Guidelines for the Examination of Pharmaceutical Patents: Developing a Public Health Perspective, ICTSD, WHO, UNCTAD, Geneva (original) (raw)
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.
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.
The Journal of World Intellectual Property, 2018
Patent laws determine access to medicines and medical devices, and all members of the World Trade Organization (WTO) are obligated to introduce minimum standards of intellectual‐property protection into their national patent laws. In the negotiations that led up to the Trans‐Pacific Partnership Agreement (TPP), in 2016, the United States attempted to introduce patents for diagnostic, therapeutic, and surgical methods to promote the interests of its pharmaceutical and medical‐device industries. These attempts were unsuccessful; however, these actions demonstrate the determination of those who advocate for higher standards of intellectual‐property protection to push for a TRIPS‐plus agenda. The United States has sought to limit the use of flexibilities in the TRIPS Agreement, including the use of compulsory licenses which allows the generic industry to produce cheaper pharmaceuticals. Despite these US actions, many developing countries are becoming emboldened and are issuing compulsor...
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.
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
Should access to medicines and TRIPS flexibilities be limited to specific diseases
Am. JL & Med., 2008
The health needs of most of the world's population are not well served by patent-based pharmaceutical markets. The poor in low-and medium-income countries (LMICs) lack the financial resources to sustain the attention of global commercial drug companies. After an extensive consultation process, in 2006 the World Health Organization's Commission on Innovation, Intellectual Property and Public Health issued its Report (the WHO CIPIH REPORT), finding this concern to be significant: "In the context of our work one of the important points is that, where the market has very limited purchasing power, as is the case for diseases affecting millions of poor people in developing countries, patents are not a relevant factor or effective in stimulating R&D and bringing new products to market." 1 On this issue, the WHO CIPIH REPORT was preceded by the Access to Medicines movement, an informal coalition of civil society organizations such as Médecins Sans Frontières, Treatment Action Campaign, Health GAP, Oxfam, and Knowledge Ecology International (formerly the Consumer Project on Technology). These groups and many others identified patents on pharmaceuticals as an inappropriate barrier to access in developing countries. They devoted particular attention to the World Trade Organization TRIPS Agreement, which is the minimum global legal standard for pharmaceutical patents. 2 In response to challenges about the need for innovation, some have reframed the movement as "Access + Innovation." This article follows in the Access + Innovation genre, attempting to simultaneously solve for both equitable access and optimal innovation. 3
Balancing intellectual monopoly privileges and the need for essential medicines
Globalization and Health, 2007
This issue of Globalization and Health presents a paper by Kerry and Lee that considers the TRIPS agreement and the recent policy debate regarding the protection of public health interest, particularly as they pertain to the Doha Declaration. In this editorial, we consider the debate, the conclusions thereof, and identify five questions that should be considered by key stakeholders in ongoing discussions.
Journal of Intellectual Property Rights (JIPR) : [776] ISSN: 0975-1076 (Online); 0971-7544 (Print) JIPR Vol.22(6) [November 2017] Page(s): 295-302, 2017
Though the UN has envisaged that accessibility to essential medicines is a basic human right, a large number of people in developing countries are denied access to essential medicines. MNCs having the branded medicines have a tendency to choke the supply chain of cheaper generic medicines using the weapon of intellectual property rights. The TRIPS Agreement has set the minimum standard of protection of Intellectual Property but it has provisions of flexibilities such as compulsory licenses, parallel imports limitations to patent rights, etc., which can be used by member states to provide access to these essential medicines to their people. However, countries like US are using provisions which are over and above the flexibilities incorporated in TRIPS to deny access to essential medicines to people in developing countries. The accessibility of essential medicines to the population in developing countries as affected by these FTAs, ACTA, TPP and TTIP agreements have been examined in this paper and a case has been made out for the unity of the developing and least developed countries to deter US from choking the supply lines of the essential medicines to poor and needy.