Doha Declaration on the TRIPS Agreement and Public Health

COVID-19 Compulsory Licenses Table, March 2021

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.

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COVID-19 Compulsory Licenses Table, February 2021

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.

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Documento de Investigación 107, Diciembre 2020

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.

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Statement, October 2020

PROPOSAL BY INDIA AND SOUTH AFRICA TO WAIVE CERTAIN PROVISIONS OF THE WTO TRIPS AGREEMENT TO SUPPORT THE GLOBAL COVID-19 PANDEMIC RESPONSE

The prolongation of the coronavirus COVID-19 pandemic threatens developing countries disproportionately, deepening the catastrophic social and economic crisis and reversing the gains made to date to eradicate extreme poverty and meet the Sustainable Development Goals (SDGs). In this situation, ensuring timely access to essential commodities by overcoming acute shortages faced by countries due to high demand and disruptions in the supply chain is critical. There is also an urgent need to speed up development of new vaccines, treatments and diagnostics, at scale, and make these widely available.

As reaffirmed by many delegations in the special session of the WHO Executive Board, transfer of technology and know-how is fundamental for scaling up manufacturing of medical products and equipment. In this regard, India and South Africa have made a joint proposal to the World Trade Organization (WTO) to temporarily waive certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to support the global Covid-19 pandemic response.

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Documents de Formation 1, Août 2020

Propriété Intellectuelle et Accès aux Médicaments : Une Introduction aux Grandes Problématiques – Quelques Termes et Concepts de Base

Par Germán Velásquez

La propriété intellectuelle et les brevets en particulier sont devenus l’une des questions les plus débattues sur l’accès aux médicaments, depuis la création de l’Organisation mondiale du commerce (OMC) et l’entrée en vigueur de l’Accord sur les aspects des droits de propriété intellectuelle qui touchent au commerce (ADPIC). Les brevets ne sont nullement les seuls obstacles à l’accès aux médicaments qui sauvent des vies, mais ils peuvent jouer un rôle important, voire déterminant. Pendant la durée de protection d’un brevet, la capacité du titulaire du brevet à déterminer les prix, en l’absence de concurrence, peut faire en sorte que le médicament soit inabordable pour la majorité des personnes vivant dans les pays en développement. Ce premier numéro du “South Centre Training Papers” vise, dans sa première partie, à fournir une introduction aux questions clés dans le domaine de l’accès aux médicaments et de la propriété intellectuelle. La deuxième partie décrit et définit certains termes et concepts de base de ce domaine relativement nouveau des politiques pharmaceutiques, qui sont les aspects liés au commerce des droits de propriété intellectuelle qui régissent la recherche, le développement et la fourniture de médicaments et les technologies de la santé en général.

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Research Paper 116, August 2020

The TRIPS Agreement Article 73 Security Exceptions and the COVID-19 Pandemic

By Frederick Abbott

The COVID-19 pandemic has caused Governments to contemplate measures to override patents and other intellectual property rights (IPRs) in order to facilitate production and distribution of vaccines, treatments, diagnostics and medical devices. This paper discusses whether the COVID-19 pandemic may be considered an “emergency in international relations” and how WTO Member States may invoke Article 73 (“Security Exceptions”) of the TRIPS Agreement as the legal basis for overriding IPRs otherwise required to be made available or enforced. It concludes that the pandemic constitutes an emergency in international relations within the meaning of Article 73(b)(iii) and that this provision allows Governments to take actions necessary to protect their essential security interests.

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Book by the South Centre, 2020

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.

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SC Webinar: Reflexiones sobre la Judicialización de la Salud en America Latina

Reflexiones sobre la Judicialización de la Salud en America Latina

Cuales son las causas de la problemática de la judicialización de la salud? Que efectos provoca sobre el sistema? Se discutira esta temática a partir del análisis de jurisprudencia y regulación en Argentina, Colombia y Ecuador.

Fecha: 23 Junio 2020

Hora: 7 pm Suiza, 2 pm Argentina, 12 pm Columbia/Ecuador

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Research Paper 114, June 2020

Equitable Access to COVID-19 Related Health Technologies: A Global Priority

By Dr. Zeleke Temesgen Boru

Since COVID-19 was first identified, infections from the virus and the death toll have spiked abysmally. The pandemic has also paralyzed the economies (particularly, global trade, tourism and transport) of many countries. The dire social and psychological ramifications associated with the pandemic are also immense. The threat posed by COVID-19 on global health and the economic downturn resulting thereof necessitates the development of health technologies (such as medicines and vaccines). A global effort to invent new health technologies or the likely application of existing technologies is also underway since the outbreak of the pandemic. Even though the race to develop these technologies can be hailed as a pivotal undertaking, the development of health technologies alone may not expedite equitable access to the outcome of such development. Particularly, the lack of access to health technologies may befall if the conventional model of health technology pricing, which is derived from monopoly rights created by IP protection, is set. However, legal as well as policy tools can be used to overcome such hurdles and ensure global access to health technologies. In this sense, this paper discusses plausible legal and policy options that can help to accelerate access to health technologies targeting COVID-19.

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SouthViews No. 200, 16 June 2020

Making Covid-19 Medical Products Affordable: Voluntary Patent Pool and TRIPS Flexibilities

By Sudip Chaudhuri

The proposal of Costa Rica to create a voluntary pool mechanism for medical products and technologies for COVID-19 has evoked huge interest and optimism. The World Health Organization (WHO) and Costa Rica have followed it up through a Solidarity Call emphasizing the need for voluntary licensing on non-exclusive basis to the Medicines Patent Pool (MPP). The success of a voluntary pool critically depends on the willingness of the patentees to join the pool. In a public health crisis, boundaries of public policy must not be determined by the patentees. MPP will work much better if the patentees are compelled or induced to join the pool. International cooperation is important in this regard. Highlighting the virtues of voluntary measures and promoting MPP without adequate emphasis on the use of compulsory licensing and other TRIPS flexibilities, actually weakens the MPP. In the light of the experience of MPP, the basic objective of this paper is to analyze to what extent voluntary pool mechanisms can be relied upon to make COVID-19 medical products affordable and accessible. It is important to appreciate the achievements of MPP. But the constraints under which it operates, and its limitations must also be kept in mind.

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Policy Brief 79, June 2020

Articles 7 and 8 as the basis for interpretation of the TRIPS Agreement

By Thamara Romero

Articles 7 and 8 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) play a central role in assuring the members of the World Trade Organization (WTO) the right to implement public health measures. The Doha Declaration on the TRIPS Agreement and Public Health is also an important element for the interpretation of any provision of the TRIPS Agreement that may have public health implications. The most recent and prominent example of the use of articles 7 and 8 for interpretation in WTO law can be found in the WTO Panel decision of 2018 on the Australia – Tobacco Plain Packaging dispute.

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Documento de Investigación 112, Junio 2020

La Judicialización del Derecho a la Salud

Por Silvina Andrea Bracamonte y José Luis Cassinerio

Este trabajo examina el incremento de los conflictos judiciales en materia de salud en América Latina. La judicialización en materia de salud se ha convertido en uno de los medios habituales por los que se reclama la protección del derecho de fundamental a la salud. La intervención de la justicia produce efectos individuales positivos ya que efectivizan el reconocimiento del derecho a la salud y a la vida. También puede tener incidencia en el uso de los recursos del sistema de salud sin planificación, determinando que se atiendan demandas no prioritarias.  La judicialización en materia de salud representa un aspecto más de un problema estructural y complejo relacionado con la inequidad y desfinanciamiento de los sistemas de salud en Latinoamérica. El trabajo analiza el proyecto de creación de una Agencia de Evaluación de Tecnologías (AGNET) y sostiene que una adecuada regulación debería establecer principios que los jueces puedan utilizar a fin de que se reconozca aquel derecho fundamental dentro de una hermenéutica constitucional razonable, que a su vez resulte más equitativa y financieramente sostenible.

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