Juridical Policies and Bioethics: The three pillars of biomedical legislative wisdom

- Judge Christian Byk,

Secretary General, International Association of Law, Ethics and Science;
62 Boulevard de Port-Royal, 75005 Paris, FRANCE


Eubios Journal of Asian and International Bioethics 5 (1995), 59-61.

In his foreword to the 1993 report on Biomedical Ethics in US Public Policy, the Director of OTA noted that "over the past two decades, a desire for mechanisms to articulate common values and foster consensus about biomedical advances in the face of cultural and religious heterogeneity resulted in the creation of Federal bioethics commissions". However to this remark, which can also apply to the many countries where bioethics bodies have been set up, can be opposed the fact that till now very few juridical policies have clearly derived from the work of these new mechanisms.

Defining juridical policies appears therefore to be a harder task than simply creating new committees or commissioning reports. The reason probably is, as Judge M. Bedjaoui reminded us during the 2nd session of the UNESCO International Bioethics Committee, that fear has always been a companion to man; fear of his enemies, fear of gods. But our intelligence of the universe has permitted us to domesticate our emotional reactions caused by the expectation of danger.

It is therefore not acceptable that we leave spectacular and in some way frightening scientific applications of biomedical sciences to govern social reactions, and in particular juridical policies. However the question is; what should we say to those who notice, among others, that scientific breakthroughs and novel medical technologies have led society to a point where pig and baboon livers have been transplanted into terminally ill persons or where women with severe brain damage have been kept alive mechanically to continue their pregnancies?

The answer would be that bioehtics cannot be determined by a series of bioethical events however unethical or, on the opposite, beneficial they can be.

The media reporting of the first test tube baby certainly played a great role in bringing new reproductive technologies to the knowledge of the public. But Louise Brown was at that time only the emerged part of the iceberg for reproductive technologies. And a good policy maker, like a good pilot, should also see the submerged part of the iceberg, which is the most important one.

"Proceed with Care" was the title of the 1993 Report of the Canadian Royal Commission on Reproductive Technologies. I will slightly change the wording by saying, "Reconstruct with care" to show how deeply related the biomedical reality and its social consequences are.

The right approach regarding the juridical process will then be to take into account the two parts of the iceberg by a process which reconstructs what is the complete reality. And this process demands three steps, each of them constituting one of the founding pillars of any juridical policy.

The three constituting pillars of biomedical legislative wisdom are:
1) Awareness - to be aware that icebergs (or reproductive technologies, for example) exist and that you could meet them.
2) Assessment - to be able to evaluate what kind of consequences would follow from such a meeting.
3) Decision Making - that you should wish to take measures to organize such meetings and their consequences.

If we keep in mind the example of reproductive medicine, many things have been written about these issues but very few in fact have ever considered looking at the three different steps. The reasons for such failure are certainly very easy to understand. The priority is not to make the history of the legislative process but to complete it. It seems more satisfactory to give an opinion on fundamental social issues than to suggest a methodology to allow others to present their opinions.

However 20 years have now gone since the first piece of legislation relating to reproductive technologies was adopted in Europe and the risk is now much more a risk or over- regulation than of a legal vacuum. It is then interesting, especially when you bear in mind the possibility of an International covenant to know how far the different European States have progressed on the way to biomedical wisdom. My objective is not to describe how good or how bad a law is. It is beyond my experience but it is simply to look at the legislative process in each country and to discuss why and how it has developed to such a point and what consequences we could draw from that both and the national and international level.

Awareness

The phrases, "bioethics", "Artificial reproduction" or "Surrogate motherhood" have become magic words and a large majority of the public has heard of these new "technological" realities, and has even seen how a test tube baby looks, or a 60 year old pregnant woman. But I am not so sure that this experience is enough to make a society aware of the importance of reproductive technologies. The news brought through the media are mainly focusing on factual events and not on the continuity of the medical development. The media also put forward very often what are the most controversial and spectacular aspects of this development and give less attention to what is the "common" practice.

The practice of a new technology is certainly the best way to make it known. Reproductive technologies are used very commonly in France and in the U.K., less in Italy and Germany or Ireland. But in these last two cases we cannot conclude that a limited practice, is evidence that public opinion is not aware of the issues. It would be just the other way around. It then means that the practice is self limited because the culture of the country will be considered as being opposed to any further extension of the new practice. Culture and other social considerations could also have a great influence on the awareness of reproductive technology issues. Where family questions are regarded as preeminent for the society medically assisted procreation in case of infertility could raise the attention of public authorities more easily.

When the health care system could not provide the population with the average health care facilities which are available in other surrounding countries, it is likely that reproductive technologies will not be considered as a priority by the public. But even in those cases, it could be observed that some countries would develop such new technologies very quickly. Two reasons could explain this. First, the encouragement given to new technologies could be a way to show that the country concerned is willing to join the club of its neighbours with sophisticated health technologies. Second, where private practice of medicine is newly established it is an "easy" method to advertise your medical experience, to respond to the new requests of the public and to earn money.

Globally it is however possible to say that the awareness of public authorities and the opinions towards reproductive technology issues does now exist in Europe. Only countries where it is still difficult to discuss openly the problems related to morals and sexuality have not yet reached to same level of awareness. This could be the case in Ireland, Greece, Poland and in some parts of Italy, Spain and Portugal.

Assessment

Although the practice of artificial insemination with donor sperm (AID) at the beginning of the 1970s in some European countries raised the problem of the legal status of the child, in vitro fertilization, the use of frozen embryos and the related research done on in vitro embryos at the beginning of the 1980s, made us conscious that broader issues, ethical, legal and social ones were presented by artificial reproduction: the concept of family, the status of the embryo, our responsibility towards future generations, the power of medicine... As a consequence of this challenge, the proposal to mandate some institutions or bodies to report on the social consequences of such technologies and eventually to propose solutions came very quickly. All the European countries, except Greece, Ireland and Eastern and Central European States have gone through this process of evaluating all the problems posed by artificial reproductive technologies.

Most of countries proceeded through ad hoc committees (The Warnock Committee in the U. K., and the Benda Commission in Germany are probably the best known). Other countries such as France and Denmark, complemented the role of ad hoc committees by establishing new permanent bodies, national ethics commissions, to deal with all issues relevant to biomedical sciences. In a few cases, existing bodies such as the national board of health played a certain role on advising authorities of their countries (for example, the Netherlands, Finland and Sweden).

A minority of countries however kept the problem either at the governmental level (Luxembourg, Portugal and in a certain way Belgium) or at a parliamentary level (Spain, Italy). In fact, an overview of the first ten years official reports or documents published in the different European countries, shows that more institutions, bodies, governmental agencies have been in fact involved in studying the impact of reproductive technologies (a good list is in the Appendix in the Office of Technology Assessment report, Biomedical Ethics in US Public Policy 1993). For example, during the period 1988-1992, we had in France at least three governmental reports and three Parliamentary reports, in addition to the opinions of the National Ethics Committee.

I stress the main trends in the evaluation of reproductive technologies. In nearly all countries, there was a feeling that such issues should not be biased by political opinions but needed a pluralistic and multidisciplinary approach. The importance of scientific and medical aspects also contributed to the choice of bodies or institutions not directly dependent on the governmental administration or on the Parliament. However, in countries where constitutional traditions still give an important role to the Parliament. It was also involved in the evaluative procedure.

But very soon additional difficulties appeared concerning this task of analysing the consequence of new technologies. Specially how can assessment be made given the ongoing progress of technologies? Some countries still preferred to make new ad hoc committees for each new problem. For example, in the U. K. after the Warnock Commission reported, a new committee was set up on the use of fetal tissue, and in 1990 a third one was created on gene therapy. But in few other countries it led to the spreading of national ethics bodies which are standing bodies with a large mandate. All the Scandinavian countries have such committees, which exist also in France, Italy, Portugal, Luxembourg, Malta. Belgium is soon to have one and some of the Eastern and Central European countries have very quickly created similar bodies (Czech Republic, Slovakia, Romania, Hungary and Russia).

Moreover, assessing new technologies requires some methodology, while, everywhere methodology seems very empirical. Data on new reproductive technologies are not satisfactory; very few research studies have been in fact completed to provide a better knowledge of medical practice or of the view of patients. Although more studies are made apart from the bodies entrusted with the responsibility to examine the chosen reproductive technologies (at the University, in laboratories, or hospitals), there is often no way to inform those concerned about the availability of such studies.

Finally those bodies have very limited means to work. Members have their main professional activities and the staff is in most cases reduced to one person for secretarial business. Except in Denmark and Norway, they have no funds to promote research and very few committees can publish the result of their own works.

Decision Making

Given such conditions, is it then possible to reach the third pillar of biomedical legislative wisdom: the decision process? Surprisingly the answer is yes, but this supposes that awareness and assessment are sufficiently well balanced to bring a political will to decide and a clear politically acceptable view about what to decide.

In Denmark, Norway, Sweden and the U.K. the process has been accomplished. Various reasons could explain it: a great attachment of the public to their constitutional institutions; a strong tradition, especially in Nordic countries, to share moral and social values; also, a pragmatical method to give solutions to the issues concerned without thinking they will definitely close the problem.

In Germany and Spain, legislation was also passed but, in my view, they did not reach the same balanced position as those I have just mentioned. The German law, because it is a criminal federal law, only focuses on the question of the protection of the embryo and does not deal with assisted procreation. The Spanish law which concerns the two aspects of the issue is liberal, but has only been approved in Parliament by the majority party and it could be questioned whether in fact it would get the support of a large part of the population.

In Italy and Belgium, a political consensus will probably be difficult to obtain. Italy and Belgium also face the question of the competence of regional authorities in the health area which brings more complexity to a coherent legislative process.

Regarding France, the legislative proposals approved by Parliament in 1994 were probably very ambitious. But such an ambitious project certainly had some justification in the fact that reproductive issues as other main bioethics problems challenged the most fundamental concepts of the law.

Therefore it is not a good policy to always refuse looking at the reality as it is. Because biomedical advances permit treating the body before birth and after death, because it makes possible alteration of our genetic identity and the transmission of this alteration to our offspring, it urges us both to recognise new rights for the human person, the embryo and the human species and to define the limits of those rights. But, if this task should start immediately, it does not mean that we could at the same time expect answer.

What kind of conclusion can we draw in the field of harmonization from this applied philosophy of biomedical policy? A comparative view of the biomedical landscape is certainly of great utility because it can help to abolish misunderstandings. It can also show how far it is possible to live without any specific legislation or what are the consequences of this newly applied legislation. Finally it could bring us a clearer view of which areas of common interest should be dealt with internationally and those which should be left entirely to the decision of the country concerned.

Rapid measures should also probably be taken. I am thinking of the necessity to cooperate and to harmonize domestic legislations to prevent forum shopping when it could lead to violations of fundamental human right. A standing international research and information centre can also be a quite useful initiative to promote concerted studies and the circulation of information to professionals, the authorities and to the public.

Regarding Asia, what then can the European experience provide? First, reasonable hope; it appears possible to reach a balanced approach between the development of scientific knowledge on one hand and social regulation regarding the application of this knowledge to humanity and his environment on the otherhand. Second, trying to harmonise rules is a necessity each time fundamental human rights are concerned. However, the regional area (Europe or Asia) is preferably a better area to harmonise because of possible cultural factors than the universal one. Third in most fields, domestic cultural views will still largely influence the practice of new biomedical technologies. For example, it is possible that in Asia a purely legal approach to biomedical issues would not prevail. As far as the cultural standards of the country concerned are subject to normal evolution, it appears to me that it should not be a question to worry about.

We would like others to provide comments on juridical wisdom reminds us of an Irish proverb which gives good advice on wisdom, "A man becomes wise only through being conscious of what is happening to him when he is not".

Note: This is based on a paper presented at "1 Congresso International de Bioethica Mexico 3-6 Octobre 1994", organised by the National Bioethics Commission, Mexico.


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