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Saturday, 12 October 2013

“Human rights and genetic manipulation”


*Il s’agit d’un article rédigé à la demande du professeur Antonio CASSESE, Président du Tribunal spécial pour le Liban, et qui a été édité par les Editions « Oxford Publications », en 2012, avant son décès.  L’article fait partie du chapitre V relatif aux problèmes globaux en besoin d’une régulation sur le plan international et dans le cadre de la publication globale intitulée :


THE FUTURE OF INTERNATIONAL LAW-- TOWARDS A REALISTIC UTOPIA
A CONTRIBUTION TO THE SHAPING OF THE WORLD COMMUNITY’S LEGAL FOUNDATIONS FOR THE DECADES AHEAD.

 Realizing Utopia The Future of International Law

Introduction

There has been a rapid increase in scientific and technological advances in the areas of genetics manipulation and genetics engineering or biotechnology[1] in the past thirty years and there is still a great deal that remains to be discovered.
Although this fast growing technology mainly applied to medicines and foodstuffs was promoted by its potential effect on welfare and growth in the field of life sciences and economy, it poses considerable risks (biodiversity, health of the human beings, environment, etc) on which researches are still scarce and thus regulatory challenges both in regional and international law. The first question we might have in mind is what was the reaction of international law to those challenges?
The evaluation of the impact of biotechnology on international law requires a plurality of approaches and different levels of inquiry, depending on the fundamental legal, social and cultural distinction between human genetics resources and other genetic resources (plants and animals), even if the gene of animals and human beings are scientifically similar. 
I. A fragmented and pluralistic biotechnology’s regulation looking for its universality
Torn between conflicting tendencies during the negotiation of many instruments through the appropriate mechanisms of competent international organisations (the UN, WTO, FAO, WHO, Council of Europe and UNESCO) the international law appeared fragmented in its treatment of genetic resources and biotechnology in general.

While the freedom of trade managed to impose its universal values and its permissive regulations through many instruments[2] developed under the auspices of what became the World Trade Organization (WTO), the UN Convention on Biological Diversity (CBD) tried first to resist to the attraction power of the WTO on this above questions [3] and was followed by the FAO International Treaty on Plant Genetic.[4]

Except when the principle of “equitable sharing of benefits” proclaimed by the CBD was confronted with the practices left to the freedom of negotiation of agreements between the private companies and the developing countries, the presumption that these treaties should be implemented in a mutually supportive and consistent manner with the WTO agreements was not problematic for the majority of States.[5]

The elusive language of “sustainable development” as a common goal of all these treaties was used as an argument for the presumed compatibility in addition to the fact that access to genetic resources is subject to the sovereign rights of States over their natural resources whether by reference to the general international law or by reference to the treaties of the UN system and WTO.

This above trend was also used by analogy to regulate the exploitation of human genetic resources in order to open this new “market” for competition and production or supply of biomedicines.[6]  The dilemma brought by this extension of technological advance to the human genetic resources was the unsolved question of compatibility of that trend with the human rights instruments, built on the concept of human dignity.[7]
 
Although stem cell research, genetic testing and cloning, taken as examples of progress in the life sciences, may be presented as giving human beings new power to improve health and to control the development processes of all living species, the concerns about the social, legal and ethical implications of such controversial progress have led to one of the most significant debates of the past century, in particular in the field of human genetic resources (the bioethics debate). 


However, the reply to challenges of misuse of human genetic resources was neither unified nor uniform in terms of normative action and the international law did not succeed in providing a universal mandatory framework coherent enough to face the current issues identified by the bioethics studies[8].

The only legally binding instruments (hard law) dealing with such issues are regional rather than universal. It consists of the Council of Europe Convention on Human Rights and Biomedicine and all its additional protocols dealing with research, cloning, transplantation of organs, genetic data and the related technology [9],without prejudice to the European Community Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions.  

It would seem difficult to advance much further on the subject of binding international instruments in the field of bioethics at the beginning of the 21st century in the absence of consensus on the relevant issues.

For example, there was no consensus on criminalising cloning on a global level, and the attempt of the United Nations to produce hard law in the field of international criminal law was unsuccessful. After the failure to adopt any draft convention on cloning owing to lack of consensus on the scope of such an instrument (regarding therapeutic cloning or reproductive cloning), the United Nations General Assembly adopted resolution in March 2005 to call for a ban on all forms of human cloning and on genetic engineering techniques ‘that may be contrary to human dignity’[10]. That resolution also refers to the UNESCO’s instruments on this item. In addition to the UN resolution, the corpus of this “emerging universal law” dealing with the human genetics mainly consists of:

-        The Universal Declaration on the Human Genome and Human Rights[11] drafted by the International Bioethics Committee of UNESCCO (hereinafter referred to as IBC), which was adopted by the UNESCO General Conference in 1997 and endorsed by the United Nations General Assembly in 1998;
-        The International Declaration on Human Genetic Data [12] adopted by the General Conference of UNESCO on 16 October 2003; and
-        The Universal Declaration on Bioethics and Human Rights, which was adopted at the General Conference of UNESCO during its 33rd session (17 October 2005).
The UNESCO Declarations constitute a first, but very important, step in the pursuit of the universal regulatory goals in the field of biotechnology, even if they are considered as non legally binding instruments and thus described as “soft law”. [13]  

In this regard, the purpose of this paper will not be to review in details[14] the provisions of that soft law or to identify all the conditions necessary for the process of creation of new customary rules of international law in each field of the biotechnology and life science.

This challenge (effects of the Declarations) will depend on the practices of the States and all the decision-makers of international law, including the UN specialized agencies, in particular UNESCO and its monitoring system based on reports to be presented by the Member States on the implementation of the declared legal and ethical principles to which they are addressed.

My focus will be on the priority which should be given de lege lata and de lege ferenda to the
criteria proclaimed by both the Council of Europe’s conventions and the UNESCO’s “Declarations” as an instrument of choice dedicated to establish certain basic principles and standards on which there is broad consensus among the members of the international community and that can serve as the basis for internationally acceptable rules and regulations capable of being incorporated into national legislation.

II. Incorporation of the Biotechnology’s regulation into the international law of human rights

Both the title and the content of Council of Europe’s instruments or UNESCO’s Instruments as described above, are very indicative to the link between all the normative standards regulating the research or the exploitation of human genetic resources and the human rights instruments[15].

The general approach of the decision-makers of those above instruments sought to globalize the benefits of technical progress and its use in a way that is compatible with respect for human rights– which confirms what Albert Einstein put more simply when he said: “[s]cience is a powerful instrument. How it is used […] depends on mankind and not on the instrument.”

To ensure that humans are not dominated by their tools, the legal instruments of UNESCO refer systematically to human rights instruments. As a result, this “self-referential” mechanism organises the scope of the new ethical -legal normative system regulating the use of human genetic resources, which appears clearly to be rooted in the international human rights law.

This trend is illustrated by two proclamations relating to the cultural diversity and to what we could call “bio-rights” in order to ensure better compatibility between the “universal” freedom of research or trade, applicable to human genetic resources, and the universal human rights law as redefined and extended by the Council of Europe conventions and the UNESCO’s Declarations to specific science cases of biotechnology.

Concerning cultural diversity, Article 12 of the UNESCO’s UDBHR states that “such considerations [relating to pluralism of ethical views[16] or to the principles of UNESCO’s Declaration on Cultural Diversity of 2001] are not to be invoked to infringe upon human dignity, human rights and fundamental freedoms, nor upon the principles set out in this Declaration or to limit their scope”.

This proclamation, based on the need for universal shared position, is completed by an other proclamation stating that “The interests and welfare of the individual should have priority over the sole interest of science or society” (Article 3 of the UNDBHR), similar to  Article 2 of the Ovideo Convention of Council of Europe, asserting the primacy of human being.[17]

However, the added value of the Council of Europe and UNESCO’s instruments resides in the emergence of a set of “bio-rights” derived from the subjective rights as recognized by the two UN international Covenants (Covenant on Civil and Political Rights and Covenant on Economic, Social and Cultural Rights) as well as the Universal Declaration of Human rights to which UNESCO’s Declarations referred expressly for its concrete application in that specific field.

Admittedly, the Council of Europe Convention on Human Rights and Biomedicine as well as its additional protocol relating to biomedicine research pave the way for reconciliation between the freedom of scientific research and the of dignity the human being by highlighting its roots in international human rights law.  It should be noted also that the Declarations of UNESCO (on the human genome and on human genetic data as well as the one on Bioethics in general) reaffirm the principle of freedom of scientific research and aspire to capture the universal dimension of the bio rights it identified while stressing that “such research and developments occur within the framework of ethical principles set out in this Declaration” (Article 2(iv) of Universal Declaration on Bioethics)[18].

Therefore, it is recognized that freedom of research on the human genome or any other elements of the human body and the resulting applications open up vast prospects for progress speculating on the tremendous potential of genetic engineering to modify human living, provided that the individual rights of each patient is respected, in particular the i) right not to be subjected without free consent to medical or scientific experimentation ii) the right to the highest attainable standard of physical and mental health and associated rights to health care;
iii) the right to protection against arbitrary interference with privacy or with the family and iv) the right to enjoy the benefits of scientific progress and its application, etc.

In other terms, subject to the respect of the principles of free consent, privacy and confidentiality, and without prejudice to the principle of non–discrimination, and a risk assessment or prior assessment of the potential risks and benefits pertaining to the intended biotechnological project having been undertaken – all research, treatment, genetic test or diagnosis affecting an individual’s genome can be undertaken and applied in a manner allowing the decision-makers concerned by such projects to benefit from the protection of the international law.

Furthermore, the collection, processing, treatment, use and storage of human genetic data, in accordance with Articles 5 and 12 of the Human Genetic Data Declaration, are permissible only for purposes of diagnosis and healthcare, including screening and predictive testing, and medical and other scientific research, without prejudice to the purposes of forensic medicine, civil, criminal and other legal proceedings, taking into account the conditions spelled out in Article 1(c) of the Declaration.

Consequently, any biotechnological project on human genetics should be compatible with the principles dealt with in the UNESCO declarations in such a way as to render indivisible the three generations of human rights instruments, if one considers its reference to vulnerable persons ( individuals , families and population groups who are particularly vulnerable to or affected by disease or disabilities of a genetic nature) and the sharing of the benefits of scientific research and its provisions relating to social responsibility with respect to the right to health and to development[19].

However, the fact that all the above instruments are rooted by substance in the international human rights law brought to this new biotechnical regulation the tensions which might occur in case of problem or conflict between the freedoms and subjective rights of the patients or the individual concerned, since the reference to human rights instruments could not itself resolve all of the problems of interpretation.

Therefore, the task of seeking balance the various rights in order to ensure the compatibility between these two branches of law cannot be addressed on the basic of generalities, but will require in depth analysis of different fields of application and areas where biotechnology plays an important role,

To this regard, the instruments of the Council of Europe and UNESCO refer explicitly to the principles applied by the international law of human rights and go further to establish procedural principles in order to give the States the guidance for solving such conflicts between different human rights holders[20]. For example, article 27 of the Universal Declaration on Bioethics provides that “If the application of the principles of this Declaration is to be limited, it should be by law, including laws in the interests of public safety, for the investigation, detection and prosecution of criminal offences, for the protection of public health or for the protection of the rights and freedoms of others. Any such law needs to be consistent with international human rights law”.

We are very far from the proclamation of “underogeable bio-rights”, even if the issue of legality of any limitation to any subjective right, such the right to life, the right to privacy and the right to consent or not is left to the hard law and to the customary law, without prejudice to the importance of concepts of human dignity and heritage of humanity as emerged from the instruments of Council of Europe and UNESCO.

III. The reconfirmation of the human dignity as fundamental legal concept and as standard constraining the tendency for permissive actions in the manipulation of human genetic resources

 
Recalling Article 1 of the Universal Declaration of Human Rights (UDHR)[21], the preamble and Article 1 of the Oviedo Convention (Council of Europe) refer to the protection of “dignity and identity of all human beings” as well as the preamble and Article 1 of the Universal Declaration on the Human Genome or Article 2 of the Universal Declaration on the Bioethics and Human Rights, aimed to “to promote respect for human dignity and protect human Rights”. It is important to note the juxtaposition of the term “dignity” to the term “human rights” in those instruments. 

Looking at the value of respect for human dignity through the lens of bio-rights as referred to in the Council of Europe and UNESCO’s instruments has produced a very important debate on the concept of dignity.

In the well known case of Netherlands v European Parliament and Council, Advocate General Jacobs stated that human dignity is ‘perhaps the most fundamental right of all, and is now expressed in Article 1 of the Charter[22]’. However, for David Feldman, dignity is not a right per se but a value underpinning all fundamental rights and constitutional principles[23]. In a rather similar vein, Bertrand Mathieu suggested that safeguarding dignity can be best viewed as a sort of meta-value or “matrix” providing a guiding pathway for the configuration of other specific rights and duties or their reconciliation[24].

Finally, Roger Brownsword completed this interesting debate by identifying two different roles for the concept of dignity: in the first, the idea of dignity acts, under a rights-driven ethic, in support of individual autonomy (human dignity as “empowerment”)[25]   and, in the second, it acts, under a duty-driven ethic, as a constraint on autonomy (human dignity as “constrains”). [26]

This debate was intensive when permissive actions to legitimate the euthanasia where linked to the “right to die in dignity” or when actions where proposed for the use of Embryonic Stem Cells in therapeutic research (so called therapeutic cloning) or when paragraph 2 in Article 5 of Directive 98/44/EC on the legal Protection of Biotechnological inventions admitted that “an element isolated from the human body or otherwise produced by means of a technical process [….] may constitute a patentable invention”. Furthermore, the failure at the United Nations to achieve a treaty consensus against cloning was attributed in part to the tension between human dignity as empowerment and human dignity as constraint. [27]

Whatever Scholars argue whether human dignity can be properly viewed as a fundamental right (as opposed to a constitutional principle or objective) or as empowerment or as constrain for the right-holders, it is a fact that the hard law of the Council of Europe was gradually supplemented by other reference to dignity in the additional protocols which deal in detail with the prohibition of human cloning[28] in order to justify this ban. Even in the EC Directive on the Legal Protection of Biotechnological Inventions, the need for patent law to respect dignity is emphasised. (Article 5.1)[29].

Such use of the concept of dignity as a constraint for reproductive cloning has also many objective justifications derived from the UNESCO Declarations admitting a real dualism of the concept of dignity. In that sense, the Declarations of UNESCO were in the vanguard of attempts to forge a worldwide bioethical consensus in order to “moralize” international trade and to ban human reproductive cloning as clearly proclaimed by Article 11 of the Universal Declaration on the Human Genome and Human Rights[30] or as stated in its Article 2 (b) “that dignity makes it imperative not to reduce individuals to their genetic characteristics”.

Those of UNESCO’s declarations that state that “a person’s identity should not be reduced to genetic characteristics, since it involves complex educational, environmental and personal factors and emotional, social, spiritual and cultural bonds with others and implies a dimension of freedom”[31] seek to affirm the reality of the dualism in the legal concept of the human being, considered both as an individual and as part of the human family, to which the concept of dignity is attached and introduced in law in order to reconcile the international public order with human rights. What is protected here is ‘humanity’, construed as both the species and the family. But the concept also covers the indivisibility of the human being, who should not be reduced to separate aspects of his or her identity.

This means that “dignity” as a legal standard for the concept of public order is part of an interpersonal relation that modifies the scope of the principle of consent (for example, the free will of any individual seeking to be cloned, even with his or her own consent).

It is not the first time that the international law has imposed such a restriction on the principle of individual autonomy. For example, Article 11 of the Geneva Protocol prohibits experimentation on the civil population even if a member of the population has given his or her consent to such experimentation. The same could be said about the prohibition of slavery. 

In fact, the public order nature of dignity occasionally makes it possible to conceal in legal guise an ethic similar to that of the notion of accepted standards of behaviour or of decency, the meaning of which is both variable and imprecise in any legal system.

However, this analogy is limited in that dignity cannot be reduced to a simple situation of fact, and implies a duality that is central to its value. The dual nature of the principle of dignity is illustrated by the fact that the rights arising from it must be made compatible with other rights and freedoms. On the one hand, the subjective right is what gives value to the dignity and personality of the individual. On the other hand, human dignity, the matrix principle underlying all human rights, seems in the legal instruments of Council of Europe and UNESCO to go beyond the subjective rights arising from it, to merge with the notion of an international public order governing humanity as a whole or to establish a normative standard in which freedom and subjective rights can be reconciled. Council of Europe and UNESCO’s legal discourse has thus transformed human dignity into a legal standard modifying the concept of international public order, which is at the origin of the limitation on both scientific power and the principle of the autonomy of the patient’s will.

IV. The timid emergence of the concept of the human genome as part of the common heritage of humanity


In comparison with the instruments of Council of Europe in this field, the added value of the UNESCO declarations is the linkage between the concept of the common heritage of humanity and the of human dignity and as made right at the beginning of the Universal Declaration on the Human Genome and Human Rights, where the concept of “heritage of humanity” reflects a deep change in the approach to human dignity proclaimed for humanity as a whole.

This idea is reflected by Article 1 of the Human Genome Declaration, which proclaims that

“The human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity."
Under international law, the expression “common heritage of humanity” is applicable to resources the use of which it is deemed desirable to regulate in the interests of humanity as a whole. The concept of common heritage was introduced for the purpose of characterizing property considered to be of universal interest and which the international community is duty-bound to safeguard, for example, as in the UN Convention on the Law of the Sea or the UNESCO Convention for the Protection of the World Cultural and Natural Heritage of 16 November 1972.

Thus, by symbolically characterising the human genome as the heritage of humanity, the Declaration was originally following the tradition of the legal texts mentioned above to ensure the preservation of universal values in response the future exploitation of human genetics, without trying to entirely assimilate the human genome or human resources as constituting an object of law like any other good.

Speaking generally, the declaration that the human genome is common heritage of humanity was not immediately understandable, because of the dispute that occurred between the UNESCO governmental experts on the expertise of those entitled to dispose of or to take advantage of the said heritage, as well as on the legal status of the genome, i.e. on whether or not it should be considered as a good over which one could have property, or intellectual property, rights.

With regard to the qualification of the human genome as the heritage of humanity, in 1997 during the discussions of the IBC group of experts, it was suggested that the Declaration should emphasize that, before being part of the common heritage, the human genome was first and foremost the “property” of the individual. But, other experts felt that, legally speaking, the notion of common heritage could create tension between the individual heritage of a person and the heritage of the species, for each gene is thus deemed to be the property of an individual, and an inalienable property of humanity.

Several experts felt it necessary to consider the specific legal consequences of the adoption of such a notion. Mrs Noelle Lenoir, Chairperson  of the IBC, pointed out that it would be difficult to state in a declaration that the individual was the ‘owner’ of his or her genome, since this would go against the legislation of certain countries, which did not recognize ownership of the human body.

The same tension was raised about the status of the human embryos which has never been determined by the human rights instruments. In fact, those secular instruments do not recognise a direct human right to life for an embryo, since the legal personality enabling the human being to be subject of law is only recognised for a person who has been born. It is thus legally inconsistent to speak about the individual human dignity of the embryo.[32]For this reasons, the experts were discussing the necessity of a legal tool other than the dignity to protect the human embryo.

The concept of the human genome as part of the heritage of humanity was therefore designed to establish a dynamic balance between the protection of the inalienable rights of the individual and the common interests of humanity covered by the concept of human dignity. The indivisibility of these values must be emphasized: the rights of the individual with regard to his or her genome are subject solely to those constraints arising from the need to respect the rights of others.

On this above basis, there was an agreement on the necessity for maintaining the symbolic reference to the genome as being part of the heritage of humanity in order to insist on the moral obligation to preserve the universal value of mankind. It is highly significant that the concept of heritage of humankind was used for the first time not to limit the excess of States’ sovereignty over spaces of communal interest, but explicitly as a limitation on the potential of individuals to dispose of their human genome at will as well as an attempt to secure the broadest possible protection of the human genome against damage that might endanger the very survival of humankind. In addition, the notion of heritage covers the knowledge accumulated by men and women about themselves as a source of potential for the progress of humankind.

This idea appears later on, in other provisions of the Universal Declaration on the Human Genome and Human rights, as a restriction on the practice of the free exploitation of human genetics by any individual, like the provisions of Article 4 stating that
 
 “the human genome in its natural state shall not give rise to financial gains”.
In addition to this ban, the new Universal Declaration on Bioethics and Human Rights[33] refers in its preamble to “the principles already stated in the Universal Declaration on the Human Genome and Human Rights and the International Declaration on Human Genetic Data” and provides by its  Article 21 (e) that:

States should take appropriate measures, both at the national and the international level, to combat bioterrorism, illicit traffic in organs, tissues and samples, genetic resources and genetic-related materials”
Those Articles emphasize the principle of the “inalienability” of the human body, including the human genome, and especially prohibits the commercialisation of human genes.

Despite the above-mentioned constraints, the prohibitions are not absolute, and there is a graduation from ban, to restrictions, to permissive actions, the positioning depending on the purposes of the medical or biotechnological scientific researches or practices, including those relating to the genetics resources.

In fact, the principle of non-appropriation of the human body and its elements, as admitted by the UNESCO declarations and other hard law regional instruments and many national internal laws, is designed to retain the indivisibility of the legal personality of the human person, considered as subject of law and not as an object. The slave trade, as prohibited by the human rights instruments, is an example of the signification of that principle and of the danger of considering the human being as object of law like any other “good” or property, including animals and plants.

Surly, the use of the qualifying phrase ‘heritage of humanity [..] in a symbolic sense’ has been understood as weakening the legal strength of this Article. However, a more convincing explanation given by Francesco Francioni is that “the adjective ‘symbolic’ is rather intended to stress that the human genome is not to be treated in a patrimonial sense, like the mineral resources of the sea bed, and that it is not subject to forms of individual or collective appropriation. Its value for humanity is thus not so much in is potential to yield economic benefits, as is the case for the tangible natural resources to which the same concept had previously been applied, but rather in its reflexive capacity to establish an ethical obligation, owed to humanity as a whole, to preserve and safeguard the continuity of the human species when faced with the unfathomable applications of biotechnologies to human genetic engineering”[34].

Conclusion

Can such body of law, rich in potential legal concepts where the human genome could form a symbolic part of the heritage of humanity, where dignity could serve both as a democratic ideal and as the foundation for the prohibition of the use of the human body for financial gain and, finally, where bio-rights could be attributed both to the individual and to the communities serve as the basis for a coherent international order regulating the use of human genetics?

Notwithstanding the uncertainties about the feasibility of a single hard-law instrument embracing all the questions raised above that depend on a extraordinary and rapid development of science and technology, Council of Europe and UNESCO’s instruments are fed by potential norms that might feet the customary international law and address the best balance between fast technology and secure law, between ethic and legal norms, and finally, between compatible norms in the trade field and in the field of medical or technological research.

This trend in international law is not specific to biotechnology’s regulation on human genetic, since the soft law approach exists also in the field of misuse of other new technology (internet) or in the field of climate change[35], despite many appropriate replies going beyond the self-regulation promoted by the providers of those new technologies.[36]

Time factor is very important in this field, not only to determine the effectiveness of those new rules in the field of biotechnology but also – and perhaps more importantly – to check whether the therapeutic promises of science and technology are revealed as being accurate before questioning the rational of the restrictions introduced in this above fragmented corpus of mixed hard law and soft law.

The Council of Europe and UNESCO’s instruments are in fact serving as an experimental normative mechanism. The results of this can be observed only after a certain period of time, within the framework of an evaluation process aimed to establish compatibility between the biotechnological regulations and trade regulations.

Confronted with the current dramatic tensions between the old society of states hinging on self-interest and reciprocity[37], on the one side, and emerging community values, on the other, the Bioethics’ issues raised openly the gradual need to transform the world society into a really international community so that public or collective concerns may prevail over private interests.  

Otherwise, a supermarket where human beings could change parts of their body and replace it by other parts sold in the market could exist on the price of more legal simplicity.

In fact, legal simplicity has been generated as a result of strong industrial and scientific pressure to provide a broad interpretation of the scope of freedom of trade in services and goods. However, this is not in this case sufficient to encompass the complexity of the scientific stakes and their relationship with the economy without solving the problem of the status of genetic resources, the scope of the rights recognised to patients and the principle of sharing benefits by means of a new reconciliation of all the principles confirmed by the conventional international law relating to human rights and trade. This complexity, excluding the ethical dimension in the emergence of the new law, or reducing the concept of heritage of humanity or the human dignity to simple questions of free choice of each individual may in certain situations produce disadvantages of which we must become aware now, in order to avoid finding later that it generates more problems than it solves.

In this sense, the rich conceptual contribution of the Council of Europe and UNESCO’s instruments, in particular in the following fields:

-                             to establish the status of human genes as being used for scientific purposes only in a way that would neither endanger the value of mankind within the concept of the heritage of humanity nor affect the concept of human dignity, construed both individually and collectively;
-                              to conciliate the principle of non-appropriation of the human body and its elements with the need to benefit the mankind from the scientific progress in a spirit of  solidarity, equal treatment and sharing benefits ;
-                             to enhance the idea of an international public order that monitors bioethics practices with the involvement of the States requested to admit new duties that will also be the future rights of the individual or of humanity in this area;

will enable the decisions-makers to review their law, sometimes judged permissive or vague and sometimes restrictive or poorly adapted depending on the technological and human issues at stake, even if there is reasonable ground to understand the adoption of a gradual approach in the codification of universal legal frameworks in this field, due to the rapid scientific and technological development.



[1] Genetic manipulation and genetic engineering are terms that apply to the direct manipulation of an organism’s genes as a subject of biology and life sciences that involve the use of living things in technology, medicine and other useful applications. Those terms related to plants and animals or human beings are used in accordance with the definition provided in the UN Convention on Biological Diversity covering also the definition of biotechnology as “any technological application that uses biological systems, living organisms, or derivates from them, in order to make or modify products or processes for specific use”. (See article 2. “Use of terms”)
[2] The General Agreement on Trade in Services was established in 1994 and was one of the trade agreements adopted for inclusion when the World Trade Organization (WTO) was formed in 1995. See also the relevant provisions of the Trade Related Aspects of Intellectual Property Rights (TRIPs) and article XX (a) of the GATT agreements relating to moral exceptions and public health.
[3] See, Abdulqawi Yusuf, " The UN Convention on Biological Diversity" , in International Legal Issues Arising under the United Nations Decade of International Law, Kluwer Law International Publisher, 1995, pp. 1163-1195. See also the Cartagena Protocol on Biosafety, available at www.biodiv.org 
[4] See the International Treaty on Plant Genetic Resources for Food and Agriculture adopted by the FAO Conference on 3 November 2001 and entered into force on 29 June 2004.This treaty was based on the recognition of the “sovereign rights of states over their phyto-genetic resources”. (articles 10 to 13). See also the Directive 2001/18//EC and the Council Directive 90/220/EEC, 2001 O.J.L/106/1.

[5] See Laurence Boisson de Chazournes and Makane Moïse Mbengue “Trade, environment and biotechnology: on coexistence and coherence”, P.205-245 in  In “Genetic Engineering and the world trade system”, Under the Direction of Daniel Wüger and Thomas Cottier. Cambridge University Press. 2008.

[6] Souheil EL ZEIN, “The regulation of human genetics by international soft law and international trade”, p.315.  In “Genetic Engineering and the world trade system”, Under the Direction of Daniel Wüger and Thomas Cottier. Cambridge University Press. 2008.

[7]  See Francesco Francioni “Genetic Resources, Biotechnology and human rights: the international legal framework”. In Biotechnologies and international human rights. Oxford and Portland, publishing, 2007. p.3

[8] Since the creation of International Bioethics Committee (IBC) following the Resolution 27 C/5.15 (15 November 1993) of the UNESCO’s General Conference to follow progress in the life sciences, many important reports were produced: genetic screening and testing (1994), human gene therapy (1994), ethics and neurosciences (1995), human population and genetics research (1995), experimental treatment and experimentation on human subjects (1996), the use of embryonic stem cells in therapeutic research (2001), the cooperation between developed and developing countries concerning the human genome (2001), intellectual property and genomics (2002) and pre-implantation genetic diagnosis and germ-line intervention (2003). All these reports are available at http://www.unesco.org.

[9] See Council of Europe site at http://conventions.coe.int/ in particular Oviedo Convention CETS n° 164 (1997) and its additional protocols CETS n° 168 (1998), CETS n° 186 (2002) and CETS n° 195 (2005).
[10]             The text of the resolution (A/RES/59/280) is available at http://www.un.org/Depts/dhl/resguide.
[11]             The text of this Declaration, adopted by the UNESCO General Conference at its 29th session in 1997 (Resolution 29 C/16), is available at http://www.unesco.org/legal_instruments.
[12]             The text of this Declaration, adopted at the 32nd Session of the General Conference in 2003 (Resolution 32 C/22) is available at http://www.unesco.org/legal -instruments.
[13]             To avoid more detailed comments on the legal value of the “soft law” of these declarations, it is important to mention that the Universal Declaration of Human Rights raised the same question in general international law. In its advice dated 8 July 1996 on the legality of the threat or use of nuclear weapons, the International Court of Justice (ICJ) stated that “The Court notes that General Assembly resolutions, even if they are not binding, may sometimes have normative value. They can, in certain circumstances, provide evidence important for establishing the existence of a rule or the emergence of an opinio juris. To establish whether this is true of a given General Assembly resolution, it is necessary to look at its content and the conditions of its adoption; it is also necessary to see whether an opinio juris exists as to its normative character. Or a series of resolutions may show the gradual evolution of the opinio juris required for the establishment of a new rule." (Paragraph 70 ). See the Web site of the ICJ. http://www.icj-cij.org/icjwww/icases/iunan/iunanframe.htm.

[14] See S. El Zein, “La Déclaration universelle sur le génome humain et les droits de l’homme”, p.18 in Treizièmes Rencontres Internationales d’Aix-en-Provence, a Symposium organized by the Institut d’Études Politiques d’Aix-en-Provence, La communauté internationale et les enjeux bioéthiques, Pedone Publisher. Paris, 2006.

[15] For example, the first Council of Europe  instrument is entitled “the Convention on Human Rights and Biomedicine”, while the title of the last instrument of UNESCO was changed during the General Conference of 2005 from “Declaration on Universal Norms on Bioethics” to “Universal Declaration on Bioethics and Human Rights.

[16] See Roger Brownsword “Genetic engireering, free trade and human rights: global standards and local ethics”, p.287. In “Genetic Engineering and the world trade system”,; under the Direction of Daniel Wüger and Thomas Cottier. Cambridge University Press. 2008. In his views, different opinions on this field are not between Europe and the rest of the world, but also inside Europe and inside every country where the decision-makers are divided into three categories of thinking: the dignitarian, the utilitarian and the human right fighters.

[17] Article 2 of this convention proclaims that “the interests and welfare of the human being shall prevail over the sole interests of society and science”.

[18]  See also Article 12 of the Human Genome Declaration and Article 1 of the Human Genetic Data Declaration.
[19]             All the preambles of the UNESCO declarations refer to the United Nations Convention on the Elimination of All Forms of Discrimination against Women of 18 December 1979, the United Nations Convention on the Rights of the Child of 20 November 1989, and the Standard Rules on the Equalization of Opportunities for Persons with Disabilities adopted by the General Assembly of the United Nations in 1993. The purpose is to insist on the need to respect special conditions in the selection of the group chosen for experimentation or researches as far as special care and consent of those incapable or ill are concerned, as clearly provided by Article 8 of the Universal Declaration on Bioethics and Human Rights of 2005, proclaiming that “In applying and advancing scientific knowledge, medical practice and associated technologies, human vulnerability should be taken into account.  Individuals and groups of special vulnerability should be protected and the personal integrity of such individuals respected”.

[20] The reference to procedural mechanisms through the ethical committees, the process of the decision-making following open consultation and the reference to the general principles of law such proportionality or the good faith are important to confer a legal effect that transcends the role normally ascribed to customary law or to declarations as normative instruments in the international arena.

[21]  Article 1 of the UDHR provides that “all human beings are born free and equal in dignity and rights”, giving solid ground for the concept of dignity linked or separated from human rights.

[22] Opinion of AG Jacobs of 14 June 2001 in Case C-377/98 Netherlands c European Parliament and Council [2001] ECR I-7079, para 197.
[23] David Feldman “Human Dignity as legal Value- Part 1 (1999) Public Law review 682-702 and Part II (2000) PL.61-76.

[24] B. Mathieu “Pour une reconnaissance de “principes matriciels » en matière de protection constitutionnelle des droits de l’homme. Dolloz chronique. 1995, 27,211-212 and “Génome humain et droits fondamenteaux . Paris, Economica, 2000.

[25]             See Deryck Beyleveld and Roger Brownsword in “Human Dignity in Bioethics and Biolaw”. Oxford. Oxford University Press. 2001.

[26] See Roger Brownsword “Genetic engireering, free trade and human rights: global standards and local ethics”, p.287. Ibid. and  “Ethical Pluralism and the Regulation of Modern Biotechnology. In Biotechnologies and international Human Rights.  P. 45 to 70. Oxford. 2007.

[27] See Roger Brownsword  Ibid. page 296.
[28] In the preamble of this additional Protocol signed 12 January 1998 it is stated that “ the instrumentalisation of human beings through the deliberate creation of genetically identical human beings is contrary to human dignity and thus constitutes a misuse of biology and medicine”. The same could be said about the Council of Europe Protocol of 24 January 2002 concerning Transplantation of Organs and Tissues of Human Origin.

[29] Directive 98/44/EC,OJ (1998).

[30] Article 11 of this Declaration provides that “Practices which are contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted.”


[31] See Article 3 of the International Declaration on Human Genetic Data. In the same spirit, Article 3 of the Universal Declaration on the Human Genome and Human Rights of 1997 states that the human genome “contains potentialities that are expressed differently according to each individual’s natural and social environment [including health and education].”
[32]             For example, the preamble of the Convention on the Rights of the Child adopted on 20 November 1989 and which entered into force 2 September 1990, declares that “Bearing in mind that, as indicated in the Declaration of the Rights of the Child”… “the child, by reason of his physical and mental immaturity, needs special safeguards and care, including appropriate legal protection, before as well as after birth”. But this legal protection is considered as an obligation of the parents and the scientists dealing with the health of the unborn child and does not create a subjective right of an unborn child to decide whether or not he or she has the right to born.
[33] It is important to note that Article 2 (viii) of this Declaration proclaims that its aim  is “to underline the importance of biodiversity and its conservation as a common concern of humankind”.

[34] Ibid; “Genetic Resources, Biotechnology and Human Rights: the international Legal Framework. Oxford.2007.p 11.
[35] UNESCO created the World Commission on the Ethics of Scientific Knowledge and Technology (COMEST) as a specific subsidiary body, dealing also with drafting a study on the advisability of preparing a declaration of code of conduct for States and other actors in relation with the consequences of climate change, even if the Kyoto Protocol was adopted in 1997, since the UN Framework was built on cycles of negotiation leaving a wide discretion for the parties (like the soft law) in dealing with substantive items.

[36] See S. EL ZEIN, "L’indispensable amélioration des procédures internationales pour lutter contre la criminalité liée à la nouvelle technologie" - UNESCO 1999. in "The law of Cyberspace", Lyons University (Lyon III) 2000.

[37] G. Fitzmaurice, ‘The Future of Public International Law and of the International legal System in the Circumstances of Today, in Institute de droit international, Livre du Centenaire 1873-1973, S. Karger S.A., Bâle 1973, at 259.