The grant of patents and the exorbitant cost of “lifesaving” drugs
By Germán Velásquez
The important relationship between the examination of patents carried out by national patent offices and the right of citizens to access to medicines hasn’t always been well understood. Too often these are viewed as unrelated functions or responsibilities of the state. And the reason is clear: patentability requirements are not defined by patent offices, but frequently by the courts, tribunals, legislation or treaty negotiators. This is the case when patent policy is implemented in isolation from, rather than guided by, public health policy. (more…)
Of all the issues currently being negotiated on the Trans Pacific Partnership Agreement, none are more important than the ability of patients to get life-saving medicines at affordable prices, which many fear may be a victim of the agreement. (more…)
His rivals called him a “pirate” but grateful millions whose lives were saved by his cheap generic medicines consider him a Robin Hood—Yusuf Hamied, leader of India’s giant company, Cipla.
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.
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. (more…)
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.
Beyond ‘Patent Quality’: Basic Concepts of the Patent System Need To Be Reviewed
By Carlos M. Correa
A proposal has been made to initiate a debate on ‘patent quality’ at the World Intellectual Property Organization (WIPO). The expression ‘patent quality’ ambiguously alludes to a growing problem, faced in both developed and developing countries alike: the overwhelming majority of patents are applied for and granted over incremental developments on existing technologies. Although the patent system is supposed to reward inventiveness, in many cases patents cover minor improvements or trivial ideas.
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.
