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Submission from CMF to the Science and Technology Committee in response to the Review of Human Reproductive Technologies and the Law

Published: 26th May 2004

Introduction

Christian Medical Fellowship (CMF) is interdenominational and has over 4,500 members throughout the United Kingdom and Ireland who are Christian doctors and who desire their professional and personal lives to be governed by the Christian faith as revealed in the Bible. We have members in all branches of the profession, and through the International Christian Medical and Dental Association (ICMDA) are linked with like-minded colleagues in more than 90 other countries.

Our ethical code [1] is based on the Judeo-Christian ethic as revealed in the Bible; and is broadly in conformity with historical ethical codes such as the Hippocratic Oath, Declaration of Geneva (1948) and International Code of Medical Ethics (1949).

CMF is a regular contributor to official consultations on medical ethics and past responses are available on our website [2] including the following in areas governed by the HFEA/HGC:

We welcome the opportunity to contribute to this consultation, and are very willing to give oral evidence later. As Christian doctors we support the use of science and technology to prevent, treat and relieve the suffering of infertility but believe that this should be guided by sound ethical principles based on a profound respect for all human life as made in the image of God (and thereby deserving of the utmost respect, protection, empathy and care); and for marriage as the divinely ordained context for sex, procreation and the raising of children.

Our main concerns are as follows:

  1. We believe that the HFEA has exercised freedom beyond the intentions of those framing the HFE Act in extending its provisions to endorse new technology without proper parliamentary review or public debate – especially with regard to therapeutic cloning, PIGD for tissue typing and parthenogenesis.
  2. The composition of the HFEA does not accurately reflect the range of ethical views held by scientists, ethicists and faith communities in the UK.
  3. Under current funding arrangements, the HFEA is too easily subject to being influenced in its decisions by the vested interests of one section of the scientific community.

Response

1. To consider a) the balance between legislation, regulation and reproductive freedom; b) the role of Parliament in the area of human reproductive technologies; and c) the foundation, adequacy and appropriateness of the ethical framework for legislation on reproductive technologies.

1.1

Reproductive freedom is not absolute and so there needs to be enforceable primary legislation governing decisions about artificial reproduction which establishes core ethical principles and clearly defines boundaries that cannot be crossed. Difficult and emotive cases with high media profile should not lead to new case law that moves those boundaries. A regulatory authority like the HFEA is necessary to enable decisions to be made on new technological developments within the field; but this must be the servant of primary legislation making decisions only within its bounds. The regulatory authority should be fully representative of the range of ethical views on these issues; and all vested interests of members must be openly declared. All major decisions must be subject to public consultation in which both those on committee and those giving evidence are representative of the range of views in society at large. Whilst the input of scientists and the biotechnology industry is essential, decision-making must be ruled by ethical principle and not their vested research and commercial interests.

1.2

Parliament should take a clear lead in setting the boundaries within which the reproduction 'industry' can work. In recent years we have seen new methods licensed or endorsed by the HFEA without a clear indication of the legal status, and without proper public or parliamentary debate [3] and there are further new developments that may fall outside current legislation.[4] The safety and ethical issues these raise need to be openly discussed and carefully considered, in a manner that is transparent to the public and allows them full engagement with the discussion.

The HFEA has the responsibility to monitor and control research under the Act and to report to Secretary of State on developments; and must not usurp the role of Parliament in altering statutory boundaries nor campaign on changing specific provisions. In view of the current review there should be a moratorium on all new developments to prevent any unregulated practices in the UK, and to allow time for discussion on new comprehensive primary legislation.

1.3

We believe the current ethical framework for the legislation is inadequate and many of us have grave reservations about both the use of donor gametes, and about any reproductive research or treatment involving freezing, destructive research or disposal of human embryos. We believe that decisions about artificial reproduction should respect both the integrity of the marriage bond and the humanity of the embryo and that it was the failure of the Warnock report and HFE Act to define these clear boundaries that has led to almost all of the recent developments that have caused such public disquiet.[5] Once donor gametes and embryo research/disposal is allowed, such developments logically follow and cannot be controlled.

We also believe that freedom of choice must be balanced with the need for responsibility towards all those on whom the decisions impinge: parents, existing children, vulnerable third parties, and that in particular the rights of the resulting embryo/fetus and child must be paramount in the decision-making process.

Many of us hold a high view on the status of the human embryo and share this with many in the medical profession, faith communities and society generally; and yet we have been consistently marginalised whilst ethicists and clergy with extreme views on the disposability of embryos [6] have been welcomed onto the HFEA and its committees. This is profoundly undemocratic.

2. To consider the provisions of the Human Fertilisation and Embryology Act 1990 in the context of other national and international legislation and regulation of medical practice and research.

- To include related legislation such as the EU human tissue directive, and law covering human rights, surrogacy, adoption and abortion.
- To include relevant declarations and statements by international bodies.
- To compare the safety and welfare provisions of the Human Fertilisation and Embryology Act 1990 with those that cover other areas of medical practice.

2.1

Medicine, science and technology are increasingly global; and the internet and the ease of international travel have made national laws on reproductive technologies increasingly difficult to enforce. In order to uphold the right and duty for states to make laws in the best interests of their citizens it is essential that nations cooperate with each other in respecting each other's national legislation and preventing reproductive tourism. UK law should ensure that clinics licensed by HFEA are not permitted to import embryos obtained from abroad using techniques illegal in the UK, nor export embryos created here by techniques that are illegal abroad.

2.2

All clinics offering sperm donation should be licensed under the Act so that their practice can be regulated and reviewed with regard to health and safety, labeling, and counseling of both donor and recipient. Clinics in this country should not be permitted to sell sperm over the internet. The difficulties raised by a woman who returns to the UK pregnant with a child conceived through illegal techniques must also be discussed. It is desirable that such situations should be avoided as far as possible – perhaps requiring other countries to refuse to treat UK residents.

2.3

The UK is increasingly out on a limb with law on reproductive technology that is amongst the most liberal in the world. Many countries have legislation that prohibits embryo freezing, experimentation or disposal [7] and many others are now putting in place legislation that bans both reproductive and therapeutic cloning. Furthermore this more conservative legislation is coming not just in Islamic and Catholic countries but is getting support from broad coalitions from both traditionally pro-life and pro-choice camps who are concerned to place limits on the manipulation of life.

2.4

The Declaration of Geneva (1948) stipulates that doctors 'should maintain the utmost respect for human life from the time of conception' and in like manner the International Code of Medical Ethics (1949) says that a doctor 'must always bear in mind the obligation of preserving human life from the time of conception until death'. The Declaration of Helsinki (1975) says that in biomedical research 'the interest of science and society should never take precedence over considerations related to the well-being of the subject'. 'In any research upon human beings, each potential subject should be adequately informed of the aims, methods, anticipated benefits and potential hazards for the study...' and 'the subjects should be volunteers'. 'It is the duty of the doctor to remain the protector of the life and health of that person on whom biomedical research is being carried out'. Embryo research and disposal violates these ethical principles.

2.5

The statutory duty bestowed upon the Secretary of State by section 1(1) of the NHS Act 1977 is: '… to continue the promotion in England and Wales of a comprehensive health service designed to secure improvement – (a) in the physical and mental health of the people of those countries, and (b) in the prevention, diagnosis and treatment of illness, and for that purpose to provide or secure the effective provision of services in accordance with this Act.' Infertility is not an illness per se; but rather the symptom of an underlying disease process. Couples have a liberty rather than a right to reproduce; and the state arguably does therefore not have a reciprocal duty to provide infertility treatment. Furthermore it needs to balance the high costs and low success rates of much infertility treatment [8] against the costs and success rates of other curative and palliative procedures offered on the NHS. [9] We do not accept that same sex couples (who are not in any sense ill) should be eligible for access to NHS reproductive services. Neither can a single woman who is fertile be considered ill such that she should be provided with sperm donation through the NHS. Resource limitations demand that infertility treatment is limited to couples that cannot procreate as a result of illness in either partner.

2.6

A comprehensive strategy for dealing with infertility needs to deal equally with prevention of infertility and promotion of alternatives. This raises much deeper sociological issues: the promotion of embryo [10] and baby adoption [11] as alternatives to embryo disposal and abortion, [12] and the prevention and proper treatment of the sexually transmitted diseases that account for so much infertility.[13]

2.7

Adoptions in the UK are subject to comprehensive statutory guidelines and procedures in order to ensure the safety and security of the adopted child; and yet reproductive technologies can be employed by anyone with the financial means or living in a favourable postcode area. Given that IVF children as face many of the same problems of identity adopted children there should be more consistency between criteria for adoption and for using reproductive technologies.

2.8

Under s.1(1)d of the Abortion Act (as amended by the HFE Act) babies can be aborted up until term if there is 'a substantial risk' that the baby might be 'seriously handicapped'. That this provision is increasingly out of line with public opinion and being abused has been recently demonstrated by the Joanna Jepson case in which a baby with cleft palate was aborted at 28 weeks gestation. In view of this and improvements in viability (such that babies at 22-24 weeks are now on the limits of viability) we recommend that the law should be changed so that no baby that would be treated actively at the same gestation in a neonatal unit should be aborted.

2.9

The HFEA should have power and funding to commission research into relevant medical and social issues of the techniques they regulate. Regulation is not enough - society needs information on the results, far broader than just the number of babies born. Such research, establishing the safety, efficacy and social impact of already existing procedures should be given preference over research into reproductive technologies. For example into the incidence of congenital abnormalities in babies born after PIGD, IVF and ICSI [14] or social and psychological effects of PIGD 'search and destroy' procedures on those surviving with the 'selected out' condition. (eg thalassemia) Very late terminations of pregnancy became legal in 1990. There is an urgent need for information as to how the several hundred women who have undergone such procedures have fared, particularly where the fetus had a non-lethal abnormality.

3. To consider the challenges to the Human Fertilisation and Embryology Act 1990 from a) the development of new technologies for research and treatment, and their ethical and societal implications and b) recent changes in ethical and societal attitudes.

- To include new areas of research, treatments and interventions, such as cloning, cell nuclear transfer, transplants of ovarian and testicular tissue, embryo splitting, selection of genetic characteristics (including sex selection), stem cell therapy and the use of immature gametes.

3.1

Many controversial new technologies have been developed by application of the controversial ethical presuppositions of the HFE Act – namely that donor gametes and embryo freezing/experimentation/disposal are admissible: PIGD, Savour siblings, Therapeutic cloning, Parthenogenesis. It is essential that parliament revisits and reassesses these core principles in the light of subsequent developments.

3.2

Pre-Implantation Genetic Diagnosis (PIGD) should be kept for the detection only of serious single gene disorders, although even for this indication societal attitudes are changing with the rise of the disability rights movement and concerns about the use of genetic knowledge for eugenic ends (ie. The elimination of 'genetically inferior' human beings before birth such that the number of children born with Down's syndrome and other parentally detectable genetic conditions is falling dramatically). The number of children born following the use of PIGD is still very small so its long-term safety has not yet been fully evaluated. PIGD should not be used for tissue typing or sex determination.

3.3

Saviour siblings. The use of PIGD and embryos disposal to produce tissue matched donors for siblings with inherited genetic disease such as thalassemia is undesirable due to: the degree of stress on the mother because of the low success rate and need for many eggs; the destruction of embryos in the selection process; the unknown effects on sibling relationships; the expense and technically demanding nature of the laboratory work.

3.4

Sex selection. We endorse the overwhelming public support for rejecting sex selection for family balancing either by sperm sorting techniques or PIGD.

3.5

Therapeutic cloning to produce embryonic stem cells. We have consistently argued against this practice on grounds that it is unproven in terms of therapeutic potential in human and mammalian trials; unethical because alternative treatments exist; unsafe because of the genetic abnormalities in mammalian reproductive clones produced by the same process; dangerous because of the slippery slope to reproductive cloning and unnecessary because of the existence of ethical alternatives in the use of 'adult' stem cells from cord blood, children or adults. We believe that the Donaldson report, on which the decision to legalise therapeutic cloning was made, was based on yesterday's science and an overly pessimistic view of the versatility of adult stem cells to provide treatments for patients with degenerative conditions such as Parkinson's disease and Alzheimers. We are also very concerned about difficulties identified in research with embryo stem cells (uncontrolled growth, difficulty to culture and neoplastic potential) and furthermore believe that both parliament and the general public have been misled about the scientific facts bearing on this debate. We are also deeply concerned at the way the democratic process was undermined in the way the legalisation of therapeutic cloning was whipped through parliament on the advice of scientists who represented only one side of the argument without most MPs attending the debate.

3.6

The use of ovarian tissue. Where this is taken and stored prior to chemotherapy in a person there is little ethical problem, though attention should be paid to safety and follow up of the children. But with respect to the use of tissue from aborted fetuses, apart from our concern that the end does not justify the means in research, we believe that the HFEA was wrong to ignore the intuitive 'yuk factor' felt by the majority of the population. The potential psychological effects and social oddity of being the genetic offspring of a foetus, as well as a general lack of necessity for such a procedure, should cause us to reject this option outright.

3.7

We agree that donor anonymity should be abolished but this should not be retrospective as this would be highly unjust for those who donated because their anonymity was part of the contract. Lack of anonymity is likely to result in a fall in donor numbers but this may well be a temporary result. Sensitive recruitment is needed especially among minority ethnic groups. However with the regular use of ICSI has the need for donors not been reduced? Parents should be encouraged to be open with their children as to their genetic origins since deception is inherently undesirable.

3.8

New techniques. We believe that there should be a moratorium on the development of all new techniques not currently covered by the HFE Act until revised primary legislation is in place.[15]

3.9

Ownership of gametes and embryos. In view of the point made in above it is reasonable for the father to have greater 'rights' than in a pregnancy conceived without 'extraordinary means'. The matter of the use of the embryos in situations of divorce or separation should be included in the pre-IVF counselling and agreements signed by both parties in person. Without this the agreement should be invalid.

3.10

The use of gametes and embryos posthumously should not be permitted as not being in the best interests of the child, and because the marriage relationship has ended.


4. To consider the composition, expertise and approach of the Human Fertilisation and Embryology Authority, its code of practice, licensing arrangements and the provision of information to patients, the profession and the public.

4.1

It is perhaps inevitable that scientific experts on the HFEA will be enthusiasts for new research and development; but it is essential that they also have some training in ethics and that those providing ethical input should reflect the diversity of views within the medical profession, faith groups, disability rights groups and society generally rather than being polarized by the exclusion of all people who for example take a high view on the moral status of the embryo. The current balance in favour of the non-expert members should be retained and all potential conflicts of interest should be declared. Faith communities should be represented not just by those sympathetic to the ethics of the biotechnology industry.

4.2

In order to ensure confidence in the HFEA there is a need for much more transparency with respect to conflicts of interest and decision-making and more public accountability. It is unclear what bearing public consultations have on decision-making. Public consultations must not be just a listening exercise to satisfy the critics, but the HFEA must respect and be seen to take on board the concerns of individuals and groups who invest huge amounts of time and resources in contributing to the debate, and yet often feel marginalised and excluded from the decision-making process.

4.3

The HFEA Code of Practice must be fully in line with the provisions of the Act and not add to, contradict or distort the basic ethical principles on which the Act is framed. The principle remains that the HFEA is servant of the Act, not its framer.

4.4

Licensing arrangements. There should be no incentive financial or otherwise for the HFEA to award licenses. Any member with a perceived conflict of interest regarding any individual license should be excluded from the decision-making process to maintain impartiality. In addition the HFEA should gain its income directly from government on the basis of a predetermined budget as the current arrangement whereby a substantial amount of income comes from licensing fees is open to financial vested interests.

4.5

Public information. There must be far greater transparency and public accountability in the decision-making processes of the HFEA across the whole range of activities. Resources should be made available for this so that questions asked by members of the public about the HFEA's composition, activities and decisions are much more fully in the public domain.

References

  1. www.cmf.org.uk/ethics/cmf_ethics_affirmation.htm
  2. www.cmf.org.uk/ethics/submissions
  3. eg. Therapeutic cloning, PIGD for tissue type and Parthenogenesis
  4. eg. Human-human chimerical embryos, human-animal hybrid embryos
  5. eg. Paternity disputes, PIGD for sex selection and tissue typing, postmenopausal conceptions, Embryo mix-ups
  6. eg. John Harris and the Bishops of Rochester and Oxford
  7. Italy has very recently tightened it laws to prohibit these practices
  8. IVF has a success rate of 25% per cycle and costs £8-16,000 per 'take home baby'
  9. The annual costs of IVF treatment under new NICE guidelines is £400 million pa
  10. Such as www.snowflakes.org
  11. Baby adoptions have fallen from 15,000 pa in the 1960s to about 200 pa now
  12. About 70,000 babies have been born through IVF since 1978 yet there are 180,000 abortions a year
  13. Chlamydia infection affects 10% of women and is itself increasing 20% each year
  14. Particularly following a recent report from the University of Porto in Portugal indicating that using sperm from men with low sperm counts results in more genetic defects in resulting embryos, and an increased risk of imprinting disorders.
  15. Parthenogenesis, human or animal chimeric procedures, production of gametes by artificial means (eg from somatic cells)

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.

Christian Medical Fellowship:
uniting & equipping Christian doctors & nurses
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