Select Committee on Science and Technology Fifth Report

9  A new approach

390. We have argued that there should be balance between the freedom of individuals to make their own reproductive choices and the legitimate interests of the state, but that any intervention into reproductive choice must have a sound ethical basis and also take into account evidence of harm to children or to society. We propose that the current regulatory model, which provides the HFEA with a large amount of policy-making flexibility, should be replaced with a system which devolves clinical decision-making and technical standards down to patients and professionals while at the same time strengthening Parliamentary and ethical oversight. This system has three strands: a dedicated Government regulator to ensure high standards of treatment; professional regulation to ensure the highest level of conduct by practitioners; and a system of ethical oversight.

Figure 2: Regulation of assisted reproduction and embryo research in the 21^st century.

Legislation

391. Legislation should reflect the fact that assisted reproduction is now a standard clinical procedure and its focus should be on improving clinical standards and ensuring safety. Intending parents should be able to seek appropriate services, subject to the professional regulation of safety and quality. This would ensure that reproductive decisions remain primarily in the private domain, governed by professional ethics and the law of consent. However, legislation will be needed to offer appropriate protection for the human embryo and to accommodate status and other legal issues.

STATUS AND PROTECTION OF THE EMBRYO AND GAMETES

392. The legislation will not define the embryo, although it will not come under the protection of the law until it has reached the two cell stage after around 36 hours. It will introduce a definition of gamete to encompass all haploid human cells but a distinction will be made between mature gametes on one hand and immature and artificial gametes on the other. Only embryos created through the union of human sperm and egg can be implanted in a woman, unless otherwise specified. Embryos formed by any process identified in the legislation must be destroyed at a specified stage of development if they are not implanted in a woman. This stage should be set at 14 days but this should be capable of amendment by Parliament. Research on any embryo containing human chromosomal material is permissible up until the specified stage of development if it has received approval from a local research ethics committee and—where appropriate—peer review from a public research funding agency. These provisions are intended to prohibit human reproductive cloning or indeed assisted reproduction using any procedure that does not involve the union of mature gametes. However, legislation should be sufficiently flexible to enable Parliament to reconsider these prohibitions as technology advances.

CONSENT AND CONFIDENTIALITY

393. Issues of consent to receiving assisted reproduction techniques will continue to be governed by the common law on information disclosure and consent to treatment. The legislation's treatment of confidentiality will permit the appropriate sharing of information and high quality research.

REGULATORY AGENCY

394. Legislation will create the Regulatory Agency for Fertility and Tissues funded by fees from accredited facilities. It would have an advisory body drawn from the relevant professional bodies. The Agency will:

a)  Ensure that clinics using procedures covered by the Act are appropriately accredited, through the use of an in-house inspectorate or recognised external accreditation bodies;

b)  Regulate gamete and embryo donation and donation services, including the maintenance of a national database;

c)  Set maximum limits for multiple pregnancies for treatment centres using procedures falling within the legislation;

d)  Collect and analyse outcome data;

e)  Validate new materials or processes for the handling or embryos of gametes;

f)  Provide information to patients, including the cost of treatment. It could intervene to ensure that patients were not charged excessive costs by private clinics;

g)  Ensure that research proposals have received adequate ethical and scientific review and publish a lay summary of all approved research projects covered by the legislation;

h)  Be supported by an advisory body for technical standards under the auspices of the Royal College of Obstetricians and Gynaecologists and the Royal College of Pathologists.

i)  Undertake the role currently envisaged for the Human Tissue Authority. There should be provision for secondary legislation to bring regulation of non-reproductive tissues into line with that for assisted reproduction and embryo research in consultation with relevant professional bodies and accreditation services.

Technical standards

395. Professional bodies under the auspices of the Royal College of Obstetricians and Gynaecologists would draw up technical standards for clinics offering assisted reproduction and undertaking embryo research as a basis for accreditation. The guidelines should set out how assisted reproduction techniques should be undertaken but would not specify what those techniques would be used for. These standards should be consistent with the EU Tissue and Cells Directive and cover:

a)  Organisation and quality management system

b)  Personnel

c)  Premises and environment

d)  Equipment, information systems and reagents

e)  Procedures

f)  Evaluation and quality assurance.

396. There will be no welfare provisions in the standards beyond the requirement that the risks to any child conceived from treatment as a result of the procedures are minimised within the constraints of available knowledge. To take the example of preimplantation genetic diagnosis, the professional bodies would set out the technical standards to undertake the procedure but not what genetic conditions could be diagnosed. This body would also specify which techniques could be accredited and which could only be undertaken as part of a clinical trial. The technical standards would cover the requirements for training staff. The standards would specify that treatment centres must maintain clinical records in a form that would enable their use for future targeted analysis. Funding would be provided by grant-in-aid.

Professional regulation

397. Medical practice is well covered by generic regulation. The professional bodies under the Council for Healthcare Regulatory Excellence are charged with maintaining the professional standards of conduct of healthcare professionals. The Healthcare Commission has a statutory obligation to monitor the performance in the private and public sectors. The National Institute for Clinical Excellence makes recommendations on treatments and care using the best available evidence. Combined, we believe that they provide sufficient statutory weight to ensure that clinical standards are maintained and decisions are supported by the best available guidance. Guidance in the field of assisted reproduction is provided by the professional bodies, notably the Royal College of Obstetricians and Gynaecologists, the British Fertility Society and the Association of Clinical Embryologists.

Parliamentary Standing Committee on Bioethics

398. We have argued for greater Parliamentary oversight over issues relating to assisted reproduction and embryo research. To achieve this we propose a new Parliamentary Standing Committee on Bioethics. This would undertake annual scrutiny of the Regulatory Agency for Fertility and Tissues, make recommendations on the need to amend or introduce legislation and scrutinise draft legislation brought before Parliament within its remit. All statutory instruments under the new Act would automatically be referred to this Committee instead of the Joint Committee on Statutory Instruments. As with human rights, this is an issue that requires collaboration of MPs and Peers and the Committee would be made up of members of both Houses, unlike the Stem Cell Research Committee set up by the House of Lords in 2001. It would appoint a panel of advisers and have a specialist secretariat. Any lack of consensus on statutory instruments would trigger a debate in both Houses.

Human Genetics, Fertility and Tissue Commission

399. We propose the creation of a new Human Genetics, Fertility and Tissue Commission would expand the remit of the Human Genetics Commission to include the issues currently the domain of the HFEA and the relevant areas from the Human Tissue Authority. The bodies would provide advice and recommendations on issues which it considered that there were societal implications, such as selection for social reasons and preimplantation tissue typing, but would not provide clinical guidance. It would be informed by public consultations and could commission social science research.

Research

400. Embryo research would need to be undertaken in an accredited facility, have been scrutinised by a local or regional research ethics committee, which would ensure that adequate consent had been sought from donors, and have been scientifically peer reviewed. We believe that the MRC's guidelines would be sufficient to ensure that research projects involving embryos were of real clinical benefit and suggest that it take on the peer review process for applications even if they do not involve a request for MRC funds.

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Prepared 24 March 2005