pp. 26-34 in
Bioethics in Asia
Editors: Norio Fujiki and Darryl R. J. Macer, Ph.D.
Eubios Ethics Institute
Copyright 2000, Eubios Ethics Institute
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1.3. A Map to a New Treasure Island: The Human Genome and the Concept of Common Heritage
Judge Christian Byk, International Association of Law, Ethics and Science, France.
While the challenge of mapping and sequencing the human genome has considerably mobilized the scientific community (OTA, 1988; Bernot, 1996), the potential and possible uses of information deriving from this project have also raised fears and anxieties about risks of misuse of such information (Byk, 1994b). Such an attitude is however not specific to genetics. New scientific developments and further knowledge of the human being have always had a social and political impact.
Therefore what is new is not the social aspect of science and technology development but the will shown to consider it properly (with a view to reconciling the scientific community with public opinion) through public discussion and the elaboration of legislative policy, specially at the international level (Byk, 1992a).
This is the purpose of the Universal Declaration on the Human Genome and Human Rights adopted by UNESCO, the international organization in charge of science and education within the United Nations system. In fact, in this text all the principles that should govern research on the human genome (II) proceed from a fundamental declaration that the human genome is the common heritage of humanity (I) (IBC, 1996).
1. Declaring the human genome the common heritage of humanity
Choosing a Declaration as the appropriate instrument to rule on the human genome is an internationally meaningful approach. But more fundamental is the choice to ground this Declaration on the assertion that the human genome is the common heritage of humanity because this is the first time that man as such has been regarded as a comrnon heritage to be protected.
A. The declarative approach
Elaborating a declaration on the human genome has, at least, two very specific meanings. First, it is evidence that the authors of this document are inspired by the philosophy of human rights. Second, as a declaration is a non-binding instrument, it clearly shows that flexibility is an important requirement to facilitate the acceptance of the principles encapsulated in the text.
1) The spirit of human rights
Within the U.N. system, the most famous texts regarding human rights have been written in the form of a declaration. It would be enough to quote the "Universal Declaration of Human Rights" of 10 December 1948 (inspired in its wording by the French "Declaration des droits de l'homme et du citoyen" of 1789) but other texts - some of them are mentioned in the preamble to the genome Declaration - can also serve as good examples. However, in our view, the human rights approach has two other characteristics: the document declares principles; these principles are universal.
a) Rights can be encapsulated in other types of instrument than in a Declaration recommendation, resolution, bill, covenant, convention ... The formal advantage of the Declaration is that the Declaration does not create the right but simply acknowledges its exlstence. Let us illustrate this characteristic. When the Monarchy was restored in France in 1814 after the exile of Napoleon, the king granted his subjects a constitution and "rights" through a Charter. Therefore these "rights" were not for him the acknowledgement that "all men are born equal bearing the same rights" but they were the demonstration of his good will as King of France by the grace of God. Declaring rights also suggests that the declared rights are for all of us a kind of common heritage that we keep alive by using these rights and by being able to enrich their content and meaning (Cornavin, 1985).
In this sense, the principles which are set forth in the Declaration do not solely create new rights and should not solely be regarded as elements of the legal system. They are a basis for a discussion on the existing and conflicting relationship between scientific knowledge - the Community - and the individual. In particular, they serve as an incentive to initiate a discussion about the specific protection which is granted to the human genome: against misuse and abuse. However, the human genome is declared a common heritage which implies that while we all could be offenders as well as victims of such abuse, our offspring and the future generations will only be our potential victims (Knoppers, 1991).
Therefore, by declaring that there is a necessity to protect the human genome, we declare humanity, the human species, a heritage to be protected. Non-existing people are for the first time prevailing in rights over existing people. Can we consequently conclude that the concept of the declaration has been perverted? A declaration would suppose that as soon as a right is acknowledged, this right can serve as a support for the recognition or the protection of an individual. Here the question is: how could future generations and the human species as such be discussants in establishing the limits of the rights posed by the Declaration? We will come back to this important issue when we consider the concept of common heritage.
b) Another important element of the declarative approach, deeply related to the philosophy of human rights, is its universality which has further meanings than purely formal (Galloux, 1996).
First, the declaration is not simply national. This is the clear affirmation that those countries which have developed research programmes regarding the human genome are not the only nations concerned by the Declaration. It also means that whatever the differences in the cultural approach to the social issues raised by the knowledge acquired through the human genome might be, the principles set in the Declaration have the same value everywhere.
Second, the Declaration is not strictly international in the sense that it would aim at governing a specific techno}ogy or it would address a specialized scientific community. No, the Declaration has no frontier: it is designed for all groups, individuals, instances, wherever they are and whatever their social responsibility )
Third, the Declaration is timeless. Of course, its elaboration is related to the progress of gene technology and the awareness of some potential uses of the human genome. Of course, we can expect that the Declaration would be, in due time, modified. But as the text is dra~ed the principles are as true today as they always were and as they always will be in the future.
For all these reasons the strength of the declarative approach is very great although a declaration is a non binding document.
2) Flexible Law
Legally a declaration would not create any obligation other than moral to the states that subscribe to it. Here, this flexibility seems to present two advantages, two different aspects: passive and active flexibility.
a) Passive flexibility
This is the traditional meaning of flexibility. A state can approve the declaration but the authorities know that they can never be compelled to implement it: most of the UN members have accepted the Universal Declaration of Human Rights while only a few of them do actually respect such rights This traditional meaning often has a few advantages.
First, it reinforces the moral leadership of the principles encapsulated in the declaration. In the case of a binding instrument, although they can be universal, the provisions of the covenant will mainly be the affair of the commmunity of member parties. The principles which are declared do exist as such. The fact that they are not legalty binding or that some states would not accept the declaration creates a situation which is more difficult for the states concerned than for the declaration itself.
Second, in a pragmatic approach, it would facilitate the adherence to the declaration of those states which would have difficulty in satisfying the implementation of the principles 100% but which really intend to go further in this way.
Third, a declaration can be adopted more easily than a convention. I do not allude only to the political aspect but also the legal one. Regarding the draft Declaration on the human genome being drawn up by UNESCO, the process implies a vote by the General Conference. A convention would imply further developments by national authorities such as signature and/or ratification. Domestic legislation would also be necessary in some cases to implement the obligations created by the convention.
The Declaration on the human genome and human rights benefits from all these advantages but the frame of the document also encourages some kind of active flexibility b) Active flexibility
When initiating its work on the human genome and human rights, the International Bioethics Committee thought that the idea of setting up a binding instrument should also be considered (IBC, proceedings)
This choice explains why the Declaration does not deal only with principles but also with the way to give them life. Two sections are indeed devoted to this task. The first one addresses the promotion of the principles encapsulated in the Declaration and seems very mandatory for the states. Two areas are mainly designated: "States shall undertake to promote ... teaching and research concerning the ethical, social and human basis of ... human genetics" and "States shatt undertake to encourage other forms of research, training and information conducive to raising awareness of society and atl of its members oftheir responsibilities...".
The second precisely concerns the implementation of the Declaration: "States shall undertake to ensure that the principles ... are respected" and "promote ... their ... application" while "the IBC of UNESCO ... shall make recommendations ... concerning foltow-up".
Furthermore, we can observe that two other sections respectively entitled "Conditions for the exercise of scientific activity" and "Duty of solidarity" have nearly atl their principles beginning as follows: "States shall ensure, provide, foster or recognise ...". This last section also contains articles on international cooperation.
Therefore, the Declaration on the human genome and human rights seems to be more precise on the implementation of its provisions than the European Convention on biomedicine of the Council of Europe (C. d'Autume, 1996). How far is this assertion related to the concept of common heritage which is a key concept of the present Declaration? This is a question that we should now examine.
B. The concept of common heritage
Although not completely new (Dupuy 1985, Kiis 1983, Rigaux 1979), the concept of common heritage is for the first time applied here to the human species as such which certainly poses new questions, in particular for lawyers.
1) The history of the concept
a) The concept of common heritage can find some roots (Byk, 1992-2) in the old legal concept of "res communis". Indeed essential characteristics of the concept of "res communis" are used in the concept of "common heritage": that is the principle of no ownership and the fact that the things concerned are to be devoted to a common utility. But the concept of "common heritage" is more complex and supposes a set of regulations to govern the things for the administration of which such a concept was developed.
b) After the Second World War several international treaties used the concept of common heritage in various fields. The treaty on the Antarctic of 1 December 1959 can be considered as the first international instrument of this type although only states which are parties can enjoy settlements on this "common territory".
For other treaties the right to benefit from a natural resource can clearly be enjoyed as soon as a state has the necessary scientific and economic means. We could quote the 27 January 1967 treaty on extra-atmospheric space, the 18 December 1979 agreement ruling activities on the moon or the 10 December 1982 Montego Bay Convention on Ocean Deeps (Dupuy 1985).
These conventions also give an interesting view about the possibility of managing such a heritage on behalf of humanity. Whereas the management of natural resources by the different states was the only rule when the concept of common heritage began to be applied, the 1982 Montego Bay Convention opened the way to an alternative. It created an international board with the authority to fulfil the objectives determined by the treaty for the common good of humanity.
However, a question is left: can such an authority be completely independent from the states who appoint its members? Can these members ignore the national interests which will sometimes be opposed to the absolute safeguard of natural resources? In general a common heritage status would imply that no private property should be established, that some social utility should be the aim of any utilization and that such utilization should only be made according to specific ways (Rigaux, 1979). But evolution in the practice of common heritage can show that the concept can also be used to facilitate industrial exploitation of natural resources by the most advanced states. What then can we draw from this experience for the human genome?
2) The model of common heritage of humanity applied to the human genome
The definition and characteristics of the human genome are in some ways very different from other components to which the concept of common heritage has been applied in the past. Therefore it raises new legal issues.
a) Ambivalence and difficulties in defining the human genome.
The first major difference with other components such as the oceans, space ... is that those components cannot be appropriated. They are common properties. In the case of the human genome although no property rights can be claimed, subjective rights exist because, as the draft Declaration states, "The genome of each individual represents a specific genetic identity" (article 2a).
Another remark concerns the substance of those subjective rights. Because "Individuals cannot be reduced to their genetic characteristics" (article 2b), no specific new right provides a general protection for the human genome of an individual but this protection can only be granted through the protection of individual dignity and rights (article 2c - "Everyone has a right to respect for their dignity and for their rights regardless of their genetic characteristics"). Subjective rights are nevertheless created in particular circumstances when an intervention could affect an individual's genome (article 6), when it is necessary to prevent discrimination (article 7), to protect confidentiality (article 8), or to guarantee a just reparation resulting from an intervention on the human genome (article 9). Even in those circumstances, we can note that, with the exception of article 9, all the other principles are applications, in the field of the human genome, of existing principles: the principle of autonomy (the right to free informed consent), the principle of equality between all men (the right not to be discriminated against) and the respect for privacy (principle of confidentiality) .
Finally, is this difference in contradiction with the concept of common heritage ? We could answer negatively by mentioning the fact that a cultural monument can be privately owned or be the property of a state, and, nevertheless, be proclaimed as a common heritage of humanity. But the appropriate answer can be found here in article 1 of the Declaration which says that "The human genome is common heritage of humanity. It underlies the fundamental unity of all members of the human family, as well as the recognition of the inherent dignity of each of its members" .
The subjective rights afforded to the individual have, therefore, two aims: to underlie the fundamental unity of all members of the human family and to found the recognition of the dignity of each member. Which should prevail? The declaration, which was broadly revised in the December 1996 version to reduce this potential conflict (a former text considered the protection of the individual as a means "to safeguard the integrity of the human species, as a value in its own"), does not tell. There lies the ambivalence of the concept of common heritage applied to the human genome.
The difficulty of the definition is that indeed there is no definition of what the human genome is. We do not ask for a scientific definition but we would have liked to know what reality is covered by the qualification of common heritage of humanity. In short, all we learn is a tentative definition of the individual genome (it represents the specific genetic identity of the individual) but none of the human genome except that "(it) is common heritage of humanity".
Conversely, we learn what could infiuence the human genome "which by its nature evolves, is subject to mutations ... contains potentialities that are expressed differently according to the education, living conditions, food, state of health of each individuat ... " (article 3)
b) Legal problems
The major problem for lawyers is how to implement a system which could possibly protect the human species as such. Methodologicatly, the declaration is elusive on this fundamentat issue. (Does it mean the Dec. 1996 version has given up this point?) Two ways are used to set up potential protection.
One consists in transferring to the states the duties and responsibilities to guarantee the effectiveness of the protection (see sections D to G of the Declaration). It is particularly interesting to note that even in the case of intemationat cooperation, the UNESCO Declaration onty relies on states' actions and never refers to the possibility of an intemationat body acting in this field. The intervention of the IBC of UNESCO has onty been made possible to "disseminate the principles set out in this Declaration" by means of recommendations or advice.
The other way is using the technique of subjective rights. The role of protecting the human genome is given to individuats claiming the protection of their own rights. Existing rights are only applied and if necessary extended to the human genome but no specific new rights are proclaimed. Therefore this methodology seems to forget the originality of the concept of common heritage. It seems that the authors of the Declaration have been afraid of the consequences of the recognition of the human genome as a common heritage. It is particularly true when the Declaration states that the genome is fundamental but that the individual's personality cannot be reduced to the genetic characteristics. If the genome is not all of or a substantial part of the individual's personality, why is the genome so fundamental for the human species? (The Dec. 1996 revised version does not use the word fundamental any more). The answer to our methodological question can probably be found in the substantial principles recognised by the Declaration to govern research and interventions on the human genome.
2. Protecting the human genome
The attitude of the public towards the tremendous developments made in the field of the human genome during the 90s is very ambivalent. It encompasses both a strong desire to benefit from the medical applications derived from the knowledge acquired via the human genome project and also a recurrent fear and anxiety that "manipulating the human genome" is in some way "playing God" (Knoppers, 1991). The international implementation of the human genome project which was technically (and financially) very successful, also contributed in a sort of political appraisal of the question (US Congress OTA, 1988).
It appears then quite logical that the risks raised by this project should also be assessed and recognised internationally (Byk, 1992a). This is the reason for the initiative taken by UNESCO to substantiate in a universal Declaration the founding principles of the protection of the human genome (IBC proceedings 1992).
As is recalled in the prearnble of the Declaration, the role of UNESCO is to advance "through the educational and scientific and cultural relations of the peoples of the world, the objectives of international peace and of the common welfare of mankind for which the United Nations Organization was established and which its Charter proclaims". It means that UNESCO, while acknowledging the importance of science and technology, should promote them with the objective that they should benefit the human species in respect of the human rights values proclaimed in international charters.
Consequently the preamble recognizes that "research on the human genome and the resulting applications open up vast prospects for progress in improving the health and well-being of individuals and humankind as a whole" but also that such "research should fully respect human dignity and individual rights, as well as the prohibition of all forms of discrimination based on genetic characteristics". This balanced approach is an evidence that the human genome issue is a key point of the public debate on biomedicine. Two fundamental principles confirm this view while different provisions promote the scope of the protection of the human genome.
A The two founding principles and their adjunct rules
1) The protection of the human genome is not simply an issue for researchers but for society as a whole
Because the risks it can raise are not limited to medical or biological risks that could be solved scientifically but interfere with ethical and social issues, research in biology and genetics entails special responsibilities as regards the "meticulousness, caution (and) intellectual honesty" required of researchers (article 10). This particularity does create specific duties and responsibilities not only to researchers (we will see below) but also to the states that shall recognize the value of promoting, "an open international debate, ensuring the free expression of socio-cultural, religious and philosophical opinions" (article 18). This means that in a democratic society the state has to provide the means of good information for the citizens in order to allow them to participate in some way in the decision process
In proclaiming these two principles, the Declaration asserts that research in biology and genetics and its derived applications are a political issue that has to be ruled according to social and cultural values. Two values encapsulated in the Declaration define quite well the balanced approach which has been chosen to protect the human genome.
2) The values expressing the philosophy of the Declaration
The Declaration adopts a positive perspective towards research and its applications. It is legitimate but should benefit each individual. Article 4b explains that scientific progress is a right for each individual ("Benefit ... should be made available to all"). This statement, which derives from the belief that medical advances are elements of a better well-being, could certainly surprise those who have been challenging the equation between new scientific development and a better society or individual well-being. Legally it is also very interesting because it goes a step further in the recognition of the access to health as a human right. With this provision it is not only access to the existing health system which becomes a right for the individual but also access to the advances in biology and genetics.
In continuity with the previous article ("... with due regard to the dignity and rights of each individual"), article 5 states that "No research applications should ... prevail over the respect for human dignity and human rights ...". More positively we can say that they are contributing to the completion of human rights and human dignity. Proclaiming such values would however be a bit incantatory if a strict framework for the protection of the human gend/me was not also proposed.
B The framework for safeguarding the human genome
Protection to guard the human genome relies on two categories of measures. The first refers to the traditional protectioii granted to the human body. The second deals with the obligations that the present research in biology and genetics has to satisfy in order to offer the minimum of guarantees required for the protection of the human being and the human species when the new technologies are applied to them.
1) Human genome and the protection of the human body
The traditional protection covers the integrity of the person and his privacy with particular provisions regarding vulnerable persons or groups.
a) General protection of integrity and privacy
Integrity: Article 6a provides that "Research, treatment or diagnosis affecting an individual's genome shall be undertaken only after rigorous and prior assessment of risks and benefits pertaining thereto ..." and (art. 6b) "the prior, free and informed consent of the person concerned shall be obtained ... ~or) ... from his or her representatives, guided by the person's best interests ...". This provision sets the limits of any intervention that could affect an individual human genome: this intervention should have research, therapeutic or diagnostic purposes. However the text, contrary to the European Convention on Human Rights and Biomedicine, does not place any prohibition, especially regarding germ line gene therapy. It only suggests the application of two guiding principles: the principle of precaution which implies a rigorous and prior assessment of risks and benefits and the principle of autonomy which supposes the prior free and informed consent of the person concerned or of his or her representatives when needed. But the text also refers to national regulations and international guidelines.
As a consequence of the protection due to the human body, article 9 states that "Every individual has the right to a fair compensation for any injuries sustained as a direct and determining result of an intervention affecting his or her genome". It is not clear, however, if such a right is based on a non fault system although the explanatory memorandum could give that impression. But finally, the implementation of such a right is left to domestic legislations according to the specificities of their economies and health systems.
Privacy: Article 8 assures that "Genetic data associated with a named person and stored or processed for the purposes of research or any other purpose must be held confidential and protected against disclosure to third parties". Although data protection rules are not new (Byk 1994), the importance of such a rule in the field of the human genome is particularly obvious with regard to two aspects. First, genetics is revealing new types of information which are particularly sensitive for the privacy of the individual, its present and its future, what is certain and what potential. Second, the information collected through genetic technology does not concern only an individual but members of his family who are genetically related to him. So the consequences of any disclosure to third parties could be disastrous, creating in some cases real discrimination. Some persons or groups seem to be even more vulnerable to such discrimination and consequently deserve specific protection.
b) Specific protection of the vulnerable
Article 7 provides that "No one may be subjected to discrimination based on genetic characteristics that is intended to diminish or has the effect of diminishing human dignity or impairing the right to be treated equally".
Although article 7 protects all individuals who co.uld be discriminated against on the basis of genetic characteristics, it could also allow the emphasizing of the risk of discrimination towards specific groups of population sharing similar genetic characteristics. However, the wording of the text only prohibits discrimination which aims to injure or has the effect of injuring the recognition of human dignity or the enjoyment of personal rights on the grounds of equality. It would therefore be possible to take into account some genetic traits when it is for the benefit of the person and in the interest of the common good.
As a rule not to discriminate will not be sufficient to protect those who are de facto handicapped by genetic disease, article 14 makes it a duty for the states to "ensure respect for the duty of solidarity towards individuals, families and population groups that are particularly vulnerable or affected by disease or disability linked to anomalies of a genetic character". It confirms that human rights, in the health field, also imply positive actions from the states. That is also the meaning of the different measures proposed as a framework to regulate research on the human genome and its applications.
2) Promoting a regulatory framework for research and medicine
That is the purpose of the definition of research on the human genome given by the Declaration as well as of different provisions concerning the rights and obligations of researchers.
a) The definition of research
Although article 4 views research as an element of the freedom of thought, (it is also an essential activity of our industry, i.e. our capacity to develop new devices) this text gives us the objectives of research: "the progress of knowledge" and it should "... relieve suffering and improve the health of individuals and the well-being of humankind as a whole". For many researchers the first definition would have been enough to define research because this activity could only bring us to new objects of knowledge. But for the social acceptance of research, the community demands that research should have anthropocentric objectives and applications. And our concern for ethics implies that those applications should be highly moral.
It is regrettable in our view that we impose too much of a burden on research. The causes of human suffering do not have their origins only in diseases or disabilities. Most of our suffering has its origin in human activity which is also in some way influential on the development of certain diseases or disabilities. Therefore we should rely more on ourselves than on scientific research understood as something completely separated from the social world That is precisely why the whole community should ensure favourable intellectual and material conditions for researchers.
b) Rights and obligations of researchers (the section is now entitled: "Conditions for the exercise of scientific activity")
Article 11, which states so, appears then perfectly justified in its first sentence, the reference to the goals of research already mentioned above being irrelevant for us as we have just explained.
We will be less critical towards article 12 because the obligation to "provide the framework for the free exercise of research ... with due regard for democratic principles, in order to safeguard the dignity and rights of the individuals, to protect health and the environment" is directed to states. It means that not only researchers but society as a whole is concerned by adopting such a framework. Therefore the democratic principles and the respect for the dignity and rights of the individual to which it refers should also be, in a balanced approach, those of the researchers. The limits that could be imposed on them by application of the principle of precaution would concern the potential effects of their work on health and the environment because research is not simply the search for knowledge per se but also the respect for scientific methodology.
3. Concluding remarks
The attempt to proclaim the human genome as a common heritage of humanity in an international declaration presents some real advantages. Socially, it is an effort to take into consideration two different tendencies - the revolution in medical practice and in the field of research derived from gene technology, and the fear of a "Brave new world" in public opinion - and to try to reconcile them. Juridically, it is an incitement to apply the principles of human rights to new fields and even to develop a new step in the development of such rights. Politically, it is a good opportunity for the international (governmental) community, in particular UNESCO, to demonstrate that appropriate replies to new problems can be elaborated with effficiency.
However, the project also deserves some major criticism. First, while protecting the human genome, it emphasizes broadly the importance of such elements both for individual and human identity. Therefore there is a risk of making genes sacred (although the December 1996 version of the text considerably took this issue into account). Second, the dedaration does not clearly choose or propose a methodology to enforce the concept of common heritage. Third and consequently, the risk is great that the Declaration would serve as a flag for principles and not an instrument to be used for or to guide a practical approach to genetic issues.
The reality of this risk will largely depend on the capacity of those who have been the mentors of the elaboration of the declaration - mainly the States through UNESCO and its International Bioethics Committee - to resist further requests for international regulation so long as the declaration has not found a legal and moral justification.
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*The Association is a member of CIOMS and an international and multidisciplinary forum for discussing policy approaches of ethical and legal issues posed by the development of science. The International Journal of Bioethics is the bilingual (French/English) quarterly review of the Association, Edt. A. Lacassagne, 162 avenue Lacassagne, 69424 LYON CEDEX 03.
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