Pre-ARM briefing paper 2018: Time limits for embryo research

Transcription

1 Pre-ARM briefing paper 2018: Time limits for embryo research February 2018 British Medical Association bma.org.uk

2 The BMA has endeavoured to print all material relating to ARM 2018 using recycled or FSC-certified paper. We have done this to uphold BMA policy (see below) and the Representative Body s wish to look after the environment. That this meeting calls for all papers relating to BMA ARM and AGM to be printed on either 100% recycled paper or 100% FSC-certified paper from sustainable sources. (2016)

3 British Medical Association Pre-ARM briefing paper 2018: Time limits for embryo research 1 Pre-ARM briefing paper 2018: Time limits for embryo research This briefing summarises the current ongoing debate about extending the current statutory time limit for research involving human embryos. It is intended as a background paper for members to inform discussion at the BMA s 2018 Annual Representative Meeting. Introduction The Human Fertilisation and Embryology Act 1990 permits research involving human embryos up to 14 days after fertilisation, or the appearance of the primitive streak (the first structure in the embryo when cells begin to specialise), whichever is sooner, subject to a licence for each research project being issued by the Human Fertilisation and Embryology Authority (HFEA). Until recently nobody had been able to culture an embryo in vitro for more than around one week without it losing its coherence and structure; this is around the time at which the embryo usually implants. In 2016, Professor Magdelena Zernicka-Goetz and colleagues 1 published two papers reporting that they had succeeded in keeping human embryos alive and intact for 13 days, by using specially designed culture conditions. These reports represented a very significant advance in embryological science, opening up the possibility of exploring new avenues of research. The research was stopped at this stage to prevent the statutory time limit being breached and it is not clear how much longer the embryos could have been kept had this not been the case. This development has led to debate about whether the 14-day time limit for human embryo research should be extended, perhaps to 21 or 28 days, to maximise the potential benefit that can derive from such research. This would require a change in primary legislation. There are no immediate calls for this change to take place but it is an issue that is increasingly being debated in the professional, public and political sphere. Given the BMA s traditional interest and interventions in this area, the ARM may wish to debate this issue to facilitate our continued involvement in this important debate as it develops. Origins of the 14-day time limit The origins in the UK of the 14-day limit for human embryo research lie with the Committee of Inquiry into Human Fertilisation and Embryology chaired by Baroness Mary Warnock which reported in 1984 (the Warnock Report 2 ). The Warnock Committee recommended that research on human embryos up to 14 days after fertilisation should be permitted subject to a statutory licensing system. The BMA supported the 14-day limit in evidence submitted to the Warnock Committee and has continued to support research up to the 14-day limit ever since. The recommendation on embryo research proved controversial at the time of the Warnock Report s publication and there were calls, in the subsequent Parliamentary debates, for a moratorium on embryo research until legislation had been passed. A Private Members Bill by Enoch Powell MP, to prohibit research involving human embryos, won considerable support in the House of Commons in 1985 but did not progress. There followed a period of considerable activity by those working in the field and those who supported embryo research to provide educative materials for the public and Parliamentarians about this topic, both about what embryos are and the aims and potential of the research. In the years between the publication of the Warnock Report in 1984 and the Human Fertilisation and Embryology Bill appearing in 1989, those undertaking and supporting embryo research were keen to be open and transparent both about what they were doing, and what they were hoping to achieve. By the time the Bill was debated in Parliament in 1989, the vote in support of embryo research was overwhelming in both Houses of Parliament.

4 2 British Medical Association Pre-ARM briefing paper 2018: Time limits for embryo research Current legislative framework The Human Fertilisation and Embryology Act 1990 (HFE Act), as passed, required that all research projects involving human embryos must be approved, in advance, by the statutory regulatory body, HFEA. Carrying out embryo research involving human embryos without a licence, or beyond the 14-day time limit is a criminal offence. Before approving any research project, the HFEA must be satisfied that the use of human embryos is necessary or desirable for one or more of the following purposes: (a) (b) (c) (d) (e) 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. This original list was extended, by Regulations, in 2001, to include: (e) increasing knowledge about the development of embryos, (f) increasing knowledge about serious disease, or (g) enabling any such knowledge to be applied in developing treatments for serious disease. A list of all approved research projects can be found on the HFEA s website ( When the HFE Act was reviewed in 2008 some amendments were made to the definition of embryo in the Act to take account of developments such as the use of cell nuclear replacement (rather than fertilisation) to create human embryos, but the 14-day limit remained unchanged. Embryos used for research are either donated, when they are no longer required for IVF treatment, or are created specifically for, or in the course of, research from gametes donated for that purpose. In addition, there have recently been advances in work involving the development of synthetic embryo-like entities that could be used for research. The rationale behind the 14-day time limit A key issue in the debate around embryo research is the moral status of the human embryo and what, if any protection or respect, the embryo is entitled to. This is not a question to which there is a factual answer but rather is one of belief and members of society, and members of the medical profession, have a range of views on this issue. Some take the view that the human being is to be respected and treated as a person from the moment of conception. 3 This position is based on the view that at the moment of the fusion of the gametes a new individual is created. Some people also believe that every human being, from the moment of conception, has a spiritual soul directly created by God. A variation on this approach is to view the embryo not as a person from the moment of conception but a potential person or a person with potential, who should be afforded the same legal status and protection as other human beings. Those who take this view are unlikely to support any form of embryo research that results in the destruction of the embryo. The development of the primitive streak at around 14 days after fertilisation is considered by some to be a morally significant stage of development and this underpins the current 14-day time limit recommended by the Warnock Committee. Until this point it is possible for twinning to occur and the embryo could result in either one individual or more than one. It is argued, therefore, that it is not until after this point that the new individual is truly formed. At this stage it is also clear which cells will go to make up the embryo or embryos and which will form the placenta. Other stages that could be seen as having moral significance include the point at which the neural system first appears or begins to develop or the stage of organogenesis, when the organs are formed and the process going forward is mainly one of growth rather than development. Some have argued that the embryo/fetus does not gain moral status until much later in development including up to and beyond birth. Views on this issue should therefore be seen as being on a spectrum. Embryological development is a continuous process and although various significant

5 British Medical Association Pre-ARM briefing paper 2018: Time limits for embryo research 3 events and stages can be identified throughout this process, there is no single point that emerges from analysis of the scientific evidence, or ethical discourse, as being the point up to which embryos begin to matter morally and beyond which it should not therefore be permissible to use them for research. In such circumstances, where policy decisions are needed, the aim is usually to search for a position that is broadly acceptable to society, accepting that not everybody will agree with the position taken. The 14-day limit has been referred to as arbitrary, a fudge and a compromise but it has succeeded in providing clarity to those working within the system, and those responsible for policing it, and providing reassurance to the public that there are limits and controls. The BMA s views on embryo research In its evidence to the Warnock Committee in 1983 the BMA supported human embryo research up to 14 days after fertilisation. In all of its discussions on the moral status of the embryo and fetus, over many years, the BMA has adopted a gradualist position, taking the view that that the respect and protection owed to the embryo/fetus increases as it develops. In addition, we have always been supportive of the regulatory mechanism around embryo research and have publicly expressed the view that it is as a result of having a well-established and trusted regulatory body to oversee research that the UK is able to move forward in exploring new issues such as stem cell research, mitochondrial transfer and gene editing with public support. We have made public statements, issued Parliamentary briefings and contributed to consultations in support of embryo research in debates on stem cell research, and the extension of the purposes for which research can be conducted, and in relation to mitochondrial transfer and gene editing. The debate around extending the time limit The key argument made for extending the 14-day time limit is the prospect of improvements in knowledge and treatments that will benefit human health. Very little is known about embryological development in humans beyond the first week after fertilisation. The subsequent period is often referred to as the black box because so little is known about this time period, during which important stages of embryological development take place. The ability to learn about development beyond 14 days could bring significant new and important knowledge in, for example: basic understanding of early post-implantation human embryos; identification of possible causes of early pregnancy loss; improved IVF efficacy by identifying markers of successful development; understanding the critical process of gastrulation when the body plan is laid down and tissues form; understanding development of the central nervous system; the origin of congenital defects; and differentiation of human embryonic stem cells for regeneration. Those who support an extension to 21 or 28 days have argued that it will permit research which will be a huge benefit to human health. 4 Others have argued, however, that it is too early to begin to make such a change. Baroness Warnock has been quoted as saying that researchers should more fully explore the potential presented by the possibility of researching up to 14 days before seeking an extension to the time limit. 5 Underpinning some of the reluctance to open the debate again lies a fear that attempts may be made to limit embryo research further, and perhaps to prohibit it altogether; when the Regulations to extend the research purposes were debated in 2001 there were those who continued to argue that all such research should be stopped. The debate that has ensued has raised the issue of whether an extension now will inevitably lead to further extensions in the future (the so-called slippery slope arguments). Whilst some see the maintenance of the 14-day time limit as evidence that limits can be set and maintained in relation to research, others have pointed out that the limit was only maintained because it was not possible to exceed it: as soon as the possibility of research beyond that point arose, calls have been made to extend it.

6 4 British Medical Association Pre-ARM briefing paper 2018: Time limits for embryo research Public opinion Issues around assisted reproduction and embryo research feature regularly in the media and this debate is no different. A number of newspapers and radio programmes have already covered this debate and will, no doubt, continue to do so as it progresses. Given that a key reason behind the 14-day limit, and the statutory regulation of assisted reduction and embryo research more generally, was to maintain public trust and confidence, the views of the public will continue to play a prominent role in any debates. Public engagement and support were an important consideration for the government when considering how it responded to developments in research on, and the potential for clinical application of, mitochondrial transfer. At that time the HFEA conducted a vast programme of engagement both to educate and to seek views from the public. Such work has yet to be undertaken on extending the time limit but a YouGov poll carried out on behalf of BBC Radio 4, in January 2017, found that 48% would support a doubling of the 14-day limit to 28 days; 19% thought the limit should remain at 14 days and 10% believed that embryo research should be prohibited altogether, while 23% were unsure. 6 The BMA has always argued that developments in this area should be subject to public debate with a view to seeking broad agreement for any new avenues or developments in research. Those who support an extension of the time limit have taken a similar approach, aware of the need to maintain public trust in a system that has helped to facilitate research in the past. The process through which mitochondrial transfer was taken from initial research stages, through to approval for its use in clinical practice with both public and professional education, engagement and support provides a good model that could be followed here. Views of the Medical Ethics Committee The BMA has historically contributed to debates on human embryo research and the ARM may wish to consider whether updated policy in this area would be helpful to facilitate our continued involvement in the forthcoming debates on this issue. The Medical Ethics Committee debated this issue in the 2016/17 committee session and concluded that there were reasonable grounds to consider extending the time limit but that the benefits of doing so needed to be properly articulated and explained. In order to maintain public confidence in this area of research, the MEC also called for in-depth public and professional consultation before any change was made. Additional resources In addition to the information provided in this briefing, representatives may find the following resources helpful: BBC Radio 4, Revisiting the 14-day rule, 23 January 2017; An interview with a number of senior individuals in the field, published in Nature Biotechnology in November ; and A collection of articles published by the Nuffield Council on Bioethics in August 2017, following a workshop on the topic. 8 Endnotes 1 Deglincerti A, Croft GF, Pietila LN, Zernicka-Goetz M, Siggia ED, Brivanlou AH (2016) Self-organization of the in vitro attached human embryo. Nature vol 533: ; and Shahbazi MN, Jedrusik A, Vuoristo S, Recher G et al. (2016) Selforganization of the human embryo in the absence of maternal tissues. Nature Cell Biology vol 18(6): Committee of Inquiry into Human Fertilisation and Embryology (1984) Report of the Committee of Inquiry into Human Fertilisation and Embryology (Cmnd 9314) HMSO London. Available at: 3 Catholic Bishops Conference of England & Wales (2004) Cherishing life. The Catholic Trust Society: London, p Dr Simon Fishel quoted in: Katie Gibbons. Double the time limit on embryo tests, urge scientists. The Times, 5 December McKie R. A leap forward or a step too far? The new debate over embryo research. The Guardian on line, Sunday 4 December Available at: 6 BBC Radio 4, Revisiting the 14-day rule, 23 January Available at: ; Leida A, Almost half of UK public support extending 14 day rule, BioNews, 23 January Available at: bionews.org.uk/page_ asp 7 Hurlbut JB, Hyun I, Levine AD, et al. Revisiting the Warnock Rule, Nature Biotechnology (2017), 35: Nuffield Council on Bioethics (2017) Human Embryo Culture. Discussions concerning the statutory time limit for maintaining human embryos in culture in the light of some recent scientific developments. NCB, London.

7

8 British Medical Association BMA House, Tavistock Square, London WC1H 9JP bma.org.uk British Medical Association, 2018 BMA