Feedback to SSRN (Beta)
What type of feedback would you like to send?
Abstract: On June 19, 2001, the WTO TRIPS Council held its first meeting on the implications of the TRIPS Agreement for access to medicines and public health. In connection with that meeting, and a follow on meeting of July 25, 2001, WTO Members have made a number of specific observations regarding the terms, structure and spirit of the Agreement. This report analyzes issues presented by the TRIPS Agreement and its present and prospective impact on access to medicines. A number of these issues have previously been raised and analyzed by this author and other commentators, and the discussions initiated in the TRIPS Council already focus on several of them. Nevertheless, it may be useful to consider in a relatively concise and systematic format the central elements of discussion in connection with the prospective Ministerial Conference in Doha on November 9-13, 2001. There are two ultimate objectives of this report. The first is to assist Members in formulating recommendations regarding a possible Doha Ministerial Declaration on TRIPS and Public Health, or a near-term formal interpretation of the TRIPS Agreement. The second is to raise issues that might more appropriately be the subject of a longer-term review of the TRIPS Agreement.
Abstract: On August 30, 2003, the member countries of the WTO adopted the Decision on Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health. This Decision provides flexibility for the export of pharmaceutical products under compulsory license (which flexibility might otherwise have been limited by the terms of the TRIPS Agreement). This article analyzes negotiating strategies used by developing countries to achieve their objectives regarding the Decision at the WTO. The United States is pursuing the negotiation of bilateral and regional trade agreements that restrict the regulatory flexibility of developing (and developed) countries under the WTO TRIPS Agreement, Doha Declaration and Decision. This article considers whether developing countries might adapt strategies used effectively at the WTO to prevent further loss of regulatory flexibility in alternative negotiating fora. The final version of this article was published in the American Journal of International Law.
TRIPS Agreement, public health, WTO, pharmaceuticals
Abstract: 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 International Trade Committee of the European Parliament, the authors argue that acceptance of the Amendment will provide a net benefit for countries seeking to improve access to medicines. At the insistence of WTO delegations acting on behalf of the originator pharmaceutical industry lobby, Article 31bis regrettably is saddled with unnecessary administrative hurdles. Nonetheless, through skillful lawyering, political determination and coordinated planning, the system can be made to work. Among other options, expeditious back-to-back compulsory licensing linked with pooled procurement strategies may effectively achieve economies of scale in production and distribution of medicines. The authors doubt that the international political environment would support renegotiation of an improved solution. They express concern that failure to bring the Amendment into force will open the door to a campaign to undermine the Waiver Decision. Recent events in Brazil and Thailand illustrate both the opportunities and risks associated with implementing TRIPS exception mechanisms, and help to inform views on the negotiating environment. Specific proposals for regional cooperation in implementing the Amendment are laid out, and the authors emphasize the importance of pursuing concrete transfer of technology measures in support of developing country pharmaceutical manufacturing. Over-reliance on private market mechanisms for the supply of public health goods leaves the international community with an unresolved collective action problem on a large scale.
Abstract: The entry into force of the 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 International Trade Committee of the European Parliament, the authors argue that acceptance of the Amendment will provide a ¿net benefit¿ for countries seeking to improve access to medicines. At the insistence of WTO delegations acting on behalf of the originator pharmaceutical industry lobby, Article 31bis regrettably is saddled with unnecessary administrative hurdles. Nonetheless, through skillful lawyering, political determination and coordinated planning, the system can be made to work. Among other options, expeditious back-to-back compulsory licensing linked with pooled procurement strategies may effectively achieve economies of scale in medicines production and distribution. The authors doubt that the international political environment would support renegotiation of an 'improved' solution. They express concern that failure to bring the Amendment into force will open the door to a campaign to undermine the Waiver Decision. Recent events in Brazil and Thailand illustrate both the opportunities and risks associated with implementing TRIPS exception mechanisms, and help to inform views on the negotiating environment. Specific proposals for regional cooperation in implementing the Amendment are laid out, and the authors emphasize the importance of pursuing concrete transfer of technology measures in support of developing country pharmaceutical manufacturing. Over-reliance on private market mechanisms for the supply of public health goods leaves the international community with an unresolved collective action problem on a large scale.
public health, trade, WTO, TRIPS Agreement, pharmaceuticals
Abstract: This paper examines issues surrounding the development and transfer of technologies for addressing the problem of climate change based on the experience of developing countries in addressing problems of innovation and access in the field of medicines. It looks at alternative energy resources (AERs) and climate change mitigation technologies (MTs), at the forms of intellectual property rights (IPRs) used to promote and protect innovation, and at the ways these IPRs may have different effects and implications for AERs/MTs as compared with pharmaceutical technologies. It is generally assumed that the originator pharmaceutical sector is highly dependent on strong patent protection, mainly because of the high cost involved in developing novel drug therapies and the low cost of reverse engineering these new drugs. Preliminary research suggests that most AERs/MTs industries may be less dependent on strong patent protection, and/or that patents are less likely to cause significant bottlenecks in the development and transfer of AERs/MTs. While it is premature to come to a definitive conclusion because researchers are only now focusing on the evidence, there is some basis for anticipating that IPRs will present fewer risks for developing countries in the context of climate change than for public health. Developing country negotiators understood that the GATT Uruguay Round negotiations on trade related aspects of intellectual property rights would affect access to medicines. The resulting WTO TRIPS Agreement did, in fact, present serious risks to public health. These risks were addressed through negotiation of the Doha Declaration on the TRIPS Agreement and Public Health, the Article 31b is amendment and the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property. The “Doha Declaration process” broadly speaking has resulted in some positive movement. There are a number of lessons that can be drawn from the public health-related negotiations, at the WTO and other forums that may be useful to developing country negotiators addressing IPRs and climate change. Some of these lessons are relatively straightforward: economic and political power substantially influences the outcome of negotiations; the involvement of NGOs and other stakeholders is essential; it is important to shape public opinion through effective communication. Other lessons may be somewhat less evident. Public health negotiations suggest that zero-sum bargaining is unlikely to be productive from the standpoint of developing countries, and that appeal to “equity” as the basis for demanding concessions is not enough. The private sector in the developed countries controls most pharmaceutical technology and AERs/MTs. Governments in developed countries are unlikely to “order” that technology be transferred by the private sector. Developing countries therefore might usefully focus on establishing frameworks for mutually beneficial joint venture economic arrangements between developed and developing country enterprises that will stimulate innovation and concrete transfers of technology to address climate change. To the extent possible, technology transfer commitments resulting from climate change negotiations should be specific and concrete. “Soft” commitments on transfer of technology typically do not bear fruit. A number of developing countries and NGOs have proposed that a declaration comparable to the Doha Declaration on the TRIPS Agreement and Public Health be adopted with respect to IPRs and Climate Change. Even if current multilateral IPRs rules incorporate flexibilities and exceptions adequate to address most foreseeable obstacles to technology transfer, a declaration may be useful in the progressive development of international law so that it properly balances the rights of innovators and access by the public to the benefi ts arising from new technologies.
Climate Change, Intellectual Property, Public Health, Technology Transfer, UNFCCC, Patents, Pharmaceuticals
Abstract: This paper addresses a World Trade Organization (WTO) dispute settlement remedy commonly known as 'cross-retaliation', and specifically the mechanism by which a WTO Member can suspend concessions in the field of trade-related intellectual property rights (TRIPS) to redress an injury suffered with respect to trade in goods or services. A WTO Member enforces compliance with a ruling by the Dispute Settlement Body (DSB) by suspending trade concessions enjoyed by the non-compliant Member. This might involve raising tariffs on products imported from the non-compliant Member. Economically powerful WTO Members are not likely to be harmed by the suspension of trade concessions in goods or services by substantially less powerful Members. The trade impact will be too small to 'induce compliance' and, equally important, the types of suspension that may be used in the fields of goods and services may cause economic harm to the less powerful Members using them. The WTO dispute settlement process strongly favors economically powerful countries, leaving most developing and least developed Members with few options for inducing compliance. Attention is increasingly being focused on the possibility for developing Members to suspend concessions relating to intellectual property rights (IPRs) as a means of inducing compliance by developed Members. Cross-retaliation is expressly contemplated by the WTO Dispute Settlement Understanding (DSU). WTO arbitrators have so far approved TRIPS cross-retaliation on two occasions: in favor of Ecuador (against the European Communities (EC)) and Antigua (against the United States (US)). Constructing and implementing a cross-retaliation program involving IPRs raises a substantial number of complex legal questions. The DSU establishes principles and procedures that must be respected. The various forms of IPR – copyright, patent, trademark, etc. – serve different social and industrial policy functions and have their own unique characteristics. There are multilateral and bilateral agreements and rules outside the WTO context that may influence the shaping of a cross-retaliation program. National constitutions and rules relating to property rights need to be addressed. This paper anticipates many legal questions raised by cross-retaliation in TRIPS and seeks to provide answers to them. It analyses the cross-cutting issues raised by external commitments and national IPRs-related rules, and looks at each major forms of IPR to suggest practical approaches to suspending (or not suspending) those forms. One of the difficult challenges less powerful WTO Members face in seeking to implement cross-retaliation in TRIPS is political pressure from industry groups as well as the governments of more powerful Members. While exporters of goods have not persuaded international media outlets that the suspension of tariff concessions is 'piracy of trade rights', IP-dependent industry groups use sophisticated and expensive propaganda campaigns that result in media portrayal of IPR suspension as 'piracy' and 'theft'. WTO Members must be prepared to deal with industry-induced media pressure.
TRIPS Agreement, intellectual property, dispute settlement, international trade
Abstract: In connection with the run-up to the Cancun Ministerial Conference, the author was asked whether there are grounds for recommending amendment of WTO TRIPS Agreement rules addressing competition. The general conclusion of the study is that the TRIPS Agreement in its present form provides substantial discretion to WTO Members in the formulation and application of competition rules regulating intellectual property, and this arrangement serves the best interests of developed and developing countries. Potential amendments were considered across a matrix of interested country groups: North-North, North-South, South-North and South-South. Although country groups with different interests might seek to modify TRIPS competition-related rules to their perceived advantage, there is little reason to believe that consensus would be reached on such changes. The study acknowledges that global welfare benefits might flow from a more highly integrated international competition regime with powers to investigate and enforce agreed upon rules. There is, however, little identifiable near-term impetus for building such a regime, whether at the WTO or elsewhere. Competition laws of certain developed countries expressly exempt conduct with wholly foreign effects from the application of rules regulating anticompetitive practices, including those concerning intellectual property. Such exemptions appear inconsistent with advocacy of liberal market principles, and they are damaging to developing country interests. As part of the Doha Development Round commitment to developing countries, a decision by developed countries to eliminate these exemptions would be constructive.
Abstract: The First Report on Parallel Imports approaches the exhaustion/parallel imports question in broad economic terms, asking whether there may be an economic and social welfare benefit to permitting IPRs holders to block parallel imports that outweighs the potential harm to liberal trade. The Report addresses each major form of IPR (patent, trademark and copyright) separately. It concludes with respect to each form that the evidence of benefits that might flow from allowing parallel imports to be blocked is insufficient to justify the potential inhibition of trade. The Report observes that most objectives which IPRs holders seek to achieve by the allocation of geographic markets can be attained through less trade restrictive means, namely through the vertical allocation of distribution territories by contract. The interests of the developing countries are a focus of the Report. Some economists have suggested that allowing rules on parallel information to enforce price discrimination in favor of developing countries may increase global economic welfare. The Report concludes that developing and developed countries are better served by open markets and the operation of comparative advantage. The Report recommends that the WTO adopt a rule precluding governments from blocking parallel imports save in certain exceptional cases, and it also suggests that further study of this issue would be desirable.
Abstract: This special issue on trade-related aspects of intellectual property rights (TRIPS) is introduced with a perspective that focuses on the urgency of narrowing the gap in living standards between the rich nations and the poor. The 1997/98 world economic crisis highlights the question of whether creating an international market in intellectual property sufficiently addresses the interests of developing countries in the diffusion and use of knowledge. It is suggested that substantial intervention by international institutions with interests in promoting development is also required. The role of IPRs in economic development is analyzed, and this contribution points to a few areas in which consensus among international IPRs specialists is emerging. Among these is that the role of IPRs is context-sensitive, depending on the particular characteristics of countries in which IPRs systems are introduced, and depending on the specific industries in which these IPRs are employed. This context-sensitive role argues for flexible implementation of the TRIPS Agreement in developing and newly industrializing countries. In WTO implementation of the TRIPS Agreement (including a review of national laws and dispute settlement) and in forthcoming WTO TRIPS negotiations (in areas such as biotechnology and genetics, the digital environment and electronic commerce, exhaustion of rights, non-violation causes of actions, competition and investment), the specific interests of the developing countries must be given a priority. Just as developed countries have traditionally balanced the IPRs interests of producers, consumers, and the science and research communities, so also must the WTO balance respective global interests in technology and creativity. The author urges a more extensive role for institutions such as the World Bank in technology capacity-building.
Abstract: The adoption by Ministers on 14 November 2001, in Doha, of the Ministerial Declaration on the TRIPS Agreement and Public Health marked a turning point in political and legal relations at the WTO. Developing country Members sent a clear signal that they would take steps to protect and advance their essential interests. These Members demonstrated that by establishing a coalition, and maintaining it throughout a negotiating process, they could prevent themselves from being outmaneuvered by the EU-US block.
The essence of the Declaration is captured in paragraph 4:
"We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all."
The TRIPS Agreement is a flexible legal instrument, and the decision of Ministers will prove significant in supporting interpretations that promote the protection of public health. While the Declaration does not resolve developing country concerns regarding access to medicines and TRIPS, it is a significant milestone.
WTO, TRIPS Agreement, Access to Medicines
Abstract: Over the past decade, government trade and finance ministries have increasingly turned toward negotiating bilateral and regional trading arrangements, and away from negotiations in multilateral forums like the WTO. There are several reasons for this shift, including changes in the global political environment and negotiating obstacles encountered by the multinational business community at the multilateral level. This shift appears to be an embedded phenomenon. Positive and negative aspects of preferential trading arrangements (PTAs) are in evidence. Trade creation-trade diversion economic analysis suggests the results may be net global welfare enhancing, although such analysis does not readily assess distributional effects. The global economy is enjoying a period of sustained and widely distributed economic growth, suggesting that the PTA phenomenon is not an immediate economic threat. On the negative side, the PTAs lead to administrative complexity, and may be somewhat destabilizing as businesses are encouraged to relocate. Some countries may suffer if left out, but this risk is ameliorated by the wide availability of potential negotiating partners. The PTA negotiating environment strongly favors powerful economic actors like the United States and European Union, which are largely dictating terms to developing (and developed) countries. Developing countries, particularly the less economically powerful, are losing autonomous decision-making authority. The consequences of this are difficult to quantify, and may raise questions better attuned to moral philosophers than economists. The WTO continues on its way, relegated to a less central status. A return to the WTO might reinvigorate the role of less powerful actors, but such return does not appear an immediate prospect. The PTA phenomenon, on balance, does not appear aggressively threatening. We may, however, be underestimating the positive role of multilateralism.
Abstract: This article examines the complex relationship between the institutions and legal rules of the NAFTA and the World Trade Organization. The juridical relationship between the NAFTA and WTO Agreement is of considerable interest from the standpoints of policy and technical analysis of legal norms. As a matter of policy, a decision by NAFTA negotiators whether to accord legal priority to the NAFTA or WTO would appear to involve a choice whether to accord a greater degree of attention and concern to more narrow regional economic and political interests, or to broader multilateral interests. In light of the importance that trade policy makers have ascribed to the potential for conflict between the regional and multilateral integration models, NAFTA negotiators might have been expected to make a clear choice in this hierarchy of interests. Evidence from the text of the NAFTA and from the early NAFTA dispute settlement panel reports suggests that no such overarching policy determination was made or that, if it was made, the determination was implemented in an uncertain manner. The uncertainty surrounding the relationship between the NAFTA and WTO Agreement may reflect the dynamic political tensions faced by the NAFTA negotiators, tensions that continue to influence the formation and implementation of policy in the NAFTA Parties. On one side, the NAFTA was and is portrayed by its proponents as a means of accelerating integration on the North American continent in a way that is consistent with the political and social interests of a variety of disparate groups, including the business community, labor unions and environmentalists. The NAFTA is politically justified by its attention to interests that are more difficult to address at the WTO multilateral level. If the results of NAFTA negotiations are placed beneath WTO Agreement norms, then in theory this attention to regionally-specific interests might be jeopardized by the superiority of more generalized WTO norms. There are, therefore, political and social motivations for advocating priority for the NAFTA. On the other side, NAFTA negotiators were and remain well aware of concerns among GATT-WTO Members about efforts by particular countries and regions to gain advantages by extending regional preferences. NAFTA negotiators would be hesitant to make a clear statement of regional legal preference that might galvanize opposition to the agreement, or that might jeopardize future multilateral negotiations. NAFTA negotiators may well have maintained a preference for multilateralism among themselves, yet nevertheless have been reluctant to clearly express such preference in the NAFTA because this might be found objectionable by interest groups within the region whose support was required to assure successful conclusion of the agreement. Though the NAFTA-WTO hierarchy of norms is uncertain, and while such uncertainty is bound to lead to or exacerbate future NAFTA disputes, the political and social forces that impelled the initial state of ambiguity have not dissipated. While interests in political stability and economic efficiency might be enhanced through the clarification of this matter by the NAFTA Parties through the adoption of a clarifying amendment or an inter-governmental understanding, the Parties may be in no more favorable position to agree on such a clarification in the year 2000 than they were in 1993.
Abstract: This paper observes a trend in international trade governance toward the use of hard legal instruments and undertakes to analyze and explain that trend in the context of the NAFTA. The author suggests that hard law: (1) reduces inter-governmental transaction costs associated with trade and investment; (2) reduces private risk premiums associated with trade and investment; (3) promotes transparency and provides corollary participation benefits; (4) tends to restrain strategic political behaviors, and (5) may increase the range of integration effects by encouraging private actions to enforce inter-governmental obligations. The specific legalization formula used in the NAFTA includes high levels of precision and obligation, and a moderate level of delegation. The adoption of this particular formula is explained by political objectives and constraints under which Canadian, Mexican and United States trade negotiators were operating. The NAFTA legalization formula is compared to the European Union formula that includes high levels of obligation and delegation, and a moderate level of precision. The EU has established political institutions that are empowered to adopt secondary legislation. These institutions accomplish the precision function through ex post facto decision-making. The NAFTA and EU have each succeeded in the pursuit of their integration objectives. Since these objectives differ, an empirical comparison of the effects of their different legalization formulas is not practicable. The APEC soft legalization formula, by way of contrast, has not succeeded in generating significant positive integration effects, and this lends support to the hard law approach to economic integration. The NAFTA private party investment dispute mechanism has permitted subject matter challenges that were not anticipated by its framers. Though permitting private access to dispute settlement may yield unanticipated consequences, the EU experience suggests that such consequences may be positive. If negative social outcomes result from private access under the NAFTA, this may suggest that underlying NAFTA norms should be revisited. The durability of the NAFTA hard law model has yet to be tested by a substantial divergence in political policies among its Parties.
Abstract: WTO governance has traditionally reflected the interests of producers channeled through government trade negotiators. The producer-driven governance model is not suited to the highly integrated international society of the 21st century. The WTO governance structure should be adapted to account for more diverse interests, including those of marginalized developing countries, NGOs, and individuals. One aspect of this adaptation should involve more highly integrated relations between the WTO and other multilateral institutions. The inter-institutional relationship that has evolved between the WTO and the World Intellectual Property Organization (WIPO) since the conclusion of the Uruguay Round evidences a number of characteristics that might usefully form the basis for relations between the WTO and other international organizations. The WTO-WIPO relationship effectively enhances the breadth of subject matter interests and the administrative capacity of each organization, and it provides a suitable forum for the negotiation of incremental and experimental intellectual property rules that are needed in response to technological change. A second aspect of institutional adaptation concerns increasing the participation of wider segments of international society in multilateral rule-making. The WIPO Internet Domain Name Process was a unique governance exercise that employed elements of direct democracy at the international level and the management of an organizational bureaucracy (the WIPO International Bureau). This type of process might usefully be employed in other contexts, such as by the FAO/WHO in developing health and safety guidelines in connection with genetically modified organisms (GMOs).
© 2009 Social Science Electronic Publishing, Inc. All Rights Reserved. Terms of Use Privacy Policy This page was served by apollo 2 in 0.344 seconds.
