IPR, R&D, Human Rights and Access to Medicines: An Annotated and Selected Bibliography
About the Book: The South Centre seeks to provide the appropriate technical assistance and country support to developing countries, within a comprehensive and coherent national IP Strategy, to promote the implementation of the TRIPS Agreement that is consistent with the protection of public health and promotion of access to medicines. To this end, the South Centre has prepared this selected and annotated bibliography to assist developing countries to implement IP policies and regulations consistent with development goals and public health principles.
Authors: Germán Velásquez, Carlos Correa and Xavier Seuba
Financial Crisis and Global Imbalances: A Development Perspective
About the book: This book examines – from a standpoint of promoting stability and growth in developing countries – key policy lessons to be drawn from the devastating global economic crisis of 2008-09. In this collection of papers on the 2008-09 Great Recession and its implications, leading economist Yılmaz Akyüz underlines the need for economic restructuring along the above lines with a view to more effective crisis prevention and intervention. Given their vulnerability to shocks and limited capacity to respond, he says, this reform process is an endeavor in which developing economies have a crucial interest.
About The Book: This book examines in detail the purpose and characteristics of the patentability standards and analyses typical claims in pharmaceutical patents. It provides recommendations on ways of implementing such standards in a manner that avoids the grant of patent right on developments which are genuine innovations or which are not properly described.
Editor: Carlos M. Correa is Special Adviser on Trade and Intellectual Property at the South Centre, Geneva.
Food Security and Access and Benefit-Sharing for Genetic Resources for Food and Agriculture
About the book: A study prepared for the UN FAO (Food and Agriculture Organisation) on whether, and how, national and regional laws, guidelines and other arrangements on access to genetic resources and benefit-sharing (ABS) may impact upon agriculture and food security.
Authors: Gurdial Singh Nijar, Gan Pei Fern, Lee Yin Harn and Chan Hui Yun
How Developing Countries Can Manage Intellectual Property Rights to Maximize Access to Knowledge
This book addresses the debate on access to knowledge in three parts. Part I describes some of the challenges for access to knowledge. Part II of the book provides an account of recent developments in multilateral forums. Part III of the book seeks to advance the strategic considerations that should be useful to developing countries in addressing the challenges with regard to access to knowledge. It is hoped that the analysis, conclusions and recommendations presented in this book will contribute to a better understanding of the challenges to access to knowledge and of how to frame development-oriented policies to address them. The book is intended to reach a broad set of readers: it provides guidelines for developing countries’ governments in participating in multilateral and bilateral negotiations as well as to design national IP regimes consistent with those countries’ development objectives. It may also be of value to scholars, teachers, and students whose interests cover such areas as law, economics, political economy, diplomacy, international relations and other social science fields.
THE USE OF FLEXIBILITIES IN TRIPS BY DEVELOPING COUNTRIES: Can they Promote Access to Medicines?
This study was commissioned to: (1) examine the extent to which the flexibilities contained in the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have been incorporated into the legislation of developing countries and the extent of the actual use for public health purposes; (2) review the stated trade policies of major industrialized countries, particularly the United States and the European Union , vis-à-vis developing countries, to determine whether they take adequate account of the public health priorities of developing countries; and (3) examine the practical effect and implications of recently concluded bilateral and regional free trade agreements (FTAs) for public health protection in developing countries. The study has been compiled based on existing literature and other available evidence.
Overall, the study finds that the use of TRIPS flexibilities can promote access to medicines in developing countries. Most developing countries whose laws and practices we reviewed had incorporated one or more of the TRIPS flexibilities and there has been increasing usage of these flexibilities such as compulsory licensing for public health purposes. However, there remain important gaps both in terms of incorporation and usage of flexibilities, which will need to be addressed if the TRIPS flexibilities are to be used effectively across the developing world.
With respect to the stated trade policies of the United States and the EU relating to the protection of intellectual property in third countries, especially developing countries, we find that although some concern for the public health needs of developing countries is reflected, in general, the policies fail to adequately take into account the public health priorities of developing country trading partners.
Finally, with respect to FTAs, we find that a number of provisions in recently concluded FTAs between developed countries (essentially the United States) and developing countries, pose a real risk of undermining the effective use of TRIPS flexibilities in developing countries for public health purposes.
UTILIZING TRIPS FLEXIBILITIES FOR PUBLIC HEALTH PROTECTION THROUGH SOUTH-SOUTH REGIONAL FRAMEWORKS
Despite the significant scientific and technological developments of the 20th century, there continue to exist unacceptable inequalities in the health status of people as between developed and developing countries as well as within developing countries. It is in this context that efforts have been underway over the last several years to make medical technology work better for developing countries and for poor people. A major component of these efforts has focused on the impact of the expansion of patent protection to pharmaceutical products and processes under the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The initial challenge related to the scope and interpretation of the policy flexibilities embodied in the Agreement that could be used to improve availability and access to essential patented medicines. This challenge was resolved by the Doha Declaration on the TRIPS Agreement and Public Health (the Doha Declaration), which affirmed that public health considerations can and should condition the extent to which patents on pharmaceuticals are enforced and that flexibilities in the TRIPS Agreement should be used to this end.
However, while developing countries have the right to exercise the flexibilities under the TRIPS Agreement, in reality it remains difficult for many of them to make effective use of these flexibilities as a public health policy tool. For example, paragraph six of the Doha Declaration on TRIPS and public health recognized that while developing countries can issue compulsory licences; they nevertheless faced difficulties in making effective use of this policy tool due to lack of or insufficient manufacturing capacity. This is, however, just one of the constraints that developing countries face at the national level in their efforts to use TRIPS flexibilities. Other constraints include: lack of technical expertise effectively to implement the TRIPS flexibilities; insufficient technical and infrastructural capacities for medicines regulations; bilateral and other pressures not to use the TRIPS flexibilities for public health purposes and/or to adopt TRIPS-plus standards; difficulties in regulating anti competitive practices and abuse of intellectual property rights; and difficulties in accessing pricing and patent status information. Many of these constraints can be addressed by adopting complimentary policy and legal measures at the regional level.
Protection and Promotion of Traditional Medicine – Implications for Public Health in Developing Countries
Traditional medicine (TRM) includes knowledge and practices either codified in writing or transmitted orally. TRM serves the health needs of the vast majority of people in developing countries, where access to “modern” health care services and medicine is limited by economic and cultural factors. TRM is broadly used in such countries, often being the only affordable treatment available to poor people and those in remote communities. In a context of persisting poverty and marginalization and, in particular, in view of the high prices generally charged for patented medicines, the relevance of TRM in developing countries may, in the future, increase. TRM has been recognized in western science as a valuable source of products and treatments for health care. It often provides leads for the development and commercialization of new pharmaceutical products. However, western intellectual property systems have regarded TRM, as well as other components of traditional knowledge (TK), as information in the “public domain”, freely available for use by anybody. This has meant that TRM and other traditional knowledge has been exploited in Western contexts without any recognition, moral or economic, to those who originated or held the relevant knowledge. Further, diverse components of TRM have been appropriated under intellectual property rights (IPRs) by researchers and commercial enterprises, without any compensation to the knowledge’s creators or holders. While all these forms of ‘protection’ are important, this paper focuses on issues relating to protection of TRM in the context of IPRs, both as a defensive and offensive strategy. Its main purpose is to try to clarify the extent to which IPRs may be used in relation to TRM, and what the implications of such use may be for public health.
Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the TRIPS Agreement
This study focuses in depth on the specific issue of marketing approval protection under the TRIPS Agreement and its interpretation, an issue of major practical importance for the developing countries. This book is co-published by the World Health Organization and was produced with the support of the Rockefeller Foundation.
Integrating Public Health Concerns into Patent Legislation in Developing Countries
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) requires all WTO Member countries to adapt their laws to the minimum standards set out in the Agreement, within established transitional periods. Conforming with the Agreement by recognizing or strengthening the protection of pharmaceutical products and processes by intellectual property rights (IPRs) has posed a special challenge for developing countries. The way in which the required legislative reform is made may have a significant impact on public health policies, and particularly on the population’s access to drugs.
This document presents options for the design and implementation of public-health-sensitive patent policies in developing countries. It examines approaches to selected issues in patent law that may help to strike a balance between the public and private interests involved in the protection of health-related inventions, including those of States, patients, and of the suppliers of health-related goods and services. This document has been prepared as part of an initiative aimed at exploring health-related aspects of intellectual property rights that may further the needs of the poor and excluded in developing countries. It is primarily addressed to policy makers and others concerned in the field of public health in developing countries.
The issues raised in this report reflect major ongoing concerns about food security in developing countries. Several of these issues were addressed in the “Rome Declaration on World Food Security and World Food Summit Plan of Action”. However, they were dealt with in a somewhat superficial manner. Moreover, Northern interests and the liberalization agenda embedded in the “Washington consensus” heavily influenced this Summit document. More serious for the interests of the South may be that no politically realistic strategy emerged for mobilizing popularly based movements and governments to eliminate hunger.
The purpose of this publication is to emphasize in an integrated manner a set of food security issues and policies of particular concern to peoples and governments of developing countries. The South Centre hopes it will contribute to more effective actions towards universal food security. An earlier version of this paper was prepared as a contribution to discussions at the World Food Summit held at FAO Headquarters, 13-17 November 1996.
About the Book: The South Centre seeks to provide the appropriate technical assistance and country support to developing countries, within a comprehensive and coherent national IP Strategy, to promote the implementation of the TRIPS Agreement that is consistent with the protection of public health and promotion of access to medicines. To this end, the South Centre has prepared this selected and annotated bibliography to assist developing countries to implement IP policies and regulations consistent with development goals and public health principles.
