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.
The UNFCCC Virtual Regional Workshops on Gender and Climate Change 2020
By Mariama Williams
In the last week of November 2020, the United Nations Framework Convention on Climate Change (UNFCCC)’s Gender and Climate Team presented its hallmark Global Gender Event as part of the virtual United Nations (UN) Climate Dialogues 2020 (Climate Dialogues). The Climate Dialogues provided “a platform for Parties and other stakeholders to showcase progress made in 2020 and exchange views and ideas across the subsidiary bodies and COP agendas mandated for 2020”. They were held in lieu of the annual meeting of the Conference of the Parties (COP) previously slated to take place in the United Kingdom in December 2020. The virtual Global Gender Event held on November 26, 2020 occurred in two parts. Part 1, Acting on the gender and climate GAP: progress and reflections highlighted progress and reflections made at the regional workshops on gender and climate change held by the Gender team earlier in the year. Part 2, Women for Results: showcasing women’s leadership on climate change showcased women’s leadership on climate change including the five winning projects of the 2020 UN Global Climate Action Awards.
Les réformes de l’Organisation mondiale de la Santé a l’époque de COVID-19
Par Germán Velásquez
Tout au long de ses 70 ans d’histoire, l’OMS a connu plusieurs réformes dirigées par plusieurs Directeurs généraux, tels que Halfdan Mahler à la Conférence d’Almaty sur les soins de santé primaires, en 1978, Gro Harlem Brundtland avec son appel à « tendre la main au secteur privé », en 1998, et Margaret Chan avec son débat inachevé sur le rôle des «acteurs non étatiques », en 2012. Une fois de plus, la crise sanitaire de 2020 a mis en évidence la fragilité de l’organisation et a révélé que l’OMS ne dispose pas des instruments et mécanismes juridiques nécessaires pour mettre en œuvre ses normes et lignes directrices, et que son financement n’est pas durable et adéquat pour répondre au défi de la COVID-19. Ce document cherche à identifier les principaux problèmes rencontrés par l’OMS et les mesures nécessaires qu’une réforme de l’Organisation devrait prendre.
Countries’ Policy Space to Implement Tobacco Packaging Measures in the Light of Their International Investment Obligations: Revisiting the Philip Morris v. Uruguay Case
By Alebe Linhares Mesquita and Vivian Daniele Rocha Gabriel
This Policy Brief aims to provide a concise analysis of the international investment dispute involving Philip Morris subsidiaries and the Republic of Uruguay. It depicts the main legal and political background that preceded the case, analyzes the decision reached by the arbitral tribunal, and assesses the award’s major regulatory and policy implications. It intends to contribute to the discussions on how and to what extent States can adopt tobacco control measures without violating their international obligations to protect the investment and intellectual property of tobacco companies. The main lesson that can be learned from the analysis of the Philip Morris v. Uruguay case is that investors rights are not absolute and can be relativized when there is a clash between private and public interests, such as in the case of public health. As a result, claims such as indirect expropriation and fair and equitable treatment can be dismissed. Finally, one of the main consequences is the progressive change in the design of international investment treaties, containing more provisions related to the right to regulate.
The Right to Development and its Role in International Economic Law
By Olasupo Owoeye
This paper provides a brief discussion on the right to development and examines some of the criticisms often raised against its significance as a cognizable human right. The paper argues that the principles encapsulated in the right to development represent the foundational principles of the international legal order. The right to development is therefore both a human right and an economic right. Thus, the principles it embodies are not only incorporated into the International Bill of Human Rights, they are also well reflected in World Trade Organization agreements and the field of international economic law. The paper argues that the right to development can play an important role in the interpretation and enforcement of rights under international economic law.
South Centre’s Submission to the 3rd Intersessional Meeting for Dialogue and Cooperation on Human Rights and the 2030 Agenda for Sustainable Development
Strengthening human rights for fighting inequalities and building back better
The COVID-19 pandemic has caused a global crisis without precedent in modern history. Its effects have not been felt equally among all countries as it has exacerbated the profound economic and social inequalities affecting the most vulnerable. In light of the lessons, we have learned – and are still learning – from the fight against COVID-19 pandemic, the 3rd Intersessional Meeting for Dialogue and Cooperation on Human Rights and the 2030 Agenda serves as a vital opportunity to understand the needs and realities of those who are still ‘left behind’.
Repenser la R&D pour les produits pharmaceutiques après le choc du nouveau coronavirus COVID-19
Par Dr. Germán Velásquez
La crise sanitaire mondiale sans précédent provoquée par la pandémie de coronavirus –COVID-19–, au cours du premier trimestre 2020, ramène avec une urgence particulière la discussion sur le modèle de recherche et développement (R&D) pour les produits pharmaceutiques et autres technologies de la santé. La crise COVID-19 montre qu’il est urgent de repenser la gouvernance mondiale de la santé publique pour la R&D en matière de santé. L’adoption d’un instrument contraignant – comme le permet l’article 19 de la Constitution de l’OMS – sur cette question a été proposée il y a de nombreuses années. Ce document soutient qu’il est temps de relancer et de concrétiser cette initiative.
Reconsidérations sur la fabrication mondiale et locale de produits médicaux après le COVID-19
Par Germán Velásquez
La crise sanitaire mondiale sans précédent provoquée par la pandémie de coronavirus (COVID-19), au cours du premier semestre 2020, ramène avec une urgence particulière la discussion sur la production pharmaceutique locale. La crise du COVID-19 a mis en évidence l’interdépendance de la production mondiale de médicaments—aucun pays n’étant autosuffisant. De nombreux pays industrialisés prennent la décision de rapatrier ou de développer la production d’ingrédients pharmaceutiques actifs (IPA). De nombreux gouvernements commencent à parler de souveraineté pharmaceutique et/ou de sécurité sanitaire. Si cela devient une réalité, les pays en développement devront développer et/ou renforcer la production locale de médicaments et de vaccins. La guerre pour obtenir le futur vaccin pour COVID-19 ne semble pas facile avec ces nouveaux développements.
Revisiting the Question of Extending the Limits of Protection of Pharmaceutical Patents and Data Outside the EU – The Need to Rebalance
By Daniel Opoku Acquah
The European Union (EU) has instituted internal and external measures aimed at protecting and enforcing intellectual property rights. In the area of pharmaceutical patents, the Union has also sought to protect its industries through patent term extension and data exclusivity. Recent EU free trade agreements (FTAs) with developing countries contain chapters on intellectual property that extend patent terms and data exclusivity for pharmaceutical products. Such acts further prolong the lifespan of protection given to existing products and limit generic market entry. I identify the issue as one of “cross-pollination” of laws and argue that since similar laws exist in the internal regime of the EU, incorporating them into the EU would not be too technically difficult. However, to the extent that this regime is simulated in developing countries, implementation would damage the health sectors and economies of these countries. I therefore propose that developing countries should not be forced to adopt such laws through FTAs. If they are forced to adopt the laws after all, there should be a compulsory inclusion of (1) a clause on transitional arrangements for developing countries specific to intellectual property; (2) a clause that clearly links the objectives for intellectual property protection and enforcement (in this context, patent term extension and data exclusivity) to balance the promotion of technological innovation with access to medicines; and (3) a clause on Bolar exemption and a manufacturing waiver.
How Civil Society Action can Contribute to Combating Antimicrobial Resistance
By Mirza Alas Portillo
One of the key groups of actors that must be recognized for their influential role in shaping health policy outcomes are civil society organizations (CSOs). The antimicrobial resistance (AMR) space is no exception. AMR is one of the most significant health threats of our time, and many CSOs have had a critical role in shaping the national, regional and global responses to this health threat. However, CSOs working in the AMR space have received little financial support. In the final report submitted to the UN Secretary-General, the United Nations Inter-Agency Coordination Group (IACG) on AMR recommended increasing collaboration, as doing so is necessary for effective action and is an essential part of tackling AMR. IACG also provided specific recommendations for strengthening the engagement of CSOs. While the need for this engagement is broadly recognized, there is limited literature documenting how CSOs have been involved in shaping AMR policies. Increased evidence can strengthen the case for expanding financial support to CSOs work on AMR. A critical look into how CSOs are spearheading campaigns to tackle AMR and promoting accountability through monitoring governments’, international organizations’ and other actors’ AMR-related commitments, particularly in developing countries, would be especially useful.
This paper aims to contribute to the analysis of CSOs involvement in the global AMR response. It begins by defining what constitutes a CSO and offers examples of how CSOs have contributed to addressing other critical health issues to draw lessons for handling AMR. It then undertakes a case analysis of a prominent CSO coalition, the Antibiotic Resistance Coalition (ARC), and describes that organization’s essential contributions in the AMR space. Finally, the paper offers reflections on why CSO participation in the AMR space needs to be further enhanced and supported.
