Guidelines for the Examination of Pharmaceutical Patents: Developing a Public Health Perspective, ICTSD, WHO, UNCTAD, Geneva (original) (raw)
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Journal of International Economic Law - J INT ECON LAW, 2007
The entry into force of the World Trade Organization (WTO) TRIPS Agreement in 1995 transformed the international intellectual property system. The harmonization of basic intellectual property standards has operated to protect investment in innovation, limiting risks from unjustified ‘free riding’. Yet these same harmonized IP standards sharply curtailed the traditional capacity of suppliers of public goods, such as health care and nutrition, to address priority needs of less affluent members of society, particularly in (but not limited to) developing countries. In the Doha Declaration, the Waiver Decision of 30 August 2003 and the Article 31bis Protocol of Amendment, stakeholders concerned with re-opening policy space for the supply of newer pharmaceutical products pushed back against restrictive elements of the TRIPS Agreement.Governments around the world are in the process of deciding whether to ratify and accept the Article 31bis Amendment. Based on their Study for the Internatio...
Globalization and Health, 2007
Background: The World Trade Organisation's Declaration on the TRIPS Agreement and Public Health (known as the Doha Declaration) of 2001, and subsequent Decision on the Interpretation of Paragraph 6 reached in 2003, affirmed the flexibilities available under the Agreement on Trade Related Property Rights (TRIPS) to member states seeking to protect public health. Despite these important clarifications, the actual implementation of these measures to improve access to medicines remains uncertain. There are also concerns that so-called TRIPS-plus measures within many regional and bilateral trade agreements are further undermining the capacity of the poor to access affordable medicines. Methods: The paper reviews policy debates among governments, nongovernmental organisations and international organisations from 1995, and notably since 2003, surrounding access to medicines and trade agreements. The provisions for protecting public health provided by the Doha Declaration and Paragraph 6 Decision are reviewed in terms of challenges for implementation, along with measures to protect intellectual property rights (IPRs) under selected regional and bilateral trade agreements. Results: While provisions, in principle, were affirmed for member states under the TRIPS agreement to protect public health, numerous challenges remain. Implementation of the flexibilities has been hindered by lack of capacity in many LMICs. More intransigent have been stark inequalities in power and influence among trading nations, leaving LMICs vulnerable to pressures to permit the globalization of IPRs in order to protect broader trade and economic interests. Such inequalities are apparent in proposals or adopted TRIPS-plus measures which re-establish the primacy of trade over public health goals. Conclusion: Despite being hailed as a "watershed in international trade", the Doha Declaration and Paragraph 6 decision have not resolved the problem of access to affordable medicines. The way forward must begin with a simplification of their content, to enable actual implementation. More fundamentally, once agreed, public health protections under TRIPS must be recognised as taking precedent over measures subsequently adopted under other trade agreements. This requires, above all, setting aside such protections as a basic need and shared goal from trade negotiations at all levels.
Public health and international patent protection
International journal of health sciences
After the coming into force of TRIPS Agreement much importance has been given to the concept of public health. Doha Declaration on Public Health provides a legal basis for interpreting the TRIPS Agreement as consistent with public health objectives and for using the flexibility of the agreement for this purpose. However, these efforts could not resolve the apparent conflict between public health and patent protection. The right to health is a basic human right of every person and includes the right to access the essential drugs. However, right to public health cannot be ensured when there is no certainty as to the legal status of the Doha Declaration. Issues, such as, how much weightage will be given to the Declaration when the WTO Panel or the Appellate Body is adjudging a dispute which affects public health, are bound to arise.
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.
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