Universal Access: To what extent current mechanisms are appropriate and sustainable to maintain free of charge treatment? Compulsory Licensing in Brazil Carlos Passarelli

AIDS in Brazil Concentrated epidemic Stabilized HIV infection prevalence rate in the general population at levels below 1% Reduction in mortality rates in the last 12 years Increase in the proportion of cases in the heterosexual exposure category There are internal and regional inequalities that reflect on the trends of the epidemic

Main Features of the Brazilian Response Early response and political will Strong civil society participation Balanced approach between prevention and treatment, assured by: –Legislative and legal frameworks –Local production of ARVs

The crisis around the corner Transition from 1st to 2nd line has impacted on the budget: –An estimated 40% increase in associated budget due to the high proportion of the expenses that 2nd line medications represent. The number of patients on 2nd line regimen is increasing by 50-60%

Patents and ARV In 2005, the acquisition of patented drugs (EFZ, LPV/r, TDF, ATV, etc) represented 80% of the NAP budget for imported medicines – it is a risk for other diseases as well. There are evidences that some current ARV patents were granted without appropriate examination by the Brazilian Patent Office.

74,377,064,352,6 83,3 Multinational 25,723, ,4National 2001 ARV Production ,744,642,2 55,457,8 Proportional Expenditure on ARV: national and multinational production 2007 – NATIONAL 32%, MULTINATIONAL 68% - preliminary ,0 73,0

Why Issue a Compulsory License? Efavirenz is the most used imported antiretroviral treatment drug in Brazil In 2003, 49,000 people were using EFZ; now 80,000 among 190,000 Price since 2003: US$ 580 p/y or US$ 1.59 per 600 mg tablet Estimated expenditure by MoH in 2007: US$ 42,930,000

Negotiation Process From November, 2006 to April, 2007, several meetings between the MoH and the patent holder (two Ministers were present in one of the meetings) –Brazil proposed a fair price, in accordance with the public interest During the whole negotiation process, the pharmaceutical company insisted on keeping the same price since 2003

How May We Define Public Interest?

If it is still not a good definition… Let us try this one

Achievements after the CL

Proportion before CL (2006)

Proportion After CL (2007)

Access to WHO pre-qualified EFZ generic version Price reduction: From US$ to US$ ppy –US$ 0.45 (including royalties and freight) Reduction in expenditure: –In 2007: US$ 30 millions –By 2012: US$ 237 millions Increase national capacity at medium and long term

Thank you!!! Muito Obrigado!!! Muchas Gracias!!!