UNESCO Bioethics Committee and International Regulation of Gene Therapy

Journal: Gene Therapy Newsletter 4 (1994), 4-5.
Author: Darryl R. J. Macer
1. UNESCO produces "liberal" guidelines

From 19-22 September, the UNESCO International Bioethics Committee had their second meeting. I am one of the more than 50 members, selected from 35 countries. The committee is drafting general guidelines and an international declaration on the human genome and human genetics, that it is hoped will be approved by the United Nations General Assembly in 1998, the 50th anniversary of the Declaration of Human Rights.

The committee was founded one year ago, and in its first year considered three major themes, genetic screening, population genetics, and gene therapy.

The report on gene therapy has some interesting features [Nature (29 Sept. 1994) 371: 369]. The key points can be summarised as:
- Somatic cell gene therapy - encouraged for any disease
- Somatic cell gene enhancement - not to be illegal
- Germ-line gene therapy - not to be illegal
- Germ-line gene enhancement - should not be done

The conclusions are more liberal than some national guidelines [e.g. French law discussed in August issue, p. 22-3], and the Council of Europe Bioethics Convention [Sept./Oct. issue, p. 22-3]. They reflect the logic of obtaining international support and being independent of time. If we assume that the safety of gene therapy will improve, then logically inheritable, or germ-line, therapy could be acceptable. We can think of cases where it may be more logical than somatic cell therapy, in the time-frame of implementation of international declarations and conventions (e.g. up to ten years from now).

Enhancement, for example of immune system or avoiding memory loss, could also be accepted, but because of ethical concerns about germ-line enhancement, the committee recommends to draw the line at somatic cell therapy. It recognises that already some enhancement is accepted, whether it be vaccination, vitamins, or make-up. Nevertheless there are more concerns over enhancement by the public, and also fears of a slippery slope, so we should wait until we reach a wide consensus before germ-line enhancement [e.g. Fukui Statement on International Bioethics, Fukui, Japan, 1993]. A few writers have supported the concept of enhancement in the academic journals [Miller HI: Gene therapy for enhancement. The Lancet (1994) 344: 316-7]. But most think that germ-line enhancement should not be contemplated for a long time, at least our children or grand-children should decide whether to use it, not us.

The Legal Commission within the committee also tabled the first draft Declaration on Protection of the Human Genome. Several points are of relevance:

6. No research on or modification of the human genome, whether the modification has therapeutic or diagnostic aims, can be undertaken without the free and informed consent of the person concerned. In the case of minors and others legally incapacitated, parents or guardians should give such consent.

8. Everyone has the right to obtain compensation for any damages that they have suffered due to research on, or modifications of their genome.

It should be stressed that the first reports and first draft are likely to be modified, but they present some basic points that are likely to be reflected in the international declaration. Some members debated point 8 about compensation, e.g. who is liable and how much.

2. Are international guidelines justified

There is a large debate over whether national or international guidelines are appropriate [Debated in a forum in: Politics and the Life Sciences (August 1994)]. UNESCO intends countries to implement more specific national laws, if they wish, in addition to a basic international framework. The call for international approaches is based on several arguments, including shared biological heritage, and the precedents for international law to protect common interests of humanity. Those calling for national guidelines argue that each culture should make their own standards because of national autonomy and because people in each country have different attitudes.

In 1993 the International Bioethics Survey was conducted in Australia, Hong Kong, India, Israel, Japan, New Zealand, The Philippines, Russia, Singapore and Thailand. The results were compared to North America and Europe. The survey included 150 questions with 35 open questions, and some questions on genetic screening, and gene therapy. The full results are in a book [D. Macer, Bioethics for the People by the People, Eubios Ethics Institute 1994, from: P.O. Box 125, Tsukuba Science City, 305, JAPAN].

About 70-80% in all countries were willing to undergo therapy themselves, and 80+% willing for their children to undergo gene therapy to cure a usually fatal disease. The major reasons expressed in open questions ("Why?") were to save life and increase the quality of life. About 5-7% rejected gene therapy considering it to be playing God, or unnatural. There was very little concern about eugenics (0.5-2%), and actually more people gave supportive reasons like "improving genes", especially in Thailand and India. The open comments suggest eugenic thinking is found in most countries.

Another set of questions on gene therapy to treat different conditions found people do have significant discretion, supporting somatic cell gene therapy (e.g. curing cancer) and germ-line (e.g. preventing children from inheriting a usually non-fatal disease, such as diabetes), but rejecting enhancement gene therapy (e.g. improving the physical characteristics that children inherit). There must still be some debate over enhancement, as in India and Thailand, more than 50% of the 900+ respondents in each country supported enhancement of physical characters, intelligence, or making people more ethical. A 1994 Gallup poll in the UK also reports up to 20% of people accepting enhancement gene therapy, which is much higher than 1993 [Nature (1994) 371: 193].

There is support in all countries that have been surveyed in the world for gene therapy, and genetic screening. Similar results exist for the USA from an Office of Technology survey in 1987 and a March of Dimes survey in 1992. A review of international studies on public opinion in general is B. Zechendorf, "What the public thinks about biotechnology", Biotechnology (Sept. 1994) 12: 870-5. In fact, he refers to an earlier 1991 survey I conducted in Japan, and mistakedly says Japanese do not approve of gene therapy, when they do. However, in the 1993 survey there was a 15% jump in acceptance over my 1991 survey data, while genetic screening approval was unchanged, suggesting positive media influence has increased acceptance.

The diversity of views of people in countries around the world is generally similar within each country, which I have called universal bioethics. We need to recognise that people in all countries are mixed in their opinions, this diversity is universal. The types of reasons given are generally similar. This data supports the concept of international guidelines. Such guidelines could provide a minimum standards for ethical protection of users and to enable availability of service. From past experience we can not expect many countries to go the extra step and implement national laws. We could say universal access to health care and these new techniques was desirable also, but that is something we must continue to work on.

To Papers list
To Eubios Ethics Institute book list
To Eubios Ethics Institute home page

Please send comments to Email < asianbioethics@yahoo.co.nz >.