Need for Extension of the LDC Transition Period Under Article 66.1 of the TRIPS Agreement Until Graduation and Beyond
By Nirmalya Syam
Least developed country (LDC) Members of the World Trade Organization (WTO) have submitted a duly motivated request for the extension of the transition period under Article 66.1 of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which exempts LDCs from implementing the obligations for protection and enforcement of intellectual property rights under the Agreement, in view of their vulnerabilities, special needs, economic, administrative and financial constraints, and the need for a sound and viable technological base. This request, submitted prior to the expiry of the current transition period on 1 July 2021, seeks a further extension for as long as those Members remain LDCs, and also for an additional period of 12 years after their graduation. This request is legitimate in view of the varied challenges that LDCs face, which have been aggravated through the reversal of development gains due to the public health and economic impact of the COVID-19 pandemic. These vulnerabilities will also continue to afflict the LDCs even after graduation, as recognized in several reports by different United Nations (UN) agencies as well as resolutions of the UN General Assembly. Therefore, WTO Members must display political will and translate global solidarity pledges into action and unconditionally support the request for extension of the transition period for LDCs under the TRIPS Agreement.
Guía para la concesión de licencias obligatorias y uso gubernamental de patentes farmacéuticas
Por Carlos M. Correa
Al igual que otros derechos, los derechos de patente no son absolutos. Hay situaciones en las que su ejercicio puede limitarse para proteger los intereses públicos. Esas situaciones pueden surgir, por ejemplo, cuando debe garantizarse el acceso a los productos farmacéuticos necesarios. Las licencias obligatorias y el uso gubernamental con fines no comerciales son instrumentos, previstos en la mayoría de las leyes de todo el mundo, que pueden utilizarse específicamente para atender las necesidades de salud pública. El presente documento tiene por objeto proporcionar orientación jurídica para el uso eficaz de esos instrumentos, de conformidad con el derecho internacional.
Modulos de Introduccion a la Propiedad Intelectual y Salud Pública
Descripción:
Este libro contiene cuatro módulos para la capacitación en materia de propiedad intelectual y salud pública. Su objetivo es presentar una introducción a las diversas categorías de derechos de propiedad intelectual y, en particular, ilustrar sobre los derechos aplicables a la producción y comercialización de medicamentos en el marco de las llamadas ‘flexibilidades’ contenidas en el Acuerdo sobre los Aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio de la Organización Mundial del Comercio. Los módulos proporcionan elementos para comprender el alcance y las implicaciones de los derechos de propiedad intelectual, especialmente las patentes de invención, en el acceso a los medicamentos. Ellos brindan asimismo pautas para el diseño y la aplicación de esos derechos en una manera consistente con dicho Acuerdo y con políticas de protección de la salud pública. Los módulos contienen información general y enfoques prácticos para orientar a los encargados de formular y aplicar políticas públicas en el tratamiento del tema, tanto en el campo administrativo como judicial.
Responsible Investment for Development and Human Rights: Assessing Different Mechanisms to face Possible Investor-State Disputes from COVID-19 Related Measures
Developing and least developed countries (LDCs), particularly in Africa, are especially vulnerable to the unfolding effects of the COVID-19 pandemic. According to UNCTAD, foreign direct investment flows will drop drastically up to 40% during 2020-2021. A number of developed and developing countries, including LDCs, have introduced a number of measures aimed at limiting the effects of the pandemic, protecting domestic industries for strategic sectors (e.g. health industry, energy sector, telecommunication, food production, etc.), and safeguarding the real economy, particularly by offering bonds or bailouts for companies and the public in general.
Law firms and risk managers are already advising foreign investors about the possibility of initiating investor-State dispute settlement (ISDS) claims against host States on the grounds of the alleged breach of their investors’ rights, based on provisions such as : (i) full protection and security; (ii) fair and equitable treatment; (iii) national treatment and most-favoured nation treatment; and (iv) unlawful expropriation.
Pathways for leapfrogging to reconcile development and climate change imperatives in Africa
By Smail Khennas and Youba Sokona
A just energy transition toward low carbon emissions pathways is increasingly a priority not only to cope with the adverse impacts of climate change but also for achieving more sustainable economic and social development of the African continent. Fortunately, to optimize its energy mix for development according to sustainability criteria, Africa can take advantage of a rapid energy transition, thanks to its huge and largely untapped renewable energy potential and its abundance of a less polluting fossil fuel, namely, natural gas. Moreover, the fact that most of the infrastructure for energy systems in Africa is not yet built, particularly in sub-Saharan countries, offers these countries a good opportunity for leapfrogging. This Policy Brief explores guiding principles and pathways for a low carbon energy transition, including leapfrogging opportunities, energy system design and social innovation.
Intellectual Property, Innovation and Access to Health Products for COVID-19: A Review of Measures Taken by Different Countries
By Nirmalya Syam
The rising incidence of COVID-19 will require all countries, particularly developing and least developed countries, to be able to procure and manufacture the products required for the diagnosis, prevention and treatment of COVID-19. Intellectual property (IP) rights over such products can constrain the ability of countries to rapidly procure and produce and supply the products required at a mass scale. This Policy Brief describes the measures and actions taken by different countries to address potential IP barriers to access to the products required for COVID-19. A number of countries, both developed and developing, have adopted measures to enable governments to take action to overcome IP barriers in case they constrain access to the products required for COVID-19. In addition to these measures, the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) also allows considerable flexibility to adopt a number of other possible measures which can be considered by developing countries where necessary.
The COVID-19 Pandemic: Intellectual Property Management for Access to Diagnostics, Medicines and Vaccines
Developing countries and LDCs in particular in Africa are especially vulnerable to the unfolding effects of the COVID-19 pandemic. A priority area for global collaboration is to ensure that diagnostics, vaccines and medicines are made available, affordable and accessible worldwide. There is currently no vaccine and no proven safe and effective direct therapy for COVID-19. There is also the need to accelerate testing capacity and tools in developing countries and LDCs with increased access to low-cost diagnostics. The approach to the management of intellectual property rights by research institutions, pharmaceutical and biotech companies and R&D funders will decisively affect availability and access, as well as the transfer of technology and know-how. Governments must ensure that they have legislative and procedural frameworks in place to enable them to over-come, consistently with the TRIPS Agreement, any patent, data exclusivity and trade secret barriers to procure and produce COVID-19 diagnostics, vaccines, medicines and other therapeutics.
La pandemia de COVID-19: el fomento de la I+D y la gestión de la propiedad intelectual para acceder a diagnósticos, medicamentos y vacunas
PorViviana Muñoz Tellez
La rápida difusión actual de COVID-19 está poniendo a prueba la capacidad de los gobiernos y de la Organización Mun-dial de la Salud (OMS) para poner en marcha una respuesta mundial coordinada a la pandemia. Los países en desarrollo y los países menos adelantados (PMA), en particular los de África, son particularmente vulnerables a los efectos de la crisis de salud pública. Una esfera prioritaria para la colaboración mundial es el fomento de la investigación y el desar-rollo de vacunas y medicamentos que estén disponibles, sean asequibles y accesibles en todo el mundo. En la actualidad no existe una vacuna ni una terapia directa segura y eficaz probada para COVID-19. También es necesario acelerar la capacidad y los instrumentos de ensayo en los países en desarrollo y los países menos adelantados con un mayor acceso a diagnósticos de bajo costo. El enfoque de la gestión de los derechos de propiedad intelectual por parte de las instituci-ones de investigación, las empresas farmacéuticas y biotecnológicas y las entidades de financiación de la investigación y el desarrollo afectará de manera decisiva a la disponibilidad y el acceso, así como a la transferencia de tecnología y conocimientos técnicos. Los gobiernos deben asegurarse de que disponen de marcos legislativos y de procedimiento que les permitan superar cualquier barrera de patentes, de exclusividad de datos y de secretos comerciales para adquirir y producir diagnósticos, vacunas, medicamentos y otros productos terapéuticos de COVID-19.
La pandémie de COVID-19 : R&D et gestion de la propriété intellectuelle pour l’accès aux tests diagnostiques, aux médicaments et aux vaccins
Par Viviana Muñoz Tellez
La propagation rapide actuelle du COVID-19 met à l’épreuve la capacité des gouvernements et celle de l’Organisation mondiale de la santé (OMS) à apporter une réponse mondiale coordonnée à la pandémie. Les pays en développement et les pays les moins avancés (PMA), en particulier en Afrique, sont particulièrement vulnérables aux effets de la crise de santé publique. Un domaine prioritaire de collaboration mondiale consiste à faire progresser la recherche et le développement (R&D) de vaccins et de médicaments qui soient disponibles, abordables et accessibles dans le monde entier. Il n’existe actuellement aucun vaccin et aucune thérapie directe pour COVID-19 dont l’innocuité et l’efficacité ont été prouvées. Il est également nécessaire d’accélérer les capacités et les outils d’essai dans les pays en développement et les PMA en leur donnant un accès accru à des diagnostics peu coûteux. L’approche de la gestion des droits de propriété intellectuelle par les institutions de recherche, les entreprises pharmaceutiques et biotechnologiques et les organismes de financement de la R&D aura une incidence décisive sur la disponibilité et l’accès, ainsi que sur le transfert de technologie et de savoir-faire. Les gouvernements doivent s’assurer qu’ils disposent de cadres législatifs et procéduraux leur permettant de surmonter les obstacles liés aux brevets, à l’exclusivité des données et aux secrets commerciaux afin de se procurer et de produire des diagnostics, des vaccins, des médicaments et d’autres produits thérapeutiques pour le COVID-19.
COVID-19 and WTO: Debunking Developed Countries’ Narratives on Trade Measures
By Aileen Kwa, Fernando Rosales and Peter Lunenborg
In response to the COVID-19 pandemic, developing countries at the World Trade Organization (WTO) are faced with demands to i) permanently liberalize their markets in health products, and also in agriculture; ii) ban export restrictions in agriculture; and iii) conclude new digital trade rules including liberalizing online payment systems, and agreeing to free data flows. There seems to be a confusion between short-term and long-term responses. For the short-term, governments must take measures needed to address the crisis, including liberalizing needed health products. However, permanently bringing tariffs to zero for the health and agricultural sectors will not support developing countries to build domestic industries. Export restrictions in agriculture cannot be given up. They can be a very important tool for stabilizing domestic prices and for food security. New digital trade rules at the WTO would foreclose the possibility for countries to impose data sovereignty regulations, including data localization requirements that can support their infant digital platforms and industries.
Non-Violation and Situation Complaints under the TRIPS Agreement: Implications for Developing Countries
By Nirmalya Syam
While the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provided for the applicability of non-violation and situation complaints to the settlement of disputes in the area of intellectual property (IP), when the World Trade Organization (WTO) agreements were adopted in 1994, a moratorium was put in place until WTO Members could agree on the scope and modalities for the application of such complaints. However, for more than two decades, discussions in the TRIPS Council on the subject have remained inconclusive. The biannual WTO Ministerial Conference has granted extensions of the moratorium with regularity. This paper reviews the debate on the applicability of non-violation and situation complaints under the TRIPS Agreement, including the arguments consistently held by two WTO Members that if the moratorium is not extended by consensus, non-violation and situation complaints would become automatically applicable. This paper argues that a consensus decision by the WTO Ministerial Conference is required to determine the scope and modalities and, hence, the applicability of such complaints under the TRIPS Agreement. Even if the moratorium was not extended, the WTO Ministerial Conference should still adopt a decision calling on the TRIPS Council to continue examination of the scope and modalities of such complaints. It also argues that in the absence of an extension of the moratorium on initiating such complaints—and although they would not be applicable—a situation of uncertainty would be created that may lead to a de facto limitation in the use of flexibilities allowed under the TRIPS Agreement.
Guide for the Granting of Compulsory Licenses and Government Use of Pharmaceutical Patents
By Dr. Carlos M. Correa
Like other rights, patent rights are not absolute. There are situations in which their exercise can be limited to protect public interests. Such situations may arise, for instance, when access to needed pharmaceutical products must be ensured. Compulsory licenses and government use for non-commercial purposes are tools, provided for under most laws worldwide, that can specifically be used to address public health needs. This document is intended to provide legal guidance for the effective use of such tools, consistently with the international law.
