INTEGRATING PUBLIC HEALTH CONCERNS INTO PATENT LEGISLATION IN DEVELOPING COUNTRIES (original) (raw)
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Yuridika, 2022
The rapid spread of the SARS-CoV-2 virus, which is responsible for the COVID-19 pandemic, has spawned an intense debate on the necessity of a waiver of some provisions of the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to increase access to medicines and other medical technologies essential for combating the disease. Through a legal research method, this article explores the potential of the TRIPS waiver as a mechanism for reconciling the conflicting norms of public health with intellectual property rights protection by interpreting the TRIPS provisions backed by relevant legal theories. It argues that while the TRIPS waiver can be an effective legal instrument that accommodates public health concerns of increasing access to medicines and medical technologies, it has, in its current form and text, many flaws that militate against its effectiveness. These flaws are evident in how the TRIPS waiver is couched, notwithstanding that the waiver presents multiple benefits, including furthering re-humanisation, distributive justice and decolonisation goals. The article offers recommendations on how the TRIPS waiver adopted during the WTO's recently concluded 12th Ministerial Conference could be strengthened to eliminate some of its defects in expanding access to COVID-19 vaccines and other therapeutics products. The research methodology used in this article is the qualitative desktop doctrinal research method.
Intellectual Property, Health, Regionalism and Development: A Third World’s Perspective
European Journal of Sustainable Development, 2016
The United Nations Sustainable Development Goals were adopted in September 2015 as a post 2015 development agenda. Goal 9 of the SDGs is to 'build resilient infrastructure, promote inclusive and sustainable industrialization and foster innovation'. Much has been written on the connection between intellectual property and development. With respect to developing countries, arguments have been canvassed both for and against intellectual property in the pursuit of their development goals. The adoption of the TRIPS Agreement in 1994 heralded a new era of global intellectual property governance aimed at a substantial harmonisation of intellectual property protection standards across the globe. This continues to raise continuing concerns in relation to the extent to which IP could foster development and industrialisation in developing countries and whether the global IP regime is designed in a way that sufficiently protects the interest of the developing and least developed nations. The development rhetoric is assuming an increasing significance in Africa given the continent's varying development challenges. This calls for some reflection on the interface between IP protection and the pursuit of sustainable human and economic development. The paper examines the link between intellectual property and health and how it relates to sustainable development in the African context.
Intellectual property rights and globalization. implications for developing countries
Science, technology and innovation discussion Paper, 1999
This paper reviews the implications of the agreement on Trade-Related Intellectual Property Rights (TRIPS) under the World Trade Organization (WTO). It focuses on the national implemention of the TRIPS agreement, technological development, plant variety protection, geopgraphical indications, and biological diversity and the associated indigenous knowledge. The paper argues that efforts to promote compliance with to the TRIPS agreement should be accompanied by measures that address public interest challenges such as health, nutrition and environmental conservation in developing countries. It suggests that addressing these issues will require policy and institutional innovations in the developed and developing countries. While some of the measures can be addressed through multilateral forums, many of them should be addressed through domestic laws and policies designed to foster innnovation and expand international trade.
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.
therefore, it may make it difficult for developing countries to gain access to medicines, especially those countries that are the least developed. This study aims to determine whether implementation of the TRIPS Agreement in Latin American and Caribbean countries has generated patent legislation that is sensitive to public health needs. Methods Legislation in 11 Latin American and Caribbean countries was analysed. The variables considered in the analysis were: the term of patents issued, patentable subject matter, transition periods (that is, time until legislation was enacted), reversal of the burden of proof of patent infringement, exhaustion of rights, compulsory licensing and the early working exception (which allows a country to complete all procedures necessary to register a generic product before the original patent expires). Findings By 2000, all of the countries studied had reformed their legislation to conform to the agreement. Brazil and Argentina used the transition period until 2005 to grant patents in the pharmaceutical industry. All countries, except Panama, made use of the safeguards and flexibilities available through the agreement by including mechanisms for compulsory licensing in their legislation. Argentina; Bolivia, Colombia, Ecuador, Peru and Venezuela (countries that represented the Andean community); the Dominican Republic; and Panama included mechanisms to allow parallel importation. Mexico did not. Brazil only permits parallel importation after a compulsory licence has been issued. The early working exception is included in legislation in Brazil and the Dominican Republic. Conclusion The countries in this study did not incorporate all of the mechanisms allowed for by the Agreement and are not adequately using the provisions that enable World Trade Organization (WTO) members to obtain better health for the public, particularly in regard to gaining access to medicines. This situation may deteriorate in future if other agreements establish more restrictive rules for intellectual property rights.
2007
Objective This study aims to propose a framework for measuring the degree of public health-sensitivity of patent legislation reformed after the World Trade Organization's TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement entered into force. Methods The methodology for establishing and testing the proposed framework involved three main steps:(1) a literature review on TRIPS flexibilities related to the protection of public health and provisions considered "TRIPS-plus"; (2) content validation through consensus techniques (an adaptation of Delphi method); and (3) an analysis of patent legislation from nineteen Latin American and Caribbean countries. Findings The results show that the framework detected relevant differences in countries' patent legislation, allowing for country comparisons. Conclusion The framework's potential usefulness in monitoring patent legislation changes arises from its clear parameters for measuring patent legislation's degree of health sensitivity. Nevertheless, it can be improved by including indicators related to government and organized society initiatives that minimize free-trade agreements' negative effects on access to medicines.
Regulation & Governance , 2020
This article analyzes the domestic drivers of regulatory state formation in India and Brazil and its consequences for the global rules governing pharmaceutical patents. The field of pharmaceutical patents offers an ideal case to examine the conditions under which emerging economies may evolve into rule-makers in their own right given their conflicting preferences vis-à-vis the regulatory status quo and the importance of patent regulations for their own economic growth. We first analyze Indian and Brazilian politics of regulatory state formation; then, in light of the extent to which the two countries have built regulatory capacity and capability in the field of patent regulation, we explore whether and how they have been able to influence the existing intellectual property (IP) regime in health. We look into two key domestic regulatory initiatives where India and Brazil made use of the flexibilities available under the TRIPS agreement and which have the potential to modify the health-IP regime: India's Section 3(d) and Brazil´s prior consent requirement. Whereas India's Section 3(d) regulation has gained international regulatory influence by diffusing to other developing countries, the same cannot be said for Brazil's prior consent regulation, which has been caught by policy-reversals. In sum, these case studies provide two key insights. Firstly, the transition towards regulatory states in emerging countries is a bulky road and does not progress in linear ways. Secondly, once regulatory capacity and capability have been solidified, domestic policy innovations can become internationally influential. This needs not work through the traditional channels of multilateralism, but can also occur horizontally through policy-diffusion to other jurisdictions.