Integrating Development into WIPO Activities and Processes: Strategies for the 2004 WIPO Assemblies.
The fortieth Series of Meetings of the Assemblies of Member States of the World Intellectual Property Organization (WIPO) will take place in Geneva from 27 September to 5 October 2004.1 The Assemblies will address various matters including issues currently under negotiation in various WIPO committees and bodies. (more…)
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.
UTILIZING TRIPS FLEXIBILITIES FOR PUBLIC HEALTH PROTECTION THROUGH SOUTH-SOUTH REGIONAL FRAMEWORKS
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.
Integrating Public Health Concerns into Patent Legislation in Developing Countries
