Access to Medicines

Policy Brief 94, Setembro de 2021

O papel dos tribunais na implementação das flexibilidades do TRIPS: Supremo Tribunal Federal (STF) do Brasil declara inconstitucionais as extensões automáticas de prazos de patentes

Por Vitor Henrique Pinto Ido

Este policy brief traz uma contextualização, um resumo e uma análise da decisão do Supremo Tribunal Federal do Brasil, de 6 de maio de 2021, que declarou inconstitucionais as extensões automáticas de prazos de patentes, revogando o Artigo 40, Parágrafo Único, da Lei de Propriedade Industrial do Brasil, de 1996. Conclui-se que esta é uma decisão histórica que contribui para a implementação de um regime de patentes mais equilibrado no Brasil, com impacto positivo no acesso a medicamentos no país. É um precedente importante no que se refere ao papel que os tribunais podem desempenhar na definição dos contornos da proteção à propriedade intelectual e das flexibilidades do Acordo TRIPS.

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WTO Public Forum 2021 Working Session: The Future of the TRIPS Agreement Post COVID-19

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.

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Research Paper 134, September 2021

Restructuring the Global Vaccine Industry

By Felix Lobo

The purpose of this report is to analyse the vaccines industry under the focus of Industrial Economics as an input for the design of the pertinent instruments to promote development, manufacturing and distribution of vaccines against SARS-CoV-2 in sufficient amounts to immunize all countries as soon as possible. We also need to be prepared for future emerging infectious diseases with the potential of global expansion.

The report shows that the vaccines industry is – and has been for a long time – far away from the competitive market paradigm with notorious market failures. As a result, the industry is underperforming with shortages and stockouts, exit of firms from the industry, underinvestment in research and development (R&D) and manufacturing, even an “anaemic development pipeline”, all signs of market failure.

After a brief review of policies implemented to tackle these problems we conclude that after the COVID-19 pandemic there is a need to implement a profound overhauling of the industry and to fundamentally reformulate and extend global public policies to stimulate R&D, manufacturing, distribution and access.

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UNDP Publication on examination of patent applications relating to pharmaceuticals, June 2016

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.

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Policy Brief 100, August 2021

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.

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Book by the South Centre, 2021

Vacunas, medicamentos y patentes

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

 

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Policy Brief 99, August 2021

The TRIPS COVID-19 Waiver, Challenges for Africa and Decolonizing Intellectual Property

By Yousuf Vawda

The intellectual property (IP) regimes of African countries are a function of their colonial past, which imposed strong protections, and which have been entrenched through the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement). This has had a devastating effect on their ability to access necessary health products both before and during the current COVID-19 pandemic. It is important to reflect on the challenges that African countries face, before considering the implications of the WTO TRIPS waiver on COVID-19 (henceforth, waiver). In assessing the challenges faced by these countries, as well as the possibilities of improving access, this paper argues that while the waiver offers the best available solution to overcome the current supply shortages of a range of COVID-19 health products, in the longer term a break from this past—the decolonization of IP regimes—is necessary.

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Policy Brief 97, July 2021

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.

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Informe Sobre Políticas 96, Julio 2021

Precios justos para la cobertura sanitaria universal: El impacto de la judicialización de la salud

Por Silvina Andrea Bracamonte y José Luis Cassinerio

En el presente trabajo se describen las principales directrices y recomendaciones sobre políticas de precios para ayudar a los países a desarrollar estrategias efectivas, como herramientas para lograr el acceso equitativo a los productos sanitarios con precios asequibles, desechando el creciente fenómeno de la judicialización de la salud como vía adecuada para abordar con un enfoque sistémico esta problemática compleja.

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UN HLPF Side Event, 6 July 2021

Ensuring a Sustainable and Resilient Response to COVID-19 and Emerging Infectious Diseases through Local Production 

United Nations High-Level Political Forum 2021 Side Event

Organized by South Centre, ReAct – Action on Antibiotic Resistance and Innovation + Design Enabling Access at the Johns Hopkins Bloomberg School of Public Health

Tuesday, 6 July 2021, 7:30 AM ET

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Documento de Investigación 118, Junio 2021

Repensando la fabricación mundial y local de productos médicos tras el COVID-19  

Por Germán Velásquez

La crisis sanitaria mundial sin precedentes provocada por la pandemia del coronavirus –COVID-19, durante el primer semestre de 2020, hace que se vuelva a plantear con especial urgencia el debate sobre la producción farmacéutica local. La crisis de COVID-19 puso de manifiesto la interdependencia en la producción mundial de medicamentos, ningún país es autosuficiente. Muchos países industrializados están tomando la decisión de repatriar o desarrollar la producción de Ingredientes Farmacéuticos Activos (API). Muchos gobiernos están empezando a hablar de soberanía farmacéutica y/o seguridad sanitaria. Si esto se hace realidad, los países en desarrollo tendrán que desarrollar y/o fortalecer la producción local de medicamentos y vacunas. La guerra para obtener la futura vacuna para COVID-19 no parece fácil con estos nuevos desarrollos. 

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