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  Intervention of Brazil to the WTO TRIPS Council (March 2011) providing details about the Brazilian HIV treatment program
  01 มีนาคม 2554

Date: 1 March 2011

Brazil made the following intervention at the WTO Council for TRIPS during discussions of the paragraph 6 system.

"Mr. Chairman,

Brazil welcomes the opportunity for this follow-up to the review on the implementation of the paragraph 6 system. Our aim here is to assess whether this system is indeed an expeditious solution for countries lacking manufacturing capacity and to address any shortcomings for the system`s effective operation.

As we have mentioned last meeting, the TRIPS Council and other fora should analyze whether the economic and political incentives provided by the system are adequate to secure investment in the production of generic medicines at affordable prices. The fact that in seven years there has been only one case of use of the system is strong evidence that they are not.

The paragraph 6 system as well as other TRIPS flexibilities are tools to help ensure access to medicines at affordable prices. This is particular important in Brazil for our Constitution guarantees to all citizens universal and equal access to health at no cost.

Mr. Chairman,
We would like to take this opportunity to present some aspects of our HIV/AIDS program that may be of interes for our discussions today.

In Brazil, all persons living with HIV/AIDS are entitled to receive free treatment, which includes the exams needed to monitor their health and all the medicines for HIV and opportunistic diseases.

There are currently 201 thousand patients under treatment for HIV/AIDS in Brazil. The number of patients increases by 30 thousand annually. The estimated cost for the HIV/AIDS program in 2011 is 500 million 
dollars, which means an annual cost per patient of 2500 dollars.

Advances in drug development have provided more effective treatment, resulting in significant gains in terms of patients longevity. This is an important achievement but also entails increased costs. As patients develop resistance, more research and investment are needed to develop next generation drugs. As a result, new generation drugs come at a higher cost. The Brazilian government thus acts to reach a balance between the rights granted to IPR owners and the interests of society as a whole.

Currently, 57% of Brazil`s HIV/AIDS patients use second and third generation antiretroviral drugs. The use of these new generation drugs increase annually as the life expectancy of HIV patients in Brazil has increased from 58 months in 1995 to 108 months in 2007.

In order to maintain the sustainability of the program, Brazil continuously negotiates with drugmakers to reduce the price of anti-retroviral and makes full use of the flexibilities provided at the TRIPS Agreement. One example of such use is the issuance of a compulsory licensing of the anti-retroviral drug Efavirenz, in 2007, which is one of the most used medicines in the anti-retroviral therapy. In 2007, 38% of the Brazilian patients were making use of it. Because of the increase in costs due both to an increase in the number of patients and to the use of new generation drugs, the costs related to Efavirenz risked jeopardize the viability of the Program.

At US$ 1.59 a dose, the purchase of Efavirenz cost approximately US$ 42.9 millions to the Brazilian Government, or US$ 580 per patient/ year. As a result of the compulsory licensing, the cost per dose was reduced to US$ 0,43.
Mr. Chairman,

Let me conclude by saying that we remain committed to make the necessary changes so that the paragraph 6 system can perform the function it was designed to perform.

In this regard, we consider it is time to include other stakeholder in this discussions so that we can better understand why the system is no being used and agree on ways to improve it."


Keywords: WTO / TRIPS / Brazil / HIV