South Centre Comments on the Draft Annotated Outline of a WHO Convention, Agreement or Other International Instrument on Pandemic Prevention, Preparedness and Response
24 June 2022
The South Centre welcomes the opportunity to provide comments on the draft annotated outline of a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response. Comments are provided with respect to the process and the content.
TRIPS WAIVER: AN INSUFFICIENT MULTILATERAL RESPONSE. TRIPS-CONSISTENT NATIONAL ACTIONS ARE CALLED FOR
After almost 20 months from the submission of a “TRIPS waiver” request by India and South Africa, co-sponsored by 65 WTO member States (and supported by more than 100 WTO Members), a “Ministerial Decision on the TRIPS Agreement” (WT/MIN(22)/W/15/Rev.2) (‘the Decision’) was belatedly adopted by the 12th Ministerial Conference of the World Trade Organization on 17 June 2022.
This Decision does recognize that, as argued by developing countries and a large number of organizations and academics, intellectual property (IP) poses obstacles for the expansion of manufacturing capacity and timely access to health products and technologies to respond to COVID-19. The response to the pandemic required a rapid increase in the supply of countermeasures, while technology holders refused to share their technologies.
Not only developed countries successfully deviated the negotiations towards an outcome different from what was pursued by developing countries’ diplomats; the process for its adoption did not allow for the full and informed participation of the latter. The process leading to the Decision confirms the need to fully use the TRIPS flexibilities to address emergency and other situations where public health and other public interests are at stake, and to review the current international IP regime (including article 31bis of the TRIPS Agreement) to accelerate the sharing of technology, including know-how.
Twenty Years After Doha: An Analysis of the Use of the TRIPS Agreement’s Public Health Flexibilities in India
By Muhammad Zaheer Abbas, PhD
The World Trade Organization (WTO) linked intellectual property protection with trade. The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), however, included a number of public health flexibilities in order to provide latitude to the Member States to tailor their national patent laws to fit their individual needs. In 2001, the Doha Declaration further clarified and reaffirmed the existing TRIPS flexibilities. This paper argues that India has taken the lead role in enacting the TRIPS Agreement’s substantive and procedural patent flexibilities by introducing unique legislative measures to deal with the problem of access to medicines. This article evaluates India’s use of section 3(d) as a subject matter exclusivity provision. It examines constitutional validity and TRIPS compliance of section 3(d). It also evaluates India’s use of the flexibility to define the term “inventive step”. Moreover, this article evaluates India’s use of compulsory licensing, the most notable exception to patent rights provided under the TRIPS Agreement. This empirical study is important in the context of the COVID-19 pandemic, which has once again highlighted the same public health issues that the Doha Declaration sought to address twenty years ago.
STATEMENT BY CARLOS M. CORREA, EXECUTIVE DIRECTOR OF THE SOUTH CENTRE, TO THE MEETING OF THE NAM HEALTH MINISTERSON THE OCCASION OF THE 75TH WORLD HEALTH ASSEMBLY, MAY 20, 2022
The South Centre has closely followed issues concerning access to medicines and the work of the WHO over the years. In the last couple of years, it has provided analyses and advice in connection with the COVID-19 crisis that has so severely affected the members of NAM.
COVID-19 Vaccines as Global Public Goods: between life and profit
By Katiuska King Mantilla and César Carranza Barona
In the context of a health emergency like the COVID-19 pandemic, the global availability of and access to vaccines are imperative. This research paper provides an analysis from the perspective of international political economy, of the financing of COVID-19 vaccines and of the market strategies adopted by some of the companies that developed them. It notes that the development of vaccines was supported by substantial public funding from countries that later received preferential access to those vaccines through advance purchases. Despite such public support, the vaccines were not deemed as public goods but remained under the control of their developers.
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.
Patent Analysis for Medicines and Biotherapeutics in Trials to Treat COVID-19
by Srividya Ravi
This report provides an analysis of patents covering medicines in trials to treat COVID-19. The aim of the report is to support national patent offices and interested parties in developing countries with information that can serve as guidance for the examination of the claims contained in relevant patents or patent applications.
The medicines considered for the patent analysis in this report are remdesivir, ruxolitinib, favipiravir, molnupiravir and nirmatrelvir, and the biotherapeutics tocilizumab, siltuximab and sarilumab.
An Examination of Selected Public Health Exceptions in Asian Patent Laws
By Kiyoshi Adachi
This study examines the variations within Asia of two exceptions to patent rights that are commonly justified under Article 30 of the World Trade Organization (WTO) Agreement on Trade-related Aspects of Intellectual Property Rights (the TRIPS Agreement), namely the research and experimentation exception and the regulatory review (or “Bolar”) exception. Both these exceptions are important in the context of the 2001 Doha Declaration on the TRIPS Agreement and Public Health insofar as they are designed to provide flexibility to protect public health and support countries’ overall scientific and technological aspirations. The study examines, from a comparative perspective, examples of these respective exceptions in patent legislation in South, Southeast and East Asia, and identifies peculiarities in the variations among countries in these sub-regions.
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.
South Centre Semester Report, July – December 2021
The South Centre undertakes policy-oriented research on issues, as defined in its Work Program (https://www.southcentre.int/work-program/), that are relevant to the achievement of the Sustainable Development Goals. It supports the countries of the South to effectively participate in negotiating processes in order to build up a multilateral system that supports and does not undermine development efforts. It also provides policy and technical advice and capacity building in support of countries and institutions of the South. Catalogues of the publications of the Centre can be found at https://www.southcentre.int/publications-catalogues/.
The South Centre expands its reach and impact by leveraging cooperation with other international organizations, research institutions, academia and civil society.
This Semester Report is an account of how the South Centre’s Secretariat has fulfilled the Centre’s mission through the different workstreams for the period July – December 2021.
Mainstreaming Public Health Considerations in Adjudication of Intellectual Property Disputes: Implications of Specialized IP Courts and General Courts
By Justice (Retd.) Prabha Sridevan
How can the public interest dimension be considered in the adjudication of intellectual property (IP) disputes, in particular those concerning patents on health technologies such as medicines and vaccines? This is the main question addressed by Justice (Retd.) Prabha Sridevan, former Judge of the Madras High Court and former Chairperson of the Intellectual Property Appellate Board (IPAB) of India, as an expert facilitator, at the Asian Regional Course for Judges on Intellectual Property and Public Health organized by the South Centre in August 2021. Justice Sridevan addressed the pros and cons of adjudication through specialized courts vis-à-vis general courts.