South Centre Contribution in response to UPOV Circular E-20/246
The South Centre, as an intergovernmental observer to the UPOV Council, submits this contribution on views on the implementation of the exception of acts done privately and for non-commercial purposes in relation to smallholder farmers. The South Centre appreciates this opportunity to inform the possible development of guidance regarding the implementation of the exception of acts done privately and for non-commercial purposes in relation to smallholder farmers.
WIPO Negotiations for an International Legal Instrument on Intellectual Property and Genetic Resources
By Nirmalya Syam
Over the past few years, Member States of the World Intellectual Property Organization (WIPO) have engaged in negotiations for concluding an international legal instrument on intellectual property and genetic resources. While developing countries have a major interest in securing through this instrument a mandatory requirement for applicants of IP rights over innovations that utilize genetic resources or associated traditional knowledge to disclose their source or origin, certain developed countries that are major markets for such products are absolutely opposed to recognizing the disclosure requirement as an objective of the legal instrument under negotiation. Other developed countries are agreeable to a disclosure requirement with a narrow scope, broad exceptions, and weakened remedies against non-compliance. This Policy Brief analyses the current state of play in the negotiations considering the different positions as reflected in the draft negotiating text, as well as a proposal by the Chair of the WIPO intergovernmental committee where the negotiations are taking place, to bridge the difference and take the negotiations forward. This brief concludes that any meaningful international legal instrument on IP and GRs in WIPO must recognize the fundamental issue of misappropriation of GRs through the IP system that should be resolved through a mandatory disclosure requirement as the principal mechanism. It would also be critical to ensure that the WIPO instrument is coherent with other related international legal instruments such the Convention on Biological Diversity, the Nagoya Protocol on access and benefit-sharing; specialized instruments like the FAO Plant Treaty as well as related mechanisms or fora like the WHO (on use of pathogens as a genetic resource) and the United Nations Convention for the Law of the Sea (UNCLOS) negotiations on marine genetic resources beyond areas of national jurisdiction.
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.
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.
Guaranteeing Access to Medicines: Reforming Trade and Investment Treaties in the COVID-19 Era
Eight months into COVID-19, what is the status of the international investment regime and access to essential medicines? The GDP Center’s Working Group on Trade and Access to Medicines will host a panel discussion on trade, the investment regime, and access to essential medicines. The event is co-sponsored by the South Centre, the intergovernmental organization of developing nations based in Switzerland.
Guía para la concesión de licencias obligatorias y uso gubernamental de patentes farmacéuticas
Por Carlos M. Correa
Al igual que otros derechos, los derechos de patente no son absolutos. Hay situaciones en las que su ejercicio puede limitarse para proteger los intereses públicos. Esas situaciones pueden surgir, por ejemplo, cuando debe garantizarse el acceso a los productos farmacéuticos necesarios. Las licencias obligatorias y el uso gubernamental con fines no comerciales son instrumentos, previstos en la mayoría de las leyes de todo el mundo, que pueden utilizarse específicamente para atender las necesidades de salud pública. El presente documento tiene por objeto proporcionar orientación jurídica para el uso eficaz de esos instrumentos, de conformidad con el derecho internacional.
Designing Pro-Health Competition Policies in Developing Countries
By Vitor Henrique Pinto Ido
Competition law and policy has become an important tool for countries to promote access to pharmaceuticals. How can countries design and enforce competition policies that are suitable to the particularities of developing countries? What are the main anti-competitive tactics in the pharmaceutical sector, and how should they be dealt with? This paper deals with these issues, taking into account the socio-economic relevance of access to health products. It finds that developing countries should apply their competition laws in the pharmaceutical sector more actively, and that there is ample policy space under international law to do so. It provides an overview of the way in which competition policies have been applied in some industrialized and developing countries and explores how such policies can be designed and implemented in the context of developing countries.
Practical Implications of ‘Vaccine Nationalism’: A Short-Sighted and Risky Approach in Response to COVID-19
By Muhammad Zaheer Abbas, PhD
To end the COVID-19 pandemic and ensure a return of normalcy, an effective and safe vaccine is the best hope. The vaccine nationalism approach, adopted by some countries to gain preferential access to emerging COVID-19 vaccines, poses a threat to the fair and equitable distribution of the potential vaccines across the globe. This research paper critically evaluates the approach of vaccine nationalism and argues that this self-centred political behaviour of leaving others behind is short-sighted, potentially risky, morally indefensible, and practically inefficient in containing the pandemic. This paper highlights why it is important for national governments to support the collaborative and coordinated effort of the COVID-19 Vaccines Global Access (COVAX) facility for the timely development and efficient delivery of potential COVID-19 vaccines. It concludes that an effective response to the current health and economic crisis should be guided by values of international solidarity, multilateralism, equality, and global collaboration. It proposes the adoption of an enforceable global framework to address the concerns arising from the combination of vaccine nationalism and intellectual property exclusivities.