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.
Los retos de futuras pandemias
Entre la política y la ciencia
¿Hacia dónde va la salud mundial?
Descripción:
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
Les défis des futures pandémies
Enjeux politiques et négociations internationales
Details:
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.
AMR in Aquaculture: Enhancing Indian Shrimp Exports through Sustainable Practices and Reduced Antimicrobial Usage
By Robin Paul
This study on Antimicrobial Resistance (AMR) in Indian shrimp farming underscores its critical impact on public health, environmental sustainability, and economic viability. The global scenario with many export rejections on account of persistent residues of antibiotics, reiterate that antimicrobial use in aquaculture, demands urgent global attention.
In the Indian context, the shrimp industry grapples with a delicate balance between production demands and long-term shrimp health. Sustainable practices, including responsible antimicrobial use, are crucial for economic viability, given the industry’s reliance on specific markets like the United States, EU and China.
Sustainable aquaculture emerges as a pivotal solution, supported by government policies and a gradual industry shift towards best practices. However, challenges persist, requiring a comprehensive approach to balance economic interests with environmental conservation. The key challenges remain the large number of small stakeholders and huge geographical spread of farms which make implementation of regulations and sharing of best practices difficult. Traceability and certification programs can play a key role in promoting responsible aquaculture, ensuring transparency and accountability in the supply chain. Technological innovations, including block chain can offer efficient solutions for traceability.
The collaborative action suggested emphasizes the role of government bodies, regulatory agencies, industry players, researchers, and consumers in addressing AMR. Clearer implementable regulatory frameworks aligned with economic and environmental priorities are essential. Looking ahead, the study envisions a future where the blue economy is sustainable not just for the industry’s success but also to protect the wider environment. By enhancing domestic market presence and fostering collaboration with importing countries, the Indian industry can overcome the multiple challenges raised by AMR in shrimp aquaculture.
Equity and Pandemic Preparedness: Navigating the 2024 Amendments to the International Health Regulations
By Nirmalya Syam
The amendments to the International Health Regulations (2005) (IHR) agreed upon in May 2024 are important for strengthening global health emergency preparedness and response. The negotiations resulted in the IHR amendment now recognizing the importance of equity, including equitable access to health products, enhancing IHR core capacities, and mobilizing financing. The amendments note the role of the World Health Organization (WHO) in facilitating timely access to necessary health products by removing barriers and supporting local production and distribution. However, the WHO authority to effectively act in those areas is limited. The IHR as amended will establish a Coordinating Financial Mechanism to provide predictable and sustainable financing for its implementation, particularly in developing countries.
Despite some advancements, the amendments fall short of imposing concrete obligations on developed countries to facilitate timely access to health products and financial support and transfer of technology to developing countries. Overall, the amended IHR represent a significant step toward a more equitable global health framework, setting a precedent for future international health instruments, including the proposed pandemic treaty.
Lessons for the Global South from U.S. Legislation on Patent Thickets
By Nirmalya Syam
The US Senate’s passage of the Affordable Prescription for Patients Act (S-150) targets patent thickets, strategic barriers used by pharmaceutical companies to delay the entry of biosimilar drugs and maintain high prices. This US legislative act offers valuable lessons for the Global South, where similar reforms can strengthen patent review processes, encourage competition, and utilize TRIPS flexibilities to improve access to affordable medicines, fostering a more equitable healthcare system.
The Vaccine Industry After the COVID-19 Pandemic: An International Perspective
By Felix Lobo
The purpose of this report is to analyze the impact that the COVID-19 pandemic has had on the vaccine industry from an international perspective. The objective is to learn from the experience and contribute to the design of better tools for future vaccine development and manufacturing, as we must be prepared for future emerging infectious diseases with the potential for global expansion. This industry makes fundamental contributions to global social welfare, but from a business point of view it is complex and difficult to manage, and from an economic point of view it is an industry that does not fit the paradigm of competitive market efficiency with notorious market failures.
We examine the impact of the pandemic on innovation and the scientific, technological and industrial development of vaccines and find that certain elements of the industry’s structure have changed, while others have remained. We also summarize the lessons learned from the deployment of some public policies to boost supply and drive demand, paying particular attention to the inequity in the global distribution of vaccines and to the COVAX program. We conclude that some of the policies have been very effective, while others have not fully achieved their objectives. From the achievements and limitations, lessons can be drawn for the reformulation and expansion of global public policies that would stimulate R&D, manufacturing, distribution and access.
