Pharmaceutical Innovation, Incremental Patenting and Compulsory Licensing.
Despite the decline in the discovery of new chemical entities for pharmaceutical use, there is a significant proliferation of patents on products and processes that cover minor, incremental innovations. A study conducted in five developing countries – Argentina, Brazil, Colombia, India and South Africa – evidenced a significant proliferation of ‘evergreening’ pharmaceutical patents that can block generic competition and thereby limit access to medicines. (more…)
Comments on the 3rd high level forum on aid effectiveness. Final Draft of the Accra Agenda for Action.
This South Centre Analytical Note looks at the 25 July 2008 final draft text of the Accra Agenda for Action (AAA) that is being proposed for adoption by participants at the Third High Level Forum on Aid Effectiveness in Accra, Ghana, in September 2008. (more…)
Buying power: aid, governance and public procurement.
This South Centre Analytical Note looks at the donor-driven agenda in the reform of public procurement – the rules that guide government purchasing of goods, works and services – as one of major components in the good governance agenda being incorporated by donors into their aid programmes. (more…)
Comments to the Draft Modalities for WTO NAMA Negotiations dated 17 July 2007.
This note contains preliminary comments on the Draft NAMA Modalities submitted by the Chairman of the WTO Negotiating Group on Market Access (Job (07)/126). While the text will need to be discussed, amended and, if agreed, adopted at a later stage, (more…)
The Suspension of the WTO DDA Negotiations: Scenarios and identification of pressure points for Developing Countries.
This note identifies some opportunities and challenges that the suspension of the WTO Doha negotiations has created for developing countries. In fact, an early identification of pressure points in the negotiations can contribute to the preparedness of developing country delegations for the time negotiations resume. (more…)
Operationalizing the concept of policy space in the UNCTAD XI mid-term review context.
This South Centre Analytical Note provides a brief historical overview of the development of the concept of “policy space” for development in international forums and tries to suggest ways on how, in the context of the UNCTAD XI Mid-Term Review process, (more…)
Project to support Developing Countries in WTO NAMA Negotiations.
This note presents a brief assessment of individual elements of the NAMA section of the Hong Kong Ministerial Declaration and highlights possible strategies available to developing country negotiators in the aftermath of Hong Kong. (more…)
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.
Hong Kong Ministerial Conference: Bottom Lines for LDCs in the GATS Negotiations.
This analytical note aims to assist least developed countries (LDCs) participate more actively in the General Agreement on Trade in Services (GATS) negotiations leading up to the Sixth Hong Kong Ministerial Conference of the World Trade Organisation in December 2005 by (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.
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…)
