Select Committee on Science and Technology Written Evidence


Memorandum 46

Submission form the Human Fertilisation & Embryology Authority (HFEA)

INTRODUCTION

  1.  The HFEA is pleased to submit evidence in support of the Select Committee's inquiry. This focuses on the position adopted by the Authority to date, including interpretation of the requirements of the Human Fertilisation and Embryology Act 1990 and the Authority's plans to conduct a public consultation on the desirability of permitting the creation of hybrid and chimera embryos for research purposes.

  2.  Relevant copies of papers presented to the Authority and its sub committees, together with minutes of those meetings, are attached[50]. Independent legal advice obtained by the Authority in relation to this issue has been withheld for the usual reasons of legal privilege. Specific references to Counsel's advice in the paper presented to the Authority on 10 January 2007 have also been removed. The legal issues considered by the Authority are however summarised in this paper.

REVIEW OF THE 1990 ACT

  3.  In 2005, the Government's public consultation on the Review of the Human Fertilisation & Embryology Act sought views on whether the law should permit the creation of human-animal hybrid or chimera embryos for research purposes only (subject to the limit of 14 days culture in vitro, after which the embryos would have to be destroyed). The HFEA's response to this (November 2005) was that:

    The creation of human-animal hybrids is permitted until the two cell stage under the current Act and the HFEA considers that research within the constraints outlined by the Government should be permitted.

    As long as it can be ensured that such entities would never be implanted into a woman or allowed to develop beyond the 14 day stage, and as long as the research would fall under current research purposes, it could be argued that the ethical justification for the creation of such entities is consistent with research as it is currently allowed.

    Nevertheless, we recommend that the Government has proper consideration to the diversity of views on this issue. The HFEA would recommend that hybrids and chimeras are defined in the new Act.

  4.  This remains the HFEA's formal position.

THE AUTHORITY'S INTERPRETATION OF THE CURRENT LEGAL POSITION

  5.  Early in 2006, UK scientists stated publicly that they might wish to create hybrid embryos by fusing human cells with rabbit eggs. The Authority therefore began to address this issue in anticipation of receiving an application for a licence to undertake this research.

  6.  A key question for the Authority at this point was whether hybrid embryos fall within it's jurisdiction under the 1990 Act. As it is the nature of the embryo, and not the process by which it is created, that is critical to the question of whether it falls within the scope of the Act, it was important to understand whether hybrid embryos could properly be categorised as "live human embryos". If there was scientific agreement that a hybrid embryo contained a full human genome, a reasonable interpretation of the Act would be that such embryos should be treated as live human embryos unless it could be clearly proved that the embryo could never be viable. The implication of a judgement that hybrid embryos are not live human embryos is that such research involving the creation of hybrid embryos could be undertaken free from regulation.

  7.  In April and May 2006 respectively, the Authority's Scientific and Clinical Advances Group (SCAG) and Ethics and Law Committee (ELC) were asked to consider this and related issues. SCAG's general opinion was that this type of hybrid embryo should be classed as human. ELC agreed that an embryo containing human nuclear DNA and mitochondria of animal origin should be regarded as an "embryo" for the purposes of the 1990 Act. ELC also took the view that the creation, keeping or use of such an embryo was capable of being regarded as necessary or desirable for one of the purposes set out in Schedule 2 of the Act.

  8.  Subsequently, in November 2006, the Authority sought further expert scientific opinion from relevant members of the HFEA Horizon Scanning Expert Panel. Those who responded agreed that this type of hybrid embryo would contain a complete human genome. However, there was no consensus on whether a hybrid embryo would be capable of implantation (ie whether it would potentially be viable and therefore afforded the protection of the Act). There was also a lack of consensus on whether the embryo would be human from day one.

  9.  This advice and opinion, together with a summary of the ethical issues, was presented to the Authority at its meeting on 10 January 2007 (by which time two research licence applications had been received). The Authority's conclusion—that, under current legislation, this sort of research potentially falls within the remit of the HFEA to regulate and licence—reflects the remaining scientific uncertainties particularly on the potential viability of hybrid embryos and the fact that this conclusion has not been tested by the courts.

HANDLING OF RESEARCH LICENCE APPLICATIONS

  10.  Two applications for research licenses for derivation of embryonic stem cells from hybrid embryos were received by the Authority on 7 November. The paper presented to the Authority on 10 January 2007, makes clear that acceptance that hybrids fall within its remit requires these applications to be referred on to a licence committee of the Authority for consideration. The Authority was invited to consider developing a policy statement which a licence committee could take into account in reaching a decision. However, advice given to the Authority on the day of the meeting provided a further option—to delay reaching a policy position and consideration by licence committee pending a full public consultation.

  11.  The decision to undertake a full and detailed consultation was taken by the Authority on the grounds that it would be wrong to make an immediate judgement on these complex and controversial matters before a proper body of evidence had been built up. Although the Government's consultation on the review of the 1990 Act detected public disquiet in this area, it addressed it in limited detail and in the context of a large number of other questions.

HFEA CONSULTATION

  12.  Although the Authority's consideration of hybrids to date has been prompted by two particular licence applications, its scope will be much wider. The consultation will address all types of chimera and hybrid embryos, ie embryos which contain some elements of animal DNA.

  13.  The consultation exercise is currently being planned, but we expect the consultation to run from late April to late July and for the Authority to use the results to arrive at a policy position at its meeting on 5 September. The Authority is currently exploring the option of using a number of methods for gathering public views, including a formal written consultation, a public opinion poll, a large scale public debate, focus groups, small scale meetings with individuals or stakeholder groups and briefing to Parliamentarians. Throughout this process, the Authority will work closely with the scientific community, the various interest groups and the public to develop a proper understanding of the different types of science and outcomes that hybrid and chimera research would involve.

CONCLUSION

  14.  The Authority's chief concern in addressing the issue of hybrids and chimera is to exercise its responsibilities as a regulator in a way that is fair to all interests whilst meeting its responsibilities under the 1990 Act. We also hope that the information gained during our consultation will help to inform Ministers and Parliament in reviewing the 1990 Act. We are pleased that the Select Committee is also actively engaged in considering these issues.

January 2006






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