Esta tese visa aprofundar o entendimento das dinâmicas de interação entre atores estatais e não estatais nos processos de criação, continuidade e mudança de regimes internacionais. A pesquisa se apresenta como um estudo de caso demarcado a partir da criação do novo regime internacional de proteção dos direitos de patentes, instituído em 1994 quando da adoção do Acordo sobre Aspectos dos Direitos de Propriedade Intelectual Relacionados ao Comércio (TRIPS) pelos países membros do GATT. Inclui as disputas entre as empresas farmacêuticas e o governo da África do Sul, o contencioso entre Brasil e Estados Unidos, na Organização Mundial do Comércio, e as negociações que culminaram na adoção da Declaração sobre o Acordo TRIPS e Saúde Pública, em novembro de 2001. A partir da problematização das decisões do governo dos Estados Unidos, nos vários momentos do caso, se propõe, como argumento central do trabalho, que a mídia constitui um importante elemento de ligação nos processos através dos quais atores não estatais com capacidade material reduzida exercem influência sobre atores estatais nas decisões acerca da política externa tanto no âmbito bilateral como multilateral / This thesis aims to deepen the understanding of the interactive dynamics between governmental and non governmental actors in the processes of creation, continuity, and change of international regimes. The research is presented as a case study delimited from the creation of the new international regime of intellectual property rights, instituted in 1994, when the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) was adopted by the GATT member-countries. It includes the disputes between the pharmaceutical companies and the government of South Africa, the controversy between Brazil and the United States, in the World Trade Organization, and the negotiations that culminated in the Declaration on the TRIPS Agreement and Public Health, adopted in November 2001. From the problematization of decisions of the United States Government, in the various moments of the case, as central argument it is proposed that the media is an important linkage element in the processes through which non state actors with reduced material capacity exercise influence on state actors on foreign policy decisions in regard to both bilateral as well as multilateral decisions

Eastern and southern Africa, a region that is home to a twentieth of the world’s population, accounts for half the number of people living with HIV globally, including an increasingly drug resistant Tuberculosis epidemic. The high mortality and untold human suffering associated with HIV in the region during the late 1990s and early 2000s has mostly been mitigated by a rapid scale up of national HIV treatment programmes over the past decade, largely made possible by generic competition from Indian pharmaceutical manufacturers. The sustainability of treatment programmes in the region depends on various factors. National HIV treatment programmes are largely financed by multilateral donor mechanisms which are facing a decline in funding for the first time in the history of the AIDS response. Indian pharmaceutical manufacturers are increasingly encountering patent barriers stemming from the country’s implementation of its intellectual property obligations under the World Trade Organisation’s TRIPS Agreement. As eastern and southern African countries increasingly focus on local pharmaceutical production and south-south co-operation as vehicles for treatment sustainability, this thesis examines the extent to which public health related flexibilities present in the TRIPS Agreement can be used to as enablers of affordable treatment, both in domestic intellectual property legislation, and relevant regional platforms. The thesis undertakes case studies of the policy and legislative environment in two countries with very different profiles: The United Republic of Tanzania as a least developed country with a nascent local pharmaceutical manufacturing industry and South Africa, as the country with the largest pharmaceutical industry on the continent present the full range of country profiles in the region. Conclusions are drawn regarding the optimization of legislative and policy frameworks to facilitate both the importation and local production of health technologies. Finally, the thesis explores challenges and opportunities facing various south-south co-operation initiatives in the region.

Geographical indications assumed prominence in terms of juridical development and economic importance with their inclusion in the TRIPS Agreement. Due to their nexus with place of origin, the importance of agricultural GIs has increased manifold. Pakistan has a strong agriculture-based economy. It has many valuable GIs, like Basmati rice, with significant trade worth billions of dollars. Nevertheless, not a single GI has been registered in Pakistan due to factors such as the inadequacies in the present system of protection of GIs in Pakistan, institutional weaknesses and the absence of an active role of the state. This thesis argues that a sui generis law for the regulation of agricultural GIs will facilitate better protection of GIs and economic development in Pakistan provided that it is also accompanied by the necessary institutional reforms. Pakistan is making efforts to enact a separate GI law for better protection of its GIs. However, there are administrative hurdles and institutional incapacities in Pakistan which need to be reformed. Examples have been taken from the sui generis laws of the EU and India in the discussions on legislative and institutional reforms in Pakistan. The EU and Indian sui generis laws have shown better protection of their GIs resulting in the registration of hundreds of their GIs and economic development. The situation in neighbouring India was the same as is currently found in Pakistan until 2003 when it introduced its sui generis law; it has now registered hundreds of GIs. Besides literature reviews, interviews have been conducted with public and private sector stakeholders to gain an insight into the weaknesses and strengths of the system of protection of GIs in Pakistan, as well as potential reforms. Based on the findings, a sui generis law and institutional reforms for better protection of agricultural GIs and economic development in Pakistan are proposed.

In 2000, Jordan signed the Agreement on Trade-related Aspects of Intellectual Property Rights (the TRIPS Agreement) and a free trade agreement with the US (USJFTA). Both commitments have required Jordan to comply with various obligations, including full compliance with the minimum standards for the protection of intellectual property rights (IPRs) under the TRIPS Agreement and TRIPS-Plus IP standards set out under the terms of the USJFTA. Enticed by views that strong IP protection would create prosperity in the Kingdom by promoting technological innovation and inducing transfer and dissemination of technology to Jordanians, Jordan implemented the provisions of TRIPS and the USJFTA to the letter. However, Jordan focused little attention on important “TRIPS flexibilities”. In particular, Jordan has qualified parallel importation and limited the grounds of compulsory licenses. In addition, Jordan provides pharmaceutical testing data with data exclusivity. This thesis focuses on the Jordanian experience in the pharmaceutical sector. It argues that strong patent protection has not been conducive to the promotion of technological innovation and the transfer and dissemination of technology. Moreover, this protection has resulted in adverse outcomes such as increased drug prices, unavailability of essential medicines in some public hospitals for serious diseases, and a dwindling local pharmaceutical industry, in part, as a consequence of its inability to access advanced, patented technology on reasonable commercial terms. The thesis also investigates the legitimacy of establishing certain grounds of compulsory licensing by Jordan, even in light of the TRIPS-Plus obligations under the USJFTA. It advocates that such grounds contribute to the promotion of technical innovation, lead to the transfer of advanced technology, and above all improve access to affordable medicines. Finally, the thesis explores Jordan’s obligations to protect pharmaceutical testing data under TRIPS and USFTA arguing that neither of these two instruments requires data exclusivity as claimed by Pharmaceutical Research and Manufacturers of America (PhRMA) and some developed countries.

In 2000, Jordan signed the Agreement on Trade-related Aspects of Intellectual Property Rights (the TRIPS Agreement) and a free trade agreement with the US (USJFTA). Both commitments have required Jordan to comply with various obligations, including full compliance with the minimum standards for the protection of intellectual property rights (IPRs) under the TRIPS Agreement and TRIPS-Plus IP standards set out under the terms of the USJFTA. Enticed by views that strong IP protection would create prosperity in the Kingdom by promoting technological innovation and inducing transfer and dissemination of technology to Jordanians, Jordan implemented the provisions of TRIPS and the USJFTA to the letter. However, Jordan focused little attention on important “TRIPS flexibilities”. In particular, Jordan has qualified parallel importation and limited the grounds of compulsory licenses. In addition, Jordan provides pharmaceutical testing data with data exclusivity. This thesis focuses on the Jordanian experience in the pharmaceutical sector. It argues that strong patent protection has not been conducive to the promotion of technological innovation and the transfer and dissemination of technology. Moreover, this protection has resulted in adverse outcomes such as increased drug prices, unavailability of essential medicines in some public hospitals for serious diseases, and a dwindling local pharmaceutical industry, in part, as a consequence of its inability to access advanced, patented technology on reasonable commercial terms. The thesis also investigates the legitimacy of establishing certain grounds of compulsory licensing by Jordan, even in light of the TRIPS-Plus obligations under the USJFTA. It advocates that such grounds contribute to the promotion of technical innovation, lead to the transfer of advanced technology, and above all improve access to affordable medicines. Finally, the thesis explores Jordan’s obligations to protect pharmaceutical testing data under TRIPS and USFTA arguing that neither of these two instruments requires data exclusivity as claimed by Pharmaceutical Research and Manufacturers of America (PhRMA) and some developed countries.

Esta tese visa aprofundar o entendimento das dinâmicas de interação entre atores estatais e não estatais nos processos de criação, continuidade e mudança de regimes internacionais. A pesquisa se apresenta como um estudo de caso demarcado a partir da criação do novo regime internacional de proteção dos direitos de patentes, instituído em 1994 quando da adoção do Acordo sobre Aspectos dos Direitos de Propriedade Intelectual Relacionados ao Comércio (TRIPS) pelos países membros do GATT. Inclui as disputas entre as empresas farmacêuticas e o governo da África do Sul, o contencioso entre Brasil e Estados Unidos, na Organização Mundial do Comércio, e as negociações que culminaram na adoção da Declaração sobre o Acordo TRIPS e Saúde Pública, em novembro de 2001. A partir da problematização das decisões do governo dos Estados Unidos, nos vários momentos do caso, se propõe, como argumento central do trabalho, que a mídia constitui um importante elemento de ligação nos processos através dos quais atores não estatais com capacidade material reduzida exercem influência sobre atores estatais nas decisões acerca da política externa tanto no âmbito bilateral como multilateral / This thesis aims to deepen the understanding of the interactive dynamics between governmental and non governmental actors in the processes of creation, continuity, and change of international regimes. The research is presented as a case study delimited from the creation of the new international regime of intellectual property rights, instituted in 1994, when the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) was adopted by the GATT member-countries. It includes the disputes between the pharmaceutical companies and the government of South Africa, the controversy between Brazil and the United States, in the World Trade Organization, and the negotiations that culminated in the Declaration on the TRIPS Agreement and Public Health, adopted in November 2001. From the problematization of decisions of the United States Government, in the various moments of the case, as central argument it is proposed that the media is an important linkage element in the processes through which non state actors with reduced material capacity exercise influence on state actors on foreign policy decisions in regard to both bilateral as well as multilateral decisions

This thesis deals with global governance and its changing structures reflected in the challenges to the functioning of post-war intergovernmental institutions. The main aim of the thesis is to find out whether the World Trade Organization is effective enough in dealing with emerging global issues, which is tested on the case study of the adoption of the TRIPS agreement with special focus on pharmaceuticals. In the first chapter, it provides a theoretical framework of the global governance theory and the means for evaluating the effectiveness of international institutions in global governance through input and output legitimacy. The second chapter deals with the role of the World Trade organization in global governance and evaluating its performance. The third chapter evaluates the role of the World Trade Organization in protection of intellectual property rights with focus on pharmaceuticals. The methods used in the thesis include analysis, synthesis, deduction while the research is supported with quantitative data, tables and case study.

Esta dissertação tem por escopo estudar a interface do Acordo TRIPS com o a Convenção sobre Diversidade Biológica, sob a perspectiva dos países em desenvolvimento. Para tanto, resgata a construção epistemológica Ocidental do conhecimento, direito, propriedade intelectual e desenvolvimento. Esta base teórica constituída é questionada pela CDB, que apresenta direitos relativos ao acesso de recursos genéticos e / ou conhecimento tradicional que subvertem a ordem estabelecida de geração do conhecimento e acumulação econômica. Tal subversão é parte integrante de movimento maior que questiona o próprio modelo de desenvolvimento e a relação Norte e Sul. Esta pesquisa contextualiza a estruturação legal e organizacional do tema e revisa as contribuições de autores que estudam este, sistematizando-as. Com este arcabouço, ela levanta hipóteses e reflete sobre as respostas destas, identificando paradoxos, compatibilidades e desafios. Apresenta (ndo) se, por fim, uma análise da governança institucional deste tema, através de uma nova configuração cognitiva e legal do mesmo. / This MA dissertation aims at studying the interface of the \'TRIPS Agreement\' with the \'Convention on the Biological Diversity\', under the view of the developing countries. As such, it ransoms the epistemologic building of the Ocidental knowledge, as well as the rights, intelectual property and development. This theoretical basis is questioned by \'CDB\', which presents rights related to the access of genetic resourses/ and the traditional knwledge, which subvert the established order of knowledge generation and economic accumulation. Such subvertion is part of a larger movement that questions its own development model and the North/ South relation. This research contextualizes the legal orgazing structuralization of the theme and revises the contributions of authors that study it, systematizing them. With this backbone, it rises hypotheses and thinks of these hypotheses, identifying paradoxes, compatibilities and challenges. It finally presents an analysis of the institutional governing of this theme, via a new cognitive and legal configuration of the same.

Made available in DSpace on 2016-03-15T19:34:26Z (GMT). No. of bitstreams: 1 Henrique Romanini Subi.pdf: 1009215 bytes, checksum: 5ca95369df8dd46db7fb1f12851fa832 (MD5) Previous issue date: 2015-08-13 / Intellectual property rights have been object of expansion in recent decades, when they began to be recognized on things and innovations hitherto immune to private appropriation, like living organisms, business methods and even the human genome. We live, as well, a second "enclosure movement" of the property, led by high-tech industry rooted in developed countries and aims to ensure the highest possible financial return on their investments in R&D. The extension of these rights creates situations of abuse that, besides diverting their purpose, cause damage to other principles applicable to the market, such as free competition and free enterprise. International treaties play an important role in this reality, with the TRIPS Agreement as the main one and that, despite his attempt to prevent such abuses, turns out to be too open in their terms and indirectly empower them and give them legal lair. / Os direitos de propriedade intelectual vêm sendo objeto de ampliação nas últimas décadas, quando passaram a ser reconhecidos sobre coisas e inovações até então imunes à apropriação privada, como organismos vivos, processos de negócios e até o genoma humano. Vivemos, assim, um segundo movimento de cercamento da propriedade, capitaneado pela indústria de ponta radicada nos países desenvolvidos e que visa a garantir o maior retorno financeiro possível aos seus investimentos em pesquisa. O alargamento desses direitos gera situações de abuso que, além de desviarem sua finalidade, causam prejuízos a outros princípios caros ao mercado, como a livre concorrência e a livre iniciativa. Os tratados internacionais têm participação importante nessa realidade, sendo o Acordo TRIPS o principal deles e que, a despeito de sua tentativa de evitar tais abusos, acaba por ser demasiadamente aberto em suas cláusulas e indiretamente os autoriza e lhes dá guarida jurídica.

<p>For many years pharmaceutical patents and their impact on prices have been at the centre of the international debate over insufficient access to lifesaving HIV/AIDS medicines in developing countries. The conflict has largely revolved around the implementation of an intellectual property system in the developing world, subsequent the adaptation of the TRIPS Agreement, which has made a 20 year pharmaceutical patent protection mandatory for these countries and consequently contributed to high drug prices for patented medicines as well as limited the use of generic drugs.</p><p>Developing countries, where patents are already in place, have sought to reduce high drug prices by making use of compulsory licensing, a safeguarding practice allowing the production or importation of a generic medicine without the consent of the patent holder. Compulsory licences are allowed under the TRIPS Agreement, but disagreements about the conditions, under which compulsory licences are available for ‘essential medicines’, have restricted their use. A definition of the extent to which compulsory licensees can export generic drugs to developing countries unable to manufacture their own has been missing, but on 30 August 2003 the WTO announced that it had resolved this problem by lifting the TRIPS Agreement’s restrictions on exports and permitting exports of drugs produced under a compulsory license as an exception to a patent right. The main question is whether the compulsory licensing system as prescribed in the recent Decision is an ample means of improving access to patented AIDS medicines in the developing world.</p><p>By means of legal and economic reasoning this master thesis argues that the 30 August Decision on lifting TRIPS’ restrictions on exports of patented pharmaceuticals produced under compulsory licences provides complex and uncertain rules, rendering an unreliable employment of compulsory licensing. It is desirable that further recommendations are given on which generic producing companies should be awarded compulsory licences and also on which premises. In reality, the debate about compulsory licensing is part of a much wider structural problem in development policy. The solution to the inaccessibility problem requires a mix of courses of action with a functioning compulsory licensing system included. However, disagreements such as how necessary funding should be divided equitably between developed countries could protract the reaching of a pragmatic solution.</p>