1. Challenges in ensuring access to HIV medicines and IP rights: country experiences (Brazil) Dr Jorge Bermudez, Vice President of Health Production and Inovation (VPPIS – FIOCRUZ) UNITAID – 3rd Consultative Forum Geneva, October 2011

2. National experiences – Brazilian background In 1988 - National Constitution – “Health is a right of all and a State duty” In 1996 -Law 9.313, 13 November 1996 - Guarantees free access to antiretroviral therapy. National industries currently manufacture eight antiretroviral drugs and Brazil is in a strong position to negotiate prices with patent holders. In 1999 -Law 9.782, 26 January 1999 - Creates the National Regulatory Agency ANVISA, which decides the sanitary surveillance policies and regulation. -The State, with the full power of the Constitution to support it (1988), became the repository of a wide range of sanitary surveillance responsibilities, looking after the rights of the consumer and assuming responsibility for providing better health conditions for the population. In 1999 -Law 9.787, 10 Februrary 1999 - Alters Law nº 6.360, of 23 September 1976, concerning sanitary surveillance, establishes the generic drug policy, decides upon the use of generic names in pharmaceutical products, among other procedures. -Generics Drugs – The introduction of generic drugs on the brazilian market changes all the pharmaceutical market share and the pharmaceutical industries approaches.

3. Relevant Landmarks In 2000 - Faced with Merck’s refusal to reduce the price of an antiretroviral, the Brazilian government raised the possibility of issuing a compulsory license to manufacture the product. In 2004 - Brazil and Cuba have undertaken joint projects in biotechnology. Among the most important are the production of recombinant erythropoietin and interferon, as well as development and supply to Africa (at WHO’s request) of a meningitis vaccine. In 2007 - The first compulsory license was effectively issued for the antiretroviral drug efavirenz, used by 75.000 patients. In 2009 - Declaration by Brazil and India at WTO criticizing the European Union’s policy restricting the entrance of generic drugs and the FTA, following Schiphol confiscation of products in transit.

4. Generic Medicines in Brazil There are 2792 generic medications registered in Brazil (90% domestic manufacturing). The volume of generics has been growing from 223 million units distributed in 2007 to 330 million in 2010. Generics are 25% of all medications sold in Brazil, and there is more potential market. The share of generics is 50% in the United States and 45% in Europe.

5. ANVISA Prior Consent According to the Intellectual Property Rights Law amendment - “The prior consent for a patent to a pharmaceutical product is dependent on the previous evaluation of the Brazilian Health Regulatory Agency - ANVISA (Agência Nacional de Vigilância Sanitária).” This new legal mechanism, known as Anuência Prévia (Prior Consent), divides the examination of patent applications for pharmaceutical products and processes between two federal agencies in Brazil; the main one being the National Institute of Intellectual Property (INPI) and the second being ANVISA.

6. ANVISA Prior Consent The law permits ANVISA, the federal agency devoted to the protection of public health, to consider the public interest when deciding whether to allow the grant of patents approved for patentability by INPI (Patent Office). Predictably, the law has instigated debate within Brazil and throughout the world as to the procedure's legality and policy, including the so-called 4 th requisite. What would be Prior Consent's proper place within Brazil and under the international regime of intellectual property law, which is mainly defined by the WTO TRIPS Agreement is currently under debate.

7. “Breaking Patents?” The Brazilian government, March 2006, publicly threatened to issue CL on four anti-retroviral medications -- Merck's Efavirenz, Abbott Laboratories' Lopinavir and Ritonavir, and Gilead's Tenofovir - if the companies did not agree to allow Brazil to produce generic equivalents or buy those patented drugs at discounted prices. Eventually, Brazil reached an agreement with Abbott to lower the cost of Lopinavir and Ritonavir, (Kaletra R) from $1.17 to 63 cents a pill, while still protecting the drug's patent. Under the terms of that agreement, Brazilian manufacturers can not produce a generic version of the drug for their domestic market. Brazil, according to writers, is now the world's tenth-largest economy, in part because of "this illegal seizure" of technology and information. All procedures are strictly legal and complying with international agreements.

9. Innovation Incentives and IP Protection On the federal level, Brazil has taken steps toward strengthening IP protection. In December 2004, the federal government passed Law No. 10,973, which "introduces provisions on incentives for innovation and scientific and technology research in the production environment”, adding that this law encourages public- private R&D partnerships and enables public subsidies to private technology commercialization initiatives. "With this law, the legislature and executive [branch] have confronted head on the overriding obstacles to technology innovation and commercialization in Brazil."

10. MPP - License agreement signed July 12th 2011 -The first license agreement signed between the Medicines Patent Pool Foundation and a private pharmaceutical company (Gilead Sciences) -Brazil formally complained on:.non-exclusivity.non-discrimination.transparency

11. Federal Government expenditure with ARV R$ 895.070.562,07 see next slide... Medicine Demand (units) 2010 SupplierExpenditure (R$) Atazanavir 200mg4.800.000 LAWRENCE 19.958.400,00 Atazanavir 300mg10.200.000 LAWRENCE 76.683.600,00 Darunavir 300mg12.960.000 JANSSEN 103.161.600,00 Didanosina EC 250mg1.200.000 LAWRENCE 2.058.840,00 Didanosina EC 400mg1.376.250 LAWRENCE 3.095.901,90 Didanosina (4g)9.000LAFEPE 555.570,00 Efavirenz Cápsula 200mg330.030 UNICEF 119.052,00 Efavirenz 600mg54.000.000 FIOCRUZ 36.450.000,00 LAFEPE 12.150.000,00 UNICEF 7.386.981,00 Efavirenz24.500MERCK 747.201,00 Enfuvirtida (T-20) 90mg/ml21.750ROCHE 54.403.779,19 Estavudina 30mg3.852.000FIOCRUZ 885.960,00 Estavudina20.000CRISTÁLIA 1.167.018,00 Etravirina 100mg403.200 JANSSEN 4.209.408,00 Fosamprenavir 700mg1.800.000GLAXO 6.913.800,00 Fosamprenavir 95ml1.480GLAXO 304.732,00 Indinavir 400mg4.950.000LAFEPE 1.488.960,00 LAFEPE 372.240,00 LIFAL 2.233.440,00 LIFAL 558.360,00

12. Lamivudina 150mg63.000.000 FIOCRUZ 17.325.000,00 FURP 11.781.000,00 Lamivudina IQUEGO 5.544.000,00 Lamivudina91.000IQUEGO 1.885.520,00 Lopinavir+Ritonavir 200mg + 50mg106.080.000ABBOTT 137.655.772,80 Lopinavir+Ritonavir 100mg + 25mg660.000ABBOTT 571.071,60 Lopinavir+Ritonavir 80mg/ml + 20mg/ml25.000ABBOTT 1.946.375,00 Nevirapina 200mg16.451.160FIOCRUZ 4.811.400,00 FUNED 4.811.400,00 FUNED 1.202.850,00 Raltegravir 400mg5.100.000MERCK 86.134.104,00 Ritonavir 100mg20.400.000ABBOTT 11.453.000,00 Ritonavir530ABBOTT 282.389,30 Saquinavir 200mg1.015.200 CRISTÁLIA 1.705.536,00 Tenofovir 300mg30.000.000GILEAD 120.750.000,00 Tipranavir 250mg136.080BOEHRINGER 1.166.205,60 Tipranavir 100mg/mL1.676BOEHRINGER 623.472,00 Zidovudina 100mg6.200.000 FIOCRUZ 1.612.000,00 Zidovudina 10mg/ml18.000 CRISTÁLIA 88.369,20 Zidovudina 50mg/5ml129.000 LAFEPE 917.190,00 Zidovudina+Lamivudina 300mg + 150mg133.750.080FIOCRUZ 59.812.500,00 FURP 29.301.294,00 FUNED 28.105.044,00 Zidovudina+Lamivudina 300mg + 150mg IQUEGO 10.766.250,00 LAFEPE 19.140.000,00 479.005.936 895.070.562,07 72,66%650.315.422,39 Medicine Demand (units) 2010 SupplierExpenditure (R$)

13. “O Brasil defende o acesso aos medicamentos como parte do direito humano. Sabemos que é elemento estratégico para a inclusão social, a busca da equidade e o fortalecimento dos sistemas públicos de saúde. (...) O Brasil respeita seus compromissos em matéria de propriedade intelectual, mas estamos convencidos de que as flexibilidades previstas no Acordo TRIPS da OMC, na Declaração de Doha sobre TRIPS e Saúde Pública, e na Estratégia Global sobre Saúde Pública são indispensáveis para políticas que garantam o direito à saúde”. Presidente Dilma Rousseff 19 Set-2011