regulatees and the community. This would enable everyone to discuss risk

perceptions, avoid stereotyping, and avoid institutional insularity, or pressures that have the


Page 323

potential to lead to an environment where wrongdoing might occur, whilst fostering trust

and co-operation with those regulated. The conclusion drawn from the results of the

fieldwork and the discussion in Chapter Six, again support the argument that neither

jurisdiction has adopted the best regulatory strategies or enforcement approaches, and that

introducing responsive regulation is warranted.

Having evaluated the regulatory systems and arguments concerning the better modes

of regulation design strategies and enforcement approaches in Chapters Four to Six, Chapter

Seven considers the regulatory inadequacies in the United Kingdom’s and Australia’s

regulatory systems, and proposes models for change. The most important thing about the

proposed models is that they recognise the different levels of compliance/non-compliance

with which a responsive regulatory system might deal and then make suggestions for how to

improve or add to the regulatory structures currently in place in each jurisdiction. The models

vary from each other in the sense that the United Kingdom is already moving towards better

regulation, and is in the process of implementing greater responsive regulatory approaches

whilst maintaining the HFEA. This thesis argues that further co-regulatory strategies should

be adopted in that jurisdiction to achieve better regulation. The model suggested for

Australia also emphasises co-regulation at the base of the regulatory pyramid, and an

increase in cooperative, educative and persuasive enforcement approaches. However, it

suggests utilising a self-regulatory body as first preference for conducting licensing and

oversight functions because of identified differences in each jurisdiction. In the alternative, a

second model is also suggested for Australia in which the current NHMRC Licensing

Committee’s functions and operation be significantly reviewed but again, the principles of

responsive regulation, co-regulatory design strategies and cooperative, educative and

persuasive enforcement approaches, are included.

Ultimately, it is proposed that the top level ‘command and control’ design strategies

and deterrence approaches present in the United Kingdom and Australia current regulatory

systems be maintained for breaches of legislation by non-licence holders and serious

breaches by licence holders. However, a level of co-regulatory strategies should be

introduced in both jurisdictions and cooperative, educative and persuasive enforcement

approaches increased, when regulating licensed research involving human embryos and

cloning. Such a regulatory approach would enable continued government oversight and

appropriate boundary setting by encouraging dialogue between regulators, regulatees and

the public, whilst recognising that better regulation is responsive to, and respected by, those

regulated. It would also enable increased participation of regulatees in their own regulation.

This thesis does not argue that review of the mode of regulation and enforcement

approaches should lead to the removal of strict prohibitions for things that are deemed

unacceptable, but rather that in regulating permissible research a more cooperative,

responsive approach be taken and that regulatory bureaucracy be reduced.

III. IMPLICATIONS FOR THEORY, POLICY AND PRACTICE IN RELATION TO

REGULATING EMERGING TECHNOLOGIES

Modern biotechnology has given rise to a plethora of regulatory challenges. Such

challenges have been discussed above in relation to the rationales for regulating research

involving human embryos and cloning, the gap between regulation and technological

expertise, the rapidity with which technology can (and does) change, regulatory problems of

keeping pace with such change, and the need to choose a regulatory model that is flexible,

transparent, respected by those being regulated, responsive and cost effective.


Page 325

Choosing better regulatory strategies in the context of research involving human

embryos and cloning therefore has significant implications for theory, policy and practice for

regulating emerging technologies. Whilst the suggested regulatory model might not suit all

emerging technologies – and in fact has been shown here to require different form in

different jurisdictions – there are some relevant ‘take home messages’ for those wishing to

design or implement regulation in areas of science that face similar ethical, moral and risk

dilemmas.

One important implication of this study is that although much of the research on

responsive regulation has been done in the context of business compliance,880

A level of regulation that implements a co-regulatory design strategy and increased

cooperative, educative and persuasive enforcement approaches is suggested to ensure that

insularity or internal pressures do not lead to wrongdoing, and to enable external

the resultant

theories translate well to the context of regulating science in the contexts of hospitals,

research institutes and universities. In relation to research involving human embryos and

cloning, this thesis has shown that ‘responsive regulation’ is in fact the best mode of

regulation.

The starting point for making policy decisions about when and how to regulate in the

context of science should be the recognition that researchers and practitioners generally

reflect the values of the broader society in which they live, possess special expertise and

understanding of their field that many regulators might not possess, and are therefore

deserving of trust and input into the regulatory system that regulates them. This contrasts

with previous policy positions which have taken an authoritative, deterrent approach and

emphasised punishment rather than persuasion.

880 Braithwaite, Restorative Justice and Responsive Regulation, above n8; Parker, above n289.

government rule setting (via legislation and/or regulations) and some degree of oversight.

Nonetheless, such regulation should be proportionate to the risks involved in such research

and again draw on researchers’ and practitioner’s willingness to comply. As a matter of

policy, increased intervention should only occur if and when non-compliance is apparent.

IV. LIMITATIONS

A. Fieldwork – Limitations Regarding Sample Size and Self-Report

This study was limited by the small sample size of researchers and practitioners

interviewed. This was unavoidable given the specialised field that was being considered –

there are few researchers and practitioners that work in the area of research involving

human embryos and cloning. Specific researchers and practitioners were targeted for their

expertise and experience in the field, and as such the insight they could provide in relation

to whether and how the regulatory systems might affect them.

Another limitation of the interviews is that the resultant data is of course self-

reported as discussed in Chapters Five and Six. This means that they might not reveal a

person’s true intentions or behaviour but rather how they would like to be perceived.

These potential limitations were addressed by looking to published researched

materials from the fields of psychology, sociology and the law to give a broader perspective

to issues raised by the fieldwork (and the question of how to regulate research involving

human embryos and cloning). Conclusions and recommendations made in this paper were

therefore not solely (or even mainly) based on the self-report of researchers and

practitioners, but rather a combination of methods and materials.


Page 327

B. Difficulties in Obtaining Information from NHMRC and RTAC

The researcher experienced some difficulty in obtaining responses from members of

the NHMRC and RTAC when making enquiries about the NHMRC’s view on licensing (in

relation to the disparate legal situation in Western Australia to the Commonwealth

legislation), and; RTAC’s views on whether they would be positioned to function as is

recommended in this thesis.

The author sent two emails to the member of the NHMRC Licensing Committee with

legal expertise in early August 2008 enquiring about the NHMRC Licensing Committee’s

position regarding the conflict between Western Australian and Commonwealth legislation,

and seeking an indication of whether the NHMRC would/could grant a license under the

RIHE Act to a corporation, but not to an individual for SCNT which remains prohibited under

the state Act. These emails were not answered. After a follow up email on 21 August,881 the

member replied suggesting that the author ‘obtain a formal comment from the Secretariat’

and that the author should then follow up with him ‘to gain his personal view’.882 To date

(April 2009), the author has not received a response from that member concerning the

follow-up query made on 28 August 2008 in relation to the licensing issue and the NHMRC’s

‘wait and see’ position.883

A response from RTAC to a query sent to them on 1 December 2008 regarding a

misstatement of law in their Code of Practice and the RTAC Scheme document, and asking

them whether they would be in a position to take over the licensing and oversight functions

In this instance however, it is noted that an ‘official view’ was

received from the NHMRC Director of Licensing despite the actual member’s lack of

response.

881 Email from Sonia Allan to Professor Donald Chalmers, 21 August 2008. 882 Email to Sonia Allan from Professor Donald Chalmers, 25 August 2008. 883 Email from Sonia Allan to Professor Donald Chalmers, 28 August 2008.

as recommended in this thesis was also difficult to obtain.884 On following up the initial

enquiry, the author was told by the RTAC secretariat that given that ‘the Board is a

voluntary one who all have busy full time jobs’885 that she should expect a belated response

in mid-January 2009. A response in mid-January was not forthcoming. After a number of

further emails and phone calls which were not responded to by the secretary,886 the author

emailed the President of the Fertility Society of Australia,887 Professor Peter Illingworth,

who contacted the author by phone on 17 February 2009.888

V. FURTHER RESEARCH

He was most gracious,

apologetic and forthcoming at that time, stating that the issues raised by the author would

be addressed by the Committee at their next meeting in mid-March. He indicated

preliminary approval of the recommendations made in this thesis.

Whilst the recommendations made in this paper do not rely on such specific

responses, knowing the NHMRC and RTAC positions would have shed more light on the

practicalities of such recommendations. It may also indicate that neither body is in fact

presently functioning in a way that truly serves to inform members of the public. Further

research on these issues would be valuable.

Further research with regards to how both NHMRC Licensing Committee and RTAC

function is suggested above. A move to implement the proposed models in this thesis would

require that particular details be the subject of further inquiry and development to ensure

884 Email from Sonia Allan to Kim O’Dea (Secretariat), 1 December 2008; Email from Sonia Allan to Kim O’Dea, 17 December 2008; Email from Sonia Allan to Kim O’Dea, 28 January 2009. 885 Email from Kim O’Dea to Sonia Allan, 17 December 2008. 886 Email from Sonia Allan to Kim O’Dea, 28 January 2009; phone call from Sonia Allan to Kim O’Dea, 6 February 2009; phone call from Sonia Allan to Kim O’Dea, 16 February 2009; email from Sonia Allan to Kim O’Dea 16 February 2009. 887 Professor Illingworth is also a former member of the NHMRC Licensing Committee. 888 Email from Sonia Allan to Professor Illingworth, 16 February, 2009; Phone call from Peter Illingworth to Sonia Allan, 17 February 2009.


Page 329

all regulatory requirements and concerns relating to the regulation of research involving

human embryos and cloning are satisfactorily addressed. There is scope for further research

in relation to exactly how the recommendations made within this paper might be

implemented including (but not limited to) such things as costs analysis and the

practicalities of instituting such changes.

Public consultation regarding the acceptability of the proposals made in relation to

how to regulate is also imperative. It is possible that the general public only approve the

current balance on what to regulate and where to draw the line between permissible and

prohibited research activities because they realise the current regulation is quite

authoritarian.

Further research may also be undertaken in relation to how the recommendations

made here, in the context of research involving human embryos and cloning, might apply to

other emerging technologies in areas that share similar ethical or moral dilemmas and those

that don’t.

Finally, in returning to the question of what to regulate and where to draw the line

between permissible and prohibited research, ongoing research and continual policy review

is needed. The issue of extensive delay in Australia regarding the time it takes between

legislative review and any changes to legislation also needs further investigation in order to

be addressed. Continual assessment of the risks posed by research involving human

embryos and cloning is necessary in order to only regulate where necessary and to continue

to make informed choices about where to draw the line, and to enable better regulatory

and legislative responses to rapidly changing technology.

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APPENDIX 1

Example of other jurisdictions laws, regulatory structures and polices on research involving human embryos and/or cloning: (** HESC = Human Embryonic Stem Cells; SCNT = Somatic Cell Nuclear Transfer) (*** This list is not comprehensive, but rather serves to provide a brief overview of a sample of other jurisdictions’ laws and regulatory approaches where such information was available)

COUNTRY Prohibits derivation of

HESCs

Prohibits derivation of

stem cells but allows

importation of HESC lines

Allows research involving human

embryos excess to IVF/ART

Prohibits creation of

human embryos for

research including

SCNT

Allows creation of

human embryos for

research including

SCNT

Prohibits human

reproductive cloning

LAW/ REGULATORY STRUCTURE/POLICY/FURTHER INFORMATION

Austria

X

X

X

The Austrian Reproductive Medicine Act (Fortpflanzungsmedizingesetz) 1992 strictly prohibits usage of cells showing developmental potential for any other purpose than assisted reproduction (§9.1); intervention into the germline is also prohibited(§9.2); Trading of cells showing developmental potential, gametes or donors is prohibited (§21.1-3).

Belgium

X

X

X

Betreffende het onderzoek op embryo’s in vitro:Art. 3 Research on embryos in vitro is allowed pursuant to conditions imposed by the law. Such conditions include that:

• the research has a therapeutic purpose or contributes to better knowledge about fertility, infertility, organ and tissue transplantation, prevention or treatment of diseases;

• the research is founded on the most recent scientific findings and conforms to the requirements of correct scientific methodology;

• the research is conducted in a licensed laboratory that is linked to an academic programme for assisted reproduction or human genetics and is performed in appropriate technical and material conditions; …

• the research is conducted under the supervision of a specialist or a qualified


HESCs







human embryos for

research including

SCNT

Allows creation of

human embryos for

research including

SCNT

Prohibits human



person; • the research is performed on embryos during the first 14 days of development,

the period of freezing not included; • There is no other research method that is equally efficient.

Art. 4 § 1. The creation of embryos in vitro for research purposes is prohibited, except if the goal of the research cannot be achieved by research on supernumerary embryos.

Art. 5 Prohibits the following:

• Placing human embryos in animals, creating chimeras or hybrids; • Placing embryos on which research has been conducted in humans, except

when the research had a therapeutic benefit for the embryo itself or when it concerns an observation method that does not harm the embryo’s integrity;

• using embryos, gametes and embryonic stem cells for commercial purposes; • conducting research or treatment for eugenic purposes, i.e. directed at the

selection or enhancement of non-pathological characteristics of the human species;

• conducting research/treatment directed at sex selection, except when selection is performed to prevent sex linked diseases.

Art. 6 Reproductive cloning of humans is prohibited.

Art. 7 § 1. Each research project on embryos in vitro should be brought before the local ethics committee of the academic institute that is involved and before the Federal Commission for medical and scientific research on embryos in vitro. …

Art. 9 § 1. Establishes a Federal Commission for medical and scientific research on embryos in vitro. … Art. 10 § 1. The Federal Commission:

• collects and centralises information on the different projects on embryos in vitro, including those for which the local ethics committee issued a negative


HESCs







human embryos for

research including

SCNT

Allows creation of

human embryos for

research including

SCNT

Prohibits human



advice; • prevents scientifically unjustified research projects involving identical research; • evaluates the application of this law; • issues recommendations for future legislative initiatives or other measures; • issues recommendations regarding the adaptation of the law for the local

ethics committees.

§ 2. The Commission should evaluate all research projects that are submitted to it. § 3. The Commission decides with a two third majority , and reports yearly to the legislative chambers § 4.

Art. 11 Every researcher sends a report on the progress of his/her research to the Commission. This report includes:

• the purpose, methodology and time period of the research; • the manner in which the provisions of the law were respected; • the advice of the local ethics committee • the progress of the research.

Penalty provisions exist in relation to breaches of the Act. For example, Art. 12 provides that persons who do not send the yearly report will be punished with a fine of 50 to 5000 euro; and Art. 13 provides that persons who perform acts prohibited in articles 3, 5°, 4, 5 and 6 of the law will be punished with a prison sentence of one to five years and a fine of 1000 to 10000 euro.

Bulgaria

X

X

HEALTH LAW Effective 1 January 2005, amended SG No. 13/8 February 2008, Art. 134. Oocytes, sperm and fertilized oocytes which have not been used to create offspring may be granted to scientific, educational and medical facilities in the country and abroad for medical, scientific and educational purposes with the donor’s written informed consent, and in the case of fertilized oocytes – with the consent of both donors, following a procedure provided for in a regulation by the Minister of Health-not prepared.


HESCs







human embryos for

research including

SCNT

Allows creation of

human embryos for

research including

SCNT

Prohibits human



Canada

X

X

X

Assisted Human Reproduction Act 2004 (as updated to 18 February 2009)

The three primary objectives of the AHR Act are to:

• prohibit certain unacceptable activities such as human cloning;

• protect the health and safety of Canadians using AHR to build their families, by regulating acceptable practices such as in vitro fertilization (IVF);

• ensure that AHR related research, which may help find treatments for infertility and other diseases, takes place within a controlled environment.

There are certain prohibitions in the Act for activities such as human cloning and payment to egg and sperm donors along with provisions on "controlled activities" such as the manipulation of human reproductive material to create a human embryo. In addition, the Act calls for the establishment of the Assisted Human Reproduction Agency of Canada, to license, inspect and enforce activities controlled under the AHR Act.

China

X

X

X

Ethical Guiding Principles on Human Embryonic Stem Cell Research (2003-460) Authorised translation from http://www.chinaphs.org/bioethics/regulations_&_laws.htm#_Toc113106142 at 14 March 2009: The Ethical Guiding Principles …are formulated for the purpose of bringing human embryonic stem cell research …conducted in the People’s Republic of China to accord with bioethical norms, to ensure internationally recognized bioethical guidelines and domestic related regulations to be respected and complied with, and to promote a healthy development of human embryonic stem cell research. Human embryonic stem cells described in the Guiding Principles include stem cells derived from donated human embryos, those originated from germ cells and those obtained from somatic cell nuclear transfer technology. Any research activity related to human embryonic stem cells conducted in the territory of the People’s Republic of China

http://www.chinaphs.org/bioethics/regulations_&_laws.htm#_Toc113106142�


HESCs







human embryos for

research including

SCNT

Allows creation of

human embryos for

research including

SCNT

Prohibits human



must abide by the Guiding Principle. Any research aiming (sic) at human reproductive cloning [is] prohibited. Human embryonic stem cells used for research purpose can only be derived from: Spare gamete or embryos after in vitro fertilization (IVF); fetal cells from accidental spontaneous or voluntarily selected abortions; embryos obtained by somatic cell nuclear transfer technology or parthenogenetic split embryos; and germ cells voluntarily donated. All research activities related to human embryonic stem cells shall comply with the following: • Embryos obtained from IVF, human somatic cell nuclear transfer, parthenogenesis

or genetic modification techniques, its in vitro culture period shall not exceed 14 days starting from the day when fertilization or nuclear transfer is performed.

• It is prohibited to implant embryos created by the means described above into the genital organ of human beings or any other species.

• It is prohibited to hybridize human germ cells with germ cells of any other species. • It is prohibited to buy or sell human gametes, fertilized eggs, embryos and fetal

tissues. • The principle of informed consent and informed choice must be complied with, the

form of informed consent shall be signed, and subjects’ privacy shall be protected in all research activities related to human embryonic stem cells.

• The informed consent and informed choice mentioned above refers to that the researchers shall use accurate, clear and popular expressions to tell the subjects the expected aim of the experiment as well as the potential consequences and risks and to obtain their consent by signing on a form of informed consent.

Research institutions …shall establish an ethics committee, which consists of research and administrative experts in biology, medicine, law and sociology to provide scientific and ethical review, consultation and supervision of the research activities related to human embryonic stem cells. Research institutions engaged in research related to human embryonic stem cells shall formulate corresponding detailed measures and regulatory rules in compliance with the Guiding Principles. The Ministry of Science & Technology and the Ministry of Health of the People’s Republic of China shall be responsible for the interpretation of the Guiding Principles. …


HESCs







human embryos for

research including

SCNT

Allows creation of

human embryos for

research including

SCNT

Prohibits human



Denmark

X

X

X

Law no 535, Chapter 7 §25 and § 28: Embryo research is allowed in Denmark under certain conditions. That is, to improve In-vitro fertilisation or other techniques; to improve techniques for pre-implantation diagnosis; to achieve new knowledge that can improve the treatment of human diseases. Prohibited practices include cloning; preformation of human beings by fusion of genetically different embryos before transfer; forming transgenetic human individuals; developing a human being in a different species uterus Aspiration and fertilisation of oocytes for other purposes than described in §25 are not allowed. Research according to §25 has to be approved by the scientific committee. §26. It is only allowed to keep embryos in vitro in 14 days after fertilization and therefore embryos used in research must be destroyed within 14 days of fertilisation. §27. Embryos used for research are only allowed for transfer if the embryos are genetically unmodified and the research has not damaged the embryo in its development.

France

X

X

X

Legal framework: Law no. 2004-800, August 6th 2004, relating to bioethics; Decree no. 2006-126, February 6th 2006, relating to research on embryos and embryonic cells

Article L.2151-1of the Public Health Regulations: The conception of an embryo in vitro or its constitution by human embryo cloning for research purposes is prohibited.

Article L. 2151-5: In principle, research on embryos is prohibited. However, exceptionally, if a woman and man give their consent, studies not damaging the embryo may be authorised provided that certain conditions are respected.

By special dispensation, and for a period limited to five years (beginning on February 7th 2006), research may be carried out on embryos and embryonic cells if such research is likely to lead to major progress in the development of treatments and provided that it could not have been carried out by an alternative method of comparable efficacy, based on current scientific knowledge. Research can only be carried out on embryos conceived in vitro by assisted reproductive technology, and which are no longer required by the ‘parents’. Such research can only be carried out if and after both members of the couple


HESCs







human embryos for

research including

SCNT

Allows creation of

human embryos for

research including

SCNT

Prohibits human



from which the embryo was created provide written consent or if and after such consent is obtained from the sole survivor of that couple, once these individuals have been duly informed of the possibility of donating their unwanted embryos to another couple or of stopping their storage. Research can only be carried out if the corresponding protocol has been authorised by the Biomedicine Agency, based on expert advice. The decision to authorise embryo research is based on the scientific pertinence of the research project and the conditions under which it will be carried out, taking into account both ethical principles and the interests of public health.

The embryos used for research must not be transferred for the purposes of gestation.

Article L. 2151-6: The importation and exportation of embryonic and foetal tissues and cells for research purposes is subject to prior authorisation from the Biomedicine Agency.

Article L. 2151-7: All organisations responsible for storing embryonic stem cells for scientific purposes most hold an authorisation from the Biomedicine Agency.

Germany

X

X

X

X Research using HESC lines created before 1 March 2007 is permitted under the German Stem Cell Act 2002 (amended in 2008). The German Embryo Protection law from January 1991 strictly forbids embryo research. It forbids fertilizing eggs, creating embryos or donating embryos for another purpose than inducing a pregnancy in the egg-donor. §2 (1) Whoever sells, buys or uses an embryo before transfer or donates the embryo for another reason than its development and survival will be punished with a prison sentence of up to 3 years or with a fine. (2) Whoever cultures an embryo in vitro for another reason than inducing a pregnancy will also be punished.

Greece

X

X

X

Law 3305/2005: • Remunerated donation of ova or fertilized ova (embryo) donation is prohibited. • Only supernumerary embryos can become the object of donation and only adult

persons can become donors. • All medical data concerning the donor(s) are stored in a codified form.


HESCs







human embryos for

research including

SCNT

Allows creation of

human embryos for

research including

SCNT

Prohibits human



• Research can take place in supernumerary human gametes or fertilized ova, which have been donated for this purpose.

• Donated material which has been used for research purposes cannot be used for the achievement of a pregnancy (Article 11), unless the purpose of the research concerns successful implantation of a fertilized ovum or the birth of a healthy child (Article 12).

• For such research to be carried out, permission from the National Authority on Medically Assisted Reproduction is required.

Israel

X

X

X

The Prohibition of Genetic Intervention (Human Cloning and Genetic Manipulation of Reproductive Cells) Law, 5759-1999 prohibits human cloning and the creation of a human being created through germ-line modification. The prohibitions apply only to the two kinds of genetic intervention addressed (human cloning and genetic modification of reproductive cells), but not to other possible modes of genetic research or therapeutic genetic intervention (concerning, for instance, cells and tissues taken from aborted foetuses). Therapeutic cloning is not prohibited nor is research involving human embryos. In 2001 The Israel Academy of Science and Humanities issued a paper ‘The Use of Embryonic Stem Cells for Therapeutic Research’ which emphasised the promise of HESC research. It permits within the framework of ART treatment the use of spare embryos which will not be used to implant in utero for reproductive purposes. It also states that ‘[a]lthough ethically debatable, the Committee considers it ethically permissible to experiment with new in vitro technologies to produce ES cells, such as reprogramming somatic cell nuclei by transfer into enucleated oocytes (so-called therapeutic cloning, without reproductive purposes).’

Italy

X

X

X

X

Law no. 40 (19/2/2004) - Regulation of Medically Assisted Reproduction: attributes to the human embryo the right of a person from the moment of fertilization (Art.1) As a consequence, embryo research is completely banned as described in Art. 13. Art. 13 - Research on human embryos. 1. Any experiment on a human embryo is prohibited. 2. Clinical and experimental research on each human embryo is only permitted on condition that it solely aims to reach therapeutic and diagnostic goals related to the


HESCs







human embryos for

research including

SCNT

Allows creation of

human embryos for

research including

SCNT

Prohibits human



health and development of the embryo itself, and if no other alternative procedure is available. 3. The following are also prohibited: 1. the production of human embryos for research or experiment or for purposes different from those stated in the law; 2. every form of eugenic selection of embryos and gametes...; 3. procedures of cloning through nuclear transfer or early embryo splitting or of ectogenesis both for reproductive and research purposes; 4. the insemination of a human gametes by gametes from different species and the production of hybrids and chimeras. Penalties for doing any of these things range from 2 to 6 years imprisonment and with a penalty of 50.000 to 150.000 euros. In case of violation of one of the prohibitions of clause 3, the sanctions will be increased. Any health professional condemned for any of the crimes mentioned in this article will be suspended from professional practice for a period of 1 to 3 years.

Japan

X

X

X

In May 2008 Japan moved to allow cloning of embryos for research into incurable diseases in limited circumstances.

Norway

X

X

X

Lov om humanmedisinsk bruk av bioteknologi m.m. (bioteknologiloven) Embryo research Chapter 3. Research on fertilized eggs, cloning and more. § 3-1. Prohibition of research on fertilized eggs and more It is forbidden to do research on human embryos and cell lines cultured from human embryos. § 3-2. Forbidding the creation of human embryos by cloning and more. It is forbidden to: Create human embryos by cloning; Do research on cell lines cultured from human embryos by cloning; and Create embryos by cloning with human genetic material into egg cells of animals. It is forbidden to use techniques intended for the creation of genetically identical individuals.

Portugal

X

X

X

Portuguese Law on Assisted Reproductive Technologies - 26th July 2006 , Forbidden purposes: Art. 7º, 1 – Reproductive cloning with the objective of creating genetically identical human beings is forbidden Research on embryos: Art. 9º, 1 – ART can not be used to deliberately create embryos for


HESCs







human embryos for

research including

SCNT

Allows creation of

human embryos for

research including

SCNT

Prohibits human



purposes of scientific research. 2 – However, research on embryos is allowed with the objective of prevention, diagnosis or therapy of the embryo himself, to improve assisted reproductive techniques, to constitute banks of embryonic stem cells for transplantation programs or any other therapeutic purposes. 3 – Scientific research on embryos is only allowed if it is reasonable to expect any kind of benefit for mankind, pursuant to each scientific project being subject to evaluation and approval by the National Council for Assisted Reproductive Technologies. 4 – For purposes of scientific research only the following are permitted for use: a) Cryopreserved surplus embryos that are no longer required for any kind of parental project; b) Embryos that lack quality for uterine transfer or cryopreservation with procreation aim; c) Embryos with serious genetic anomalies identified by pre-implantation genetic diagnosis; d) Eggs that have not been previously fertilized by spermatozoa. 5 – Using embryos under a) and c) depends on the prior written informed consent of the couple that has originated the embryo.

Singapore

X

X

X

The Human Cloning and Other Prohibited Practices Act 2004, section 5 prohibits human reproductive cloning. Embryo research is permitted.

South Korea

X

X

X

The Bioethics and Biosafety Act 2005 prohibits reproductive cloning. The use of supernumerary embryos from IVF and SCNT is permitted. The now abolished Ministry of Science and Technology was previously responsible for the governance of public and private research. Its functions have been folded into those of the Ministry of Education and the Ministry of Industry and Natural Resources.

Spain

X

X

X

Law 14/2007 allows SCNT for research. It expressly prohibits human reproductive cloning. (Other law permits creation of embryos via SCNT for research purposes, and allows research using excess human embryos)

Sweden

X

X

X

Embryo research, genetic diagnosis and donation are regulated by the Genetic Integrity Act (SFS 2006:351) and the Biobanks in Medical Care Act (SFS 2002:297). Research on human gametes and human embryos up to 14 days permitted provided approval


HESCs







human embryos for

research including

SCNT

Allows creation of

human embryos for

research including

SCNT

Prohibits human



obtained from ethics committee and informed consent given by ‘donors’.

United States

The United States has a regulatory ‘system’ based upon a mix of federal and state laws. At the federal level, under the ‘Bush administration’ public funding of embryo research was regulated by means of a supplementary note to the Omnibus Consolidated and Emergency Supplemental Appropriations Act [for Fiscal Year] 1999 (which governs the setting aside of money for the US Department of Health and Human Services (DHHS)). The supplementary note effectively banned public funding of research that would destroy embryos created after 9 August 2001 or that utilised cloning technologies. Of note is that such laws did not apply to research funded by private sources, which are subject to very few restrictions. On 9 March 2009, US President Barrack Obama made an order to ‘remove these limitations on scientific inquiry, to expand NIH support for the exploration of human stem cell research, and in so doing to enhance the contribution of America's scientists to important new discoveries and new therapies for the benefit of humankind.’ (See Barrack Obama, The White House, Executive Order: Removing Barriers to Responsible Scientific Research Involving Human Stem Cells, 9 March 2009). State laws differ widely from having no laws or regulations, to having laws which permit research on human embryos, to outright bans on research and/or human reproductive cloning.

Information in this appendix has been obtained from a number of sources including:

i. Flannery Ellen J. & Javit, Gail H. ‘Analysis of Federal Laws Pertaining to Funding of Human Pluripotent Stem Cell Research’ in National Bioethics Advisory Commission Ethical Issues in Human Stem Cell Research: Commissioned Papers D-1, D-6 (2000), < http://bioethics.georgetown.edu/nbac/stemcell2.pdf> at June 2003.

ii. Report of the Bioethics Advisory Committee, The Israel Academy of Sciences and Humanities, The Use of Embryonic Stem Cells for Therapeutic Purposes (2001). (Also see http://bioethics.academy.ac.il/english/DocPage3-e.html at 14 March 2009.

iii. The European Society of Human Reproduction and Embryology website: http://www.eshre.com/page.aspx/16 at 14 March 2009.

iv. United States White House http://www.whitehouse.gov/briefing_room/PresidentialActions/ at 14 March 2009.

See also Kirsten Matthews, World Cloning Policies at http://cnx.org/content/m14836/latest/ although note this was last updated on 3 August 2007 and does not contain any changes to laws or regulations in the jurisdictions listed after this date; and Australian Stem Cell Centre, Global Regulation of Human Embryonic Stem Cell Research and Oocyte Donation, 18 September 2008. (However, note that on checking the information in this table it is not completely up to date).

http://bioethics.georgetown.edu/nbac/stemcell2.pdf�

http://bioethics.academy.ac.il/english/DocPage3-e.html�

http://www.eshre.com/page.aspx/16%20at%2014%20March%202009�

http://www.whitehouse.gov/briefing_room/PresidentialActions/�

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APPENDIX 2

Amendments up to 2005 to the Human Fertilisation and Embryology Act 1990 (UK) ∗

Legislation

Principal effects

The Human Fertilisation and Embryology (Statutory Storage Period) Regulations 1991/1540

Extend the maximum storage period for gametes (as set out in section 14 of the Act) in respect of people "whose fertility since providing them has or is likely to become, in the written opinion of a registered medical practitioner, significantly impaired".

The Human Fertilisation and Embryology (Licence Committee and Appeals) Regulations 1991/1889

These Regulations prescribe the composition and procedures of HFEA licence committees and the appeals procedure.

The Human Fertilisation and Embryology (Special Exemptions) Regulations 1991/1588

Extended the purposes for which gametes could be stored: during investigations into offences under the HFE Act; and for research, testing of pharmaceutical products and teaching.

The Parental Orders (Human Fertilisation and Embryology) Regulations 1994/2767

Regulations made under the Act that gave effect to the scheme set up by s30 of the 1990 Act as an alternative to the adoption procedure in relation to children born following a surrogacy arrangement.

The Human Fertilisation and Embryology (Statutory Storage Period for Embryos) Regulations 1996/375

Extends the storage period for frozen embryos in certain cases.

The Human Fertilisation and Embryology (Research Purposes) Regulations 2001/188

Extended the purposes for which licences to include therapeutic research.

The Human Reproductive Cloning Act 2001 c.23

Created an offence of placing a human embryo in a woman other than by fertilisation.

The Human Fertilisation and Embryology (Deceased Fathers) Act 2003 c. 24

Allows a man to be registered as the father of a child conceived after his death using his sperm or using an embryo created with his sperm before his death.

Human Fertilisation and Embryology Authority (Disclosure of Donor Information) Regulations 2004

Removed the right of new donors to remain anonymous once the child has reached 18 years.

∗ The above table is taken from the United Kingdom Parliament, Select Committee on Science and Technology: Fifth Report (2005). It does not include significant amendments since 2004 pursuant to the Human Fertilisation and Embryology Act 2008 (UK) which are discussed within the thesis.

APPENDIX 3 Legal challenges up to 2005 to the Human Fertilisation and Embryology Act 1990 (UK)∗

Case

Significance

R v Secretary of State for Health, ex parte Bruno Quintavalle (on behalf of Pro-Life Alliance [2001].

It was claimed that organisms created by cell nuclear replacement did not fall within the definition of "embryo" in s.1(1) Human Fertilisation & Embryology Act 1990. Successful in the High Court but overturned in Court of Appeal.

Rose v Secretary of State for Health and the HFEA [2002] EWHC 1593

Joanna Rose was born before as a result of donor conception before the HFE Act was passed. The judge ruled that a case could be brought under the Human Rights Act challenging the rights of post-1990 donors to remain anonymous.

R (Quintavalle) v Secretary of State for Health [2003] UKHL 692.

Josephine Quintavalle sought and obtained permission to seek judicial review of the HFEA's decision announced on 13 December 2001 to award a licence to treat the Hashmi family. She challenged that decision on the ground that the HFEA had no power to issue a licence that permitted the use of HLA typing to select between healthy embryos. Her challenge succeeded but was initially lost on appeal on 16 May 2003. Quintavalle has since been given leave to take the case to the House of Lords. The case was heard in March 2005.

Evans v Amicus Healthcare and ors [2003] EWHC 2161.

Natalie Evans wished to use her stored embryos to have a child. However, her former partner withdrew her consent for the procedure. Evans contested this on human rights grounds but lost. She is now taking the case to European Court of Human Rights.

Leeds Teaching Hospitals NHS Trust v A and others [2003] EWHC 259 (QB)

Sperm mistakenly used in IVF implantation resulting in genetic father not being husband of genetic mother. The case resolved the issue of paternity

R. (on the application of Assisted Reproduction and Gynaecology Centre) v Human Fertilisation and Embryology Authority [2002] EWCA Civ 20 [2003] 1 F.C.R. 266

The HFEA's policy of allowing only two embryos to be transferred in most cases was challenged but the HFEA was vindicated.

R. v Human Fertilisation and Embryology Authority Ex p. Blood [1999] Fam. 151 [1997] 2 W.L.R. 807

Diane Blood sought permission from the courts to be inseminated with her dead husband's sperm. HFEA ruled that consent had not been given. Eventually, Mrs Blood won the right under European law to take the sperm abroad.

∗ This table is taken from the United Kingdom Parliament, Select Committee on Science and Technology: Fifth Report 2005. It is included to illustrate a number of legal challenges made in relation to the HFE Act 1990 (UK) and is not meant to be an exhaustive list.

APPENDIX 4 Licensed research projects in the United Kingdom, February 2009

Licensee

Licensed Research Project(s)

Assisted Conception Service, Glasgow Royal Infirmary

• The effect of biomass reduction on embryo development after biopsy of either one or two blastomeres (R0175)

Birmingham Women’s Hospital / Institute of Biomedical Research

• Human Gamete Interaction and Signalling (R0172 / R0173)

Bourn Hall, Cambridge • The Disaggregation of Embryos for the Purpose of

Deriving Stem Cells from Human Surplus Embryos (R0167)

Cardiff Assisted Reproduction Unit • Investigation into the Role of Sperm PLC- Zeta in Human

Oocyte Activation (R0161)

Centre for Assisted Reproduction, Coventry

• Indicators of Oocyte and Embryo Development (R0155)

Centre for LIFE, Newcastle-upon-Tyne • Epigenetic Studies of Preimplantation Embryos and Derived Stem Cells (R0145)

• Derivation of Human Embryonic Stem Cell Lines using Nuclear Transfer and Parthenogenically Activated Oocytes (R0152)

• Mitochondrial DNA Disorders: Is there a way to prevent transmission? (R0153)

Centre for Stem Cell Biology, University of Sheffield

• Optimisation of human embryonic stem cell derivation and the development of treatments for degenerative diseases (R0115)

Clarendon Wing, Leeds General Infirmary

• Maturation of fertilisation of human eggs in vitro (R0104)

Guy’s Hospital, London • Improving methods for biopsy and preimplantation

diagnosis of inherited genetic disease of human preimplantation embryos (R0075)

• Correlation of embryo morphology with ability to generate embryonic stem cell lines and subsequent growth differentiative characteristics (R0133)

Licensee


Human Genetics and Embryology Laboratories, University College Hospital, London

• The development of novel preimplantation genetic diagnosis (PGD) procedures and the study of early human development (R0113)

Lister Hospital, London • Analysis of the Impact of Human Embryo Mosaicism on

the Reliability of Pre-implantation Genetics Screening (PGS) (R0163)

London Fertility Centre • Analysis of chromosomes in human preimplantation

embryos using FISH and CGH (R0169)

Ninewells Hospital, Dundee • Studies of Embryo Development and Metabolism (R0154)

NURTURE, Nottingham • Evaluation of cardio myocytes derived from embryonic

stem cells as a means to characterise receptor/channel expression in human tissue (R0141)

Oxford Fertility Unit • Development of a model to study implantation in the

human (R0111) • To derive human embryonic stem cells and trophoblast

cell lines (R0143) • To Develop Pre-implantation Genetic Diagnosis (PGD)

for Mitochondrial DNA Disease (R0149)

Reproductive Genetics Institute, London

• Investigation of Major Histocompatability Complex Products and Soluble Protein Expression in Human Embryos at the Pre-implantation Stage (R0165)

Roslin Institute, Edinburgh • Platform technologies underpinning human embryonic

stem cell derivation (R0136) • Derivation of Human Embryo Stem Cells by Cell Nuclear

Replacement for Technology Development and the Study of Motor Neuron Disease (R0158)

Scottish Biomedical

• Derivation of a human embryonic stem cell line for the development of drugs for human disease (R0182)

Licensee


St Mary’s Hospital, Manchester / Manchester Fertility Services / University of Manchester

• In vitro development and implantation of normal human preimplantation embryos and comparison with uni- or poly- pronucleate pre-embryos (R0026)

• Derivation of Human Embryonic Stem Cell Lines from Embryos created from Clinically Unused Oocytes or Abnormally Fertilised Embryos (R0170/171)

University of Cambridge • Derivation of Human Stem Cells from Human Surplus

Embryos: The Development of hES Cultures, Characterisation of Factors Necessary for Maintaining Pluripotency and Specific Differentiation towards Transplantable Tissues (R0162)

University of Newcastle Upon Tyne, Centre for Stem Cell Biology & Developmental genetics, Institute of Human Genetics

• Derivation of Embryonic Stem cell Lines from Interspecies Embryos produced by Somatic Cell Nuclear Transfer (R0179)

University of Southampton • Environmental Sensitivity of the Human Pre-Implantation Embryo (RO142)

University of Warwick, Clinical Sciences Research Institute

• The generation of human embryonic stem cells by transferring a human cell into recipient pig eggs (R0183)

University of York • Biochemistry of early human embryos (R0067)

Welcome Trust Centre for Stem Cell Research, University College Cambridge

• Derivation of Pluripotent human embryo cell lines (RO132)

The above information is taken from http://www.hfea.gov.uk/en/374.html as updated by the HFEA on 07 January 2009, accessed on 19 February 2009.


APPENDIX 5

NHMRC LICENSED RESEARCH PROJECTS 2006 & 2009. Licensed research projects in Australia, 2006.

Licensee


Sydney IVF Limited Improvement in Laboratory Conditions for Embryo Culture

Sydney IVF Limited Effect of an Additive on Embryo Culture: Analysis of Growth and Epigenetic Programming

Sydney IVF Limited Development of Methods for Preimplantation Genetic and Metabolic Evaluation of Human Embryos

Sydney IVF Limited Development of Human Embryonic Stem (ES) Cells

Melbourne IVF Limited Development of testing procedures for unbalanced chromosome errors in human embryos

Melbourne IVF Limited A collaborative project between Melbourne IVF Pty Ltd and Stem Cell Sciences Pty Ltd to derive Human Embryonic Stem Cell Lines

IVF Australia Pty Ltd A collaborative project between IVF Australia and the Diabetes Transplant Unit, Prince of Wales Hospital to derive Human Embryonic Stem Cell Lines for the treatment of Diabetes

Monash University Derivation of embryonic stem cell lines from the human embryo

Monash IVF Pty Ltd Use of Excess ART Embryos for Training in Embryo Biopsy

Licensed research projects in Australia, as at January 2009

Organisation Licence Title Date of issue Status Sydney IVF Limited Limited Improvement in

Laboratory Conditions for Embryo Culture

16 April 2004

Current to 16 April 2009

Sydney IVF Limited Effect of an Additive on

Embryo Culture: Analysis of Growth and Epigenetic Programming

16 April 2004


Sydney IVF Limited Development of Methods for Preimplantation Genetic and Metabolic Evaluation of Human Embryos

16 April 2004


Sydney IVF Limited Development of Human Embryonic Stem (ES)

16 April 2004 Current to 16 April 2010

Cells Melbourne IVF Limited Development of testing

procedures for unbalanced chromosome errors in human embryos

16 April 2004


Melbourne IVF Limited A collaborative project between Melbourne IVF Pty Ltd and Stem Cell Sciences Pty Ltd to derive Human Embryonic Stem Cell Lines

11 June 2004 Current to 11 June 2009

Sydney IVF Limited Derivation of human embryonic stem cells from embryos identified through preimplantation genetic diagnosis to be affected by known genetic conditions

7 May 2007 Current to 7 May 2009

Sydney IVF Limited Reproducible production of human embryonic stem cell lines from somatic cell nuclear transfer (SCNT) of nuclei from human cumulus cells into clinically unusable human eggs.

16 September 2008 Current to 16 September 2011

Sydney IVF Limited Reproducible production of human embryonic stem cell lines from somatic cell nuclear transfer (SCNT) of nuclei from adult human fibroblasts into clinically unusable human eggs.


Sydney IVF Limited Reproducible production of human embryonic stem cell lines from somatic cell nuclear transfer (SCNT) of nuclei from previously established human embryonic stem cell lines into clinically unusable human eggs.


APPENDIX 6 Recommendations of the Legislation Review Committee (Australian Government),

Legislation Review: Prohibition of Human Cloning Act 2002 and the Research Involving

Human Embryos Act 2002, Reports, Canberra, December 2005.

National legislation 1. Clinical practice and scientific research involving assisted reproductive technologies (ART) and the creation

and use of human embryos for research purposes should continue to be subject to specific national legislation.

Reproductive cloning 2. Reproductive cloning should continue to be prohibited. Prohibitions on developing and implanting embryos 3. Implantation into the reproductive tract of a woman of a human embryo created by any means other than

fertilisation of an egg by a sperm should continue to be prohibited. 4. Development of a human embryo created by any means beyond 14 days gestation in any external culture

or device should continue to be prohibited. 5. Implantation into the reproductive tract of a woman of a human animal hybrid or chimeric embryo should

continue be prohibited. 6. Development of a human animal hybrid or chimeric embryo should continue to be prohibited, except as

indicated in Recommendation 17. 7. Placing a human embryo into an animal or into the body of a human apart from into a woman's

reproductive tract, or placing an animal embryo into the body of a human, for any period of gestation, should all remain prohibited.

8. Implantation into the reproductive tract of a woman of an embryo created with genetic material provided

by more than two people should continue to be prohibited. 9. Implantation into the reproductive tract of a woman of an embryo created using precursor cells from a

human embryo or a human fetus should continue to prohibited. 10. Implantation into the reproductive tract of a woman of an embryo carrying heritable alterations to the

genome should continue to prohibited. 11. Collection of a viable human embryo from the body of a woman should continue to be prohibited. Creation of human embryos by fertilisation 12. Creation of human embryos by fertilisation of human eggs by human sperm should remain restricted to

ART treatment for the purposes of reproduction.

13. Creation of human embryos by fertilisation of human eggs by human sperm to create embryos for the purposes of research should continue to be prohibited except in the situation described in Recommendation 15.

Use of excess ART embryos in research 14. Use of excess ART embryos in research should continue to be permitted, under licence, as under current

legislation. ART clinical practice and ART research 15. Research involving fertilisation of human eggs by human sperm up to, but not including, the first cell

division should be permitted for research, training and improvements in clinical practice of ART. 16. Testing of human oocytes for maturity by fertilisation up to, but not including, the first cell division or by

parthenogenetic activation should be permitted for research, training and improvements in clinical practice of ART.

17. Certain interspecies fertilisation and development up to, but not including, the first cell division should be

permitted for testing gamete viability to assist ART training and practice. 18. The Licensing Committee should develop a simple proforma application for licences to undertake training

and quality assurance activities for ART clinics. 19. Consideration should be given to the use of cytoplasmic transfer (including transfer of mitochondrial

DNA), under licence, for research on mitochondrial disease and other uses to improve ART treatment. Use of fresh ART embryos 20. An expert body should formulate objective criteria to define those embryos that are unsuitable for

implantation. 21. Fresh ART embryos that are unsuitable for implantation, as defined by the objective criteria, should be

permitted to be used, under licence, for research, training and improvements in clinical practice. 22. Fresh ART embryos that are diagnosed by preimplantation genetic diagnosis (according to the ART

guidelines) as being unsuitable for implantation should be permitted to be used, under licence, for research, training and improvements in clinical practice.

Use of human embryos created by somatic cell nuclear transfer 23. Human somatic cell nuclear transfer should be permitted, under licence, to create and use human embryo

clones for research, training and clinical application, including the production of human embryonic stem cells, as long as the activity satisfies all the criteria outlined in the amended Act and these embryos are not implanted into the body of a woman or allowed to develop for more than 14 days.

24. In order to reduce the need for human oocytes, transfer of human somatic cell nuclei into animal oocytes

should be allowed, under licence, for the creation and use of human embryo clones for research, training and clinical application, including the production of human embryonic stem cells, as long as the activity satisfies all the criteria outlined in the amended Act and these embryos are not implanted into the body of a woman or allowed to develop for more than 14 days.

Use of human embryos created by activation methods not involving fertilisation of a human egg by a human sperm or somatic cell nuclear transfer 25. Creation of human embryos and human embryo clones by means other than fertilisation of an egg by a

sperm (such as nuclear or pronuclear transfer and parthenogenesis) should be permitted, under licence,

for research, training and clinical applications, including production of human embryonic stem cells, as long as the research satisfies all the criteria outlined in the amended Act and these embryos are not implanted into the body of a woman or allowed to develop for more than 14 days.

26. Creation of human embryos using the genetic material from more than two people, or including heritable

genetic alterations, should be permitted, under licence, for research, training and clinical applications, including production of human embryonic stem cells, as long as the research satisfies all the criteria outlined in the amended Act and these embryos are not implanted into the body of a woman or allowed to develop for more than 14 days.

27. Creation of embryos using precursor cells from a human embryo or a human fetus should be permitted,

under licence, for research, training and clinical applications, including production of human embryonic stem cells, as long as the research satisfies all the criteria outlined in the amended Act and these embryos are not implanted into the body of a woman or allowed to develop for more than 14 days.

Definition of a human embryo 28. The definition of a `human embryo in both Acts should be changed to:

`A human embryo is a discrete living entity that has a human genome or an altered human genome and that has arisen from either:

(i) the first mitotic cell division when fertilisation of a human oocyte by a human sperm is complete; or

(ii) any other process that initiates organised development of a biological entity with a human nuclear genome or altered human nuclear genome that has the potential to develop up to, or beyond, 14 days and has not yet reached eight weeks of development.'

Consent arrangements for the donation of embryos 29. The National Health and Medical Research Council (NHMRC) should review its guidelines in relation to

consent to research on excess ART embryos, in order to clarify the consent process in relation to the following issues:

• the circumstances, if any, where those who choose to donate excess ART embryos to research may be

able to choose not to be contacted at some later stage to give consent to a particular research proposal • the circumstances, if any, where a human research ethics committee can determine that the researcher

need not ask for further consent to use embryos already declared `excess' • the development of an appropriate form of consent that could be completed by the

responsible persons for excess ART embryos shortly after the declaration that the embryos are excess

• the manner in which those who donate embryos or gametes for the creation of ART embryos may express any preference for the type of research for which the tissue will be used, once the embryo is declared excess.

30. The NHMRC should develop ethical guidelines for the use of embryos that are unsuitable for implantation

for research, training and improvements in clinical practice. Egg donation 31. The current principles of consent for participation in medical research must apply to sperm, egg and

embryo donors, so as to ensure that decisions are freely made. 32. The NHMRC should develop guidelines for egg donation.

33. The present prohibition of the sale of sperm, eggs and embryos should continue, but the reimbursement of reasonable expenses should continue to be permitted.

34. The Embryo Research Licensing Committee of the NHMRC (the Licensing Committee) should continue to

be the regulatory body responsible for assessing licence applications, issuing licences and monitoring compliance, as under current arrangements.

35. The role of the Licensing Committee should be extended to include assessment of licensing applications

and issuing licences for any additional activities permitted, under licence. 36. The Australian Parliament and the Council of Australian Governments should give urgent attention to the

problem of delays in the filling of vacancies on the Licensing Committee. 37. There should be no attempt to recover the cost of administration, licensing, monitoring and inspection

activities associated with the legislation from researchers at this point in time. Monitoring powers 38. The Licensing Committee should continue to perform its functions in relation to licences and databases for

research permitted by licences under the Research Involving Human Embryos Act. 39. Licensing Committee inspectors should be given powers, under the Prohibition of Human Cloning Act and

the Research Involving Human Embryos Act, of entry, inspection and enforcement in relation to non-licensed facilities in the same manner and by the observance of the same procedures as applicable to search warrants under Commonwealth legislation, if such powers do not clearly exist.

Oversight of ART clinical practice and research 40. There should be a continuation of the role of the Reproductive Technology Accreditation Committee in

the regulation of ART. Import and export of human reproductive materials for personal use 41. The import or export of a patient's reproductive material, including ART embryos, for the purpose of that

person's ongoing ART treatment should not require any regulation other than that required under existing quarantine regulation.

Trade and international exchange of human reproductive materials and stem cells 42. The import or export of ethically derived viable materials from human embryo clones should be permitted

after approval by the appropriate authority. 43. The existing requirements for the import and export of human biological materials are satisfactory and,

for ethically derived human embryonic stem cells, no further restrictions are necessary. Biotechnology and commercialisation 44. Trade in human gametes or embryos, or any commodification of these items, should continue to be

prohibited. 45. Donors of tissue that is going to result in an immortal stem cell line should be informed by means of

processes monitored by human research ethics committees about the potential use of that stem cell line, including the potential for commercial gain and the fact that they may not have any rights in potential stem cell developments.

46. The development of biotechnology and pharmaceutical products arising from stem cell research should be supported.

National stem cell bank 47. A national stem cell bank should be established. 48. Consideration should be given to the feasibility of the Australian Stem Cell Centre operating the stem cell

bank. 49. A national register of donated excess ART embryos should be established. Regulatory approach to legislation 50. The Licensing Committee should be authorised under the Prohibition of Human Cloning Act to give binding

rulings on the interpretation of that Act, or the regulations made under that Act, on condition that it reports immediately and in detail to the NHMRC and to parliament on such rulings.

51. The Licensing Committee should be authorised by the Research Involving Human Embryos Act to give

binding rulings and to grant licences on the basis of those rulings for research that is not within the literal wording of the Act, or the regulations made under the Act, but is within their tenor, on condition that the Committee reports immediately and in detail to the NHMRC and to parliament on any rulings it gives, or any licences it grants, in that way.

52. A researcher who conducts research on the basis of a ruling or a licence should be protected from liability

under the legislation, provided that they act in accordance with the relevant ruling or licence. 53. In view of the fast-moving developments in the field, and the range of amendments proposed herein, the

two Acts should be subject to a further review either six years after royal assent of the current Acts or three years after royal assent to any amended legislation.

Public education 54. There should be ongoing public education and consultation programs in the areas of science that are

relevant to the Acts.

APPENDIX 7

Horizon Scanning Expert Panel Members

Name Field of expertise Institution

Professor Twink Allen Equine Reproduction University of Cambridge, UK

Professor Peter Andrews Stem cell University of Sheffield, UK

Professor Keith Campbell Animal cloning (Involved in the group that created Dolly the sheep)

University of Nottingham, UK

Dr Jacques Cohen Assisted reproductive technology/ PGD

New Jersey, USA

Professor Alan Decherney Obstetrics and Gynaecology UCLA School of Medicine, USA

Dr David Edgar Stem Cell University of Liverpool, UK

Dr Martin Evans Vertebrate developmental genetics

Cardiff University, UK

Professor Chris De Jonge ART expert University of Minnesota, USA

Professor Paul Devroey Assisted reproductive technology

Free University in Brussels, Belgium

Professor Hans Evers Past chair of ESHRE Academic Hospital, Maastricht, Netherlands

Professor Stephen Hillier Reproductive endocrinology, IVF research and ovarian pathophysiology

Centre for Reproductive Biology, Edinburgh, UK

Professor Martin Johnson Pre-implantation mammalian development

Department of Anatomy, University of Cambridge, UK

Professor Gab Kovacs Medical Director, Monash IVF Monash IVF, Australia

Professor Henry Leese Early mammalian embryology (mouse cow, pig, human)

Department of Biology, University of York, UK

*See http://www.hfea.gov.uk/docs/2007_Horizon_Scanning_Expert_Panel_members_-_location_and_expertise.pdf)

Dr Norio Nakatsuji Mammalian embryonic stem

cells Kyoto University, Japan

Professor Andre Van Steirteghem

Assisted reproductive technology

University Hopsital Brussels, Belgium

Professor Alan Trounson Embryonic stem cells California Stem Cell Centre

Dr Maureen Wood Cryopreservation Aberdeen Fertility Clinic, Aberdeen Maternity Hospital, UK

Professor Stéphane Viville PGD Université Louis Pasteur, Strasbourg

Professor John Carroll Professor of Reproductive Physiology

UCL, UK

Dr Joyce Harper PGD UCL, UK

Professor Outi Hovatta PGD Huddinge University Hospital, Sweden

Professor David Barlow Executive Dean of Medicine University of Glasgow, UK

Dr Mark Hughes PGD Genesis Genetics Institute, Detroit, USA

http://www.hfea.gov.uk/docs/2007_Horizon_Scanning_Expert_Panel_members_-_location_and_expertise.pdf�

http://www.hfea.gov.uk/docs/2007_Horizon_Scanning_Expert_Panel_members_-_location_and_expertise.pdf�

APPENDIX 8

THE UNIVERSITY OF MELBOURNE

SCHOOL OF LAW

CONSENT FORM FOR PERSONS PARTICIPATING IN RESEARCH PROJECTS

PROJECT TITLE: Research involving human embryos and Cloning, and the Law. NAME OF PARTICIPANT NAME OF RESEARCHER: Ms Sonia Allan (PhD Candidate)

(Supervised by Dr. Christine Parker and Professor Loane Skene) 1. I consent to participate in the project named above, the particulars of which—

including details of the interview I have been asked to participate in—have been

explained to me. A written copy of the plain language statement has been given to

me to keep.

2. I authorise the researcher to interview me, consistently with the explanation

referred to in (1) above.

3. I acknowledge that:

a. The project is for the purpose of research;

b. The possible effects of the interview—including publication of what I say during

the interview—have been explained to me to my satisfaction;

c. Information obtained in the interview may appear in Sonia Magri’s PhD thesis, in

journal articles, conference papers, submissions made to government enquiries

or comments in the news or media about her research,

d. My participation in the interview is completely voluntary;

e. I am free to withdraw from this project at any time without explanation or

prejudice and to withdraw any unpublished data previously supplied;

f. Until publication, the confidentiality of my remarks during the interview will be

safeguarded subject to legal requirements;

g. If I opt not to be identified by name in any publication, it is possible that, due to

the small number of people being interviewed, someone may still be able to

identify me as the source of the information provided to the researcher.

4. I consent to being identified by name in any publication arising from the research:

YES / NO (tick appropriate box)

5. I consent to my interview being audio-taped


6. I consent to the audio-tape being transcribed by an assistant audio-typist hired by

the researcher.


7. I would like to receive a copy of the transcript of my interview so that I may

comment upon it and/or make any clarifications, before anything I said during the

interview is published.


Print Name: Signature: Date:

(Participant)

APPENDIX 9

PLAIN LANGUAGE STATEMENT UNITED KINGDOM RESEARCH

PROJECT TITLE: Research involving human embryos and Cloning, and the Law. NAME OF RESEARCHER: Ms Sonia Allan (PhD Candidate) Supervised by Dr. Christine Parker; Professor Loane Skene ACADEMIC QUALIFICATIONS OF SONIA ALLAN: B.A. (Hons) (Psych) LLB (Hons), Grad. Dip. Legal Practice, PhD Candidate (Law). Dear [INSERT NAME] I am currently undertaking a PhD at the University of Melbourne, supervised by Dr. Christine Parker, an experienced socio-legal researcher with expertise in the field of regulatory theory, and Professor Loane Skene, a specialist in Health & Medical Law. I also teach law at the University of Melbourne, Australia and work as a Research & Policy Officer at the Victorian Law Reform Commission on their reference on assisted reproductive technology (ART). The research that I am requesting you to participate in will form part of my PhD, which aims to consider: 1) issues raised for and against research involving human embryos and cloning by members of the public, research scientists, and people who work in the field of assisted reproductive technology; 2) the regulatory responses to such issues; and 3) the responses of scientists and doctors to such regulation focusing upon their perception of how the regulation affects their work and the factors influencing compliance with the regulation.

I am therefore interested in interviewing research scientists, ART practitioners, and some members of the regulatory authorities in the United Kingdom and Australia.

I plan to interview researchers and practitioners specifically in the field of research involving human embryos, cloning and/or ART who are based at the major universities and/or research institutes. I have obtained your details through one of the following: publicly available records, visiting the website of your organisation, or another participant suggested I speak with you. Whether or not you participate in my research project is entirely up to you. Participating would involve being interviewed by me for approximately one hour. I will be visiting the United Kingdom between 19 November 2005 and 19 December 2005. If you are available during this period, and agree to participate, I will need to arrange a time and place of your choosing to conduct the interview prior to my arrival. The point of the interview is for me to learn details of how highly skilled scientists and/or practitioners perceive legislative regulation (found in legislation or codes of practice written under such legislation by government authorities) as opposed to self-regulatory systems (such as where industry sets its own standards of practice) with regards to research involving human embryos and/or cloning. In particular I am interested in finding out about the extent to which they feel such regulation affects their work (if at all), what makes people comply with different types of regulation, and the perceived pros and cons of such regulation’. I will ask you a number of questions in this regard, but it is completely up to you whether or not you answer any or all of the questions. I am only interested in learning about matters that are appropriate for the wider public to know about, so I won’t be asking you to reveal any confidential information. With your permission, I would like to audio-tape the interview so that I have an accurate record of what you say. But, if you do not wish to be audio-taped, I am happy to take written notes during the interview instead. If at any time you no longer wish to participate in the interview, you can say so and the interview will end. I am happy to provide you with a copy of the final report of the interview so that you may check that I have not made any errors concerning the details of what you said, and/or clarify any points you feel necessary. If you do participate, then I will be taking into account what you tell me when I consider the regulatory model we have implemented in Australia and compare it to that of the UK. In particular the interview will inform my consideration of how such regulation is perceived by research scientists and ART practitioners. Such information will appear in my PhD thesis but may also appear in journal articles, conference papers, submissions that I make to government enquiries or comments in the news or media about my research. As part of the process I may want to publish some of what you have said in the interview. So, you should take this possibility into account when you are deciding whether or not you agree to participate. If you later decide that you do not wish some or all of what you said to be published, then you can withdraw your comments at any time prior to their publication. You may choose not to be mentioned by name in my PhD or any other presentation I give or document I publish. If you would prefer to remain anonymous, I will simply refer to you by your occupation. However, you should be aware that due to the small number of people

being interviewed, it is still possible that someone might be able to work out that you were the source of the information. If you are worried about this, you should either not participate, or indicate to me which of your comments I am not permitted to use. Until publication, I will keep what you said confidential, unless I am legally obliged to reveal it, for example because a court orders me to do so. During that time, the only other people who may have access to the remarks will be:

1. my research supervisors (if and only when necessary for them to provide feedback to me about my research project, and not for their own or any other purposes); and

2. an assistant who may transcribe any audio-tape of the interview into written form (should I decide to engage such services to assist me in the transcription).

In all instances, the above people will be bound not to disclose what you said to anyone else, subject again to any legal requirements. In keeping with my promise to maintain confidentiality all data will be de-identified (a reversible process whereby any identifying information is replaced by a code); records and data in relation to the interviews (including audio-tapes) will be kept in a locked filing cabinet at the University of Melbourne, on my return to Australia. All identifying information (For example, the key to the de-identified data) will be kept in a separate locked filing cabinet, and any computer files (For example, Typed transcripts) will be password protected. If you ask to withdraw from the project prior to publication, then I will personally destroy all records of your interview. Otherwise, your interview will be stored for at least five years, in line with standard university procedures. If you have any queries about any aspect of this project, please feel free to contact me. I can be reached by phone on +61 3 8344 1104. I can also be reached by email at [email protected]. If at any time you have concerns about the way I am conducting this research, please contact my University Ethics Committee by either writing to the Executive Officer, Human Research Ethics, The University of Melbourne, Victoria 3010, Australia; phoning +61 3 8344 2073; or faxing +61 3 9347 6739. You may also contact either of my supervisors: 1. Dr. Christine Parker, at the socio-legal studies centre, Oxford University (September-

Dec 2005) (ph: +44 (0) 1865 284220, email: [email protected]); University of Melbourne from Jan 2006 ph: +61 8344 4475, email: [email protected]);

OR 2. Professor Loane Skene at the University of Melbourne, Victoria 3010, Australia by

phoning +61 8344 4475 or emailing [email protected]. I thank you in advance for considering your participation in my project.

mailto:[email protected]�




Yours faithfully, Sonia Allan Melbourne Law School University of Melbourne

APPENDIX 10

SCHEDULE OF INTERVIEW QUESTIONS FOR RESEARCH SCIENTISTS / ART PRACTITIONERS

PROJECT TITLE: Research involving human embryos and Cloning, and the Law. 18. Can you begin by briefly describing the type of research/practice that you do. 19. Could you describe the formal regulation (for example laws) that governs your

research/practice and comment on how it affects your work? 20. What is your view about the pros and cons of having a formalised licensing system

regarding research involving human embryos and cloning? 21. Do you think that such regulation sets clear boundaries about what you can/can’t do as

a scientific researcher/practitioner? 22. Do you feel that formal, legalistic regulation hinders your ability to conduct scientific

research and/or practice? 23. In your opinion, what are the main reasons why people comply with formal regulation?

(For example, fear of losing a licence, belief in the regulation, acceptance of where the boundaries have been set?)

24. Do you think that this is an area of regulation where the strict letter of the law is

important, or are there different ways of interpreting the law in this area that give people more latitude and flexibility?

25. What makes you comply with the legal regulation of your scientific activity/practice?

26. Can you now describe the way in which your industry self regulates? (For example,

industry standards, scientific and medical self regulatory bodies, etc) 27. What is your view about the pros and cons of having a system of self-regulation

regarding research involving human embryos and cloning? 28. Do you think that such regulation would be better or worse than the more formal

methods of regulation with regards to setting clear boundaries about what you can/can’t do as a scientific researcher/practitioner?

29. Do you feel that a self-regulatory system would hinder your ability to conduct scientific

research and/or practice? 30. In your opinion, what are the main reasons why people comply with self-regulatory

regimes? (For example, meeting professional standards; ethics of practice; etc) 31. Do you think professional self-regulation would suffice in the context of research

involving human embryos and cloning? Why or why not? 32. Do you think social norms and informal social disapproval play a role in influencing what

research scientists and/or ART practitioners will or won’t do? If so, what is that role and how does it influence what is/isn’t done?

33. I am going to read (and show you) a list of different types of regulatory approaches that

may be applied when regulating research scientists/practitioners in the context of research involving human embryos and cloning. Could you tell me with respect to each one, whether you:

• perceive it to be a satisfactory mode of regulation in this context (why or why

not)

• would be likely to comply with it (in a strict sense or otherwise) and why/why not?

a. Formal regulation: Strict legal rules that impose legislative boundaries on

what you can/cannot do as a research scientist. (Such rules if broken would be linked to sanctions ranging from fines, to loss of licence to imprisonment).

b. Enforced self regulation: where legislation or regulatory action forces

research scientists and/or practitioners to introduce self regulatory programmes that meet standards and goals set by the government and that can be publicly enforced.

c. Co-regulation: government and self regulatory bodies work together to set

and enforce standards.

d. Self regulation: in which the professional bodies and associations set the standards and boundaries of what is/isn’t allowed – without government interference.

e. No regulation: scientists and/or practitioners are simply left to make their

own decisions about what they wish to do in the laboratory. 16. Would you like to add anything else or make any other comments about the systems

of regulation we have discussed today?

APPENDIX 11

RTAC Critical Criteria

(Audited Annually with the RTAC Certification Scheme)

CRITICAL CRITERIA

MEASURE

1. Compliance The Organisation must comply with statutory and regulatory requirements.

Provide evidence of: identification and communication of statutory and regulatory requirements. how changes to external requirements are integrated into work practices. communication, implementation, and review of all policies/procedures. compliance with the RTAC Code of Practice. records of current signed Deed of Agreement with the FSA. all human research having been approved by a Human Research Ethics Committee (HREC) registered by the NHMRC Australian Human Ethics Committee or New Zealand equivalent. compliance with the NHMRC Ethical Guidelines on the use of ART in clinical practice and research (2007) or New Zealand equivalent, except where specific alternate policies have been directed by a registered HREC affiliated to the Unit.

2. Key Personnel The Organisation must ensure access to competent staff. Staff must include: Medical director Scientific director Nurse manager Senior counsellor

Provide evidence of: qualifications, training, education and experience of key personnel.

3. Complaints Management The Organisation must acknowledge and investigate

Provide evidence of implementation and review of policies/procedures which include: information on how patients make a complaint and

CRITICAL CRITERIA

MEASURE

complaints. how they receive feedback. acknowledgement and investigation of complaints. systematic recording, review and corrective action of complaints.

4. Adverse Events The Organisation must acknowledge and investigate adverse events.

Provide evidence of implementation and review of: policies/procedures to systematically collect, analyse causal factors, review and act on all adverse, unplanned and untoward events.

5. Identification and Traceability The Organisation must ensure that gametes, embryos and patients are correctly identified and matched at all times.

Provide evidence of implementation and review of: policies/procedures to identify when, how and by whom the identification, matching, and verification are recorded for gametes, embryos and patients at all stages of the treatment process. the process that constitutes the traceability of gametes and embryos at all stages of the treatment cycle. regular (at least annual) audit of the patient, gamete and embryo identification process.

6. Drug Administration The Organisation must ensure the safe management of drug storage, supply and administration.

Provide evidence of implementation and review of policies/procedures which include: authorising orders for drugs that are to be supplied or administered to patients. recording in the patient’s individual file / record, all drugs, including batch numbers where applicable, that are supplied or administered to patients. maintenance of accurate records and audit of the drug management system. the safe procurement, storage and disposal of drugs. management of returned drugs to ensure drugs are not reissued.

7. Multiple Pregnancy The Organisation must minimise the incidence of multiple pregnancy.

Provide evidence of implementation and review of policies/procedures that: regularly audit (at least annually) multiple pregnancy rates and corrective actions that continuously attempt to reduce the incidence of multiple pregnancies in all treatment cycles, including artificial insemination and ovulation induction. recommend to patients that no more than one embryo or oocyte is transferred in the first treatment cycle where the oocyte is obtained from a woman aged less than 35 years at the time of oocyte collection. must ensure that no more than two embryos or oocytes are transferred in any one treatment cycle in

CRITICAL CRITERIA

MEASURE

a woman under the age of 40 years at the time of oocytes collection. must ensure that no more than two embryos or oocytes are transferred to a recipient woman, of any age, in any one treatment cycle, where the oocytes are donated from a woman aged less than 40 years at the time of oocyte collection. must ensure that patients receive information on the economic, medical, social and psychological hazards associated with multiple pregnancy.

8. Ovarian Hyperstimulation Syndrome

The Organisation must minimise the incidence of Ovarian Hyperstimulation Syndrome (OHSS).

Provide evidence of implementation and review of policies/procedures: for the identification and management of patients at risk of or experiencing OHSS. that measure and attempt to minimise the incidence of OHSS. that must ensure patients receive information on the risks, symptoms and management of OHSS. that must ensure patients receive information on how to access help, advice or care out of normal hours or in the event of medical emergency.

9. Emergency Care The Organisation must ensure access to emergency care.

Provide evidence of implementation and review of policies/procedures: on emergency care. that must ensure patients receive information on how to access emergency care including out of normal hours. Provide evidence of implementation and review of policies/procedures: to identify, collect, analyse and review data to monitor treatments and treatment outcomes at planned intervals.

10. Data Monitoring The Organisation must undertake regular reviews of treatment outcomes.

Provide evidence of implementation and review of policies/procedures: to identify, collect, analyse and review data to monitor treatments and treatment outcomes at planned intervals.

11. Data Reporting

The Organisation must provide the Australian and New Zealand Assisted Reproduction Database (ANZARD) with required data in the stipulated timeframe.

Provide evidence of: compliance with ANZARD data input. compliance with FSA / RTAC fee payment. implementation and review of policies/procedures for informing patients on the use of identifying and de-identified medical information that will be provided to statutory, regulatory and legislative

CRITICAL CRITERIA

MEASURE

The Organisation must pay all FSA/RTAC fees. The Organisation must inform patients of the uses to which their medical information may be put

authorities.

12. Donor Requirements

The Organisation must ensure gametes, embryos and tissues are safe for donation.

Provide evidence of compliance. Review recipient and donor files using ANZARD supplied file codes.

APPENDIX 12

GOOD PRACTICE CRITERIA

(COMPLETE AUDIT AT LEAST ONCE IN EVERY THREE YEARS IN ACCORDANCE WITH THE RTAC CERTIFICATION SCHEME)


MEASURE

1. Quality Management System

(QMS) The Organisation must have a management system allowing planned, implemented, coordinated, and appropriate service delivery which meets the needs of all stakeholders

Provide evidence of implementation and review of the following QMS elements. 1 - Quality Management policy that: demonstrates management commitment. outlines the scope of services provided, including identification of outsourced services e.g. External consultants, Pathology, Ultrasound. shows organisational objectives. 2 - Management review processes that review the scope, organisational objectives and relevance of quality management system. 3 - Integration of all personnel. 4 - Systems of internal communication: copies of meeting minutes, emails, memos. 5 - Document control system: evidence of implementation, approval and review of internal and external documents. 6 - Records management: compliance with statutory and regulatory authorities. 7 - Personnel and training: management commitment to adequate staffing and training. identification of training needs. records of training. outline of responsibility and authority. 8 - Competency of personnel: competency criteria including skill, education, training and experience.


MEASURE

records of individual’s competency for all services both internal and external. 9 - Buildings and facilities: assessment of requirements to meet organisational goals. adequate facilities and equipment to meet objectives. records of validation, maintenance and service of equipment. security, particularly to protect confidentiality of records and integrity of gametes and embryos. management of risks. e.g. emergency equipment, power, gas. 10 - Risk management and infection control: assessment of risks. review of risk. incident reporting and response. corrective and preventative action. 11 - Key supplier management: identification and review of key suppliers. 12 - Auditing: audit schedule. internal audits in compliance with the audit schedule.

2. Patient Information

The Organisation must provide patients with information that is accurate, timely and in formats appropriate to the patient.

Provide evidence of implementation and review of policies/procedures: to ensure patients receive written and verbal information covering diagnosis, investigation and fertility treatment options. Information must include but not be limited to: processes, costs, risks and outcomes. drugs and side effects. availability of counselling and support groups. patient rights and responsibilities.

3. Consent Processes

The Organisation must have a process whereby clinicians ensure that consent is obtained from all patients (and, where relevant, their spouses, partners and/or donors).

Provide evidence of implementation and review of policies/procedures: which define the consenting process. to ensure that consent is informed, voluntary, competent, specific, documented and remain current. Review patient records to show consent has been obtained.

APPENDIX 13

NHMRC Licensing Committee Inspections There are four different types of inspections of Licence Holders:

• Records audit inspection: conducted within first month of a licence being issued to audit record keeping and document systems in accordance with licence conditions. Inspectors will report to the NHMRC Licensing Committee on compliance with the legislation, the licences and their conditions. The records audit inspection determines the subsequent frequency of inspections;

• Monitoring inspection: inspection of the premises, documents and records to ensure continued compliance with the legislation and licence conditions;

• Final inspection: immediately preceding the licence expiry to ensure licence holders meet Final Report responsibilities; and

• Unannounced inspection: The NHMRC may conduct inspections of licence holders and non-licence holders without prior notice.

Since its inception the following information regarding inspections has been reported in the NHMRC Licensing Committee Report to the Parliament of Australia for the Period: 1 April 2008 to 30 September 2008 Licence Holder Licence Number Inspection Type Inspection Date Name Melbourne IVF 309704 Monitoring 6 May 2008 Melbourne IVF 309709 Monitoring 6 May 2008 Stem Cell Sciences Ltd 7 May 2008 Sydney IVF Ltd 309710 Monitoring 18 July 2008 1 October 2007 to 31 March 2008 Licence Holder Licence Number Inspection Type Inspection Date Name Sydney IVF 309702B Monitoring 5 October 2007 Sydney IVF 309703 Monitoring 5 October 2007 Monash IVF 309700 Final 13 December 2007 Monash University 309707 Final 14 December 2007 IVF Australia 309708 Monitoring 12 February 2008

NHMRC Licensing Committee Inspections Cont... 1 April 2007 to 30 September 2007 Licence Holder Licence Number Inspection Type Inspection Date Name Sydney IVF 309710 Records Audit Inspection 7 May 2007 Melbourne IVF 309704 Monitoring Inspection 25 July 2007 Sydney IVF 309701 Monitoring Inspection 31 August 2007 Sydney IVF 309702A Monitoring Inspection 31 August 2007 1 October 2006 to 31 March 2007 Licence Holder Licence Number Inspection Type Inspection Date Name Sydney IVF 309702B Monitoring inspection 11 October 2006 Monash University 309707 Monitoring inspection 10 Nov 2006 Sydney IVF 309703 Short notice inspection 20 Nov 2006 IVF Australia 309708 Monitoring inspection 6 February 2007 Melbourne IVF 309709 Monitoring inspection 27 March 2007 Non Licence Holder Inspection Name Inspection Type Inspection Date Stem Cell Sciences Inspection of a non-licence 28 March 2007

holder (Relates to 309709) One investigation into a potential breach of a condition of Melbourne IVF Licence 309709 for a failure to report result of investigation was that there was no evidence suggesting the licence holder’s failure to report in accordance with Standard Condition 2301 was intentional or reckless or likely to be repeated. The NHMRC Licensing Committee subsequently decided not to suspend, revoke or vary Licence 309709, but that NHMRC inspectors should conduct a monitoring inspection of the licence. 1 April 2006 to 30 September 2006 Licence Holder Licence Number Inspection Type Inspection Date Name Monash University 309707 Monitoring inspection 21 April 2006 Sydney IVF 309703 Monitoring inspection 3-4 May 2006 Melbourne IVF 309709 Monitoring inspection 8 June 2006 Melbourne IVF 309704 Monitoring inspection 2 August 2006 Non Licence Holder Inspection Name Inspection Type Inspection Date Stem Cell Sciences Inspection of a non-licence 9 June 2006

holder (Relates to 309709)

NHMRC Licensing Committee Inspections Cont... 1 October 2005 to 31 March 2006 Licence Holder Licence Number Inspection Type Inspection Date Name Monash University 309707 Monitoring Inspection 4 October 2005 IVF Australia 309708 Monitoring Inspection 16 February 2006 1 April 2005 to 30 September 2005 Licence Holder Licence Inspection Type Inspection Date Name Number Monash IVF (VIC) 309700 Records Audit Inspection 4 April 2005 Monash IVF (QLD) 309700 Records Audit Inspection 15 April 2005 IVF Australia 309708 Monitoring Inspection 18 April 2005 Melbourne IVF 309704 Monitoring Inspection 7 June 2005 Melbourne IVF 309709 Monitoring Inspection 13 July 2005 Sydney IVF 309701 Monitoring Inspection 11 August 2005 Sydney IVF 309702A Monitoring Inspection 11 August 2005 Sydney IVF 309702B Monitoring Inspection 11 August 2005 Sydney IVF 309703 Monitoring Inspection 11 August 2005 Monash University 309707 Short Notice Monitoring Inspection 15 August 2005 Non Licence Holder Inspection Name Type Inspection Date Stem Cell Sciences Inspection of a non-licence holder 14 July 2005 1 October 2004 to 31 March 2005

Licence Holder Name

Licence Number Inspection Type Inspection Date

Monash University 309707 Records Audit Inspection 3 February 2005 IVF Australia 309708 Records Audit Inspection 18 November 2004 Melbourne IVF / Stem Cell Sciences

309709 Monitoring Inspection 23 November 2004

NHMRC Licensing Committee Inspections Cont... 1 April 2004 to 30 September 2004: Licence Holder Name Licence Number Inspection Type Inspection Date Sydney IVF 309701 Records Audit Inspection 04 May 2004 Sydney IVF 309702A Records Audit Inspection 04 May 2004 Sydney IVF 309702B Records Audit Inspection 04 May 2004 Sydney IVF 309703 Records Audit Inspection 04 May 2004 Melbourne IVF 309704 Records Audit Inspection 19 May 2004 Sydney IVF 309703 Monitoring Inspection 29 June 2004 Melbourne IVF 309709 Records Audit Inspection 20 July 2004 1 October 2003 to 31 March 2004 Nil 1 April 2003 to 30 September 2003 Nil 19 December 2002 to 31 March 2003 Nil ****In all instances Licensing Inspections have found the licence holder to be compliant.

APPENDIX 14

NHMRC Licensing Committee Information Exchange Visits Since its inception the following information regarding information exchange visits has been reported in the NHMRC Licensing Committee Report to the Parliament of Australia for the Period: 1 April 2008 to 30 September 2008 No information exchange visits were conducted during the reporting period. 1 October 2007 to 31 March 2008 No information exchange visits were conducted during the reporting period. 1 April 2007 to 30 September 2007 Nine information exchange visits were conducted during this reporting period in response to the introduction of the amendments to the Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002. Date Location 17 April 2007 Sydney 18 April 2007 Sydney 20 April 2007 Brisbane 23 April 2007 Melbourne 24 April 2007 Melbourne 1 May 2007 Adelaide 2 May 2007 Perth 28 May 2007 Hobart 5 June 2007 Canberra 1 October 2006 to 31 March 2007 No information exchange visits were conducted during this reporting period. 1 April 2006 to 30 September 2006 During the reporting period, information exchange visits were provided to the following organisations and institutions in Queensland, South Australia and Western Australia: • Griffi th University Human Research Ethics Committee (HREC), Queensland; • The University of Queensland, Queensland; • Central Northern Adelaide Health Service HREC, South Australia;

• Genesis, Western Australia; • Pivet Medical Centre, Western Australia; • Concept Fertility Centre, Western Australia; • University of Western Australia, Western Australia; • Health Consumers’ Council of WA, Western Australia; and • The Reproductive Technology Council, Western Australia. 1 October 2005 to 31 March 2006 During the reporting period, NHMRC Inspectors undertook Information Exchange Visits to the following organisations and institutions in New South Wales, South Australia and Queensland: • Diabetes Transplant Unit, Prince of Wales Hospital, Sydney; • Q-Gen Pty Ltd, Brisbane; • Queensland Institute of Medical Research, Brisbane; and • Royal Women’s and Children’s Hospital Human Research Ethics Committee, Adelaide. On 11 May 2005, NHMRC Inspectors held a workshop on research involving human embryos as part of the NHMRC’s Ethics in Human Research Conference. The workshop informed and provided advice to participants on the legislation that governs research involving human embryos and the application of ethical guidelines concerning the use of assisted reproductive technology in research. Inspectors also used this opportunity to receive feedback from participants and Human Research Ethics Committees concerning the framework that governs research involving human embryos in Australia. 1 April 2005 to 30 September 2005 During the reporting period, NHMRC inspectors undertook information exchange visits to the following organisations and institutions in Victoria and the Australian Capital Territory: • IVF Friends, Epworth Hospital, Victoria; • John James Memorial Hospital, Australian Capital Territory; and • Mercy Hospital for Women, Victoria. The information exchange visit with IVF Friends was the first involving an IVF support group. 1 October 2004 to 31 March 2005 During the reporting period, NHMRC Inspectors undertook Information Exchange Visits to the following organisations and institutions within Western Australia and Queensland:

• Concept Fertility Centre, Western Australia; • Hollywood Fertility Centre, Western Australia; • Pivet Medical Centre, Western Australia; • Keogh Institute for Medical Research, Western Australia; • Health Consumer Council, Western Australia; • Queensland Fertility Group, Brisbane; • Monash IVF, Sunnybank; and

• Monash IVF, Gold Coast. 1 April 2004 to 30 September 2004: During the reporting period, the NHMRC monitoring and compliance team undertook Information Exchange Visits to the following organisations and institutions in Tasmania, South Australia and Victoria: • Tasmanian IVF, Tasmania; • Sydney IVF Launceston, Tasmania; • South Australian Research and Development Institute, South Australia; • Repromed, South Australia; • The University of Adelaide Research Centre for Reproductive Health, South Australia; • Flinders Reproductive Medicine, South Australia; • The Howard Florey Institute, Victoria; and • Victorian Department of Human Services Human Research Ethics Committee, Victoria. 1 October 2003 to 31 March 2004 No information exchange visits were conducted during the reporting period. 1 April 2003 to 30 September 2003 During the reporting period, inspectors undertook information exchange visits to four IVF Units in the Australian Capital Territory and New South Wales. 19 December 2002 to 31 March 2003 No information exchange visits were conducted during the reporting period.

the regulation of research involving human embryos and

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