The United Nations Human Rights Commission has termed the commercial exploitation of genetic material from human subjects of the developing world as a grave human rights violation. The Office of the United Nations High Commissioner for Human Rights (OHCHR) based at Geneva has decided to have broader cooperation with agencies like WIPO, UNFPA, FAO, WTO, and UNCTAD in developing international law of patents that can ensure adequate benefit sharing and patenting of the genome between the developed and the developing world.
Accepting the recommendations of the High Commissioner's Expert Group on Human Rights and Biotechnology the experts from the international agencies are to conduct a human rights analysis of the patent as a legal instrument conferring rights on individuals and entities. It will call for a study of the various options to facilitate sharing of benefits deriving from the exploitation of genetic material (particularly from developing world), both in terms of a return to the community and in terms of technology transfer and an evaluation in human rights terms of existing mechanisms designed to protect genetic material from exploitation.
The Experts considered the linked issues of the ability to patent genetic material and the sharing of benefits deriving from commercial exploitation of that material to be the most important issues in the area of human rights and biotechnology at this time, says Dr S. K. Brahmachari, director, Institute of Genomics &Integrative Biology. Dr Brahmachari is the only Indian expert in the High Commissioners Expert Group that drafted the recommendations recently. The OHCHR initiative is to help the developing countries that have rich genetic diversity in a big way, he felt.
Preparation of a human rights analysis of the recent advances in biotechnology; closer and more specific interagency cooperation between OHCHR and UNESCO and WHO; broader cooperation agencies like WIPO, UNFPA, FAO, WTO, and UNCTAD; and an advocacy role in making clear the case for the benefits of diversity in humankind are to be the immediate priorities of OHCHR.
The Experts noted that, from a human rights perspective, the enormous benefits promised by biotechnology must not be restricted to one group or society. The sharing of these benefits involves not only compensation for the contribution of genetic materials, but also the facilitation of technology transfers between developed and developing countries (Article 19 of the UDHGHR). The growing trend of biotechnological research being largely restricted to developed countries risks the development of a 'genetic divide' between these societies. A priority for the work of the High Commissioner should be a study of the various options to facilitate benefit sharing in this area, both in terms of compensation and in terms of technology transfer. In regard to the former, the examples from a number of developed countries of National Genetic Reserves could be studied as possible models for preserving the genetic assets of developing countries.
While noting the importance of intellectual property rights in today's society, the experts noted the serious concerns raised regarding the appropriateness of applying patent laws to genetic material and the human genome, particularly in terms of the requirements of novelty and inventiveness. In this respect, the experts noted the recent Draft Report on the Follow-up of the International Symposium on 'Ethics, Intellectual Property and Genomics' published by the IBC in August 2001 (SHS-501/01/CIB-8/2) and the recommendations made therein relating to the patentability of genetic material.
The urgency and importance of these issues are related to the growing commercial exploitation of genetic techniques and the increasing commodification of genetic material. The 'discovery' of the large commercial value of genetic techniques and material and the intense pressure to exploit this value, accompanied by a similar realisation that while much of the richest genetic diversity exists in developing countries, genetic research in endogamous communities would provide clues about a population's genetic predisposition/resistance to certain diseases highlighted its importance.
Equally important is that regardless of this rich genetic diversity, the costs associated with harvesting or surveying genetic material in developing countries are far less than in developed countries. This is particularly relevant in respect of genotyped clinical trials (pharmacogenomics) involving the study of behaviour responses and sensitivity to drugs. The fourth development is the contemporaneous global and regional liberalisation of trade in goods and services, which facilitates the international trade in genetic materials and in services for clinical trials. Use of patents and other instruments to claim intellectual property in human genetic and genomic material, and the global standardisation of intellectual property protection regimes in the form of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), negotiated in the context of the WTO are other factors which made OHCHR take this decision.
Experts felt that the above said developments have fostered market and regulatory systems which allow genetic material to be removed from individuals, particularly in developing countries, and exported for commercial exploitation with little or no immediate benefit to the individual or society. “Little or no immediate benefit to those who participate in surveys of genetic characteristics in order to develop genetic products, benefits from commercial exploitation of an individual's genetic and genomic material to accrue solely to a patent-holder; and a concentration of biotechnological knowledge in developed countries and a focus of research on the medical concerns of developed countries” were the possible negative fallouts of this situation.
These developments have raised the broad question of how the common genetic heritage of humanity should be used and for whose benefit. In human rights terms, a number of specific and serious issues arise, including: the right to privacy, in particular: the question of prior informed consent to scientific experiments, surveys and the removal of genetic material; and the use of an individual's genetic information.
The right to health, including states' obligations to: recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health (Art. 12 ICESCR); respect and promote the practice of solidarity towards individuals, families and population groups who are particularly vulnerable to or affected by disease or disability of a genetic character (Art. 17 UDHGHR); and ensure that the applications of research, including applications in biology, genetics and medicine concerning the human genome seek to offer relief from suffering and improve the health of individuals and humankind as a whole (Art. 1(b) UDHGHR). Respect for the rights of indigenous peoples, particularly relating to the human body and use of resources; the rights of individuals to benefit from scientific progress and its applications (Art. 15 ICESCR); rights to property, including intellectual property; and the obligations of states to share scientific knowledge (Art. 15 ICESCR, Arts 12(a), 18 and 19 UDHGHR).