House of Commons - Science and Technology

Select Committee on Science and Technology Fifth Report

2 Regulation of assisted reproduction

The Warnock Committee

8. The public's reaction to the birth of Louise Brown has been described as a mixture of "pride in the technological achievement, pleasure at the new-found means to relieve, at least for some, the unhappiness of infertility, and unease at the apparently uncontrolled advance of science, bringing with it new possibilities for manipulating the early stages of human development".[7] In 1982 the Government set up the Committee of Inquiry into Human Fertilisation and Embryology, under the chairmanship of Dame Mary (now Baroness) Warnock.[8] Although Baroness Warnock is a philosopher, the 16-member Committee was dominated by scientists and health professionals, although only Professor Malcolm MacNaughton had professional involvement in assisted reproduction. The Committee's terms of reference were:

"to consider recent and potential developments in medicine and science related to human fertilization and embryology; to consider what policies and safeguards should be applied, including consideration of the social, ethical and legal implications of their developments; and to make recommendations."

The Committee published its report in July 1984. A key conclusion was that the human embryo had a special status, entitling it to "some protection in law".[9] It recommended new legislation setting out legal limits on assisted reproduction and embryo research and the setting up of a licensing authority.

VOLUNTARY LICENSING AUTHORITY/INTERIM LICENSING AUTHORITY

9. In March 1985, the Medical Research Council (MRC) and Royal College of Obstetricians and Gynaecologists (RCOG), recognising that the introduction of a statutory body would take time, founded the Voluntary Licensing Authority for Human in vitro Fertilisation and Embryology (VLA) under the Chairmanship of Dame Mary Donaldson. The VLA consisted of people drawn from both the scientific and medical professions but was balanced by the inclusion of lay people. The VLA comprised members who carried out the licence inspections and issued licences to centres as appropriate and a secretariat. All potential centres had to make a written application to the VLA describing the particulars of the treatment services or research that they wished to undertake or were already providing.

10. Following a consultation, in 1987 the Government published a White Paper, Human Fertilisation and Embryology: A Framework for Legislation, in which it committed itself to legislation.[10] In April 1989 the VLA decided to emphasise the temporary nature of its existence by changing its name to the Interim Licensing Authority for Human in vitro Fertilisation and Embryology.

Human Fertilisation and Embryology Act 1990

11. The Human Fertilisation and Embryology Bill was given a second reading in the House of Lords in December 1989. The debates in Parliament focused on three main issues: embryo research; welfare of the child; and abortion. The Bill received Royal Assent on 1 November 1990, with the HFEA taking up its full statutory responsibilities in August 1991. While the Act contains a number of prohibitions on the uses of human embryos, it gives wide powers of interpretation to the HFEA. The Act set out the duties of the HFEA, including the requirement to publish a Code of Practice and maintain a register of those receiving treatment and born as a result of treatment, and also its composition.

12. The HFE Act also makes an amendment to the 1967 Abortion Act, its principal effect being to limit the time limit for abortions to 24 weeks (save in limited specific circumstances), and to the Surrogacy Arrangements Act 1985. The effect of this latter amendment was to make it clear that surrogacy arrangements could not be legally enforced and to extend the Act to include cases where sperm and eggs, rather than an embryo, are placed in a woman.

Subsequent legislation

13. There have been a number of revisions to the HFE Act and these are shown in Table 2.Table 2: Relevant legislation since 1990.

Legislation Principal effects

The Human Fertilisation and Embryology (Statutory Storage Period) Regulations 1991/1540 Extend the maximum storage period for gametes (as set out in section 14 of the Act) in respect of people "whose fertility since providing them has or is likely to become, in the written opinion of a registered medical practitioner, significantly impaired".

The Human Fertilisation and Embryology (Licence Committee and Appeals) Regulations 1991/1889 These Regulations prescribe the composition and procedures of HFEA licence committees and the appeals procedure.

The Human Fertilisation and Embryology (Special Exemptions) Regulations 1991/1588 Extended the purposes for which gametes could be stored: during investigations into offences under the HFE Act; and for research, testing of pharmaceutical products and teaching.

The Parental Orders (Human Fertilisation and Embryology) Regulations 1994/2767 Regulations made under the act that gave effect to the scheme set up by s30 of the 1990 Act as an alternative to the adoption procedure in relation to children born following a surrogacy arrangement.

The Human Fertilisation and Embryology (Statutory Storage Period for Embryos) Regulations 1996/375 Extends the storage period for frozen embryos in certain cases.

The Human Fertilisation and Embryology (Research Purposes) Regulations 2001/188 Extended the purposes for which licences to include therapeutic research.

The Human Reproductive Cloning Act 2001 c.23 Created an offence of placing a human embryo in a woman other than by fertilisation.

The Human Fertilisation and Embryology (Deceased Fathers) Act 2003 c. 24 Allows a man to be registered as the father of a child conceived after his death using his sperm or using an embryo created with his sperm before his death.

Human Fertilisation and Embryology Authority (Disclosure of Donor Information) Regulations 2004 Removed the right of new donors to remain anonymous once the child has reached 18 years.

Legal challenges

14. The interpretation of the HFE Act has been at the centre of a number of legal challenges in recent years, all of which have so far been unsuccessful. The key cases are shown in Table 3.Table 3: Significant cases surrounding the HFE Act.

Case Significance

R v Secretary of State for Health, ex parte Bruno Quintavalle (on behalf of Pro-Life Alliance [2001]. It was claimed that organisms created by cell nuclear replacement did not fall within the definition of "embryo" in s.1(1) Human Fertilisation & Embryology Act 1990. Successful in the High Court but overturned in Court of Appeal.

Rose v Secretary of State for Health and the HFEA [2002] EWHC 1593 Joanna Rose was born before as a result of donor conception before the HFE Act was passed. The judge ruled that a case could be brought under the Human Rights Act challenging the rights of post-1990 donors to remain anonymous.

R (Quintavalle) v Secretary of State for Health [2003] UKHL 692. Josephine Quintavalle sought and obtained permission to seek judicial review of the HFEA's decision announced on 13 December 2001 to award a licence to treat the Hashmi family. She challenged that decision on the ground that the HFEA had no power to issue a licence that permitted the use of HLA typing to select between healthy embryos. Her challenge succeeded but was initially lost on appeal on 16 May 2003. Quintavalle has since been given leave to take the case to the House of Lords. The case was heard in March 2005.

Evans v Amicus Healthcare and ors [2003] EWHC 2161. Natalie Evans wished to use her stored embryos to have a child. However, her former partner withdrew her consent for the procedure. Evans contested this on human rights grounds but lost. She is now taking the case to European Court of Human Rights.

Leeds Teaching Hospitals NHS Trust v A and others [2003] EWHC 259 (QB) Sperm mistakenly used in IVF implantation resulting in genetic father not being husband of genetic mother. The case resolved the issue of paternity

R. (on the application of Assisted Reproduction and Gynaecology Centre) v Human Fertilisation and Embryology Authority [2002] EWCA Civ 20 [2003] 1 F.C.R. 266 The HFEA's policy of allowing only two embryos to be transferred in most cases was challenged but the HFEA was vindicated.

R. v Human Fertilisation and Embryology Authority Ex p. Blood [1999] Fam. 151 [1997] 2 W.L.R. 807 Diane Blood sought permission from the courts to be inseminated with her dead husband's sperm. HFEA ruled that consent had not been given. Eventually, Mrs Blood won the right under European law to take the sperm abroad.

International law and treaties

EUROPEAN CONVENTION FOR THE PROTECTION OF HUMAN RIGHTS

15. The Council of Europe Convention for the Protection of Human Rights, originally drawn up in 1950, was transposed into UK law by the Human Rights Act 1998. It has three Articles with relevance to the 1990 HFE Act.

Article 8—Right to respect for private and family life

"Everyone has the right to respect for his private and family life, his home and his correspondence."

"There shall be no interference by a public authority with the exercise of this right except such as is in accordance with the law and is necessary in a democratic society in the interests of national security, public safety or the economic well-being of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others."

Article 12—Right to marry and found a family

"Men and women of marriageable age have the right to marry and to found a family, according to the national laws governing the exercise of this right."

Article 14—Prohibition of discrimination.[11]

The enjoyment of the rights and freedoms set forth in this Convention shall be secured without discrimination on any ground such as sex, race, colour, language, religion, political or other opinion, national or social origin, association with a national minority, property, birth or other status.

16. These articles do not, according to Sarah Elliston of Glasgow School of Law, "seem to support an absolute right to have children or to be provided with assistance to do so. At most therefore, there seems to be a requirement that states do not place unreasonable obstacles in the path of people who wish to have children".[12] There have been concerns that elements of the HFE Act may be incompatible with the Human Rights Act. However, until now there has been only one successful challenge when Joanna Rose successfully argued that maintaining the anonymity of gamete donors engaged Article 8 of the Convention but the HFE Act did not contain a provision that directly infringed her human rights; the worst that could be said of it was that it failed to afford them a mechanism whereby their particular human right might best be vindicated.

EUROPEAN CONVENTION ON HUMAN RIGHTS AND BIOMEDICINE

17. The UK is not a signatory to the 1997 European Convention on Human Rights and Biomedicine, unlike most other European countries.[13] There are several significant articles that conflict with UK legislation. Article 14 on "Non-selection of sex" states:

"The use of techniques of medically assisted procreation shall not be allowed for the purpose of choosing a future child's sex, except where serious hereditary sex-related disease is to be avoided."

18. While the HFEA's policy is not to license the use of PGD for sex selection for social reasons, it is not illegal. Also, sperm sorting techniques are currently not covered by the HFE Act. However, Article 18 is the most significant in that it states:

"1. Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo.

2. The creation of human embryos for research purposes is prohibited."

It is this second point that makes the Convention popular with some witnesses as it would reduce the number of embryos available for research, and would prohibit therapeutic cloning in particular. CARE, a Christian charity, strongly believes that we ought to sign up to this Convention "Otherwise the UK will continue to be apart internationally and forfeit the chance to influence in this area".[14] However, the UK is not alone in not signing this Convention. We are joined by Germany, Ireland, Russia, Austria and Belgium, among others and it has still to be ratified by France, Italy, Spain, Netherlands and Sweden.

19. There are several additional protocols, one of which is the 1998 protocol on cloning, which prohibits "Any intervention seeking to create a human being genetically identical to another human being, whether living or dead".[15] A 2005 protocol on biomedical research expressly excludes in vitro research on embryos.

UNITED NATIONS

20. The Universal Declaration on the Human Genome and Human Rights, adopted by the General Conference of the United Nations Educational, Scientific and Cultural Organization on 11 November 1997, states that practices that are contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted (article 11). The UN General Assembly, in resolution 56/93 of 12 December 2001, decided to establish an Ad Hoc Committee for the purpose of considering the elaboration of an international convention against the reproductive cloning of human beings. All countries agree on the need to ban 'reproductive' cloning - the cloning of a human to produce another human. One group of more than 40 countries, led by Costa Rica, the United States and the Vatican, wants also to outlaw therapeutic cloning. The other group, led by Belgium and France, proposes that individual nations be left to decide whether or not to allow therapeutic cloning. The Costa Rican motion states that "Any person commits an offence within the meaning of this Convention if that person intentionally engages in an action, such as somatic cell nuclear transfer or embryo-splitting, resulting in the creation of a living organism, at any stage of physical development, that is genetically virtually identical to an existing or previously existing human organism."

21. In November 2003 the United Nations postponed its decision on proposals to ban human cloning after nations failed to agree whether such a ban should include cloning for research purposes. At a meeting of the UN General Assembly's legal committee on 6 November 2003, countries voted narrowly, by 80 votes to 79, with 15 abstentions, to defer talks on the proposed ban for two years. However, the issue was discussed at a meeting of the legal committee on 21-22 October 2004 but once again no agreement could be reached. A compromise was reached to issue a non-binding declaration, a draft of which was published on 19 November. This states:

a) Member States are called upon to prohibit any attempts to create human life through cloning processes and any research intended to achieve that aim;

b) Member States are called upon to ensure that, in the application of life science, human dignity is respected in all circumstances and, in particular, that women are not exploited;

c) Member States are also called upon to adopt and implement national legislation to bring into effect paragraphs (a) and (b) above;

d) Member States are further called upon to adopt the measures necessary to prohibit applications of genetic engineering techniques that may be contrary to human dignity.

The UN's legal committee voted 71 to 35 in favour of this declaration with 43 abstentions on 18 February 2005. The declaration passed to the full 191-nation General Assembly, which voted 84 to 34 in favour, with 37 abstentions on 8 March 2005. The UK voted against the declaration.

EU CHARTER OF FUNDAMENTAL RIGHTS

22. At the Cologne meeting of the European Council in June 1999, it was decided to establish a Charter of fundamental rights in order to make their overriding importance and relevance more visible to the Union's citizens. The Presidents of the European Parliament, the Council and the Commission signed and proclaimed the Charter on behalf of their institutions on 7 December 2000 in Nice. The Charter contains the fundamental rights and freedoms as well as basic procedural rights guaranteed by the European Convention for the Protection of Human Rights and Fundamental Freedoms and derived from the constitutional traditions common to the Member States, as general principles of Community law. Article 3 of the Charter - the Right to the integrity of the person - has particular relevance to our inquiry:

1. Everyone has the right to respect for his or her physical and mental integrity.

2. In the fields of medicine and biology, the following must be respected in particular: