Select Committee on Science and Technology Written Evidence


Memorandum from Comment on Reproductive Ethics


  Comment on Reproductive Ethics (CORE) was established in 1994 as a public interest group focusing on the ethical problems raised by human reproduction, particularly the new technologies of assisted conception. The first public meeting of CORE that year addressed the role of the Human Fertilisation & Embryology Authority (HFEA or Authority) and questioned their authority to make ethical decisions in this field. This has been a key concern of CORE throughout the past decade, and will be the major focus of our submission to your committee.


The HFEA has extended its role beyond its statutory remit

  1.  Colleagues from the Lawyers' Christian Fellowship will be dealing in greater detail with this aspect of the HFEA in relationship to the HFE Act 1990, but there are some general points CORE would like to make insofar as this argument dovetails into the major thrust of our submission, namely that the HFEA is neither a democratic nor representative body.

  2.  As very clearly reiterated on their own website, when the HFEA was established in 1991 its role was almost exclusively a regulatory one. CORE has no difficulty in accepting the necessity of robust regulation in the field of assisted reproduction, including such aspects as licensing, monitoring and the supervision of good technical practice. Data collection is also a significant and necessary part of regulation.

  3.  CORE is, however, concerned with ethical decisions made by the HFEA without any clear justification, statutory or otherwise. There is no historical indication that the HFEA was ever intended to take on the role of ethical policy maker, and even in the HFEA's current statement of their duties such an assumed role is nowhere justified. The nearest one gets to any explicitly declared stance which goes beyond the strictly regulatory and into ethical policy making is where it is stated that the HFEA "where appropriate" will "advise the Secretary of State for Health on developments in these fields". (HFEA website) That the HFEA passes on advice to the Secretary of State has an inevitable logic and is again not a major problem for CORE, but this in no way gives automatic authority to the HFEA to make decisions in relationship to the legality or ethical acceptability of new developments or applications in assisted reproduction.

  4.  The HFEA clarifies on its website what it does not do. These include:

    —  It is not a pressure group.

    —  It is not involved in funding for treatment.

    —  It is not a research body.

  CORE suggests that the HFEA be invited to defend such claims in the light of the following sample of recent activities:

    —  The HFEA is currently involved, together with the Department of Health, in overt promotion of gamete donation. At an HFEA meeting in October 2003 it was minuted that "The HFEA could make a significant contribution to changing the climate around sperm donations and encouraging different groups to donate".

    —  The Chair of the HFEA has made widely publicised public announcements that the clause from the Act that refers to the child's need for a father should be removed from the Act.

    —  A payment of £15,000 was made in 2002-03 for survey and research by the HFEA to the National Infertility Support Network CHILD, whose Executive Director, Clare Brown, is a member of the HFEA.

    —  It developed together with the MRC a pilot scheme to target IVF clinics for embryos for research, minuted in September 2003. "MRC is keen to use one consent form covering research and treatment, and not enable patients to opt out of one for the purpose of the pilot", does not make comfortable reading.

The process of public consultation in this field is in urgent need of review

  5.  We welcome the lead taken by the Science & Technology Select Committee (Committee) in consulting with the public and are very much in favour of public consultation in this highly sensitive field. We do not consider it appropriate, however, for a regulatory body such as the HFEA to supervise consultation exercises on wide reaching and controversial ethical issues. CORE was founded in response to serious dissatisfaction with a 1994 HFEA consultation on donated ovarian tissue, which having recorded public opinion then virtually ignored it. Our dissatisfaction has increased over the years and was reinforced following the recent consultation on "Sex Selection". CORE's response to that consultation included a general criticique of the HFEA process which we attach as (Annexe A not printed).

The HFEA is neither democratic nor representative

  6.  Were it possible to contain the activities of the HFEA within their actual Parliamentary remit, the membership of the HFEA would be of little interest to CORE. It is because the HFEA has assumed such an overt policy-making role that we raise concerns in this area.

  7.  The Committee in 2002 highlighted the non-democratic character of the HFEA, during a questioning session with the then Chair of the HFEA, Ruth Deech. She was asked why the Authority had taken an ethical decision in relationship to tissue-typing without any external consultation, let alone Government involvement. Ms Deech asserted that the HFEA was protecting "Members of Parliament from direct involvement in that sort of thing". You will remember your Committee's robust reply that "Parliament does not need protecting and democracy is not served by unelected quangos taking decisions on behalf of Parliament".

  8.  It will be known to the Committee that CORE felt obliged to challenge the HFEA's tissue-typing policy decision, not because of the specific ethical dilemmas involved, but because it believed that public interest and the democratic process had been seriously abused.

  9.  Because the HFEA has increasingly assumed a role which extends far beyond its original Parliamentary remit, and over the years has been making major ethical decisions of significance for society as a whole, it is of great concern to CORE that the appointment system to the HFEA effectively excludes from policy decisions any organisations or sections of the public with a similar perspective to our own.

  10.  There is no more apposite defence of our argument that the HFEA is deliberately unrepresentative than the exchange which follows.

  On 18 October 2002, Ms Suzi Leather, Chair of the HFEA, gave evidence to US President's Council on Bioethics in Washington D.C. She was questioned by Prof Gilbert C. Meilaender, as to whether there were any members of the HFEA who were opposed to embryo research.

    Ms Leather's replied: "Your question (is) about should we have people who are opposed to it."

    Prof Meilaender: "The question is do you?"

    Ms Leather: "No, we don't. This does come up as an issue, and I think that the government has felt in a sense of what would be the purpose of having somebody there. It is not as if we are not continually reminded that there are many people who hold very firm views against what we do.

    And I believe that those views should be respected, but they are out with the moral consensus in the UK at the moment, and I don't think we need them continually on the committee saying that I am opposed to all of this . . . because I think that would stop the decision making that we have to do." (Transcript USA Govt website

  11.  It is extremely difficult to obtain clear information as to how appointments are made to the HFEA. The paper answer is that these appointments are made by the Minister of Health, following response to public advertisements. One would have to be incredibly naïve to believe that the Department of Health is making these choices, except at the level of Chair, and not simply rubber-stamping recommendations put forward by senior committee members.

  12.  It is fortunately not at all difficult to obtain information about the appointment process from existing or former committee members, which is how CORE learned that the process is even less democratic than thought. It is common HFEA practice to approach people directly and invite them to apply.

  13.  Nobody from a pro-life perspective who has applied to join the HFEA over the last 13 years has even been called for interview. The job description for membership openly stipulates that those who apply must subscribe to the objectives of the HFEA, so possibly the more conservative applicants were wasting their time anyway, particularly in light of Ms Leather's extraordinary admission quoted above.

  14.  And what exactly are the HFEA's objectives? Are these so pre-determined that they exclude a priori any opposing views, even in advance of new technologies such as tissue-typing, cell nuclear transfer, or whatever lies around the corner?

  15.  The HFEA would do well to study carefully to what extent their appointment system respects the Code of Practice of The Commissioner for Public Appointments.

  We draw attention to the following points:

    —  Merit (and diversity): 2.04 departments must guard against positive discrimination.

    —  Equal opportunities: 2.08 . . . Care must be taken, at every stage, not to discriminate on the grounds of gender, race, age, disability, religious belief or similar philosophical belief . . .

    —  Probity—The problem most likely to arise is that of actual or perceived conflict of interest: 2.09.1 In relation to conflict of interests, there are five issues most frequently encountered which could lead to real, or apparent, conflicts of interest: financial interests or share ownership, candidates who are actively sought from within a field of expertise in which the public body works. Such a connection does not preclude an appointment, but it might well be perceived by the public as a conflict of interest and will need to be handled sensitively.

    —  Role description and person specification: 3.10 . . . the person specification does not contain unnecessary requirements that will rule out applications from a particular group within society

  16.  According to the HFEA website, the Authority encourages variety in its membership. "To ensure that the HFEA has an objective and independent view, the HFE Act requires that the Chair, Deputy Chair and at least half of the HFEA Members are neither doctors nor scientists involved in human embryo research or providing infertility treatment. HFEA Members bring to the HFEA a broad range of expertise from medicine to law and religion to philosophy."

  17.  There have been only 65 members of the HFEA since its establishment in 1991 so it has not been difficult to analyse the profile of the committee and the general ethos of the members over the years, but we will restrict ourselves to an overview of the current committee, to explore briefly the concepts of objectivity and independence.

  18.  There are currently 18 HFEA members, including the Chair, who is a declared member of the Labour Party and by necessity in agreement with Government policy on cloning, stem cell research and so on. The Deputy Chair is a pro-choice philosopher/bioethicist, and a member of The Stem Cell Steering Committee.

  19.  Of the remaining 16 members, seven are directly involved in IVF treatment. Four of the seven are also involved in stem cell research and a list of their involvement with pharmaceutical companies through share-holdings, consultancies or departmental research grants includes Astra Zeneca, Eli Lilly, Merck, Pharmacia, Servier, Takeda, Serono Pharmaceuticals, Ares Serono, Organon, Schering and others. One of the four was the lucky recipient of the first embryonic stem cell licence to be issued by the HFEA.

  20.  There are three members of patient infertility groups, understandably self-interested, a liberal Anglican Bishop who is a major proponent of embryonic stem cell research, and an academic lawyer who has argued publicly in favour of maximum reproductive freedom including the right to social sex selection and human cloning. Her presence adds the first touch of genuine independence to the Authority's profile, but one wonders how such a polarised position can be justified at the same time as applicants from the opposite spectrum are categorically excluded.

  21.  The final four members come from a business or media background, and attendance by CORE at open meetings of the HFEA has not shown any of them to have reservations about activities of the Authority. To consider such a committee independent and objective is untenable.

  22.  One does not wish to suggest that no member since 1991 has ever expressed any conservative opinions about HFEA activities. The philosopher, Professor Brenda Almond, for example, recorded her opposition to the designing of tissue-matching embryos in a letter to The Times, (26 July 2002). As she was on the HFEA Ethics Committee at the time the controversial policy decision was taken, her opposition provided CORE with some small solace. It is unfortunate that Professor Almond's membership was terminated after only three years, as her academic background seriously enriched the composition of the Authority.

The HFEA, established as a fertility watchdog, does not have the scientific background or organisational resources to become involved in the complex issues of embryonic stem cell research

  23.  The HFEA is already seriously over-stretched in maintaining existing standards in the growing infertility industry, and should not extend itself any further, and certainly not into embryonic stem cell research. It is bad business practice to have too diverse a portfolio.

  24.  The HFE Act was established to provide at least some respect and protection to the human embryo. This simply cannot be ensured under the present situation, particularly in relationship to embryonic stem cell research, the justification for which embraces nearly every field of disease or accident known to man.

  25.  The Authority is placed inevitably in a position of conflict of interest when it becomes involved in negotiating embryo donation or specific embryo creation for stem cell purposes. CORE is concerned that a growing number of members of the Authority, as well as subsidiary group members, are now involved in stem cell research. It is absolutely impossible for the public to feel comfortable when the HFEA awards members of the HFEA or peer reviewers or inspectors licences to conduct embryonic stem cell research, as is increasingly happening.

  26.  Parliament endorsed embryo research in 1990 and extended it in 2002, but always under the strictest conditions. The only way the public can be reassured that there are no abuses in this area is if there is maximum transparency in relationship to all those involved in research, and if we can be reassured that the HFEA has a restrictive or at the very least a neutral position on this matter.

  27.  One of the safeguards we would like to see upheld is that embryos are never used for research purposes unless it is impossible to do the research in any other way, and that the use of the human embryo is the only legitimate way forward. This restriction can be implemented only if there are sufficient peer reviewers and experts involved in the process of licence applications who have real experience in animal or adult stem cells or other alternatives, as well as expertise in diabetes, Parkinson's, Alzheimer's, heart disease, spinal cord injuries, blood disorders and the myriad other diseases which it is claimed will benefit from embryonic stem cell research. Such a Herculean task is beyond the capabilities of any one organisation, let alone an HFEA whose principal role is the regulation of the infertility network.

The HFEA is not professionally qualified to make ethical decisions

  28.  We have argued that the HFEA does not have Parliamentary authority to make ethical decisions, and that its undemocratic and unrepresentative nature is unlikely to inspire public confidence on those occasions when it does assume such a role, but we also argue that the HFEA simply does not have the academic expertise to make such decisions anyway.

  29.  Obviously they are well qualified to deal with matters of health and safety, laboratory standards, and the various protocols surrounding embryo creation, culture and cryopreservation, data storage and so on, but ethical dilemmas of wide and significant social import require a different approach altogether and should be deliberated by specifically qualified academics, as distanced as possible from any potential beneficiaries of the proposed innovations.

  30.  How such a group might be established and its ideal composition needs to be fleshed out, but we suggest that the President's Council on Bioethics would be an excellent model to look at. It is of high and balanced academic calibre with an appropriate range of interests represented. It has no legislative power but functions in a high-level advisory capacity.

  31.  The French National Consultative Bioethics Committee is another suggested model. While preparing research for CORE's Judicial Review of the HFEA's decision on tissue typing, we found a superb and considered opinion on new developments in pre-implantation genetic diagnosis prepared by this committee, in which they addressed the ethical dilemmas of creating tissue-matching siblings. No such documents have ever been created by the HFEA. We attach the French Opinion as Annexe B (not printed), as a pdf file with our covering letter.

  32.  The United Kingdom Parliament should set up such a think-tank, with focus on philosophers, theologians and qualified ethicists rather than scientists. Such a group, far removed from any possible accusations of conflict of interest, would address the ever-increasing ethical issues arising in the field of reproductive technology and stem cell research, and report its conclusions for the benefit of Westminster and the country at large.


  We repeat CORE'S recommendations as set out in the executive summary, calling for:

    1.  A re-statement of the role of the HFEA exclusively as a regulatory body.

    2.  A review of the process of public consultation in the field of assisted reproduction.

    3.  A thorough inquiry into, and reform of, the process of appointments to the HFEA.

    4.  The establishment of a new body, independent of the HFEA, to regulate and licence embryo research for stem cell purposes.

    5.  The establishment of an independent bioethics think tank to address ethical issues in this field.

May 2004

previous page contents next page

House of Commons home page Parliament home page House of Lords home page search page enquiries index

© Parliamentary copyright 2005
Prepared 24 March 2005