Wednesday, September 19, 2018
 
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Using Competition Law to Promote Access

12/7/2011

Trends in Local Production of Medicines and Related Technology Transfer

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1971924

World Health Organization 2011

This report identifies and analyses trends in the local production of medicines in developing countries and related technology transfer. The objective is to assist the World Health Organization (WHO) in its support for Member States in implementing the global strategy and plan of action on public health innovation and intellectual property with particular reference to the promotion of capacity-building for local production in developing countries. The methodology of research included interviews with a range of stakeholders, including industry actors, operators of product development partnerships (PDPs), government officials and members of public health advocacy groups; review of literature and Internet resources; and participation in meetings with stakeholder groups in Africa, Asia and Latin America.

This report makes a number of recommendations. These are focused mainly on the role that WHO, working in partnership with others, can take with respect to transfer of technology and local production of medicines in developing countries.

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Emerging Markets

12/7/2011

Trends in Local Production of Medicines and Related Technology Transfer

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1971924

World Health Organization 2011

This report identifies and analyses trends in the local production of medicines in developing countries and related technology transfer. The objective is to assist the World Health Organization (WHO) in its support for Member States in implementing the global strategy and plan of action on public health innovation and intellectual property with particular reference to the promotion of capacity-building for local production in developing countries. The methodology of research included interviews with a range of stakeholders, including industry actors, operators of product development partnerships (PDPs), government officials and members of public health advocacy groups; review of literature and Internet resources; and participation in meetings with stakeholder groups in Africa, Asia and Latin America.

This report makes a number of recommendations. These are focused mainly on the role that WHO, working in partnership with others, can take with respect to transfer of technology and local production of medicines in developing countries.

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Review of Trilateral Study

12/7/2011

Trends in Local Production of Medicines and Related Technology Transfer

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1971924

World Health Organization 2011

This report identifies and analyses trends in the local production of medicines in developing countries and related technology transfer. The objective is to assist the World Health Organization (WHO) in its support for Member States in implementing the global strategy and plan of action on public health innovation and intellectual property with particular reference to the promotion of capacity-building for local production in developing countries. The methodology of research included interviews with a range of stakeholders, including industry actors, operators of product development partnerships (PDPs), government officials and members of public health advocacy groups; review of literature and Internet resources; and participation in meetings with stakeholder groups in Africa, Asia and Latin America.

This report makes a number of recommendations. These are focused mainly on the role that WHO, working in partnership with others, can take with respect to transfer of technology and local production of medicines in developing countries.

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Domain Names

12/7/2011

Trends in Local Production of Medicines and Related Technology Transfer

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1971924

World Health Organization 2011

This report identifies and analyses trends in the local production of medicines in developing countries and related technology transfer. The objective is to assist the World Health Organization (WHO) in its support for Member States in implementing the global strategy and plan of action on public health innovation and intellectual property with particular reference to the promotion of capacity-building for local production in developing countries. The methodology of research included interviews with a range of stakeholders, including industry actors, operators of product development partnerships (PDPs), government officials and members of public health advocacy groups; review of literature and Internet resources; and participation in meetings with stakeholder groups in Africa, Asia and Latin America.

This report makes a number of recommendations. These are focused mainly on the role that WHO, working in partnership with others, can take with respect to transfer of technology and local production of medicines in developing countries.

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EU Economic Partnership Agreements

12/7/2011

Trends in Local Production of Medicines and Related Technology Transfer

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1971924

World Health Organization 2011

This report identifies and analyses trends in the local production of medicines in developing countries and related technology transfer. The objective is to assist the World Health Organization (WHO) in its support for Member States in implementing the global strategy and plan of action on public health innovation and intellectual property with particular reference to the promotion of capacity-building for local production in developing countries. The methodology of research included interviews with a range of stakeholders, including industry actors, operators of product development partnerships (PDPs), government officials and members of public health advocacy groups; review of literature and Internet resources; and participation in meetings with stakeholder groups in Africa, Asia and Latin America.

This report makes a number of recommendations. These are focused mainly on the role that WHO, working in partnership with others, can take with respect to transfer of technology and local production of medicines in developing countries.

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ECJ Philips/Nokia Judgment

12/7/2011

Trends in Local Production of Medicines and Related Technology Transfer

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1971924

World Health Organization 2011

This report identifies and analyses trends in the local production of medicines in developing countries and related technology transfer. The objective is to assist the World Health Organization (WHO) in its support for Member States in implementing the global strategy and plan of action on public health innovation and intellectual property with particular reference to the promotion of capacity-building for local production in developing countries. The methodology of research included interviews with a range of stakeholders, including industry actors, operators of product development partnerships (PDPs), government officials and members of public health advocacy groups; review of literature and Internet resources; and participation in meetings with stakeholder groups in Africa, Asia and Latin America.

This report makes a number of recommendations. These are focused mainly on the role that WHO, working in partnership with others, can take with respect to transfer of technology and local production of medicines in developing countries.

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Local Production of Medicines

12/7/2011

Trends in Local Production of Medicines and Related Technology Transfer

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1971924

World Health Organization 2011

This report identifies and analyses trends in the local production of medicines in developing countries and related technology transfer. The objective is to assist the World Health Organization (WHO) in its support for Member States in implementing the global strategy and plan of action on public health innovation and intellectual property with particular reference to the promotion of capacity-building for local production in developing countries. The methodology of research included interviews with a range of stakeholders, including industry actors, operators of product development partnerships (PDPs), government officials and members of public health advocacy groups; review of literature and Internet resources; and participation in meetings with stakeholder groups in Africa, Asia and Latin America.

This report makes a number of recommendations. These are focused mainly on the role that WHO, working in partnership with others, can take with respect to transfer of technology and local production of medicines in developing countries.

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Meeting the Challenge

11/15/2011

Intellectual Property and Public Health: Meeting the Challenge of Sustainability

 

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1965458

Global Health Programme Working Paper No. 7/2011, November 15, 2011

In the decade since the Doha Declaration was adopted, significant progress has been made in addressing problems associated with innovation and access to medicines, including through expanded financial support for procurement and distribution of treatments and vaccines and the establishment of new research and development (R&D) mechanisms. There has been enhanced cooperation among WHO, WIPO and the WTO. Nevertheless, significant gaps remain in placing the development and supply of medicines to the world’s population on a sustainable footing; gaps that are exacerbated by the present trend toward restrained government spending. This paper reflects on the political and legal constellation making progress on global public health matters difficult, and on economic and scientific trends in the medicines sector that may affect policy over the next decade. A sustainable medicines supply system should proceed from “first principles”, encompassing financing mechanisms to assure that essential medicines are provided for all, while affording opportunity to countries at all levels of development to offer access to advanced treatments on a fair compensation basis. Improved mechanisms to incentive R&D are necessary and feasible. First principles should encompass rational prescribing based on the best interests of the patient, and should attend to regulation and enforcement adequate to assure quality, safety and efficacy. Development of a sustainable system could require some modification to the WTO TRIPS Agreement, but this should not be a determinative factor in considering an improved international framework. A new mechanism for global coordination of medicines strategy may be helpful.

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An International Legal Framework

10/1/2010

An International Legal Framework for the Sharing of Pathogens: Issues and Challenges

Download here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1704522

ICTSD Programme on IPRs and Sustainable Development, No. 30, October 2010

Access to biological material with human pathogenic potential (pathogen materials) is important because research directed toward the development of new drugs and vaccines is dependent on scientific analysis of the underlying causes of disease. Member States of the World Health Organization (WHO) began to address problems associated with the sharing of pathogen materials when controversy arose in 2007 following Indonesia’s decision to withhold samples of biological material containing the H5N1 virus (avian flu) from WHO researchers. As a general proposition, states have sovereign rights of ownership and control over access to biological resources located within their territories and thus may determine the conditions of access to those resources. This includes ownership and control over access to pathogen materials. Sovereign control over pathogen materials and access to them is complicated by the fact that they have a tendency to spread geographically, and at some stage, to cross national borders in the absence of intentional human intervention. These sovereign rights, however, do not imply that the host state is not constrained by international legal obligations, such as the obligation to protect human rights related to life and health and the obligation to protect against harm to neighboring states. As a general proposition, states have sovereign rights of ownership and control over access to biological resources located within their territories and thus may determine the conditions of access to those resources. This includes ownership and control over access to pathogen materials. Sovereign control over pathogen materials and access to them is complicated by the fact that they have a tendency to spread geographically, and at some stage, to cross national borders in the absence of intentional human intervention. The ownership and control of pathogen materials are regulated at the international level by a set of norms involving: public international law, the Convention on Biological Diversity (CBD), the WHO Constitution and the International Health Regulations (IHR), the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and international human rights norms. Supplemental norms are under negotiation at the WHO (in the Intergovernmental Meeting on Pandemic Influenza Preparedness) under the CBD (in the Ad Hoc Open-Ended Working Group on Access and Benefit Sharing) and at the WTO (as part of the Doha Round). The reasons pathogen materials may, or may not, be subject to the regime established by the CBD are technically complex from a legal standpoint. Pathogen materials, as a general matter, probably are covered by the CBD, though this is not intended to suggest that the CBD is better equipped than the WHO to address the sharing of pathogen materials in the public health context, but rather addresses the existing or “default” legal situation. There is room for debate concerning whether the CBD, or at least its provisions on ABS, covers viruses, because of specific definitional language in the CBD. New rules related to pathogen materials sharing should most appropriately be negotiated at the WHO, because of the specific relationship to public health, which is most closely associated with the WHO charter. Protecting global health will require that countries share at least some categories of pathogen materials. An important element of the WHO negotiations is to define the availability of IPRs protection for the results of research and development. A negotiated framework must necessarily address the question of the extent to which recipients of such materials may apply for and obtain patents and/or the terms and conditions that will be applicable with respect to any patents obtained. Underlying the WHO negotiations is the question of affordable access to vaccines and treatments for developing countries, which is a presumed condition of a pathogen materials sharing obligation, at least among some WHO Member States. There is a real risk that the result will be a two-tiered system of access to pathogen materials: one addressing certain influenza viruses under the auspices of the WHO and another addressing pathogen materials more generally under the auspices of the ABS Protocol and/or the CBD. As a practical matter, subjecting states, economic operators and individuals to separate agreements covering the same subject matter may create confusion, particularly if the relationship between the agreements is not clearly specified and the rights and obligations are not in harmony. When public health interests are at stake, it is important to avoid a result that generates legal uncertainty and insecurity. Recognizing that negotiators at the WHO and the CBD are engaged in substantially independent and complex exercises each in their own right, greater attention should be focused on how the results of these exercises will relate to each other. Moreover, negotiators at the WHO should be cognizant of the fact that the current IGM-PIP negotiations are not taking place in a legal vacuum. This not only suggests that increased effort should be made to bring the current negotiations that address influenza viruses to a satisfactory conclusion, but also that these negotiations should be followed by a broadened effort to more generally address pathogen materials.
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NAFTA Encyclopedia Entries

12/7/2011

Trends in Local Production of Medicines and Related Technology Transfer

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1971924

World Health Organization 2011

This report identifies and analyses trends in the local production of medicines in developing countries and related technology transfer. The objective is to assist the World Health Organization (WHO) in its support for Member States in implementing the global strategy and plan of action on public health innovation and intellectual property with particular reference to the promotion of capacity-building for local production in developing countries. The methodology of research included interviews with a range of stakeholders, including industry actors, operators of product development partnerships (PDPs), government officials and members of public health advocacy groups; review of literature and Internet resources; and participation in meetings with stakeholder groups in Africa, Asia and Latin America.

This report makes a number of recommendations. These are focused mainly on the role that WHO, working in partnership with others, can take with respect to transfer of technology and local production of medicines in developing countries.

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International Intellectual Property in Max Planck Encyclopedia

12/7/2011

Trends in Local Production of Medicines and Related Technology Transfer

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1971924

World Health Organization 2011

This report identifies and analyses trends in the local production of medicines in developing countries and related technology transfer. The objective is to assist the World Health Organization (WHO) in its support for Member States in implementing the global strategy and plan of action on public health innovation and intellectual property with particular reference to the promotion of capacity-building for local production in developing countries. The methodology of research included interviews with a range of stakeholders, including industry actors, operators of product development partnerships (PDPs), government officials and members of public health advocacy groups; review of literature and Internet resources; and participation in meetings with stakeholder groups in Africa, Asia and Latin America.

This report makes a number of recommendations. These are focused mainly on the role that WHO, working in partnership with others, can take with respect to transfer of technology and local production of medicines in developing countries.

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Emerging Market Supply

12/7/2011

Trends in Local Production of Medicines and Related Technology Transfer

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1971924

World Health Organization 2011

This report identifies and analyses trends in the local production of medicines in developing countries and related technology transfer. The objective is to assist the World Health Organization (WHO) in its support for Member States in implementing the global strategy and plan of action on public health innovation and intellectual property with particular reference to the promotion of capacity-building for local production in developing countries. The methodology of research included interviews with a range of stakeholders, including industry actors, operators of product development partnerships (PDPs), government officials and members of public health advocacy groups; review of literature and Internet resources; and participation in meetings with stakeholder groups in Africa, Asia and Latin America.

This report makes a number of recommendations. These are focused mainly on the role that WHO, working in partnership with others, can take with respect to transfer of technology and local production of medicines in developing countries.

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Regional Assessment

12/7/2011

Trends in Local Production of Medicines and Related Technology Transfer

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1971924

World Health Organization 2011

This report identifies and analyses trends in the local production of medicines in developing countries and related technology transfer. The objective is to assist the World Health Organization (WHO) in its support for Member States in implementing the global strategy and plan of action on public health innovation and intellectual property with particular reference to the promotion of capacity-building for local production in developing countries. The methodology of research included interviews with a range of stakeholders, including industry actors, operators of product development partnerships (PDPs), government officials and members of public health advocacy groups; review of literature and Internet resources; and participation in meetings with stakeholder groups in Africa, Asia and Latin America.

This report makes a number of recommendations. These are focused mainly on the role that WHO, working in partnership with others, can take with respect to transfer of technology and local production of medicines in developing countries.

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Innovation and Technology Transfer

7/13/2009

Innovation and Technology Transfer to Address Climate Change

Lessons from the Global Debate on Intellectual Property and Public Health

Download Here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1433579

ICTSD Programme on IPRs and Sustainable Development, Issue Paper No. 24

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.

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Global Pharmaceutical Policy

6/30/2009

The Challenges We Face

in Frederick M. Abbott and Graham Dukes, GLOBAL PHARMACEUTICAL POLICY: Ensuring Medicines for Tomorrow's World 1-15 (2009)(Edward Elgar Publishing)

Download here

Pharmaceutical products play a central role in the prevention and treatment of disease. Making safe and effective pharmaceutical products available and affordable to individuals around the world is a central challenge to the global governance system. There are however myriad obstacles to achieving and maintaining effective worldwide availability of medicines.

Despite the fact that people around the world face largely similar challenges from disease, the policy framework for promoting innovation and regulating pharmaceutical supply is remarkably disjointed. Innovation policy, insofar as it is implemented at all, is established on a country-to-country basis with minimal attention to coordination of research and development. Regulatory structures are almost equally fragmented. Each country has its own set of approval standards and regulatory procedures that must be dealt with, and only to a limited extent are there cooperative procedures or systems of mutual recognition. Corporate decisions concerning where to concentrate innovative efforts, what to produce, where to supply it and on what terms are based on the likely impact on profits and capital markets.

There are wide disparities in levels of income both among countries and within countries. Prices that are reasonably affordable for individuals covered by health insurance in developed countries are likely to be unaffordable for individuals without health insurance in developed and developing countries. There are compelling needs for new medicines to treat diseases affecting both the rich and poor, such as diabetes, cancer, heart disease and the degenerative disorders of old age. Innovation in these areas is costly, yet even with substantial sums invested in research and development rates of innovation are surprisingly low. There are equally compelling needs for new medicines to treat disease conditions predominantly afflicting tropical regions where poverty rates are typically high. Far less is invested in the diseases of the poor because of a lack of market demand.

Medicines must be safe and effective. Making and keeping them so is a challenge for both private and public sector suppliers, for the regulators charged with promoting and protecting public health and for the policy makers who determine the framework within which regulation operates. This book examines the state of play of the international system for the development and supply of pharmaceutical products, and offers insights into how some of its challenges might be addressed. This system is enormously complex, with many moving parts, and there is not likely to be a quick fix for the many challenges. There are quite a few good ideas circulating among individuals and groups involved in formulating and implementing public policy in the field of medicines.

Certainly new initiatives are needed in this field, and existing initiatives can and should be improved. We try to identify and explain those areas in which present policies are not working, and we offer suggestions regarding ways to improve them. We put forward our own proposals regarding directions that global public policy in the field of medicines should take. We do not claim a monopoly on promising ideas. We hope that this volume will succeed at least in moving the dialogue on these subjects forward.

Number of Pages in PDF File: 15



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Cross-Retaliation in TRIPS

4/1/2009

Cross-Retaliation in TRIPS: Options for Developing Countries

Download here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1415802

ICTSD Programme on Dispute Settlement and Legal Aspects of International Trade, Issue Paper No. 8, April 2009

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.

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Seizure of Generic Pharmaceuticals in Transit Based on Allegations of Patent Infringement: A Threat to International Trade, Development and Public Welfare

1/1/2009

Seizure of Generic Pharmaceuticals in Transit Based on Allegations of Patent Infringement: A Threat to International Trade, Development and Public Welfare

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1535521

(1 W.I.P.O.J. 43 (2009)

This essay addresses the legitimacy of seizures by the customs authorities of some European Union member states of pharmaceutical products moving in transit through European ports and airports based on patents in force in the transit countries. Seizures have been directed to products off-patent in the countries of manufacture and destination. EU member state customs authorities have justified such seizures on the basis of a 2003 EU intellectual property border enforcement regulation. The seizures have generated intense controversy at the WTO and more widely among stakeholders interested in assuring affordable access to medicines. This essay argues that seizure of generic pharmaceutical products in transit contravenes GATT article V that obligates WTO Members to assure freedom of transit for goods passing through ports and airports, and obligates Members to refrain from imposing unreasonable regulations on such transit goods. It further argues that the seizures are fundamentally inconsistent with the Paris Convention principle of independence of patents that recognizes the sovereign right of states to adopt and implement patent protection as they consider appropriate, within the framework of a general set of rules. Rules permitting enforcement of transit country patents effectively deprives exporting and importing Paris Union and WTO Members of their right to make determinations regarding patents, and represents an overextension of patent jurisdiction by countries without a substantial interest in enforcement. Dutch court adoption of a manufacturing fiction to justify transit seizures – pretending that subject pharmaceuticals are manufactured in the Netherlands, when they clearly are not – represents a significant potential threat to the conduct of international trade. Each WTO Member might pretend that all manner of its domestic regulation – labor, environmental, social welfare – was violated in an exporting country when goods were manufactured, allowing the goods of that country to be seized in transit for a violation of transit country law. The international trading system could not function reasonably in such a fiction-laden environment. The seizure of generic pharmaceutical products in transit is inconsistent with the object and purpose of the Doha Declaration on the TRIPS Agreement and Public Health that promotes access to medicines for all.
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A New Dominant Trade Species Emerges: Is Bilateralism a Threat?

6/1/2007

A New Dominant Trade Species Emerges: Is Bilateralism a Threat?

download here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1152151

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.

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Parallel Importation

12/7/2011

Trends in Local Production of Medicines and Related Technology Transfer

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1971924

World Health Organization 2011

This report identifies and analyses trends in the local production of medicines in developing countries and related technology transfer. The objective is to assist the World Health Organization (WHO) in its support for Member States in implementing the global strategy and plan of action on public health innovation and intellectual property with particular reference to the promotion of capacity-building for local production in developing countries. The methodology of research included interviews with a range of stakeholders, including industry actors, operators of product development partnerships (PDPs), government officials and members of public health advocacy groups; review of literature and Internet resources; and participation in meetings with stakeholder groups in Africa, Asia and Latin America.

This report makes a number of recommendations. These are focused mainly on the role that WHO, working in partnership with others, can take with respect to transfer of technology and local production of medicines in developing countries.

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World Trade Organization Accession Agreements: Intellectual Property Issues

5/1/2007

World Trade Organization Accession Agreements: Intellectual Property Issues

download here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1915338

This paper addresses intellectual property issues that arise in the context of the accession process with a view toward assisting prospective WTO Members involved in negotiations. The Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”) is one of the Multilateral Trade Agreements or MTAs to which all WTO Members are party. As an ordinary consequence of joining the WTO, a state or autonomous customs territory would be expected to become party to the TRIPS Agreement and take on the obligations applicable to other Members at their respective levels of development. However, the terms of the WTO Agreement do not expressly limit the “entry fee” imposed on newly acceding Members to an equivalence of concessions with existing Members. As a consequence of this, accession negotiations have been used by certain Members as a mechanism for securing commitment to obligations in the field of intellectual property rights (IPRs) that are more extensive than those established by the TRIPS Agreement.

For any country which has not been a Member of the WTO, there is a strong possibility that the national regime governing IPRs in place prior to the commencement of accession negotiations will be inconsistent with the requirements of the TRIPS Agreement. In this regard, the process of joining the WTO even at the same level of obligation as existing Members may require a substantial adjustment in national law and corresponding industrial policy. The impact of bringing national law into baseline or “normal” TRIPS Agreement compliance should not be underestimated.

A fundamental characteristic of the TRIPS Agreement is that WTO Members have flexibility regarding the manner in which obligations are implemented. This flexibility has been recognized by the WTO Appellate Body in the India-Mailbox decision. Countries acceding to the WTO may have limited experience in drafting and implementing IPRs law. The way in which such law is drafted may substantially affect social welfare interests within the country. Certain WTO Members will express strong opinions regarding what types of legislation satisfy TRIPS Agreement requirements. Those views are not necessarily shared by other Members. In addition, technical advisers regarding IPRs law may have materially different viewpoints regarding the way in which the interests of IPRs-holders and the general public should be balanced. It is therefore important to approach the process of legal reform cautiously, taking into account the different perspectives and objectives of WTO Members and technical advisers.

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The Doha Round's Public Health Legacy

1/1/2007

The Doha Round's Public Health Legacy: Strategies for the Production and Diffusion of Patented Medicines Under the Amended TRIPS Provisions

Download Here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1025593

Journal of International Economic Law, Vol. 10, pp. 921-87, 2007


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.
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Comparative Study of Selected Government Policies for Promoting Transfer of Technology and Competitiveness in the Colombian Pharmaceutical Sector

1/1/2007

Comparative Study of Selected Government Policies for Promoting Transfer of Technology and Competitiveness in the Colombian Pharmaceutical Sector

Download:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1920926

Download Annexes here:

Annex 1

Annex 2

Annex 3

Annex 4

Annex 5

Annex 6

The overall conclusion of this study is that domestic pharmaceutical producers in Colombia will face increasing challenges from foreign enterprises if and as the market is further opened to competition. If there is a national interest in maintaining or improving the local and global market position of Colombian enterprises, steps should be considered to encourage upgrade of the facilities of private operators to meet standards prevalent among major international generics suppliers. Facilities upgrading would have positive consequences for the Colombian public in terms of improving the quality of products on costs, financial assistance to local firms will be required. Some restructuring of the local industry (in terms of consolidation) should be anticipated.


Strengthening Colombia’s domestic manufacturing industry should, over the long term, increase local private investment in R&D. Nonetheless, Colombia is presently at the low end of government funding for R&D programs, and at the low end of R&D as a percentage of GDP (reflecting low private investment in R&D). If Colombia seeks to take advantage of its strength in areas such as ownership of biodiverse resources, it should likely increase its public funding for R&D in sectors with potential opportunity. It might also consider promoting partnerships with firms and institutions from countries already heavily invested in biotechnology R&D, taking care in negotiations for fairly sharing in the commercial output of such ventures, and to promote training opportunities for its scientific community.

From an industrial policy standpoint, it is important to assess whether Colombia has a comparative advantage in the pharmaceutical sector that justifies government intervention and support in favor of local industry. Because government resources are scarce, it is sensible to allocate them toward industry sectors in which prospects for success in the global economy are higher. However, it also should be recognized that the pharmaceutical sector is not the same as other industry sectors. A strong local pharmaceutical industry can help to assure reasonably priced high quality medicines for local consumers, and it is important for public security. Particularly in times of public health emergency, a country runs substantial risk if it is wholly dependent on foreign sources of medicines supply. Maintaining a strong base of industrial capacity is important. Without a technologically sound local industry, the capacity to respond to public health threats may be jeopardized. This is not to suggest a policy of pharmaceutical “autarky” or self-sufficiency, but rather to emphasize that production capacity in pharmaceuticals raises different issues than production capacity in flowers or coffee. Economics and public health must be considered in tandem.
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China in the WTO 2006: 'Law and its Limitations' in the Context of TRIPS

1/1/2007

China in the WTO 2006: 'Law and its Limitations' in the Context of TRIPS

download here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1919488

China's transition from a statist to market economy over the past 15 years and its successful establishment of globally competitive industry are unprecedented historical events. Although China's entry into the WTO is not responsible for that transformation, it has played an important role. Accession to the WTO was used by the government as a means not only to stabilize access to foreign markets and increase the attractiveness of China to foreign investors but also to reorient internal policies in a way that deemphasized a profound shift in government attitudes.

However, the law of unintended consequences is always at work, and the rate of China's growth and success in world markets may have been unanticipated. Developing countries that for many years had pressed in the WTO for an agreement to eliminate textile quotas found themselves seeking to re-impose restrictions in the face of highly efficient Chinese producers. China is absorbing a large and increasing share of the world's natural resources, including oil and minerals, and Chinese demand is adding to global price and availability pressures.

China's trade relations with the rest of the world are not without friction. China maintains a large trade surplus with the United States and European Union. Politicians and economists express concern that this surplus is due, at least in part, to a Chinese policy of deliberately undervaluing its currency. In late 2005, largely in response to U.S. political pressures, China moved from a fixed currency conversion rate for the Yuan to a limited floating rate tied to a basket of currencies. This move provided modest relief from currency-related confrontation with the United States, which continues at a somewhat more subdued level.

This paper focuses on the legal and WTO governance implications of China's alleged failure to fulfill its obligations under the Agreement on Trade-Related Intellectual Property Rights (TRIPS Agreement). The significant escalation of interest by the United States and other developed countries in China's intellectual property rights enforcement activity merits special attention because of its systemic implications. This subject matter forms a critical part of China's continuing WTO dialogue with the United States, European Union, Japan, and Switzerland, and it tests the capacity of the WTO dispute settlement system to constrain state behaviors.

China appears to perceive that its national interest is not aligned with its TRIPS Agreement and Accession Protocol obligations. Though the United States may well initiate a WTO dispute settlement action, it seems unlikely that doing so will result in near-term changes to China's conduct. WTO dispute settlement is not designed to force immediate changes to government behaviors, particularly when the complained-against party is not overly concerned about the potential for withdrawal of concessions. Politicians and industry leaders who are demanding changes by China will almost certainly be frustrated at the WTO.

This response will raise two questions: will the United States be justified in imposing extra-WTO legal sanctions on China, and if this is justified, will it be a good idea? The answers to these questions, explored in this paper, are 'probably yes" and "probably no,' respectively. To paraphrase the title of Olivier Long's classic work on the GATT, this case may help define the limits of the law in the WTO system
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IP in World Trade

12/7/2011

Trends in Local Production of Medicines and Related Technology Transfer

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1971924

World Health Organization 2011

This report identifies and analyses trends in the local production of medicines in developing countries and related technology transfer. The objective is to assist the World Health Organization (WHO) in its support for Member States in implementing the global strategy and plan of action on public health innovation and intellectual property with particular reference to the promotion of capacity-building for local production in developing countries. The methodology of research included interviews with a range of stakeholders, including industry actors, operators of product development partnerships (PDPs), government officials and members of public health advocacy groups; review of literature and Internet resources; and participation in meetings with stakeholder groups in Africa, Asia and Latin America.

This report makes a number of recommendations. These are focused mainly on the role that WHO, working in partnership with others, can take with respect to transfer of technology and local production of medicines in developing countries.

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Patents, Biotechnology and Human Rights: The Preservation of Biodiverse Resources for Future Generations

1/1/2007

Patents, Biotechnology and Human Rights: The Preservation of Biodiverse Resources for Future Generations

download:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1922851

The patenting of biotechnological inventions potentially affects human rights in a number of ways. Human rights to identity and the practice of religion may be affected by the availability of patents on genetically modified human beings (or elements of the human body). Patents as mechanisms for market exclusion affect access to new medicines, including those based on biotechnological innovation. Access to medicines and health care are part of the panoply of human rights.

During the past decade, the international community has focused significant attention on the protection of biological diversity and the potential impact of patents and other intellectual property rights on that protection. All of mankind benefits from the preservation of biological diversity. Genetic resource stocks likely will be the source of future agricultural, medicinal and other innovations. The preservation of plant and animal species is important to the functioning and continuing evolution of the Earth’s ecosystem, and therefore to the preservation of human life. While the maintenance of biological diversity is not part of the traditional catalogue of protectable human rights, a generalized human interest in the preservation of such diversity might be considered part of the common human interest in the wellbeing of future generations.

Differentiated biological resources are concentrated in a group of megadiverse countries, almost all of which are developing countries. The geographic territories in which such resources are located are often populated by poor indigenous peoples. The exploitation of biological resources from territories inhabited by these individuals has the potential substantially to affect their economic well being. The maintenance of basic human rights, including rights to security, food and shelter, are dependent on a minimum level of economic welfare. The Convention on Biological Diversity (CBD) recognizes sovereign rights over biological resources located within national territories, in part with a view towards assuring that individuals benefit financially from biotechnological inventions derived from such resources. The potential for conflict between the objectives and terms of the CBD and the rules governing the international patent system has been debated since the conclusion of negotiations on the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) in late 1993. In 2006 this subject is on the active agenda of the WTO TRIPS Council, and it is being considered at the World Intellectual Property Organization (WIPO).

This chapter analyses the relationship between the CBD and the rules governing the international patent system with a view to making a recommendation regarding whether a multilaterally agreed mandatory requirement for disclosure of the source and origin of genetic resources in patent applications would aid in achieving greater complementarity. The chapter concludes that adoption of such a requirement would be useful. This chapter does not expressly address information referred to as ‘traditional knowledge’ except to the extent that such information is relevant to evaluating applications for patents on inventions under the generally applied criteria of patentability. Traditional knowledge may itself be protected as intellectual property distinct from patentable invention.

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TRIPS II, Asia and the Mercantile

12/1/2006

Trips II, Asia and the Mercantile Pharmaceutical War: Implications for Innovation and Access

Download Here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1912624

Stanford Center for International Development, Working Paper No. 308, Dec. 2006

A powerful agenda for adoption of high levels of intellectual property protection, including related regulatory protection, is being advanced by the United States (and certain other developed countries) for developing countries, including developing and emerging market countries of Asia. This agenda essentially reflects a TRIPS II exercise, but is largely being carried out in bilateral and regional negotiations, as well as in WTO accession negotiations.

The TRIPS II agenda, as the TRIPS I agenda, is explained by strong mercantile interests seeking to increase technology and expression rents. Circumstances since the launch of the GATT Uruguay Round in 1986 have changed substantially. In 1986, OECD industries were principally concerned with preventing weak developing country industries from substituting low-cost and often lower quality “copied” versions of products on local markets, but were not threatened with competition in their home markets or with respect to originator and high-quality products. The OECD industry groups driving the TRIPS II agenda are (1) the copyright-dependent audio-visual industry concerned with unauthorized duplication and distribution of video and audio content and (2) the pharmaceutical (and agricultural chemical) industry concerned with competition from generic producers and, in a forward-looking sense, emerging originator enterprises.

This paper focuses on the implications of the TRIPS II agenda for the pharmaceutical sector in the Asian region. Copyright protection has significant implications for “access to knowledge”, in addition to entertainment, and this paper acknowledges the public welfare implications of developments with respect to copyright. However, the applicable legal norms and public welfare analysis differ substantially as between the copyright-dependent and patent-dependent industry sectors, and this paper will focus on the latter. TRIPS Agreement, TRIPS II, Pharmaceuticals, Asia, Trade, Investment, Public Health

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Intellectual Property Provisions

2/1/2006

Intellectual Property Provisions of Bilateral and Regional Trade Agreements in Light of U.S. Federal Law

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1912621

UNCTAD - ICTSD Project on IPRs and Sustainable Development, Issue Paper No. 12, Feb. 2006

During the past several years, the United States has concluded a substantial number of bilateral and regional free trade agreements (hereinafter “FTAs”), largely with developing countries. Each of those FTAs includes substantial commitments in the field of intellectual property rights (IPRs) and related regulatory matters. These commitments exceed those required by the TRIPS Agreement which establishes minimum substantive standards of protection and enforcement for all WTO Members.

There is a relatively consistent view among economists studying intellectual property rights that the interests of countries with respect to standards of protection varies depending upon the level of development and other characteristics of the country adopting such protection. The TRIPS Agreement provides some flexibility to WTO Members with respect to the level of protection, allowing developing countries a measure of leeway. Since there has been little enthusiasm at the WTO for raising standards of IPRs protection above that mandated by TRIPS, the United States has shifted its attention to other fora to accomplish its objective of securing greater levels of IPRs-based rents or royalties. The U.S. FTA policy weakly takes into account developmental interests. In some areas, such as the protection of pharmaceutical patent holders, U.S. policy threatens to cause harm to the interests of comparatively poor populations. 

IPRs and related regulatory standards deemed appropriate for the United States may not be appropriate for developing countries. Even so, within the United States the law establishes a particular balance between the interests of IPRs holders and consumers. Most U.S. IPRs rules are formulated in terms of general principles, with limitations and exceptions to them. The FTAs negotiated by the United States largely reflect the general rules of application, though not in all cases. What the FTAs do not adequately reflect is the interplay between rule, limitation and exception that establishes the balance. This is of special importance in areas such as public health regulation where incomplete familiarity with the flexibility inherent in the U.S. system may lead its trading partners to conclude that restrictive implementation of the FTAs is required. Differences in the capacity of the United States and many developing countries to create and manage legal infrastructure may lead to a disparity in the way FTA rules are implemented. 

In the negotiating process, developing countries should carefully consider whether the capacity of their domestic legal and regulatory system will permit them to balance interests as does the United States. It is probably unwise to accept commitments that will strain domestic capacity and which may lead to the application of rules in a more restrictive manner than the agreements require. If commitments are accepted, developing countries should pay careful attention to implementing them in a way which properly reflects the domestic public interest.

In conclusion, this study suggests that it is not only the public in developing countries that encounters risk from these FTAs. The U.S. public faces similar risks. The USTR assures the United States Congress that the agreements do not tie the hands of the domestic legislator. This is a position perhaps comfortably asserted within the more powerful of the parties to an FTA. Yet it is almost inevitable that when Congress considers changing domestic law, arguments will be made by industry groups that to do so may violate America’s international obligations and damage the national interest. Congress may choose to ignore U.S. international obligations, but it would be surprising if Congress were not at least somewhat reluctant to do so. The United States is increasingly bound by a set of highly restrictive intellectual property and regulatory commitments that may not over time be seen to be consistent with the American public interest.

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TRIPS and Human Rights: Preliminary Reflections

1/1/2006

TRIPS and Human Rights: Preliminary Reflections

INTERNATIONAL TRADE AND HUMAN RIGHTS: FOUNDATIONS AND CONCEPTUAL ISSUES

download here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1922823

We are considering the relationship between human rights and trade-related aspects of intellectual property rights (TRIPS). Intellectual property rights (IPRs) have always reflected a balancing of general public interests and private stakeholder interests, and in this sense IPRs take into account social welfare concerns as well as those of individual inventors and artists. While the balance struck in the TRIPS Agreement is flawed, it is capable of flexible interpretation and amendment. Human rights represent the values for establishing a global constitutional balance between the interests of the public and the private holders of IPRs.

We are collectively at a somewhat early stage of analyzing from a legal standpoint the relationship between human rights and the TRIPS Agreement. The observations in this paper reflect the preliminary nature of this inquiry. From a legal perspective, the sources of human rights relating to TRIPS are customary international law, the Universal Declaration of Human Rights, and various other human rights instruments including the International Covenant on Civil and Political Rights (lCCPR) and the International Covenant on Economic, Social and Cultural Rights (ICESCR). The Report prepared by the Office of the High Commissioner for Human Rights, entitled "The impact of the Agreement on Trade-Related Aspects on Intellectual Property Rights on human rights", insightfully surveys the relevant human rights instruments and their potential application to TRIPS issues.

The idea or concept of human rights as it applies to the field of IPRs involves something beyond the specific norms we may identify in human rights instruments or customary law. Human rights involve the shared perceptions of individuals regarding basic questions of right and wrong, fairness and equity. When an overwhelming part of the world's public perceives a situation as unjust, and expresses its concern, that shared perception itself becomes a part of our human rights dialogue, and informs public policy makers in their actions.

Human rights take on character, and become appropriately multidimensional in the context of specific cases, and reflect the spirit of the times. Lawyers may incline to be dismissive of public perception because the legal profession is by nature analytical, and the lawyer prides him or herself on objectivity and precision. Yet laws do not operate in clinical isolation from events, and events (particularly those of great moment) are rarely analytical and precise. One does not stop a war on a legal technicality. In the combating of social wrongs, it is the shared perception of the public, and the willingness of the public to take on the responsibility for setting things back in their proper order, that matters.

Meetings in the TRIPS Council on access to medicines that ultimately resulted in the Doha Declaration on the TRIPS Agreement and Public Health flowed largely from efforts by developing WTO Members to deal with public health problems affecting their people. The TRIPS Council did not begin taking access to medicines issues seriously because the OECD governments became more enlightened about the consequences of TRIPS and patents. Rather, this took place because the worldwide public did not accept that the rights of pharmaceutical industry patent holders should take precedence over the rights to life and health of millions of individuals. The human rights dimension will play a substantial role in the response of the WTO and other multilateral organizations to public health issues. It is precisely because fundamental human rights are at stake, and that these rights are paramount in public consciousness, that the legal situation will adapt.

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Cycle of Action and Reaction

12/7/2011

Trends in Local Production of Medicines and Related Technology Transfer

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1971924

World Health Organization 2011

This report identifies and analyses trends in the local production of medicines in developing countries and related technology transfer. The objective is to assist the World Health Organization (WHO) in its support for Member States in implementing the global strategy and plan of action on public health innovation and intellectual property with particular reference to the promotion of capacity-building for local production in developing countries. The methodology of research included interviews with a range of stakeholders, including industry actors, operators of product development partnerships (PDPs), government officials and members of public health advocacy groups; review of literature and Internet resources; and participation in meetings with stakeholder groups in Africa, Asia and Latin America.

This report makes a number of recommendations. These are focused mainly on the role that WHO, working in partnership with others, can take with respect to transfer of technology and local production of medicines in developing countries.

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Compulsory Licensing for Public Health

7/21/2005

Compulsory Licensing for Public Health: A Guide and Model Documents for Implementation of the Doha Declaration Paragraph 6 Decision

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1913854

World Bank Working Paper No. 61 (2005)

The Doha Declaration on the TRIPS Agreement and Public Health (in its Paragraph 6) recognized that developing countries with insufficient or no manufacturing capacity in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. The WTO’s decision of August 30, 2003 set up a system intended to overcome these difficulties. The present work is a guide to the implementation of that system.

The first part gives the reader an understanding of the issues involved; the second part provides model documents for use by governments. Four model instruments of notification are included: three for notification of the WTO as required by the Decision and one for notification of the patent or right holder pursuant to Article 31 of the TRIPS Agreement. Because most countries will have to amend their legislation (typically their patent law) to implement the system, model amendment provisions have been provided both for exporting countries and for importing countries. All model documents contain their own detailed commentary.

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The WTO Medicines Decision

8/1/2005

The WTO Medicines Decision: The Political Economy of World Pharmaceutical Trade and the Protection of Public Health

Download Here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=763224

American Journal of International Law, Vol. 99, pp. 317-58, 2005

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.

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Preservation and Use of Genetic Resource Assets and the International Patent System

3/31/2005

Preservation and Use of Genetic Resource Assets and the International Patent System

download here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1924481

 

In 1992 the Convention on Biological Diversity (CBD) was adopted at the Rio Conference. In 1994 the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) was adopted in Marrakech. From the outset, questions were raised as to whether there are conflicts or potential conflicts between the objectives and rules of these two international undertakings. These questions have been on the agenda of the WTO TRIPS Council and the Committee on Trade and Environment, they have been raised in the context of work programs and negotiations at the World Intellectual Property Organization (WIPO), they have been considered by the Conference of the Parties of the CBD, and they are the subject of numerous studies and reports by governments, intergovernmental and non-governmental organizations. This study attempts to clarify the issues at stake in analysis of the relationship between the TRIPS Agreement, related international patent system rules and the CBD. It examines the conflicts or potential conflicts between the objectives and rules of these international undertakings, and it makes certain recommendations regarding the promotion of complementarity among these systems. In terms of subject matter, this study considers only genetic resources and does not address "traditional knowledge".

This study first identifies the objectives of the international patent system as it is embodied in the TRIPS Agreement and WIPO Conventions, and how these objectives are implemented. Second, it identifies the objectives of the CBD and its method of implementation. Third, it identifies conflicts or potential conflicts between the objectives and methods of implementation of the two rule systems. Fourth, it examines proposals that have so far been made to ameliorate or resolve conflicts. Fifth, it suggests means for promoting complementarity between the two systems, including rule changes where necessary or appropriate.

The study concludes that promotion of the objectives of the CBD would be furthered by multilateral adoption of a mandatory requirement for the disclosure of the source and origin of genetic resources in patent applications. Such a requirement is appropriate to protect the interests of developing and developed countries which house genetic resource stocks. This requirement would be consistent with existing rules of the TRIPS Agreement. However, to give it effect it should be adopted as a new TRIPS Agreement rule. While national action to give effect to such a requirement is permitted under existing WIPO administrative treaties, establishing a mandatory multilateral standard under such treaties would also require amendment. The strength of any set of legal rules is dependent upon its enforceability. Therefore, it is important that states be obligated to provide for the effective enforcement of a mandatory disclosure requirement.

Existing patent law standards among advanced legal systems impose upon patent applicants affirmative duties with respect to the disclosure of information and establish penalties which include determinations of invalidity or provision for revocation of patents. Because the failure to disclose information regarding the source and origin of genetic resources may be relevant to the issue of patentability, including inventorship, it is appropriate that existing equitable doctrines that protect the integrity of the international patent system be extended to this area. It should not be an objective of prospective remedial measures to introduce insecurity into the international patent system, recognizing that patents are inherently insecure. Rather, the objective of prospective remedial measures should be to effectively encourage compliance with agreed upon rules, in this case designed to promote the objectives of the CBD.
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Toward a New Era of Objective Assessment in the Field of TRIPS and Variable Geometry for the Preservation of Multilateralism

1/1/2005

Toward a New Era of Objective Assessment in the Field of TRIPS and Variable Geometry for the Preservation of Multilateralism

download here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=915556

The TRIPS Agreement emerged from the Uruguay Round negotiations as one of the three pillars of the WTO. This article offers a preliminary assessment of the first ten years under the TRIPS Agreement. Based on that assessment, it makes suggestions for the future.

The objective of the principal developed country demandeurs of the TRIPS Agreement was to increase information and technology rent payments from developing countries. Incomplete implementation and enforcement was anticipated. Taking this into account, the Agreement has resulted in a substantial transformation of legal infrastructure in developing countries and has increased rent payment outflows to the owners of intellectual property (IP) rights. From this standpoint, the TRIPS Agreement has been successful in accomplishing its objectives.

From the standpoint of developing countries, it is more difficult to identify positive effects. China is the major developing country success story of the past decade, and it has achieved its historic accomplishments in the face of intensive criticism of its IP regime. The TRIPS Agreement has come under harsh public scrutiny for the role attributed to it by the pharmaceutical industry in South Africa, ultimately leading to the Doha Declaration on the TRIPS Agreement and Public Health. As a consequence of a somewhat more balanced approach to TRIPS now achieved at the WTO, the United States in particular has shifted to bilateral and regional fora to obtain higher standards of protection and enforcement, calling into question the relevance of TRIPS Council deliberations.

This article makes several recommendations. First, that new agreements concerning IP rights be subject to objective prior impact assessment. Second, that WTO Members give greater recognition to the fact that IP rules have significantly different public welfare implications depending on their field of application and the level of development of the implementing country. As the TRIPS Agreement transition periods have largely expired, the manner by which the TRIPS Council assesses its rules and makes provision for TRIPS-plus and TRIPS-minus adjustments might be restructured along industrial subject matter and developmental lines, taking better account of the impact-in-fact of IP rules on societies.

In June 2004 a group of trade specialists was brought together at the World Trade Forum in Berne in a `preliminary stocktaking` exercise to assess the first ten years of the World Trade Organization.1 This article was prepared for that occasion and addresses the Agreement on Trade-Related Aspects of Intellectual Property Rights (the `TRIPS Agreement`) on its ten-year anniversary. 

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Procurement and IP

12/7/2011

Trends in Local Production of Medicines and Related Technology Transfer

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1971924

World Health Organization 2011

This report identifies and analyses trends in the local production of medicines in developing countries and related technology transfer. The objective is to assist the World Health Organization (WHO) in its support for Member States in implementing the global strategy and plan of action on public health innovation and intellectual property with particular reference to the promotion of capacity-building for local production in developing countries. The methodology of research included interviews with a range of stakeholders, including industry actors, operators of product development partnerships (PDPs), government officials and members of public health advocacy groups; review of literature and Internet resources; and participation in meetings with stakeholder groups in Africa, Asia and Latin America.

This report makes a number of recommendations. These are focused mainly on the role that WHO, working in partnership with others, can take with respect to transfer of technology and local production of medicines in developing countries.

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Managing the Hydra

7/30/2004

Managing the Hydra: The Herculean Task of Ensuring Access to Essential Medicines

Download Here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1913965

In INTERNATIONAL PUBLIC GOODS AND TRANSFER OF TECHNOLOGY AFTER TRIPS 393-424 (K. Maskus and J. Reichman eds.)(Cambridge Univ. Press 2005)

The task of ensuring access to essential medicines presents a complex and embedded set of problems that will remain a persistent feature of the international governance landscape for the foreseeable future. The WHO’s recommended list of essential medicines has been developed with a view to aiding procurement authorities in determining the supplies needed to treat local populations. The price of medicines is a significant factor in determining what should be included on the list since there is small utility in recommending expensive therapies that are not affordable.

Nonetheless, the most recent WHO Essential Medicines list includes a significant number of antiretroviral medicines (ARVs) that are under patent. These drugs may not be affordable for many HIV-positive individuals, even taking into account recent price declines, unless public health budgets in developing countries are supplemented by international assistance.

The world community is presently confronted with tremendous public health challenges due to HIV/AIDS, malaria and tuberculosis. Yet, populations around the world, and especially in developing and least-developed countries, face heavy public health burdens from many sources, including other infectious diseases, diarrheal diseases, cancer, diabetes, heart and circulatory disease, and other conditions. While HIV/AIDS is the most immediate problem, it is not enough to address only this scourge.

Although there has been considerable public debate concerning the effect of patents on access to medicines, ensuring adequate supplies involves an extensive regulatory framework encompassing a multiplicity of factors. These include:

* Research and Development

* Safety and Efficacy (including Liability)

* Manufacturing Systems and Controls (Good Manufacturing Practices)

* Intellectual Property * Procurement, Distribution and Dispensing

* Health Care Personnel and Infrastructure

* Financing

Each of these elements in the essential medicines supply chain can and does act as a roadblock. Yet, each element is present for a reason. It is not helpful to supply inexpensive medicines if they are not safe and effective, or if they are prescribed to treat the wrong condition.

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Contradictory Trend

12/7/2011

Trends in Local Production of Medicines and Related Technology Transfer

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1971924

World Health Organization 2011

This report identifies and analyses trends in the local production of medicines in developing countries and related technology transfer. The objective is to assist the World Health Organization (WHO) in its support for Member States in implementing the global strategy and plan of action on public health innovation and intellectual property with particular reference to the promotion of capacity-building for local production in developing countries. The methodology of research included interviews with a range of stakeholders, including industry actors, operators of product development partnerships (PDPs), government officials and members of public health advocacy groups; review of literature and Internet resources; and participation in meetings with stakeholder groups in Africa, Asia and Latin America.

This report makes a number of recommendations. These are focused mainly on the role that WHO, working in partnership with others, can take with respect to transfer of technology and local production of medicines in developing countries.

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WTO Dispute Settlement Practice Relating to the Agreement on Trade-Related Intellectual Property Rights

1/1/2004

WTO Dispute Settlement Practice Relating to the Agreement on Trade-Related Intellectual Property Rights

THE WTO DISPUTE SETTLEMENT SYSTEM 1995-2003

download here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1920816

The jurisprudence developed by panels and the Appellate Body (AB) under the TRIPS Agreement during the first six-plus years of implementation reflects a cautious and gradualist approach to interpretation of the agreement. The decisions provide a collective reminder of the importance that WTO Members attach to the use of intellectual property as an instrument of industrial and social policy and the intention of those Members to maintain adequate flexibility to address domestic circumstances. The adoption by Ministers of the Declaration on the TRIPS Agreement and Public Health at Doha on 14 November 2001 was a seminal event in the evolution of WTO law, and will influence jurisprudence under the TRIPS Agreement.

The AB began the development of TRIPS jurisprudence by cutting back on what it viewed as a too-liberal approach to interpretation by a panel, insisting that the focus of interpretation be on the terms of the agreement, and not on the "expectations" of Members and private operators. This approach by the AB was heartening to commentators who worried that the flexibility inherent in the terms of the agreement might be limited by over-attention to the perceived interests of right holders. However, it is also apparent that an interpretative approach emphasizing the plain language of the text contains built-in limitations. The TRIPS Agreement was designed to permit a substantial measure of national discretion in its implementation, and adjudicators will not find the broadly drafted provisions of the agreement perfectly instructive in some contexts.

The complex nature of TRIPS Agreement interpretation became evident in the decision of the panel in the Canada Patent Protection of Pharmaceutical Products (Canada - Generic Pharmaceuticals) case. This case involved application of Article 30 of the TRIPS Agreement concerning exceptions to patents, and demonstrated how difficult application of a balancing text is in the context of the WTO. Although the panel labored courageously to establish the "plain meaning" of the terms of what it characterized as a three-pronged test under Article 30, in the final analysis it necessarily engaged in a subjective balancing of the interests represented. The most problematic TRIPS DSU decision is that of the AB in the United StatesSection 211 Omnibus Appropriations Act of 1998 (US Havana Club) case. Although the underlying subject matter of the case was inconsequential (being nothing more than a commonplace trademark dispute between two wealthy alcoholic beverage distillers), the AB's application of extremely rigorous national and MFN treatment standards may lead to more serious questions down the road.

Language and interpretation fundamentally involve subjective inquiry. In a national constitutional framework, there are checks and balances on the exercise of subjective authority that are expected to result in a proper reflection of the public interest. Since the WTO legal system does not contain comparable checks and balances, the review under the DSU of intellectual property legislation addressing important public policy issues will continue to present a challenge to the legitimacy
of WTO governance. The Ministerial Declaration on the TRIPS Agreement and Public Health represented the beginning of efforts to introduce checks and balances.

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Are the Competition Rules in the WTO Trips Agreement Adequate?

1/1/2004

Are the Competition Rules in the WTO Trips Agreement Adequate?

download here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=917108

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.