Human Embryo Research – Human Embryo Research – informing regulatory policyinforming regulatory policy

Professor Neva HaitesProfessor Neva HaitesVice Principal of University of AberdeenVice Principal of University of AberdeenMember of the Human Fertilisation and Member of the Human Fertilisation and

Embryology AuthorityEmbryology Authority

Human EmbryosHuman Embryos

The human embryo research The human embryo research debatedebate

‘‘Special status’Special status’ Can be used Can be used

as a means to as a means to achieve achieve certain endscertain ends

Not a fetus Not a fetus

or a person or a person

or property but hasor property but has

Regulation by HFEA of use of Regulation by HFEA of use of Human EmbryosHuman Embryos

For use in Clinical purposes – both Private For use in Clinical purposes – both Private Clinics and in the National Health ServiceClinics and in the National Health Service

For Research purposesFor Research purposes

History of UK approach to History of UK approach to regulating Embryo Researchregulating Embryo Research

11stst IVF baby – UK IVF baby – UK 19781978 Warnock enquiry into Human Warnock enquiry into Human Fertilisation and Embryology reportsFertilisation and Embryology reports 1984 1984

HFEA established HFEA established 19911991 Dolly the sheep cloned Dolly the sheep cloned 19971997 CMO report into stem cell research 2000CMO report into stem cell research 2000 Legislation amended to allow useLegislation amended to allow use of embryos for stem cell research of embryos for stem cell research 20012001 UK ban on reproductive cloningUK ban on reproductive cloning 20012001 UK stem cell bank launched UK stem cell bank launched 20042004

Purposes for which a human Purposes for which a human embryo research licence may be embryo research licence may be

grantedgranted

Promoting advances in the Promoting advances in the treatment of infertility,treatment of infertility, Increasing knowledge about the Increasing knowledge about the causes of congenital causes of congenital

disease,disease, Increasing knowledge about the Increasing knowledge about the causes of causes of

miscarriages,miscarriages, Developing more effective techniques of Developing more effective techniques of

contraceptioncontraception, or, or Developing methods for detecting the presence of Developing methods for detecting the presence of

gene or chromosome abnormalitiesgene or chromosome abnormalities in embryos in embryos before implantation…….before implantation…….

Sched. 2, para. 3(2)Sched. 2, para. 3(2)

Additional HF&E (Research Additional HF&E (Research Purposes) Regulations 2001Purposes) Regulations 2001

increasing knowledge about increasing knowledge about the the development of development of embryosembryos;;

increasing knowledge about increasing knowledge about serious diseaseserious disease, or, or

enabling any such enabling any such knowledge to be applied in knowledge to be applied in developing treatments for developing treatments for serious diseaseserious disease

s.2(2)s.2(2)

Preventing: prohibitions Preventing: prohibitions of the HFE Act of the HFE Act

No person can use/store a human embryo after No person can use/store a human embryo after the appearance of the primitive streak and/or the appearance of the primitive streak and/or fourteen days after fertilisationfourteen days after fertilisation

No person can introduce a No person can introduce a human embryo into human embryo into an animal an animal

No person can introduce No person can introduce animal eggs, sperm or animal eggs, sperm or embryos into a woman’s bodyembryos into a woman’s body

Alter the genetic structure of an embryoAlter the genetic structure of an embryo

Recent Potential DevelopmentsRecent Potential Developments

Sex selection for Social reasonsSex selection for Social reasons

PGD with HLA typingPGD with HLA typing

Stem cell derivationStem cell derivation

Hybrid embryosHybrid embryos

Single embryo replacement policySingle embryo replacement policy

Public consultationsPublic consultations

International DebateInternational DebateS Korea cloning S Korea cloning

research was fakeresearch was fake

Scientist's embryo cloning faked

Journal retracts Hwang research

Embryo cloning cheat resigns in disgrace

Clone human embryo creator admits ethical lapses in work

Ethical g

lobalisatio

n

Ethical g

lobalisatio

n

Cloning crisis goes from bad to worseCloning crisis goes from bad to worse

Stem-cell scientist faces new questions over egg useStem-cell scientist faces new questions over egg use

Sex SelectionSex Selection

Technically possible to select male and Technically possible to select male and female sperm and hence choose sex of female sperm and hence choose sex of embryo apparently safely using laser sortingembryo apparently safely using laser sorting

HFEA decision, following Public HFEA decision, following Public consultation, informed British Government consultation, informed British Government decision to prohibit sex selection from non-decision to prohibit sex selection from non-medical reasonsmedical reasons

PGD and HLA TypingPGD and HLA Typing

Saviour sibling possibilitiesSaviour sibling possibilities

Testing of embryos for unaffected and Testing of embryos for unaffected and HLA matched with living affected childHLA matched with living affected child

HFEA agreed to licence under HFEA agreed to licence under appropriate clinical circumstancesappropriate clinical circumstances

Stem cell sources: what is permitted in UK

• Adult stem cells (e.g. bone marrow)• Foetal cells (foetal tissue or cord blood)• Embryonic stem cells (pre-implantation

embryos)(i) ‘spare’ IVF embryos(ii) embryos created from donated

gametes (iii) somatic cell nucleus transfer from

donated oocytes

Human Hybrid Embryo Human Hybrid Embryo ConsultationConsultation

Cytoplasmic hybrids (human somatic Cytoplasmic hybrids (human somatic nucleus into an enucleated animal ova)nucleus into an enucleated animal ova)

True hybridsTrue hybrids

ChimerasChimeras

Transgenic embryosTransgenic embryos

Hybrid EmbryosHybrid Embryos

Legally HFEA advised that cytoplasmic Legally HFEA advised that cytoplasmic hybrids fall within its jurisdiction. hybrids fall within its jurisdiction.

HFEA licence committees therefore able HFEA licence committees therefore able to consider individual applications for to consider individual applications for research licences to create human/animal research licences to create human/animal hybrid embryoshybrid embryos

Hybrid Embryos ConsultationHybrid Embryos Consultation The scientific community felt confident that the The scientific community felt confident that the

creation of cytoplasmic hybrids is an avenue of creation of cytoplasmic hybrids is an avenue of research worth exploring… and an alternative to research worth exploring… and an alternative to using human eggs, to investigate the using human eggs, to investigate the mechanisms of creating patient matched mechanisms of creating patient matched embryonic stem cells. embryonic stem cells.

Public consultation showed that the majority of Public consultation showed that the majority of those consulted would support the creation of those consulted would support the creation of these embryos if they were to be used to these embryos if they were to be used to research improved understanding and treatment research improved understanding and treatment of disease.of disease.

Joint Committee on the Draft Joint Committee on the Draft Human Tissue and Embryos Bill - Human Tissue and Embryos Bill -

20072007 Who decides what the Government should enact Who decides what the Government should enact

in the new Bill?in the new Bill?

Will there be a consistent world opinion? – and Will there be a consistent world opinion? – and does it matter?does it matter?

How do religious and non-religious views differ How do religious and non-religious views differ and how can this be taken into account in a and how can this be taken into account in a multicultural society?multicultural society?

Public Poll says ‘No’ Public Poll says ‘No’

to more embryo researchto more embryo research

‘‘Frankenstein’ Frankenstein’ researchers plan embryo researchers plan embryo

with three parentswith three parents

‘‘MOUSE MAN’ MOUSE MAN’

ARRIVING SOONARRIVING SOON

Single embryo replacement policySingle embryo replacement policy

Increased risk of death and complications Increased risk of death and complications in multiple pregnancies and births to in multiple pregnancies and births to mother and childmother and child

‘‘A single child at a time is best’A single child at a time is best’Many European countries now have Many European countries now have

protocols for single embryo replacements protocols for single embryo replacements and pregnancy rates have not droppedand pregnancy rates have not dropped

Due to costs of IVF in UK, many families Due to costs of IVF in UK, many families prefer twinsprefer twins

Single embryo replacement policySingle embryo replacement policy

As seen as a part of - Good Medical As seen as a part of - Good Medical practice – policy and protocols likely to be practice – policy and protocols likely to be derived with Professional groups and derived with Professional groups and Clinics.Clinics.

Clinics will be given advice on evidence for Clinics will be given advice on evidence for use of single and two embryo use of single and two embryo replacementsreplacements

Target level of multiples to be achieved Target level of multiples to be achieved over a few yearsover a few years

RegulationRegulation

Better regulation – minimise impact on Better regulation – minimise impact on ClinicsClinics

Code of Practice developed to inform good Code of Practice developed to inform good practicepractice

Inspecting and licensing for specific Inspecting and licensing for specific activitiesactivities

Lead clinicians to pass test on the Act and Lead clinicians to pass test on the Act and Code of practiceCode of practice

Thank you for your attention