Developments in clinical genetics in the last decade or so, and particularly the enormous increase in knowledge of the molecular structure of genes responsible for a number of inherited diseases, give promise that these diseases in the future may be alleviated by genetic modification of human body cells. The prospect of such treatment is providing hope for those families in whom these diseases occur, but also raises ethical issues about its possible applications, misapplications and consequences.
Considering that the implications of gene therapy needed to be examined before its acceptance into standard medical practice, in November 1989 the Minister of Health set up a committee on the ethics of gene therapy with the terms of reference ‘‘to draw up ethical guidance for the medical profession on treatment of genetic disorders in adults and children by genetic modification of human body cells; to invite and consider proposals from doctors wishing to use such treatment on individual patients; and to provide advice to UK health ministers on scientific and medical developments which bear on the safety and efficacy of human gene modification’’. Under the chairmanship of Sir Cecil Clothier QC the committee met 14 times. It consulted widely, not only amongst professional organisations and authorities, but also amongst a number of pressure groups.
Its report, published on 16 January 1992, contains an introductory guide to genes, genetic disorders and gene therapy, distinguishing between somatic cell gene therapy and germ line gene therapy, and indicating some of its possible dangers. It discusses the ethics of medical practice and medical research, distinguishing between innovative treatment and clinical research involving patients, and relying heavily on the codes of practice accepted by the Royal College of Physicians of London. In its considerations it accepts the purposes of ethical codes as to (a) facilitate justifiable advancement of biomedical knowledge, (b) maintain ethical standards of practice, (c) protect the subject of research from harm, (d) preserve subjects’ rights and liberties, and (e) provide reassurance to the public and the professionals that these are being done. Applying these ethical codes and the principles on which they are founded, the committee considers what is justifiable in gene therapy research and the conditions that should be met for such research to be ethical and to be seen to be so.
It finds that somatic cell gene therapy raises no new ethical principle, but the familiar issues which attend at the introduction of any new medical procedure are heightened because of the special qualities of the genetic make-up of individuals. The committee believes that all gene therapy treatments should initially be regarded as research and be governed by the exacting requirements which already apply in the United Kingdom to research involving human subjects.
Somatic cell gene therapy should be directed to the alleviation of genetic disease in individual patients and should not be used to change or enhance normal human traits. A new expert supervisory body should be established to provide scientific and medical advice on matters germane to the safety and efficacy of human gene modification and its use; this supervisory body should work in conjunction with local research ethics committees when proposals for gene therapy are made.
As regards germ line gene therapy, because there is insufficient knowledge to evaluate the risk to future generations, genetic modification of reproductive cells and germ line cells which give rise to them should not be attempted.
The government invited comments on any aspect of the report, but particularly on (a) the recommendation that gene therapy should be regarded as research on humans and thus be subject to the requirements already established for this in the United Kingdom, (b) the recommendation that an expert supervisory body should be set up and charged with providing advice on the safety and efficacy of proposals for gene therapy, including supervision, (c) the best means of co-ordinating the work and responsibilities of such an expert supervisory body with those of local research ethics committees (LRECs), and (d) whether the arrangements proposed are sufficient, or whether statutory mechanisms are needed. The Galton Institute sent its comments.
It is not expected that proposals for gene therapy will be made in the immediate future, but it is judged prudent to make arrangements for handling any proposals that may arise before substantive mechanisms are in place. As an interim arrangement, the committee on the ethics of gene therapy has been asked to remain in being. If a proposal for gene therapy is made, the details should be submitted to the appropriate local research ethics committee and at the same time copies of the proposal should be sent to the Committee on the Ethics of Gene Therapy at the Department of Health so that it can appraise them and send its comments to the relevant LREC.