Analysis of the Outcome Text of the Informal Quadrilateral Discussions on the TRIPS COVID-19 Waiver
By Carlos M. Correa and Nirmalya Syam
Almost one and a half years after the proposal for a waiver of certain provisions of the TRIPS Agreement regarding health technologies for COVID-19 was proposed by India and South Africa with the support of the majority of WTO Members, the TRIPS Council has been unable to reach consensus on the proposed waiver or engage in text negotiations. In this context, the TRIPS Council agreed to suspend the discussions to allow the possibility of some solution to emerge from informal high-level consultations between the European Union, the United States of America, India and South Africa. Recently, the WTO Director-General transmitted the outcome of the informal consultations along with a draft text to the TRIPS Council. In this context, this policy brief analyzes the elements of the draft text that has been transmitted to the TRIPS Council. The proposed solution, which offers clarifications and limited waivers on some of the provisions governing compulsory licenses on patents relating to vaccines, reflects developed countries’ strong opposition to the broader waiver sought by the proponents to rapidly expand manufacturing capacity and the supply of health products needed to address the pandemic.
A Review of WTO Disputes on TRIPS: Implications for Use of Flexibilities for Public Health
By Nirmalya Syam
The use of TRIPS flexibilities by WTO members involves interpretation of the obligations under TRIPS which can be challenged under the WTO dispute settlement system. Mutually agreed solutions, panel or Appellate Body decisions adopted in such disputes can thus impact the scope of TRIPS flexibilities to address, among others, public health objectives. This paper explores how the WTO dispute settlement system applies to disputes under TRIPS, and reviews the outcomes of the disputes relating to the implementation of TRIPS obligations in the context of pharmaceutical products. The paper points to both systemic and substantive concerns arising from the application of the dispute settlement system to disputes under TRIPS. It finds that the dispute settlement system is not aligned to the unique nature of the TRIPS Agreement in the WTO as an agreement that creates positive obligations, and consequently how jurisprudence arising under disputes concerning other covered agreements having negative obligations, have led panels and Appellate Bodies to adopt narrow interpretations of the scope of TRIPS flexibilities in some of the few disputes arising under the TRIPS Agreement. Moreover, mutually agreed settlements adopted in the context of some of the disputes arising under TRIPS have also led to the adoption of TRIPS plus standards, limiting the scope of TRIPS flexibilities. However, in a recent decision, the WTO panel has also relied on the Doha Declaration on TRIPS and Public Health as a subsequent agreement to guide the interpretation of its provisions. In this context, the paper advances some suggestions to address the systemic and substantive issues arising from the application of the dispute settlement system to the TRIPS Agreement.
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.