Experiencias internacionales sobre la concesión de licencias obligatorias por razones de salud pública
Por Catalina de la Puente, Gastón Palopoli, Constanza Silvestrini, Juan Correa
El presente estudio tiene como objetivo analizar los regímenes de licencias obligatorias (LOs) en países seleccionados, en particular los elementos económicos de la concesión de las LOs, la determinación y negociación de regalías al titular del derecho. Para ello se realizó un análisis descriptivo y exploratorio de experiencias de concesión de LO en países seleccionados, con foco en las experiencias de los países en vías de desarrollo por su proximidad al caso argentino.
En particular se discuten los ejemplos de experiencias de emisión de medidas de LOs o de UG en países en vías de desarrollo. Con especial foco en Latinoamérica, donde sólo dos países han hecho uso de dichas medidas por razones sanitarias (Ecuador y Brasil). Además se examina la eficacia del empleo de LO o de UG en la reducción de precios donde se evidencian ahorros significativos Como conclusión se propone elaborar una metodología en relación a las regalías para Argentina mediante un rango de pago que tome en consideración criterios de accesibilidad y asequibilidad poblacional a la tecnología licenciada, así como la sustentabilidad de los presupuestos de los agentes financiadores.
The WTO TRIPS Decision on COVID-19 Vaccines: What is Needed to Implement it?
By Carlos M. Correa and Nirmalya Syam
The 12th WTO Ministerial Conference adopted a Ministerial Decision on the TRIPS Agreement on 17 June 2022. This partially concluded almost two years of protracted discussions in response to a proposal by India and South Africa for a waiver from certain obligations under the TRIPS Agreement for health products and technologies for the prevention, treatment and containment of COVID-19. The adopted Decision only waives the obligation under article 31 (f) of the TRIPS Agreement. Developing country WTO members are now allowed to export any proportion of vaccines, including ingredients and processes, necessary for the COVID-19 pandemic that are manufactured under a compulsory license or government use authorization to other developing countries. It also contains some clarifications of relevant TRIPS provisions, while introducing a number of conditionalities that are not present in the TRIPS Agreement. This paper examines the object and scope of the Decision, the requirements established for its use, and the required actions to be taken by WTO members to implement it.
Utilising Public Health Flexibilities in the Era of COVID-19: An Analysis of Intellectual Property Regulation in the OAPI and MENA Regions
By Yousuf A Vawda and Bonginkosi Shozi
The paper explores the unique approaches to IP protection in the countries belonging to the Organisation Africaine de la Propriété Intellectuelle/African Intellectual Property Organization (OAPI) and the Middle East and North Africa (MENA) regions; the limited extent to which legal and policy frameworks with regard to TRIPS flexibilities have been adopted and implemented in pursuit of access to medicines in those countries; and makes recommendations in order to optimise the use of the flexibilities in advancing public health objectives. In the context of the COVID-19 pandemic, the impact of IP rights on access, and some approaches to countering the challenges to access are also discussed.
Interpreting the Flexibilities Under the TRIPS Agreement
By Carlos M. Correa
While the TRIPS Agreement provides for minimum standards of protection of intellectual property, it leaves a certain degree of policy space for WTO members, whether developed or developing countries, to implement the Agreement’s provisions in different manners, to legislate in areas not subject to the minimum standards under the Agreement, and to develop legal interpretations of such provisions to determine the scope and content of the applicable obligations. This paper focuses on some aspects of how panels and the Appellate Body of the WTO have interpreted said provisions. The paper also draws general conclusions for the implementation of TRIPS flexibilities, which are of crucial importance for the design of a pro-competitive intellectual property system and, in particular, for achieving public health objectives, as specifically recognized by the Doha Declaration on TRIPS and Public Health.
Scope of Compulsory License and Government Use of Patented Medicines in the Context of the COVID-19 Pandemic
To meet public health needs, such as in the current COVID-19 emergency, governments can use compulsory licenses and government use as a tool for procurement and import of patented medicines.
These mechanisms are provided for in most laws worldwide. The WTO TRIPS Agreement, as reaffirmed by the Doha Declaration on TRIPS and Public Health, recognises the right of WTO members to grant compulsory licenses and their freedom to determine the grounds upon which such licenses may be granted (read our Call for Action on Intellectual Property and Trade Measures to Address the Covid-19 Crisis here).
The South Centre offers a guide for the issuance of compulsory licenses and government use, see here, aquí en español.
The table below provides information of instances of their use.
Scope of Compulsory License and Government Use of Patented Medicines in the Context of the COVID-19 Pandemic
To meet public health needs, such as in the current COVID-19 emergency, governments can use compulsory licenses and government use as a tool for procurement and import of patented medicines.
These mechanisms are provided for in most laws worldwide. The WTO TRIPS Agreement, as reaffirmed by the Doha Declaration on TRIPS and Public Health, recognises the right of WTO members to grant compulsory licenses and their freedom to determine the grounds upon which such licenses may be granted (read our Call for Action on Intellectual Property and Trade Measures to Address the Covid-19 Crisis here).
The South Centre offers a guide for the issuance of compulsory licenses and government use, see here, aquí en español.
The table below provides information of instances of their use.
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.
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.
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.
Intellectual Property Rights and the use of Compulsory Licenses: Options for Developing Countries
By Dr. Carlos M. Correa
In view of the forthcoming review of the implementation of the TRIPS Agreement, and of a possible revision of its provisions in future WTO negotiations, it seems important that information is available to developing countries on the ways in which compulsory licenses have been provided for and used in developed and developing countries. The purpose of this paper is to provide concrete examples on how compulsory licenses have been provided for in national laws and, in particular, to illustrate the grounds and conditions on which such licenses have been granted in specific instances. The emphasis of the paper is not on the general principles relevant to the matter, but on the ways in which compulsory licenses have been actually provided for or used in order to satisfy diverse public interests. Many of the decisions pertaining to the granting of compulsory licenses in the developed countries may be useful in indicating the options available to developing countries wishing to have adequate legislation at the national level on this matter. The decisions referred to also make it clear that compulsory licensing is firmly rooted in the legal systems of developed countries, including those that seem to oppose that concept in international fora.
