Mise en œuvre d’une dérogation ADPIC pour les technologies et produits de santé pour la COVID-19: prévenir les réclamations dans le cadre des accords de libre-échange et d’investissement
Par Carlos M. Correa, Nirmalya Syam et Daniel Uribe
Bien que le soutien croissant des membres de l’OMC pour une proposition de dérogation à certaines obligations de l’Accord sur les ADPIC concernant les produits de santé nécessaires pour répondre à la pandémie COVID-19 ait rendu imminente une décision sur la dérogation ADPIC, celle-ci devra être mise en œuvre au niveau national par les membres de l’OMC par le biais de mesures législatives, administratives ou judiciaires appropriées, y compris par le biais de décrets qui ont été utilisés pour mettre en œuvre des mesures d’urgence dans le contexte de la pandémie COVID-19. À cet égard, la portée de la dérogation ADPIC, ainsi que les termes des accords de libre-échange (ALE) et des accords internationaux d’investissement (AII) applicables, auront également un impact sur la marge de manœuvre dont disposent les pays pour mettre en œuvre la dérogation. Il sera essentiel de garantir un large champ d’application de la dérogation, ainsi que des mesures complémentaires pour protéger la mise en œuvre de la dérogation contre d’éventuelles contestations dans le cadre des ALE ou des AII. Ce document de recherche examine certaines options qui pourraient être explorées pour permettre la mise en œuvre de la dérogation ADPIC en surmontant les obstacles qui pourraient survenir dans le cadre de tels accords.
Strengthening WHO for Future Health Emergencies while Battling COVID-19: Major Outcomes of the 2021 World Health Assembly
By Nirmalya Syam and Mirza Alas
The 74th World Health Assembly of the World Health Organization (WHO) took place in May 2021 in a time when developing countries had to confront a substantial surge in COVID-19 infections and fatalities, while continuing to face inadequate access to vaccines. Meanwhile, the majority of the global supplies were secured by a few rich countries, ignoring the pleas of the WHO Secretariat. However, even though discussions around the COVID-19 response and strengthening emergency preparedness and response dominated the Assembly, WHO Member States could not achieve any concrete outcome to addressing the question of equitable access to vaccines and other health technologies for COVID-19. In this context, this policy brief describes some of the major outcomes of the Assembly.
Del SIDA al COVID-19: La OMS ante las crisis sanitarias globales
Por Germán Velásquez
Este documento de investigación es una compilación de artículos de Germán Velásquez publicados por el “Monde Diplomatique” (ediciones francesa y española) entre el 2003 y el 2021. El autor analiza como la OMS enfrentó las grandes crisis sanitarias de los últimos 20 años. El SIDA y la llegada de los primeros antiretrovirales, la gripe H1N1 con el despilfarro del Oseltamivir (nombre de marca “Tamiflu”) y las vacunas que al final fueron destruidas en grandes cantidades, el ébola donde la OMS llegó con cuatro meses de atraso, la hepatitis C y los fármacos que podrían curarla pero fueron lanzados al mercado con precios inaccesibles y, actualmente, la pandemia devastadora del COVID-19 que ha demostrado una vez más la insoportable desigualdad en el acceso a la salud y a las vacunas y tratamientos, entre los países del Norte y los países del Sur.
El denominador común a todas estas crisis sanitarias mundiales ha sido la reacción de los países miembros de la OMS de querer reformar la Organización de tal manera que ésta pueda responder mejor a la crisis del momento. Este es exactamente el movimiento que ha desatado la COVID-19 y el tema y las negociaciones que probablemente nos ocuparán en los próximos años.
Access to Medicines and Vaccines: Implementing Flexibilities Under Intellectual Property Law
Description:
This book is an outcome of a partnership between the Max Planck Institute (MPI) for Innovation and Competition and the South Centre, which jointly organized a Global Forum on Intellectual Property, Access to Medicine and Innovation in Munich on 9– 10 December 2019.
This book examines topics of particular relevance for shaping intellectual property regimes that take into account public health concerns. It provides not only deep analyses but options for the interpretation of existing regulations or the adoption of new legislation that, being consistent with the TRIPS Agreement, can allow the judiciary and policy makers to take such concerns into account. In different chapters, the book addresses various dimensions of the flexibilities allowed under the TRIPS Agreement. Although there is a significant literature and statements on the subject, such as the ‘Declaration on Patent Protection. Regulatory Sovereignty under TRIPS’ elaborated under the auspices of the MPI, the book contains new reflections and examines recent developments in case law and legislation.
The covered issues include how the TRIPS Agreement can be interpreted to implement its flexibilities, the use of competition law to promote access to medicines, the role of cooperation in the examination of patent applications, patentability requirements, the impact of TRIPS plus provisions (such as the linkage between patents and drug regulatory approvals), the patentability in the area of CRISPR genome editing technologies, as well as an analysis of the scope of exceptions and limitations to exclusive rights provided for by the Agreement, such as the exhaustion of rights and parallel imports, compulsory licenses, the ‘Bolar exemption’, and procedural mechanisms like pre-grant oppositions. The implications of the protection of test data are also examined.
While celebrating the opportunity of working together in organizing the Global Forum, we hope that this book will assist policy makers and judges and provide new inputs for academic research. While, as mentioned, there is a differentiated impact of intellectual property rights depending on the level of development of the country where it applies, the reconciliation of such rights with public health interests, particularly in relation to access to medicines, is a matter of concern for all countries.
The International Treaty on Plant Genetic Resources for Food and Agriculture: Saving, Sharing and Taking Care of the Plants and Seeds that Feed the World
By Dr. Kent Nnadozie
This Policy Brief provides an introduction to the International Treaty on Plant Genetic Resources for Food and Agriculture and its contribution to conserve, sustainably use and fairly and equitably share the benefits of plant genetic resources for food and agriculture, for sustainable agriculture and food security. The brief also provides an update on the involvement of the ITPGRFA in the prevailing issues under discussion in various biodiversity-related fora, including ongoing negotiations for a Post-2020 Global Biodiversity Framework, and response to the COVID-19 global pandemic.
Governing Seed for Food Production: The International Treaty on Plant Genetic Resources for Food and Agriculture
By Nina Isabella Moeller
Plant genetic resources for food and agriculture (PGRFA) are part of the foundation of agriculture and of central importance to food sovereignty. These gain an increasingly pivotal role in the context of climate crises, which are threatening predictable crop production, and the erosion of agricultural biodiversity. The main instrument for the governance of PGRFA is the International Treaty on Plant Genetic Resources for Food and Agriculture. Strengthening the Treaty is crucial. The Treaty establishes a binding international framework for the conservation and sustainable use of plant genetic resources for food and agriculture, and the fair and equitable sharing of the benefits arising from their use. Since 2013, negotiations have been underway to enhance the functioning of the Multilateral System of Access and Benefit-sharing. Current informal consultations may pave the way for constructive negotiations at the next Governing Body meeting in May 2022.
Compulsory licensing vs. the IP waiver: what is the best way to end the COVID-19 pandemic?
By Olga Gurgula
This policy brief examines the currently discussed proposals at the World Trade Organization (WTO) that aim to resolve the problem of the production shortages of COVID-19 vaccines. This includes the two key submissions, i.e. the proposal by South Africa and India on the Intellectual Property (IP) waiver, partially supported by the United States (US), and the European Union (EU) proposal to clarify the use of compulsory licensing. While each of these mechanisms may help to improve the production of COVID-19 vaccines to various degrees, there is intense debate about which of these proposals is the most effective. This policy brief outlines the strengths and weaknesses of each of them with a view to informing the policy decisions by WTO Members on the best way to promptly accelerate the vaccine production that is urgently needed today. It concludes that the proposed IP waiver is a more effective solution for addressing the current emergency.
Beyond Corporate Social Responsibility: Strengthening Human Rights Due Diligence through the Legally Binding Instrument on Business and Human Rights
by Daniel Uribe Terán
The discussion on the need for mandatory human rights due diligence (HRDD) requirements has permeated the interests of policy makers, civil society organizations and international organizations. The current trend on the adoption of domestic legislation concerning HRDD standards shows a variety of options and models that might serve as a step forward to the adoption of a strong international framework of corporate accountability and remedy for human rights violations in the context of business activities.
This research paper aims at identifying the elements that characterize human rights due diligence to find a possible common definition for its implementation. It does so through analysing current regional and State practice in the adoption of mandatory HRDD legislation in different sectors. Finally, it will discuss the principles that characterize the approach taken by the United Nations Open-ended Intergovernmental Working Group in charge of adopting a Legally Binding Instrument on transnational corporations and other business enterprises and how it could serve as an important cornerstone for modern rule making on the issue of business and human rights.
The Post COVID-19 Recovery: A Stringent Test for the Business and Human Rights Discourse
By H.E. Ambassador Luis Benigno Gallegos Chiriboga
Although the global economic outlook seems to be improving for the rest of 2021 and 2022, such benefits seem to only affect developed economies, while furthering the gap with emerging markets and developing economies. This shows that ‘recovery for all’ will remain gloomy for several years, as access to the COVID-19 vaccine continues to showcase the global inequalities between the rich and the poor. In this scenario, States require to make full use of their regulatory and policy space to protect and promote the human rights of all people and persons in their jurisdictions, including the right to health, while safeguarding the necessary fiscal space towards guaranteeing development expenditures to build back fairer and better. It is time for reducing inequalities rather than increasing the gap between developed and developing nations.
South Centre Statement to the 7th Session of the Open Ended Intergovernmental Working Group on transnational corporations and other business enterprises with respect to human rights
The South Centre, as the intergovernmental organization of developing countries, has keenly followed the evolution of the process towards the adoption of a Legally Binding Instrument on transnational corporations and other business enterprises since its inception and over the various sessions of this Working Group.
We welcome the strengthening of the text of the draft LBI with contributions of State delegations and civil society organisations, particularly from the Global South. The third revised draft of the LBI being discussed this week reflects many of the comments and textual suggestions made in the previous sessions of the Working Group and streamlines the provisions for their effective implementation. The process now moves into a very important phase with State-led direct substantive intergovernmental negotiations and raises hopes for the adoption of the LBI in the near future.
Carving Out a Role for Human Rights in International Investment Law
by Barnali Choudhury
The public health burdens that have been imposed on governments by Covid-19 serve as an important reminder of the importance for states to be able to regulate public health as well as other human rights issues. Commentators are already describing the myriad of investment arbitration claims that states may expect to face for their acts in handling the Covid-19 crisis. By carving out a role for human rights in international investment law, states can ensure that protection of human dignity, not property interests, will continue to be their ultimate objective.
Uso Público No Comercial y Licencias Obligatorias en América Latina: Estado de Situación
Descripción:
Este libro examina cómo han sido regulados en el derecho latinoamericano el uso público no comercial y las licencias obligatorias de patentes de invención, una de las importantes flexibilidades en el marco del acuerdo sobre propiedad intelectual de la Organización Mundial de Comercio. Igualmente, indaga y compendia las experiencias registradas en cuanto al uso efectivo de esos instrumentos, el que no se agota en el ámbito de la salud pública, si bien han sido especialmente utilizados tanto por países desarrollados como en desarrollo para facilitar el acceso a medicamentos, incluso en el contexto de la pandemia del COVID-19.
Autor: Guillermo Vidaurreta es Abogado de la Universidad de Buenos Aires, Magister en Propiedad Intelectual por FLACSO – Argentina. Profesor de la Universidad de Buenos Aires y FLACSO – Argentina. Investigador principal y subdirector del Centro de Estudios Interdisciplinarios de Derecho Industrial y Económico de la Facultad de Derecho de la UBA (CEIDIE).
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