Book by the South Centre, 2004

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

Analytical Note, May 2002

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…)

Book by the South Centre, 2000

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