The Royal Society of Edinburgh (RSE) is pleased to respond to the House of Commons Science and Technology Inquiry into Human Reproductive Technologies and the Law. This response has been compiled by the General Secretary, Professor Andrew Miller and the Research Officer, Dr Marc Rands, with the assistance of a number of Fellows with considerable experience in this area.
The specific terms of reference identified by the Inquiry are now addressed below.
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.
Britain is a pluralistic society with the benefit of free speech and many people who comment on these issues either state a ‘scientific’ view or are suspicious that someone is taking a decision about what they, the individual, can or cannot have without their being able to influence it. There is also the belief that medical interventions are being withheld because they are expensive, i.e. it is cost-cutting that is the driving principle and that mention of safety and effectiveness is merely a cloak for saving money. This demonstrates the problem that faces any government body in making centrist decisions for the sake of consistency and fairness. However, the UK has a long and valued reputation for its attempts at national consistency and reduction of unequal access to education, health and housing, and the pursuit of fairness should continue to be upheld. Therefore, it is necessary for the government/parliament to take decisions, or create mechanisms by which such decision are taken, that regulate what is provided.
However, if the UK is to keep up with the rapidly changing theoretical potential of reproductive technologies, then legislation is counterproductive, beyond existing common law and human rights about respect for individuals, because it is slow and cannot adapt in the interests of the public to changes in what is available for them. Legislation should be restricted to setting up a visible and open process for public and professional consultation to advise a nationally appointed body that must have the responsibility of arbitrating in the light of what is available, effective and acceptable to a reasonable cross section of UK society. Instead, to maintain justice, regulation is more adaptable than legislation to variations over time and place in what interventions are provided. It is the best way to integrate state, public and professional knowledge and beliefs.
In terms of reproductive freedom, when it is said that there is a human right to found a family, the ‘right’ is a liberty. It does not necessarily imply that there is a reciprocal duty on the part of a State to assist in procreation. Of course, a State might legislate to this effect and give itself such a duty, but this is quite different from saying that there is a human right to assisted procreation. Therefore, it does not follow from the fact that expensive reproductive technology exists, or may exist, that the public can use human rights to demand that it should be used to benefit them.
To consider the provisions of the Human Fertilisation and Embryology (HFE) Act 1990 in the context of other national and international legislation and regulation of medical practice and research
The HFE Act 1990, as eventually passed, had a long and somewhat difficult history, with the result that the Act was probably better honed than most relevant declarations and statements by international bodies, which in contrast have seemed to be rather hasty 'gut reactions'. Whilst it is sensible to note such statements, their weakness as well as their strengths should be recognised. The Act, should however, be tested for its compatibility with the rights contained in the European Convention on Human Rights
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.
HFE Act allows for the storage of good quality surplus embryos, and these are sometimes used for research (with consent). However, there is another source of embryos for research which should also be covered by the Act. This source consists of eggs which did not mature at the time expected by the clinic, or where successful fertilisation by the partner's sperm did not take place. Eggs in this category are normally discarded, yet they could become a valuable source for research. Of course, even if the egg donor were willing that these eggs should be discarded as not suitable for reproductive purposes she might be uneasy about their use in research, especially if this involved fertilisation by sperm other than her partner's. Consent should, therefore, be obtained even for research on material which might otherwise be discarded.
As is true in much of science, it is the intention behind the use of the technology which should be addressed, but all too often the technology itself is focussed on. There is nothing inherently wrong, arguably, in reproductive cloning, although there may be ‘bad’ reasons for undertaking it. Of course, there are sound technical reasons not to attempt it at present. In experimental animal studies the success rate from reproductive cloning has remained at about 1% despite considerable effort to increase it, and there is a high incidence of birth defects. This being the case, there is little prospect of developing a satisfactory technique for human cloning, since the experimental stage would not be acceptable. However, if the technology to provide it safely and efficaciously did exist, it would be important that a rational and reasoned debate took place. There may be acceptable reasons for human cloning, which might, for example, include the creation of a child following the death of another- especially if the intending parents are now infertile, so long as it is clear to the parents that the clone only shares the physical characteristics of the deceased child (and not the personality). The use of cloning for some reasons might legitimately be banned but there may be merit in exploring whether or not cloning is always wrong.
Pre-implantation genetic testing
The current licensing system ensures that only adequately trained people with access to appropriate facilities can offer pre-implantation genetic testing to patients. It will be important, however, that the list of specific conditions to which it can be applied is regularly reviewed, and that full attention is given to provision for advice on the ethical dimensions of choices to be made. Research should also be undertaken in order to develop alternative procedures which would not involve the destruction of the embryo, for example in the development of diagnostic techniques involving gametes, that is, ova and spermatozoa.
It is not clear, however, on what basis there should be restrictions of PGD to only serious clinical conditions, although there may be practical reasons for wishing to do so. If there are clinical reasons for undertaking PGD at all - and given that the consultation document itself notes in paragraph 26 that few people are likely to choose it - there appears to be little logic in limiting its use to certain conditions. Of course, this balance might change if it became clear that PGD caused significant harm in large numbers of cases. The balance would then perhaps shift towards not permitting it in 'minor' clinical conditions because of the greater harm caused by using it - namely the additional damage to, or destruction of, the embryo. However, it should also be borne in mind that restricting PGD to serious conditions might mean that the (arguably) ethically less troubling option of non-implantation would be subject to more rigorous controls than the (arguably) more troubling ethical option of pregnancy termination with prenatal diagnosis (PND).
Anonymity for sperm donation
It is understandable that there is both a psychological and a genetic interest in the identity of the father. However, current human rights legislation is clear that past donors have a right to privacy unless there is overriding damage to another person, and each case should be judged on its merits. The RSE therefore supports the position taken by the Department of Health that the proposed legislation should not be retrospective. In terms of the possibility of payment for donation, this issue should be revisited and considered for the future.
All fertility services should require a written consent as the consent form can provide prima facie evidence that a discussion has taken place. This is important in all services and not just those which currently require a written consent. Where someone is prevented by incapacity (for example illness or age) from consenting to having gametes or, for example, immature testicular tissue removed and preserved, but is about to undergo treatment that might render them infertile, and are expected to recover, it should be lawful to remove and store the gametes or tissue until the point at which the individual can decide for him or herself what to do with them. This protects the possibility of future fertility when people can be presumed to want or be likely to want to reproduce in the future but are unable to offer the required consent.
It is also recommended that the law should ensure that gametes obtained unlawfully cannot be exported
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.
The procedure for public consultation followed by informed decision making by the Authority, subject to ruling by the Secretary of State (and parliamentary debate via the Authority's Report when laid before Parliament), is a key part of the Act. This allows public debate and improves general confidence in the final decision from the Authority.
The responsibility of the Authority to produce and revise as necessary a Code of Practice is also important in providing both practitioners and people to be treated with a standard to judge possibilities and constraints. It also allowed the incorporation of ethical standards as well as 'good clinical (including counselling) and laboratory practice'
There may be merit, however, in considering whether the values which underpin the Act should be clearly spelled out in any revised legislation. This was done in the Adults with Incapacity (Scotland) Act and may offer providers and intended recipients with a clear message about the underpinning aims of the Act.
In responding to this inquiry the Society would like to draw attention to the following Royal Society of Edinburgh responses which are of relevance to this subject: Consent and the Law (December 1997); Cloning Issues in Reproduction, Science and Medicine (April 1998); Review of the Common Law Provisions Relating to the Removal of Gametes and of the Consent Provisions in the Human Fertilisation and Embryology Act 1990 (April 1999); Chief Medical Officer’s Expert Group on Cloning (November 1999) and Preimplantation Genetic Diagnosis (March 2000).