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Barriers to generic drug entry in developing countries Asia Russell • Health GAP Coalition • www.healthgap.org TACD Committee on Intellectual Property Meeting on the Impact of Intellectual Property Rules on Consumers of Health Care Services October 31-November 1, 2002 NGO founded by U.S. HIV/AIDS, human rights and fair trade activists • Campaigns for changes to United States Administration and to US corporations’ policies obstructing access in poor countries to affordable medicines to treat HIV; • Campaigns for resources (money, technology transfer, other investments from governments and private sector) from donor countries to sustain medicines and treatment access in poor countries; and • Educates and mobilizes the grassroots: thousands of people living with HIV and other health care consumers in the United States Pressuring decision makers: 1999 QuickTime™ and a GIF decompressor are needed to see this picture. Essential medicines are not luxury goods, reserved for the wealthiest of the world… …but are too often priced like them, causing preventable suffering and death. Defining the problem: “The people with HIV are where the drugs are not.” Realities: AIDS death rates drop in the U.S. and other rich countries But life expectancy plummets in Africa. Barriers to generic drug entry • Pressure from the U.S. – Current (FTAA, new bilateral agreements, etc.) – Stain of recent past • TRIPS export restrictions • Patent protection in key countries where production is necessary for manufacturers to achieve economies of scale (eg South Africa, Botswana) • Patent protection of key second-line therapies • Industry-driven technical assistance • Accelerating Access Initiative: distraction from sustainable, coherent, patient-driven solutions New trade agreements • USTR position will undermine achievements of Doha • IP rules are TRIPS plus--industry effort to expand on already strict WTO rules • Proposed FTAA comprises developing countries capable of production for export; spillover affect outside South America Technical assistance: whose agenda? • US AID and other donor development assistance agencies contract with consulting firms that prioritize patent rights over patient rights – Procurement policies require purchase from originator companies • More intellectual property protection is not always better--can WIPO abide by this pro-public health standard? – Anything less is malpractice – WIPO is inexpert in technical assistance when it impacts health and medicines access WHO’s Accelerating Access Initiative Any new access to medicines is good, but… • Power in the hands of Pharma negotiators • Slow, non-transparent, redundant, cumbersome (11 countries, 2 years, only 22,000 people) • Conditional, exclusionary price reduction programs • WHO as “broker” for initiative that contravenes rational and just public health guidelines • Advocates press for multiple suppliers and generic competition to achieve prices as close as possible to the marginal cost of drug production-quickly! Pressuring decision makers: 2002 Overcoming barriers • Practical tools – Implementation of the Doha Declaration on TRIPS and Public Health at national level – WHO Pre-qualification Project – Non-exclusive voluntary and non-voluntary licenses for public and private sector • Pro-public health policies – Advocacy for rational procurement policy of the Global Fund to fight AIDS, TB, and Malaria, and for efficient procurement of generic medicines – Monitoring donor pressure on GF recipient countries Overcoming barriers: cont’d • Pro-public health policies – Doha standard must not be exceeded in new trade agreements; use Kennedy Amendment to Fast Track – Demanding procurement of generics by corporations beginning to treat their workers – Support grassroots advocacy for compulsory licenses with special attention to fixed dose combination medicines that simplify treatment – Advocate for pro-public health solution to production for export problem Declaration on the TRIPS Agreement and Public Health “We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can 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.” A word on money • 40 million currently infected; UNAIDS predicts the pandemic is “in its infancy”; almost 30 million living with HIV in sub Saharan Africa • Scarce, finite resources mean waste is criminal • Cheaper generics stretch limited resources further; prioritizing human rights over patent rights is a matter of life and death • The Bush Administration’s contributions to the Global Fund rank the US last among rich countries when assistance is measured as percent of GNP • U.S. stinginess requires high level attention to overcoming barriers preventing generic drug access Compare and contrast 0.018 0.016 0.014 0.012 0.01 0.008 0.006 0.004 0.002 0 1 2 • Rwanda gives $1 million to Global Fund • US gives $200 million to Global Fund • Making Rwanda more ten times more generous, proportionately Unfinished Business at the WTO “We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002.” TRIPS Agreement: looking past Doha • U.S. and EU currently blocking a good-faith, “workable solution” • An unworkable solution will call into question to ability to strike a balance between IPRs and public health if the present form of TRIPS is upheld • Lack of resolution on para 6. issues will beg the question of the need to reform the Agreement in favor of those who bear the greatest burden from lack of access to medicines