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India and TRIPS• India had to comply with TRIPS in 2005• Indian Parliament included key health safeguards• Indian PLHIV and health groups have filed patent oppositions to ensure continuing generic production – Lamivudine/zidovudine combination, nevirapine syrup, tenofovir, darunavir• Still key newer ARVs patented: raltegravir, etravirine• Hep-C treatment: pegylated interferon: $15,000 per person
EU-India FTA: making a bad situation worse• Negotiations started in 2007• Complete secrecy• EU not known as aggressive on IP as US• However EU-South Korea FTA made public – Several TRIPS-plus provisions• Growing concern and vague responses from EU and Indian government officials
What does the EU want?• Leaked text in 2009 and 2010 confirm aggressive TRIPS-plus demands by EU: – Patent Term Extension: Patent term to be greater than 20 years – Data Exclusivity: Monopoly on off-patent medicines – Enforcement measures: Public money used to enforce private rights; hampering judges ability to protect public health – Investment provisions: Allows MNCs to sue Indian government over health policies and laws
Indian groups protest; beaten up• DELHI• North-East• South
Activists donate 5 ml blood to get FTA message to Carla Bruni • Global Fund ambassador • As of 2009, the USFDA & WHO Prequalification Programme approved or pre-qualified 31 paediatric ARV tablets produced by Indian generic manufacturers but only eight adult FDCs & 14 paediatric ARV tablets produced by non-Indian & originator manufacturers • In 2008, Indian-produced generics accounted for 91% of paediatric ARV volume. - A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries. Journal of the International AIDS Society 2010;13:35.
MASS RALLY: Groups from India, Nepal,Cambodia, Indonesia, Thailand, Malaysia in Delhi
EU-India FTA: Update• Indian Prime Minister’s office: Nothing in FTA beyond TRIPS/domestic law• Concern on enforcement measures (EC trying to argue that it is within Indian law)• Investment provisions (allowing EU MNCs to sue Indian government over health policies, drug price control, etc.)• EC and US bilateral pressure on India to change domestic law to include TRIPS-plus provisions outside of FTA• India also negotiating FTA with EFTA (Switzerland, Iceland, Norway, Lichtenstein)
What if India says no but others countries sign FTAs?• India could produce and export• Importing countries can no longer import• EU and US both negotiating FTAs across developing world
EU negotiations across AsiaCountry Status Details of FTA NegotiationsCambodia LDC EU-ASEAN FTAIndia Developing Country EU-India EFTA-IndiaIndonesia Developing Country EU-ASEAN EU-Indonesia EFTA – IndonesiaLao Peoples Democratic Republic EU-ASEANMalaysia Developing Country EU-ASEAN EU-MalaysiaMyanmar LDC EU-ASEANPhilippines Developing Country EU-ASEAN EU-PhilippinesThailand Developing Country EU – ASEAN EU-ThailandViet Nam Developing Country EU – ASEAN EU-Vietnam
US re-joins the FTA party• Trans-Pacific Partnership Agreement: US, Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore, and Vietnam.• What does the US want: – Patents on new forms of old medicines • Exact opposite of Indian law provision Section 3(d) because of which there are no patents in India on lamivudine/zidovudine combination, tenofovir and nevirapine syrup – No pre-grant oppositions • Exact opposite of Indian law provision that allows health and PLHIV groups to challenge patent applications – Possible longer terms for patents and for data exclusivity – Investment provisions: Allows US • Even developed countries in companies to sue governments over the deal worried: Australia, health policies; in particular price New Zealand finding their control and negotiation mechanisms medical programmes under are under threat attack
Global Fund Statement on FTAs• “Free Trade Agreements with the developing world need to take into account that the world’s major pandemics predominantly affect the poorest people and should recognize the role of India in supplying quality low-cost medicines to the developing world”, said Professor Kazatchkine.• Is it enough?
Bangkok Declaration demand of GF • The GLOBAL FUND BOARD to: – call attention to & condemn FTA negotiations that include TRIPS-plus measures, – to direct the Global Fund secretariat to assess the financial impact of potential trade agreements, share this analysis publicly, – ensure the adoption of procurement systems that make optimal use of TRIPS flexibilities including encouraging countries to use compulsory licences to ensure the GFATM does not pay excessive premiums for patented medicines.
Global Fund and IP: A question of transparency• Has the Global Fund ever received letters or threats from patent holders on their money used for generic procurement? – Why not made public?• Has Global Fund ever had to give emergency excess funds for countries left out of voluntary licences? – Why not made public? – VLs will leave out Latin America, China Russia, Middle East, Easter Europe – Why open support for VLs with no concern on restrictive conditions?• Have developed countries held up Global Fund commitments over trade or investment disputes? – Why not made public? – German government actions in Philippines
Global Fund and the “middle income” game• Lets get real about India: – 1.4 billion live on less than $2 a day – Nearly 40% get pushed back into poverty because of healthcare spending – From my own experience, those accessing the AIDS programme are poor and lower middle class – and for whom even with the free medicines, the cost of getting to the ART centre is too much to bear.• So-called middle-income countries are the ones: – Struggling with TRIPS since 2005: newer ARVs patented – Being left out of voluntary licence mechanisms – Having to pay premium prices under so-called discount schemes – Being left out of the Global Fund?