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CMF Submission to DoH: HFE Act 2008 regulations

Published: 30th March 2009

1. Christian Medical Fellowship

The Christian Medical Fellowship (CMF) is an interdenominational organisation, founded in 1949, with more than 4,500 British doctors and 1,000 medical students in the UK as members. All are Christians who desire their professional and personal lives to be governed by the Christian faith as revealed in the Bible. Members practise in all branches of the profession, and through the International Christian Medical and Dental Association are linked with like-minded colleagues in over 100 other countries.

2. Relevant core beliefs

One of CMF's aims is 'to promote Christian values, especially in bioethics and healthcare, among doctors and medical students, in the church and in society'. As Christian doctors we support the use of science and technology to prevent, treat and relieve suffering, including the suffering of infertility. Science, technology and healthcare should always be guided by sound ethical principles based on a profound respect for all human life from the time of conception until natural death. Consideration of infertility treatments should in addition be based on respect for marriage as the ideal context for procreation and the protection, nurture and raising of children.

3. Relevant submissions made to other recent inquiries

CMF regularly makes submissions on ethical and professional matters to Government committees and other official bodies. All our submissions are available on our website at www.cmf.org.uk/ethics/submissions/. Of particular relevance to the background of this consultation are the following:

• January 2007 – Submission from CMF to the Science and Technology Committee's Inquiry into Government Proposals for the Regulation of Hybrid and Chimera Embryos
• November 2005 – Submission from CMF to the Department of Health's Review of the Human Fertilisation and Embryology Act
• April 2005 – Submission from CMF to the HFEA on Tomorrow's Children – a Consultation on Guidance to Licensed Fertility Clinics on Taking into Account the Welfare of Children to be Born from Assisted Conception
• February 2005 – CMF response to the HFEA's SEED consultation - The Regulation of Donor-Assisted Conception
• November 2004 – Submission from CMF to the Human Genetics Commission on Choosing the Future: Genetics and Reproductive Decision Making
• May 2004 – Submission from CMF to the Science and Technology Committee's Review of Human Reproductive Technologies and the Law
• January 2003 – Submission from CMF to the HFEA in response to Sex Selection: Choice and Responsibility in Human Reproduction

4. CMF's approach

As can be seen, CMF has commented extensively on recent developments in biotechnology and human reproduction. It will also be clear that we regret many of the radical new departures within the 2008 Act:

• Animal-human hybrids are scientifically unnecessary, are unethical, and are an offence to the dignity of all human beings
• Families headed by a father and a mother, of opposite sex, and legally married for life are the ideal context for raising children
• Extending the use of so-called 'saviour siblings' is scientifically unnecessary and further commodifies children
• Legalising without explicit consent the use of tissue from children, mentally incapacitated adults and people who have died to make cloned and hybrid embryos overturns long-established fundamental principles of ethics

We are disappointed that the government has not invested more heavily in ethical avenues of stem cell treatment involving adult stem cells and induced pluripotent stem cells (iPS), nor into umbilical cord blood banking, as we believe that both these avenues of research would have obviated the need for 'saviour siblings', cloned embryos or hybrids.

However, we recognise that this limited consultation concentrates specifically on four narrow areas of regulation required, and we offer brief comment.

5. Specific responses to four HFE Regulations

5.1 Statutory Storage Period for Embryos and Gametes

Proposal 1. Have the same infertility criteria and overall time limit applying to extension for gametes as for embryos.

While we can understand administrative convenience, this exhibits a fundamental failure of the Department to take account of the 'special status' that should be accorded to the human embryo.

This status was a key principle in the 1984 Warnock Report, the 1990 HFE Act, and the 2008 HFE Act. Gametes are reproductive human tissue, but they are not living human beings and as such do not have special status. An embryo is a new and unique human being, and as we have argued in previous submissions, CMF holds that far greater respect and better protection should be shown to him or her. We therefore have grave reservations about embryo storage per se, believing that only the number to be implanted should be produced and that surplus embryos should not be experimented on. For the same reasons we also support embryo adoption.

Proposal 2.Allow extension where someone has or will become significantly and prematurely infertile including cases where the person to be treated is not the gamete provider. For example, in cases using donated gametes or embryos and/or surrogacy.

First, we agree the change of language from 'completely and prematurely infertile' under the 1996 regulations to 'significantly and prematurely' under the 2008 regulations.

However, we do not think that all the proposed cases for which extension could be allowed should be equated. The case for a young person who is in danger of losing reproductive capacity is different from a blanket policy which would have the effect of:

• publicly promoting the practice of surrogacy – for which there is no basis in the 2008 Act or in the will of the public
• potentially widening the production of 'saviour siblings' – a particularly controversial and contested part of the 2008 Bill

Extension of storage time should always be an exception to the rule, requiring special justification. This Proposal creates a blanket rule which is far too all-embracing.

Proposal 3. Remove the age-limit for the storage of gametes and embryos and replace it with an overall time limit of 55 years, irrespective of the age of the person who put them in storage.

See comments re Proposal 1. While again we recognise the theoretical attraction of a unified approach, this proposal fails to acknowledge the obligation of clinics to take into account the welfare of the child. Regarding the 'special status' of embryos and their storage, we have two sets of concerns:

• Medical concerns of safety – we cannot possibly at this stage know whether storing an embryo for 55 years would lead to long term health concerns for the person eventually to be created, which might not become apparent for many years after birth
• Social concerns for family structure – it is a travesty of any concept of human families that it should in law be possible for a woman of 45 to store embryos to be implanted and born when (if she has survived) the donor mother is 100 years old

The present limits (storage period of ten years and the maximum age of the person being 55) are entirely reasonable and only exceptional extensions as indicated in our comments under Proposal 2 should be allowed.

Further, given the serious fundamental issues arising from some of these proposals we regret that these regulations are subject to the 'negative procedure' and only require to be laid in Parliament but not debated. We therefore urge the Department to revise them.

5.2 Procedure for Revocation, Variation or Refusal

Proposal 4. There is a lay majority on the Licence Committee that makes decisions on refusal, revocation or variation.

Agreed.

Proposal 5. The procedure to be followed when the Authority is minded to revoke, vary or refuse a licence is set out in detail in the regulations.

We generally agree the proposals for the mechanics of the Licence Committee which will consider revocation, variation or refusal of licences/applications. However, we express concern that we know little about the Licence Panel made up entirely of staff members which will make decisions on all matters perceived by the Authority as 'routine'. Given the continuing controversy of much of the activity overseen by the Authority, we would expect much greater scrutiny of all its activities.

5.3 Appeals

Proposal 6. HFEA members (current or previous) cannot sit on an Appeals Committee.

Agreed.

Proposal 7. The Chair and Deputy Chair of an Appeals Committee are legally qualified.

Agreed.

5.4 Disclosure of Information for Research Purposes

Proposal 8. The HFEA is the responsible body for considering applications for information for researchers, drawing on the expertise and resources of the Patient Information Advisory Group (PIAG) which currently approves access to NHS patient data.

We agree that the HFEA should be the responsible body. Particularly in early years before significant experience is gained, consultation with the Patient Information Advisory Group (PIAG) or other groups will be essential.

(We note that PIAG currently approves access to NHS patient data, but point out that much data referring to people having fertility treatment will have originated in the private sector and experience of oversight of that sector will therefore be important.)

Proposal 9. Donor information is excluded from the types of identifying information that can be released without consent.

Agreed.

Proposal 10. Information is released subject to certain specific conditions being met.

We are satisfied with the exhaustive criteria detailed in Regulations 1-22, and also note the external safeguards, such as the research proposed requiring ethics committee approval.

6. Conclusion

The last three sets of Regulations are uncontroversial, and on these we generally commend the Department. However, we hold strongly that the proposals on storage periods for embryos fail to take account of the 'special status' that should be accorded to them. We urge the Department to review and revise them, especially as there will be no further parliamentary debate on such fundamental issues.

We are grateful for the opportunity to take part in this consultation and are willing to help further if requested.

For further information:

Steven Fouch (CMF Head of Communications) 020 7234 9668

Media Enquiries:

Alistair Thompson on 07970 162 225

About CMF:

Christian Medical Fellowship (CMF) was founded in 1949 and is an interdenominational organisation with over 5,000 doctors, 900medical and nursing students and 300 nurses and midwives as members in all branches of medicine, nursing and midwifery. A registered charity, it is linked to over 100 similar bodies in other countries throughout the world.

CMF exists to unite Christian healthcare professionals to pursue the highest ethical standards in Christian and professional life and to increase faith in Christ and acceptance of his ethical teaching.