1. NAFTA, CAFTA and Access to Medicines and Food Security in Latin America International Aids Conference Session “Globalization and FTAs: their impact, access to medicines and food security on HIV intervention programmes Mexico City, 6 th August 2008 Gabriela Costa Chaves Brazilian Interdisciplinary Aids Association (ABIA) Working Group on Intellectual Property (GTPI) Brazilian Network for the Integration of Peoples (REBRIP)

2. Where are we after TRIPS?

3. Some experiences... Competition as the best way to get price reductionCompetition as the best way to get price reduction Access to existing technologies under threat Big efforts to implement TRIPS flexibilities ex: compulsory license in Thailand (2006, 2007,2008) and Brazil (2007) Not so much innovation suitable for developing countries needs

4. Source: Untangling the Web of Price Reductions, 9 th Edition. 2006.

5. Which experiences civil society groups have gained? Support the use of TRIPS flexibilities Avoid the granting of improper patents (pre- and post-grant oppositions)  share of experiences between developing countries (ex. TDF patents) International support to local initiatives Find solution inside the current patent system

6. Prices for lopinavir/ritonavir offered to Thailand and other middle-income countries Source: Ford N, Wilson D, Costa Chaves G, Lotrowska M, Kijtiwatchakul K. Sustaining access to antiretroviral therapy in developing countries: lessons from Brazil and Thailand. AIDS 2007. 21;4:S21-S29.

7. Situation after 2005: India TRIPS complied

8. What do we need to do now? To routinely use public health TRIPS flexibilities Avoid the granting of improper patents Think about the importance of stimulating local production of essential health technologies Avoid more than ever TRIPS-plus provisions Find ways to stimulate the innovation for developing countries needs

9. Effects of TRIPS-plus provisions Compulsory Licensing Parallel Import Bolar Exception Promotion of competition with generics Linkage between drug marketing approval and patent status Exclusivity of data submitted for registration of pharmaceuticals Restrictions for the use of compulsory licensing Patent term beyond 20 years Broad criteria for pharmaceutical patent examination Limitation in use of patent oppositions

10. Overview of FTAs between US and other American countries FTAs pending Congressional Approval –Colombia –Panama FTAs in force –NAFTA (1994) –Chile FTA pending implementation –Peru Source: Website of the Office of United States Trade Representatives (USTR)

11. NAFTACHILE*PANAMAPERUCOLOMBIA Restriction for CL +-??? Linkage between drug marketing approval and patent status -++++ Exclusivity of data submitted for registration of pharmaceuticals +++++ Extension of patent term (beyond 20 years) +++++ Source: * Rossi F., 2006. Free Trade Agreements and TRIPS-plus measures. Int. J. Intellectual Property Management, Vol.1, Nos1/2, pp150-172.

12. Other ways to implement TRIPS-plus The experience in Brazil –Bill 29/2006: inclusion of “linkage between patent and medicine registration” –Bolar provision under risk to be cancelled –Civil society published a technical report against this Bill and for policy advocacy

13. Other ways to implement TRIPS-plus The experience in Brazil Revision of Patent Office (INPI) Guideline for Pharmaceutical patent examination –Discussion on patentability of “second use” and “polymorphic forms” etc  NOT transparent process –TOTAL participation of transnational pharmaceutical companies in the discussion that will set a rule –Trying to weak the ANVISA’s role in prior consent Civil society published a technical report against this process and these guideline and developed several policy advocacy strategies.

14. Other ways to implement TRIPS-plus The experience in Brazil Inclusion of pipeline mechanism (patents prior to 1995 were granted if not commercialized anywhere) –Different from mailbox (used for transition period) –Granting patent for pharmaceuticals already filed in another country, without any analysis in Brazil –Lack of novelty –Were not evaluate by Brazilian Drug Regulatory Authority (Anvisa) –1182 patents filed. Some of them granted are Gleevec, Efavirenz, Lopinavir/ritonavir, Amprenavir, Nelfinavir, Abacavir

15. Challenges for Civil Society How to prioritize our efforts to guarantee long term access to essential medicines? –Promote the use of TRIPS flexibilities? –Avoid the granting of improper patents? –Avoid the inclusion of TRIPS-plus provisions? –Monitor FTAs? Monitor Bills in the Congress? Monitor favorable decisions in the Court to pharmaceutical companies?

16. Thank you! www.abiaids.org.br gabriela@abiaids.org.br