India prepares to supply free generic medicines
By Zofeen Ebrahim
As the northern Indian state of Rajasthan rolls out an ambitious universal healthcare plan, the discontent of the state’s doctors stands in stark contrast to the joys of the 68 million people who will benefit from the scheme.
Asian countries act to get cheap drugs
By Martin Khor
Staring with Malaysia in 2003, many Asian countries are now taking actions to promote cheaper medicines through compulsory licensing, with Indonesia being the latest case.
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India to increase supply of free generic medicines: some key issues
By Nirmalya Syam
Recent reports indicate that the Indian government plans to increase manifold its spending on procurement of generic medicines for supply free to patients. This is welcome news. However, it is important to ensure future supply of generic medicines by addressing the present problems facing the Indian drug industry.
The Nagoya ABS Protocol and Pathogens.
Pathogens are clearly within the scope of the Nagoya Protocol (NP). Preamble 16 of the NP makes clear that pathogens are within the scope of the NP. Further the preamble does not exclude the application of the benefit sharing provisions of the NP. (more…)
The Nagoya Protocol on Access and Benefit Sharing of Genetic Resources: Analysis and Implementation Options for Developing Countries.
As is common knowledge, the Nagoya Protocol was rushed through in the final hours of COP10 in an attempt to secure a binding instrument on ABS. As a result the Protocol represents, at best, a partially negotiated instrument. In the process, transparency, legal certainty and balance seem to have been sacrificed. (more…)
Developing Biotechnology Innovations Through Traditional Knowledge.
This paper suggests that by using biotechnology, traditional knowledge holders may obtain economic gain, through innovation and research and development based on the traditional knowledge. It also explores what are the obstacles in the development of biotechnology-based traditional knowledge innovation. (more…)
Towards a Digital Agenda for Developing Countries.
The last two decades of the 20th century saw a revolution in the nature of information and the way that it can be created, used and transmitted. Vast opportunities have been opened up. Developing countries, that have insufficient capacity to generate, disseminate and effectively utilize educational information and knowledge, may finally be in a position to accelerate their development. (more…)
The Threat of Technological Protection Measures to a Development-Oriented Information Society.
The new digital environment offers both opportunities and challenges for developing countries. New international legal requirements with respect to the protection of technological measures that can be used by copyright owners to control access and use of their works can hinder the ability of developing countries to promote access to knowledge for development. (more…)
The Proposed WIPO Treaty on the Protection of Broadcasting and Cablecasting Organizations.
Discussions for a new treaty to protect broadcasting and cablecasting organizations against signal theft at the WIPO are closely linked to the information evolution. Member States must carefully balance between granting increased protection to certain segments of broadcasting media to protect their commercial interests with safeguarding the public interest in access and use of the content that is broadcast. (more…)
A Development Analysis of the proposed WIPO Treaty on the Protection of Broadcasting & Cablecasting.
Since 1998, Member States of the World Intellectual Property Organization (WIPO) have discussed the creation of a new international instrument for the protection of broadcasting organizations. It is possible that final negotiations on a treaty on the protection of broadcasting organizations, including cablecasting organizations, will be initiated and conclude sometime in 2007. (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.
THE USE OF FLEXIBILITIES IN TRIPS BY DEVELOPING COUNTRIES: Can they Promote Access to Medicines?
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
