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AuthorUnited Nations Conference on Trade and Development
TitlePanel on Legal and Regulatory Issues in Biotechnology
Imprint Geneva, United Nations. 2001
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Descript 36 p


(Geneva, 3-5 July 2000). The panel examined issues related to intellectual property rights (IPRs), biosafety and other policy areas relating to the transfer and diffusion of biotechnology in the key sectors of agriculture, health and environment. The objective of the meeting was to identify the key issues and capacity-building needs that must be addressed in respect of building legal and regulatory frameworks for biotechnology. The meeting recognized that policy regimes are needed which encourage the inward transfer of biotechnology appropriate to national needs, but which at the same time manage or constrain the import and development of those technologies that present unacceptable threats. There is also a need to integrate and harmonize biotechnology-related regulations and policies with obligations under international agreements. In respect of technology transfer and diffusion, the meeting recognized that a large amount of information and new knowledge is available in the public domain, although there are still some problems in respect of access to it. The Internet was acknowledged to be an extremely valuable source of new technological information, and policies and initiatives that expand Internet use in developing countries were seen as crucial. In respect of proprietary technology, the issue of finding appropriate new mechanisms, including bioprospecting arrangements, through which to acquire the technologies was discussed. It was reported that, although the costs of the new technologies are often high, the extremely rapid developments in biotechnology mean that new innovations quickly come down in price. Where cost appears to be more significant is in building capacity to absorb the technology, and in maintaining the necessary infrastructure for its use and further development. It was clear from the country reports that many developing countries have been experiencing problems in resourcing the implementation of the Agreement on Trade-related aspects of Intellectual Property Rights at a national level, in terms of both financing and human expertise. This has in very many cases meant that countries have had to request more time for implementation from the World Trade Organization. At the same time, many developing countries have yet to decide their position on, or are firmly opposed to, IPRs for living matter. It was recognized that many organizations, including international agencies, are interested in the area of IPRs for traditional knowledge, although the extent of their activities was not clear. The panel felt that there was a need for more coordinated reporting of the activities of interested organizations, and suggested that this might be a role for the Commission. The panel discussed the appropriate timing for developing countries to formulate and implement national biosafety regulations, depending on their level of technological development. It was clear that there are two fundamental arguments on this issue?one supporting a reactive approach, the other supporting a proactive approach. However, it was noted that countries that have become or are preparing to become, parties to the Cartagena Protocol on Biosafety must introduce institutional structures and procedures that are commensurate with its terms and conditions. Also, it was pointed out that national regulations need to go beyond implementation of the Cartagena Protocol. Unfortunately, resources to formulate and implement biosafety regimes are scarce in many developing countries. The concerns here include a lack of trained personnel and institutions, and poor legal infrastructure, to assess and manage risks in those countries. It was noted that a wide range of scientific expertise is needed in order to develop meaningful regulations and procedures, including enhanced capacity in molecular biology, ecology and physiology. It was recognized that better access to information and knowledge would greatly facilitate acquisition, development and diffusion of biotechnology, and also the development of legal and regulatory frameworks to manage the technologies. Objective information about biotechnology should be provided by academics, Governments and the mass media in a form that is understandable to the general public. Key recommendations to improve the dissemination of information included support to improve information technology infrastructure, the development of national policies aimed at building effective networks and linkages between technology users and producers, and the identification of national, regional and international focal points. The meeting recognized that many developing countries felt a need for continuing international assistance in building regulatory capacity for biotechnology. This could also be a role for national, regional and international focal points. The CSTD could provide direct assistance by initiating and overseeing the development of a regulatory model to serve as a basis for developing countries to establish appropriate regimes for biotechnology management. Finally, the panel highlighted some areas in which improved understanding is needed at national and international levels in order to support capacity building in biotechnology. These include the problem of technology absorption in developing countries, the potential of bioinformatics to contribute to increased transfer of public domain knowledge, and the role of IPR regimes in encouraging the inward transfer of technology, particularly in respect of biotechnology. [English only]

International Institute for Trade and Developement : UNCTAD CollectionE/CN.16/2001/MISC.2CHECK SHELVES

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