Saúde pública, direitos de propriedade intelectual e políticas para o acesso a medicamentos: um estudo antirretroviral atazanavir.

Abstract

Abusive prices of antiretroviral drugs has evoked discussions in the international scenario, about issues relating to intellectual property, particulary on pharmaceutical patents and sustainability of access policies to these drugs. The present study describes institutional, juridical and political devices in relation to intellectual property and its impact on access to medicines in Brazil. The overall objective of the study is to analyze patent documents and public policies proposals for atazanavir drug, taking into account the industrial property as well as the relationship between drug registration, selection and adoption as a strategic product for the domestic production and the establishment of productive development partnership (PDP). The bibliographic survey was carried out in articles and patents through bibliographic indexing sources, such as National DST/AIDS Program publications, the Institute of Applied Economic Research (IPEA) and the Brazilian Ministry of Health (MS); laws and regulations related to strategic products for the Unified Health System (SUS) and to projects of innovation and technology transfer, available at the electronic portal of the MS and databases as European Patent Office (esp@cenet), National Institute of Industrial Property (INPI), National Health Surveillance Agency (ANVISA), Food and Drug Administration (FDA) and European Agency for the Evaluation of Medicinal Products (EMA). Thus, three articles have been drawn up where the first analyzes patenting strategy of the atazanavir antiretroviral in Brazil and in the world with the purpose of presenting the market, research, development, production and marketing for the product. To trace the patenting profile of the atazanavir was realized a study in the database Thomson Reuters Integrity and were identified 49 total patent documents involving the technology. The second article shows the implementation of the PDP of the atazanavir drug and checks how the results obtained through this instrument, fulfill the PDP objectives in order to supply the Brazilian MS. Was held an analysis of the overview of the PDPs in Brazil and one exploratory study to identify the PDPs that are in development at Farmanguinhos/Fiocruz. The work continued with the case study of atazanavir PDP in Brazil, by analyzing the terms of the partnership between the public entity, the pharmaceutical laboratory Farmanguinhos/Fiocruz, the private partner Bristol-Myers Squibb (BMS) and the national laboratory Nortec involved in the process. The PDP of atazanavir was formalized in late 2011 and the agreement included the transfer of technology, manufacturing and distribution of the drug for a period of five years. Finally, the third article describes the analysis of atazanavir cycle life including sanitary registration, adoption and selection as a strategic product for the domestic productions. Considering the patent system, the process of conducting the PDP and reflections on access to antiretroviral drugs, it can be concluded that the adoption of technology of the drug, i.e. technology development, the knowledge exchange and the strengthening of the productive chain national, should not occur in isolation, in order to reach the desired sustainability for drugs access policies.