Morin, J-F., 2006, "Tripping up TRIPs Debate: IP and Health ", International Journal of Intellectual Property Management, vol. 1, no1/2, p. 37-53. (original) (raw)
Related papers
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
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.
Implications of bilateral free trade agreements on access to medicines
Bulletin of The World Health Organization, 2006
The TRIPS Agreement of the World Trade Organization (WTO) mandated the introduction of protection of intellectual property rights, notably patents, for pharmaceutical products. While the implications for the access to medicines contained in the terms of this Agreement raised significant concerns, a recent new wave of free trade agreements, negotiated outside the WTO, requires even higher levels of intellectual property protection for medicines than those mandated by that Agreement. The measures involved include the extension of the patent term beyond 20 years; prohibition of use of test data on drug efficacy and safety for certain periods for the approval of generic products; the linkage between drug registration and patent protection; in some cases, limitations to the grounds for granting compulsory licences. This article reviews some of these measures that further limit the competition of generic products and discusses their possible implication for access to medicines.
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.
Bulletin of the World Health Organization, 2018
Millions of people, particularly in low- and middle-income countries, lack access to effective pharmaceuticals, often because they are unaffordable. The 2001 Ministerial Conference of the World Trade Organization (WTO) adopted the Doha Declaration on the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement and Public Health. The declaration recognized the implications of intellectual property rights for both new medicine development and the price of medicines. The declaration outlined measures, known as TRIPS flexibilities, that WTO Members can take to ensure access to medicines for all. These measures include compulsory licensing of medicines patents and the least-developed countries pharmaceutical transition measure. The aim of this study was to document the use of TRIPS flexibilities to access lower-priced generic medicines between 2001 and 2016. Overall, 176 instances of the possible use of TRIPS flexibilities by 89 countries were identified: 100 (56.8%) invol...
Millions of people, particularly in low-and middle-income countries, lack access to effective pharmaceuticals, often because they are unaffordable. The 2001 Ministerial Conference of the World Trade Organization (WTO) adopted the Doha Declaration on the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement and Public Health. The declaration recognized the implications of intellectual property rights for both new medicine development and the price of medicines. The declaration outlined measures, known as TRIPS flexibilities, that WTO Members can take to ensure access to medicines for all. These measures include compulsory licensing of medicines patents and the least-developed countries pharmaceutical transition measure. The aim of this study was to document the use of TRIPS flexibilities to access lower-priced generic medicines between 2001 and 2016. Overall, 176 instances of the possible use of TRIPS flexibilities by 89 countries were identified: 100 (56.8%) involved compulsory licences or public noncommercial use licences and 40 (22.7%) involved the least-developed countries pharmaceutical transition measure. The remainder were: 1 case of parallel importation; 3 research exceptions; and 32 non-patent-related measures. Of the 176 instances, 152 (86.4%) were implemented. They covered products for treating 14 different diseases. However, 137 (77.8%) concerned medicines for human immunodeficiency virus infection and acquired immune deficiency syndrome or related diseases. The use of TRIPS flexibilities was found to be more frequent than is commonly assumed. Given the problems faced by countries today in procuring high-priced, patented medicines, the practical, legal pathway provided by TRIPS flexibilities for accessing lower-cost generic equivalents is increasingly important.
The international trade law regime has been flourishing with the institutionalisation and judicialisation under the auspices of the World Trade Organization (‘WTO’). While some people applaud the development towards constitutionalisation, the inter-governmental nature of the legal regime, especially at the law making phase, has remained at the penumbra. Illustrative is the barrier against access to essential medicines caused by pharmaceutical patent protection under the WTO regime. Pressures have been mounting to alleviate the problem in multinational forums, and yet the initiative by the United States to set a higher level of intellectual property protection over pharmaceutical products through bilateral trade agreements has impeded change.
TRIPS-Plus Free Trade Agreements and Access to Medicines
Liverpool Law Review, 2007
The battle over access to essential medicines revolves around the rights to issue compulsory licenses and to manufacture and export generic versions of brand name drugs to expand access. Global brand name pharmaceutical firms have sought to ration access to medicines and have used their economic and political clout to shape United States trade policy. They have succeeded in getting extremely restrictive TRIPS-Plus, and even US-Plus, intellectual property provisions into regional and bilateral free trade agreements. Asymmetrical power relations continue to shape intellectual property policy, reducing the amount of leeway that poorer and/ or weaker states have in devising regulatory approaches that are most suitable for their individual needs and stages of development. While the overall trend is disturbing, some recent activities in the World Health Organization and evidence of greater unity behind health-based TRIPs flexibilities provide some grounds for cautious optimism.