Canada’s Political Choices Restrain Vaccine Equity: The Bolivia-Biolyse Case
By Muhammad Zaheer Abbas, PhD
The COVID-19 pandemic has already claimed more than 4.6 million lives and caused significant economic harm. The Coronavirus is still circulating to cause further damage. In this context, this research paper argues that Canada’s political choices have restrained the equitable distribution of COVID-19 vaccines. Part I evaluates Canada’s nationalistic approach of procuring COVID-19 vaccines more than its needs through secretly concluded pre-purchase agreements with brand-name pharmaceutical corporations as advised by a secretly born task force having clear ties with the vaccine industry. Part II examines Canada’s wavering and non-committal position on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) Waiver proposal. Canada’s confusing position of ‘not blocking’ the TRIPS Waiver while not supporting it either lacks legal clarity. Part III analyses the Bolivia-Biolyse case which highlights clear contradictions between statements and actions of the Canadian government. Since March 2021, Biolyse Pharma has been hamstrung by the first step in Canada’s Access to Medicines Regime (CAMR), where a preliminary requirement is that the COVID-19 vaccine must be added to Schedule 1 of the Canadian federal Patent Act before applying for an export-oriented compulsory licence. The Bolivia-Biolyse case is important as a test case for the CAMR system. Workability of this export-oriented compulsory licensing regime is critical for low- and middle-income countries in the Global South lacking the domestic capacity to manufacture COVID-19 vaccines. The Bolivia-Biolyse case is also important as Canada has argued at the World Trade Organization (WTO) that the TRIPS Waiver is not required because the existing mechanisms are working as intended.
Implementation of a TRIPS Waiver for Health Technologies and Products for COVID-19: Preventing Claims Under Free Trade and Investment Agreements
by Carlos M. Correa, Nirmalya Syam and Daniel Uribe
While increasing support from WTO members for a proposed waiver from certain obligations under the TRIPS Agreement with regard to health products required for responding to COVID-19 has made a decision on the TRIPS waiver imminent, the waiver will have to be implemented domestically by WTO members through appropriate legislative, administrative or judicial measures, including through executive orders that have been utilized to implement emergency measures in the context of the COVID-19 pandemic. In this regard, the scope of the TRIPS waiver, as well as the terms of applicable free trade agreements (FTAs) and international investment agreements (IIAs) will also impact the policy space available to countries to implement the waiver. Ensuring a broad scope of the waiver, as well as complementary measures to safeguard the implementation of the waiver from potential challenges under FTAs or IIAs will be critical. This research paper discusses some options that could be explored to enable the implementation of the TRIPS waiver by overcoming possible impediments that could arise under such agreements.
Accelerating COVID-19 Vaccine Production via Involuntary Technology Transfer
By Dr. Olga Gurgula
This policy brief explains that the currently discussed proposals at the WTO related to increasing the production of COVID-19 vaccines, including the EU proposal to clarify the use of compulsory licensing and the submission by South Africa and India on the intellectual property (IP) waiver, require complementary mechanisms to rapidly improve the production of COVID-19 vaccines that are urgently needed today. The key problem is that to accelerate the manufac- ture of COVID-19 vaccines, access to knowledge and know-how, that are protected by trade secrets owned by several pharmaceutical companies, is required. It is therefore important that governments implement an additional mechanism of compulsory licensing of trade secrets that would allow an involuntary transfer of COVID-19 vaccine technologies. Such a mechanism would be compliant with the TRIPS Agreement and relevant whether the TRIPS waiver is adopted or not agreed upon. While this mechanism must provide full access to the information necessary to manufacture the vaccines in question, it must also ensure the protection of the transferred trade secrets.
Working Session at the WTO Public Forum 2021: The Future of the TRIPS Agreement Post COVID-19
Wednesday, 29 September 2021
16h30 –17h30 CET
Disciplines on intellectual property protection are part of the multilateral trade system through the WTO TRIPS Agreement. The COVID-19 pandemic has brought to bear again the tension between the protection of intellectual property rights and public health, which had been addressed in 2001 through the Doha Declaration on the TRIPS Agreement and Public health. Having in view the TRIPS flexibilities, this session will discuss the role of interpretation, temporary waivers and amendments in dealing with such tension and what further actions could be taken under the WTO rules in order to promote access to medical products for all.
Guidelines for the examination of patent applications relating to pharmaceuticals
By Carlos M. Correa
This document represents a follow-up to an earlier document, Guidelines for the Examination of Pharmaceutical Patents: Developing a Public Health Perspective, which was published in 2007 as a working paper by the International Centre for Trade and Sustainable Development (ICTSD), the United Nations Conference on Trade and Development (UNCTAD) and the World Health Organization (WHO).
The present document takes into account developments since the publication of the ICTSD-UNCTAD-WHO working paper in 2007. It includes new examples of patent applications and/or grants, and analysis of and references to the initiatives of a number of countries that have adopted laws and/or policies that seek to factor in public health considerations in the examination of patent applications.
With this document, the aim is to provide guidance for the development or revision of guidelines on patent examination processes in developing countries in response to concerns about the rise of patent numbers in the pharmaceutical sector. For this purpose, a number of recommendations are made with regard to the examination of the patentability of applications relating to pharmaceutical products and processes.
EU Proposals regarding Article 31bis of the TRIPS Agreement in the Context of the COVID-19 Pandemic
By Nirmalya Syam
This Policy Brief presents an analysis of the proposal by the European Union (EU) with regards to Article 31bis of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as part of a Declaration on the TRIPS Agreement and Public Health in the circumstances of a pandemic. It discusses the EU’s proposed clarifications, why Article31bis does not provide an effective solution to promote access to pharmaceutical products and possible options.
Virtual Consultation in support of the UN Working Group’s 2021 Report to the UN General Assembly on Human Rights-Compatible International Investment Agreements
South Centre, 23 June 2021
Foreign direct investment (FDI) should support States’ efforts to “bring the SDGs and goals of the Paris Agreement to life for all people, everywhere.” However, achievement of these objectives is slowed down in the current situation where investor-State dispute settlement (ISDS) mechanisms are included in international investment agreements (IIAs). These mechanisms have increased the exposure of States to claims from foreign investors against regulatory measures taken to protect and guarantee a clean and safe environment, public health, human rights, social inclusion, and poverty reduction.
In the current scenario marked by the impact of the COVID-19 pandemic, FDI can be a valuable source of financing a better and fairer recovery, including investment needed to achieve the full realisation of all human rights. But to achieve this potential, there is a need to reshape the international investment regime, including through the reform of its substantive rules and standards, as well as of the ISDS mechanisms embedded in existing IIAs.
The South Centre and the United Nations Working Group on human rights and transnational corporations and other business enterprises convened a virtual consultation to identify and assess the different challenges developing countries face while negotiating or reforming IIAs in line with their international human rights obligations. The virtual consultation aimed at highlighting and discussing some of the most common concerns and challenges those developing countries face in the promotion of responsible investment practices, including an exploratory discussion about balancing the rights and obligations of investors in IIAs and safeguarding the sovereign right of States to regulate in the public interest for building back better and fairer in face of the COVID-19 pandemic. It also discussed possible reforms of the ISDS mechanism.
COVID-19 y la necesidad de una organización internacional
Velásquez, Germán: Vacunas, medicamentos y patentes. COVID-19 y la necesidad de una organización internacional. Vacunas covid-19: entre la ética, la salud y la economía. Desarrollo de la vacuna COVID-19; la inmunidad y el contagio; el nacionalismo de las vacunas; el mecanismo COVAX; licencias obligatorias; Acceso a medicamentos y vacunas: un nuevo actor. Medicamentos y propiedad intelectual: diez años de la estrategia mundial de la oms. Repensando la fabricación mundial y local de productos médicos tras el covid-19. Repensando la i+d para productos farmacéuticos después del covid-19. Propiedad intelectual y acceso a medicamentos y vacunas. Las reformas de la organización mundial de la salud en la época de covid-19. 2021. 244 pp. ISBN 978-9915-650-31-9.
Autor: Germán Velásquez, Asesor especial sobre políticas y salud, South Centre de Ginebra
This Semester Report summarizes the activities undertaken by the South Centre during the period 1st January to 30 June 2021. It is intended to provide information, organized by themes, about recent developments in the areas covered by the Centre’s Work Program, meetings organized or co-organized by the Centre to examine particular issues or provide analytical support for negotiations taking place in various international fora, and conferences and other meetings where the Centre has participated. It also informs about publications of the outcomes of internal policy-oriented research and external contributions made as a result of cooperation with the Centre.
The WTO TRIPS Waiver Should Help Build Vaccine Manufacturing Capacity in Africa
By Faizel Ismail
The current global health crisis created by the COVID-19 pandemic has re-focused our attention on the inadequacy of the TRIPS agreement and the patent system to address global public health crises. This time, developing countries must ensure that the TRIPS waiver succeeds in creating the impetus for the building of manufacturing capacity in the poorest countries, especially in Africa, for vaccines, pharmaceuticals and other health technologies. This is the only effective way in which African countries can reduce their dependence on imports of essential medicines and build their health security, contributing to the achievement of the sustainable development goals, for the poorest countries.
The author posits that the global public health impact of the Covid-19 pandemic along with the economic and distributional aspects of vaccines and treatments, involves a market failure without the underlying institutional safety nets for an effective, globally coordinated response. He proposes strong, self-standing institutions with clear mandates and resources to make effective interventions at three levels: political, financial and regulatory. Also, the WTO rules regarding export restrictions are at present too accommodative to allow for a quick response. For Intellectual Property, both manufacturing and licensing, and relaxation of IP rules should be considered.
Un nouveau traité international de l’OMS sur la préparation et la riposte aux pandémies : pourra-t-il répondre aux besoins des pays du Sud ?
Par Dr. Germán Velásquez et Nirmalya Syam
Dans un récent communiqué signé par 25 chefs de gouvernement et le Directeur général de l’OMS, ceux-ci ont appelé à la négociation d’un traité sur les pandémies afin de permettre aux pays du monde entier de renforcer les capacités et la résilience des pays aux niveaux national, régional et mondial face aux futures pandémies. La pandémie de COVID-19 a démontré la fragilité des mécanismes dont dispose l’OMS pour se préparer et réagir aux pandémies. L’utilisation d’instruments contraignants pour promouvoir et protéger la santé dans le contexte des pandémies est nécessaire. Si les États Membres de l’OMS décident que le recours à un traité international de préparation et de riposte aux pandémies est la voie à suivre, il serait important de clarifier dès le départ les éléments et les domaines qui feront l’objet de négociations. La première étape devrait consister à identifier les aspects de la préparation et de la réponse aux pandémies dont la crise actuelle a révélé les inefficacités, et à déterminer comment s’appuyer sur les instruments existants, notamment le Règlement sanitaire international (RSI). Ce document examine certaines des questions essentielles qui devraient être abordées dans un tel traité si les négociations sont lancées, en tenant compte des besoins des pays à niveaux de développement différents et des capacités disparates pour mettre en œuvre les obligations découlant du traité.
Velásquez, Germán: Vacunas, medicamentos y patentes. COVID-19 y la necesidad de una organización internacional. Vacunas covid-19: entre la ética, la salud y la economía. Desarrollo de la vacuna COVID-19; la inmunidad y el contagio; el nacionalismo de las vacunas; el mecanismo COVAX; licencias obligatorias; Acceso a medicamentos y vacunas: un nuevo actor. Medicamentos y propiedad intelectual: diez años de la estrategia mundial de la oms. Repensando la fabricación mundial y local de productos médicos tras el covid-19. Repensando la i+d para productos farmacéuticos después del covid-19. Propiedad intelectual y acceso a medicamentos y vacunas. Las reformas de la organización mundial de la salud en la época de covid-19. 2021. 244 pp. ISBN 978-9915-650-31-9.