Continuing the discussion carried over from its first session, the Panel examined the impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS ) under the World Trade Organization,3 the system of protection sought by the International Union for the Protection of New Varieties of Plants (UPOV), 4 and Farmers’ Rights. A discussion paper was presented by Panel member Asbjørn Eide. Following a brief discussion, it was agreed to revisit the theme at greater length during the third session.
The four core ethical issues in food and agriculture arising from the TRIPS Agreement were identified in the discussion paper as follows:
The paper suggested that the Panel should call for the improvement of the existing system under the TRIPS Agreement through measures to ensure that there is no misappropriation of genetic resources in the public domain by enterprises and plant breeders. Patents should be given only when there has been a genuine invention that has created a biological product significantly different from any that existed before, and the patent should cover only the inventive step itself, nothing beyond it.
In the ongoing review of Article 27.3(b) of the TRIPS Agreement, sui generis laws should allow for community rights, the continuation of farmers’ practices and the prevention of anti-competitive practices pursued through patenting, taking fully into account the duty to protect Farmers’ Rights as stipulated in Article 9 of the International Treaty on Plant Genetic Resources for Food and Agriculture.5
The period of transition built into the TRIPS Agreement should be extended, allowing developing countries and indigenous groups sufficient time to develop their own mechanisms to protect their interests. It might be advisable to establish or strengthen mechanisms for legal aid, to be made available for developing countries and traditional communities, providing these with the necessary technical assistance to be able to identify, defend and protect their own interests and values in relation to the application of the TRIPS Agreement. More generally, FAO could encourage donor states to contribute to a more balanced negotiating process by supporting capacity building in developing countries, to enable adequate preparation for and participation in the negotiations.
As to the structural conditions affecting the impact of the TRIPS Agreement, the Panel reiterated the call issued at the last session for greater investment in public resources in public agricultural research and increased country awareness of the advantages in carrying out research that will enhance economic development of the poorer sections of agriculture and make it possible to share the results achieved. Part of that research should be carried out in cooperation with small farmers on a range of non-proprietary, locally adapted types of farming technologies at low cost. It should also aim at developing community and area-wide approaches that offer alternatives to genetically engineered, copy-protected solutions.
During the first session, the Panel discussed issues regarding the use of GMOs for food and agriculture, including the risks, uncertainties and doubts involved in their use, and the enabling conditions needed to exploit their potential while avoiding inherent risks. Whereas the risks of most other biotechnology products are predictable, there are greater uncertainties concerning the impact of GMOs, particularly with regard to long-range environmental effects and the social and economic impacts. The Panel had therefore requested FAO to prepare a study on the status of regulations in different countries concerning the application of biotechnology and GMOs.
The commissioned study, entitled “The role of law in realizing the potential and avoiding the risks of modern biotechnology: selected issues of relevance to food and agriculture”, was presented at this second session. It indicates the extent to which international agreements and a selected group of national laws may already be assisting societies in using the potential of modern biotechnology and avoiding possible risks. It reviewed three categories of legal instruments at international and national levels dealing with biosafety, food safety and consumer protection, and it described the nature of the instruments addressing biotechnology. Major elements examined were: regulations on public participation, including access to information and labelling; monitoring or oversight mechanisms, including institutions; safety assessment; and core aspects of decision-making in these areas.
Participation and information. The study showed that at both international and national levels, the biosafety instruments examined were generally found to be more specific with regard to public participation than the food safety or consumer protection instruments examined, which demonstrates that the general principle of public participation is well established in the biosafety field, although uncertainties prevail as to application of these instruments in practice. There is, on the other hand, a general lack of reference to public participation in the food safety area.
While the consumer protection instruments examined did not promote public participation per se, they did promote access to information to enable consumers to make informed choices and to prevent fraud. Access to information is an important cornerstone of public participation and is one tool that could help to achieve the benefits and avoid the risks of modern biotechnology, but international instruments address access to information with varying degrees of specificity. The review pointed to the worrying proliferation of confidentiality provisions at both international and national levels, and a more detailed study of the use of confidentiality provisions may be required to determine whether their application can impede the public’s access to relevant information about modern biotechnologies.
Labelling, especially in the food safety and consumer protection areas, is being increasingly addressed at international and national levels. The question of when labels can or should be applied to products that may or may not contain GMOs is a major issue under consideration. In the biosafety area, there does not appear to be any international process other than examination of the issue within the United Nations Economic Commission for Europe (UNECE) Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters (Aarhus, Denmark, 1998). An important issue at the international level is to determine the need for labelling of GMOs and GMO-related products in the biosafety context. The possible role of Codex Alimentarius in this context should also be explored.
No international instruments specifically mention the need for public participation in strategic processes focusing on modern biotechnology, but some countries are taking a new approach by creating broad-based stakeholder processes for certain aspects of modern biotechnology such as the release of GMOs. These processes help governments to gauge public opinion, generate dialogue, gather useful information and develop population awareness concerning modern biotechnology.
Because of the dearth of specific references to public participation specific to modern biotechnology in policy-making at the international level, it may be useful for future international instruments, such as the preliminary draft of the International Code of Conduct on Biotechnology being considered by the FAO Commission on Genetic Resources for Food and Agriculture, to refer unambiguously to the desirability of creating such processes.
Monitoring and oversight processes. Three aspects of monitoring were examined: institutions, safety assessment and decision-making. All countries examined have some form of institutional oversight in place, but there are wide differences concerning the nature of the advisory bodies. A multidisciplinary and/or multistakeholder advisory body could play an important role in assisting competent authorities as they examine the merits of GMOs so as to maximize the benefits and minimize the risks of modern biotechnologies. With the exception of FAOpreliminary draft International Code of Conduct on Plant Biotechnology, no international instrument reviewed refers to the desirability of creating advisory bodies. Future instruments could include provisions on advisory bodies in this area.
Institutional biosafety committees can be given the ultimate responsibility within an institution working with GMOs to ensure the safety of any GMO-related work. Negotiators and lawmakers may wish to consider the allocation of responsibility when drafting future instruments. Safety assessment (e.g. hazard identification, risk assessment and risk management) is referred to in all national oversight systems and in all international instruments examined dealing with biosafety and food safety.
While the need for risk assessment is undisputed, the substantial equivalence concept in food safety needs close examination. Should the concept be used in future negotiations of international instruments, guidance on proper application should be spelled out to avoid the concept becoming a decision threshold to exempt genetically modified products from rigorous safety assessments.
In the risk management area, the precautionary approach is being referenced more frequently in international instruments since the United Nations Conference on Environment and Development (UNCED, Rio de Janeiro, 1992). The extent to which the precautionary approach is actually practised at the national level is unknown. However, the small number of second-generation biosafety and food safety laws that were reviewed do tend to refer to a precautionary approach explicitly. Guidance for applying such an approach to modern biotechnology may need to be promulgated at the international level to ensure consistent application worldwide.
Traceability is an emerging risk management tool within the biosafety and food safety areas. It could be useful where illegal export, import or release is suspected, and where environmental damage has occurred or where unforeseen food toxicity has been identified. The role of traceability in risk management at international and national levels is becoming more widely accepted and, where technically feasible, it may be useful for negotiators and lawmakers to take into consideration as they create new legal instruments.
Socio-economic effects. There is an emerging trend to take socio-economic considerations into account. Governments may need assistance in this respect, particularly in capacity building and technical guidance. The first study did not go into these questions at any length. In future work, more attention to socio-economic questions will be required. It may be desirable to commission a follow-up study addressing these issues, which can also cover countries other than those examined in the study. A more holistic approach to decision-making may result in a more accurate consideration of costs and benefits in the regulatory decision-making process.
Accountability. It is essential to ensure greater accountability in the decision-making process, which will require the reasons for decisions taken to be made publicly available, as well as provision for judicial or administrative review. These areas are at present underrepresented in international instruments, and only a handful of the national level instruments reviewed refer to all of them.
3 The TRIPS Agreement is Annex 1C of the Marrakech Agreement Establishing the World Trade Organization, signed in Marrakech (Morocco) on 15 April 1994 (see http://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm ).
4 The International Union for the Protection of New Varieties of Plants (UPOV) is an intergovernmental organization with headquarters in Geneva (Switzerland). It is based on the International Convention for the Protection of New Varieties of Plants, as revised since its signature in Paris on 2 December 1961. The objective of the Convention is the protection of new varieties of plants by an intellectual property right (see http://www.upov.int/eng/index.htm ).
5 The Thirty-first Session of the FAO Conference adopted the finalized text of the International Treaty on Plant Genetic Resources for Food and Agriculture (November 2001). This treaty is the outcome of several years of negotiations to revise the International Undertaking on Plant Genetic Resources, in harmony with the Convention on Biological Diversity (see http://www.fao.org/ag/cgrfa/itpgr.htm ).