Editors: Norio Fujiki, M.D. & Darryl R.J. Macer, Ph.D.
Knut Erik Tranoy
Professor Emeritus, Centre for Medical Ethics, Oslo University, NORWAY
(i) Norway is a small (4.3 million) European "welfare state", and, like Denmark and Sweden, a kingdom (monarchy) but a very democratic one. As measured by GNP per capita, Norway is one of the world's richest countries thanks to the North sea oil. Furthermore, and again like the other Nordic countries, Norway has a comprehensive national health service (NHS) which is responsible not only for all public health, strictly speaking, but for all personal health care as well. There is very little private and commercial medicine. What there is, comes as a supplement to the NHS in the sense that for some services, the private health care sector can also draw on the funds of the NHS.
(ii) The general level of education is fairly high, although perhaps not as high as in Japan I have now discovered. There are 9 years of compulsory school, which will become 12 if current plans go through. At present, roughly 40% of the youngsters go on to 3 years of secondary school. Finally, some 100.000 to 150.000 are in the system of higher education (universities and colleges).
(iii) Molecular medical genetics in Norway is presumably on a reasonably good European level. Practically all our geneticists go abroad, especially for continued and advanced training, to keep up with developments in their field.
Considering the resources - financial and other - which are currently being invested internationally in genetics research, it is obvious that Norway, however rich, cannot compete with the giants of genetics. From a national science policy point of view, this means that Norway cannot exert any real influence on international science policy choices. The fundamental choices have already been made elsewhere and by others. Only in a restricted sense can Norway be expected to carry out its own independent research - on premises formed and framed by others. The freedom of the "basic" science of genetics in Norway is largely the freedom to find out what the trendsetters have found. I suppose this holds more or less for all countries that do not play in the major league. There are, however, niches closer to applied genetics where Norwegian genetics research may be able to deliver contributions of interest in an international
perspective (1).
In the field of applied genetics we do have more of a choice. In order to find out what the options are, however, and to be able to advise the public and the politicians about them, Norway needs to have her own qualified geneticists. It is just not compatible with accepted notions of national independence in science policy matters to have to rely on others in such respects.
2. It is in the fields of applied genetics, then, that the moral and ethical traditions of Norway come into play. The picture then emerging is not without its own dilemmas.
By tradition, however, Norway is a country with a fairly restrictive, some would say puritanical, moral heritage. By and large this is true of all five Nordic countries. The basic attitude is clearly restrictive, not only with regard to genetic testing and other forms of genetic technology but also vis-a-vis modern biotechnology and reproductive technologies. Genetics, including genetic tests, is recognized as a resource in the face of certain kinds of serious illness. But there is also a widespread feeling in the population that molecular genetics now approaches limits which, for reasons which are clearly moral but otherwise not very clear, should not be overstepped.
Restrictive views were voiced in a government "white paper" from 1989. After a series of hearings, it was followed by restrictive legislation: a ban on research on fertilized eggs, a permission to freeze fertilized eggs but only for 12 months, no surrogate motherhood, no use of donors for sperm or ova, extremely strict rules for basic molecular genetics research. In 1993, certain liberal reforms were proposed in a new government white paper, but so far there is no new legislation (2). One might say that one of the basic challenges for Norway is to strike an acceptable balance between the need to be a modern, well informed and free country, on the one hand, while being faithful to a restrictive moral heritage which is felt to be threatened by developments in contemporary molecular genetics. It is not only Christian believers who talk sceptically about the dangers of "playing God". And in this case, the analogy (if that is the word) is not so much tied up with life and death decision making. The molecular geneticist is seen as encroaching on a "domain of creation" which so far has been closed to human intervention.
The situation in Norway is characterized, then, by a widely and strongly felt need for firm regulatory legislation. The principles in this context are the following two. In the first place, human molecular genetic technology should be used for purposes of disease control only and not for purposes of "enhancement". Secondly, antenatal and postnatal diagnosis as well as genetic tests should be permitted only within the framework of the national health service.
3. I have now used two crucial terms - disease control and enhancement - without trying to say what they mean.
Neither in Norway nor in any other country is there, as far as I know, an "authorized" definition of the term disease control. I have borrowed the term from the US Centers of Disease Control (CDC), but I do not use it with the same meaning as there (3).
I now propose the following definition of the concept of disease control: Disease control includes medical initiatives undertaken for diagnostic, prognostic, curative, rehabilitative, and palliative as well as preventive purposes. Clearly, genetic interventions can at least be used for diagnostic, curative, palliative, as well as preventive purposes. I suggest that this concept of disease control captures (most of) what we generally think are the main and legitimate aims of medicine and health care.
It is less clear what enhancement could mean. Basically it is "using gene transfer to insert genes into humans for the purposes of "enhancement" - that is, to try to "improve" desired characteristics" (4). I do not think we need a definitive definition of the notion of enhancement for present purposes. If we say that the only legitimate use of gene therapy is for purposes of disease control ("only for the treatment of disease" (5)), we in effect exclude all other purposes, enhancement not excepted.
This ties in nicely with the official Norwegian wish not to permit a commercial market in genetic services, including genetic tests and gene therapy. So far no real attempt has been made to specify the genetic services that would then be ruled out - possibly genetic tests for the use of life insurance companies. The situation is unclear at present, and Norway has no health insurance companies, so far, although we may have them in the future.
4. In Norway, as in other countries, considerable weight has been attached to the distinction between genetic interventions on germ line cells as against somatic cell intervention. We have found it useful to combine this distinction with the distinction between disease control and enhancement in a four square grid thus.
INTERVENTIONS ON somatic cells; germ line cells
FOR:
disease control: 1; 2;
For
enhancement: 3; 4.
When seen from a Norwegian health care perspective, it is only option #1 that is the ethically acceptable alternative. It is equally clear that option #4 - which can hardly shake off the eugenics label - is in any case unacceptable. There may be more dispute about the moral status of #2 and #3.
The response from geneticists to germ line scenarios is, so far, to point out that there is so much unclarity and so much risk attaching to such interventions that discussions about them are more or less premature. In the words of W. French Anderson, "Therefore, considerable experience with germ line manipulation in animals, as well as somatic cell gene therapy in humans, should be obtained before considering human germ line therapy" (6).
We could still consider human germ line therapy (option 2, that is) in the abstract. As may appear from my quotations from French Anderson, he does not mention germ line trials on humans, only trials on animals plus somatic cell gene therapy on humans. However, granted that the technical problems are solved (as we have reason to think they will be, and sooner rather than later) it would still not be ethically acceptable to use germ line intervention on people for the purpose of effecting a cure without first having done controlled trials on humans, no matter the number and success of animal experiments. Today, standard medical research ethics does require controlled tests on humans (7) in much less risky and drastic cases than curative germ line intervention on serious disease. What would such a trial look like? Could it be designed without fetuses "produced" for more or less experimental purposes? How else could we find out whether or not an intervention has been successful - and how old should the fetus (or the child) be before responsible and reliable conclusions could be drawn?
If reliable conclusions could not be drawn without trials on humans, we might have to say that there are research ethical barriers which may prevent the establishment of germ line intervention on humans. In this case, it seems that the Norwegian dream might become true for reasons which are not at all specifically Norwegian.
5. In so far as such arguments are tenable, they might also reassure those who fear that germ line intervention will be used for eugenic purposes. I suppose no one would use germ line intervention for eugenic purposes - perhaps least of all for eugenic purposes - without the standard assurance provided by controlled tests on humans.
We still have the alternative of resorting to "old fashioned" procedures of population genetics - where there are only small or negligible ethical worries - for purposes of disease control. Take Huntington's disease as an example. If all HD gene carriers were, by individual and autonomous decisions, to abstain from having children of their own, no (or fewer) new HD gene carriers will be born. It does not affect my argument if antenatal diagnosis were to be used, individually and autonomously, to abort fetuses with the HD gene. In both cases, the aggregate outcome of individual decisions not to procreate (or carry to term) would in fact amount to the same as the outcome of a successful decision to stamp out Huntington's disease by way of "eugenic" germ line intervention.
There is nothing very surprising in this. As we know so well from the euthanasia debate, the outcome intended by the agent is sometimes the overriding factor from the moral point of view. The actual outcome may be the same in two different cases - the pain is controlled and the patient may die a little sooner. But from a moral point of view the two cases may be judged very differently, depending on which of the two effects the agent "really" intended. We are, in fact, familiar with this model from the so called "law of double effect" as used, for instance, in the case of abortions: when taking the life of the fetus with the intention of saving the life of the mother (when no other option is available) is regarded as morally acceptable in spite of the fact that the death of the fetus is foreseen as an unavoidable part of the outcome - while in itself and in isolation, a provoked abortion is held to be morally unacceptable.
Indeed, the HD case I constructed above might be regarded as an example of (what we might call) a "positive version of the law of double effect". The (partial) elimination from the gene pool of the HD gene would then be an unintended but foreseeable - and welcome - aggregate outcome of individual and autonomous decisions made to realize a different intention: to abstain from procreating in order to avoid having a child with a very serious disease (8).
Concluding remarks
Let me end on a more forward looking or prospective note, in the form of two brief and summarily stated speculative predictions.
First, from the point of view of Nordic health services, preimplantation diagnostics is likely to be regarded as a preferable option. A weighty argument in favour of this conclusion is the fact that this option may reduce or altogether obviate selective late abortions which, in spite of their modest number, constitute a major moral stumbling block, at least in Norway. In general, the later the intervention with a view to preventing a foreseeable and undesirable outcome, the stronger the moral objections against it - and so (although the inference is not cogent) the earlier, the better. If genetic tests can be used for the purpose of early prediction, monitoring, and prevention, that is a point in their favour.
Second, the ultimate answer to the Nordic virgin's prayer may well be seen to lie in what I shall now venture to call molecular pre-fertilization family planning. This is not necessarily science fiction; the first contours of it are already visible on the horizon. We have long known that eggs from younger women are "better" than eggs from older women. Familiar illustrations are the age related incidence of Down's syndrome and the hard fact that from a reproductive point of view, sperm quality varies very considerably and can perhaps be improved by technological means.
I feel sure that we may still come to hear objections of a more deontological kind to all this - some of us may find it somehow offensively unnatural to intervene in such ways in the reproductive process, nurturing instead what others might call nostalgic dreams. Such dreams may turn out to have consequences we may wish to avoid. Some thresholds only become visible when one sees people stumble over them.
1. Norway has certain comparative advantages when it comes to genetics research due to the existence of good health and disease registries (e.g. for cancer); a homogeneous population; a favourable climate of cooperation due to close and good relationships between researchers, hospitals and public authorities; good research data from earlier twin research; several good collections of biological samples and exposure data.
However, this in turn raises new questions. To what extent can such data be useful for basic research? Or perhaps rather: is the distinction between basic and applied research even more problematic in genetics than in most other fields?
2. Norwegian Ministry of Health and Social Affairs, Humans and Biotechnology (Oslo, NOU 1991:6, 174 pp). The white paper is titled On Humans and Biotechnology (Oslo, St.meld. nr. 25 1992-93, 208 pp.) It is quite conceivable that some of the liberal reforms will be turned down by a new parliament.
3. Steven Jonas (with contributors), Health Care Delivery in the United States. Third edition (New York: Springer Publ. Co., 1986), p. 344: "CDCs is the national public health agency primarily responsible for prevention efforts. Its programs are aimed at preventing and controlling disease, directing foreign and interstate quarantine operations, developing programs for health education and health promotion, improving the performance of clinical laboratories, and developing the standards necessary to insure safe and healthful working conditions for all working people".
4. Anderson, W.F. (1992) Human Gene Therapy. Science 256: 808-813. There are, of course, many other ways of achieving "enhancement" of human characteristics. As I have pointed out in an earlier paper, all systematic training and education aims at that kind of enhancement which we sometimes prefer to call self-realization. See K.E.Tranoy, "Ethics, genetics and science policy", Bulletin of Medical Ethics, Number 77, April 1992, pp. 13-20, esp. p. 16.
5. Anderson, W.F., 1992, p. 812.
6. Anderson, W.F., 1992, p. 813
7. "Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects". Declaration of Helsinki, Introduction.
8. The general point involved in this way of reasoning could also, perhaps, be formulated in the following way. The way in which we describe (define or determine) the goal of a course of action also determines/influences the criteria of success. Therefore the goal description may also influence the conduct and reactions of medical staff/counsellors in, say, cases of genetic and/or antenatal counseling. If the goal is understood as individual disease control, staff is conceivably more respectful of individual patients' autonomy than they might see reason to be if the goal were described as elimination from the gene pool of genes harmful from society's point of view. In the latter case, it seems likely that non-directive counseling would be less probable than in the former.
These reflections echo a conversation I had with Dr. Angus Clarke (of the Institute of Medical Genetics for Wales, Cardiff, UK) in Fukui after presenting my paper. See also Angus Clarke, "Genetics, ethics, and audit", The Lancet 335 (May 19, 1990) pp. 1145-1147.