1. Trade Related Intellectual Property Rights (TRIPs) and Public Health From DOHA to July framework and Beyond: Implications for LDCs By Wole Olaleye Actionaid International-Southern Africa Partnership Programme

2. INTRODUCTION “"to build a culture of life" should be stronger, more urgent and immediate…to find a permanent solution on how to ensure sustainable supply of essential generic medicines to the millions of people dying everyday, particularly in Africa…this dedication and determination seems to be lacking, as four years have passed since this issue had been raised but Members were not moving closer to finding a permanent solution to this problem” Rwanda Ambassador for Trade

3. Background to TRIPs The Trade Related Aspect of Intellectual Property Rights (TRIPS) Agreement is Annex 1C of he Marrakesh Agreement Establishing the World Trade Organisation, signed in Marrakesh, Morocco on 15 April 1994 TRIPS Agreement sets out minimum levels of standards concerning intellectual property in the form of copyrights, trademarks, patents industrial designs, geographical indicators, integrated circuits and trade secrets Intellectual Property Rights (IPRs) were brought into GATT Uruguay Round Agenda in the late 1980s through direct pressure by USA pharmaceutical companies The developing countries resisted the introduction of IPRs into GATT, but they lack the critical mass to block it

4. Background to TRIPs As a compromise, trade related aspects of IPRs were included - TRIPs. The idea was that this would only cover trade related issues IPRs was introduced into GATT for two major reasons: technological revolutions in industrialised nations information technology and the biotechnology industry

5. Background to TRIPs Critique: The TRIPs Agreement itself does not focus on trade issues (e.g. eradicating trade barriers). Instead, it sets standards for the protection of IPR under false pretences: baseless promises of investment and technology transfer to developing countries. It is often said that countries providing strong intellectual property protection will attract greater inflows of foreign investment and technology, but there is no empirical evidence to back this up TRIPs was basically included because of the comparative advantage that developed countries have in these technologies, and their commercial interest to maintain economic control over such products.

6. TRIPs: A Dividing Line Negotiations in the World Trade Organisation (WTO) on TRIPs and Public Health that were supposed to be complete by the end of 2002 has failed to yield any positive results due to the mixing of issues by the US and EU countries in an attempt to save the corporate interests of pharmaceuticals The WTO TRIPs Council through numerous negotiation rounds has to agree on a solution under Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health

7. TRIPS: A Dividing Line The US rejected the solution due to concerns over the scope of diseases covered. The US suggested the inclusion of a footnote that would expand its previously proposed three-listed diseases to 23 The developing countries rejected US proposal because it restrict the mandate given by the Doha declaration, which refers more generally to measures to protect public health

8. TRIPS: A Dividing Line The Doha Declaration on TRIPS and Public Health has provisions that provide for LDCs without manufacturing capacity of drugs to use flexibilities in the TRIPs Agreement of Compulsory Licensing until 2016. Compulsory licensing is granting authority to a third party to manufacture generic equivalence of patented drugs without the consent of the patent holder under certain conditions. However, after four years of intensive negotiations, no consensus has being reached by WTO members to implement Paragraph 6 of the Declaration.

9. TRIPS: A Dividing Line Some member of EU countries, USA, Japan, and Canada insisted that the solution cover all health problems whilst other, especially the US wanted only a limited number of diseases They proposed the removal of vaccines from the list of diseases Their argument was that vaccines were not technically pharmaceuticals yet they play a major part in addressing potential public health problems

10. TRIPS: IMPLICATIONS FOR LDCs Biotechnology: the TRIPs Agreement mandates 20 year patent protection for all innovations whether products or processes in all fields of technology, subject to the normal tests of novelty, inventiveness, and industrial applicability. TRIPs also requires National Treatment of patents and patent holders, which means that a foreign company or product in a Member state has to be treated the same way (or better than) a comparable domestic company or product.

11. TRIPS: IMPLICATIONS FOR LDCs Patents provide ownership over inventions, meaning no one can use them without permission or payment. Companies in the US are currently patenting a broad range of “inventions” in the field of life sciences: genes, gene sequences, basic techniques of recombinant DNA, plant varieties per se, characteristics or traits, even entire species. As a result farmers then have to pay to use knowledge claimed by companies, for every generation of a biological organism. This translates into high cost for farmers.

12. TRIPS: IMPLICATIONS FOR LDCs Patenting of Life Forms: article 27 allows a few exceptions to patentability. Plants and animals (not micro-organisms) can be excluded, but plant varieties must be protected, either by patent or by sui generis system. But many countries, do not actually know what an effective sui generis system is. It simply means “of its kind”, but it must be some kind of intellectual property rights protection for plant varieties.

13. TRIPS: IMPLICATIONS FOR LDCs One of these areas in “patents’’ includes plant variety protection. Article 27.3(b) allows Member States to exclude plants and animals from patent protection subject to the establishment of an “effective’’ sui-generis system. LDCs – were supposed to have put a sui- generis system in place by the end of 1999. Some countries are considering the sui-generis option to compliance.

14. TRIPS: IMPLICATIONS FOR LDCs The Union for the Protection of New Crop Varieties of Plants (UPOV) is actively persuading governments that application of UPOV principles or membership of the Union will satisfy the demands of Article 27.3(b) of TRIPS. For LDCs there are grave consequences associated with intellectual property protection of plant varieties. It can be argued that protection of plant varieties will place undue restriction on farmers’ practices, lead to genetic erosion and adversely impact on research and development.

15. TRIPS: IMPLICATIONS FOR LDCs There is also fundamental conflict between TRIPS and Convention on Biological Diversity (CBD). Whereas the CBD calls for national sovereignty over biodiversity (community rights to indigenous knowledge) the TRIPS Agreement promotes the application of IPRs and monopoly ownership and commodification of biodiversity. This private proprietary ownership by mostly corporate companies will lead to the decline of the biodiversity, which sustains people’s livelihoods.

16. TRIPS: IMPLICATIONS FOR LDCs The patent system of intellectual property rights denies property rights to local and indigenous knowledge, practices and innovations. TRIPs only recognises as worthy of protection inventions that conform to the Northern definition. Rights are recognized only when they generate profits and capable of industrial application. This excludes all sectors of society who produce outside the industrial code of production and for social good. TRIPS only accorded patent rights to trade related innovation

17. TRIPS: IMPLICATIONS FOR LDCs Innovations in the public domain for local and domestic use are denied recognition. This situation seriously affects the rights and opportunities for poverty relief and alleviation in LDCs. Local people end up being exploited and made even poorer by developed countries because their knowledge is accessed freely then “treated” in laboratories in the North and ownership rights claimed through patents. Those who make use of the patented products then pay royalties to new owners.

18. LDCs: CHALLENGES FOR HONG KONG Biopiracy: under TRIPs, the right of communities to control their natural resources is not guaranteed. Indeed TRIPs does not recognise a community’s ownership of the resources it has tended for thousands of years. While the Convention on Biological Diversity has been written in an attempt to prevent the theft of indigenous knowledge, the exact relationship between TRIPs and the CBD remains unclear. Until this apparent conflict is resolved, corporations from the developed countries will continue to be able to patent and profit from the knowledge of indigenous communities across developing countries

19. LDCs: CHALLENGES FOR HONG KONG Farmers’ Rights: are not provided for under the TRIPs agreement. TRIPs does not permit farmers to save seed grown on their own land for future use. Corporations from the developed countries are attempting to use TRIPs to force farmers to purchase new seed every season. TRIPs Agreement appears to be in conflict with other international agreements, such as the International Undertaking on Plant Genetic Resources for Food and Agriculture, and the Global Plan of Action for the Sustainable Use of Plant Genetic Resources for Food and Agriculture (GPA), both of which provide for the right of farmers to save seed.

20. LDCs: CHALLENGES FOR HONG KONG Health and Pharmaceuticals: As the Doha Declaration confirms, TRIPs includes mechanisms intended to safeguard public health while respecting intellectual property rights. But while the principle of the need to increase access to medicines in poor countries is widely recognised, the means of doing so is disputed.

21. LDCs POSITION Must be guided by the DOHA Declaration on TRIPs and Public Health including paragraph 4 which states that “We agree that the TRIPS Agreement should not prevent members from taking measures to protect public health … and should be interpreted and implemented in a manner supportive of WTO members´ right to protect public health, and in particular, to promote access to medicines for all” Must reaffirm the position of the LDCs on the review of Article 27.3B of TRIPs which makes distinction between life-forms and living organisms

22. LDCs POSITION Must ensure that community resource rights regimes is designed to economically empower communities to benefit from the resources biodiversity occurring within specific localised areas Must ensure protection of indigenous knowledge systems, practices, innovations and technologies Must ensure farmers rights to conserve, save, exchange, share, multiply and market farmers varieties and utilise them on a sustainable basis

23. LDCs POSITION Must ensure harmonisation and rationalisation of various contradictions within international instruments, which addresses issues related to Plant Breeders Rights, Community Resources Rights, Farmers Rights and Access and Benefit Sharing in a broad framework Must ensure the right of LDCs to have equal access to medical technologies without being expected to pay the same price as the developed countries – that public health must take precedence over companies profit while recongnising the right of companies to benefit from investment on technologies

24. CONCLUSION Another Africa is Possible! Thank you!!!