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.
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.
Negotiating Health and Autonomy: Data Exclusivity, Healthcare Policies and Access to Pharmaceutical Innovations
By Henrique Zeferino De Menezes, Julia Paranhos, Ricardo Lobato Torres, Luciana Correia Borges, Daniela De Santana Falcão and Gustavo Soares Felix Lima
This paper analyzes the debate over the international dissemination of data exclusivity as a form of protection for clinical trial data. This is a critical demand for pharmaceutical companies seeking larger market shares and longer periods of monopoly in order to recover investments in research and development and greater profitability. However, this is a sensitive issue with economic and social repercussions for developing countries that adopt this protection regime. This paper highlights critical issues for the political economy of innovation and presents a review of empirical studies that show that data exclusivity delays the entry of generic drugs into the market, increasing prices and reducing access. At the same time, its adoption has no benefits because there are no positive effects on internal technological innovation, nor reduction of the “International drug lag”, nor the development of drugs for specific epidemiological demands.
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.
South Centre Statement to the Sixty-Fifth Series of Meetings of the Assemblies of the Member States of WIPO (2024)
10 July 2024
At the WIPO Assemblies 2024, the South Centre calls for rapid adherence to the WIPO Treaty on IP, Genetic Resources & Associated Traditional Knowledge, for the revision in this regard of the Patent Cooperation Treaty, for advancing the agenda on copyright L&Es and for upholding the WIPO Development Agenda.
Statement on the Amendment to the International Health Regulations
We congratulate the WHO members for the adoption of the amendments to the International Health Regulations to advance equity in access to health products, increase collaboration and finance to develop, strengthen and maintain core capacities. Efforts must continue to finalise a pandemic treaty.
What Can Cambodia Learn from Thailand and India as It Prepares to Graduate from Least Developed Country Status?
By Brigitte Tenni, Deborah Gleeson, Joel Lexchin, Phin Sovath, and Chalermsak Kittitrakul
Cambodia is expected to graduate from Least Developed Country status soon, at which time it will be required to make patents available for pharmaceutical products and processes to meet its obligations under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Given its impending transition from LDC status, there is a need to balance Cambodia’s intellectual property (IP) policies and regulations with public health priorities to ensure access to affordable life-saving medicines. This will be critical to achieving universal health coverage, one of the United Nations’ Sustainable Development Goals. This paper examines Cambodia’s IP laws and regulations to identify provisions that could reduce access to affordable generic medicines when it starts granting patents for pharmaceuticals. It systematically compares Cambodia’s IP laws and regulations with those of Thailand and India – two developing countries that have had some successes in preserving access to medicines despite the introduction of pharmaceutical patents. It identifies lessons for Cambodia from the experiences of Thailand and India in implementing TRIPS and using TRIPS flexibilities such as compulsory licensing to ensure access to a sustainable supply of affordable generic medicines. Key recommendations for reform for Cambodia include strengthening the use of preventive and remedial TRIPS flexibilities and removing criminal sanctions for patent infringements. Cambodia should reject any TRIPS-plus provisions in its patent legislation and avoid membership in bilateral or plurilateral trade agreements that include TRIPS-plus provisions as well as signing patent treaties and memorandums of understanding that may facilitate the granting of unwarranted patents.
Compulsory Licensing as a Remedy Against Excessive Pricing of Life-Saving Medicines
By Behrang Kianzad
The COVID-19 crisis intensified decade-long debates on the interaction between intellectual property rights (IPRs), competition law and access to affordable life-saving treatments and vaccines. Compulsory licensing of patented medicines is a tried-and-tested method to expand access, particularly in a situation of “national emergency or other circumstances of extreme urgency” within the meaning of Article 31(b) of the TRIPS Agreement. Some legislations, such as European competition law, offer a toolbox for curbing the exercise of IPRs if they would be found in conflict with certain competition rules, such as rules prohibiting excessive pricing by dominant undertakings. The paper analyses the interface between intellectual property law and competition law in general, moving on to the settled case law of the Court of Justice of the European Union (CJEU) on this matter. It provides a general overview of legal and economics arguments related to excessive pricing prohibition and the main case law of European competition law on the matter and discusses whether compulsory licensing as a remedy against excessive pricing of patented life-saving pharmaceutical products can be a viable and appropriate remedy. Finally, the paper offers policy recommendations relating to compulsory licensing based on excessive pricing.
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