1. Access to ARVs in Brazil: challenges for civil society XVII International Aids Conference Satellite Meeting on Access to Medicines and Intellectual Property Mexico City, 5 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. Brazilian Interdisciplinary Aids Association (ABIA) Created in 1986: to mobilize society in order to overcome the HIV/Aids epidemic To monitor public policies on health, education, prevention, treatment and human rights “Aids is not only a disease or a health problem, but also a cultural and political problem which demands a response from differents sectors of the society.” Betinho, 1986

3. Network composed by several NGOs and social moviments Monitoring of Free Trade Agreements and its implications on public interest local policies Brazilian Network for the Integration of Peoples (REBRIP) - 2001 AgricultureTrade and Environment ServicesGenderParliament Intellectual Property Working Groups

4. ABIA (coordination), HIV/Aids organization and fora from different regions of Brazil, local consumer’s rigths NGO (Idec), human rights NGO (Conectas), National Federation of Pharmacists (FENAFAR), MSF, Oxfam, researchers and experts Working Group on Intellectual Property (GTPI) Aims to monitor and try to minimize the negative impact of patent system on access to medicines in Brazil

5. Access to medicines scenario in Brazil Legal Overview

6. Access to health care (including medicines) Federal Constitution 1988 “right to health for all Brazilian citizens is an obligation of the State, through social and economical policies” Brazilian Patent Act - 1996 National Medicines Policy - 1998 Unified Health System (SUS) – 1990 –Including access to medicines Sarney Act – 1996: guarantee access to treatment and care for people living with HIV/Aids (ARV and opportunistic infections)

7. TRIPS public health flexibilities in Brazilian patent legislation Act 9.279/96 Act 10.196/01 Compulsory license Experimental use Bolar exception MoH participation in the process for granting of pharmaceuticals patents (drug regulatory authority - ANVISA) Decree 3.201/99 Decrre 4.830/03

8. Problems in Brazilian Patent Act National exhaustion of rights – No parallel import –Limited to one case of compulsory license Pre-grant opposition exists in a very limited way  “support to examination” Inclusion of pipeline mechanism –Different of mailbox –Granting patent for pharmaceuticals already filed in another country, without any analysis in Brazil –Lack of novelty Limited use of transition period allowed by TRIPS to grant patents to pharmaceuticals (one year)

9. GTPI/Rebrip Advocacy Strategies Pressure to the use of public health TRIPS flexibilities Avoid the granting of improper patents Avoid the implementation of TRIPS-plus provisions Advocacy Strategies Legal strategies Technical reviews and lobby Monitoring and incorporation in the local health movement problems related to patents

10. GTPI/Rebrip Advocacy Strategies Pressure to the use of public health TRIPS flexibilities Avoid the granting of improper patents Avoid the implementation of TRIPS-plus provisions Advocacy Strategies Legal strategies Technical reviews and lobby Monitoring and incorporation in the local health movement problems related to patents

11. 2005: Price negotiations between MoH and Abbot Step forward to CL: declaration of public interest for Lopinavir/ritonavir Step back to CL: agreement signed between government and Abbot -Commitment to not use compulsory license for this medicine or any of its component  TRIPS-plus decision - The price was fixed until 2011 at 1.380 US$ per year per patient. - Commitment to increase the price of the new formulation (tablet of Lop/ritonavir)

12. Organizations involved – Working Group on Intellectual Property (GTPI) 5 NGOs/Aids 1 Human rights 1 Consumer’s rigth Federal Public Attorney Public Civil Action - 2005 Demanding the Executive Level to issue a Compulsory licensing for fixed-dose- combination Lopinavir/ritonavir (Kaletra ® ) for HIV/Aids

13. To involve the Judiciary level in this kind of debate To raise public awareness on the negative implications of intellectual property rules on access to health To stimulate and involve the Judiciary level to take measures to pressure the Executive level to implement public health flexibilities Main objectives of the Public Civil Action on Lopinavir/Ritonavir

14. To prove the national capacity to produce medicines locally for HIV/Aids (public and private laboratories) Technical Study Lead by GTPI/Rebrip and MSF http://www.abiaids.org.br/media/ARV.pdf

15. 2007: by the end of the year, there were 75.000 patients being treated with efavirenz US$580 per patient/year since 2003 - Several negotiations between MoH and Merck, which offered 2% price reduction - Efavirenz was declared by government of public interest - Government issued the 1 st CL for efavirenz (ARV) – May 2007 - Generic version pre-qualified by WHO imported from Indian companies – July 2007 - Local production being prepared

16. Some lessons learned Pressure in the mass media against the measure taken by the government Strong support from civil society groups International support from civil society groups, key-players and government representatives

17. http://www.abiaids.org.br/media/EFAVIRENZ.pdf Questions and Answers about the Compulsory License of Efavirenzin Brazil – GTPI/Rebrip

18. GTPI/Rebrip Advocacy Strategies Pressure to the use of public health TRIPS flexibilities Avoid the granting of improper patents Avoid the implementation of TRIPS-plus provisions Advocacy Strategies Legal strategies Technical reviews and lobby Monitoring and incorporation in the local health movement problems related to patents

19. Tenofovir case December 1 st 2006: GTPI/Rebrip presented in INPI a support to examination against the grant of the patent claim for “tenofovir disoproxil fumarate” Main argument: lack of inventiveness Additional information: –Number: PI9811045-4; –Priority date: 25/07/1997

20. Tenofovir case 2008: the Ministry of Health declared Tenovofir of public interest  request for the “priority examination” In the same day, INPI move forward with the TDF process: publication of technical review questioning the patent claim. –Gilead had 90 days to give a feedback. Decision is pending

21. Tenofovir case 2008: ABIA and Sahara (Indian organization) presented an opposition in India against the granting of TDF patent A local decision in India has a global impact on access to medicines in developing countries

22. GTPI/Rebrip Advocacy Strategies Pressure to the use of public health TRIPS flexibilities Avoid the granting of improper patents Avoid the implementation of TRIPS-plus provisions Advocacy Strategies Legal strategies Technical reviews and lobby Monitoring and incorporation in the local health movement problems related to patents

23. 1 – AIDS: Abacavir Amprenavir Efavirenz (patent from 92) Nelfinavir Lopinavir/Ritonavir 2 - Chronic Mieloid Leukemia : Imatinib (Gleevec) 3 – Heart conditions: Clopidogrel (plavix) 1182 pipeline patents were filed!!! TRIPS-plus in the Brazilian Patent Act

24. Civil society and Pipeline Patents July, 2007: –Open meeting with the main Brazilian Constitutionalists to discuss legal arguments –Overcrowded and lots of pharmaceutical companies lobbyists and INPI representatives November, 2007: –Public audience in the Parliament –Several congressmen  “Pipeline is a crime” –National Federation of Pharmacists (Fenafar), on behalf of Brazilian Network for the Integration of Peoples (Rebrip) presented a proposal of unconstitutionality of pipeline patents to the General Public Attorney –Expectation that the General Attorney proposes an Direct Action of Unconstitutionality (ADIN) against pipeline patent

25. Civil society and Pipeline Patents January, 2008: several international support –Colombia: Health Action International, Fundación IFARMA,Fundación Misión Salud –Thailand: Thai network of people living with HIV/AIDS (TNP+) in solidarity with: AIDS ACCESS Foundation, Thai Foundation for consumers,Thai Rural Doctors society, Thai Chronic renal failure network, Thai Alternative Agriculture network,Thai Parents network, Thai Rural Pharmacist society, Thai NGOs Coalition on AIDS, FTA Watch, Drug Study Group –India: Lawyers Collective HIV/AIDS Unit, Indian Network for People Living with HIV/AIDS, Delhi Network of Positive People, Alternative Law Forum, Cancer Patients Aid Association, ActionAID India January, 2008: several technical reviews supporting the case –Professor Broke Baker (Northeastern University, USA) –Professor Kevin Outterson (Boston University, USA) –Professor Lisa Foreman (University of Toronto, Canada) –James Love (Knowledge Ecology International) –Third World Network

26. 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 TRIPS-plus provision in the Legislative

27. New Monopolistic Practices Against Access to Medicines The case o tipranavir - The product is being tested in Brazil - Company did not file the registration in Brazil - Main arguments: The company will wait for the patent decision Brazil is not in the “company’s marketing list” - Brazilians are only used to be tested for medicines that will be commercialized in other countries - Company only filed the registration claim in Feb/2008

28. Ongoing Challenges for Civil Society Challenges National Treatment Guideline New medicine Which patent claim? Find the patent number Pending decision Patented Find the status of several patents for the same product Find technical arguments Involvement of civil society groups to move forward Pre-grant opposition? Find the status of several patents for the same product Promote the implementation of experimental use and Bolar exception Post-grant opposition? Compulsory license Political support Capacity to produce Possibility to import

29. Ongoing Challenges for Civil Society Strength solidarity between developing countries Find potential collective strategies between developing countries

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