Public Law Challenges to the Regulation of Pharmaceutical Patents in the US Bilateral Free Trade Agreement (original) (raw)
Related papers
2013
La internacionalización de la protección de la propiedad intellectual e industrial fue objeto en los años 90 de un desplazamiento de foro desde la OMPI a la OMC, bajo la presión de los países exportadores de tecnología y sus empresas: el producto fue el ADPIC. Este acuerdo fue diseñado para elevar los estándares de protección empleando una estructura regulatoria basada en meros periodos de transición y minusvalorando los efectos sociales de la eventual pero previsible falta de capacidad de producción farmacéutica en muchos países en desarrollo (artículo 31.f). A resultas, los países exportadores e importades de tecnología están inmersos hoy en día en un proceso de reregulación dirigido a asegurar las “flexibilidades” inherentes al ADPIC, bajo el estandarte del acceso a medicamentos asequibles en el mundo en desarrollo.The internationalization of intellectual property protection was subject to a historical forum shift from WIPO to WTO in the 90s under the pressure of technology-expor...
Patents and Public Health in the WTO, FTAs and Beyond: Tension and Conflict in International Law
By mandating patent protection for pharmaceutical products, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) of the World Trade Organization (WTO) creates difficulties for developing countries seeking to import medicines to deal with serious public health concerns. In 2001, WTO Members began working towards a solution to this problem. Their work led to a temporary waiver of certain TRIPS obligations and a proposal for a formal amendment of the TRIPS Agreement. However, the waiver remains underutilized and the amendment still lacks the necessary support of WTO Members for it to come into effect, suggesting that Members need to re-evaluate their commitment to affordable medicines while testing the workability of the waiver before making it permanent. Moreover, the potential of bilateral approaches to the problem of access to medicines for developing countries in the context of international trade is not being realized. On the contrary, preferential trade agreements concluded with the United States (US), in particular, are extending patent protection and diminishing flexibilities available under the TRIPS Agreement to address public health concerns. A pattern of contradictions exists between the WTO rhetoric on the one hand and Members' domestic frameworks, bilateral agreements, and unilateral actions on the other. When it comes to attaining a coherent approach under international law towards reconciling patents and public health, the outlook is bleak.
Trade Rules and Intellectual Property Protection for Pharmaceuticals
This paper provides an account of how certain trade and intellectual property (IP) rules agreed at the WTO or in bilateral and regional trade agreements impact upon access to medicines, especially in the developing world. As most changes in the area of pharmaceutical IP protection were set in motion through the WTO TRIPS agreement, the chapter focuses on the actors and rationales that underpinned TRIPS negotiations, making the argument that TRIPS was not negotiated with public health or other social goals in mind. Taking this as the starting point, the chapter then details how TRIPS and ‘TRIPS plus’ IP pharmaceutical provisions pose significant challenges to expanding affordable access to medicines. Awareness about such detrimental consequences has informed the IP-access to medicines contests from the late 1990s onwards and with some (qualified) successes, although many issues still remain contested and unresolved. More broadly, the argument presented here is that most of the problems that present themselves at the intersection of trade rules, IP protection and pharmaceuticals stem from two seemingly irreconcilable frameworks – one that seeks to fashion trade and IP rules regarding pharmaceuticals as a matter of competitiveness (central to the US and EU position), and another that seeks to subdue trade and pharmaceutical IP rules to the achievement of public health goals. Any efforts to improve healthcare worldwide would have to include a reassessment of the social purpose of IPRs: in the case of pharmaceuticals, public access to lifesaving medicines.
Today, along with the relative expansion of public health around the world, various diseases such as AIDS, malaria, etc. are increasing in human societies. In this regard, the pharmaceutical industry is one of the most important industries that should be supported so that the inventors of new drugs have enough motivation to produce more effective drugs. On the other hand, the undeniable benefits of supporting pharmaceutical inventions pose a serious threat to developing and less developed countries, and may endanger the public health of these societies. In such situation, we should know which of these two principles is preferable to other and should be given priority: Public health as a basic human right or protection of pharmaceutical patents as an exclusive right of its owners? One of the most important issues discussed directly and indirectly in the World Trade Organization is ”public health”, especially the drug trade and the protection of pharmaceutical patents, and this organization has always protected the rights of drug inventors to maintain a balance between public health and freedom of access to medicine. Therefore, any legal system that wants to join this organization may face problems due to these two issues. This study aims to investigate the conditions and challenges of supporting pharmaceutical patents in legal systems in case of accession to the World Trade Organization.
Patents for Drugs and the Right to Development in International Law
Law and Development Review, 2015
This article explores the connection of health to human and socio-economic development and the protection of pharmaceutical patents. It examines the concept of development and the right to development in international law in the context of access to medicines and patents protection. The provisions of the General Agreement on Tariffs and Trade (GATT) and the Agreement on Trade Related aspects of Intellectual Property Rights (TRIPS Agreement) that are significant to the pursuit of development are discussed. The article argues that there is a cognisable right to development in international law that is well recognised in international trade law and the pursuit of development should be duly taken into account in the negotiation and implementation of trade and IP agreements. The article highlights the potential danger in eroding the flexibilities in the TRIPS Agreement through the negotiation of free trade agreements and emphasises the need for IP and trade agreements to sufficiently acc...
Towards a New Dialectics - Pharmaceutical Patents, Public Health and Foreign Direct Investments
International Economic Law eJournal, 2015
This article highlights the emergence of a new dialectics between the protection of intellectual property and public health in international investment law and arbitration. International investment law is a vital area of international law, which has furthered the protection of intellectual property, considering it a form of investment and providing intellectual property owners access to investor-state arbitration. While investor–state arbitration constitutes a major development in international law and facilitates the access of foreign investors to justice, it may endanger the fundamental values of the international community as a whole, unless arbitrators duly take into account their role as “cartographers” of international law within their role as “adjudicators.” Have arbitral tribunals taken public health considerations into account when adjudicating pharmaceutical patent-related cases? If so, have they considered public health either as an exception to investment treaty standard...
Patents, trade and medicines: past, present and future
Review of International Political Economy, 2019
This paper analyzes the spread of intellectual property in trade agreements. We explain how the integration of intellectual property with international trade rules led to the globalization of pharmaceutical patenting, and then how additional provisions related to pharmaceutical products have been introduced by regional and bilateral trade agreements. We describe the additional "TRIPS-Plus" rules contained in recent trade agreements, which go beyond the requirements of the World Trade Organization's TRIPS Agreement, and explain the potential challenges that they may create for developing countries. We draw attention to the conceptual and methodological challenges of assessing the effects of patent provisions in trade agreements on prices and access to drugs, with particular emphasis on the importance of timing. Depending on when countries began allowing drugs to be patented, TRIPS-Plus provisions have different effects; and when pharmaceutical patenting has been in place for more countries for more time, the effects of TRIPS-Plus provisions will change again.
The Transatlantic Colossus,: lobal Contributions To Broaden The Debate On The EU-US Free Trade Agreement, eds. David Cardoso, et al.., 2014
Issues surrounding patent protection for pharmaceuticals and access to essential medicines have long been a source of controversy in the context of multilateral trade agreements. Even as the battles that crystallized over anti-retroviral therapies for HIV/AIDS treatment and the implementation of the WTO's agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) have subsided, new fault lines have opened up in recent years. The increasing proliferation of regionally based regimes for trade/investment liberalization has created new opportunities for the pharmaceutical lobby to re-open what were on their way to becoming settled issues. In the process, the fragile consensus that was beginning to emerge regarding TRIPS-compliant methods of creating exceptions to excessively strict standards of patentability in the pharmaceuticals context has come under great pressure. While such matters have started to attract significant attention among civil society actors monitoring the ongoing talks concerning the Trans Pacific Partnership (TPP), they have been less visible in discussions of the TAFTA | TTIP. In this article I consider the potential risks the TAFTA | TTIP poses to the hard-won exceptions to patentability in the pharmaceuticals context through functioning as a Trojan horse for advancing a so-called TRIPS-plus agenda. 1 The Doha texts are available at: http://www.wto.org/english/tratop\_e/ dda_e/dohaexplained_e.htm#top
The WTO’s Compulsory Licencing of Patented Pharmaceuticals: Implementation Challenges
Međunarodna politika 75(1190):39-55, 2024
The focus of the research is the topic of compulsory licensing, the right under the Agreement on Trade-Related Aspects of Intellectual Property Rights, for countries to use patented medicines without the patent holder’s consent as a form of relief (flexibilities) for developing countries. The research aims to assess whether the application of compulsory licencing has fulfilled its primary goals and purpose. The research problem is the in consistency between the compulsory licencing application in practice and the original purpose. It is reflected in the mass use of this right by countries with higher incomes and, secondly, in the symbolic presence of contagious diseases. That was investigated using the Generalized Linear Model. The results confirmed that the actual situation of public health and the income level of beneficiaries had been marginalised as grounds for exercising compulsory licencing. The arbitrary application of compulsory licencing has led to the situation that the poorest countries, with the most significant health crises, remain in the background of this World Trade Organisation mechanism.
In 2008 and 2009, customs officials in the European Union, alleging patent infringement detained and seized generic medicines in transit from India to Brazil. The two countries requested consultations through the World Trade Organization’s Dispute Settlement Understanding based on alleged violations of the Agreement on Trade-Related Aspects of International Property Rights and other international agreements. These disputes are different from all prior ones—they are premised upon the claim that the EU violated the TRIPS agreement through the use of its border measures that went beyond the TRIPS minimum standards, rather than claiming that the other country did not meet those minimum obligations. They also show how developed countries seek to enact such intellectual property standards outside the WTO and limit global access to medicines. This note examines how developing countries can use the DSU to challenge these restrictions, and pursue policies that promote global access to medicines.