pp. 447-448 in Bioethics in Asia

Editors: Norio Fujiki and Darryl R. J. Macer, Ph.D.
Eubios Ethics Institute

Copyright 2000, Eubios Ethics Institute All commercial rights reserved. This publication may be reproduced for limited educational or academic use, however please enquire with the author.

F32. The New Genetics and its Regulation in the UK

David Shapiro.

lately Executive Secretary, Nuffield Council on Bioethics, and Consultant, Wellcome Trust, UK

My intention today is to use recent developments in the UK as an example of national policy strategies on the application and the regulation of the new genetics. It should be clear at the outset that the UK is being offered as a case study. It is not my intention in any way to suggest that other nations should follow the example of the UK.

Indeed, let me indicate the very specific characteristics of the UK which may make it unsuitable as an example to be followed by other societies. The provision and regulation of health care in the UK has a number of distinguishing features that affect the handling of the issues raised by the new genetics. Among these features are:

1 Britain has a National Health Service (NHS). The public therefore expects that, in health matters, the Government will take a lead.

2 Professional self regulation has long been a feature of medical law and ethics in the UK. In this respect, the role of the Medical Royal Colleges in modern times has been of great importance.

It is important to emphasise that, in the UK, there is a close relationship between professional self regulation and the law. Traditionally, British law has assumed that doctors acting within professional guidelines cannot be judged professionally negligent provided that doctors can demonstrate that their treatment of patients fell within those professional guidelines. Thus, such professional guidelines carry with them an inherent mechanism for enforcement. On the other hand, these guidelines do not have statutory force, they are not legislation - and are possibly easier to change, in consequence, as scientific and medical knowledge advances.

The development of service provision in the UK for the new genetics has been built up around a number of regional genetics centres. Each centre is typically associated with a teaching hospital with a strong commitment to research. In this way, the UK has built up a network of genetics centres that combine a strong research interest together with a commitment to advancing the clinical practice of the new genetics. The future of these regional genetics centres has been made somewhat uncertain both by the changes to the NHS administrative regions and also by the introduction of the administrative split between purchasers and providers. Thus far, however, the regional genetics centres seem to be surviving the reforms in the NHS.

The development of UK public policy on the new genetics can be briefly summarised. The distributed handout gives a somewhat selective picture of the development of public policy. You will observe that, by the beginning of the 1990s, the Royal College of Physicians had developed a whole series of brief reports that summarised professional concerns. The newly created Nuffield Council on Bioethics had little doubt on its establishment that its first task would be to report on the ethical issues raised by genetic screening and by genetic tests. This it did at the end of 1993 in its report Genetic Screening : Ethical Issues. This report received considerable publicity in the serious press. It made recommendations on six main points:

1 Providing information and obtaining consent.

2 The results of genetic screening and testing and their confidentiality.

3 Employment.

4 Insurance.

5 Public policy, including education and the monitoring of any genetic screening programmes.

6 The need for a central coordinating body with responsibility for the implementation of screening programmes.

The Government response was to say that everything was in hand or else, for example in the case of employment, was not necessary. Fortunately, an early public presentation of Genetic Screening : Ethical Issues caught the attention of the Parliamentary official of the House of Commons Select Committee on Science and Technology. With the enthusiastic support of the chairman and members of that Select Committee, they devoted the Parliamentary session of 1994-95 to the compilation of a major report Human Genetics: the Science and its Consequences. This report largely took over the recommendations made by the Nuffield Council on Bioethics and called for the creation of an overarching government body to deal with the whole range of issues within human genetics.

The Government's first reaction was to concede that the Department of Health should appoint an Advisory Committee on Genetic Testing (ACGT) with relatively restricted terms of reference. In particular, it objected to the creation of a statutory overarching government body. The Select Committee stuck to its guns. It pointed out that it had recommended an overarching body that, in the first instance, might well be non-statutory. Experience would dictate whether it might be appropriate eventually to turn it into a statutory body. The Select Committee took the unusual course of revisiting the topic immediately and summoning Ministers to justify their refusal to set up an overarching body. The then Secretary of State for Health, Stephen Dorrell, took the decision to bend to the storm. In the summer of 1996 it was announced that the Government would be setting up the Human Genetics Advisory Commission (HGAC).

Where does UK policymaking on the new genetics stand? The new overarching body, Human Genetics Advisory Commission (HGAC), held its first meeting in February 1997. It has indicated that its first priority has been to review the insurance implications of the new genetics. A report on that is expected shortly. The Advisory Committee on Genetic Testing (ACGT) has issued in September 1997 a Code of Practice and Guidance on Human Genetic Testing Services supplied direct to the public. Particular aspects of the new genetics are dealt with by the statutory Human Fertilisation and Embryology Authority (HFEA) and by the Gene Therapy Advisory Committee (GTAC). The Nuffield Council on Bioethics will publish in early 1998 a new report on genetics and mental disorders.

A final plea. I suspect that most of us are puzzled to know how best to conduct public policymaking on the new genetics. In Europe we have a diversity of institutions and a diversity of systems for the delivery of health care. We share a commitment to a range of common ethical concerns. By contrast with the USA, European countries in doctrine and health care provision emphasise an ethic of 'solidarity'. My plea would be that we should not press unduly for harmonisation but rather use our diversity to experiment. A range of experiments in public policymaking is what the present situation in the new genetics calls for.


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