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.
Intellectual Property in Investment Agreements: The TRIPS-plus Implications for Developing Countries.
This analytical note examines, in particular, the implication of the emerging approaches relating to the fair and equitable treatment and the national and mostfavoured nation (MFN) treatment in investment agreements for the overall regimes for the protection and enforcement of IP in developing countries. (more…)
Establishing a ‘Development Agenda’ for the World Intellectual Property Organization (WIPO): Commentary on Proposal by Argentina and Brazil.
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. The Assemblies will address various matters including issues currently under negotiation in various WIPO committees and bodies. (more…)
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…)
A Development Agenda for Intellectual Property Negotiations in 2004 and Beyond.
In 2003, activities in the World Trade Organization’s (WTO) Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) were fairly subdued, save for the negotiations relating to the implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health. (more…)
Implementation-Related Issues and Concerns: The Way Forward After Cancun.
This paper looks primarily at the history of implementation issues in the WTO since the 2001 Doha Ministerial Conference, and at some of the major initiatives that developing countries have suggested in order to push the negotiations on implementation issues forward. (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.
The Balance of Negotiations and Discussions in the Doha Work Programme: Overview Matrix of Negotiating and Non-Negotiating Areas.
The Doha Ministerial Conference of the WTO, held in November 2001, launched an ambitious work programme. The discussions/ negotiations initiated under this work programme include a number of issues in addition to the WTO built-in agenda and purely trade-related issues. (more…)
Background note on the implementation-related issues: History, Implementation, and Negotiating strategy for developing countries.
First, this paper looks at the history of implementation issues in the GATT/WTO system, and how such issues were dealt with up to the conclusion of the Uruguay Round. (more…)
Review of the Existing Special and Differential Treatment Provisions: Implementing the Doha Mandate.
By placing Special and Differential Treatment (hereafter referred to as ‘S&DT’) at the heart of the WTO Agreements, the Doha Ministerial Declaration explicitly acknowledged that S&DT is a fully accepted core principle in the WTO legal regime. (more…)
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.
