Brasil e Estados Unidos têm apresentado posições políticas divergentes em relação à propriedade intelectual desde a década de 1970. O contencioso das patentes farmacêuticas na OMC foi iniciado em 2000 com um pedido de consulta dos Estados Unidos em relação à lei de patentes brasileira e está inserido nesse contexto de divergência entre os dois países. O contencioso foi solucionado por meio de um acordo no qual os Estados Unidos retiraram a queixa contra o Brasil em 2001. O envolvimento político de redes transnacionais de ONGs levou o assunto ao conhecimento da opinião pública mundial, fato que parece ter influenciado o resultado do contencioso. Sob o marco teórico da transnacionalidade, este estudo tem o objetivo de dimensionar o grau de influência política das ONGs organizadas em redes e seu impacto no resultado do contencioso. Para isso, (1) identifica as principais ONGs envolvidas na campanha global de acesso a medicamentos essenciais no período compreendido entre 1997 e 2001; (2) resgata o conflito em propriedade intelectual existente entre Brasil e Estados Unidos desde as décadas de 70 e 80; analisa (3) as estratégias das redes transnacionais de ONGs dentro da campanha de acesso a medicamentos essenciais e (4) os principais condicionantes do papel das ONGs na política mundial. Com base no estudo empírico da campanha de acesso a medicamentos essenciais, a conclusão reflete um esforço em dimensionar o papel das redes transnacionais de ONGs no contencioso entre Brasil e Estados Unidos na OMC, interpretando-o como parte de um movimento transnacional anti-hegemônico que gerou resultados benéficos em questões de propriedade intelectual aos países em desenvolvimento entre 1997 e 2001. / Brazil and the United States appear to have defended divergent intellectual property policies since the 1970s. The controversy on pharmaceutical patents at the World Trade Organization (WTO) started back in 2000 with a complaint by the United States about the Brazilian patent law and it is part of this context of divergence between both countries. The controversy was solved by means of an agreement in which the United States withdrew the complaint against Brazil in 2001. The political engagement of transnational NGOs networks leveraged this issue to the concern of global public opinion. This fact appears to have influenced the outcome of the case at the WTO. Based on theoretical approaches on transnationalism, this study aims to dimension the degree of political influence of networkbased NGOs and its impact on the conflict outcome at the WTO. For this purpose, the research work (1) identifies the main NGOs engaged in and involved by the Global Access to Essential Medicines Campaign between 1997 and 2001; (2) reviews the conflicts on intellectual property between Brazil and the United States which have been taking place since the 1970s and 80s; analyses (3) the transnational NGOs networks’ strategies in the scope of the Global Access to Essential Medicines Campaign and (4) the main conditioning factors to the role of NGOs in world politics. Based on the empirical study on the Global Access to Essential Medicines Campaign, the conclusion reflects an effort to dimension the role of transnational NGOs networks in the controversy between Brazil and the United States at the WTO, interpreting it as part of an anti-hegemonic transnational movement that generated beneficial outcomes on intellectual property issues to developing countries between 1997 and 2001.

O modelo de promoção da inovação em saúde predominante na atualidade é baseado na proteção da propriedade intelectual por meio da concessão de patentes. A patente permite ao seu titular explorar o objeto protegido com exclusividade por um determinado período de tempo, no qual seria obtido o retorno do investimento feito na pesquisa e desenvolvimento do produto. A obtenção de retorno do custo da P&D pela comercialização do produto final, potencializada pelo monopólio conferido pela patente, faz com o que o detentor da tecnologia estabeleça preço de venda elevado. O sistema de patentes potencializa, assim, a maximização de lucros das empresas farmacêuticas, ampliando seu interesse no desenvolvimento de produtos rentáveis e na mercantilização da saúde. Foram identificadas e sistematizadas evidências que demonstram que a aplicação do sistema de patente na área da saúde tem gerado problemas de inovação, ao direcionar recursos de P&D voltados para a produção de produtos rentáveis e não voltados a atender necessidades de saúde; e de acesso, uma vez que o preço elevado excluí milhões de pessoas do consumo do produto. Ficou demonstrada a necessidade de busca de medidas para superação desses problemas. Identificou-se medidas existentes dentro do sistema de patentes que poderiam ser utilizadas para minimizar os problemas identificados em curto e médio prazo, com uma abordagem caso a caso. Optou-se por utilizar uma abordagem sistêmica, demonstrando a necessidade de medidas alternativas ao sistema de patentes para resolução dos problemas identificados a longo prazo. A identificação de medidas alternativas foi realizada por meio da revisão de mais de uma centena de propostas enviadas em chamada aberta e recomendações feitas por diferentes órgãos da Organização Mundial de Saúde no período de 2003 a 2012. As medidas identificadas foram descritas, sistematizadas e analisadas. Conclui-se que a principal proposta atualmente em discussão é a criação de um Fundo Global de P&D, no marco de uma Convenção Global de P&D em saúde, que financiaria a P&D mediante a concessão de prêmios, e não de patentes. Os resultados da P&D seriam tratados como bens públicos, e poderiam ser produzidos por qualquer interessado. Esse modelo visa desvincular os custos da P&D do preço final do produto. Com isso, tem o potencial de solucionar os problemas de inovação e acesso à saúde identificados no sistema de patentes. No entanto, enfrenta grande oposição dos defensores do sistema de patentes, principalmente grandes empresas farmacêuticas interessadas na ampliação da mercantilização da saúde. / The model for promoting innovation in health prevalent nowadays is based on the protection of intellectual property by granting patents. The patent allows the holder to exploit the protected object with exclusivity for a certain period of time, in which he could obtain the return of investment made in research and development. The need to obtain the return of the investments made on R&D by selling the final product, boosted by the monopoly conferred by the patent, allows the patent holder to establish high price. The patent system maximizes profits of pharmaceutical companies, expanding its interest in developing profitable products and in health commodification. We identified and systematized evidence to show that the application of the patent system in the health sector has generated innovation problems, by directing R&D resources to the production of profitable products and not driven by health needs; and access, since the high price excludes millions of product consumption. It was demonstrated the need for seeking measures to overcome these problems. We identified existing measures within the patent system that could be used to alleviate the problems identified in the short and medium term, with a case-by-case approach. We chose to use a systemic approach, demonstrating the need for alternative measures to the patent system to resolve the problems identified in the long-term. The identification of alternative measures was conducted through review of more than a hundred proposals submitted in open call and recommendations made by different bodies of the World Health Organization from 2003 to 2012. The measures identified have been described, systematized and analyzed. It is concluded that the main proposal currently under discussion is the creation of a Global R&D Fund, as part of a Global R&D Convention on health, which would finance R&D by granting prizes, and not patents. The results of R&D would be treated as public goods, and could be produced by any interested party. This model aims to delink the costs of R&D from the final price of the product. Thus, it has the potential to solve the problems of innovation and access to health identified in the patent system. However, it faces strong opposition from advocates of the patent system, especially large pharmaceutical companies interested in expanding health commodification.

O modelo de promoção da inovação em saúde predominante na atualidade é baseado na proteção da propriedade intelectual por meio da concessão de patentes. A patente permite ao seu titular explorar o objeto protegido com exclusividade por um determinado período de tempo, no qual seria obtido o retorno do investimento feito na pesquisa e desenvolvimento do produto. A obtenção de retorno do custo da P&D pela comercialização do produto final, potencializada pelo monopólio conferido pela patente, faz com o que o detentor da tecnologia estabeleça preço de venda elevado. O sistema de patentes potencializa, assim, a maximização de lucros das empresas farmacêuticas, ampliando seu interesse no desenvolvimento de produtos rentáveis e na mercantilização da saúde. Foram identificadas e sistematizadas evidências que demonstram que a aplicação do sistema de patente na área da saúde tem gerado problemas de inovação, ao direcionar recursos de P&D voltados para a produção de produtos rentáveis e não voltados a atender necessidades de saúde; e de acesso, uma vez que o preço elevado excluí milhões de pessoas do consumo do produto. Ficou demonstrada a necessidade de busca de medidas para superação desses problemas. Identificou-se medidas existentes dentro do sistema de patentes que poderiam ser utilizadas para minimizar os problemas identificados em curto e médio prazo, com uma abordagem caso a caso. Optou-se por utilizar uma abordagem sistêmica, demonstrando a necessidade de medidas alternativas ao sistema de patentes para resolução dos problemas identificados a longo prazo. A identificação de medidas alternativas foi realizada por meio da revisão de mais de uma centena de propostas enviadas em chamada aberta e recomendações feitas por diferentes órgãos da Organização Mundial de Saúde no período de 2003 a 2012. As medidas identificadas foram descritas, sistematizadas e analisadas. Conclui-se que a principal proposta atualmente em discussão é a criação de um Fundo Global de P&D, no marco de uma Convenção Global de P&D em saúde, que financiaria a P&D mediante a concessão de prêmios, e não de patentes. Os resultados da P&D seriam tratados como bens públicos, e poderiam ser produzidos por qualquer interessado. Esse modelo visa desvincular os custos da P&D do preço final do produto. Com isso, tem o potencial de solucionar os problemas de inovação e acesso à saúde identificados no sistema de patentes. No entanto, enfrenta grande oposição dos defensores do sistema de patentes, principalmente grandes empresas farmacêuticas interessadas na ampliação da mercantilização da saúde. / The model for promoting innovation in health prevalent nowadays is based on the protection of intellectual property by granting patents. The patent allows the holder to exploit the protected object with exclusivity for a certain period of time, in which he could obtain the return of investment made in research and development. The need to obtain the return of the investments made on R&D by selling the final product, boosted by the monopoly conferred by the patent, allows the patent holder to establish high price. The patent system maximizes profits of pharmaceutical companies, expanding its interest in developing profitable products and in health commodification. We identified and systematized evidence to show that the application of the patent system in the health sector has generated innovation problems, by directing R&D resources to the production of profitable products and not driven by health needs; and access, since the high price excludes millions of product consumption. It was demonstrated the need for seeking measures to overcome these problems. We identified existing measures within the patent system that could be used to alleviate the problems identified in the short and medium term, with a case-by-case approach. We chose to use a systemic approach, demonstrating the need for alternative measures to the patent system to resolve the problems identified in the long-term. The identification of alternative measures was conducted through review of more than a hundred proposals submitted in open call and recommendations made by different bodies of the World Health Organization from 2003 to 2012. The measures identified have been described, systematized and analyzed. It is concluded that the main proposal currently under discussion is the creation of a Global R&D Fund, as part of a Global R&D Convention on health, which would finance R&D by granting prizes, and not patents. The results of R&D would be treated as public goods, and could be produced by any interested party. This model aims to delink the costs of R&D from the final price of the product. Thus, it has the potential to solve the problems of innovation and access to health identified in the patent system. However, it faces strong opposition from advocates of the patent system, especially large pharmaceutical companies interested in expanding health commodification.

The prevalence of the Constitution emphasizes the axiological hegemony of principles that become normative pedestal of the legal system, stopping the function of ensuring an interpretive and integrative criterion, a spongy, incomplete and imperfect system. On this track of thought, axiological validity of fundamental rights demand the legitimacy of state prerogatives with communication between state and citizen, in a dialectical relationship that requires democratic participation from the enjoyment of basic rights as defined from the notion of citizenship. This dissertation analyzes the fundamental right to health, through the public health system (SUS). Being a theoretical work, analyzes its guiding principles and corresponding laws. In the face of objective reality and fateful, critical and analytical approach is urgent and imperative to share some of the numerous existing problems, but also important it is to analyze and discuss possible solutions. In this respect, it is particularly highlighted public-private partnerships and its peculiarities. Therefore, to express the real potential of these analyzes to pharmaceutical assistance as a complementary activity object of the private sector through the model of publicprivate partnerships, implementation of the right policies to access to medicines and pharmaceutical patents and their relativity as form of effectiveness of the principle of efficiency in pharmaceutical care. It makes up this long journey in pursuit of making efficient and effective the fundamental right to health. / A prevalência da Constituição acentua a hegemonia axiológica dos princípios, que se convertem em pedestal normativo do sistema jurídico, detendo a função de assegurar um critério interpretativo e integrativo, num sistema lacunoso, incompleto e imperfeito. Nesta esteira de pensamento, a validade axiológica dos Direitos Fundamentais demanda a legitimação das prerrogativas estatais com a comunicação entre Estado e cidadão, numa relação dialética que pressupõe a participação democrática a partir da satisfação dos direitos fundamentais, definidos a partir da noção de cidadania. A presente dissertação analisa o direito fundamental à saúde, passando pelo sistema público de saúde (SUS). Sendo um trabalho teórico, analisa-se seus princípios norteadores e leis correspondentes. Diante da realidade fática e fatídica, a abordagem crítica e analítica se torna premente e imprescindível para externar alguns dos inúmeros problemas existentes, mas também, importante se torna analisar e discutir as soluções possíveis. Neste aspecto, assume especial destaque as parcerias público privadas e suas peculiaridades. Portanto, para exprimir o real potencial destas, analisa-se a assistência farmacêutica como objeto de atuação complementar da iniciativa privada por meio do modelo das parcerias público privadas, as políticas de implementação do direito ao acesso a medicamentos e as patentes farmacêuticas e sua relativização como forma de efetividade do princípio da eficiência na assistência farmacêutica. Faz-se este longo caminho, na busca de tornar eficiente e efetivo o direito fundamental à saúde. / Mestre em Direito Público

En 2010, l'Organisation Mondiale de la Santé (OMS) a publié de nouvelles recommandations pour le traitement contre le Vih/Sida dans le but d'améliorer la qualité des thérapies antirétrovirales (TARV) distribuées dans les pays en voie de développement (PED). Cependant, les coûts de plus en plus importants liés à l'incorporation des antirétroviraux (ARV) de nouvelle génération, associés à l'intensification de la protection des droits de la propriété intellectuelle (DPI), accentuent le déséquilibre entre les priorités d'expansion de la couverture des patients et les objectifs d'amélioration des traitements, ce qui favorise la pérennité d'un double standard de soins dans le monde. Cette thèse a pour objectif d'analyser les déterminants de l'incorporation des nouvelles technologies et de l'évolution des prix des ARV pour mieux comprendre leur impact sur la qualité et l'accessibilité financière des TARV dans les PED. La présente recherche est basée sur la politique brésilienne de TARV et les leçons qu'elle peut apporter dans la lute contre l'épidémie du Vih/Sida. La première partie de la thèse porte sur les critères utilisés pour l'incorporation des nouveaux médicaments dans les protocoles cliniques de TARV. L'étude part des méthodes de l'analyse de contenu et statistique pour examiner l'impact des prix des ARVs sur les recommandations thérapeutiques et comment celles-ci influencent la pratique médicale. / In 2010, the World Health Organization (WHO) published new HIV/AIDS treatment recommendations which aim at improving the quality of antiretroviral therapy (ART) delivered in developing countries. Nonetheless, the higher costs of incorporating new and more potent antiretrovirals (ARVs), coupled by the intensification of intellectual property rights (IPRs) protection, put in evidence a growing trade-off between patient coverage expansion priorities and treatment quality objectives, which tend to favor the perpetuation of a double standard of HIV care in the world.This thesis aims at analyzing the determinants of technology incorporation and price evolution in HIV care as the basis for discussing how these can impact both the quality and affordability of ART in low and middle-income settings. The present research takes as reference the Brazilian ART policy and the insights it may provide in the fight against the HIV/AIDS epidemic. The first part of this thesis addresses the criteria used for the incorporation of novel drugs in ART guidelines. Content and statistical analyses are used to examine the impact of ARV prices on therapeutic recommendations and how the latter have been able to influence clinical practice. They show that, although efficacy, toxicity and dosing convenience represent major determinants of ART incorporation decisions in Brazil, costs have most recently started influencing deferral in the use of new ARVs. The second part takes into account the role of patent protection on pharmaceutical innovation and pricing, further employing descriptive and econometric approaches to analyze ARV market structure and prices in Brazil.

"The implementation of the TRIPS Agreement, within the wider context of globalisation, has brought about a conflict between the obligation of states to promote and protect health and the achievement of economic goals pursued under the WTO regime. Since trade is the driving engine of globalisation, it is imperative that, at the very least, rules governing it do not violate human rights but rather promote them. The problem of IP and the right to health therefore lies in ensuring that the integration of economic rules and institutional operations in relation to IPRs coincide with states’ obligations to promote and protect public health. ... This study centres on the specific debate about health and IPRs in the context of the International Covenant on Economic, Social and Cultural Rights (ICESCR) and the WTO rules on IP protection. In terms of a human rights approach to the TRIPS Agreement, the ICESCR has been chosen for several reasons. First, the ICESCR specifically recognises both the right to health and the right to the protection of inventions in clearer terms than any other human rights instrument. Secondly, at least 111 of the state parties to the ICESCR are also members of the WTO including a large number of developing countries. Thirdly, if one sees the ICESCR as a vehicle for the fulfilment of the obligation to promote and protect human rights under the United Nations Organisation’s (UN) Charter, it can be argued that in line with article 103, the implementation and interpretation of TRIPS by all UN members states must take into account basic human rights. However, even with primary focus being on the ICESCR, most of the discussion on practical issues will focus on the experiences in Sub-Saharan Africa because the inequalities and problems of access to health care are most dramatically played out in this part of the world. The objective of the study is to examine the relationship between the obligation of states to progressively realise and guarantee the right to health, and the IP rules under the TRIPS Agreement. The specific objective is to examine the relationship between the exceptions under the TRIPS Agreement and the obligation to protect health and the identification of a consistent way of achieving a convergence between the implementation and interpretation of the rules of the two regimes in the area of health." -- Chapter 1 / Mini Dissertation (LLM)--University of Pretoria, 2001. / http://www.chr.up.ac.za/academic_pro/llm1/dissertations.html / Centre for Human Rights / LLM

Dans les pays en développement (PED), les problèmes engendrés par le VIH/SIDA et l’inaccessibilité des antirétroviraux (ARV) s’avèrent être la cause de ravages extrêmement préoccupants à tous les niveaux (démographique, politique, social et économique). Dans le cadre de l’Organisation mondiale du commerce (OMC), et notamment de l’Accord sur les aspects des droits de propriété intellectuelle qui touchent au commerce (« Accord sur les ADPIC »), un nombre croissant de PED ont ou sont en train d’intégrer un standard international de protection des brevets de produits et de procédés pharmaceutiques à leur législation nationale. Cette intégration a eu et continue de jouer un rôle majeur dans la problématique de l’accès aux médicaments dans les PED. Les conditions et les effets du régime de protection des innovations suscitent de vifs débats entre les partisans d’une protection accrue des brevets et les défenseurs de l’accès aux médicaments essentiels. Une des principales motivations de notre travail de recherche est de fournir une étude permettant de trouver des solutions à la fois favorables à l’amélioration de l’accès aux médicaments et à la préservation de l’innovation. Le problème complexe de l’accès aux médicaments ARV dans les PED est influencé par la pluridisciplinarité et l’interdépendance de nombreux facteurs. Le système des brevets ne constitue pas « l’unique » solution au problème. Toutefois, il doit être plus sérieusement considéré dans sa fonction d’équilibrage entre l’intérêt privé et l’intérêt collectif. C’est un outil juridique précieux pour le développement économique et technologique des PED et la réalisation de l’intérêt commun contre la pandémie. / In developing countries, problems brought about by HIV/AIDS and inaccessibility of antiretrovirals (ARVs) are proving to be the cause of serious damages at all levels (demographic, political, social and economic). Within the context of the World Trade Organization, and in particular the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”), a growing number of developing countries have integrated or are in the process of integrating into their national law an international standard of patent protection for pharmaceutical products and processes. Such integration continues to play a major role in the issue of access to medicines in developing countries. The conditions and effects of the protection regime respecting innovations give rise to heated debates between supporters of an increased patent protection and defenders of the access to essential medicines. One of the main motivations for our research is to provide a study that helps to find solutions that are both in favour of improving access to medicines and protecting innovation. The complex problem of access to ARV drugs in developing countries is influenced by the multidisciplinarity and interdependence of many factors. The patent system does not solve the problem on its own. However, it should be seriously considered in its function of balancing the private and collective interests. It is a valuable legal tool for the economic and technological development of the developing countries and to achieve the common interest against the pandemic.