Human Genetics Commission
- The HGC was formed in 1999 as the result of a review of the advisory and regulatory framework for biotechnology conducted by the Office of Science and Technology and the Cabinet Office. It took on the responsibilities of the former Advisory Committee on Genetic Testing, Advisory Group on Scientific Advances in Genetics and Human Genetics Advisory Commission. The HGC is an advisory non-departmental public body under the Department of Health and Office of Science and Technology and has a secretariat of four drawn from these departments. Its brief is to analyse current and potential developments in human genetics and advise ministers; advise on strategic priorities in the delivery of genetic services by the NHS; advise on strategic priorities for research; and consult the public and other stakeholders and encourage debate on human genetic technologies.
Funding and activities
- The HGC is funded by the Department of Health, with contributions from the Office of Science and Technology, National Assembly for Wales, Northern Ireland Assembly and the Scottish Executive. The HGC's total budget for 2000-01 was £425,000. Our predecessor Committee recommended in 2001 that the Government should, with urgency, review the funding of the HGC. The Government's response was disappointing, saying merely that it "is committed to keeping the resources available to all of its advisory bodies under review". It is clearly a concern of Baroness Kennedy, who told us that "I am one of those people who, whenever I see a minister, never misses the opportunity of saying that we could do with more money".
- Much of the HGC's non-staff expenditure goes on committees and public events. A vital part of the HGC's work is to engage the public in discussion about issues in human genetics. Its terms of reference state that it should "develop and implement a strategy to involve and consult the public and other stakeholders and encourage debate on the development and use of human genetic technologies and advise on ways of increasing public knowledge and understanding". Baroness Kennedy told us that the HGC "did a consultation on the privacy issues around genetics and that cost us in the region of about £50,000". Truly effective public consultation does not come cheap and the HGC's budget gives it little hope of generating better awareness of human genetics and addressing the public's concerns. The Prime Minister said recently that he wishes to avoid a "retreat into a culture of unreason". A good place to start would be to ensure that the Human Genetics Commission has access to sufficient funds to enable it to conduct an extensive and genuine dialogue with the public.
Advisory and regulatory framework
- The foundation of the HGC had been recommended by our predecessor Committee in 1995 but our predecessors were disappointed that initially only an advisory committee, the HGAC, was set up. The Committee's recommendation in 1995 had been that the HFEA provided a good model for a Commission, with statutory regulatory powers combined with an advisory role and a research budget. In its 2001 Report on the Scientific Advisory System, our predecessor Committee welcomed the establishment of the HGC but regretted that it had not been given statutory powers and expressed concern that "The status accorded different advisory bodies at present appears haphazard".
- Although the HGC replaced three advisory committees, it still leaves other advisory and regulatory bodies active in medical genetics: the Gene Therapy Advisory Committee and the Genetics and Insurance Committee. It could be argued that these should have been incorporated into the HGC in the first place. The plethora of advisory and regulatory bodies was a concern of the Committee in the last Parliament: "a lot of committees have grown up over the years, and ... they are not in any rational pattern". In its recent report Inside Information, the HGC suggests that the division of responsibilities with the Genetics and Insurance Committee has not worked well. We recommend that the Government conduct a thorough review of advice and regulation across the fields of medical genetics, embryology and reproductive medicine, with a view to producing a more streamlined structure.
- Stem cells provide the potential to treat a wide range of diseases by virtue of their ability to differentiate and develop into a range of cell types. A technique called cell nuclear replacement (CNR), which was used to create Dolly the Sheep, offers the prospect of increasing our understanding of cellular processes and of creating stem cells with a particular genetic make-up, which may be of therapeutic value. Under the Human Fertilisation and Embryology Act 1990, as enacted, research on embryos for therapeutic purposes could not be licensed by the HFEA. In November 2000, following the recommendations of a report by the Chief Medical Officer (the Donaldson Report), the Government laid draft Regulations before Parliament, allowing the HFEA to license research involving embryos for the purposes of (a) increasing knowledge about development of embryos, (b) increasing knowledge about serious disease and (c) enabling any such knowledge to be applied in developing treatment for serious disease. The draft Regulations were passed by both Houses and came into effect on 31 January 2001 as the Human Fertilisation and Embryology (Research Purposes) Regulations 2001.
- The ProLife Alliance sought a judicial review of the 2001 Regulations, claiming that "human embryos created by cell nuclear replacement, which process does not involve 'fertilisation', do not satisfy the definition of 'embryo' in section 1 of the 1990 Act". On 15 November 2001 the High Court granted a declaration in the terms sought, in effect removing embryos created by CNR from regulation by the HFEA. In response, and to ensure that CNR was not used for human reproductive cloning, the Government introduced the Human Reproductive Cloning Bill on 21 November, which became law on 4 December 2001. It provides that "A person who places in a woman a human embryo which has been created otherwise than by fertilisation is guilty of an offence". At the same time the Government appealed against the High Court's judgment. On 18 January 2002 the Court of Appeal allowed the appeal, in effect bringing embryos created through the use of CNR within the scope of the 1990 Act. The ProLife Alliance has been given leave to appeal against this ruling to the House of Lords and a hearing is expected before the end of 2002.
- During the debate on the Regulations on 22 January 2001, some members of the House of Lords were concerned about the speed with which legislation was being introduced and that the creation of cloned embryos could lead to human cloning (CNR could result in a cloned human if the resulting embryo were implanted in the womb). This was met by an amendment calling on the Government to support the appointment of a House of Lords Select Committee to report on the issues connected with human cloning and stem cell research, and to undertake to review the Regulations following the report of that Committee. The House of Lords Stem Cell Research Committee's report, published on 27 February 2002, affirmed the importance of this area of research and concluded that the current regulatory framework provided sufficient protection against the development of CNR leading to human reproductive cloning. On 28 February 2002 the HFEA approved two applications for research on human embryos to produce stem cell lines, neither of which involves CNR. The Government published its response to the Lords Committee on 4 July 2002.
- Embryonic stem cells are not considered to be embryos and do not fall within the remit of the HFEA. Neither does the HFEA have jurisdiction over clinical trials involving adult stem cells. The Lords Committee suggested either that a new advisory committee be set up to regulate clinical studies on all types of stem cells or that the remit of the Gene Therapy Advisory Committee be extended. The question arises, however, why not simply extend the remit of the HFEA to cover stem cell lines? The Lords Committee took the line that research on established stem cell lines did not require the level of regulation to which human embryo research is currently subject by the HFEA. This is true, but the HFEA could readily operate a 'lighter touch' regulatory regime for stem cell research. We note that Ms Leather showed no enthusiasm for the HFEA taking on this role but in our view there would be benefit in avoiding the creation of yet another body in this already overcrowded regulatory field. The Government, in its response to the Lords Stem Cell Committee, says it will consider whether "further oversight of ... clinical trials involving embryonic stem cells is desirable" but highlights important differences between stem cell therapy and gene therapy.
- The Lords Committee endorsed the Department of Health's request to the Medical Research Council to establish a stem cell bank. The MRC has set up a National Stem Cell Bank Advisory Committee which will choose an independent national laboratory as the location and oversee the bank once it has been established. Both Baroness Kennedy and Dame Ruth felt that the body that regulates clinical trials involving stem cells could include a cell bank within its remit.
- We recognise that different areas of expertise are needed to assess different areas of clinical research, but the Government should operate from the principle that no more advisory and regulatory bodies should be created than are absolutely necessary and it is better to reinforce the success of existing bodies by extending their remit than to spawn ever more small specialised bodies.
- Modern medical science is a global activity. The negotiations for the European Commission's Framework Programme 6, in which some countries wished to limit the funding available for research on stem cells, demonstrate that countries with different cultural and religious backgrounds can take very different ethical stances. In October 2001, the European Parliament's Temporary Committee on Human Genetics and Other New Technologies in Modern Medicine visited Westminster. It was clear from the discussion that there was considerable tension on the stem cell issue. The Council of Europe's Convention of Human Rights and Biomedicine was published in 1998. In permitting CNR, the Human Fertilisation and Embryology (Research Purposes) Regulations 2001 are in conflict with Article 18 of the Convention, which prohibits the creation of cloned embryos for research. There is provision for a State to sign the Convention with a reservation where it is in conflict with existing legislation (Article 36), however. The UK is not a signatory to the Convention and we believe the Government should consider whether it should join as part of an international effort to prohibit human cloning. We note that the Government is supporting a draft UN convention to outlaw human reproductive cloning. We believe that the Government should remain active on the international stage, as well as domestically, in ensuring that scientific advances are facilitated yet appropriately balanced by regulatory and legislative control.
- It is now 12 years since the Human Fertilisation and Embryology Act was enacted, and the science that informed it has been superseded. As Dame Anne McLaren says, "the HFEA seems to have a wider sphere of responsibility with every year that passes", presenting new challenges to the organisation. Some of these issues create unease in some quarters. We asked the witnesses whether it was time to review the 1990 Act. Dame Ruth said that the Act might need to be amended to take account of human rights legislation and that there was too much emphasis on confidentiality in the Act (she told us that this made it difficult for the HFEA to get its computers repaired, for example).
- Baroness Kennedy also suggested an area where legislation was necessary. She believed that theft of DNA should become a criminal offence and that a new body should be set up to regulate DNA databases. Already there are signs that inappropriate use of DNA is taking place and the BioBank initiative, the funding of which was announced on 29 April 2002, has also raised concerns. The HGC's recent report Inside Information discusses this and many other issues surrounding the use of personal genetic data. We are aware that some see a need for much stronger legislation in this area to protect genetic privacy, to prevent genetic discrimination and to regulate the commercial exploitation of genetic samples.
- Some witnesses told the Lords Stem Cell Research Committee that they believed the 2001 Regulations to be ultra vires the Human Fertilisation and Embryology Act in extending the Act to cover basic research. While the Stem Cell Committee did not believe this to be the case, it suggested new legislation to make "express provision for such basic research as is necessary as a precursor for the development of cell-based therapies". In its response to the Stem Cell Committee, the Government said it had "no reason to believe that legislation will be required for the foreseeable future". The Committee identified where scientific advances might require new legislation: the mixing of animal eggs with human cells; the dedifferentiation of adult stem cells to form the equivalent of a zygote (a fertilised egg) which could go on to form an embryo; the generation of an embryo from an oocyte (egg); the induction of differentiation using animal material; and the induction of embryonic stem cells into an embryo. The House of Lords Stem Cell Research Committee has identified several areas which might require new legislation. The Government should work on the premise that these developments will happen sooner rather than later and introduce legislation accordingly.
- The ProLife Alliance is appealing to the House of Lords over the High Court's decision that embryos formed by CNR are covered by the HFE Act. This would leave any embryo formed by means other than by fertilisation completely unregulated, although the Human Reproductive Cloning Act has made illegal the implantation of such an embryo in the womb. The Government remains "satisfied that any embryo research that used CNR is covered by the 1990 Act". Should the ProLife Alliance's appeal to the House of Lords be successful, we urge the Government to introduce new legislation to bring the creation of embryos by whatever means within the remit of the 1990 Human Fertilisation and Embryology Act.
- On 13 December 2001, the HFEA decided to allow tissue typing in conjunction with preimplantation genetic diagnosis (PGD) for serious genetic diseases. This decision led to a clinic being awarded a licence from the HFEA to implant an embryo with a genetic profile that would enable the baby to donate bone marrow to an older sibling with beta thalassaemia. Questioned on the decision, Dame Ruth asserted that "The public has been consulted about preimplantation genetic diagnosis". The consultation of which she spoke was begun in November 1999 by the HFEA and the former Advisory Committee on Genetic Testing. Yet this did not address the issue of tissue typing to benefit an existing family member. Indeed, the HFEA/HGC Joint Working Party set up in December 2000 to consider the results of the consultation specifically ruled out such a procedure, stating in its report that "there were sufficient ethical difficulties with this approach that it should be subject to further discussion". Further discussion did indeed take place before a decision was made, but only within the HFEA's own ethics committee. The HFEA's decision to allow tissue typing in conjunction with preimplantation genetic diagnosis went beyond the scope of its own public consultation. It is vital that the public are taken along with decisions of such ethical importance.
- We take issue with Dame Ruth's assertion that the fact that the HFEA took the decision on PGD "protects Members of Parliament from direct involvement in that sort of thing". Parliament does not need protecting and democracy is not served by unelected quangos taking decisions on behalf of Parliament. A pressure group, Comment on Reproductive Ethics, is seeking judicial review in the High Court on PGD on the grounds that the 1990 Act only permits distinguishing between embryos on the basis of whether they are healthy or not or for providing treatment services to the mother. Should this ultimately be successful, Parliament's intervention may be inevitable.
- The Government has recently been conducting a consultation on the question of introducing new Regulations under the HFE Act to enable the offspring resulting from donated sperm, eggs or embryos to learn the identity of the donor. The issue was considered in Parliament during the passage of the Act but this may be another area that needs an overhaul.
- Dame Ruth felt that new legislation on human embryology risked becoming "enmeshed with opponents of abortion". This may be true but we cannot accept that Parliament should not be asked to consider major ethical issues for fear that elected representatives might come to a view that is different from that of the scientific community. The debates that took place on the Human Fertilisation and Embryology (Research Purposes) Regulations in December 2000 (Commons) and January 2001 (Lords), and on the Human Reproductive Cloning Bill in December 2001 showed that Parliament is well capable of considering these sensitive subjects sensibly. The Government's apparent reluctance to enact new legislation in this sensitive area has led to a position where the 1990 Act is open to legal challenge. We recommend urgent action to remedy this and reconnect the Act with modern science.
23 The Advisory and Regulatory Framework for Biotechnology: Report from the Government's Review,
Cabinet Office, Office of Science and Technology, May 1999 Back
24 See www.hgc.gov.uk Back
25 Fifth Report of the Science and Technology Committee, Session 2000-01, Genetics and Insurance, HC 174, Appendix 26 Back
26 Ibid, para74 Back
27 Government Response to the Report from the House of Commons Science and Technology Committee: Genetics and Insurance, Cm 5286, para 48 Back
28 Q59 Back
29 Q50 Back
30 Speech made by the Prime Minister at the Royal Society on 23 May 2002 Back
31 Third Report of the Science and Technology Committee, Session 1994-95, Human Genetics: The Science and its Consequences, HC41-I, paras 285-286 Back
32 Fourth Report of the Science and Technology Committee, Session 2000-2001, The Scientific Advisory System, HC 257, para 30 Back
33 Ibid, para 77 Back
34 Inside Information: Balancing Interests in the Use of Personal Genetic Data, a report by the Human Genetics Commission, May 2002 Back
35 Stem Cell Research: Medical Progress with Responsibility, Report of the Chief Medical Office's Expert Advisory Group on Therapeutic Cloning, Department of Health, August 2000 Back
36 R(Quintavalle) v Secretary of State for Health Back
37 House of Lords Stem Cell Research Committee, Session 2001-2002, HL 83(i), para 5.24 Back
38 From the Centre for Genome Research in Edinburgh and from Guy's Hospital in London. Back
39 Government Response to the House of Lords Select Committee Report on Stem Cell Research, July 2002, Cm 5561 Back
40 HL 83(i), para 8.22 Back
41 Ibid, para 8.23 Back
42 Qq 32-43 Back
43 Cm 5561, pp 16-17 Back
44 HL 83(i), para 8.29 Back
45 Q46 Back
46 The Committee met with members of our predecessor Committee (including members of the current Committee) and the House of Lords Science and Technology Committee. Back
47 Cm 5561, pp 13 Back
48 Ev 12 Back
49 Q31 Back
50 Q62 Back
51 Joint news release issued by the Wellcome Trust, the Medical Research Council and the Department of Health Back
52 HC Deb, 3 July 2002, cols 365-372 Back
53 Inside Information: Balancing Interests in the Use of Personal Genetic Data, a report by the Human Genetics Commission, May 2002 Back
54 Response to HGC consultation on personal genetic information from Human Genetics Alert, see ww.hgalert.org Back
55 HL 83(i), para 8.10-8.15 Back
56 Cm 5561, pp 16 Back
57 HL 83(i), paras 8.18-8.19 Back
58 Cm 5561, pp 6 Back
59 Q7 Back
60 Outcome of the Public Consultation on Preimplantation Genetic Diagnosis, HGC/HFEA, November 2001,
paragraph 29 Back
61 Ethical Issues in the Creation and Selection of Preimplantation Embryos to Produce Tissue Donors, Ethics Commitee of the HFEA, November 2001 Back
62 Q5 Back
63 Q33 Back