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.
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.
Access to Covid-19 Vaccines, Medicines and Diagnostics: Voluntary and Compulsory Licenses, TRIPS Waiver
The South Centre and Médecins Sans Frontières Access Campaign organized a Webinar on 7 December at 2.00p.m. CET on patent licensing in the context of the COVID-19 pandemic.
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.
The COVID-19 pandemic has revealed that, despite the magnitude of the global health challenges it has to face, the WHO is currently unable to fully enforce its directives, norms and standards. It also shows that its funding is neither sustainable nor adequate to respond effectively to current and future global health crises. Overreliance on voluntary targeted funding puts at risk its capacity to operate as the global agency responsible for public health. These are some of the main challenges facing the WHO today.
Creative imitation at the front of pharma biotechnology opportunities: some lessons from late late industrialization countries
By Pablo Lavarello and Sebastián Sztulwark
Given that high-cost biopharmaceutical drug patents have started to expire since the early 2000s, biotechnology opens up opportunities for developing countries to pursue an upgrading process by entering the sector as early imitators. Developing these opportunities was transformed on priority needs of health systems since the outbreak of COVID-19. Certain developing countries have advanced in a strategy of imitating biotechnological reference drugs once their patents have expired, opening a possibility for a catching up process.
