Associação Brasileira Interdisciplinar de AIDS
July, 2005
As you may know, the Ministry of Health of Brazil has issued a decree in June 2005, declaring the lopinavir/ritonavir combination (Kaletraâ) as a Public Interest medicine. This decision is totally legal, based on the flexibilities accorded in the TRIPS Agreement, emphasized in the Doha Declaration, and does not represent any breach of international agreements on Intellectual Property Rights, which are fully respected by the Brazilian government. This decree was supposed to be a first step towards issuing a compulsory license, but the Ministry of Health also sent Abbott a letter including a ten-day deadline, allowing the company to propose price reduction of the combination and technology transfer of its manufacturing process. Otherwise, the compulsory license would be issued. Abbott presented a gradual price reduction proposal up to 2010, foreseeing an increase on the number of patients from around 23 to 60 thousands in this period. Additionally, the company would offer the technology transfer from 2009 onwards, only 6 years before the patent expires in Brazil.
Abbott's proposal does not benefit Brazil, as it limits its local manufacturing capacity, creating a market niche for this product, and guaranteeing the monopoly until the patent expiration. Briefly, the main hindrances are described below:
For these reasons, it remains clear that the compulsory license and local manufacturing of the combination lopinavir/ritonavir produced by Abbott are the only feasible alternatives to obtain price reduction of the drug, and, at the same time, to create more alternatives for middle income countries to ensure second line treatments for all patients in need. The same applies for the other drugs which technical capacities for local manufacturing is already possessed by Brazil, which are tenofovir and efavirenz, that are still protected under patents. By issuing the compulsory license of these drugs, Brazil should be in conditions to manufacture the whole manufacturing process, it means, since the raw material synthesis until the formulation of the final product.
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