Biotechnology and International Law

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As its title suggests, this book deals with possible impacts of modern biotechnology on international law and how international law can be adapted to meet the new challenges presented by such technology. It grew out of a collective research project in the period between 2003 and 2005 by a number of scholars and experts in this field, including academics, practitioners and officials of international organisations. The book is divided into five parts, covering general aspects, and implica¬tions of biotechnology for environmental protection, international trade, human rights and regional economic integration systems, respectively.

Public international law in the past has frequently had to deal with new problems posed by scientific and technological advancements, most notably in the areas of the law of the sea and of outer space; but never has it been faced with such thorny issues as are intimately associated with the very notion of human beings. The biotechnology revolution, by making it possible to perform inter-species transfer of genetic information from one organism to another, opens up a whole range of new horizons previously undreamed of. Huge benefits can be reaped while, at the same time, many risks remain to be analysed, anticipated and controlled. With the ambiguity of the technology itself came the ambivalence, inde¬cision and, unavoidably, conflicts of interests and accompanying philosophies. Is a genetically modified organism (GMO) a wondrous boon or a monstrous bane? What about a 'transgenic animal* like a lamb with a human gene? Who has the final say as to what research and development is and is not allowed? How does one define 'human' now that human behaviour can be reconstructed through microscopic manipulation of the human body? If human nature itself is infinitely malleable as merely the sum total of the manifestations of a lump of laboratory material, there can be nothing inherently special in a human being that distinguishes him/her from a guinea pig; can there then be any right that can exclusively be called 'human'? The sense of almost impending doom is vividly captured in Francis Fukuyama's Our Posthuman Future: Conse¬quences of the Biotechnology Revolution (2002). Not surprisingly, the issues connected with biotechnology, in that they are inextricably interwoven with moral issues and often compounded by legal, political, social and religious considerations, have proven to be most controversial and divisive. Society, whether at the national or international level, finds it extremely difficult to reach any consensus on, for example, GM food, the ownership and control of genetic resources, and research on and use of stem cells of human embryos in biomedicine. Inevitably, these issues have become the concern of governments in general, of inter-governmental organisations, and of international lawyers. The pressing need for international law to live up to the changed realities must have been keenly felt within the UN, where government representatives regu¬larly gather to discuss matters of common concern. In 1998, the UN General Assembly in its Resolution 53/152 endorsed the UNESCO's 1997 Universal Declaration on the Human Genome and Human Rights; and in 2005, the UN GA again adopted the Declaration on Human Cloning (A/RES/59/280). This book is hence a timely and expert exposition of the international legal issues created by and relating to biotechnology with its often sub¬versive implications.

Part I provides an overview ol the general aspects and in a way sets the keynote for the whole book. Francioni proposes certain basic principles for what he calls an 'international law for biotechnology'. In particular, he examines how and to what extent the principle of perma¬nent sovereignty over natural resources and that of 'common heritage of mankind' can work in a mutually complementary manner to provide a legal basis for the ownership of genetic resources. He also considers the utility of the principle ol 'equitable sharing of bene! its', which has been developed chiefly in the context of non-navigational uses of international water-courses. This latter view- is shared by Pavoni in discussing the emerging international legal regimes concerning biotechnology.

Environmental protection is the subject of Part II. Redgwell analyses the risks posed by biotechnology to biodiversity through the so-called 'Living Modified Organisms' and finds it still questionable what benefits biotechnology may bring to sustainable development; while Cataldi discusses the possible harmonisation of the UN Convention on the Law of the Sea, whose provisions concerning living resources are predominantly 'exploitation oriented' and the Convention on Biological Diversity, which focuses on the protection of species and habitat. Considerable space is also devoted to bio-prospecting on the Deep Seabed (Scovazzi) and in Antarctica (Vigni; Guyomard).

Part III treats of the impact ol biotechnology on international trade. Through a case study of the WTO dispute over the EC import restrictions on GMOs, Petersmann takes a close look at the complicated issues straddling international trade law, environmental law and biotechnology law. In particular, the staggering number of legal rules made by a multitude of national and intergovernmental law-makers throws into sharp focus the need for harmonisalion. Such need becomes even more urgent when the legal frameworks governing international trade in GMOs are viewed in the light of the concerns of the developing countries in their effort to find the appropriate balance between pursuing their development objectives and complying with their multilaterally agreed obligations (Zarrilli). By the same token, Ullrich finds that, with respect to the protection of biodiversity-related traditional knowledge, there exist 'systemic conflicts' between the different principles embodied in the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs Agreement), on the one hand, and the Convention on Biological Diversity, on the other. The need for harmonisation and coordination is also highlighted by the studies in Part V on the biotechnology-related practices.within regional economic integration systems (Sturma, Poli and Novak).

The need for further development of the law is made especially evident by the studies in Part IV on the far-reaching implications of the biotech¬nology revolution for human rights. In a survey of the international governance for agricultural biotechnology, food security and human rights, Footer notes the 'multiplicity of fora, actors and instruments that may be difficult to contain and is leading to a plethora of competing claims on the use of resources and their effective manage¬ment'. Likewise, Lenzerini finds that the knowledge of the human genome augurs 'a nebulous future'. After considering a range of bioethical and legal issues, such as human cloning, eugenics, the transplantation of human organs and tissues, and free and informed consent, he proposes that the primacy of human dignity should be the leading principle for future developments. The law also needs to protect indigenous peoples' rights in regard of biogenetic resources, which are being threatened by the economic interests of big multinational companies (Fraboni and Lenzerini).

The common theme that runs through all the studies in this book is the need for harmonious and coordinated regulation of various applica¬tions of biotechnology. A combination of the development of new norms and the adaptation of existing ones is held to be the way forward. The striking impression, however, is that the conclusions contained in this book are largely exploratory and tentative. This is hardly surprising given the deeply divisive nature of the problems tackled by the authors. But that is precisely where the value of this book lies. At the stage where the ramifications of biotechnology remain to be fully appreciated, what one needs is a good multi-faceted approach that provides a complete and balanced picture of what needs to be seen and done. The book provides a lawyers well-reasoned response to a wide range oi issues denoted by the 'bio-' buzzwords of our time: bioscience, bioengineering, biosafety, biogen¬etics, and bioethics, etc. As such it is bound to be a must-read for academics, students, practi¬tioners and government officials, who are concerned with the legal, political and ethical issues of biotechnology.

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