Alliance for Responsible Trade

Background

Intellectual property rights (IPR) are theoretically intended to balance the interests of inventors, artists and other creators of socially useful products with those of society at large. However, the recent wave of trade agreements generally favors commercial activity over the public interest. Moreover, the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), which has become the standard for intellectual property rights provisions, is biased towards protecting and compensating private institutions, instead of society's more creative individuals.

Of special concern are the TRIPs rules that privatize, accommodate and monopolize products derived from biodiversity. Under these provisions, corporations have the right to patent products, processes and organic material such as medicines, biotechnology and seeds. These rights raise new ethical, economic and social issues because they affect the self-determination of individuals, groups and peoples, as well as their ability to meet basic human needs.

Traditionally, knowledge of biodiversity has been treated as the common property of local communities. In the FTAA and other trade negotiations, there has been a push for rules that go beyond those agreed to in the WTO, which we could call "TRIPs-plus". These rules even more rigorously facilitate private monopoly rights, despite the efforts of several regional groups to establish principles defending sovereignty and community rights to traditional knowledge and biological diversity.

Guiding Principles

1. Life forms and biological and genetic materials should be excluded from patentability. This would especially exclude patents on biological and genetic processes related to research on human reproduction, as well as research and marketing of embryos and human clones.

2. Each country should remain free to establish rules for the protection and enforcement of intellectual property rights that reflect their specific social, cultural, economic and environmental contexts. Developing countries should remain free to develop intellectual property systems that reflect their level of development.

3. National governments have the right to invoke compulsory licensing, parallel importing and public non-commercial use provisions intended to ensure access to essential medicines, as well as to protect biodiversity, indigenous knowledge that of traditional and farming communities. These safeguards are necessary to protect the basic human rights to life, food and health guaranteed in the Universal Declaration of Human Rights.

4. No trade or investment agreement should be allowed to supercede national laws requiring foreign investors to transfer appropriate technology to the host country. Any such agreements should facilitate the transfer of technology on fair and most favorable terms in order to reduce the enormous gap in technical and scientific knowledge, and the gap in benefits derived thereof, between nations-a provision explicitly stated (albeit ignored) in the WTO TRIPs Agreement.

5. International agreements affirming these principles and establishing appropriate enforcement mechanisms should be negotiated through bodies such as the Conference of Parties to the Convention on Biological Diversity (CBD), the World Intellectual Property Organization (WIPO), the World Health Organization (WHO), and the United Nations Conference on Trade and Development (UNCTAD) and not through trade agreements.

6. In no case should trade sanctions force countries to adopt measures that subordinate the interests of the national population to those of transnational corporations or to their national subsidiaries. The International Court of Justice should review possible conflicts between international trade agreements and international human rights, health and environmental law and policy to ensure that an appropriate balance between private and public interests is achieved globally.

7. Any proposed rules on the protection and enforcement of intellectual property rights should be subjected to a detailed, forward-looking assessment that examines the potential effect of any proposed rules on, among other things, the following issues:

   a) Human rights. A United Nations Subcommittee on Human Rights has declared that "there are apparent conflicts" between TRIPS and human rights, specifically the right to food, the right to health, and the right to self-determination." Sovereign nations and intergovernmental institutions should demand that human rights have priority over trade laws, including those involving intellectual property.

   b) Market competition in sectors covered by strengthened intellectual property rules. In many key markets for developing countries, particularly in agriculture and medical biotechnology, current rules are leading to reduced competition. Examples include: increasingly broad patent claims (e.g., over new crop varieties and pharmaceuticals); the acquisition and strategic use of patent portfolios to prevent competition by similar but non-infringing products; and continued blurring of the lines between invention and discovery. This consolidation of key industries into monopolies has serious implications for social welfare, including access to food, health, and nutrition for citizens in both developed and developing countries. This suggests that before countries agree to rules, they should consider the relationship between strengthened intellectual property rights, competition in these industries, and the economic and developmental interests of developing countries.

   c) Investment in countries at different levels of development. The assessment should examine how strengthened intellectual property protections might affect the level and nature of investment in participating countries. In particular, attention should be given to the potential for strengthened intellectual property rights to: 1) undermine the opportunity for investment in follow-up research by permitting patents on fundamental research processes; 2) limit the extent to which local companies can invest in adapting existing technology to local conditions; and 3) otherwise limit access to fundamental products and processes.
   
   d) Innovation in different sectors, including in the informal sector. Innovation exists in many countries with little or no enforceable intellectual property rights protection, illustrating that the existence of intellectual property rights is at best only one factor contributing to technological innovation and economic development. It is also possible, as has been observed in North American universities, that given the possibility of gaining a future patent, researchers stop sharing their results, reducing the pace of current discoveries. Countries should assess the potential implications of strengthened intellectual property rights on local innovation, particularly in the informal sector.

   e) The implementation of other international agreements, including the Convention on Biological Diversity (CBD) and the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGR). Governments should ensure that any intellectual property rules are based on the CBD. In particular, governments should bear in mind Article 16.5 which calls on "Parties to co-operate, subject to national legislation and international law, to ensure that IPRs are supportive of and do not run counter to the CBD's objectives." Particularly in light of their submissions to the WTO's Council on TRIPs regarding the relationship between TRIPs and the CBD, developing countries should be careful not to adopt rules in any hemispheric agreement that would exacerbate concerns about the potential for IPRs to undermine the CBD's objectives. The ITPGR proposes the guideline that patents should not be authorized if they have the effect of limiting access to genetic resources for food and agriculture, specifically that they should not be authorized for "their parts or components, in the form received from the Multilateral System." Therefore, countries supported in the ITPGR should be careful not to create conflicts with this restriction on intellectual property rights according to this international treaty.

Specific Objectives

1. Exclude from patentability all life forms, including plant and animal species, microorganisms, biological and genetic material and processes and combinations thereof, including that derived from the human body. Specifically, exclude the patentability of biological and genetic processes related to research on human reproduction and human-animal crossgenetics as well as the manipulation, research and marketing of human embryos and clones. This would establish strong linkages between patenting systems, bioethics and biological rights, and law. It is important to emphasize that bioethical principles should be at the center of any patent systems, since they influence the limits and determine the scope and meaning of protection of the human species and the planet's ecosystem.

   There are six different bracketed proposals in the draft text of the FTAA on what can be patented. None of them would prohibit patents on all life forms, although four options would definitively exclude patents on plant varieties and species, animal species and races, including explicit reference to genetic processes or to material that can replicate itself. There options also clarify the definition of an invention and include other important exceptions. However, these options do permit patents on genetically modified organisms, incorporating various aspects of the text of paragraph 27.3(b) of the TRIPS that states that a government can deny patents on plants and animals that are not microorganisms, and on fundamental biological processes to produce plants and animals that are not microorganisms. But paragraph 27.3(b) of TRIPS is itself subject to a debate within the WTO and subject to change. Currently, various governments grant patents on life forms under this article.

2. Require the holders of pharmaceutical patents to accept compulsory licenses for producers of generic medicines. Compulsory licensing does not abolish patent rights but it does oblige patent holders to allow others the right to produce copies in return for payment of royalties. Generic medicines typically sell at lower prices than brand name pharmaceuticals.

   Compliance with this objective would require resistance to three U.S. proposals found in the draft FTAA text that would give greater protection to pharmaceutical companies than TRIPS itself and that would violate the text and the spirit of the Doha Ministerial Declaration on TRIPS and Public Health:

   a) While the Doha Declaration would permit the use of compulsory licenses in order to introduce competition in the market under any circumstances, the U.S. proposal in the FTAA would limit their use "only for public non-commercial ends or in situations of a declared national emergency or other situations of extreme urgency."

   b) The United States proposes the prolongation of patents beyond the 20 years granted under TRIPS in order to compensate patent holders for delays in granting a patent.

   c) The United States proposes that information relative to the safety and effectiveness of a pharmaceutical or agricultural product be the exclusive property of the patent holder for five years. It will therefore be much more difficult for generic producers to produce copies because they will have to replicate all of the tests performed by the patent holder instead of demonstrating the "bioequivalency" of their product.

3. Assert the primacy of international agreements on human rights, human health, food security and biodiversity over TRIPs and other trade agreements in international law.

4. Support the Draft Declaration on the Rights of Indigenous Peoples and other agreements defending indigenous peoples' a priori rights in the face of genetic research that uses their traditional knowledge and biological resources (including human tissue, blood or DNA samples, or their craft designs and techniques) or stores them in databases without their knowledge and consent. Defend women's and men's rights to information and autonomy regarding research that utilizes organic components of reproductive systems and prohibit any kind of marketing of parts or components of the human reproductive system. While various proposals in the FTAA recognize the value of traditional knowledge and the obligation to treat indigenous peoples equitably, none of them reflects the more important provisions in the Draft Declaration such as indigenous peoples' sovereignty and their right to deny access to their resources and knowledge. On the contrary, all of the options listed in the FTAA text require that governments establish some system of intellectual property for genetic resources and traditional knowledge.

5. Protect the rights and livelihoods of farmers to store, use and sell seed grains, as well as and communities (and especially indigenous peoples) that act as the guardians of biodiversity. Support calls by local communities for a moratorium on bio-prospecting and encourage the development of national legislation to subordinate the terms of any bioprospecting contracts to conditions preferred by local communities.

6. Support internationally-recognized farmers' rights to save, use and sell farm-saved seed and the patent-free free exchange of germplasm held in the public domain as an international obligation under any agreement in the Americas.

7. Support the negotiation of strict liability rules and traceability-and-labeling requirements under the Cartagena Protocol on Biosafety, enforced with criminal, civil, and/or trade sanctions for the illegal transboundary movement of genetically engineered organisms.

8. Intellectual property-related contracts that prohibit the saving of seed or allow the burning of crops as punishment for violating the terms of such contracts should be superceded by "ordre public"-an international law term allowing governments to take measures for the general public benefit and public health considerations relating to food security.

9. Complement intellectual property rules with new mechanisms and dedicated funding to promote the transfer of technology on fair and most favorable terms to developing countries, including through the processes established in existing multilateral and regional agreements.

10. Ensure that the Convention on Biological Diversity's provisions on benefit sharing (including Article 15), preservation of and respect for the knowledge, innovations and practices of local and indigenous communities (including Article 8(j)), and transfer of technology (including Article 16) are given primacy over intellectual property rules. Ensure recognition of the collective character of this knowledge, and because of that, the collective right to decide on the access and use of that knowledge. National measures to implement these provisions should not be subject to challenge under rules for the enforcement and protection of intellectual property rights included in trade agreements.

11. Ensure that copyright laws protect artists, writers, musicians, crafts producers, and other cultural workers and not just publishers and the motion picture and recording industries as occurs under NAFTA's Article 1705. Such protections would be of special value to indigenous and female crafts producers.