1. Brazil: from universal ARV access to universal HCV treatment? Juliana Vallini Friday, 23rd, July, 2010

2. Brazilian Context Health system with universal access to the population; Fundamental human right; Integrated programs of Viral Hepatitis and AIDS.

3. Brazilian Context – Hepatitis 10.507 patients. Total expenditure: -Pegylated interferon: R$ 18.441,00 2006 – 2010 R$ 759.093.648,00. - Interferon: R$ 1.562,00 2006-2010 R$ 24.015.020,00. (rate: US$1= BR$1,79). Merck x Roche.

4. Brazilian Context Lowering ARV prices in Brazil: - Use of TRIPS flexibilities. - Not granting frivolous patents (TDF case as an example). - Information about the product.

5. Post- grant aspects and price negotiation. Prices in other developing countries (MIC) Regulatory aspects (If there is a generic registered) Local production or importation (south-south cooperation for R&D) Quantity

6. Tenofovir 1 st line ARV – increase fastly - 47,000 patients (2009) Patent deposited in Brazil in1995 Opposition MoH declared it of public interest in April 2008 Brazilian Patent Office does not grant the patent (2009) HIV/AIDS and hepatitis B. - Brazil – price reduction US$ 47 mi. - Adefovir (GSK) x Tenofovir (Gilead) CIPLA- prequalified Not granted in India too.

7. 2009 TDF = US$ 42 millions = 14,7% budget imported ARV

8. Challenges Expand access to fair prices to HV medicines. Use of the TRIPS flexibilities as reiterated by the Doha Declaration on TRIPS and Public Health and in the last WHA resolution related to VH. WHA 2008 – Global Strategy on Innovation, Public Health and Intellectual Property – put it into practice – VH is included. The need for cooperation and exchange of information among the developing countries (south- south). Transfer of technology.

9. Thank you! juliana.vallini@aids.gov.br