advance directives - the surrounding legal issues (ll.d thesis 2010)
DESCRIPTION
Following an examination of the legal issues surrounding AdvanceDirectives, complemented with a critical analysis of several legal systemsin which Advance Directives are applied, recommendations have been putforward in favour of concrete actions towards achieving legal certainty, bylegislating upon advance directives (living wills) as part of the medical plan of the patient.TRANSCRIPT
ADVANCE DIRECTIVES:
THE SURROUNDING LEGAL ISSUES
DANIELA CASSAR
THESIS SUBMITTED IN PARTIAL FULFILLMENT OF
THE DEGREE OF LL.D.
FACULTY OF LAWS OF THE UNIVERSITY OF
MALTA
MAY 2010
2
DECLARATION OF AUTHORSHIP I, Daniela Cassar, declare that this thesis entitled ‘Advance Directives: The Surrounding Legal Issues’ and the work presented in it are my own. I confirm that:
This work was done in partial fulfillment for the degree of Doctor of Laws
at the Faculty of Laws of the University of Malta.
Where any part of this thesis/dissertation/assignment has previously been
submitted for a degree or any other qualifications at this University or any
other institution, this has been clearly stated.
Where I have consulted the published work of others, this is always clearly
attributed.
Where I have quoted from the work of others, the source is always given.
With the exception of such quotations, this thesis/dissertation/assignment
is entirely my own work.
I have acknowledged all sources used for the purpose of this work.
Signed: _____________________________ Date: _______________________________
3
ABSTRACT
An Advance Directive upholds the patient’s right to involvement in end-of-
life medical decisions, which respects the principle of patient autonomy
and in turn embodies in the requirement of informed consent for any
medical intervention.
While Advance Directives are legally accepted and widely recognized in
the clinical practice of United States, in most European countries it is still
unusual to base clinical decisions on patient’s previously expressed
wishes. This means that, from a legal point of view, the validity of Advance
Directives is unclear in many European states, including Malta.
Essentially, this legal document seeks to uphold the rights of the patient
when he is no longer competent to give his informed consent to medical
treatment proposed by his physician. As a fundamental principle, a patient
may not refuse treatment which is authorised by law through an Advance
Directive. More importantly, any instructions given by the patient have to
be according to the law of the respective country.
An Advance Directive helps circumvent situations in which the family
members or the doctor himself are required to make end-of-life medical
decisions on behalf of the patient, which decisions may be conflicting with
the views or the beliefs of the patient. To the contrary, an Advance
Directive assists the patient, the physician as well as family members
when faced with increasingly complex health care decision-making. This
also encourages a stronger communication process between the
physician and his patient, and a wider exchange of information and
knowledge towards more appropriate medical decision-making free from
controlling influences.
Following an examination of the legal issues surrounding Advance
Directives, complemented with a critical analysis of several legal systems
in which Advance Directives are applied, recommendations have been put
4
forward in favour of concrete actions towards achieving legal certainty, by
legislating upon Advance Directives as part of the medical care plan of a
patient.
This would help foster a beneficial environment for the patient, his
relatives or close friends, and his physician, where shared decision-
making is based on respect for the dignity of the human person as well as
the protection of his rights when he is not able to express his will freely.
5
Dedication
To my wonderful parents, sisters and brother who have coloured my life. To my friends for making my life more meaningful.
6
Table of Contents
DECLARATION OF AUTHORSHIP ................................................................................... 2
ABSTRACT.............................................................................................................................. 3 TABLE OF CONTENTS ........................................................................................................ 6
TABLE OF CASES.................................................................................................................. 8 TABLE OF STATUTES........................................................................................................ 10
TABLE OF STATUTORY INSTRUMENTS ..................................................................... 11 TABLE OF EUROPEAN AND INTERNATIONAL MATERIALS................................ 13
ABBREVIATIONS ................................................................................................................ 15 CHAPTER 1 ........................................................................................................................... 16
INTRODUCTION.................................................................................................................. 16 1.1 THE DEFINITION OF ADVANCE DIRECTIVES .................................................................... 16
1.2 THE DIFFERENT KINDS OF ADVANCE DIRECTIVES .......................................................... 17
1.3 REGULATION OF ADVANCE DIRECTIVES: AN OVERVIEW ................................................ 19
1.4 AN OVERVIEW OF THIS THESIS........................................................................................ 25
1.5 AIMS AND OBJECTIVES OF THIS THESIS ........................................................................... 27
CHAPTER 2 ........................................................................................................................... 28
THE CONSTITUTIVE ELEMENTS OF ADVANCE DIRECTIVE .................................. 28
2.1 PATIENT AUTONOMY AND INFORMED CONSENT ............................................................. 28
2.2.1 The Element of Competence............................................................................. 30
2.2.2 The Voluntary Will and Understanding of the Patient.................................... 32
2.2.3 The Absence of Controlling Influences ............................................................ 33
2.3 A CRITICAL ANALYSIS OF THE DEVELOPMENT OF PATIENT AUTONOMY AND INFORMED
CONSENT: UK CASE-LAW .................................................................................................... 33
2.4 CONCLUSION: A PROPOSAL FOR A MALTESE LAW ON ADVANCE DIRECTIVES................ 41
CHAPTER 3 ........................................................................................................................... 46
THE VALIDITY OF ADVANCE DIRECTIVES............................................................... 46 3.1 INTRODUCTION................................................................................................................ 46
3.2 FORMALITIES: THE PROCEDURAL ASPECT OF ADVANCE DIRECTIVES............................. 50
3.2.1 The Living Will in Malta ...................................................................................... 51
3.2.2 The Lasting Power of Attorney in Malta........................................................... 54
3.3 THE ADVANTAGES OF A COMBINED ADVANCE DIRECTIVE ............................................. 60
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CHAPTER 4 ........................................................................................................................... 63
LIFE-SUSTAINING TREATMENT IN THE TERMINALLY ILL AND ARTIFICIAL NUTRITION AND HYDRATION (ANH) .......................................................................... 63
4.1 INTRODUCTION................................................................................................................ 63
4.2 THE DISTINCTION BETWEEN MEDICAL CARE AND BASIC CARE...................................... 66
4.2.1 The Use of the Words ‘Ordinary’ and ‘Extraordinary’ .................................... 70
4.3 THE ‘DOUBLE EFFECT’ DOCTRINE .................................................................................. 73
4.4 THE DOCTOR-PATIENT RELATIONSHIP............................................................................ 76
4.4.1 Do Not Resuscitate (DNR)................................................................................. 79
4.5 THE BEST INTERESTS OF THE PATIENT AND GOOD-DECISION MAKING........................... 82
CHAPTER 5 ........................................................................................................................... 88 A COMPARATIVE ANALYSIS OF THE LEGAL APPLICATION OF ADVANCE DIRECTIVES IN EUROPE.................................................................................................. 88
5.1 INTRODUCTION................................................................................................................ 88
5.2 UNITED KINGDOM: ENGLAND AND WALES..................................................................... 89
5.3 GERMANY ....................................................................................................................... 93
5.4 ITALY .............................................................................................................................. 98
5.5 SPAIN ............................................................................................................................ 101
5.6 OTHER EUROPEAN MEMBER STATES IN WHICH ADVANCE DIRECTIVES ARE REGULATED
AND MADE USE OF ............................................................................................................. 105
5.7 TABLE SHOWING THE APPLICABILITY OF ADVANCE DIRECTIVES.................................. 107
CHAPTER 6 ......................................................................................................................... 109
CONCLUSION AND RECOMMENDATIONS............................................................... 109 BIBLIOGRAPHY AND FURTHER READING.............................................................. 116
APPENDIX........................................................................................................................... 122
8
TABLE OF CASES
A Hospital vs SW [2007] EWHC 435 (fam)
Airedale NHS Trust vs Bland [1993] 1 All ER 821
Appleton vs Garrett [1996] PIQR 1, Dyson J
Ashan vs Universities Hospital Leicester [2006] EWHC 2624 (QB)
Blyth vs Bloomsbury HA [1993] 4 Med LR 151
Bolam vs Friern Hospital Management [1957] 1 WLR
Chatterton vs Gerson [1981] 1 All ER 257, 265
Chester vs Afshar [2005] 1 AC 134, 153
HE vs A Hospital NHS Trust [2003]
Herczegfalvy vs Austria 50 EHRR 437 [2002] EWHC 1911
McAllister vs Lewisham and North Southwark HA [1994] 5 Med LR 343,
351
NHS Trust vs Ms D & Mr and Mrs D [2005] EWHC Civ 2439 (Fam)
Pearce vs United Bristol Healthcare NHS Trust [1999] PIQR 53
Pretty vs the United Kingdom [2002]
R ex parte N vs DR M, A NHS Trust and Dr O [2002] EWHC 1911
9
R (on the Application of Burke) vs GENERAL MEDICAL COUNCIL [2005]
3 FCR 169
Re AK (Medical Treatment: Consent) [2001]
Re B (Adult: Refusal of Medical Treatment) [2002] 2 FCR 1
Re C [1994] 1 WLR 290
Re MB (Caesarean Section) [1997] 2 FCR 541
Re T [1992] 4 All ER 649
S vs St George’s [1998] 3 All ER 673
Sidaway vs Bethlem Royal Hospital Governors [1985] AC 871; [1985] 1 All
ER 643
Smith vs Tunbridge Wells HA [1994] 5 Med LR 334
The Englaro Case (final disposition of case) Supreme Court, first Civil
Chamber (2007) no 21748, Il foro italiano 2007, I, 3025
Welby, Tribunal of Rome, 16 December 2006, Giurisprudenza di merito
2007:996; Tribunal of Rome, (2007)
Wyatt vs Curtis [2003] EWCA Civ 1779, para 19
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TABLE OF STATUTES
England The Mental Capacity Act (MCA) [2005]
Enduring Powers of Attorney Act [1985]
Germany
Drittes Gesetz zur Änderung des Betreuungsrechts (Amendments to the
Guardianship Act) [2009]
Italy
Codice Di Deontologia Medica [1995]
Costitutione della Repubblica Italiana,Gazzetta Ufficiale [1947]
Spain Spanish Law 41/2002 [2003] on the Autonomy of the Patient and the
Rights and Obligations with regards Information and Clinical
Documentation
11
TABLE OF STATUTORY INSTRUMENTS
Bill on the Mental Health Act – Discussion Points, Malta [2007]
British Medical Association (BMA) Withholding and Withdrawing Life-
Prolonging Medical Treatment, Guidance for Decision Making, United
Kingdom [1999]
Cathecism of the Catholic Church (CCC), Latin text copyright (c) Libreria
Editrice Vaticana, Citta del Vaticano [1993]
Compendium of the Cathecism of the Catholic Church, Catholic Truth
Society; First Edition [2006]
Declaration on Euthanasia, Sacred Congregation for the Doctrine of the
Faith [1980]
Department of Constitutional Affairs (DCA) paragraph 5.7, Mental
Capacity Act: Code of Practice (TSO), United Kingdom [2007]
General Medical Council (GMC) Seeking Patient’s Consent, United
Kingdom [1998]
Maltese Code of Ethics for Nurses and Midwives: The Nursing and
Midwifery Board, Department of Health (Constitution) Ordinance Cap. 94
Part VII [1997]
Patients’ Charter of Rights and Responsibilities, Hospital Management
Committee (St Luke’s Hospital, Malta)
Pope John Paul II – Address to Participants in the International Congress
on Life-sustaining Treatments and the Vegetative State [2004]
12
Pope Pius XII 1957a, Address on Catholic Doctrine concerning
Anaesthesia. Acta Apostolicae Sedis 49:129-47
Pope Pius XII 1957b
The National Council for Palliative Care: Guidance on the Mental Capacity
Act 2005; Advance Decisions to Refuse Treatment, United Kingdom
[2005]
13
TABLE OF EUROPEAN AND INTERNATIONAL MATERIALS
Conventions
Council of Europe, Convention for the Protection of Human Rights and
Dignity of the Human Being with regard to the Application of Biology and
Medicine: Convention on Human Rights and Biomedicine, Oviedo [1997]
European Convention on Human Rights [1950]
Recommendations
Council of Europe Recommendation CM/Rec(2009)11 of the Committee
of Ministers to Member States, of the 9th of December 2009, on principles
concerning continuing powers of attorney and advance directives for
incapacity
International
Bioethics Committees at Work: Procedures and Policies, UNESCO [2005]
California Health and Safety Code - The Natural Death Act (West
Supplement, 1978) 7185-95
The Vienna Declaration and Programme of Action adopted by the World
Conference on Human Rights, [1993]
United Nations Commission on Human Rights Resolution: 1993/91 [1993]
‘Human Rights and Bioethics’
14
Acknowledgments Professor P. Mallia has been an excellent thesis supervisor. His learned advice, insightful and constructive criticism have made the writing of my thesis possible. Sincere thanks to Mr.Joseph Izzo Clarke for believing in me and for his endless support and encouragement. My deepest gratitude to my parents who have instilled in me the confidence to do anything I set my mind to. And a final thanks to all those who in any way contributed to this thesis.
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ABBREVIATIONS
ANH Artificial Nutrition & Hydration
BMA British Medical Association
CCC
Catechism of the Catholic
Church
CDBI
CPR
Steering Committee on
Bioethics
Cardiopulmonary resuscitation
DNR Do Not Resuscitate
ECHR
European Court of Human
Rights
GMC General Medical Council
ICU Intensive Care Unit
ITAELD
Italian End of Life Decision
Study
MCA Medical Capacity Act
PVS Permanent Vegetative State
UN United Nations
UNESCO United Nations Scientific, Educational and Cultural
Organization
WHO World Health Organization
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Chapter 1
INTRODUCTION
1.1 The Definition of Advance Directives
Many medical decisions taken by the medical practitioner are influenced
by their legal implications.1 For instance, requests by terminally ill patients
for the withdrawal or the withholding of life-sustaining treatment, when
they envisage a time when they will no longer be able to make such
decisions, are taken in a legal void.2 In this case, whilst on the one hand
the principle is that nobody may be compelled to undergo or receive life-
sustaining treatment, on the other hand, there is a clear knowledge that
the patient may die as a result.
This thesis addresses this legal void in Malta by analysing the role and
legal efficacy of Advance Directives, following an examination of the
current state of our law and medical practice. Mallia3 defines an Advance
Directive as a written or oral directive given by a competent person in
order to govern and to control medical decision-making at a time when he
would be incapable of taking an active decision.4 Society requires a
means by which a competent individual may make future arrangements
for the moment he becomes incapable of making choices about his or her
care and treatment. This statement precisely explains the role of Advance
1 Muscat C., ‘Ethical Issues in Medicine’ in T. Cortis (ed.), Bioethics – Responsibilities and Norms for those in Health Care (A Ministry for Social Policy Publication, 1989) 109 2 Borg Barthet A., ‘The Legal Positions in Bioethical Problems of Life and Death’ in T. Cortis (ed.) Bioethics – Responsibilities and Norms for those in Health Care (A Ministry for Social Policy Publication, 1989) 32 3 Mallia. P (2002) 4 Cauchi M.N., Bioethical Issues at the Beginning and End of Life (Ministry of Health, 2002) 135
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Directives since it enables a patient to refuse specific types of medical
intervention that may be proposed in the future.5
1.2 The Different Kinds of Advance Directives
The term Advance Directive is generic to incorporate an act whereby a
competent person makes arrangements about his future health care
decisions should he become incompetent. Advance Directives can take
two forms – a living will or a lasting power of attorney for health care,
which are not necessarily exclusive of each other, but can be
complementary.
A living will refers to a written document drawn up when the patient is in
full possession of his faculties, giving instructions to his doctor or other
health care providers as to the circumstances under which he wants life-
sustaining treatment to be provided, withheld or withdrawn. The measures
usually relate to the refusal of certain forms of treatment aimed at
preserving or prolonging of the person’s life.6 Nevertheless, they can also
be used to express the wish of receiving some treatments, such as
artificial nutrition and hydration. On the other hand, a lasting power of
attorney for health care allows individuals to appoint an agent to make
health care decisions on their behalf, in specified matters of health care, if
and when they lose the ability to do so. The power of attorney has the
significant advantage of providing a way for clarifying the patient’s
preferences when they have been formulated in ambiguous terms in a
living will, as well as for dealing with unexpected developments that have
not been specifically addressed by the patient. 7
5 Eg. resuscitation 6 Gleason K., Going Home to the Father – A Catholic Perspective on End-of-Life Care (2001) 9 7 Steering Committee on Bioethics (CDBI), 35th meeting, Strasbourg, ‘The previously expressed wishes relating to health care; Common principles and differing rules in national legal systems’. (Report to the Council of Europe based on the June 2008 ‘Exploratory Workshop on Advance Directives’ organised by the Institute of Biomedical Ethics of the University of Zurich with the Support of the European Science Foundation (ESF), by Prof. Roberto Andorno (2009)).
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The difference between the two forms lies in the fact that in a living will,
the patient expresses his own will and his choices, whereas by granting a
lasting power of attorney for health care, the patient delegates the
authority to decide to another person. The power of attorney is an attempt
to allow decision-making about treatment decisions to be influenced by
the patient’s own view through a substitute, who is chosen by the patient
to make such decisions on his behalf, usually a person who has an in-
depth knowledge of the patient, his history and his preferences. The
person chosen should be of a good moral character having a certain
practical wisdom, is known to make sound decisions in difficult
circumstances and someone who understands and is willing to fulfil the
responsibility of acting in accordance with the patient’s needs and wishes.
This person could be either a spouse or a close friend who is able to take
the entire situation into account and act in the patient’s best interests. It is
also advisable to designate an alternative person, in the event that the first
person chosen is unable or unavailable to make decisions. Most
importantly, it is advisable for the principal to carefully discuss values,
religious beliefs and wishes with the agent before the document is signed.
It is also wise for the principal to keep such a dialogue open.8
Amongst the most fundamental criteria is that all provisions within such
directive made by a patient have to be within the law of the respective
country.
This subject matter is becoming increasingly important, primarily due to
the growing value attached to patient autonomy in health care decision-
making. This is complementary to the shift away from medical
paternalism, which dominated the doctor-patient relationship until a few
years ago. Another reason is the advancements in clinical treatment and
in life-sustaining technologies, which may allow the prolonging of life for
8 Juengst and Weil, ‘Making Sense of Advance Directives’ (1989), 91
19
years, but which may however compromise the dignity of the patient when
they are no longer beneficial, but are instead medically futile.9
1.3 Regulation of Advance Directives: An Overview
Reference to Advance Directives was made for the first time in the Karen
Ann Quinlan judgment,10 in the United States of America in the year 1976.
In this judgment, the court granted a petition for the removal of a ventilator
from a persistently vegetative state (PVS) patient, so that she could die a
natural death. This prompted the enactment of the first living will statute in
the USA, the Natural Death Act of California11 in 1976. Since then, living
wills, lasting powers of attorney, or more popular, a combination of the
two, have become legally accepted and widely recognized in the clinical
practice of the United States. Such legislation established certainty about
the legal position on Advance Directives in the United States.
The concept of the Advance Directive needs to be analysed in the context
of bioethics and medical law. Regulation in the area of bioethics and the
creation of a legal framework within which good medical practice must
operate have been an area of controversy over the years, primarily since
medical law is considered as the sphere of the individual and the family,
and not a sphere of public domain. Nevertheless, major advances in
medical technology led to an outburst of bioethical discussion throughout
the world. It appears that the progress and advance of science has been
faster than the ethical, legal and social implications of such scientific
development. Nielsen12 identified the basic difficulties relating to the
regulation of bioethical issues in medical decision-making to include the
9 Steering Committee on Bioethics (CDBI) (n7) 10 Re Quinlan, 70 N.J. 10, 355 A.2d 647 (1976) 11 California Health and Safety Code - The Natural Death Act (West Supplement, 1978) 7185-95 12 Nielsen L., ‘From Bioethics to Biolaw’, in Cosimo Marco Mazzoni (ed.), A legal framework for Bioethics (Kluwer Law International, 1998) 39
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protection of patient autonomy, human dignity and the private space of the
patient.
In Malta, the principles of informed consent and patient autonomy in
health care decision-making are mentioned in various sources.
Particularly, the Bill on the Mental Health Act13 makes reference to people
suffering from mental disorders, establishing a patient’s rights to be
adequately informed about the disorder, as well as the medical treatment
and services available to improve his condition. Such a person is also
entitled to actively participate in the formulation of a treatment plan, as
well as to give his ‘free and informed consent before any treatment or care
is provided and such consent shall be recorded in the patient’s clinical
record’.14 The Bill also provides for the situation where special treatment is
required; this cannot be carried out on a person suffering from a mental
disorder without his written informed consent. Alternatively, where such
person is not able to give consent due to his mental health disorder, then
consent shall be given by the person in charge. The informed consent of
the patient is also obligatory prior to the administration of any treatment;
where this is however impossible to obtain, the right is passed onto the
person in charge.15 This is affirmed in the case of special treatment, which
cannot be provided on a patient suffering from a mental disorder unless
such person gives his consent in writing. This provision shall not apply in
the case of an emergency where the patient’s life is at risk.
The Maltese ‘Patients’ Charter of Rights and Responsibilities’16 is founded
on the principle of patient empowerment and their rights to be treated as
partners by the health care professionals providing the service. Besides
affirming the right of every patient to considerate care with respect to his
13 A Bill on the Mental Health Act – Discussion Points (2007) <http://www.sahha.gov.mt/showdoc.aspx?id=785&filesource=4&file=Mental%20Health%20Act%20_%20Ver5.pdf> 14 ibid, Part II, Article 3(g),(h) and (i) 15 ibid, Part IV, Article 15 16 Patients’ Charter of Rights and Responsibilities, Hospital Management Committee (St Luke’s Hospital) Malta
21
human dignity,17 it also highlights the right of the patient ‘to make informed
decisions and to participate in decisions that have implications on his well
being’.18 An exceptional rule is created in emergency circumstances when
the patient lacks decision-making capacity and the need for treatment is
urgent.19 Moreover, the implications of refusing or requesting the
withdrawal of any intervention or procedure must be carefully explained to
the patient, where the latter exercises his right of refusal of diagnostic or
treatment procedure.20 Under this charter, a patient is also entitled to
receive spiritual and moral assistance in accordance with his religious
beliefs.21
Provisions on these salient principles are also found in the Maltese Code
of Ethics for Nurses and Midwives,22 which encourages patients to
participate in the planning of their own care, and involve their family
members if they so desire. The provision of ‘adequate and correct
information’ is also highlighted upon, so that patients may make ‘a free
and informed choice as to the provision of their own care’.23 The principle
of respect for the patient is interpreted as recognising the patient as
autonomous in nature, as ‘self-determining and as self-governing’; this
also includes understanding the patient’s wishes and needs.24
17 ibid, Article 1-01.02 18 ibid, Article 2-02.04 19 ibid 20 ibid, Article 2-02.05 21 ibid, Article 1-01.04 22 Maltese Code of Ethics for Nurses and Midwives (1997), the Nursing and Midwifery Board, under the Department of Health (Constitution) Ordinance Cap. 94 Part VII Section 34(e) 23 ibid, Preamble, Responsibilities towards Patients/Clients 24 ibid, Article 1-1.1
22
However, Malta has not signed the European Convention on Bioethics
which entered into force in November 1996.25 The Convention, considered
by the Steering Committee on Bioethics (CDBI), as the only European
legal framework on this issue,26 proclaims protection of the dignity and
identity of all human beings and guarantees everyone, without
discrimination, respect for their integrity and other rights and fundamental
freedoms with regards to the application of biology and medicine.27 Malta
should take the necessary steps towards discussing the issue of
becoming a signatory to this Convention, in order that it may ensure that
the interest and welfare of the human being prevails over the sole interest
of society or science,28 and that an intervention in the health field may
only be carried out after the person concerned has given free and
informed consent to it.29 It also makes direct references to Advance
Directives in Article 9, which provides that:
The previously expressed wishes relating to a medical intervention by a patient who is not, at the time of the intervention, in a state to express his or her wishes shall be taken into account.
On a European level, with an aim to achieve a greater unity between its
member states, in particular by promoting adoption of common rules in
legal matters, the Council of Europe has issued a Recommendation in
relation to principles concerning continuing powers of attorney and
advance directives for incapacity.30 It asserts that Member States should
promote the principle of self-determination for adults with capacity in the
25 Council of Europe, Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Oviedo (1997) 26 Steering Committee on Bioethics (CDBI) (n7) 27 ibid, Article 1 28 ibid, Article 2 29 ibid, Article 5 30 The Council of Europe Recommendation CM/Rec(2009)11 of the Committee of Ministers to Member States, of the 9th of December 2009, on principles concerning continuing powers of attorney and advance directives for incapacity
23
event of their future incapacity, by means of continuing powers of attorney
and advance directives.31 Considered as essential in respecting the
human rights and dignity of human beings, the patient’s self-determination
is better promoted if governments of Member States introduce legislation
on continuing powers of attorney and Advance Directives. Some Member
States have in actual fact already passed or proposed such legislation, in
which adults of all ages increasingly make use of them, according to such
Recommendation.32
On the international plane, we also find a growing shift towards the
recognition of human rights and bioethics as being closely interlinked. Particular reference is made to the Decision adopted by the United
Nations High Commissioner for Human Rights, entitled ‘Human Rights
and Bioethics’.33 The Commission hereby ‘recognises the need to develop
a life sciences ethic at the national and international levels’, and ‘the need
to develop international rules and cooperation in order to ensure that
mankind as a whole benefits from the use of the life sciences’. It also
addresses Governments about the importance of research intended for
the improvement of the health of human beings, but also about ‘the need
to safeguard the rights of the individual and his dignity’.34
The Vienna Declaration and Programme of Action adopted by the World
Conference on Human Rights35 highlights the need to find the right
balance between the right to enjoy the benefits of scientific progress and
the need to preserve the integrity, dignity and human rights of the
individual. Furthermore, it appeals for international cooperation to ensure
31 ibid, Principle 1 32 ibid, Preamble 33 Commission on Human Rights Resolution 2003/69, 62nd meeting (2003) 34 ibid, Point 7 35 Vienna Declaration and Programme of Action adopted by the World Conference on Human Rights (1993)
24
that human rights and dignity are fully respected in this area of universal
concern.36
UNESCO has also made noteworthy contributions to the field of bioethics
in the form of regulations, campaigns as well as other projects. In 2005,
UNESCO published a guide entitled Bioethics Committees at Work:
Procedures and Policies37 suggesting that chairpersons and members of
Bioethics Committees consider and evaluate certain procedures and
policies to guide them in fulfilling their mandates. It claims that Bioethics
Committees have worked concretely to influence societies in respecting
human dignity; they have become instruments of fairness and justice and
they have enhanced human values, bearing in mind that these values,
norms or preferences may vary among Member States. Moreover, the
establishment of these committees has widened the base of bioethical
discussions, to not only include experts or researchers in decision-making
concerning bioethical problems, but to reach the public at large.
Malta has its own Bioethics Consultative Committee38 which was
established in 1989, its main role being the assessment of bioethical
issues relevant to the community and the formulation of advice to the
Minister of Health.39 The opinions sent to the Minister of Health are not
legally binding.
36 ibid, Article I -11 37 Bioethics Committees at Work: Procedures and Policies <http://unesdoc.unesco.org/images/0014/001473/147392E.pdf> 38 The European Group on Ethics in Science and New Technologies to the European Commission EGE Secretariat, Ethics in the New Member States [2004] <http://ec.europa.eu/european_group_ethics/publications/docs/rptnwnec_en.pdf> 39 The Committee is multidisciplinary consisting of twelve members and a Chairman, all appointed by the Minister of Health. Members come from the medical, scientific, legal and ethical fields and are appointed on their personal merit and do not represent specific organisations. There is also one member from the general public.
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1.4 An Overview of this Thesis The principles of patient autonomy and informed consent dominate this
thesis as they constitute the underlying elements of Advance Directives.
Chapter 2 highlights the importance of involving incapacitated patients to
the fullest extent possible in decision-making regarding their health care.
This ties strongly with the importance of communication between the
doctor and the patient, which is both reciprocal and effective. An
appreciation of who should decide on the patient’s behalf and about the
role of the patient’s family is made.
On the basis that our medico-legal system refers to the English legal
system in its examination of bioethical issues, an English law perspective
has been adopted. This element is highlighted in this chapter wherein a
number of English court judgments and legal authors have been cited to
strengthen the arguments put forward. For instance, the English legal
scholar Kennedy40 advocates the principle of self-determination as a right,
allowing the patient to determine for himself whether he will undertake
certain medical procedures. The principle of self-determination and
informed consent are also reflected in the English case Pearce vs United
Bristol Healthcare NHS Trust,41 which establishes that the doctor is
responsible of informing the patient of a significant risk that would affect
the judgment of a reasonable patient, in determining for himself what
course should he adopt.
Chapters 3 and 4 take a closer look at Advance Directives and promote
them as a legal tool to enhance patient autonomy and which embodies the
right of involvement of the patient. The criteria according to which an
Advance Directive has to be drawn up are explored, while emphasising
that all the provisions contained within the Advance Directive must respect
the law of the respective country. The different forms of Advance
40 Kennedy I.,Treat me Right, Essays in Medical Law and Ethics (Clarendon Paperbacks, 1988) 41 Pearce vs United Bristol Healthcare NHS Trust [1999] PIQR 53
26
Directives, namely the living will and the lasting power of attorney, are
also explained, followed by a discussion of which is the more
advantageous of the two.
A critical analysis of specific regulatory frameworks of European states
with regards patientsʼ rights, and particularly, the application of Advance
Directives, is made in Chapter 5. This largely contrasts with the situation
in Malta, where Advance Directives and the surrounding legal issues are
not regulated under any law. This often results in the removal of patient
autonomy since decisions are taken on behalf of the patient, without the
latter having made his desires and beliefs known.
Chapter 6, marking the end of the thesis, consists of concrete
recommendations, suggesting ways to improve the end-of-life medical
care of a patient, fundamentally by the proposal of a law on the right of a
patient to draw up an Advance Directive, as part of his medical care plan.
This thesis puts forward a number of arguments in favour of Advance
Directives. Besides providing the dying patient with a voice that will be
heard, Advance Directives also encourage a global approach to future
health and promote advance planning that helps relieve family members
of their tension relating to crucial medical decisions. The Advance
Directive enshrines such qualities that have defined a person’s life and
ensures that these are not compromised or ignored at the moment of
dying. They help relieve the patient himself of his concerns that he may be
forced to linger on in a state of advanced physical or mental deterioration,
which conflict strongly with a good death marked by serenity, bodily
integrity and powerfulness. This is in line with the Catholic teachings, as
the Declaration on Euthanasia, prepared by the Sacred Congregation for
the Doctrine of the Faith42 maintains that a patient may not be forced to
undertake burdensome medical procedures that are disproportionate to
the outcome.
42 Declaration on Euthanasia, Sacred Congregation for the Doctrine of the Faith, May 5, 1980
27
1.5 Aims and Objectives of this Thesis
This thesis evaluates the subject matter of Advance Directives,
particularly:
i. The distinction between Advance Directives, living wills and legal
powers of attorney in health care;
ii. A critical analysis of the legal principles and ethical
considerations surrounding Advance Directives;
iii. The current status of the law and medico-legal practice in Malta
and other European states;
iv. The advantages of the use of Advance Directives in current
medical practice and why should they become regulated in
Malta;
v. Final recommendations to introduce a law on Advance Directives
in Malta.
28
Chapter 2
THE CONSTITUTIVE ELEMENTS OF ADVANCE DIRECTIVE
2.1 Patient Autonomy and Informed Consent
Effective communication based on mutual trust between doctors and
patients empowers patients to express their needs and preferences as
well as to participate in decisions about their care, according to the
principle of patient autonomy. Except for such circumstances in which the
law allows compulsory treatment, informed consent from a competent
adult43 is the trigger that allows treatment or a medical examination to take
place.44 In the context of health care treatment, consent is equivalent to
permission.
Certain general principles have been identified as fundamental by the
British Medical Association Ethics Department when considering the
medical treatment for patients lacking capacity, such as patient autonomy
and informed consent.45 Patients undertaking medical treatment should
have access to the following rights:
i. Liberty: Interventions that restrict liberty or reduce the capacity to
enjoy life in a disproportionate manner should be avoided,
unless such intervention is necessary to prevent a greater harm
to the patient or to others. Treatment options should be the least
restrictive effective option and any restraints must be justified;
ii. Patient autonomy: The principle of patient autonomy should be
promoted in a manner that is consistent with the needs and
wishes of the patient;
43 In this case, an adult is a person who has reached 18 years of age. 44 British Medical Association Ethics Department, Medical Ethics Today, The BMA’s Handbook of Ethics and Law (2nd Edition, 2004) 91 45 ibid
29
iii. Dignity: Patients should be treated with respect, taking into
account their social, cultural and religious values;
iv. Informed Consent: The patients’ views should be taken into
account, by involving them to the fullest extent possible in
decision making, even when incapacitated. This especially holds
when the patient has drawn up an Advance Directive when he
was still competent;
v. Privacy: Patients should be free from any medical procedures
unless there are good therapeutic reasons for them;
vi. Confidentiality: This refers to personal health information which
should be treated confidentially;
vii. Medical necessity: The medical needs of the patient should be
met as fully as practicable while recognising that the availability
of resources may limit treatment options;
viii. Free from unfair discrimination: Treatment options should be
considered on the basis of the patient’s needs and patients
should not be treated differently solely because of the condition
giving rise to the incapacity;
ix. Relatives: The views of people close to them should be taken
into account, even when they are not entitled in law to make
decisions on behalf of the patient.46
Respect for patient autonomy lies amongst the key principles in health
care. This is closely linked with the option given to a patient to resort
voluntarily and out of his own free will to self rule, ‘just like a government
governs its own territory’, or chooses to ‘act under an authority’.47 Mallia48
refers to the concept of informed consent, on receiving information about
his medical condition, as ‘the key’ to give proper consent. For such
consent to be effective, the patient must be competent at the moment of
46 ibid, 100 47 Mallia P., You & Your Doctor (Agenda, 2006) 94 48 Mallia P. (2006)
30
giving it.49 Therefore, the following conditions are required for there to be
proper consent:
i. The element of competence at the time of consent;
ii. The voluntary will and understanding of the patient; and
iii. The absence of controlling influences.50
2.2.1 The Element of Competence51
A person must be competent to be able to provide legally effective
consent.52 In England, the Mental Capacity Act (MCA)53 explains that a
person is considered incompetent ‘if at the material time he is unable to
make a decision for himself in relation to the matter because of an
impairment of, or a disturbance in the functioning of the mind or brain’.54 It
must also be shown that the patient is unable to make a decision for
himself since he is unable to understand, use and weigh the information,
representing the fundamental aspect of the process of decision-making,
and is unable to communicate his decision by any possible means.55 Lack
of capacity may not merely be established by reference to age and
appearance of the patient, or to his behaviour, otherwise this will lead to
the patient becoming the subject of abuse.56
49 Herring J. (ed.), Medical Law and Ethics, (Oxford University Press, 2008) 138 50 Mallia P. (n 47) 94 51 In England, the terms mental ‘capacity’ and ‘competence’ are often used interchangeably, in British Medical Association Ethics Department (n 44) 102 52 Lee S., ‘Towards a Jurisprudence of Consent’ in J. Eekelaar and J. Bell (eds.) Oxford essays in Jurisprudence, in Herring (n 49) 138 53 The Mental Capacity Act (MCA) (2005) (The Mental Capacity Act entered into force in April 2007 and forms the legal basis for Advance Decisions in England) 54 Herring J. (n 49) 138 55 Mental Capacity Act, 2005, Article 3(1) 56 Mental Capacity Act, 2005, Article 2(3)
31
Furthermore, a list of key principles to guide doctors to verify whether a
patient has capacity to give or withhold consent for medical treatment has
been established by the British Medical Association Ethics Department
(BMA) in England. An individual should be able to:
i. Understand in simple language what the medical treatment is, its
purpose and nature, and why it is being proposed;
ii. Understand its principal benefits, risks and alternatives;
iii. Understand the consequences of not receiving the proposed
treatment;
iv. Take a decision after being allowed time for reflection and
judgment;
v. Make a choice free from any pressure or influence57.
The assessment of an adult patientʼs capacity to make a decision about
his own health care is a matter for clinical judgment guided by
professional practice and subject to legal requirements. It is the
responsibility of every doctor to assess whether a patient has the required
competence to give valid consent to a proposed medical
treatment. Competence is assessed in the light of the decision being
made and not on the basis of the ʻordinary reasonable manʼ test, as
capacity may be influenced by medication, pain, fatigue, time of the day
and other variables.58 Competence may be enhanced by providing the
patient with the best opportunity to participate and be engaged in
decision-making. Amongst the factors that may be taken into
consideration are the time and place where the decision is being made.
The patientʼs own home may reduce anxiety caused by unfamiliar
surroundings. Doctors should also allow the side-effects of medication to
diminish before assessing capacity. To break decisions into a series of
57 British Medical Association Ethics Department (n 44) 104; These key principles arise from the law in England 58 ibid, 106-7
32
small choices or to reduce the information or communication into written or
other forms may prove helpful as well.59
2.2.2 The Voluntary Will and Understanding of the Patient
The doctrine of informed consent states that a patient can only provide
effective consent if given the relevant and necessary information to help
him take a decision. It is necessary that the patient understands ‘in broad
terms the nature of the procedure which is intended’.60 Consent may be
declared invalid by the court for reasons of misinformation, failure to
inform or fraud, which may also give rise to criminal proceedings. A case
in point was Appleton vs Garrett,61 in which a dentist was found to have
intentionally misinformed his patients in order to persuade them to agree
on unnecessary treatment for financial gain. Consent is also declared
invalid in the following circumstances:
i. Misrepresentation of the nature of the proposed treatment;
ii. Misrepresentation of the nature of the patient’s present condition;
and
iii. Withholding of information deliberately.62
The extent to which information must be given is measured by the
patient’s need of information to render a knowledgeable consent. It is
incumbent upon those responsible of medical procedures to provide
evidence in a court of law that sufficient information had been given and a
legally valid consent has been obtained.63
59 ibid, 108 60 Chatterton vs Gerson [1981] 1 All ER 257, 265 61 Appleton v Garrett [1996] PIQR 1, Dyson J 62 Chatterton vs Gerson (n 39) 257, 265 63 Giesen D., International Medical Malpractice Law – A Comparative Stduy of Civil Liability Arising from Medical Care (Martinus Nijhoff Publishers, 1988) 318
33
2.2.3 The Absence of Controlling Influences
A patient may be competent and aware of all the circumstances. However,
if his consent is not given freely, it will not be legally valid and so will not
have legal force.64 In the Re T case,65 the court found that the refusal of a
blood transfusion by a girl who had been raised as a Jehovah’s Witness
was not an expression of an independent decision. This conclusion was
based on the fact that T was in a state of weakness and the proximity of T
to her mother meant that the latter was in a position where she could
exercise undue influence. In conclusion, the doctors took the approach of
the best interests of the patient.66
2.3 A Critical analysis of the Development of Patient Autonomy and Informed Consent: UK Case-Law
No statute specifically governing the law of consent in the context of
health care interventions exists in England and Wales. The legal rules
have developed as part of the common law primarily through case-law.67
The House of Lords case, Sidaway,68 is a 1985 landmark judgment
concerning the extent of information that must be provided, reflecting the
approach of the English law. In this case, the plaintiff was left partially
paralysed following an operation to relieve a trapped nerve. She brought
legal proceedings against the hospital, not on the basis that the operation
64 Pattinson S. (2002a), ‘Undue Influence in the Context of Medical Treatment’, Medical Law International 5:305, in Herring (n 49) 143 65 Re T [1992] 4 All ER 649 66 ibid 67 Maclean A. R, ‘Magic, Myths and Fairytales: Consent and the Relationship between Law and Ethics’, in M. Freeman (ed.), Law and Bioethics (Oxford, 2008) 115 68 Sidaway vs Bethlem Royal Hospital Governors [1985] AC 871; [1985] 1 All ER 643
34
was performed negligently, but on the basis that the risks connected with
the operation were not explained to her. While the judges were unanimous
in deciding that the physician was not negligent, the case is important due
to the different approaches adopted by the judges.69 The fact that prior to
the Sidaway Case the duty to disclose the risks of a procedure was
determined by the Bolam test70 must be taken into account.
In this judgment, Lord Diplock emphasised the respect and honour that
the medical profession is worthy of. His approach was underscored by his
belief that the beneficent medical profession would advise what was best
for the patient, and, unless the patient specifically requested the
information, medical professionals should be allowed to control medical
information in order to ensure that they were not deterred from consenting
to the recommended treatment. This was because according to Lord
Diplock, patients would generally lack the kind of education and training
that would make it appropriate for them to want to decide for
themselves.71 This approach, reflecting medical paternalism that used to
dominate the doctor-patient relationship, is rejected all throughout this
thesis, as it renounces the principles of patient autonomy and informed
consent.
In the same case, Lord Bridge rejected the doctrine of consent because it
is ‘impractical’. For him, whether a particular risk should be disclosed in
order to enable the patient to make a ‘rational’ decision or not was
‘primarily [...] a matter of clinical judgment’ governed by the Bolam test.72
Nevertheless, he added the caveat that ‘a substantial risk of grave
adverse consequences’73 must be disclosed.74 This means that although
69 Herring (n 49) 149 70 Bolam v Friern Hospital Management Committee [1957] 1 WLR 582, 587: The Bolam Test holds that a medical professional would not be acting negligently if he was acting in accordance with a respectable body of medical opinion. 71 Sidaway vs Bethlem Royal Hospital Governors (n 68) 871, 895 72 ibid 900 73 Lord Bridge used the example of a 10 % risk of stroke
35
generally the Bolam test would apply in non-disclosure of risk cases, there
might be some circumstances in which the court would declare that non-
disclosure of serious risks amounts to negligence.75 Similarly to Lord
Diplock’s opinion, this approach allows a lot of discretion to the attending
doctor, who is only obliged to disclose a substantial risk of grave negative
consequences, rather than allowing an effective dialogue to form between
the relevant parties, particularly between the patient and the attending
doctor, based on mutual trust and shared decision-making.
Lord Scarman deviated from these two positions and upheld the doctrine
of informed consent which favours the right of a patient to decide whether
or not to receive medical treatment. This is in line with the English Mental
Capacity Act of 2005, to which view this thesis subscribes, which provides
that a competent person may decide to refuse or request the withdrawal of
a treatment, which has been specified in an Advance Decision.76
According to Lord Scarman, in order to give effect to this right, a patient
had to be given the material information necessary to make the decision.
To measure whether information was material, he proposed the ‘prudent
patient test’ to be incorporated within English law, such that if a
reasonable person in the patient’s shoes would have regarded the
information as significant, the patient had a right to know it. He continued
saying that health care professionals could nonetheless rely on a defence
of therapeutic privilege, which permitted doctors not to disclose a risk if
that disclosure would seriously harm the health of the patient.77 The fact
that the doctor is only obliged to disclose information which is considered
as ‘material’ according to the ‘prudent patient test’ may however result in
shortcomings, since all the information related to one’s end-of-life has
significance and may impact on the decision-making process of the
patient.
74 Sidaway vs Bethlem Royal Hospital Governors (n 68) 871, 895 75 ibid 871, 895, 882 76 Mental Capacity Act, 2005, Article 24(1) 77 Sidaway vs Bethlem Royal Hospital Governors (n 68) 871, 895, 882
36
Furthermore, in his argument in favour of self-determination, Lord
Scarman stated that ‘the patient’s right to make his own decision might be
seen as a basic human right protected by the common law’.78 Such
concept is defined as the right of the patient to determine for himself
whether he will or will not accept the doctor’s advice.
Following the Sidaway79 Case, the Court of Appeal followed Lord
Diplock’s approach in the 1993 case Blyth vs Bloomsbury HA,80 on the
fact that the patient had not asked any questions. The Court held that
where questions were asked, the Bolam test applies, hence, there will be
no case for negligence if a doctor gives a response which would be
considered appropriate by a responsible body of medical opinion, even if
that answer was not full.81
Lord Bridge’s opinion in the Sidaway Case was later adopted in the 1994
judgment McAllister vs Lewisham and North Southwark HA,82 in which the
Court found the defendants liable for the surgeon’s failure to disclose the
serious and significant risks of the surgery. In rejecting the opinion of the
defendant’s expert witness, the judge noted that ‘within certain limitations,
a patient is entitled to be given sufficient information on the risks of an
operation to allow him or her to exercise a balanced judgment: After all it
is their life which is going to be affected’. On the contrary, the judge
accepted the opinions of the plaintiff’s experts, who maintained that
responsible practice required ‘sufficient information to enable her to make
a properly informed choice’.83
78 ibid 79 ibid 80 Blyth vs Bloomsbury HA [1993] 4 Med LR 151 (decided in 1987) 81 ibid 82 McAllister vs Lewisham and North Southwark HA [1994] 5 Med LR 343, 351, 352 83 ibid
37
The importance of the disclosure of risks was also emphasised in the
1994 case Smith vs Tunbridge Wells HA.84 This case went beyond the
rule that a patient was entitled to sufficient information on risks. The judge
took the view that the body of medical opinion that claimed it was not
necessary to warn of a risk of impotence which accompanied an operation
was neither reasonable nor responsible,85 stressing the patient’s right to
informed consent.
Another significant ruling on the requirement of the disclosure of risks in
England, was Pearce vs United Bristol Healthcare NHS Trust86 of 1999,
on the requisite standard of information disclosure. The case involved the
advice given by the doctor to his patient to continue with the treatment;
however, the doctor failed to explain that the medical procedure carried a
slight risk of stillbirth. To determine whether such failure of disclosure
constituted negligence, reference was made to the Sidaway case, citing
the Bolam test, which is subject to the caveat that:
...if there is a significant risk which would affect the judgment of a reasonable patient, then in the normal course it is the responsibility of the doctor to inform the patient of that significant risk, if the information is needed so that the patient can determine for him or herself as to what course he or she should adopt.87
In the more recent case Chester vs Afshar88, of 2005, the House of Lords
established that surgery performed without the informed consent of the
patient is unlawful. The judge in this case made reference to the relevant
law on the duty to warn in the UK by citing the Bolam test as the
appropriate test to apply to the defendant’s conduct. He continued that in
line with Lord Bridge’s opinion in Sidaway, when questioned by a patient
of apparently sound mind about the risks of a particular treatment, the
84 Smith vs Tunbridge Wells HA [1994] 5 Med LR 334, 339. 85 Herring (n 49) 151 86 Pearce vs United Bristol Healthcare NHS Trust [1999] PIQR 53 87 ibid, 59 88 Chester vs Afshar [2005] 1 AC 134
38
doctor’s duty must be to answer both as truthfully and as fully as the
questioner requires. The patient has an ‘important’ right to an ‘appropriate
warning’ that should be given ‘effective protection whenever possible’.89
The judge also took into consideration the fact that had Miss Chester been
adequately warned as to the risk, she would not have consented to the
operation. The House of Lords concluded that, though the failure to warn
was not a direct cause of injury, it did result in negligence.
Whilst Lord Diplock in the Sidaway judgment and the court in Blyth vs
Bloomsbury HA uphold the principle of medical paternalism, where the
decision-making power is fully with the attending doctor who considers his
patient as lacking the necessary knowledge to be able to participate and
make an appropriate decision, judgments such as Smith vs Tunbridge
Wells HA, Pearce vs United Bristol Healthcare NHS Trust as well as
Chester vs Afshar emphasise the importance of disclosure of risks of the
medical intervention being proposed by the attending doctor, as a caveat
to the Bolam test. This view was put forward by Lord Bridge in the
Sidaway judgment, which, whilst marking a positive move towards patient
autonomy and informed consent, it falls short of the requirements of a
doctor-patient relationship, based on mutual trust and shared decision-
making.
According to the General Medical Council (GMC) of United Kingdom, the
exchange of information between doctor and patient is central to good
decision-making. The extent of information a doctor should share with his
patient varies, depending on the patient’s individual circumstances.
Discussions with a patient should be based on the patient’s:
i. Needs, wishes and priorities;
ii. Level of knowledge about, and understanding of, his condition,
prognosis and the treatment options;
iii. The nature of his condition;
iv. The complexity of the treatment, and
89 ibid 144, para. 17
39
v. The nature and level of risk associated with the investigation or
treatment.
Professional guidelines on which the doctor-patient relationship should be
based were also decided by the General Medical Council (GMC) of United
Kingdom.90 These guidelines include a number of circumstances that
should be disclosed by doctors when discussing a proposed treatment
with a patient. These include:
i. The diagnosis and prognosis;
ii. Any uncertainties about the diagnosis or prognosis, including
options for further investigations;
iii. Options for treating or managing the condition, including the
option not to treat;
iv. The purpose of any proposed investigation or treatment and what
it will involve;
v. The potential benefits, risks and burdens, and the likelihood of
success, for each option;
vi. Whether a proposed investigation or treatment is part of a
research programme or is an innovative treatment designed
specifically for the patient’s benefit;91
vii. The people who will be mainly responsible for and involved in the
patient’s care, what their roles are, and to what extent students
may be involved;
viii. The patient’s right to refuse to take part in teaching or research;
ix. The patient’s right to seek a second opinion;
x. Any bills the patients will have to pay;
xi. Any conflicts of interest that the doctor may have;
xii. Any treatments that according to the doctor have greater
potential benefit for the patient than those that the doctor can
offer.92
90 General Medical Council (GMC) Consent: patients and doctors making decisions together (2008) 91 The patient should be told how the proposed treatment differs from the usual methods, why it is being offered, and if there are any additional risks or uncertainties.
40
Furthermore, whilst the General Medical Council highlights the importance
of ensuring that the advice has been understood by the patient, it
maintains that the patient may need to be given more information and
enough time to reach a decision. The doctor should also clarify that a
patient may change his mind about a decision at any time.93 Family
members may also need to be involved in discussions or to help them
make decisions.94 The fact that no one else can make a decision on
behalf of an adult who has capacity is nevertheless highlighted.
A patient must always receive the required information in order to give his
consent; otherwise his consent would not be valid.95 In the event that the
information is declined by the patient, this has to be recorded by the
doctor in the medical plan, who shall also clarify that the patient may
change his mind and request more information at any time. No information
which is considered necessary for making decisions should be withheld,
unless the doctor believes that giving it would cause the patient serious
harm. A record to this effect must be made by the doctor in the patient’s
medical records, who should be prepared to explain and justify his
decision. Such decision must be regularly reviewed in consultation with
the patient.96
Such regulations for doctors aimed at ensuring good medical practice are
concrete evidence of the shift away from medical paternalism and a
physician-centred approach, towards a patient-centred approach, in the
United Kingdom. Guidelines for Maltese doctors and medical practitioners
should be discussed and drawn up, adopting the patient-centred approach
found in the General Medical Council guidelines, where the patient is fully
involved in the decision-making process related to his own medical care.
92 General Medical Council (GMC) (n 90) Point 9 93 ibid, Point 11 94 ibid, Point 22 95 ibid, Point 15 96 ibid, Points 16 and 17
41
Such decision made by the patient must be respected, even if it entails
refusing an investigation or treatment, which, according to the doctor, is
wrong and irrational. However, the doctor is responsible to explain his
concerns to the patient, outlining the possible repercussions of such
decision.
In the United Kingdom, such informed consent could be expressed both
orally and in writing; but in cases which involve higher risk, consent must
be always recorded in writing.97 Where a patient’s capacity may be
impaired at a future stage, the physician must encourage him to consider
what his needs and wishes are in terms of future care, such as treatments
he would refuse, beliefs or religious values or persons that he would like to
be involved in health care decisions.98 This could be made through an
Advance Decision drawn up by the attending doctor, in accordance with
the Mental Capacity Act of 2005.
2.4 Conclusion: A Proposal for a Maltese Law on Advance Directives
Legislation on Advance Directives in Malta must have as its core principle
the element of informed consent, which guarantees individual autonomy to
the patient.
The law in Malta shall state that any medical intervention shall only take
place after a competent patient has received sufficient information,
enabling him to provide his consent. A definition of the term incompetence
shall be established and included in the law, based on the English Mental
Capacity Act of 2005, and guidance for doctors to attest the competence
of their patients to give or withhold consent for medical treatment, shall be
modelled on the key principles laid down by the British Medical
Association Ethics Department. This means that a set of guidelines shall
be established and shall include that a patient should be able to
97 ibid, Points 45 - 47 98 ibid, Point 57
42
understand what the medical treatment is, as well as its purpose, its
principal benefits and its principal risks. Moreover, this guidance shall
include the requirement that a patient is allowed time to reflect on his
decision, and particularly that he may make a final choice free from
pressure and influence.
In order that the patient’s consent may be valid, the doctor-patient
relationship must be based on an effective dialogue based on mutual trust
and the disclosure of adequate information. The relevant authorities in
Malta shall, by referring to the publication on consent by the General
Medical Council, decide on guidelines regarding the circumstances that
should, by law, be disclosed by doctors when discussing a proposed
treatment with a patient. Such disclosure by medical professionals should
not be limited to the circumstances in the abovementioned UK judgments,
namely significant risks of grave adverse consequences, which would
affect the judgment of a reasonable patient. Instead, the circumstances
that should be disclosed by the doctor should include the diagnosis and
any uncertainties about such diagnosis, the options to treat or otherwise,
details about any investigation that might be carried out, the potential
benefits, risks and burdens, and the likelihood of success, for each option,
amongst others.
Such considerations would result in the proper regulation of patient
autonomy and informed consent in Malta, instead of allowing the
application of already existing rules which were not designed for a medical
law context. Consequently, any action in violation of the law would result in
the unlawfulness of the action.
Essentially, the application of a holistic approach to the regulation of
informed consent needs to be adopted by the legislator. Besides giving
adequate information, the attending doctor is obliged to provide advice
and a full explanation of the circumstances to his patient and ensure that
he has understood all that has been divulged to him, before he may
request the patient’s consent. The Bristol Royal Infirmary has actually
43
reported that ‘one of the principal ways of empowering the patients is to
ensure that they have the necessary information to allow them to
understand and participate in their care to the extent desired’.99
Another element that deserves emphasis in the regulation of informed
consent is the ethical duty not to coerce or deceive in the process of
communication. This argument was put forward by Mallia100, who affirms
that the doctor may do his best to convince the patient, without undue
pressure and without any manipulation or coercion, which would be
tantamount to a breach of professional ethics.101 An approach to a healthy
communication process would help increase the interdependence of the
two parties, as well as the trust and trustworthiness in each other
throughout the decision-making process.
Agius102 also points out that in addition to being thoroughly informed, the
patient must also understand clearly his right to make choices about the
type of care received. Nevertheless, the pre-eminence of the patient’s
choice does not preclude the physician’s responsibility to make and to
share with the patient his personal and professional judgment. He
continues saying that dying patients have the right to exercise their
autonomy and control to the fullest possible extent at the end of their lives.
Doctors provide patients with information to enable them to do this but,
particularly at the end of life, the doctor-patient relationship demands more
than the simple provision by the doctor of a list of options. The physician
has a special obligation to listen to the doubts and fears expressed by
patients who are hopelessly or terminally ill.103
99 Kennedy I. (Chairperson), ‘The Report of the Public Inquiry into Children’s Heart Surgery at the Bristol Royal Infirmary’ 1984 - 1995: Learning From Bristol (CM5207, 2001) 285 100 Mallia (2006) 101 Mallia P., You & Your Doctor (Agenda, 2006) 93 102 Agius E., ‘The Rights of the Dying Patient’ (Appendix 2), in M. N. Cauchi, Bioethical Issues at the Beginning and End of Life (Ministry of Health, 2002) 145 103 ibid
44
One way of facing these fears and uncertainties that come about at the
end-of-life stage is by drawing up an Advance Directive. Amongst the
benefits of Advance Directives, as laid down by the President’s
Commission Report104 on deciding to forego life-sustaining treatment,
there is:
i. The expression of patient autonomy which for some patients is
reassuring, should they suffer from serious permanent illness or
disability, or terminal illness;
ii. The completion of an Advance Directive may alleviate the fear of
unbearable pain in terminal malignant disease;
iii. Discussions between patients and doctors on the use of
Advance Directives will create increased medical awareness of
anxieties relating to advanced incurable and terminal disease;
iv. The so-called defensive or over-intrusive medical care is likely to
be discouraged by the existence of Advance Directives;
v. An Advance Directive may aid doctors and others confronted
with the ethical dilemmas of cancer medicine, intensive care
medicine, resuscitation and geriatric medicine;
vi. An Advance Directive is likely to reduce the level of stress and
distress of the patient’s relatives;
vii. The arbitrariness of medical decision-making in response to
certain ethical dilemmas may be reduced by the use of an
Advance Directive.105
This report by the President’s Commission106 on the making of health care
decisions recognised the legal origins of informed consent and claimed
that it was primarily a moral requirement, based on self-determination but
involving shared decision-making. It ‘strongly affirms the supremacy of
104 USA, President’s Commission Report – ‘Deciding to Forego Life-Sustaining Treatment’ (1983) <http://bioethics.georgetown.edu/pcbe/reports/past_commissions/deciding_to_forego_tx.pdf> 105 Age Concern Institute of Gerontology, Centre of Medical Law and Ethics: The Living Will - Concern to Treatment at the End of Life, A Working Party Report (1988) 46 106 USA, President’s Commission Report (n 104)
45
patient autonomy and commended the wider exchange of information and
opinions between doctors and patients’.107
In conclusion, importance shall be given to the education of the general
public as well as health care professionals on Advance Directives and the
central issues that surround it. It is fundamental that the legislator makes a
reference to this aspect of education when drafting the law. Only this shall
ensure the proper and beneficial application of Advance Directives in
Malta.
107 Age Concern Institute of Gerontology, England (n 105), 46
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Chapter 3
THE VALIDITY OF ADVANCE DIRECTIVES
3.1 Introduction
Advance care planning is amongst the main functions of a law on
Advance Directives, which seeks to ensure timely access to safe, effective
care and continuity in how to best manage the patient’s care and to meet
the patient’s needs. This needs to be done through an early and sensitive
discussion with the patient, and by following the necessary procedural
requirements to ensure the validity of an Advance Directive.108
The General Medical Council (GMC) established guidelines on treatment
and care towards the end of life,109 in order to address situations where a
patient under care has a condition that will impair his capacity as it
progresses, or where loss or impairment of capacity are foreseeable.110 A
discussion between the doctor and his patient, which must be recorded in
an advance care plan, such as an Advance Directive, should cover:
i. The patient’s wishes and future preferences with regard to health
care;
ii. The feelings, beliefs or values that may impact the decision of
the patient;
iii. The involvement of family members or persons close to the
patient in decisions relating to this care;
iv. Interventions which may be considered or undertaken in an
emergency, such as cardiopulmonary resuscitation (CPR);
v. The preferred or most beneficial place of care;
108 General Medical Council, Treatment and care towards the end of life: good practice in decision making (2010) 31, Point 50
109 ibid 110 ibid, Point 53
47
vi. Religious, spiritual or other personal support required by the
patient.
In the United Kingdom, the patient’s right to refuse treatment exercised
through an Advance Decision was confirmed in the English judgment Re
T,111 in which the court outlined a number of conditions that must be
satisfied for an Advance Decision to be legally valid:
i. The patient must be competent at the time of the declaration;
ii. The patient must be informed in broad terms about the nature
and the effect of the procedure;
iii. The patient must have anticipated and intended the refusal to
apply to the circumstances that subsequently arise;
iv. The patient must be free from undue influence when issuing the
declaration.112
The legal weight of valid Advance Decisions was subsequently supported
by the House of Lords in the 1993 Bland113 judgment, in which the plaintiff,
Airedale NHS Trust, filed an application requesting the court to allow the
withdrawal of all life sustaining treatment, including Artificial Nutrition and
Hydration (ANH), in order that the Persistent Vegetative State (PVS)
patient may die peacefully and in dignity. Such declaration was granted by
the High Court and affirmed by the Court of Appeals and the House of
Lords, on the basis that ANH is considered as medical treatment that can
be legitimately withdrawn or withheld from a mentally incompetent patient
by doctors, where that person previously, while competent, made a legally
binding Advance Directive requesting the refusal of food and fluids should
they become incompetent.
111 Re T [1992] 4 All ER 796-797 112 Kessel A. S. and J. Meran, Advance Directives in the UK: Legal, Ethical and Practical Considerations for Doctors (British Journal of General Practice, May 1998) 113 Airedale NHS Trust vs Bland [1993] 1 All ER 821
48
This position in support of Advance Directives was taken further in the
case Re C114 on refusal of medical treatment, in which the Court was
prepared to endorse an Advance Decision. This is considered as a
landmark judgment since it made the advanced refusal of treatment
legally binding under common law. The court ruled that the patient was
competent to refuse medical treatment at the time that the request was
made, establishing the competence test, which later became known as
the Re C Test.
The General Medical Council also lays down the main considerations that
are taken into account in the UK when assessing the validity and
applicability of an advance refusal of treatment that has been recorded in
the patient’s care plan. These include:
i. The age of the patient, set at 18 years old and above;
ii. The capacity of the patient;
iii. The patient was not subject to undue influence while making the
decision;
iv. Adequate information was provided to the patient;
v. Where the decision relates to treatment that may prolong life, the
advance refusal must be made in writing, signed and witnessed,
and include a statement that it is to apply even if the patient’s life
is at risk;
vi. The decision has not been withdrawn by the patient;
vii. The patient has not appointed a proxy to make such decisions on
his behalf;
viii. More recent actions or decisions of the patient are clearly
inconsistent with the terms in the advance refusal document, or
in some way indicate that he has changed his mind.
Moreover, for an advance refusal to be applicable in the UK, certain
considerations must be taken into account, including:
114 Re C [1994]1 WLR 290
49
i. Whether the decision is applicable to the patient’s current
circumstances and the particular treatment about which the
decision is made;
ii. Whether the decision specifies particular circumstances in which
the refusal of treatment should not apply;
iii. When was the decision made and whether it has been reviewed
or updated since then;
iv. Whether there are reasonable grounds for believing that
circumstances exist which the patient did not anticipate and
which would have affected his decision if anticipated.
The situation in Malta, however, is very different since Advance Directives
are not popular and Maltese law is silent on this subject matter.115
Generally in Malta, when a patient has lost his decisional capacity, the
medical team consults the patient’s family to learn more about the
patient’s wishes. Decisions are therefore taken on behalf of the patient,
setting aside the principle of patient autonomy, as the patient would not
have made any explicit requests with regards to decisions being taken
about his own medical care.116 Effective advance care planning should be
given prominence in health care services in Malta and should be amongst
the basis on which the promulgation of legislation on Advance Directives
is made. Clarity and consistency in the rules regulating Advance
Directives lie amongst the primary goals of this thesis, and this is achieved
mainly by making reference to the abovementioned sources, the General
Medical Council guidelines on treatment and care towards the end of life
and good practice in decision making in force in the United Kingdom.
115 Mallia P., ‘The Advance Directive’ (Appendix 1), in M. N. Cauchi, Bioethical Issues at the Beginning and End of Life (Ministry of Health, 2002) 116 ibid, 136
50
3.2 Formalities: The Procedural Aspect of Advance Directives
Several procedural concerns need to be addressed in the discussion to
regulate Advance Directives in Malta. A statute must regulate the way a
Directive should be drafted and when does it become enforceable,
amongst other matters.
According to the English Mental Capacity Act of 2005, for instance, an
Advance Decision should be executed by a person who has attained
eighteen years of age, after he has been informed of a diagnosis.117 This
creates the advantage that the instructions are established in the context
of the actual, rather than the hypothetical, choices to be made. Under
English law, an Advance Directive is only valid if it specifies the treatment
in question, or if ‘there are reasonable grounds for believing that
circumstances exist which the patient did not anticipate at the time of the
Advance Decision, and which would have affected his decision had he
anticipated them’.118 This means that Advance Decisions have to be
drafted with sufficient precision to cover the treatment in question.
However, at times it becomes inevitable for patients to fail to anticipate
important factors, so this is also taken into account when an Advance
Decision is evaluated.
The Mental Capacity Act requires the patient to have capacity the moment
the Advance Decision is drawn up. However, it only gains relevance and
becomes enforceable the moment he loses such capacity to consent to a
treatment, which has been proposed to be carried out or continued.119 The
Mental Capacity Act also limits Advance Decisions to ‘negative’ decisions,
that is, decisions to refuse treatment. Therefore, an Advance Decision
cannot be used to compel a medical professional to provide treatment.
Moreover, amongst other criteria, the law in England lays down that if the
117 Mental Capacity Act, 2005, Article 24 118 Mental Capacity Act, 2005, Article 25(4) 119 Mental Capacity Act, 2005, Article 25(3)
51
Advance Decision rejects life-saving treatment, it must be in writing,
signed by the patient and witnessed by a third party.120 The patient should
also make a statement to the effect that the decision is to be respected
even if his life is at risk.121
Another salient principle, established within the English judgment HE vs A
Hospital NHS Trust,122 is that in the event that the patient requires life-
saving treatment and it is unclear whether an Advance Decision is
applicable, the presumption must be in favour of life. A court may also be
reluctant to rely on an Advance Decision refusing life-saving treatment, if
there is evidence that the patient acted in a way which indicates that such
refusal no longer represents his wishes.123
3.2.1 The Living Will in Malta
Three requisites are considered as important in order that a living will may
achieve its purpose of providing effective end-of-life medical care for the
patient:
i. The terms in the declaration should reflect what the person
considers to be the circumstances in which it must be used, also
known as the triggering event;
ii. These circumstances should be identifiable;
iii. The recommendations contained in the declaration should be
capable of being implemented within the accepted ethical and
legal standards of medical practice in the respective country.124
120 Mental Capacity Act, 2005, Article 25(6) 121 Mental Capacity Act, 2005, Article 25(5) 122 [2003] EWHC 1017 123 Herring J. (ed.), Medical Law and Ethics, (Oxford University Press, 2008) 158-159 124 HE vs A Hospital NHS Trust [2003] EWHC 1017, 49
52
Authoritative opinions on whether there should be a particular model act
on which the legal document containing the living will is based are divided.
Essentially, correct interpretation of a living will is ensured if the text is
carefully drafted, with particular attention directed to the event125 that will
trigger the effect of the living will, and to the procedures to be carried out
when the time for implementation arrives. With regards to whether
instructions should be specified in a general or specific way, Spencer126
opines that:
The patient ordinarily trusts his physician not only to act in his best interests during his life but also to see that his death is as comfortable, decent and peaceful an event as possible. This is an implied trust that he may not want to verbalise or discuss.127
This statement unequivocally reflects the physician’s role in his vocation
and implied responsibility to take care of his patient, which does not have
to be specified in an Advance Directive. Another interesting approach is
put forward by ‘The American Legal Advisors Committee of Concern for
Dying’, which proposed a ‘Model Act for the Right to Refuse Treatment’.
Their recommendation regarding how an Advance Directive should be
phrased reads that ‘no specific form or document is included because we
believe the individual’s wishes will be more likely to be set forth if their
own words are used’.128
In Malta, the law will require the relevant authorities to establish a
standard application form, which should be reviewed and updated on a
regular basis. This standard application form must avoid ambiguities and
ensure certainty with regard to the wishes of the patient. By making
reference to the draft of a Combined Advance Directive, which has been
125 The event is usually incompetence, or incompetence combined with an illness. 126 Spencer S.S. (1979) 127 Spencer S.S. (1979), ‘Code’ or ‘No Code’: A non-legal opinion, New England Journal of Medicine: 300: 138-40 128 Legal Advisors Committee of Concern for Dying (1983) ‘The right to refuse treatment: A model act’, American Journal of Public Health, 73: 918-21.
53
included in the Appendix of this thesis,129 a Maltese Living Will Declaration
made by an attending physician for his patient while still in sound mind,
will state that medical treatment which merely prolongs his death shall be
withheld or withdrawn if he is in an incurable or irreversible mental or
physical condition with no reasonable expectation of recovery.
Nevertheless, palliative care and other measures to keep him comfortable
and relieve him from pain, ensuring a dignifying death, shall be
compulsory.
Another declaration relating to the obligation of the attending physician,
family and any person involved in the care of the patient, to act according
to the patient’s wishes, shall be included in the Living Will Document, who
shall not be held civilly or criminally responsible for their actions if they
carry out the instructions in good faith.
Nevertheless, such legal document should avoid statements that entirely
refuse certain treatment under all circumstances. Alternatively, the focus
should be on general end goals and the best interests of the patient rather
than specific medical procedures. Therefore, the third part of the
Combined Advance Directive, included in the Appendix of this thesis,
should be excluded from Malta’s living will standard application form.
Since the draft document in the Appendix of this thesis is a combined
document, it provides for a Proxy Designation Clause, such that if the
patient becomes unable to communicate his instructions as stated above,
a person shall be designated to act on his behalf. This would serve as
guidance to the designated person in the execution of the living will.
Finally, the signature of the patient as well as the signature of the
attending physician who has drawn up the living will shall be made at the
end of the document. The presence of two competent witnesses should
also form part of the procedural requirements, together with their
129 Appendix (i) Draft of an American Combined Advance Directive taken from Age Concern Institute of Gerontology, Centre of Medical Law and Ethics: The Living Will - Concern to Treatment at the End of Life, A Working Party Report (1988)
54
signatures and the signature of the lawyer who has assisted in the
drawing up of the living will, mainly as a safeguard against coercion.
Similarly to testamentary wills, the date is also significant especially in the
case where a patient has more than one living will. The most recent
directive shall override an older one. The date shall be added next to the
signature of the patient.
3.2.2 The Lasting Power of Attorney in Malta130
The procedural requirements applicable to living wills also apply in the
case of a lasting power of attorney for health care. A Maltese law on
Advance Directives shall provide that when a patient of sound mind
exercises his right to have a legal power of attorney for health care, a
legal document is drawn up, in which one person, the principal, names
another person, the agent or proxy, to make decisions on his behalf in
relation to end-of-life medical care. A power is lasting if it remains legally
effective, and only becomes effective when the principal becomes
incapable of making health care decisions. Amongst the procedural
requirements, a request for a power of attorney shall be drafted in writing
and signed by the relevant parties.131
Both the principal and the agent are presumed to have the required
capacity and to be of sound mind on entering such an agreement. A
person of sound mind means that he has the ability to understand and to
communicate the decision to execute a lasting power of attorney for health
care and the effect of the document. Section 2(7)(a) of the English
Enduring Powers of Attorney Act132 provides that a power of attorney
cannot be an enduring power unless, when he executes the instrument
130 A person appointed by the patient to make decisions on his behalf when he becomes incapacitated. 131 This is reflected in Article 1 of the UK Statute Law, Enduring Powers of Attorney Act (1985) Chapter 29, which clearly establishes that an enduring power of attorney is to survive the mental incapacity of a donor. 132 Enduring Powers of Attorney Act, 1985
55
creating it, the attorney is an individual who has attained eighteen years of
age and is not bankrupt. A power of attorney also requires the presence of
two competent witnesses when creating it; however, the person in whose
favour the power of attorney is executed shall not be considered as a
competent witness.
Article 2(1) of the English Enduring Powers of Attorney Act133 lays down
three conditions for a power of attorney to be considered as a lasting
power within the meaning of the same Act. The instrument which creates
the power shall be:
i. In the prescribed form;
ii. It shall be executed in the prescribed manner by the donor and
the attorney; and
iii. It shall incorporate, at the time of execution by the donor, the
prescribed explanatory information.
The law in Malta shall state that a legal power of attorney for health care
becomes operative when an attending physician determines that his
patient lacks decisional capacity and becomes unable to give his informed
consent. In the case where the desires and views of the patient are known
to the proxy, the latter shall decide according to the principle of
‘substituted judgment’. This signifies that the agent’s decision is based on
the known wishes of the principal; therefore the agent makes the
decisions which the principal would have made. On the other hand, where
the desires and views of the patient are not known, the ‘best interests’
criterion shall be applied, meaning that the decision taken is objectively
deemed to be in the best interests of the principal, even if it is not the
decision the latter would have made.
Within this context, the US President’s Commission report inclines
towards the criteria of ‘substituted judgment’ which promotes the
56
underlying values of patient autonomy and self-determination better than
the ‘best interests’ standard does. However, it claims that when the
patient’s wishes or views are unknown, the agent should resort to the
‘best interests’ standard and decide according to what will promote the
patient’s well being as it would probably be conceived by a reasonable
person in the patient’s circumstances.134
Terms of limitation on the agent’s power135 could also be specifically
defined within the draft creating the power of attorney. For instance, the
law in Malta shall preclude a proxy from appointing a substitute or
successor to take the decisions in his stead, in the event that he would not
be able to execute the instructions in the legal power of attorney. Such
decision should instead be left in the hands of the court. Furthermore, the
agent may subscribe to a disclaimer stating that he shall not be compelled
to make a decision on behalf of the principal. If a disclaimer is expressly
made, it shall not be valid unless the attorney gives notice of it to the
principal while still competent, or, if he is not, by notice to the court.136
The Maltese law in relation to the legal power of attorney should also
provide for the event of suspicion of bad faith or unreasonable
interpretation by the agent, in which case the agent’s decision may be
challenged. A case review will be carried out by the relevant authorities,
based on specified grounds set out in the law.137
Neither the durable power of attorney nor the living will is a simple
document and should not be treated as such. Both should be drafted to
meet an individual’s beliefs and needs. The law should oblige a patient to
consult a trusted lawyer as well as his physician and spiritual leader about
134 Jonsen A. R., R. M. Veatch and L. Walters, Sourcebook in Bioethics (Georgetown University Press,1998) 182 135 Eg. Delegation of power in case of the agent being temporarily or permanently unable or unwilling to act. 136 Enduring Powers of Attorney Act, 1985, Article 2(11) 137 Age Concern Institute of Gerontology, Centre of Medical Law and Ethics: The Living Will - Concern to Treatment at the End of Life, A Working Party Report (1988) 77
57
the prospect of creating an Advance Directive. This ensures that all
aspects, especially the legal, medical and spiritual are covered.138
Bureaucratic paperwork and complicated procedures must be avoided
when drawing up an Advance Directive in fulfilment of the formalities set
out by the law. The procedure should be easy to comprehend, taking into
account the vulnerability of the elderly or the circumstances surrounding
the person requesting the Advance Directive.139
Furthermore, the Maltese law shall provide for the establishment of an
Advance Directive Registry, a national electronic registration system for
both living wills and legal power of attorney for health care, where a copy
of the latest version of a person’s Advance Directive, identified by its
unique registration number, shall be kept.
An Advance Directive drawn up by the attending physician on the request
of his patient will be completed as soon as it is registered in the Advance
Directive Registry, the regulatory procedure of which is to be decided by
the relevant authorities. An Advance Directive ID Card, containing the
personal details of the patient together with his signature, the date of
registration and the registration number, will then be handed to the patient,
as evidence that an Advance Directive exists in his name. Such ID card
shall be valid for a fixed period of time, on the expiration of which the
Advance Directive will be deemed invalid. The Registry shall also agree
that personal information of the registered person shall remain private and
confidential, as in the case of medical records.
The person registered shall be contacted on a regular basis by the
Registry, in order to confirm that the patient has not amended or revoked
his Advance Directive, as well as to confirm his actual contact information
138 Gleason K., Going Home to the Father – A Catholic Perspective on End-of-Life Care (2001) 12 139 Age Concern Institute of Gerontology, England (n 137) 54
58
and other personal details. This will ensure that the document consistently
represents the patient’s views.
Such electronic registration will render a patient’s Advance Directive
accessible to those involved in his end-of-life care, namely his attending
physician, his lawyer, his family members and any person holding a legal
power of attorney. Accessibility of the document takes place by entering
the registration number found on the Advance Directive ID card in the
Registry’s secure automated system. This would ensure the
implementation of the wishes of the patient. A hard copy of the Advance
Directive shall also be kept in the patient’s medical report.
Revocation of the Advance Directive should be allowed at any time, by
way of requesting its removal from the Advance Directive Registry, on
satisfying the established regulatory procedure. Similarly to the
requirement of the element of competence for the drawing up of a will, a
living will cannot be revoked by a person who is incompetent.
Furthermore, the Mental Capacity Act of 2005 in England provides that an
Advance Decision may be held to be invalid where the patient, who has
capacity:
i. Has withdrawn the Advance Decision;
ii. Has created a lasting power of attorney after making the
Advance Decision, and has given the agent the power to make
the decision in question; or
iii. The patient has done an act which is clearly inconsistent with the
instructions in the Advance Decision.140
The above provision shall also apply to an Advance Directive in Malta,
with regard to the circumstances that will render the patient’s instructions
invalid. In addition, similarly to the Enduring Powers of Attorney Act, the
law shall provide that bankruptcy of the agent is amongst the conditions
140 Mental Capacity Act, 2005, Article 25
59
for revoking such legal power. Such revocation is made by the court on
exercising its powers.141
With regard to the duration of an Advance Directive, it shall be valid for a
fixed period of time to be agreed by the relevant authorities, subject to
renewal on a regular basis, due to the probability of change in the
circumstances surrounding the patient. A patient may also carry out
changes in the instructions given in a legal power of attorney or the
designation in light of changed circumstances.
No civil liability or criminal prosecution shall be incurred by the attending
physician, if he reasonably and in good faith and after appropriate
consultation, executes the living will. To the contrary, if he deliberately
disregards the instructions of an Advance Directive, such physician shall
be requested to appear before a medical board so that a sanction may be
applied against him.142 The legislator shall also take this into consideration
when drafting the law in Malta.
Finally, if a patient has life assurance policy, as foreseen by the English
Working Party on Bioethics,143 the execution of a living will shall not have
any impact upon the terms of an existing policy. Moreover, the law in
Malta shall include that instructions to forego life-sustaining treatment
should be regarded as invalid where the patient is pregnant.144
141 Enduring Powers of Attorney Act, 1985, Article 2(11) 142 Age Concern Institute of Gerontology, England (n 137) 54 143 ibid
144 ibid
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3.3 The Advantages of a Combined Advance Directive
There are different views as to which kind of Advance Directive, the living
will or the legal power of attorney for health care, is the more
advantageous. For instance, reaching a compromise in the way a living
will should be drafted is usually the hardest part and striking a balance
between terms which are too general and those which are too specific is
sometimes unattainable.
On the one hand, if the declaration is too general, it might fail to achieve
the goal of patient autonomy because a large measure of discretion will
need to be left with the doctor. On the other hand, if it is too specific, it
may not be able to cover generalities, while if it is too general, it may not
be good enough to deal with the specific problem.
A lasting power of attorney for health care is considered as the preferred
option and most consistent with Catholic teaching. It enables the agent to
respond to the particularities of the patient’s actual circumstances and to
make a decision in response to them. The agent becomes the patient’s
‘voice’ in the event of loss of decisional capacity.145
The disadvantage of the lasting power of attorney is the possibility of
abuse by the person in whose favour the power of attorney is issued, who
may be subconsciously influenced by improper considerations.146 Persons
with an interest may be prevented from acting as witnesses, but they are
usually the very persons chosen, and hence they cannot be excluded from
the power of decision-making under a lasting power of attorney. Like in
the case of mandate or power of attorney in legal or business matters, in
this case trust is a crucial element.
145 British Medical Association Ethics Department, Medical Ethics Today, The BMA’s Handbook of Ethics and Law (2nd Edition, 2004) 10 146 Eg. The prospect of release from the burden of caring for the patient at home.
61
With regard to the procedure in the execution of an Advance Directive, the
case of a power of attorney is naturally more cumbersome and entails a
higher degree of responsibility on part of the agent, as opposed to the
living will declaration, where the attending physician primarily acts
according to the instructions therein. This follows that where the agent is
suitable for the purposes of executing the power of attorney in the best
interests of the patient, the power of attorney becomes more
advantageous than a living will. To the contrary, in the case where a
suitable agent is lacking, the living will becomes more advantageous.
The most advantageous option which should be adopted by the law on
Advance Directives in Malta for various reasons is the ‘Combined
Document’ option. In a situation where a living will gives rise to uncertainty
due to the way it has been drafted, a Combined Advance Directive would
allow the chosen agent to contribute in a more effective manner to the
decision–making process. Furthermore, the statement of wishes
contained in the living will declaration may be used to provide guidance to
the agent in his execution of the will.
In the likely event that a person executes a living will and a legal power of
attorney in separate instruments, the Maltese legislator should clarify
whether the more recent document between the two should revoke the
earlier one, or whether the power of attorney should be construed as
designed for the implementation of the living will.
The advantages of having a Combined Advance Directive are expressed
by the US President Commission Report,147 which asserts that by
combining a lasting legal power of attorney for health care with specific
instructions in a living will, the patient’s representative could control both
the content and the process of decision-making on medical care in the
case of incapacity of the patient. This is because the patient would be
147 USA, President’s Commission Report – ‘Deciding to Forego Life-Sustaining Treatment’ (1983) <http://bioethics.georgetown.edu/pcbe/reports/past_commissions/deciding_to_forego_tx.pdf>
62
allowed to define his desires and views with regards to end-of-life
circumstances, and to name an individual to make decisions on his behalf,
consistent with the desires as expressed in the declaration through a
combined Advance Directive.
Thus, a Maltese law on Advance Directives which encourages patients to
complete both documents guarantees the most comprehensive guidance
regarding their care. The law should also require that the basis for any
decision taken is carefully documented in the medical notes of the patient.
Any decision shall be reviewed before and after the implementation, as
appropriate, in order to take into account any changes of circumstances.
Comfort, care and emotional support to the patient and his family
members shall be ensured at all times. The emotional and psychological
burden on the staff involved with the withdrawal or the withholding of life-
sustaining treatment should also be recognized, and the relevant support
mechanisms should thereafter be made available.
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Chapter 4
LIFE-SUSTAINING TREATMENT IN THE TERMINALLY ILL AND ARTIFICIAL
NUTRITION AND HYDRATION (ANH)
4.1 Introduction
Following an examination of the requirements that shall be taken into
consideration when drafting the law on Advance Directives in Malta, this
thesis proceeds to evaluate the other important considerations of Advance
Directives. Of significance is the concept of life-sustaining treatment and
whether there are instances where it can be withheld or withdrawn.
The element of competence of the patient when he requests an Advance
Directive and while it is drawn up by his attending physician is a major
underlying factor of Advance Directives. English law holds that only a
legally competent person is empowered to make treatment choices,
whether in a written form or not. The element of competence is significant,
thus if the individual is not competent to make a decision and he does not
have an Advance Directive, the doctor can legally provide the life-saving
treatment.148
In a key judgment, Re B149 revolving around the subject of refusal of
medical treatment, the patient made it clear that she wanted to have the
ventilator turned off. Her clinicians accepted that Ms B was competent to
make such a decision to withdraw treatment; however they could not
abide to her request due to emotional reasons. In response, the patient
reiterated the fundamental principle that:
If [...] the patient, having been given the relevant information and offered the available options chooses to refuse, that
148 Re MB (Caesarean Section) [1997] 2 FCR 541 149 Re B (Adult: Refusal of Medical Treatment) [2002] 2 FCR 1
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decision has to be respected by the doctors. Considerations of the best interests of the patient were irrelevant.150
The fact that the doctors felt that her decision was wrong did not justify
their decision to ignore it. The court ruled that by refusing to follow her
instructions, the doctors acted unlawfully and were responsible for
damages.151
A fundamental statement that the right to determine issues surrounding
one’s death was an aspect of private life was made in the Diane Pretty
Case,152 which also reached the European Court of Human Rights. The
ECHR Court held that:
In an era of growing medical sophistication combined with longer life expectancies, many people are concerned that they should not be forced to linger on in old age or in states of advanced physical or mental decrepitude which conflict with strongly held ideas of self and personal identity.153
The English Mental Capacity Act of 2005 clarifies that in issues
concerning life-sustaining treatment, the physician must not intend to
cause the death of a patient when determining whether the treatment
proposed is in the best interests of the person concerned.154
Doctors are required to comply with any effective applicable Advance
Directive issued by a patient stating that he does not wish to receive life-
sustaining treatment. If there is no effective Advance Directive, the ‘best
interests’ standard applies. Furthermore, judicial permission should be
obtained before hydration and nutrition are withdrawn from a patient in a
persistently vegetative state (PVS).155
150 ibid, para. 100 151 ibid 152 Pretty vs the United Kingdom [2002] 153 ibid, 65 154 Mental Capacity Act, 2005, Article 4(5)
65
This is in line with the position taken by the House of Lords in Airedale
NHS Trust vs Bland.156 Mr. Bland had been in a coma for three years and
was diagnosed as suffering from PVS. Both his family and his medical
team sought a declaration from the courts to the effect that it was lawful to
switch off the life support machine and cease giving him nutrition and
hydration. It was held that the doctor’s duty towards Mr. Bland was to
provide him with treatment that was considered in his best interests. The
judgment went on to say that continued treatment for the patient in
question would neither harm him but nor would it be in his best interests,
according to general medical professional opinion, protecting the doctor
from liability if he switched off the life-support machine. In this case, the
withdrawal of artificial hydration and nutrition was also justifiable because
it was part of the general medical treatment being given to Mr. Bland and
was not benefiting him.157
The British Medical Association Ethics Department issued guidance in
relation to the withholding and withdrawing of life-prolonging medical
treatment. The guidance establishes that the artificial provision of food
and water is considered as medical treatment, which can therefore be
withdrawn under the Bland ruling. However, this is based on the condition
that it no longer promotes the best interests of the patient.158
155 A patient suffering from Permanent Vegetative State is still alive as he has not yet suffered brain death. Even though the switching off of the life support machine may result in the patient’s death, no legal consequences will arise under common law since such an act is considered as an omission (BMA (2007b) and Auckland Area Health Board vs A-G [1993] (New Zealand)) in J. Herring (ed.), Medical Law and Ethics, (Oxford University Press, 2008) 454-5.
156 Airedale NHS Trust vs Bland [1993] 1 All ER 821 157 ibid 158 British Medical Association Ethics Department (1999), Withholding and Withdrawing Life-Prolonging Medical Treatment: Guidance for Decision Making (BMA).
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4.2 The Distinction between Medical Care and Basic Care
The court in Airedale NHS Trust vs Bland distinguished between basic
and advanced medical care. Whilst it is appropriate to remove medical
procedure on the instructions of a patient, through an Advance Directive
or otherwise, or on the basis that it is in the patient’s best interests, it is
not appropriate to withdraw basic care, such as feeding or cleaning. To
permit the withdrawal of sustenance may also lead to the dangerous
approach of the slippery slope, as it may seem to permit the death of a
person, not from an illness, but from the lack of basic provision.
Furthermore, expert evidence given in the above case found that in
certain circumstances, artificial feeding and hydration may worsen a
patient’s medical condition.159
The above ruling was reaffirmed in A Hospital vs SW,160 which established
that the Bland decision was still the law.
The Welby Case,161 an Italian judgment, also caused controversy on
whether the withdrawal of artificial ventilation was justified in view of the
patient’s deteriorated condition. The Health Council (Consiglio Superiore
di Sanita’) issued a declaration that the artificial ventilation provided to
Welby was not futile, and amongst the reasons was that artificial
ventilation in Welby’s case was not ‘medical treatment’ but ‘normal care’,
and therefore it could not be withdrawn. The other reasons were that his
condition was severe but his death was not ‘imminent’, and that the
artificial ventilation served to improve his quality of life, as it supported his
cardiovascular, renal and cognitive functions.162 Despite this declaration,
159 Herring J. (ed.), Medical Law and Ethics, (Oxford University Press, 2008) 158-159; Expert evidence given in R (Burke) vs General Medical Council [2005] 3 FCR 169. 160 [2007] EWHC 435 (fam) 161 Welby, Tribunal of Rome, 16 December 2006, Giurisprudenza di merito 2007:996; Tribunal of Rome, 22 October 2007, Bioteca 2007 162 Griffiths J. & H. Weyers, M. Adams, Euthanasia and Law in Europe (Hart Publishing, 2008) 402
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in December of the year 2006, the withdrawal of ventilation accompanied
by intravenous administration of sedatives and pain-killers163 took place
on Welby’s fully voluntary and well-considered request. Rather than
ceasing basic or normal care, this action was described as stopping an
unwanted invasion of the body of the patient, at the patient’s request. The
case was clearly one of refusal of life-sustaining treatment by a competent
patient, a right enshrined in Articles 20 and 35 of the Medical Ethical
Code164 and Articles 13 and 32 of the Constitution,165 and the doctor had a
correspondent duty to comply with Welby’s request to cease all vital
support.166
A strong debate also ensued in the Italian courts when a petition was
submitted demanding the withdrawal of artificial nutrition and hydration
(ANH). The Englaro Case167 concerned a woman who was involved in a
car accident, and after two months in a coma, started to breathe
spontaneously. For this reason, she was subjected to Artificial Nutrition
and Hydration (ANH) since her car accident in the year 1992, even though
a very reliable prognosis that she would never regain consciousness could
be made, due to the severe brain damage she had suffered. It is held that
Persistent Vegetative State (PVS) patients have a life expectancy of
several years if ANH is maintained.168
The petition submitted by her father, Englaro, in the capacity of a
guardian, was rejected by the court on the grounds that the Italian legal
163 ibid, 404; The dose of sedatives and pain-killers had been within the limits established by the professional protocols regulating palliation, hence breaking the causal link between Welby’s death and the injection. 164 The Italian Code of Medical Ethics (Codice Di Deontologia Medica, 1995) 165 Costitutione della Repubblica Italiana 166 Griffiths J. & H. Weyers, M. Adams (n 162) 405; This was reaffirmed in the preliminary hearing against Welby’s doctor, which was subsequently quashed by the magistrate herself (Tribunal of Rome, 22 October 2007. Bioteca 2007(3):5) 167 The Englaro Case (final disposition of case) Supreme Court, first Civil Chamber, 16 October 2007, no 21748, Il foro italiano 2007, I, 3025 168 Griffiths J. & H. Weyers, M. Adams (n 162) 410
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system grants unconditional protection to human life.169 His appeal from
this ruling was also rejected by the Court of Appeals, which held that in
the current state of the scientific debate, ANH must be regarded as ‘basic
care’ and as such cannot be withdrawn.170
Consequently, a ‘Working Group on Nutrition and Hydration in Irreversibly
Unconscious Patients’, entitled the ‘Oleari Commission’, was appointed in
order to examine the notion of ANH. It was concluded that on the basis
that ANH constitutes medical treatment, decisions to withdraw nutrition
and hydration are legitimate, if based on the will of the patient expressed
before becoming incompetent. In the absence of such an expression of
will, decisions should be made by the patient’s guardian. Therefore, the
withdrawal of nutrition and hydration should be possible if requested by
the guardian and authorised by the guardianship magistrate.171 In the
belief that the Oleari Report had put an end to this controversy concerning
the legal status of ANH, Englaro lodged a new claim, which was however
rejected again, due to the lack of official statements of the College of
Physicians; reference to the ‘full protection of life’ upheld by the Italian
legal system was made once again.172
A submission of evidence by Englaro that his daughter, before becoming
incompetent, had expressed the wish not to be kept alive in a condition of
permanent unconsciousness, was also rejected by the Court of Appeal,
claiming that Advance Directives carry no legal status in Italy and provide
no legal ground for decisions to withdraw treatment. The court also noted
that the Oleari Report had no binding effect on the court.173 The following
year, Pope John Paul II affirmed the position of the Catholic Church that
persons suffering from PVS had the right to basic health care, the right to
appropriate rehabilitative care and to be monitored for clinical signs of
169 ibid, 411; Court of Lecco (1999) 170 ibid, 411; Court of Appeals of Milan (1999) 171 ibid, 411 172 ibid, 411; Tribunal of Lecco (2002) 173 Court of Appeal of Milan (2003)
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eventual recovery. He stressed that the administration of water and food,
even when provided by artificial means, always represents a natural
means of preserving life, not a medical act. Nevertheless, this is true in so
far as and until it is seen to have attained the benefits of providing
nourishment to the patient and alleviation of his suffering.174
An advisory document issued by the National Bioethics Committee on
Artificial Nutrition and Hydration (ANH) and the Permanent Vegetative
State (PVS) in 2005, gave rise to conflicting opinions by the Committee
members. The majority of the members supported the statement that ANH
is considered as ‘basic care’. Subsequently, a dissenting statement was
issued in response, to the effect that ANH must be regarded as ‘medical
treatment’ that can be withdrawn at the patient’s request, or at the request
of a representative acting by proxy, or by the doctor himself on the
grounds of ‘best interests’ or ‘substituted judgment’. Reference was made
to the Advance Directive, through which one may also refuse ANH, since
a competent patient has the right to refuse any treatment on grounds of
Article 51 of the Medical Ethical Code.175
The landmark ruling was given in the year 2007,176 following the reversal
of the decision of the lower courts, by the Supreme Court. It held that ANH
amounts to medical treatment, meaning that it can be withdrawn in cases
where the patient is in a Persistent Vegetative State. Nevertheless, two
conditions must be present for this to apply:
i. The patient’s condition must be medically irreversible;
ii. There must be a clear indication that this is what the patient
would have wanted.177
174 John Paul II (2004) International Congress on "Life-Sustaining Treatments and Vegetative State: Scientific Advances and Ethical Dilemmas". 175 Griffiths J. & H. Weyers, M. Adams (n 162) 412 176 Supreme Court, First Civil Chamber [2007], no 21748; Il Foro Italiano, 2007, I, 3025 177 Griffiths J. & H. Weyers, M. Adams (n 162) 413
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4.2.1 The Use of the Words ‘Ordinary’ and ‘Extraordinary’
A distinction is drawn between ordinary treatment, which doctors are
obliged to provide to their patients, and extraordinary treatment, which
they are not obliged to provide. In these circumstances, the question as to
what extent should a doctor prolong the life of a patient arises, combined
with the need to protect the dignity of the patient at the end of his life. In
the case NHS Trust v Ms D & Mr and Mrs D178 it was argued that the PVS
patient:
...should be allowed as dignified a passing as is achievable. Some might say that her dignity has already been severely compromised by the progress and incidence of this awful disease. To subject her body to further grossly invasive procedure can only further detract from her dignity.179
For certain commentators, the distinction is useful but the words ‘ordinary’
and ‘extraordinary’ are misleading,180 because the focus should not be on
whether the treatments are often used or not, but on whether the
treatment is proportionate or beneficial to the patient. Kelly181
distinguishes between ‘ordinary’ and ‘extraordinary’ treatment:
Ordinary means are all medicine, treatments and operations which offer a reasonable hope or benefit and which can be obtained and used without excessive expense, pain, or other inconvenience. Extraordinary means are all medicines, treatments, and operations, which cannot be obtained or used without excessive expense, pain, or other inconvenience, or which, if used, would not offer a reasonable hope of benefit.182
178 [2005] EWHC Civ 2439 (Fam) 179 NHS Trust v Ms D & Mr and Mrs D [2005] EWHC Civ 2439 (Fam) para. 44 180 USA, President’s Commission Report – ‘Deciding to Forego Life-Sustaining Treatment’ (1983) <http://bioethics.georgetown.edu/pcbe/reports/past_commissions/deciding_to_forego_tx.pdf> 181 Kelly G. (1951) 182 Kelly G., ‘The Duty to Preserve Life’, Theological Studies 550 (1951) 36
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As seen in the Bland judgment, a distinction is also drawn between
advanced medical treatment and basic care, where although it may be
legitimate to withdraw advanced medical treatment from a patient through
an Advance Directive or otherwise, it is never permissible to withdraw
basic care such as feeding or cleaning. The rationale is that to deny basic
care amounts to torture or inhuman or degrading treatment, in violation of
Article 3 of the European Convention on Human Rights. This follows that
whereas a patient has the right to refuse medical treatment, he cannot
draw up an Advance Directive refusing basic care.183
This position reflects the Catechism of the Catholic Church (CCC)184
which advocates that people whose condition has weakened are entitled
to special respect and that sick or incapacitated persons should be helped
to lead lives as normal as possible.185 The CCC strongly rejects acts of
euthanasia ‘whatever its motives and means’, labelling it as ‘morally
unacceptable’.186 It states that an act or omission which leads to death,
with the intention of eliminating suffering, amounts to a ‘murder gravely
contrary to the dignity of the human person’.187
The CCC establishes that the discontinuing of medical procedures which
are considered ‘burdensome, dangerous, extraordinary or
disproportionate to the expected outcome can be legitimate’. It explains
that in this case, death is not caused intentionally. Such a decision should
be taken by the patient if he is competent or if not, by those legally
authorised to act for the patient whose legitimate interests and wishes
must always be respected.188
183 Herring (n 159) 466 184 Cathecism of the Catholic Church (CCC), Latin text copyright (c) Libreria Editrice Vaticana, Citta del Vaticano, 1993 185 Cathecism of the Catholic Church, 2276 186 Cathecism of the Catholic Church, 2277 187 Cathecism of the Catholic Church, 2277 188 Cathecism of the Catholic Church, 2278
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The patient is however entitled to basic care, even in the case where
death is imminent. The CCC clarifies that:
The use of painkillers to alleviate the sufferings of the dying, even at the risk of shortening their days, can be morally in conformity with human dignity if death is not willed as either an end or a means, but only foreseen and tolerated as inevitable.189
The teachings of the Church therefore promote the use of painkillers
which do not aim at death but rather, are targeted against ‘over-zealous
treatment’, meaning the utilisation of disproportionate medical procedures
without reasonable hope of a positive outcome.190
The Declaration on Euthanasia by the Sacred Congregation for the
Doctrine of the Faith191 holds that the sick must be provided with the care
that seems necessary or useful. A distinction between ‘ordinary’ and
‘extraordinary’ treatment is made, claiming that in the past, moralists
believed that one was never obliged to use ‘extraordinary’ means. The
declaration establishes that the term ‘extraordinary’ is considered as
imprecise, especially due to the rapid progress made in the treatment of
sickness. For such purpose, the terms ‘proportionate’ and
‘disproportionate’ are more suitable.192 To determine whether a treatment
is proportionate to its outcome, the medical team should examine the type
of treatment proposed and establish the degree of complexity or risk and
its cost. The condition of the sick person, both physical and moral, is to be
taken into consideration.193 The refusal of burdensome treatment by a
patient implies an acceptance of the human condition or a wish to avoid
the application of medical procedures which are disproportionate to the
189 Cathecism of the Catholic Church, 2279 190 Compendium of the Cathecism of the Catholic Church, Catholic Truth Society; First Edition (2006), 471
191 Declaration on Euthanasia, Prepared by the Sacred Congregation for the Doctrine of the Faith, (Rome, 1980) 192 ibid 193 ibid
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expected results. The teachings of the Catholic Church allow such refusal
of treatment which only secures ‘a precarious and burdensome
prolongation of life’. Nevertheless, the normal care due to the sick person
must not be interrupted.194
4.3 The ‘Double Effect’ Doctrine
The doctrine of double effect is often invoked to explain the permissibility
of an action that causes serious harm as a consequence of promoting a
good end. This theory finds its popularity primarily in discussions on
palliative care and medical care for patients with terminal illness in need of
pain relief.
Pope Pius XII instructs that the doctrine of double effect implies that
administration of pain relief in doses that might hasten death is
permissible, if based upon ‘a clinical indication’ such as ‘inoperable cancer
and incurable illness’, ‘violent pain’ and ‘depression and anguish’.195
Abstention from life-prolonging treatment is justified if the soul has already
‘parted from the body’. The example Pope Pius XII gives is that of an
unconscious patient kept alive by artificial ventilation, while the withdrawal
of such life-sustaining treatment has been requested through an Advance
Directive or by the family members of the patient.196 Hence, if the doctor’s
intention is to relieve pain and not to cause death, administration of pain
relief with potential life shortening effect is justified on the basis of the
‘double effect’ doctrine.197 Thus, the suppression of pain and
consciousness by the use of narcotics is permitted by the Catholic
Church, since the intention is simply to relieve pain effectively and not to
cause death, even if the risk of it is reasonably taken. Nevertheless, the
194 Ibid 195 Pope Pius XII 1957a, Address on Catholic Doctrine concerning Anaesthesia. Acta Apostolicae Sedis 49:129-47 196 Pope Pius XII 1957b 197 Griffiths J. & H. Weyers, M. Adams (n 162) 395
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right to deprive the dying person of consciousness is qualified by the
requirement of ‘a serious reason’.198
This declaration criticises the technological advancement in medicine
when this becomes a threat to the protection of the patient at the moment
of death and abuses of both the dignity of the human person and the
Christian aspect of life, such that it becomes medically futile. This affirms
the view that it is morally acceptable to abstain from ‘disproportionate’ life-
prolonging treatments through an Advance Directive. Nevertheless,
certain criteria apply for a patient to be entitled to refuse treatment through
an Advance Directive. These include:
i. A very short life expectancy;
ii. Death must be ‘imminent’ and ‘inevitable’;
iii. ‘Normal care’ cannot be withheld.199
It is fundamental to state that at a particular stage in the dying process,
even Artificial Nutrition and Hydration may no longer be morally obligatory
when they cease to benefit the patient. Refusal of such treatment when
death is imminent is interpreted as an acceptance of the human condition.
Where the patient states his wishes and instructions through an Advance
Directive that he does not wish to have such treatment provided in time of
imminent death, he would be taking a huge burden off his family and
friends.200 This is in line with the Catechism of the Catholic Church (CCC)
which holds that discontinuing medical procedures that are burdensome,
dangerous, extraordinary, or disproportionate to the expected outcome
can be legitimate.201
198 Declaration on Euthanasia (n 191), citing Pope Pius XII’s 1957 199 Artificial nutrition and hydration falls within the category of ‘normal care’ due to the sick person - Pope John Paul II 2004, Address to Participants in the International Congress on Life-Sustaining Treatments and the Vegetative State (March, 2004) 200 ibid 201 Cathecism of the Catholic Church, 2278
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Any decision taken in such circumstances for or against the use of such
therapies should be based on the patient’s wishes, expressed by him in
writing or verbally, for instance through an Advance Directive. In the
absence of an Advance Directive, it is usually left for the family members,
as they are likely to honour the wishes and values of the patient. However,
this will not apply where, for instance, it has been determined that the
treatment is physiologically futile and it will cause him suffering.202 On the
other hand, refusing a life prolonging treatment that is not ‘futile’ is
regarded as equivalent to suicide and is therefore unacceptable. These
positions were confirmed in the New Catechism of the Catholic Church203
and again in the Encyclical Evangelium Vitae.204 It is of fundamental
importance to note that financial considerations should play no role in
medical treatment decisions.
The British Medical Association Ethics Department agreed on a number of
factors that may guide decisions relating to the prolonging of treatment
and whether such prolonged treatment provides an overall benefit to the
patient. These factors include:
i. Clinical judgment about the effectiveness of the proposed
treatment;
ii. The likelihood of the patient experiencing severe unmanageable
pain or suffering;
iii. The likelihood of irreversible loss of consciousness;
iv. The likelihood and extent of any degree of improvement in the
patient’s condition if treatment is provided;
v. Whether the invasiveness of the treatment is justified in the
circumstances.205
202 Ethics & Medicine, An International Journal of Bioethics (Vol. 25:3, Fall 2009) 203 Sacra Congregatio Pro Doctrina Fidei 1992: Paras. 2277-2279 204 Pope John Paul II (1995) Ch III, Paras. 64 - 67 205 British Medical Association Ethics Department (1999), (n 158)
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Additionally, the prior wishes and values of the patient should be
ascertained if possible, and the family should be involved, making their
views about what the patient would desire in the circumstances, known.206
4.4 The Doctor-Patient Relationship
The stronger the doctor-patient relationship is, the less likely that conflicts
or legal consequences will arise. Effective dialogue and constant
communication between the two parties is crucial, particularly in the
context of Advance Directives. Living wills cannot cover all conceivable
end-of-life decisions; it is therefore recommended that patients
communicate with their physicians and family members about their end-of-
life wishes.207
In the event that a medical professional ignores an effective Advance
Directive in which the patient requests the withdrawal or withholding of
treatment, this may give rise to a criminal or civil action. However, certain
legal systems contemplate safeguards giving protection to medical
professionals faced with Advance Directives. The Mental Capacity Act208
provides that no liability shall be incurred by the medical professional
where he proceeds with the treatment, unless at the time he is aware that
a valid Advance Directive refusing such treatment exists.209 Additionally,
protection from liability is also provided where a health care professional
withdraws or withholds treatment believing that there is a valid Advance
Decision requiring this.210
206 Working Group on Clinical Ethics, of the Hospital Authority Clinical Ethics Committee (2002) 5.4.2 207 Cachia E., ‘Why Palliative Care? Encountering Challenging Issues’, Malta Medical Journal, Vol. 20, Issue 04 (2007) 9 208 Mental Capacity Act, 2005 209 Mental Capacity Act, 2005, Article 26(2) 210 Mental Capacity Act, 2005, Article 26(3)
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Critics are concerned that this provision does not adequately protect the
right of patients incorporated within an Advance Directive211 and therefore
doctors should be required, not merely encouraged, to take reasonable
steps in order to confirm whether an Advance Decision has been drawn
up by the patient, when this is entrenched in the law. The reason
supporting the abovementioned position laid down within the Mental
Capacity Act is that Parliament believes that it imposed an obligation
which was too onerous on medical staff. Moreover, the English law
strongly encourages that in case of doubt over the validity or applicability
of an Advance Decision, an application to court should be made for a
declaration.212
The doctor, in the drawing up of an Advance Directive acts in accordance
with the best interests of the patient. The role of the doctor is crucial in
giving advice, and the establishment of a long term relationship enjoyed
by the physician with the patient’s loved ones, based on trust, goes a long
way in enhancing the understanding of what the patient truly needs. It also
ensures that the drawing up of a directive is made in the best interests of
the patient.
Morgan213 identifies four models of the doctor-patient relationship, being:
i. A paternalistic relationship, whereby the physician controls the
relationship and decides what is best for the patient;
ii. A relationship of mutuality, in which the doctor and patient are
equal partners engaged in a sharing of information and ideas,
designed to produce the best treatment for the patient;
211 Michalowski S., ‘Advance Refusals of Life-Sustaining Medical Treatment: The Relativity of an Absolute Right’, Modern Law Review 68: 958 (2005) 212 Mental Capacity Act, 2005, Article 26(5) 213 Morgan M. (2003) ‘The Doctor-Patient relationship’ in G. Scambler (ed.) Sociology as Applied to Medicine (Saunders) 61-62
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iii. A consumerist relationship, where the patient is the active and
dominant party, demanding treatment and assistance from a
doctor, whose primary role is to meet the requests of the patient;
iv. A relationship of default, in which neither party takes a leading
role. This normally leads to a non-productive result of the
encounter.214
The most ideal kind of relationship is that of mutuality, which describes the
doctor and the patient as equal partners who exchange information,
towards fulfilling the best interests of the patient.
Another interesting model of a doctor-patient relationship is that which
regards the doctor as a fiduciary. Grubb215 claims that a fiduciary
relationship develops when a patient (the beneficiary) entrusts another
(the fiduciary) with a power which may affect the beneficiary’s interest and
which is to be exclusively exercised for the beneficiary’s benefit. The
advantage of this model is that it recognises the reality that the medical
professional has the power of knowledge and authority in the relationship.
It emphasises the obligations carried by that power and insists that it is
used for the benefit of the patient.216 The element of patient autonomy is
also present since decisions are taken on the basis of an effective
dialogue between the doctor and the patient.
This communication is strongly encouraged, since, as claimed by Katz217
‘disclosure and consent seek to pierce the isolation, to eliminate the
feelings of abandonment, and to reverse the lack of control’ that patients
sometimes experience.
214 ibid 215 Grubb A. (2004) and P. Bartlett (1997), ‘The Persistent Vegetative State: A Duty (not) to Treat and Conscientious Objection’, European Journal of Health Law 4:157
216 ibid 217 Katz J. (2002) ‘The Silent World of Doctor and Patient’, 208
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4.4.1 Do Not Resuscitate (DNR)218
The doctor-patient relationship based on mutual trust constitutes an
important element in DNR orders. Kennedy219 submits that:
Confidence and trust can only prosper if the patient is treated as a partner, to be taken into confidence by his doctor, to be trusted to participate in the enterprise called treatment.220
According to medico-legal experts, the vast majority of complaints made
against doctors, whether or not resulting in litigation, arise from the
doctor’s failure to communicate properly with his patient, particularly by
withholding information.221 Patients have the right for information about
cardiopulmonary resuscitation (CPR)222 in order to be able to participate in
decision-making regarding end-of-life care. Such information includes up-
to-date details about its effectiveness and appropriate use, ensuring a
sufficient understanding of what is involved.223 Giesen224 quotes the
results of an enquiry into medical disclosure practices in Germany,
undertaken by a leading medical journalist. It concerned the extent to
which physicians communicated with hospitalised patients, or their
families or both, about whether they desire cardiopulmonary resuscitation
if it became necessary. The author concluded that only 19 %,225 had
218 Also referred to as Cardiopulmonary Resuscitation (CPR) 219 Kennedy I. (1984) 220 Kennedy I., ‘The Patient on the Clapham Omnibus’ (1984) in Giesen D., International Medical Malpractice Law – A Comparative Study of Civil Liability Arising from Medical Care (Martinus Nijhoff Publishers, 1988) 395 221 Giesen D., International Medical Malpractice Law – A Comparative Study of Civil Liability Arising from Medical Care (Martinus Nijhoff Publishers, 1988) 395 222 Eg. The BMA’s model information leaflet for patients: ‘Decisions about Cardiopulmonary Resuscitation’ (British Medical Association, 2002) 223 General Medical Council (2006), ‘Withholding and Withdrawing – Guidance for Doctors’, No. 88 <http://www.General Medical Council-uk.org/guidance/ethical_guidance/witholding_lifeprolonging_guidance.asp#cardio> 224 Giesen (n 221) 225 30 out of 154 patients were resuscitated at the Beth Israel Hospital, Boston, in 1981.
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discussed resuscitation before the cardiopulmonary arrest with an
attending medical professional.226 The competent patients227 who survived
cardiopulmonary resuscitation were then interviewed in order to compare
their actual attitudes about resuscitation, with their physician’s opinions
about their attitudes. It was found that the physician’s opinion about a
patient’s desire for resuscitation ‘correlated only weakly with the
preference expressed by the patient’.228
Cachia229 holds that it is important to identify patients for whom
cardiopulmonary arrest represents a terminal event in their illness and for
whom CPR will not prove beneficial. As a means to ensure good medical
practice, the General Medical Council (GMC)230 issued a guidance setting
out the standards expected of doctors. It is established that since CPR
carries risk of complications and harmful side effects, it may cause more
harm than good if used inappropriately leading to the degrading of the
patient’s condition. In a situation where the death of a patient is imminent,
attempts to resuscitate him are likely to be futile and not in the patient’s
best interests.231 Medical professionals are recommended to seek advice
from expert bodies232 on when it is appropriate to attempt to resuscitate a
patient, as well as circumstances when it is appropriate to make an
Advance Decision not to attempt resuscitation, known as a DNR order.233
226 Giesen (n 221) 396 227 24 patients. 228 Bedell & Delbanco, ‘Choices about Cardiopulmonary Resuscitation in the Hospital’, 310 (1984), in Giesen (n 221) 396 229 Cachia E., ‘Why Palliative Care? Encountering Challenging Issues’, Malta Medical Journal, Vol. 20, Issue 04 (2007) 8 230 General Medical Council (2006) (n 223) 231 General Medical Council (2006) (n 223) 84; Futility exists if resuscitation will be of no benefit in terms of prolonging life of acceptable quality (European Resuscitation Council Guidelines for Resuscitation, 2005) 232 Eg. ‘CPR Guidance for Clinical Practice and Training in Hospitals’, February 2000 and ‘CPR Guidance for Clinical Practice and Training in Primary Care’, July 2001 (UK), London. 233 General Medical Council (2006) (n 223) 85
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It is fundamental to identify patients who do not want CPR, who may
competently refuse it through such an order.
Cachia refers to a study entitled ‘SUPPORT’234 conducted in a hospital in
America. It resulted that decisions to withhold extraordinary treatments in
relation to DNR for patients near death, were procrastinated and taken
only a few days before arrest. Furthermore, physicians often had no
knowledge of patient preferences not to have CPR. This study was
divided into two phases;235 in Phase I, it was observed that only 47 % of
physicians knew when their patients preferred to avoid CPR and that 46 %
of do-not-resuscitate orders were written within two days of death. 38 % of
those patients who died spent at least ten days in an intensive care unit
(ICU). Phase II showed that there was no improvement in the
communication between the doctor and his patient; neither was there any
improvement in the making or timing of written DNR orders and the
physician’s knowledge of his patient’s preferences not to be resuscitated.
On the contrary, where a patient is seriously ill with a foreseeable risk of
cardiopulmonary arrest, the competent patient or, if a patient lacks
capacity to decide, those close to the patient, must be offered an early
opportunity to discuss the patient’s future care or whether CPR should be
attempted. Such discussions should be central to the final decision, which
should be ‘made in advance as part of the care plan’ for the patient.236
The decision of the patient to refuse resuscitation is normally grounded on
the belief that it may reduce suffering or prolongation of the dying process,
respecting the religious values and dignity of the patient. Cachia gives
prominence to the duty of the doctor to maintain transparent
communication with the patient and the family. This is especially important
234 The SUPPORT Principal Investigators - A controlled trial to improve care of seriously ill hospitalized patients: The study to understand prognosis and preferences for outcomes and risks of treatments (SUPPORT), (Jama, 1995; 274: 1591-8). 235 Phase I consisted of a 2-year prospective observational study with 4301 patients, followed by Phase II, which consisted of a 2-year controlled clinical trial with 4804 patients and their physicians, randomised by specialty group to the intervention group or control group. 236 General Medical Council (2006), (n 223) 86
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in relation to the patient’s personal goals and the goals of the treatment
being provided, towards truly honouring the patient throughout the course
of his disease until his death.
Cachia also mentions the Advance Directive as a legal document which
may be used to register the patient’s care preferences.237 According to the
General Medical Council guidance, an Advance Decision containing a
DNR order not to attempt to resuscitate a patient must be recorded fully,
including the basis on which the decision was reached and the names of
those with whom the discussions were held. Such decision must also be
communicated to all persons involved in the care of the patient.238 In
Malta, the law on Advance Directives shall require that a DNR order be
completed on registration in the Advance Directive Registry according to
the regulatory procedure laid down by law. This shall also be reviewed
regularly to ensure that it remains appropriate in the patient’s current
condition
4.5 The Best Interests of the Patient and Good-Decision Making A 1994 report239 on good decision-making for incompetent patients sought
to find out whether Advance Directives contributed towards improving
decision-making for such patients and how can it be improved for better
use in the future. Another question posed relates to what other forms of
advance care planning are optimal when patients do not have Advance
Directives.
Two central issues that surround decision-making for incompetent patients
concern who should decide for the incompetent patient and what
237 The National Council for Palliative Care: Guidance on the Mental Capacity Act 2005; Advance Decisions to refuse treatment (2005); 8:12-3. 238 General Medical Council (2006), (n 223) 93 239 Brock Dan W., ‘Good Decision-making for Incompetent Patients’, Special Supplement, Hastings Center Report 24, No. 6 (1994).
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standards or principles should guide the decisions. The concept of the
lasting legal power of attorney for health care seeks to address the first
concern by enabling persons while competent to designate who will
decide for them should they become unable to make their own decisions.
The availability of such legal powers of attorney represents an agreement
that the proxy decision-maker should be the person whom the patient
wanted, and so chosen to be his surrogate.
The principle of self-determination and autonomy is central in the
agreement. It emphasises that the person requesting the drawing up of
the Advance Directive is interested in participating in decisions related to
his own health care and his own life, based on his personal values and
beliefs, or conception of a good life. In the case of a durable power of
attorney, self-determination is especially exercised in giving instructions to
the agent in order to guide him as to what and how decisions should be
carried out on behalf of the principal. In the absence of the appointment of
a durable power of attorney for health decisions on behalf of the patient,
the common practice is to turn to a family member or a close friend. As
this would in normal circumstances be the person that the incompetent
patient would choose as a proxy, such practice also respects the patient’s
self-determination. A close family member is also the most likely person to
make the best decisions.
However, Brock240 claims that this presumption could be rebutted in two
instances; firstly, by bringing evidence that the decisions taken by the
proxy are in conflict with the expressed wishes of the patient, or in the
case where these are unknown, they do not coincide with the fundamental
interests of the patient. Another instance would be where since the date of
the appointment of the proxy, the circumstances have changed and there
is strong evidence that the latter is no longer the person ‘whom the patient
would want to be the decision-maker’.241
240 Brock Dan W., (n 239) 241 ibid
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In Malta, an ad hoc committee shall be set up by the relevant authorities,
with the principal task of drafting guidelines and rules of procedure aimed
towards ensuring the best interests of the patients in decision-making.
Such rules and guidelines must contribute towards achieving the
necessary balance between respecting the patient’s self-determination, by
selecting the person whom the patient would have wanted to represent
them, and on the other hand, ensuring that the wishes of the patient are
upheld.242
The guidelines in Malta should be based on the provisions of the English
Mental Capacity Act of 2005, which establish that in deciding what is in
the patient’s best interests, the following circumstances must be taken into
consideration:
i. a) whether it is likely that the person will at some time have capacity in
relation to the matter in question; and
b) if it appears likely that he will, when that is likely to be.243
This means that if the person is soon to regain capacity it may be better, if
possible, to postpone making a decision so he can make it for himself.
ii. [The decision-maker] must so far as reasonably practicable, permit and
encourage the person to participate, or to improve his ability to participate,
as fully as possible in any act done for him and any decision affecting
him.244
Even if it is not possible for the patient to make a decision for himself, he
should still be involved, to a reasonable extent, in the decision-making
process, most importantly by taking his views into account.
242 ibid 243 Mental Capacity Act, 2005, Article 4(3) 244 Mental Capacity Act, 2005, Article 4(4)
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iii. [The decision-maker] must consider, so far as is reasonably
ascertainable:
a) The person’s past and present wishes and feelings;
b) The beliefs and values that would be likely to influence his decision if
he had capacity; and
c) The other factors that he would be likely to consider if he were able to
do so.245
Even though the English Mental Capacity Act does not adopt the
‘substituted judgment test’,246 the abovementioned factors require the
views of the person while competent to be taken into account, and to
assess what decision he would have made if competent. In deciding what
is in the patient’s best interests, the case Ashan vs Universities Hospital
Leicester247 highlighted that a patient should be cared for, ‘as far as
practicable’ in a way that his personal dignity and religious beliefs are
taken into account in decision-making.
iv. [The decision-maker] must take into account, if it is practicable and
appropriate to consult them, the views of:
a) Anyone named by the person as someone to be consulted on the
matter in question or on matters of any kind;
b) Anyone engaged in caring for the person or interested in his welfare;
c) Any donee of a lasting power of attorney granted by the person; and
d) Any deputy appointed for the person by the court, as to what would be
in the person’s best interests [...].248
v. There are two factors which should not be taken into account:
245 Mental Capacity Act, 2005, Article 4(6) 246 The ‘substituted judgment’ test requires that decisions are based on the desires of the patient in question. 247 [2006] EWHC 2624 (QB) 248 Mental Capacity Act, 2005, Article s 4(7)
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A decision as to what is in a person’s best interests should not be made
merely on the basis of:
a) The person’s age or appearance; or
b) A condition of his, or an aspect of his behaviour.249
This is especially relevant when combating assumptions about elderly
people and what is best for them. Reference should be made once again
to the case where in deciding on life-sustaining treatment, the decision-
maker must not be motivated by a desire to cause his death.250
Alongside the above considerations, the law on Advance Directives in
Malta shall follow the English Code of Practice251 with regard to the
medical decision as to what is in the best interests of the patient. The
Code of Practice lays down that all relevant factors that are reasonable to
consider must be taken into account by decision-makers252. The element
of medical necessity has also been identified as another factor that must
be taken into account when considering the best interests of the patient,
by the European Court of Human Rights (ECHR) in the judgment
Herczegfalvy vs Austria253, in line with Article 3 of the European
Convention on Human Rights that protects a person against torture or
inhuman or degrading treatment.254 Also on the element of medical
necessity, the judgment R ex parte N vs DR M, A NHS Trust and Dr O255
explained that to force medical treatment on an incompetent patient would
249 Herring (n 159) 163 250 Mental Capacity Act, 2005, Article 4(5) 251 Mental Capacity Act Code of Practice (TSO), para. 5.7, Department of Constitutional Affairs (DCA) (2007) 252 ibid 253 50 EHRR 437, para. 82 254 ECHR [1950], Article 3: No one shall be subjected to torture or to inhuman or degrading treatment or punishment. 255 [2002] EWHC 1911
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be in violation of such provision, unless it was convincingly shown that the
treatment was a medical necessity.
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Chapter 5
A COMPARATIVE ANALYSIS OF THE LEGAL APPLICATION OF
ADVANCE DIRECTIVES IN EUROPE
5.1 Introduction
A comparative analysis of the application of Advance Directives is
essentially fundamental due to the move towards harmonisation of laws
as well as the sharing of good practices between legal systems, especially
within Europe where several legal traditions coexist. This is made by
giving special consideration to the cultural, religious and other dynamic
aspects of a given country, yet in conformity with basic and universally
accepted human rights.
This chapter illustrates an analysis of the legal status of Advance
Directives in a few countries in Europe, namely England and Wales,
Germany, Italy and Spain.
The legal analysis delves into whether a law on Advance Directives and
patient rights is in force in the respective countries and how could such
laws be made applicable to the Maltese context. The significance of the
principles of ‘informed consent’ and ‘self-determination’, as the basis of
Advance Directives, is clearly brought out in this comparative analysis. In
addition, a review of the circumstances and formalities that ensure the
validity of a directive brings out even more the different perspectives
adopted by the various legal systems towards Advance Directives.
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5.2 United Kingdom: England and Wales
Since the Mental Capacity Act came into force in 2007 in England and
Wales, anticipatory refusals of treatment, including the refusal of life-
sustaining treatment, have become legally valid.256 Prior to the enactment
of this statute, common law allowed for persons to refuse unwanted
treatment in advance of incapacity. This was only applicable to adults.257
According to the Mental Capacity Act of 2005, a competent person may
decide to refuse or request the withdrawal of a ‘specified’ treatment. This
decision shall then enter into force the moment that such person lacks
capacity to consent to the carrying out or the continuation of medical
treatment, provided that the circumstances and the medical treatment are
specified by means of an Advance Directive, also known as an Advance
Decision.258 The attending doctor is required to abide by such an effective
decision even if it will hasten the death of the patient. Moreover, it cannot
be overruled in order to pursue the patient’s best interests.
A law on Advance Directives in Malta shall, similarly to the Mental
Capacity Act of 2005, provide for the right of a sound patient to request
the drawing up of a living will declaration by his attending physician, in
order that medical treatment that merely prolongs death shall be withheld
or withdrawn if he is in an incurable or irreversible mental or physical
condition with no reasonable expectation of recovery. However, contrary
to the Mental Capacity Act provision that the Advance Directive shall
mention ‘specified’ treatment depending on the medical diagnosis of the
patient, the Maltese living will declaration shall avoid statements that
entirely refuse ‘specified’ treatment under all circumstances. On the other
hand, the instructions shall target general end goals as well as the best
interests of the patient. The execution of a Maltese living will declaration
256 Mental Capacity Act, 2005, Article 25(5); If the advance refusal is to apply to life-sustaining treatment, this must be specifically mentioned in the document. 257 Re T (1992), Bland (1993), Re C Adult Refusal of Treatment (1994), Re AK (Medical Treatment:Consent) (2001), HE vs A Hospital NHS Trust (2003). 258 Mental Capacity Act, 2005, Article 24 (1)(a)(b)
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shall take place the moment that such person lacks the capacity to
participate in decisions related to his own medical treatment. Its drawing
up and execution shall essentially be guided by the ‘best interests of the
patient’ principle, while taking into account the wishes and values of the
patient, if known. The attending doctor shall have the important role of
giving advice in relation to the Advance Directive, and to understand the
needs and wishes of the patient at the end of his life. He must also take all
measures to keep the patient comfortable and relieve him from any pain
throughout his end-of-life care, guaranteeing respect for the dignity of the
human person as well as the protection of his rights when he is not able to
express his will freely.
In England and Wales, if the Advance Directive is ambiguous or there are
doubts as to its validity, the courts may refuse to enforce it, where to do so
would lead to the patient’s death. A law in Malta shall similarly uphold the
principle in favour of life. The establishment of a standard application form
in Malta shall avoid ambiguities and ensure certainty with regard to the
wishes of the patient.
In the absence of an Advance Directive in England, the law is governed by
the Mental Capacity Act, which upholds the principle that nothing in the
law authorises a medical professional to perform an act which intentionally
causes death.259 The position of the Maltese law shall follow the
Cathecism of the Catholic Church, which strictly rejects acts of
euthanasia, stating that an act or omission that result in the death of a
patient, even if done with the intention to eliminate suffering, amounts to a
voluntary homicide.260
Similarly to England and Wales, In Malta an Advance Directive may be
withdrawn or altered at any time while the individual remains
competent.261 The Advance Directive will neither be enforceable if there
259 Herring J. (ed.), Medical Law and Ethics, (Oxford University Press, 2008) 498 260 Catechism of the Catholic Church, 2277 261 Mental Capacity Act, 2005, Article 24(3)
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are reasonable grounds for believing that present circumstances, which
were not anticipated by the patient, may have affected his decisions when
drawing up the Advance Directive.262
5.2.1 The Formalities of Advance Directives in England and Wales
Same as the proposed law on Advance Directives in Malta, in England
and Wales a person must be over the age of eighteen and have sufficient
capacity to request an Advance Directive. In England, the presumption is
in favour of capacity; yet in case of doubt, the question may be decided
upon by a court of law. In Malta, it shall be the responsibility of the
attending doctor to assess whether a patient has the required competence
to request an Advance Directive and to give valid consent to a proposed
medical treatment.
The patient must sign or acknowledge the document in the presence of a
witness who must sign it, or acknowledge the signature of the patient.263
This shall also be the case in Malta, wherein the law shall also require the
signature of the attending physician who has drawn up the living will. The
signature of two competent witnesses accompanied with the signature of
the assisting lawyer shall also be made at the end of the document.
In contrast with the proposed law in Malta, the law in England and Wales
accepts Advance Directives made in the form of witnessed oral
statements, signed printed cards or discussion notes recorded in patients’
medical files. Moreover, Advance Directives do not need to be witnessed
by a solicitor and there is no registration procedure.264 The Maltese law
shall provide for a different scenario; an Advance Directive Registry -
262 Mental Capacity Act, 2005, Article 25(4)(c) 263 Mental Capacity Act, 2005, Article 25(6) 264 Alzheimer Europe on Advance Directives <http://www.alzheimer-europe.org/EN/Policy-in-Practice2/Country-comparisons/Advance-directives/United- Kingdom-England-and-Wales>
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national electronic registration system for both living wills and legal power
of attorney for health care has been proposed for the Maltese case, in
which a copy of the latest Advance Directive of a patient shall be
registered.
Advance Directives in England and Wales may include decisions relating
to life-supporting treatment, care and welfare decisions, life-saving
treatment and the appointment of a health care proxy. Nevertheless, they
may not contain statements ordering the refusal of basic care, including
procedures essential to keep the person comfortable, such as warmth,
shelter, pain relief and the management of distressing symptoms, the offer
of food and drink by mouth or requests for euthanasia or unreasonable
treatment.265
In England and Wales an Advance Directive is legally binding when it is
clear, unambiguous and reasonably proximate. The Maltese law shall
follow the same course; Moreover, doctors are legally obliged to perform
in the best interests of the patient, taking into account the wishes and
values of the patient, if known.
Yet the law in Malta shall not apply the Mental Capacity Act provision that
states that Advance Directives may not demand the doctor to perform a
specific treatment, since in England Advance Directives are only binding
when they concern the refusal of treatment.
In Malta, the law will avoid statements that entirely refuse certain
treatment under all circumstances, and shall allow statements that request
the performance of treatment, if it promotes the best interests of the
patient. In England and Wales, general statements or preferences are
taken into consideration, even though they are not legally binding.266 The
English Act highlights that a decision by a competent person at the time of
the medical treatment overrides any decision made in an Advance
265 ibid 266 ibid
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Directive. Doctors are required to comply with Advance Directives even if
they go against their personal beliefs or values. Where the doctor refuses
to comply, another doctor shall be requested to take charge of the
patient’s treatment.267 This provision shall also be applicable to the
proposed law in Malta.
Amendments or revocation of an Advance Directive can be carried out at
any time provided that the person has the capacity to do so. This need not
be in writing in England and Wales, as long as it does not refer to life-
sustaining treatment.268
In the case of Malta, the revocation of an Advance Directive may be
carried out by a patient while still competent any time, by way of
requesting its removal from the Advance Directive Registry, on satisfying
the regulatory procedure established by the relevant authorities. The
same shall apply to the case where the patient requires amendments to
his Advance Directive.
5.3 Germany
The German Parliament adopted a law on Advance Directives269, which
entered into force on September 1 of 2009, making Advance Directives in
Germany legally enforceable. Such law, based on the principle of the right
to self-determination, provides legal force to living wills which have
already been drafted. The regulation strikes a balance between a patient’s
desire to die in dignity and a doctor’s need for legal protection. Dying with
dignity is ultimately the goal that most patients have when they draft a
living will.270
267 ibid 268 Mental Capacity Act, 2005, Article 24 (4)(5) 269 The German law on Advance Directives passed by the Bundestag on the 18th of June 2009, applicable since the 1st of September 2009 270 Spiegel Online International <http://www.spiegel.de/international/germany/0,1518,631447,00.html>
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No one in Germany is obliged to have a living will, but it is the personal
decision of each and every individual.271 Yet where a patient has
established a living will, the attending doctor is obliged to follow a
patient’s written instructions unconditionally regarding life-sustaining
treatment, independently of the type and the stage of his illness, meaning
even if the illness does not irreversibly lead to the patient's death.272 This
will apply even if as a result the patient will die, or in cases where the life
of the patient could be prolonged if further measures were taken.273 This
largely contrasts with the law to be proposed in Malta since the attending
physician shall only execute a living will and withdraw or withhold life-
sustaining treatment where the patient is in an incurable or irreversible
mental or physical condition with no reasonable expectation of recovery.
According to the law in Germany, Advance Health Care Directives are
honoured regardless of the date when they were drawn up and
irrespective of whether patients were in a healthy state or not on such
date.274 In the event of discrepancy between the instructions of the patient
within a living will and the illness of the patient, doctors are required to
consult with the patient’s family members or his guardian, in order to
decide whether such decisions are relevant to the actual living situation
and proposed medical treatment. Any conflicts shall be resolved before
the guardianship court.275 The guardianship court shall also decide cases
in which the attending doctor and the guardian have different opinions as
to which course of action is according to the will and desire of the patient
271 Drittes Gesetz zur Änderung des Betreuungsrechts (Amendments to the Guardianship Act) Article 1901a(4)
272 In Focus; Euthanasia Legal Regulations <http://www.drze.de/in-focus/euthanasia/legal-regulations> 273 ibid 274 ibid 275 Drittes Gesetz zur Änderung des Betreuungsrechts (Amendments to the Guardianship Act) Article 1901a(1)
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or in cases where there exists the danger that the patient dies or suffers
grievous injuries as a result of the measures being proposed. 276
Moreover, the amendments to the German Guardianship Act include a
reference to the legal power of attorney, stating that in the absence of a
living will, those authorised to act must ensure that the wishes and
desires of the patient are followed, on the basis of previously spoken or
written wishes, ethical or religious convictions and other personal moral
values of the patient.277 In turn, the act of providing medical treatment
against the written and actual will of a patient becomes bodily assault and
an act against his private liberty.278 Close members of the family or other
trusted persons of the patient shall be given the opportunity to express
their concerns without significant delay.279
The instructions contained within the living will should be based on
sufficient medical information about the medical treatment proposed. Such
medical measures should be discussed as a basis for the living will of the
patient.280 This highlights the requirement of clarity of instructions and the
manifest desire of the patient to have the treatment withdrawn.281 The law
to be proposed in Malta should also give priority to the element of medical
information, in order that any decisions taken with regard the patient
would be according to medical necessity and the best interests of the
patient.
276 ibid, Article 1904(1) 277 ibid, Article 1901a(2) 278 ibid 279 ibid, Article 1901b(2) 280 ibid, Article 1901b(1) 281 ibid
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5.3.1 The Formalities of Advance Directives in Germany
An Advance Directive in Germany, which is valid if drawn up in written
form or in a comparable form such as a video-recording, forms part of the
Law on Guardianship. Furthermore, a patient must be competent and not
subject to any form of coercion. The presumption is in favour of capacity.
Contrary to the case in Malta, where it shall be the responsibility of the
attending doctor to examine whether a patient has the required capacity to
request an Advance Directive, in Germany, verification in case of doubt is
obtained from a notary. The instructions contained therein should refer to
specific treatment or specific circumstances in conformity with the law of
Germany. This is also different from the proposal for the Maltese context,
as the law here will instead target general end goals beneficial for the
patient, and will avoid statements that entirely refuse certain treatment
under all circumstances. In Germany, a patient may request the
withdrawal or withholding of any medical intervention, including life-
sustaining treatment. The assistance of a doctor is advisable in order to
ensure the validity of a directive.282 This matter shall also be given
extreme importance in the law in Malta, where an Advance Directive is to
be drafted to meet an individual’s beliefs and needs. The law in Malta
should oblige a patient to consult the attending doctor as well as his
spiritual leader and trusted lawyer about the prospect of creating an
Advance Directive. This ensures that all aspects, especially the legal,
medical and spiritual are covered.283
Advance Directives are considered to offer useful guidance to doctors in
Germany in the determination of the desires of a patient who is no longer
competent. Criminal charges may even be brought against the doctor on
ignoring the instructions refusing treatment laid down within the Advance
282 Alzheimer Europe on Advance Directives <http://www.alzheimer-europe.org/EN/Policy-in-Practice2/Country-comparisons/Advance-directives/Germany> 283 Gleason K., Going Home to the Father – A Catholic Perspective on End-of-Life Care (2001) 12
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Directive. Nevertheless, the current wishes of an incompetent patient
override the wishes expressed within an Advance Directive. As the case in
the United Kingdom, doctors who object to complying with Advance
Directives must request another doctor to take charge of the patient in his
stead.284 Such position could also be considered and applied to the
Maltese context, where doctors should be allowed the right not to act
against their own personal values and beliefs
A Directive drawn up in Germany is not limited to a fixed duration of time.
This also differs from the proposal for the law in Malta, since the duration
of an Advance Directive here shall be valid for a fixed period of time to be
decided by the relevant authorities. The reasoning behind this statement
is that there is a high probability of change in the circumstances
surrounding the patient, since the date when the Advance Directive had
been drawn up.
In Germany, an Advance Directive is subject to amendments at any time
following its drawing up. It may also be revoked at any time verbally, in
writing or even through the patient’s expressions which clearly indicate
this decision. The patient does not need to be in his full faculties to carry
out such an action.285
In Malta, legal regulation with regard amendments and revocation of an
Advance Directive shall be stricter, in the sense that a directive may be
amended or revoked at any time following its drawing up, but the element
of capacity of the patient must be present in order that this may take
place.
Furthermore, any amendments made in an Advance Directive, or its
revocation shall be carried out by way of requesting its removal from the
284 Alzheimer Europe on Advance Directives <http://www.alzheimer-europe.org/EN/Policy-in-Practice2/Country-comparisons/Advance-directives/Germany> 285 ibid
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Advance Directive Registry, on satisfying the regulatory procedure
established by the relevant authorities.
5.4 Italy In contrast to the situation of England and Wales and Germany, Italy does
not yet have a legally recognised form for Advance Directives, making the
instructions of the patient contained within such document not binding, but
merely advisory upon the doctor who is administering medical
treatment.286
Nevertheless, the principle of informed consent of the patient, establishing
that no person may be obliged to undergo particular medical treatment
except under the provisions of the law, and highlighting the protection of
the human person against violation of his rights, is enshrined in the Italian
Constitution.287 In 1992, the Italian National Bioethics Committee issued a
document entitled ‘Information and Consent to Medical Treatment’,
claiming that consent has to be ‘personal, free, specific and conscious’.
This was followed by the revision of the Italian Code of Medical Ethics288
on the principles reflecting the ever-changing relationship between the
medical profession and society, and between doctors and patients. It also
introduced the right to refuse treatment, in support of protecting, as far as
practicable, the quality of life of the patient who has reached the end of
life, and relieve him from unnecessary suffering produced by medical
futility.289
In 2003, the National Bioethics Committee published an advisory
document on Advance Treatment Statements, in the belief that the
legislature should intervene on this subject by obliging doctors by law, to
take an advance treatment statement drawn up by a patient into account
286 Alzheimer Europe on Advance Directives <http://www.alzheimer-europe.org/EN/Policy-in-Practice2/Country-comparisons/Advance-directives/Italy> 287 Costitutione della Repubblica Italiana, Article 32(2),Gazzetta Ufficiale (1947) 288 Codice Di Deontologia Medica (1995) 289 Codice Di Deontologia Medica (1995), Article 37 (Assistenza al malato inguaribile)
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in the provision of medical treatment. Most importantly, the law should
oblige physicians to provide an explanation for their decision in medical
records. Reference is also made to the legal power of attorney, with whom
physicians must consult in the taking of decisions, when the consent of
the patient is not available.290
According to the view of the Bioethics Committee, advance statements
must not be considered as a practice that could lead to or facilitate the
withdrawal or withholding of medical treatment. On the other hand, they
are encouraged only to the extent that they comply with certain criteria,
which include being made in writing by competent persons under no
duress. Requests for euthanasia will be declared invalid.
Advance Directives should instead guarantee a personal expression of
patients’ wishes regarding their future health care, ideally with the
assistance of a physician.291 In 2006, five bills aimed at regulating
Advance Directives were introduced in Parliament by members of centre-
left parties and two bills by members of centre-right parties; however,
these have so far been given no effect.292 Supporting the argument in
favour of Advance Directives is the study carried out by ITAELD,293 which
indicates that 55 % of the respondents agree with the statement that
‘doctors should always comply with Advance Directives requesting
abstention from life-sustaining treatment, even if this could hasten the end
of the incompetent patient’s life’.294
290 Italy’s National Bioethics Committee; Information and Consent to Medical Treatment (1992) (Abstract) 291 ibid
292 Bills by centre-left parties - Nos. 357, 542, 687, 773 and 1463; Bills by centre-right parties Nos. 3 and 433 293 ITAELD - Italian End of Life Decision Study, in J. Griffiths & H. Weyers, M. Adams (n 178) 409 294 The partial figures for north, centre and south Italy are 60 %, 58 % and 51 % respectively.
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With regards to the legal power of attorney in health care in Italy, the
practice of substitute health care decision-making is based on the
procedure of incapacitation,295 aimed at the protection of individuals of
unsound mind. Yet case-law296 has shown that this procedure is
cumbersome and does not provide for a suitable legal framework for
health care proxy decision-making.297 In 2004, a reform was undertaken,
which saw the emergence of a new legal figure in health care decision
making, the trustee.298 With regards to health care proxies, the ITAELD
study also showed that the majority of the medical profession is in favour
of legal regulation of health care representation, with 64 % of the
respondents claiming that ‘every patient should be given the possibility to
appoint a proxy entitled by law to make end-of-life decisions in case of
incompetence’.299
5.4.1 The Formalities of Advance Directives in Italy
One of the main requirements of Advance Directives in Italy is the
mentioning of a specific form of treatment in specific circumstances. This
is also the case in England and Wales and in Germany, but shall not be
proposed for the case in Malta. Amongst others, the requests may refer to
specific medical treatment, care and welfare decisions, basic care, life-
supporting treatment as well as life-saving treatment, the refusal of which
shall not be in violation of the law in Italy.300
A health care representative may be designated by means of an Advance
Directive, if he possesses the necessary capacity. The designation must
295 Procedimento di Interdizione 296 Eg. The Englaro Case (n 181) 297 Griffiths J. & H. Weyers, M. Adams, Euthanasia and Law in Europe (Hart Publishing, 2008) 409 298 Amministratore di Sostegno, Law 6/2004 of the Italian Civil Code. 299 Griffiths J. & H. Weyers, M. Adams (n 297) 409; The partial figures are 66 % for the north 67 % for the centre and 61 % for the south of Italy. 300 Alzheimer Europe on Advance Directives (n 286)
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be made in writing by a notary public in order for it to be recognised by
law.301
5.5 Spain The law in Spain recognises a patient’s right to refuse life-prolonging
treatment and allows a doctor to withdraw or withhold futile treatment on
the basis of an Advance Treatment Directive.
At the national level in Spain, the primary legal sources related to patients’
rights in end of life treatment are the General Law on Public Health of
1986 and the Basic Law 41/2002.302 The latter sets the basis for the
principle of patient autonomy by providing that the information and
decision-making process in the health care setting depends on the
patient’s right to decide on issues concerning his own health.
Furthermore, the patient has the right to accept or reject health care
interventions based on his own values and personal objectives.
The informed consent of the patient lies at the core of patient rights in
Spain. The Law defines the concept of informed consent as:
The free, voluntary and conscious decision of a patient, stated in the full use of his faculties after receiving proper information, so that an action concerning his health can be undertaken.303
The consent must be obtained once truthful information has been
communicated to the patient, in a manner that is comprehensible and
suited to his needs. The physician shall also help the patient take
301 ibid 302 Spanish Law 41/2002 (2003) on the Autonomy of the Patient and the Rights and Obligations with regards Information and Clinical Documentation. 303 Patient Rights in the EU - Informed Consent, Spain (1) <http://europatientrights.eu/countries/ratified/spain/spain_right_to_informed_consent.html>
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decisions in accordance to his best interests.304 A law proposal in Malta
shall adopt a holistic approach to the regulation of informed consent, such
that besides giving adequate information, the attending doctor is obliged
to provide advice and a full explanation of the circumstances to his patient
and ensure that he has understood all that has been divulged to him,
before he may obtain his consent. Having the necessary information to
help him understand and participate in decisions relating to his care would
undoubtedly empower the patient.305
In Spain, the requirement of informed consent shall not apply in
exceptional circumstances specified in the law on patients’ rights, for
instance where the non-performance of the medical treatment creates a
risk for public health, and if an immediate serious risk for the physical or
mental integrity of the patient exists and the consent of the patient or his
family is not forthcoming.306
The right to refuse medical treatment is also acknowledged by the
Spanish law on patients’ rights; a patient may also request for his consent
to be revoked in writing at any moment.307
The code of medical ethics of the ʻOrganizacion Medical Colegialʼ
(OMC)308 condemns ʻhopeless, useless and obstinateʼ treatment. When
nothing can be done to cure the patient or to improve his state, it is the
doctorʼs obligation to ʻuse adequate measures to secure the patientʼs well-
beingʼ even if this has the consequence of shortening his life. Euthanasia
is against the law in Spain, therefore the attending doctor is prohibited
304 ibid, Spain (2) 305 Kennedy I. (Chairperson), ‘The Report of the Public Inquiry into Children’s Heart Surgery at the Bristol Royal Infirmary’ 1984 - 1995: Learning From Bristol (CM5207, 2001) 285 306 Patient Rights in the EU - Informed Consent, Spain (4) (n303) 307 ibid, Spain (5) 308 ‘Organizacion Medical Colegial’ (OMC): The National Society of Physicians and the Official Voice of the Medical Profession. It enjoys disciplinary and regulatory power (Real Decreto 757/2006)
103
from doing anything with the aim of causing the death of a patient, even in
the case of an express request by the patient.309
5.5.1 The Formalities of Advance Directives in Spain
The introduction of Advance Directives was a very important step in the
law on patients’ rights in Spain.
For the document to be considered valid and for the patient’s wishes to be
complied with, the author must have the necessary capacity and must
have attained the age of eighteen years at the moment of writing it.310
Similarly to the case in Germany, this legal document may be signed in
the presence of a notary, who shall also confirm that the person has the
necessary capacity. In the case of private living wills, the presence of
three witnesses shall suffice, whose signatures shall also verify the
capacity of the author. A particular requirement is that two out of the three
witnesses must not be family members or have any economic or business
relationship with the person making the Advance Directive.311 The option
of a private living will shall not be provided for in the Maltese law proposal;
instead, only one standard form application established by the relevant
authorities shall be available.
Similarly to the Maltese law proposal, in Spain, formalities governing the
validity of Advance Directives shall include the legality of the instructions
and that they are not contrary to ‘lex artis’ or good medical practice.
However, in contrast to the Maltese context, they shall not be limited to a
fixed duration. Advance Directive Registries establishing formalities to
ensure the validity of such legal documents may also be found in several
regions in Spain. Legislation aimed towards the creation of a national
309 Griffiths J. & H. Weyers, M. Adams (n 297) 448 310 Patient Rights in the EU - Informed Consent, Spain (n 303) 311 Alzheimer Europe on Advance Directives <http://www.alzheimer-europe.org/EN/Policy-in-Practice2/Country-comparisons/Advance-directives/Spain>
104
registry for Advance Directives is still pending.312 The Maltese legislator
shall also follow this course of action by proposing the establishment of an
Advance Directive Registry, a national electronic registration system for
both living wills and legal power of attorney for health care.
A patient may also appoint a legal representative or power of attorney,
who will act as an intermediary with the physician or the medical team in
order to fulfil the patient’s will, after the latter has lost his competence. If
the patient has no legal representative, the consent may be provided by a
member of his family.313
As in the other countries referred to in this Chapter, Advance Directives in
Spain may be amended, renewed or revoked at any time provided that the
person has the necessary capacity to do so. This may be done in writing,
by a notary or the organisation ‘Exit’, in contrast to Malta, in which an
Advance Directive may only be amended or revoked by referring to the
Advance Directive Registry.
Moreover, according to the Spanish law, If there is more than one
Advance Directive, only the most recent one shall be considered valid.314
312 ibid 313 Patient Rights in the EU - Informed Consent, Spain (8) (n 303) 314 Alzheimer Europe on Advance Directives (n 311)
105
5.6 Other European Member States in which Advance Directives are Regulated and Made Use Of
In The Netherlands and Belgium, Advance Directives are considered to
have a strong legal status, primarily since there are no limits as to which
circumstances or medical interventions a patient may refuse. Furthermore,
in the Netherlands, one may refuse any treatment for any reason, even if
this includes the right to die, giving the patient utmost power over
decisions related to his own health care. The Netherlands has also been
identified as the country with the lowest age requirement, that of sixteen
years. In Belgium extensive information about the medical condition as
well as the treatment being proposed to the patient is demanded, and the
health care professional shall assist his patient both medically and morally
at the end of his life.
The situation in Luxembourg is different since no law has yet been
enacted to govern Advance Directives; thus even though a patient may
issue an Advance Directive, it shall not have any legal weight, and so is
not enforceable in a court of law. This also applies to France where
Advance Directives are not legally binding, but used as mere guidance in
determining the desires of the patient, who is no longer competent, in
relation to his end-of-life health care.
The salient principles of informed consent and self-determination are
highlighted in most of the respective jurisdictions, particularly in Denmark
where Danish law makes such principles central, with an emphasis that no
treatment may be begun or continued without the patient’s informed
consent, involving him as much as possible in the decisions taken on his
health care. Spanish law qualifies this information given to the patient by
the term ‘truthful’, and in a manner that can be grasped by the patient.
Spain also encourages the involvement of the doctor in decision-making,
ensuring that the best interests of the patient are given prominence, whilst
Finland requires that the patient still has to be cared for in a manner
106
agreed by both the patient and his doctor, notwithstanding the patient’s
request for refusal of treatment.
The notion of a Living Will Registry is brought to the discussion by the law
on patient rights in Denmark, as an effective means to ascertain whether a
patient has registered an Advance Directive or not, before a physician
may provide any medical treatment. Another interesting requirement
established by the law in Denmark is that a request for the withdrawal of a
medical intervention shall not be complied with unless death is certain and
imminent.
In Sweden the situation is peculiar since no specific act on patient rights
may be found here, which may provide regulation for Advance Directives.
A case-study was nevertheless carried out aiming at throwing light on the
current circumstances, such as the submission of proposals to the
Government for clearer guidelines on issues of a bioethical nature, like
end-of life care, as well as the legal enforcement of legal representatives
in health care for incompetent adults or the introduction of Advance
Directives.
Other European Member States, such as Bulgaria, Cyprus, Greece and
Poland, amongst others, have specific codes of law governing patient
rights, but no reference is made to the concept of Advance Directives.
Certain other countries, such as Malta and Romania, neither have specific
codes of law regulating patient rights, nor the application of Advance
Directives as part of their legal systems.315
315 Alzheimer Europe on Advance Directives <http://www.alzheimer-europe.org/EN/Policy-in-Practice2/Country-comparisons/Advance-directives>
107
5.7 Table showing the Applicability of Advance Directives316
Country Applicability of Directives
Applicable Law Basic Formalities Advance
The Netherlands Yes Medical Treatment Contracts Act (WGBO) (1994)
16 years old and above; no strict formalities; identity and competence of the author must be expressly specified.
Belgium Yes The Law on Patients’ Rights (2002)
Certainty of the author with the necessary capacity; relates to well-defined medical intervention; made in writing.
Luxembourg No Proposal of Law relating to Palliative Care, (Loi relative aux soins palliatifs et à l’accompagnement en fin de vie’)
18 years old and above; have the necessary capacity; resident of Luxembourg; Advance Directive must be registered in the Department of Health.
England Yes Mental Capacity Act (2005)
18 years old and above; have sufficient capacity; presence of a witness; must contain signature, be clear, unambiguous and reasonably proximate;
France Yes Code de la Sante’ Publique (2005)
Have sufficient capacity; not legally binding, but serve as mere guidance to the doctor.
Germany Yes Drittes Gesetz zur Änderung des Betreuungsrechts (Amendments to the Guardianship Act, 18.06.2009)
Must have the necessary capacity; instructions based on sufficient medical information, are clear and reflect the manifest desire of the patient; in conformity with German law.
Italy No No law; 5 bills on the regulation of Advance Directives were presented in Parliament in 2006.
In writing; by a competent person under no duress; relates to specific treatment in specific circumstances; not in violation of Italian law.
316 All information on the application of Advance Directives in certain states in Europe has been taken from the internet site, Alzheimer Europe on Advance Directives < http://www.alzheimer-europe.org/EN/Policy-in-Practice2/Country-comparisons/Advance-directives > and the publication by J. Griffiths & H. Weyers, M. Adams, Euthanasia and Law in Europe (n 297).
108
Spain
Yes The General Law on Public Health of 1986; Basic Law 41/2002 (2003)
18 years old and above; have the necessary capacity; signed in the presence of a notary; the legality of the instructions; must not be contrary to ‘lex artis’ or good medical practice.
Denmark Yes Law on Patients’ Rights (1998) No. 482
18 years old and above; not under guardianship; relates to specific treatment; registration procedure at the Central Registry; death must be imminent and cure or improvement of health inconceivable.
Sweden
No
No law; the Swedish National Ethics Council presented proposals to the Government on end-of-life care.
Finland Yes Act on the Status and Rights of Patients No. 785/1992
Must have sufficient capacity; relates to refusal of treatment; the patient still has to be cared for in ways reached by mutual compromise.
109
Chapter 6
CONCLUSION AND RECOMMENDATIONS
The discussion on matters of a bioethical nature is very much alive and
dynamic, as has been proved by the critical analysis made in this thesis.
Advance Directives have also been widely disputed, the subject having
reached parliaments as well as courts in a number of states in Europe.
Contextual differences exist from one state to another, giving rise to
divided opinions on Advance Directives and the beneficial goals they seek
to achieve. As this thesis indicates, Advance Directives provide a patient
with an effective voice in the ongoing dialogue with his doctor, when due
to his lack of decisional-making skills, the former becomes unable to give
contemporaneous consent to medical treatment. A patient-centred
approach is encouraged in medical care, balanced with the professional
medical judgment of the doctor. This helps to empower the patient to
participate in decisions related to his health care, towards achieving the
best quality of life possible, based on the principles of patient autonomy
and informed consent. Moreover, a patient-centred quality care should be
based on the goal to preserve the dignity of the person in question, and
any decisions taken by the medical professional should revolve around
the physical as well as the moral needs of the patient.
The legitimacy to refuse or request the withdrawal of life-sustaining
treatment which is considered burdensome, dangerous, extraordinary or
disproportionate to the expected outcome is equivalent to sound medical
practice and should therefore be legally recognized as such.
In states where the position in law on the withdrawal or withholding of life-
sustaining treatment is not clear, there is the possibility of varied medical
practice and arbitrary decision-making. The absence of laws gives rise to
a subjective and social ethic that differs from objective medical standards
authorizing or condemning practices of a bioethical and sensitive nature.
110
This is not what society desires. International regulation, such as the
Oviedo Convention, may widen the protection and provide further
harmonization. However, the benefits of treating the matter at a national
level would mean that the cultural aspects, religious beliefs and other
principles and moral values embraced by the respective society are taken
into account. Such ethical principles and beliefs can only be enforced by
becoming law, ‘in the binding and compulsory rule which calls for a
specific code of conduct’.317
Concrete action towards achieving legal certainty is needed and this is
only possible by codifying existent legal and ethical principles in Malta,
and by creating a legal framework on patient rights, including the right to
draw up Advance Directives as part of the patient’s care plan. A code of
laws would help foster a healthy environment for both doctors and
patients, enabling them to make the right choices to attain a high level of
health and well being. Essentially, a code of laws would grant both the
patient as well as the doctor legal standing under which their rights may
be guaranteed.
A comprehensive analysis of the local current medico-legal situation is
imperative and the proposals for a national law on Advance Directives
must have as its primary consideration the impact that such legal
documents will have on Maltese society. The guiding light should
persistently be the utmost respect for the well-being and the dignity of the
human person as well as the protection of his rights when he is not able to
express his will freely, towards attaining excellence in the health sector.
As part of the Maltese Government’s vision 2015318 for the health sector,
measures to promote patients’ rights and responsibilities through a
modern legislative framework, which is aimed at empowering patients and
their families, were put forward. It is held that a shift from a paternalistic
317 Cosimo Marco Mazzoni (ed.), A legal framework for Bioethics (Kluwer Law International, 1998) 42 318 Malta Office of the Prime Minister, National Policy, Vision 2015 <https://opm.gov.mt/vizjoni-2015?l=1>
111
approach in providing medical services, to an approach in which both the
doctor and the patient work together to achieve the best possible
outcomes, is needed.319 The right to informed consent is also envisaged
as a fundamental patient right and therefore should be enshrined in the
law.320
In acquiescence of the importance of the above principles and the role of
Advance Directives as a means of enhancing the doctor-patient
relationship and the communication of the patient’s wishes concerning
future medical care, particularly at the end of life, the following
recommendations for a law on Advance Directives have been put forward.
A stronger doctor-patient relationship and more effective communication
would allow the patient to express his needs and preferences as well as to
participate in decisions about his end-of-life care. The patient’s views must
be taken into account, primarily by involving him to the fullest extent
possible in decision-making about his end-of-life care, as well as the views
of the people close to the patient. Such relationship shall also be
enhanced with a system of registration of the patient with a specific
doctor, which will in turn increase cooperation and commitment towards
better end-of-life care.
An Advance Directive in Malta shall be either in the form of a living will, a
lasting legal power of attorney for health care or a combination of both. Instructions as to the circumstances under which life-sustaining treatment
shall be provided, withheld or withdrawn, may be given through a living
will. The patient may, for example, refuse cardiopulmonary resuscitation,
through an Advance Directive known as a Do-Not-Resuscitate Order.
Alternatively, the patient may appoint an agent to make health care
decisions on his behalf, in specified matters of health care through a
319 The Ministry of Finance, the Economy and Investment, Pre-Budget Document 2009, Malta (Chapter 8 on Health, the Elderly and Community Care) 110, Article 8.8 320 ibid, Article 8.9
112
lasting power of attorney, if and when he becomes incapable of taking
decisions himself.
Nevertheless, a combined Advance Directive is considered as the most
advantageous option which should be adopted by the law on Advance
Directives in Malta, since in the event that a living will gives rise to
uncertainty and ambiguity, a combined document would allow the legal
power of attorney to contribute in a more effective manner to the decision–
making process. The statement of wishes within the living will declaration
may also provide comprehensive guidance to the agent in his execution of
the will. In turn, the doctor is obliged to take reasonable steps in order to
confirm whether, prior to losing competence, the patient had drawn up an
Advance Directive.
The law on Advance Directive in Malta shall, above all, establish that the
patient shall be in full possession of all his faculties at the time of drawing
up the Advance Directive and shall have the ability to understand the
consequences related to the proposed medical treatment, and to decide
freely and without any pressure or influence regarding his end-of-life care.
The medical professional shall be responsible to clinically assess whether
a patient has the required competence to give a legally effective and
informed consent to a proposed medical treatment.
The proposal for a Maltese law shall include that the patient is informed by
his attending doctor of the legitimacy to refuse or request the withdrawal of
medical treatment which is considered burdensome, dangerous,
extraordinary or disproportionate to the expected outcome, and therefore
deemed to be medically futile, in accordance with the position of the
Catechism of the Catholic Church. This may be done through an Advance
Directive. All the provisions contained in such an Advance Directive should
be capable of implementation within the accepted ethical and legal
standards of medical practice in the respective country.
113
In its guidelines on treatment and care towards the end of life, the General
Medical Council in the United Kingdom upholds that the patient shall seek
the advice of a doctor, in order for the Advance Directive to reflect current
medical thinking. Such requirement shall also be included in the Maltese
law on Advance Directives. In addition, the patient is advised to consult a
lawyer as well as a spiritual leader in whom he trusts, about the prospect
of creating an Advance Directive. In the case of a legal power of attorney,
it is advisable that the patient discusses values, religious beliefs and
wishes with the appointed agent before the document is signed, and for
this dialogue to remain open.
The law in Malta shall require that an Advance Directive be drawn up and
executed, according to the required formalities laid down in law, by an
adult who has the necessary capacity to give his informed consent, after
he has been informed of a diagnosis. This is the position of the English
Mental Capacity Act of 2005, since this helps the instructions to be
established in the context of the actual, rather than the possible, choices
to be made. However, while the law in England and Wales states that an
Advance Directive is only valid if it specifies the treatment in question, the
law in Malta shall focus on general end goals rather than specific medical
procedures. An Advance Directive becomes enforceable in Malta the
moment the patient loses capacity to consent.
The drafting of an Advance Directive in Malta shall be done with sufficient
precision, ensuring that the terms in the declaration reflect the desires and
needs of the patient. This is also in line with the requirements established
within the English Mental Capacity Act of 2005 in order to cover the
treatment in question. The establishment of a standard application form by
the relevant authorities, by making reference to the draft of the Combined
Advance Directive included in the Appendix of this thesis, may contribute
towards the avoidance of ambiguities and the production of realistic
directives. Such standard application form shall be reviewed and updated
on a regular basis.
114
The attending doctor shall comply with an effective applicable Advance
Directive, by acting in accordance with the best interests of the patient and
ascertaining the prior wishes and values of the same, involving the
patient’s family where necessary.
Another recommendation put forward by this thesis is for a Maltese ad hoc
committee to be set up for the purpose of drafting guidelines and rules of
procedure aimed towards ensuring the best interests of the patients in
end-of-life decision-making. Such guidelines and rules shall be based on
the provisions of the English Mental Capacity Act of 2005, which
establishes the circumstances that must be taken into consideration when
deciding what is in the patient’s best interests. An attempt must be made
to achieve a balance between respecting the patient’s autonomy as well
as giving priority to the medical professional judgment of the doctor.
Above all, medical necessity should be amongst the main relevant factors
that are reasonable to consider when deciding on the best interests of the
patient.
A comprehensive analysis of the current medico-legal situation on
patients’ rights in Malta must be carried out, including an evaluation of the
impact that Advance Directives will have on Maltese society. The general
public and health care professionals must be educated about the benefits
of the right to have an Advance Directive. This may be achieved by the
organization of seminars, national local conferences, national campaigns,
and the writing of articles on the subject of end-of-life health care and
Advance Directives on newspapers, amongst others.
In conclusion, a law on the right of the patient to request an Advance
Directive, as part of his medical care plan, shall be discussed. Such
discussions on legislative proposals should evolve in a socio-cultural
context. In order that this may be achieved, a working group under the
realm of the relevant authorities must be set up with the challenge to carry
out a study on the medical, ethical and legal questions that may arise
when people are no longer able to make their wishes known.
115
This will set the grounds for the initiation of a Maltese law on the
application of Advance Directives in Malta, which attempts to set the truly
necessary limits indispensable to guaranteeing a tolerable societal life, in
respect of our cultural religious values, beliefs and practices.
116
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previously expressed wishes relating to health care; Common principles and differing rules in national legal systems’. (Report to the Council of Europe based on the June 2008 ‘Exploratory Workshop on Advance Directives’ organised by the Institute of Biomedical Ethics of the University of Zurich with the Support of the European Science Foundation (ESF), by Prof. Roberto Andorno, 2009). <http://www.coe.int/t/dg3/healthbioethic/activities/09_euthanasia/CDBI_2008_29%20Andorno%20e.pdf>
The Council of Europe Recommendation CM/Rec(2009)11 of the
Committee of Ministers to Member States, of the 9th of December 2009, on principles concerning continuing powers of attorney and advance directives for incapacity <https://wcd.coe.int/ViewDoc.jsp?id=1563397&Site=CM>
The European Group on Ethics in Science and New Technologies to the
European Commission EGE Secretariat, Ethics in the New Member States [2004] <http://ec.europa.eu/european_group_ethics/publications/docs/rptnwnec_en.pdf>
The Italian Code of Medical Ethics (Codice Di Deontologia Medica, 1995)
< http://www.privacy.it/codeome.html>
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The Ministry of Finance, the Economy and Investment, Pre-Budget
Document 2009, Malta (Chapter 8 on Health, the Elderly and Community Care) 110 <http://finance.gov.mt/image.aspx?site=MFIN&ref=2009_chapter8-pdf>
The SUPPORT Principal Investigators - A controlled trial to improve care
of seriously ill hospitalized patients: The study to understand prognosis and preferences for outcomes and risks of treatments (SUPPORT), (Jama, 1995; 274: 1591-8) <http://www.ncbi.nlm.nih.gov/pubmed/7474243>
USA, President’s Commission Report – ‘Deciding to Forego Life-
Sustaining Treatment’ (1983) <http://bioethics.georgetown.edu/pcbe/reports/past_commissions/deciding_to_forego_tx.pdf>
Vienna Declaration and Programme of Action adopted by the World
Conference on Human Rights (1993) <http://www.unhchr.ch/huridocda/huridoca.nsf/(symbol)/a.conf.157.23.en>
HA Guidelines on Life-sustaining Treatment in the Terminally Ill; Working
Group on Clinical Ethics, of the Hospital Authority Clinical Ethics Committee (2002) 5.4.2, <http://www.ha.org.hk/haho/ho/cc/clinicalethicreport_eng_graphic.pdf>
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APPENDIX
(i) Draft of a Combined Advance Directive taken from: Age Concern Institute of Gerentology, Centre of Medical Law and Ethics: The Living Will – Consent to Treatment at the End of Life, A Working Party Report (1988)
(ii) Draft of a Catholic Declaration on Life and Death: Advance Health Care Directive taken from Diocese of Portland, Office of the Bishop <http://www.portlanddiocese.net/docs/61.EOL_CARE_PKG.pdf>