Scope of Compulsory License and Government Use of Patented Medicines
To meet public health needs 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.
This table provides information of instances of their use.
Statement of the Executive Director of the South Centre, Dr. Carlos Correa, at the NAM Health Ministers’ Meeting on the sidelines of the 78th World Health Assembly (May 19-27, 2025)
The decisions to be made at the 78th World Health Assembly will have direct implications not only for national health systems, but also for the very architecture of international cooperation in health. Read the statement by the Executive Director of the South Centre, Dr. Carlos Correa, at the NAM Health Ministers’ Meeting on the sidelines of the 78th WHA.
Leaving the WHO? The US Just Shot Itself in the Foot
By Germán Velásquez
At the start of his second term, United States president Donald Trump has again announced that the US will formally leave the World Health Organization (WHO) in 2025. Leaving the WHO is a financial blow to the Organization, as many have pointed out, but it is much more than that. Trump’s decision to abandon WHO is counterproductive and puts at risk the capacity of the organization to perform its role as the global health agency. The WHO has been central to responding to global health emergencies for more than seven decades. Its work in the fight against diseases such as smallpox, polio, Ebola and HIV/AIDS, or the binding international convention against tobacco use, has saved millions of lives.
The US’ withdrawal from WHO will have a serious impact on various aspects of global health, and the US will itself be directly affected. WHO members should unite to strengthen the WHO and counteract this decision by the current US Administration.
South Centre Statement to the Resumed Thirteenth Meeting of the Intergovernmental Negotiating Body to Draft and Negotiate a WHO Convention, Agreement or Other International Instrument of Pandemic Prevention, Preparedness and Response
7 April 2025
Negotiations resume for a WHO pandemic agreement, aiming to finalise the text in 5 days. Will Member States show the needed leadership and will to deliver an impactful outcome with equity at the core?
Strengthening Antimicrobial Stewardship Policy: Insights from COVID-19 and Future Pandemic Preparedness
South Centre Webinar
Date: 14 April 2025 Time: 12:00 PM – 1:00 PM CEST | 6:00 AM – 7:00 AM EDT | 3:30 PM – 4:30 PM IST Location: Virtual (Zoom)
In this one-hour webinar, we will explore how the COVID-19 pandemic impacted antimicrobial stewardship (AMS) programmes and what lessons can strengthen future pandemic preparedness, especially in low- and middle-income countries (LMICs).
Application de l’Exception Bolar: Différentes approches dans le droit de l’UE
Par Dmytro Doubinsky
Ce Document de recherche aborde le problème toujours plus aigu de l’accès aux médicaments essentiels, en se concentrant sur le rôle des droits de propriété intellectuelle, en particulier les droits de brevet, qui restreignent l’accès en permettant des monopoles sur le marché pharmaceutique qui maintiennent les prix des médicaments à un niveau élevé. Le document explore l’exception Bolar, un mécanisme juridique conçu pour permettre aux fabricants de médicaments génériques de demander l’approbation réglementaire avant l’expiration d’un brevet, empêchant ainsi l’extension de facto des monopoles de brevets. L’étude examine la transformation de l’exception Bolar d’un cas juridique spécifique en un instrument important en matière de droit de la propriété intellectuelle, de droit commercial et de droit pharmaceutique. Elle analyse les principaux cadres juridiques internationaux et les directives européennes relatifs à l’exception Bolar et met en évidence les interprétations divergentes de l’exception dans les jurisprudences allemande et polonaise. Grâce à cette analyse comparative, le document encourage une mise en œuvre plus large des exceptions Bolar afin d’améliorer l’accès à des médicaments abordables et de réduire les coûts des soins de santé.
Submission by the South Centre to the Office of the United Nations High Commissioner for Human Rights on Inputs for the comprehensive report on ensuring access to medicines, vaccines and other health products (HRC resolution 50/13)
January 2025
The South Centre has provided input for the OHCHR report on new developments and challenges in ensuring access to medicines, vaccines and other health products.
Application of the Bolar Exception: Different Approaches in the EU
By Dmytro Doubinsky
This Research Paper addresses the growing problem of access to essential medicines, focusing on the role of intellectual property rights, particularly patent rights, in restricting access by enabling pharmaceutical market monopolies that keep drug prices high. The paper explores the Bolar exception, a legal mechanism designed to allow generic drug manufacturers to seek regulatory approval before a patent expires, thus preventing the de facto extension of patent monopolies. The study examines the transformation of the Bolar exception from a specific legal case into a significant tool of intellectual property, commercial, and pharmaceutical law. The paper analyzes key international legal frameworks and European directives related to the Bolar exception and highlights divergent interpretations of the Exception in German and Polish case law. Through this comparative analysis, the paper argues for the broader implementation of Bolar exceptions to improve access to affordable medicines and reduce healthcare costs.
Las nuevas pandemias son inevitables. ¿Cómo podemos estar mejor preparados para ellas y, sobre todo, cómo podemos evitar los errores e injusticias cometidos durante la pandemia de COVID19? Actualmente se están llevando a cabo negociaciones para formular un tratado internacional vinculante sobre prevención y preparación que garantice respuestas más justas a futuras pandemias. Este libro pretende ser una contribución crítica a estos debates en curso.
¿Cómo garantizar un acceso equitativo a los medicamentos y diagnósticos cuando la mayoría de ellos se producen en un número reducido de países? ¿Cómo explicar que la financiación actual de la cooperación sanitaria esté en manos de un pequeño grupo de países y fundaciones del Norte? ¿Cómo reforzar el papel de la Organización Mundial de la Salud, que actualmente desempeña un papel secundario en la coordinación de las políticas de salud pública? ¿Por qué se ha sustituido el concepto de «medicamentos esenciales», gran avance de la política de salud pública, por el de «contramedidas médicas», término más acorde con el afán de lucro del sector privado?
Autor: Germán Velásquez, Asesor especial sobre políticas y salud, South Centre de Ginebra
De nouvelles pandémies sont inéluctables. Comment mieux s’y préparer et surtout comment éviter les erreurs et injustices commises durant la pandémie du Covid-19 ? Des négociations sont en cours pour formuler un traité international contraignant sur la prévention et la préparation pour des réponses plus justes aux futures pandémies. Ce livre se veut une contribution critique aux débats en cours.
Comment garantir l’accès équitable aux médicaments et diagnostics, alors que la majorité d’entre eux sont produits dans un petit nombre de pays ? Comment expliquer que le financement actuel de la coopération en matière de santé se retrouve entre les mains d’un groupe réduit de pays et fondations du Nord ? Comment renforcer le rôle de l’Organisation mondiale de la santé, qui ne joue plus qu’un rôle mineur dans la coordination des politiques de santé publique ? Comment se fait-il que le concept de « médicaments essentiels », une avancée majeure dans les politiques de santé publique, soit remplacé par celui de « contre-mesures médicales », un terme qui s’accorde plutôt à la logique de profit du secteur privé ?
La préparation aux futures pandémies nous oblige à nous interroger : comment préserver l’intérêt général, la défense des droits de l’homme et la santé publique ?
Auteur: Germán Velásquez est conseiller spécial en matière de politique et de santé au South Centre à Genève.
Webinar: Enhancing Antimicrobial Resistance Surveillance in Developing Countries
18 November 2024
Virtual event
Time: 3-4:00 PM CEST / 9-10:00 AM EDT / 7:30 – 8:30 PM IST
The South Centre will organize a webinar during the World Antimicrobial Awareness Week 2024 to highlight essential strategies and success stories in antimicrobial resistance (AMR) surveillance and stewardship across developing countries, focusing on bridging gaps in data collection and accuracy. Challenges such as limited funding, technical infrastructure, and trained personnel hinder effective AMR surveillance.
The webinar will explore cost-effective digital solutions, regional collaboration, and resource-efficient strategies to help build resilient AMR surveillance systems, enhancing sustainable antimicrobial stewardship (AMS), combating AMR, saving patient lives, and improving global public health outcomes.
The webinar will have two sessions, designed to provide practical insights and evidence-based recommendations to improve AMR surveillance, policy, and clinical practices, particularly in resource-limited settings.
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