Made available in DSpace on 2014-06-11T19:24:16Z (GMT). No. of bitstreams: 0 Previous issue date: 2009-09-04Bitstream added on 2014-06-13T18:52:03Z : No. of bitstreams: 1 carrazza_lc_me_arafcl.pdf: 676852 bytes, checksum: 079c044190870ccb56c82e8ef9eebc47 (MD5) / Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) / O presente trabalho procura investigar inicialmente a questão das patentes, enfatizando a construção do marco regulatório internacional sobre o tema e o debate sobre o patenteamento de medicamentos. Busca-se em seguida caminhar na direção da discussão do licenciamento compulsório de medicamentos como instrumento fundamental de proteção à saúde pública nos países em desenvolvimento (PEDs), procurando tanto explicitar sua inserção no marco regulatório internacional como averiguar sua efetiva utilização. Para tanto, analisar-se-á o tema a partir da inserção da proteção aos direitos de propriedade intelectual nas regras multilaterais de comércio, através do Acordo Trade-Related Aspects of Intellectual Property Rights (TRIPS), de 1995, no âmbito da Organização Mundial do Comércio, no qual todos os países-membros da OMC teriam que reconhecer patentes em todos os campos tecnológicos, inclusive para produtos e processos farmacêuticos. Foi possível observar que, à luz desse novo marco regulatório internacional, os interesses das grandes companhias farmacêuticas e dos países desenvolvidos (notadamente os Estados Unidos da América) – que buscam por meio do monopólio via patentes elevar os retornos econômicos dos investimentos em P&D e limitar a eventual concorrência dos países em desenvolvimento – se contrapõem aos interesses das organizações de defesa dos direitos humanos e dos PEDs, que buscam garantir que medicamentos essenciais estejam disponíveis a preços acessíveis, de modo a permitir a sustentabilidade de programas sociais relacionados à saúde pública. A partir dessa constatação, e considerando a crise global da AIDS e a Declaração de Doha sobre o Acordo TRIPS e a Saúde Pública, de 2001 – que reforçou a importância da licença compulsória - o trabalho se volta para as experiências dos PEDs, especialmente o Brasil, que concederam... / This paper aims initially to investigate the issue of patents emphasizing the construction of the international regulatory framework on the topic, and to debate on the patenting of medicines. From this point, it addresses the discussion of compulsory licensing of patented medicines as a fundamental instrument of public health protection in developing countries, seeking to explicit its inclusion in the international regulatory framework as well as ascertaining its effective usage. Therefore, it will examine the issue from the insertion of the intellectual property rights in the multilateral trade rules through the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in 1995 of the World Trade Organization, in which all WTO members would have to recognize patents in all technological fields, including pharmaceutical products and processes. It was possible to observe, according to the new international regulatory framework, that the interests of the large pharmaceutical industry (known as big pharma) and developed countries (notably the United States of America) – which seek by patent monopoly to raise the economic returns of investment in R & D and to limit competition from developing countries – oppose the interests of human rights organizations and developing countries, which seek to ensure that essential drugs are available at affordable prices, in order to make sustainable public health policies. After this, and considering the AIDS global crisis and the Doha Declaration on the TRIPS Agreement and Public Health (2001), which emphasized the importance of compulsory license - the paper turns to the experiences of developing countries, especially Brazil, which granted compulsory licensing for access to medicines, mostly antiretroviral. It was possible to conclude that despite the effectiveness results obtained of the usage of compulsory licensing by developing... (Complete abstract click electronic access below)

Orientador: Benedito Rodrigues de Moraes Neto / Banca: Luciana Togeiro de Almeida / Banca: Lia Hasenclever / Resumo: O presente trabalho procura investigar inicialmente a questão das patentes, enfatizando a construção do marco regulatório internacional sobre o tema e o debate sobre o patenteamento de medicamentos. Busca-se em seguida caminhar na direção da discussão do licenciamento compulsório de medicamentos como instrumento fundamental de proteção à saúde pública nos países em desenvolvimento (PEDs), procurando tanto explicitar sua inserção no marco regulatório internacional como averiguar sua efetiva utilização. Para tanto, analisar-se-á o tema a partir da inserção da proteção aos direitos de propriedade intelectual nas regras multilaterais de comércio, através do Acordo Trade-Related Aspects of Intellectual Property Rights (TRIPS), de 1995, no âmbito da Organização Mundial do Comércio, no qual todos os países-membros da OMC teriam que reconhecer patentes em todos os campos tecnológicos, inclusive para produtos e processos farmacêuticos. Foi possível observar que, à luz desse novo marco regulatório internacional, os interesses das grandes companhias farmacêuticas e dos países desenvolvidos (notadamente os Estados Unidos da América) - que buscam por meio do monopólio via patentes elevar os retornos econômicos dos investimentos em P&D e limitar a eventual concorrência dos países em desenvolvimento - se contrapõem aos interesses das organizações de defesa dos direitos humanos e dos PEDs, que buscam garantir que medicamentos essenciais estejam disponíveis a preços acessíveis, de modo a permitir a sustentabilidade de programas sociais relacionados à saúde pública. A partir dessa constatação, e considerando a crise global da AIDS e a Declaração de Doha sobre o Acordo TRIPS e a Saúde Pública, de 2001 - que reforçou a importância da licença compulsória - o trabalho se volta para as experiências dos PEDs, especialmente o Brasil, que concederam... (Resumo completo, clicar acesso eletrônico abaixo) / Abstract: This paper aims initially to investigate the issue of patents emphasizing the construction of the international regulatory framework on the topic, and to debate on the patenting of medicines. From this point, it addresses the discussion of compulsory licensing of patented medicines as a fundamental instrument of public health protection in developing countries, seeking to explicit its inclusion in the international regulatory framework as well as ascertaining its effective usage. Therefore, it will examine the issue from the insertion of the intellectual property rights in the multilateral trade rules through the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in 1995 of the World Trade Organization, in which all WTO members would have to recognize patents in all technological fields, including pharmaceutical products and processes. It was possible to observe, according to the new international regulatory framework, that the interests of the large pharmaceutical industry (known as big pharma) and developed countries (notably the United States of America) - which seek by patent monopoly to raise the economic returns of investment in R & D and to limit competition from developing countries - oppose the interests of human rights organizations and developing countries, which seek to ensure that essential drugs are available at affordable prices, in order to make sustainable public health policies. After this, and considering the AIDS global crisis and the Doha Declaration on the TRIPS Agreement and Public Health (2001), which emphasized the importance of compulsory license - the paper turns to the experiences of developing countries, especially Brazil, which granted compulsory licensing for access to medicines, mostly antiretroviral. It was possible to conclude that despite the effectiveness results obtained of the usage of compulsory licensing by developing... (Complete abstract click electronic access below) / Mestre

Submitted by Renata Lopes (renatasil82@gmail.com) on 2016-10-14T17:42:00Z No. of bitstreams: 1 lucianaalvesdominato.pdf: 266751 bytes, checksum: 77579ed12e08f1ddbdb337a6697d64cd (MD5) / Approved for entry into archive by Adriana Oliveira (adriana.oliveira@ufjf.edu.br) on 2016-10-22T13:08:18Z (GMT) No. of bitstreams: 1 lucianaalvesdominato.pdf: 266751 bytes, checksum: 77579ed12e08f1ddbdb337a6697d64cd (MD5) / Made available in DSpace on 2016-10-22T13:08:18Z (GMT). No. of bitstreams: 1 lucianaalvesdominato.pdf: 266751 bytes, checksum: 77579ed12e08f1ddbdb337a6697d64cd (MD5) Previous issue date: 2008-09-30 / O presente estudo tem por escopo discutir o licenciamento compulsório de patentes dos anti-retrovirais como uma escolha do Estado para a implementação de determinada política pública na área da saúde. Para tanto, apresentamos a evolução histórica das políticas públicas de saúde no país, a forma de financiamento da saúde hoje e os critérios utilizados para a alocação de recursos na saúde. Posteriormente discutimos o papel dos atores sociais para a determinação da agenda, especificamente no campo da saúde e por fim, analisamos alguns aspectos do direito patentário e a possibilidade de utilização do licenciamento compulsório como um instrumento hábil para garantir o acesso universal à saúde, ponto em que ocorre um embate do Estado x Mercado. / This study aims to discuss the compulsory license for anti-retroviral drugs as a governmental choice for the implementation of certain public health policies. In order to accomplish such assignment, we present the historical evolution of public health policies in Brazil, the means of financial support concerning health policies today, and the criteria used for the allocation of financial resources in health policies. After, we discuss the role played by social actors in the determination of the health agenda, and, finally, we analyze some aspects of patent law in regards to the possibility of deploying compulsory license as an efficient instrument to ensure the universal access to health policies, which turns out to be a collision point between the government and the market.

Made available in DSpace on 2015-03-05T17:38:51Z (GMT). No. of bitstreams: 0 Previous issue date: 7 / Coordenação de Aperfeiçoamento de Pessoal de Nível Superior / O sistema jurídico na modernidade identifica os bens produzidos intelectualmente como modalidade de propriedade privada, desde então, a patente foi o instrumento racionalmente criado para proteger uma invenção. Todavia a patente é um instrumento paradoxal, pois trata da apropriação privada sobre bens de natureza coletiva. No final do século XX, os direitos de propriedade intelectual foram (re)direcionados para o âmbito da OMC mediante o acordo TRIPS. Ao tratar os direitos de propriedade intelectual no âmbito do comércio internacional os Estados-membros da OMC, levando em conta os graves problemas sanitários globais, como a SIDA positivaram a Declaração de Doha como forma de apoiar a saúde pública em relação ao acesso aos medicamentos. Sustenta-se que ambos os sistemas, sanitário e patentário, são essenciais à sociedade global, todavia a própria sociedade coloca-se em risco toda vez que opta em padronizar o monopólio patentário para todos os setores de pesquisa. Garantir o acesso aos medicamentos a todos aque / The juridical system in the modernity identifies the goods produced intellectually as private property modality, and since then, the patent has been the instrument rationally created to protect an invention. However the patent is a paradoxical instrument, because it deals with the private appropriation of goods of collective nature. At the end of the 20th century the intellectual rights of properties were re-addressed to WTO’s scope by the TRIPS Agreement. When dealing with the intellectual rights of properties in the scope of the international commerce the WTO’s state-members, carrying into account the serious global sanitary problems, as AIDS legalized the Doha’s Declaration as a form of supporting the public health regarding the access to medication. It sustains that both systems, sanitary and patent, are essences to the global society, however the very society puts itself in risk every time it opts in standardize the patent monopoly for all the research sectors. To guarantee the access to the medicatio

智慧財產權保護的利益包括道德利益，社會利益與經濟利益，然而三種利益彼此可能互相衝突，醫藥品專利便是其中一種常見案例，若醫藥品在專利權的保護下，價格與可得性皆容易成為取得必需醫藥品的高門檻。關於如何使病人取得所需的專利藥物，「強制授權」制度被認為是一種可使用的彈性手段。 本篇論文旨在分析專利強制授權制度對藥物可近性可能造成之影響。第二章從國際公約中對於強制授權的規範切入，說明目前國際上強制授權的運作條件；第三章說明強制授權的功能，其在專利權制度中可達到之經濟與公共利益的調和與平衡，對於反對者所認為「強制授權造成的經濟傷害」論點予以駁斥，並說明強制授權造成專利權人的經濟損失並不如反對者宣稱的巨大，反而因強制授權制度的存在，能有效減少濫用權利的誘因；第四章則著重分析強制授權對公共衛生政策的影響，對於開發中國家而言，建立起穩定的強制授權制度，有助於他們跨過初始的專利障礙，開始扶植本國藥廠並建立本國的藥物供應鏈，以達到獲取藥物的自主性；第五章以美國、加拿大、印度等國實施強制授權的案例，闡述強制授權在已開發國家與開發中國家的實施和效果，強調無論是以強制授權或是其他更為強勢的手段，在專利的壟斷性下，為社會利益保留一項具有彈性與最後手段的措施之必要性；第六章則就我國的專利法修法沿革分析，提出關於現行專利法中強制授權的彈性不足會造成的影響及修改的方向。 / The protection of intellectual property rights includes moral interests, social interests and economic interests, but the three interests may conflict with each other. Patents of pharmaceutical product are the common cases. If the products are under the protection of patents, the price and accessibility will become the obstacles for obtaining essential medicines. The "compulsory license" system is considered to be a flexible instrument that can be used when patented drugs are required by patients. This research aims to analyze the possible impact of patent compulsory license system on accessibility of medicines. In the second chapter, I points out the rule of operation of compulsory license from international conventions, introducing the current international conditions. Chapter 3 describes the function of compulsory license, that the reconciliation and balance between the economic and public interests can be achieved in the patent system. The opponents consider that economic harm would be caused by compulsory license. However, the actual economic loss of the patent owner is not as great as the opponents describe. In contrast, the incentive for the abuse of the right can be effectively reduced through the existence of the compulsory license system. Chapter 4 focuses on how compulsory license system affects public health policies. For developing countries, the establishment of a stable compulsory license system helps them to cross the initial barriers and start to foster their own pharmaceuticals industry. Building their own medicines supply chain helps them to achieve the accessibility of medicines. Chapter 5 illustrates the attitude toward compulsory license in developed and developing countries. The chapters introduce means of compulsory license in the United States, Canada, India and other countries. It emphasizes that, whether compulsory license or other more powerful means, to retain a flexible method for social interests is important in the patent law system. Chapter 6 analyzes the history of Taiwan's patent law. This chapter emphasizes the impact on lack of flexibility about compulsory license, and it mentions the direction of the amendment to Taiwan Patent Law.

The privileges arising from patent protection on pharmaceutical products often prevent the full realization of the right to health, especially in developing countries with scarce resources. This thesis first identifies the international agreements that have established the right to health in international law, obligations and violations associated with it, the problems encountered in the implementation of human rights on the field, compared with the implementation and sanctions associated with economic rights from the World Trade Organization regulatory framework. A comparative study of the legislative frameworks of both developed and developing countries will reveal to what extent Canada, the United States, the European Union, Brazil, India, and South Africa conformed with patent protection exceptions arising from international patent law to protect public health. Finally, the author identifies the crucial indicators that need to be considered in order to assess the conformity of a given approach with the right to health, before he underscores the temporary character of the relevant WTO measures, and the future stakes concerning an increased access to essential medicines. / Les droits issus des brevets d'invention sur les produits pharmaceutiques empêchent souvent la réalisation pleine et entière du droit à la santé, plus spécialement dans les pays en voie de développement ayant des ressources plus limitées. Ce mémoire de recherche retrace d'abord les accords internationaux ayant établi le droit à la santé en droit international, les obligations et les violations qui en découlent, la problématique quant à la mise en oeuvre des droits de l'homme sur le terrain, en comparaison avec la mise en oeuvre et les sanctions pour le non-respect de droits économiques dans le cadre réglementaire de l'Organisation Mondiale du Commerce (OMC). Ensuite, une étude comparative des cadres législatifs de pays développés et de pays en développement révèlera dans quelle mesure le Canada, les États-Unis, l'Union Européenne, le Brésil, l'Inde, et l'Afrique du Sud se sont conformés aux exceptions aux règles de protection issues du droit international des brevets pour cause de santé publique. L'auteur identifie finalement les points de première importance qu'il considère primordial de considérer afin d'évaluer si une approche conforme au droit à la santé a été respectée dans le commerce de médicaments essentiels, avant de souligner l'aspect temporaire des mesures courantes prévues dans l'OMC et des futurs enjeux quant à l'accroissement de l'accès aux médicaments essentiels.

The privileges arising from patent protection on pharmaceutical products often prevent the full realization of the right to health, especially in developing countries with scarce resources. This thesis first identifies the international agreements that have established the right to health in international law, obligations and violations associated with it, the problems encountered in the implementation of human rights on the field, compared with the implementation and sanctions associated with economic rights from the World Trade Organization regulatory framework. A comparative study of the legislative frameworks of both developed and developing countries will reveal to what extent Canada, the United States, the European Union, Brazil, India, and South Africa conformed with patent protection exceptions arising from international patent law to protect public health. Finally, the author identifies the crucial indicators that need to be considered in order to assess the conformity of a given approach with the right to health, before he underscores the temporary character of the relevant WTO measures, and the future stakes concerning an increased access to essential medicines. / Les droits issus des brevets d'invention sur les produits pharmaceutiques empêchent souvent la réalisation pleine et entière du droit à la santé, plus spécialement dans les pays en voie de développement ayant des ressources plus limitées. Ce mémoire de recherche retrace d'abord les accords internationaux ayant établi le droit à la santé en droit international, les obligations et les violations qui en découlent, la problématique quant à la mise en oeuvre des droits de l'homme sur le terrain, en comparaison avec la mise en oeuvre et les sanctions pour le non-respect de droits économiques dans le cadre réglementaire de l'Organisation Mondiale du Commerce (OMC). Ensuite, une étude comparative des cadres législatifs de pays développés et de pays en développement révèlera dans quelle mesure le Canada, les États-Unis, l'Union Européenne, le Brésil, l'Inde, et l'Afrique du Sud se sont conformés aux exceptions aux règles de protection issues du droit international des brevets pour cause de santé publique. L'auteur identifie finalement les points de première importance qu'il considère primordial de considérer afin d'évaluer si une approche conforme au droit à la santé a été respectée dans le commerce de médicaments essentiels, avant de souligner l'aspect temporaire des mesures courantes prévues dans l'OMC et des futurs enjeux quant à l'accroissement de l'accès aux médicaments essentiels. / "Mémoire présenté à la Faculté des études supérieures en vue de l'obtention du grade de Maîtrise en droit des biotechnologies". Ce mémoire a été accepté à l'unanimité et classé parmi les 10% des mémoires de la discipline. Commentaires du jury : "Le jury est impressionné par l'ampleur de la recherche et de la synthèse très instructive du débat Nord-Sud".

Le Brésil figure parmi les plus grands marchés consommateurs de médicaments. Cependant, le droit à l'accès aux médicaments, prévu dans sa Constitution Fédérale, ne fait pas partie de sa réalité. Cette situation est attribuable à plusieurs facteurs: le Brésil n'est pas capable de répondre à ses besoins internes et la consommation de médicaments n'est pas équilibrée. En réaction à cette constatation, nous analyserons la situation juridique actuelle du Brésil, afin d'indiquer les lacunes et barrières au plein accès aux médicaments et, surtout, de trouver une solution qui pourrait améliorer cette situation. Les organismes gouvernementaux brésiliens jouant un rôle important dans le développement des nouveaux médicaments sont présentés et, ensuite, l'encadrement juridique applicable à la recherche clinique et à l'autorisation de mise en marché des nouveaux médicaments est analysé; un bref survol de la législation applicable aux médicaments génériques est fait. Dans un deuxième moment de l'étude, la question d'accès aux nouveaux médicaments est mise en lumière: la législation brésilienne relative aux brevets, ainsi que le régime de licence obligatoire sont abordés; de plus, nous évaluons la compatibilité de ce régime avec l'Accord sur les ADPIC et nous évoquons les conflits internationaux qu'il a suscités. En vue de trouver des solutions aux difficultés brésiliennes identifiées, nous concluons notre étude avec l'examen de l'initiative canadienne pour favoriser l'accès aux médicaments aux pays du Sud (RCAN). Nous constatons que l'utilisation du RCAM pourrait, à court terme, favoriser l'accès aux médicaments au Brésil et, à moyen terme, aider à réduire les conflits internationaux. Finalement, à long terme, nous croyons que le Brésil pourrait jouer un rôle de leader international en adoptant une loi semblable à celle du Canada et, ainsi, il serait capable d'aider d'autres pays dans le besoin, qui n'ont aucune capacité de production locale, comme par exemple, plusieurs pays en Afrique. / Brazil is amongst the largest markets for medication and, even though the access to it is guaranteed by Brazilian Federal Constitution, it cannot be taken for granted. This situation is due to several factors: Brazil is not capable of fulfilling its needs and the consumption of drugs does not follow a balanced pattern. Given these facts, we will analyze Brazil's current legal system in order to assess which barriers and gaps prevent the population from gaining full access to medication and, most importantly, what could be done to change this reality. Brazil's government agencies involving in the development of new drugs will be presented, followed by an analysis of the legal norms applicable to clinical research and authorization to market new drugs; also, a brief assessment of the generic drugs legislation will be made. Besides, the access to new drugs issue will be put under light: Brazilian legislation concerning patents and compulsory licensing will be analyzed; as a complement, we will evaluate the compatibility of these rules with the system implemented by the TRIPS Agreement and the international conflicts related to this issue will be shown. Aiming at finding a solution to these issues, this study will focus its final part on the Canadian initiative to improve medication access on the South countries (CAMR). We find that CAMR's initiative could, on the short run, improve medication access in Brazil and, later on, could help to decrease international conflicts. On the long run, we believe Brazil could play a key role in the international scene by adopting a law similar to the Canadian one in order to be able to help countries in need that lack local production capacity, e.g., most of African countries.

Le Brésil figure parmi les plus grands marchés consommateurs de médicaments. Cependant, le droit à l'accès aux médicaments, prévu dans sa Constitution Fédérale, ne fait pas partie de sa réalité. Cette situation est attribuable à plusieurs facteurs: le Brésil n'est pas capable de répondre à ses besoins internes et la consommation de médicaments n'est pas équilibrée. En réaction à cette constatation, nous analyserons la situation juridique actuelle du Brésil, afin d'indiquer les lacunes et barrières au plein accès aux médicaments et, surtout, de trouver une solution qui pourrait améliorer cette situation. Les organismes gouvernementaux brésiliens jouant un rôle important dans le développement des nouveaux médicaments sont présentés et, ensuite, l'encadrement juridique applicable à la recherche clinique et à l'autorisation de mise en marché des nouveaux médicaments est analysé; un bref survol de la législation applicable aux médicaments génériques est fait. Dans un deuxième moment de l'étude, la question d'accès aux nouveaux médicaments est mise en lumière: la législation brésilienne relative aux brevets, ainsi que le régime de licence obligatoire sont abordés; de plus, nous évaluons la compatibilité de ce régime avec l'Accord sur les ADPIC et nous évoquons les conflits internationaux qu'il a suscités. En vue de trouver des solutions aux difficultés brésiliennes identifiées, nous concluons notre étude avec l'examen de l'initiative canadienne pour favoriser l'accès aux médicaments aux pays du Sud (RCAN). Nous constatons que l'utilisation du RCAM pourrait, à court terme, favoriser l'accès aux médicaments au Brésil et, à moyen terme, aider à réduire les conflits internationaux. Finalement, à long terme, nous croyons que le Brésil pourrait jouer un rôle de leader international en adoptant une loi semblable à celle du Canada et, ainsi, il serait capable d'aider d'autres pays dans le besoin, qui n'ont aucune capacité de production locale, comme par exemple, plusieurs pays en Afrique. / Brazil is amongst the largest markets for medication and, even though the access to it is guaranteed by Brazilian Federal Constitution, it cannot be taken for granted. This situation is due to several factors: Brazil is not capable of fulfilling its needs and the consumption of drugs does not follow a balanced pattern. Given these facts, we will analyze Brazil's current legal system in order to assess which barriers and gaps prevent the population from gaining full access to medication and, most importantly, what could be done to change this reality. Brazil's government agencies involving in the development of new drugs will be presented, followed by an analysis of the legal norms applicable to clinical research and authorization to market new drugs; also, a brief assessment of the generic drugs legislation will be made. Besides, the access to new drugs issue will be put under light: Brazilian legislation concerning patents and compulsory licensing will be analyzed; as a complement, we will evaluate the compatibility of these rules with the system implemented by the TRIPS Agreement and the international conflicts related to this issue will be shown. Aiming at finding a solution to these issues, this study will focus its final part on the Canadian initiative to improve medication access on the South countries (CAMR). We find that CAMR's initiative could, on the short run, improve medication access in Brazil and, later on, could help to decrease international conflicts. On the long run, we believe Brazil could play a key role in the international scene by adopting a law similar to the Canadian one in order to be able to help countries in need that lack local production capacity, e.g., most of African countries.