Human Embryo Research – informing regulatory policy Professor Neva Haites Vice Principal of University of Aberdeen Member of the Human Fertilisation and Embryology Authority

Human Embryos Human Embryos

The human embryo research debate ‘Special status’ Can be used as a means to achieve certain ends Can be used as a means to achieve certain ends Not a fetus or a person or property but has

Regulation by HFEA of use of Human Embryos For use in Clinical purposes – both Private Clinics and in the National Health Service For use in Clinical purposes – both Private Clinics and in the National Health Service For Research purposes For Research purposes

History of UK approach to regulating Embryo Research 1 st IVF baby – UK st IVF baby – UK1978 Warnock enquiry into Human Warnock enquiry into Human Fertilisation and Embryology reports1984 Fertilisation and Embryology reports1984 HFEA established 1991 HFEA established 1991 Dolly the sheep cloned 1997 Dolly the sheep cloned 1997 CMO report into stem cell research 2000 CMO report into stem cell research 2000 Legislation amended to allow use Legislation amended to allow use of embryos for stem cell research 2001 of embryos for stem cell research 2001 UK ban on reproductive cloning2001 UK ban on reproductive cloning2001 UK stem cell bank launched 2004 UK stem cell bank launched 2004

Purposes for which a human embryo research licence may be granted  Promoting advances in the treatment of infertility,  Increasing knowledge about the causes of congenital disease,  Increasing knowledge about the causes of miscarriages,  Developing more effective techniques of contraception, or  Developing methods for detecting the presence of gene or chromosome abnormalities in embryos before implantation……. Sched. 2, para. 3(2)

Additional HF&E (Research Purposes) Regulations 2001  increasing knowledge about the development of embryos;  increasing knowledge about serious disease, or  enabling any such knowledge to be applied in developing treatments for serious disease s.2(2)

Preventing: prohibitions of the HFE Act No person can use/store a human embryo after the appearance of the primitive streak and/or fourteen days after fertilisation No person can use/store a human embryo after the appearance of the primitive streak and/or fourteen days after fertilisation No person can introduce a human embryo into an animal No person can introduce a human embryo into an animal No person can introduce animal eggs, sperm or embryos into a woman’s body No person can introduce animal eggs, sperm or embryos into a woman’s body Alter the genetic structure of an embryo Alter the genetic structure of an embryo

Recent Potential Developments Sex selection for Social reasons Sex selection for Social reasons PGD with HLA typing PGD with HLA typing Stem cell derivation Stem cell derivation Hybrid embryos Hybrid embryos Single embryo replacement policy Single embryo replacement policy

Public consultations

International Debate S Korea cloning research 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 globalisation Cloning crisis goes from bad to worse Stem-cell scientist faces new questions over egg use

Sex Selection Technically possible to select male and female sperm and hence choose sex of embryo apparently safely using laser sorting Technically possible to select male and female sperm and hence choose sex of embryo apparently safely using laser sorting HFEA decision, following Public consultation, informed British Government decision to prohibit sex selection from non-medical reasons HFEA decision, following Public consultation, informed British Government decision to prohibit sex selection from non-medical reasons

PGD and HLA Typing Saviour sibling possibilities Saviour sibling possibilities Testing of embryos for unaffected and HLA matched with living affected child Testing of embryos for unaffected and HLA matched with living affected child HFEA agreed to licence under appropriate clinical circumstances HFEA agreed to licence under appropriate 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 Consultation Cytoplasmic hybrids (human somatic nucleus into an enucleated animal ova) Cytoplasmic hybrids (human somatic nucleus into an enucleated animal ova) True hybrids True hybrids Chimeras Chimeras Transgenic embryos Transgenic embryos

Hybrid Embryos Legally HFEA advised that cytoplasmic hybrids fall within its jurisdiction. Legally HFEA advised that cytoplasmic hybrids fall within its jurisdiction. HFEA licence committees therefore able to consider individual applications for research licences to create human/animal hybrid embryos HFEA licence committees therefore able to consider individual applications for research licences to create human/animal hybrid embryos

Hybrid Embryos Consultation The scientific community felt confident that the creation of cytoplasmic hybrids is an avenue of research worth exploring… and an alternative to using human eggs, to investigate the mechanisms of creating patient matched embryonic stem cells. The scientific community felt confident that the creation of cytoplasmic hybrids is an avenue of research worth exploring… and an alternative to using human eggs, to investigate the mechanisms of creating patient matched embryonic stem cells. Public consultation showed that the majority of those consulted would support the creation of these embryos if they were to be used to research improved understanding and treatment of disease. Public consultation showed that the majority of those consulted would support the creation of these embryos if they were to be used to research improved understanding and treatment of disease.

Joint Committee on the Draft Human Tissue and Embryos Bill Who decides what the Government should enact in the new Bill? Who decides what the Government should enact in the new Bill? Will there be a consistent world opinion? – and does it matter? Will there be a consistent world opinion? – and does it matter? How do religious and non-religious views differ and how can this be taken into account in a multicultural society? How do religious and non-religious views differ and how can this be taken into account in a multicultural society?

Public Poll says ‘No’ to more embryo research ‘Frankenstein’ researchers plan embryo with three parents ‘MOUSE MAN’ ARRIVING SOON

Single embryo replacement policy Increased risk of death and complications in multiple pregnancies and births to mother and child Increased risk of death and complications in multiple pregnancies and births to mother and child ‘A single child at a time is best’ ‘A single child at a time is best’ Many European countries now have protocols for single embryo replacements and pregnancy rates have not dropped Many European countries now have protocols for single embryo replacements and pregnancy rates have not dropped Due to costs of IVF in UK, many families prefer twins Due to costs of IVF in UK, many families prefer twins

Single embryo replacement policy As seen as a part of - Good Medical practice – policy and protocols likely to be derived with Professional groups and Clinics. As seen as a part of - Good Medical practice – policy and protocols likely to be derived with Professional groups and Clinics. Clinics will be given advice on evidence for use of single and two embryo replacements Clinics will be given advice on evidence for use of single and two embryo replacements Target level of multiples to be achieved over a few years Target level of multiples to be achieved over a few years

Regulation Better regulation – minimise impact on Clinics Better regulation – minimise impact on Clinics Code of Practice developed to inform good practice Code of Practice developed to inform good practice Inspecting and licensing for specific activities Inspecting and licensing for specific activities Lead clinicians to pass test on the Act and Code of practice Lead clinicians to pass test on the Act and Code of practice

Thank you for your attention