Bioethics and the Impact of Human Genome Research in the 21st Century

2.1. Law of Technology, Technology of Law
pp. 10-13 in Bioethics and the Impact of Human Genome Research in the 21st Century

Author: Christian Byk (Secretary General, IALES, France)

Editors: Norio Fujiki, Masakatu Sudo, and Darryl R. J. Macer
Eubios Ethics Institute

Copyright 2001, Eubios Ethics Institute All commercial rights reserved. This publication may be reproduced for limited educational or academic use, however please enquire with the author.

This is obviously not to the first time in the history of the relationship between science and society that applications of science have been considered as risky or challenging to social values. However, as soon as human beings had limited power over their lives, they could more easily accept what they believed to be their destiny. Today modern human beings want to be in control. People feel that as soon as they are presented with a new biomedical possibility such as reproductive technologies, genetic diagnosis, or gene therapy, it should be available to all. Yet, at the same time the more complex the new techniques are, the less willing people are to accept the risks inherent in their application.

Faced with these various and sometimes divergent demands there is a call for legislation that would satisfy both the requests of the individuals as patients and the health care providers as researchers. Should, however, the lawyers and the policy makers take into account all the wishes expressed by the above mentioned groups without having a clear view of what ethical issue is really at stake today and what influence the law could play to solve such an issue?

1. To the new challenges of reproductive technologies and genetic engineering and applied it to human beings
A. In so far as we consider procreation to be the process by which the man and a woman to generate of spring, we have seriously to consider what kinds of roles such a process should obey.

The fact that this process has been constantly repeated since the human species appeared on of does not mean of course that procreation, which is therefore viewed as a natural process by some, does not follow particular rules. Although our scientific knowledge about human procreation is quite new, particularly regarding genetic issues, we know that procreation is governed by physiological roles as well as by the laws of genetics.

Anthropology has also made us aware of the existence of the role played by customs and symbols in the human societies. Procreation is therefore a cultural phenomena are which has its own social rules. But what about the legal rules? Does procreation need to be considered by the law? And, if the answer is affirmative, to what extent? In fact, the answer to this question largely relies on the ambiguous nature of procreation: both a private and a social act. Historically, the legal approach to procreation largely took into account this aspect in establishing the founding principles of family law, and lawyers have always been conscious of the importance of biology, sociology and symbolism in elaborating laws in this field.

Can the emergence of reproductive technologies that presuppose the involvement of physicians and biologists in the intracorporeal process of procreation, therefore be viewed as something essentially artificial as opposed to something which should be regarded as mostly natural? Certainly not. It does not mean, however, that the use of these technologies could not affect our representation of procreation and of human sexuality.

B. The risks associated with the medical uses of gene technologies

Genetic tests

Given the potential benefits to the individual, the possibility of predictive testing renders this genetic testing a powerful tool. But, as with any new medical tool, the quality of the technology and the professional competence of those who are using it are important. The two main reasons why the health authorities in many countries have assumed control are because many genetic procedures are classified as higher technology services whose use is generally the subject of regulation, and that such services could well prove very costly for the National Health System.

Gene therapy

A crucial distinction in gene therapy, from a legal and ethical point of view, is the distinction between a somatic gene therapy and germ line gene therapy. The former involves genetic modification that will not be transmitted to the offspring of the patient treated, while the latter kinds of modification are hereditary.

The risks of somatic gene therapy are limited to the person treated and are mainly related to the skills involved in mustering the techniques. In germ line gene therapy there are three main types of danger: it could adversely affect the entire constitution of the children developing from treated sperm or egg; the damage would be irretrievable; and it would extend to future generations. At present germ line gene therapy is not technically feasible, so the risks are essentially potential.

If we keep to our historical experience, the conflict between the medical community and society is today of the completely new dimension. There is indeed a great difference between what can be called the Galileo approach and the present approach. In the first case, Galileo's discovery and theory challenged the view that the Catholic Church, which was at that time the dominant authority and ideology, had of the organization of the universe. In the second case, the reactions expressed towards biotechnology in Western countries came from what we can call today the public and amongst it from various groups of citizens. It proves that, although our interest in biotechnology is induced by special insights, our awareness of its potential applications is greater, because people are now more easily able to imagine the potential side effects of this innovation then they could have imagined the impact of Galileo's theory on their everyday life. Another reason is that today public opinion and citizenship make a great difference to the way in which science and society issues are discussed. Consequently, what is at stake is no longer the institutionalization of the hegemonic system of social and ethical values, since it is the right of individuals or groups to press for their own views to be taken into consideration in biomedical applications.

Therefore as the use of reproductive technologies can affect our representation of procreation and the use of genetics our legal and on theological view on humans and the human species, there is a need for the law to ensure that what new technologies make possible will not cause fundamental damage to a balanced respect for biology, sociology and symbolism in regard to the image of the individual and the family, although this image should evolve.

Regarding gene technology, different types of fear may be identified. One is related to the technical aspects of the new procedures applied not only to the human being. Our increasing knowledge about the links between genes and diseases raises a number of questions. What shall we do with this new information? Who to use it? How are all we to protect the integrity of the individual person? Another type of fear is derived from the belief, shared by ordinary citizens, philosophers and other members of the intelligensia, that the new genetic techniques may affect human nature itself. What is at stake in this last example is an ethical value, a reference to the ontology of the human being, and not only practical issues such as the degree of safety associated with an innovation.

New problems, and sometimes more crucial ones, have appeared as science has evolved and it is necessary that legal rules take this evolution into account.

2. The need for and rationality of the law
When ethical issues are at stake in the law then takes in ethical meaning. It formulates society's view not of the technology itself but of what such technology symbolically represents. The way in which artificial reproductive technologies and genetic engineering are approached today depends on the strength of cultural attachment to social or biological parenthood. To change the law then implies that society has developed a strong and real will to do so. A common mistake would, however, be to see such signs of the need for change merely in the evolution of social habits or in a strong political event such as a political vote. In order to change the law, other criteria must be met, the most important of them being that the existing law can't be interpreted to cover the quantitatively new issues posed by technological innovation.

A. An operating concept of legal conservatism

A notorious French professor of law once wrote that the best thing he could ever teach to lawyers is it that they could never be as good as their predecessors. This opinion should not be misunderstood. It is not evidence of magisterial arrogance, but is simply the view that it is not the law, its concepts and the way to apply them, which has to be changed when faced with any kind of the innovation. Lawyers and, by their mediation, society, can find in existing legal theory the means to approach and regulate what appears as new. Consequently the application of the theory of legal conservatism does not imply that we should dispense with innovation.

This conservatism is even beneficial to the social acceptance of new technologies because it offers a ready made approach to any kind of innovation.

Methodologically, the experience of legal conservatism is also very interesting since, as it uses substantial legal principles to approach an issue, it also uses a large range of legal mechanisms to permit social discussion and to reach an legal solution that could be enforced afterwards through a system of legal sanctions. Contractual arrangements and court debating play as significant role in defining the legal nature of new technologies and the rights and obligations could be derived from their insertion in the legal judicial world.

However, the rationality of legal conservatism has some limits. The first limit is a time limit because it is time consuming process. The second limit is a space limit because our world no longer has closed borders, but constructs permeable borders from geographical and cultural components.

Therefore legal conservatism as a methodology has to address what may be called Internet symptoms. As it is possible to have it easy access to any type of information produced in the world that could bring answers to any specific issue as soon as such an issue emerges, the question is why should we use an old fashioned methodology which supports the application of concepts which appear related to specific and limited social content? In other words, the complexity of the legal context, especially in the field of technological law, makes less efficient, even less productive, the legal conservatism approach which is based upon a permanent search for consistency between pieces of legislation which have not been drafted according to this perspective. To rely extensively on this approach could lead to or worsen the deconstruction of the legal system.

B. The deconstruction of the legal system

The deconstruction of the legal system results from the combination of four phenomena. These are, first, the diversity of the interests concerned: this diversity has never been so broad. The interests at stake are no longer simply those which exert direct influence on individuals, that is those legally protected in relation to the relevant issue. But any kind of social interest for which individuals, groups, I should say lobbies, demonstrate in the public arena should also be considered. Second, the legal doctrine, I mean those lawyers influential in initiating new legislation, has lost its moral authority and has been replaced by the concept of expertise which in practice means a huge number of professional experts, each of them dealing with a specific field. Third, following the same logic, the legislator cannot now out act in splendid isolation; rather the legislation or the regulatory process must take account of the views of a variety of national and supra national bodies, and refer to binding rules rather then suggested guidelines, to fundamental principles as distinct from technical regulations, to public provisions rather than private ones. Fourth, there is great diversity in how and how far regulatory rules are enforced. There could be indirect sanctions in that a grant could be refunded or withdrawn; or there could be different legal sanctions, administrative, civil, criminal.

We can logically think of the steps of the debate including answers, assessment and decision making. Envisaging a three step process, professionals and lobbies would confirm their initiating role in the first step while they would be first or second class actors in this second step, depending on the role public authorities want to play in it. Finally, their role in a third step would largely depend on the type of rules that are supposed to result from this process. Obviously the most socially recognized rules are adopted by the legislators while regulations are often the task of government agencies and the guidelines a product of professional and academic circles. In the real world, things are in fact more confused and make difficult any attempt at rationalizing and adapting the process to new "democratic ways" because the strategies of different actors concerned are very often unclear, although there not at all reluctant to press such strategies.

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