Select Committee on Science and Technology Fourth Report


The Science and Technology Committee has agreed to the following Report:








  1. Our Committee has taken a long-standing interest in medical genetics research and its application. Our predecessor Committee's 1995 Report on Human Genetics: the Science and its Consequences followed an extensive and wide-ranging inquiry and anticipated many of the issues that lay ahead in this field.[1] In 2001 our predecessors reported on Genetics and Insurance, recommending a moratorium on the use of positive genetic tests by insurers and highlighting a number of problems with the existing regulatory framework in this area.[2] Their 2001 report on The Scientific Advisory System discussed the role of the Human Genetics Commission (HGC) as part of a wider examination of government scientific advisory committees.[3] In March 2002 we held a seminar with leading researchers in the fields of embryology and stem cell research to discuss the policy and regulatory implications of recent advances of research using embryos.[4] It is our intention to monitor developments in this area over the course of the Parliament.
  2. On 24 April 2002 we took oral evidence from Dame Ruth Deech, former Chair of the Human Fertilisation and Embryology Authority (HFEA), Helena Kennedy (Baroness Kennedy of the Shaws), Chair of the HGC, and Suzi Leather, Chair of the HFEA. Dame Ruth, a family and property lawyer, was Chair of the HFEA from 1994 to 2002. She was replaced in April 2002 by Ms Leather, who has a background in consumer representation on health, food and agricultural issues and is also Deputy Chair of the Food Standards Agency. Baroness Kennedy is a criminal lawyer and has chaired the HGC since its foundation in December 1999. The transcript of this evidence session is printed with this Report, together with supplementary evidence provided by the HFEA, Professor Robin Lovell-Badge, from the National Institute for Medical Research, Dame Anne McLaren from the Wellcome Trust/Cancer Research UK Institute of Cancer and Developmental Biology and Professor Austin Smith from the Centre for Genome Research at Edinburgh University.[5]
  3. This short Report draws attention to particular areas of concern raised by the witnesses, follows up on issues raised by inquiries from our predecessor Committees and makes recommendations to Government where action is urgently needed. Later this year the Government will publish its Green Paper on Genetics, to examine "the ethical, clinical, scientific and economic issues" surrounding genetics.[6] We welcome the intended breadth of the forthcoming Green Paper on Genetics and hope it embraces the views we express in this Report.


    Organisations and their structures


    Human Fertilisation and Embryology Authority



  5. The HFEA was established in 1991 by the Human Fertilisation and Embryology Act 1990.[7] It is an executive non-departmental public body sponsored by the Department of Health and has a staff of around 30. No research on human embryos may be undertaken except under licence from the HFEA. It also licenses all UK treatment clinics offering in-vitro fertilisation or donor insemination, or storing eggs, sperm or embryos.

    Income and expenditure

  7. The HFEA generates income by charging fees to in-vitro fertilisation centres holding licences. It is set an expenditure limit (1,575,000 in 2000-01). The Department of Health and the devolved administrations fund the difference between the levied charges (1,242,000 in 2000-01) and this expenditure limit.[8] The funding mechanism ensures that the HFEA's income remains the same whatever the income raised by fees, and therefore that it has no direct incentive to award licences. Given the importance of avoiding such an incentive, it is curious that the Department of Health has set a target for the HFEA to raise 70% of its income from fees. (In practice, it has exceeded this target: between 1994-95 and 2000-01 the HFEA raised 88% of its expenditure through fees, and in 1998 and 2000 made a profit.)[9] The overall expenditure limit has presumably been set at the level the Department of Health thinks has been necessary for the HFEA, though how this figure has been reached is unclear.
  8. Dame Ruth said that "If the HFEA were set up today, in the light of public fears about anything with the word "genetic" in it, whether it is BSE or genetically modified food or whatever, there would be a much more exhaustive approach. I believe that we have the least funding of any comparable organisation".[10] Ms Leather said that when she saw the budget for the first time she "thought they had got the decimal point in the wrong place".[11] In June 2002, the HFEA issued a consultation document on its future funding.[12] It states that the HFEA needs "ongoing operating funding of at least 4.5 million" to perform its licensing and regulatory functions.[13] (This is in addition to 3 million a year which it foresees will be needed for "information systems and accommodation".[14]) It cites scientific and clinical developments, public expectations and government policy as justifications for the increase. It states that the Department of Health has indicated that it will continue to provide 0.6 million baseline funding but that any increase in funding should come from licence fees.[15] (It is not clear whether the HFEA will be subject to an expenditure limit in the future.) The HFEA sets out for consultation two alternative ways of raising the funding of 4 million from fees. The HFEA is asking for its income to be more than doubled. We accept that its activities have increased in recent years but, for such a large increase, it needs to make a more detailed financial case than its consultation document provides. If it can prove the need for such a large increase, it should be met by increased contributions from Government as well as from licensees. We are concerned that the Government's insistence that any increase in funding should be met from licence fees alone undermines the principle that the HFEA should have no incentive to award licences.


  10. The HFEA has been largely successful in ensuring public confidence in its regulation of fertility treatments and research. The Lords Stem Cell Research Committee reported that the HFEA is "highly regarded, both at home and abroad ... [and] has the full confidence of the scientific and medical research community".[16] We are unclear on what evidence it based this assertion. While many of its problems can be explained by a lack of funding, some criticisms can be levelled against the organisation. Professor Austin Smith, a stem cell researcher at Edinburgh University, has found the HFEA to be "inefficient ... and lacking in specialist knowledge" and "a slow and reactive" body. Professor Smith has found the issue of consent forms particularly problematic: "The HFEA provides no guidelines for drawing up consent forms for embryo donors and gives no advice to the licence applicant".[17] Dr Robin Lovell-Badge indicates that researchers have found the HFEA frustrating to deal with and that there has been criticism from researchers regarding the time the HFEA takes to process licence applications.[18] Ms Leather said that the average time for research applications to be processed was four months.[19] We have been told that some applications have taken a good deal longer than this. We note that in the year 2000-01 the HFEA missed its targets for licence renewal (for both treatment and research) by some margin, especially for research licences, though we recognise the problems it has had with high staff turnover.[20] Britain is well placed to be a world leader in human genetics and embryology research and it is crucial that our scientists, in complying with regulatory requirements, are not hampered by bureaucracy.
  11. The HFEA's communication strategy seems to be focused on licensees and patients. While this may be in part because of a lack of resources, the HFEA does not appear to have made much effort to communicate more widely, yet the public has a legitimate interest in its work and administration. Until recently, the HFEA's website reflected poorly on the importance it attached to transparency and accessibility. The new-look site is a step in the right direction. The recently published Annual Report for 2000-01 said that the second quinqennial review of the HFEA recommended that it adopt "more open and transparent working practices".[21] Suzi Leather said that "communicating what we are doing, communicating what the possibilities of science are, what the benefits and disbenefits are, is probably the core challenge for the HFEA".[22] The HFEA's new emphasis on communication with the public is welcome. Continued public confidence demands that the HFEA takes the lead in encouraging awareness and debate about research and treatment involving human embryos.




1   Third Report of the Science and Technology Committee, Session 1994-95, Human Genetics: the Science and its Consequences, HC41-I Back

2   Fifth Report of the Science and Technology Committee, Session 2000-2001, Genetics and Insurance, HC 174 Back

3   Fourth Report of the Science and Technology Committee, Session 2000-2001, The Scientific Advisory System,

HC 257 Back

4   This took place on 13 March 2002. The Committee heard from Dame Anne McLaren, Cambridge University; Professor Austin Smith, Edinburgh Centre for Genome Research; Professor Robin Lovell-Badge, National Institute for Medical Research; and Dr Alan Colman, PPL Therapeutics. Back

5   Ev 1-14 Back

6   Speech by Rt Hon Alan Milburn MP, Secretary of State for Health, 19 April 2001 Back

7   See Back

8   Ev 12-13 Back

9   Income from licences issued for research is negligible (around 22,000). The HFEA is planning a consultation of the funding of its activities relating to research. Back

10   Q12 Back

11   Q14 Back

12   HFEA Consultation on the Modernisation of Regulation and New Fee Strategy, June 2002 Back

13   Ibid, para 61 Back

14   Ibid, para 62 Back

15   Ibid, para 61 Back

16   House of Lords Stem Cell Research Committee, Session 2001-2002, HL 83(i), para 8.1 Back

17   Ev 14 Back

18   Ev 11 Back

19   Q10 Back

20   Tenth Annual Report and Accounts 2001, HFEA, annex 6, p. 39 Back

21   Ibid, p.10 Back

22   Q20 Back

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Prepared 18 July 2002