Re-thinking Global and Local Manufacturing of Medical Products After COVID-19
By Dr. Germán Velásquez
The unprecedented global health crisis caused by the coronavirus (COVID-19) pandemic since the first quarter of 2020 has reopened the now-urgent discussion about the role of local pharmaceutical production in addressing the health needs in developing countries. The COVID-19 crisis has highlighted the interdependencies in the global production of pharmaceuticals—no country is self-sufficient. Many industrialized countries are making the decision to repatriate or initiate the production of active pharmaceutical ingredients (APIs) and medicines. Governments are beginning to talk about ‘pharmaceutical sovereignty’ or ‘health security’. If this becomes a reality and the production of pharmaceuticals is led by nationalistic policies, developing countries that still lack manufacturing capacity will have to start or expand the local production of pharmaceuticals, whether at the national or regional level. The war to get access to the future vaccine for COVID-19 does not look easy with these new developments.
The TRIPS Agreement Article 73 Security Exceptions and the COVID-19 Pandemic
By Frederick Abbott
The COVID-19 pandemic has caused Governments to contemplate measures to override patents and other intellectual property rights (IPRs) in order to facilitate production and distribution of vaccines, treatments, diagnostics and medical devices. This paper discusses whether the COVID-19 pandemic may be considered an “emergency in international relations” and how WTO Member States may invoke Article 73 (“Security Exceptions”) of the TRIPS Agreement as the legal basis for overriding IPRs otherwise required to be made available or enforced. It concludes that the pandemic constitutes an emergency in international relations within the meaning of Article 73(b)(iii) and that this provision allows Governments to take actions necessary to protect their essential security interests.
Coronavirus pandemic: the vaccine as exit strategy
A GLOBAL HURDLE RACE AGAINST TIME WITH A SPLIT JURY
By Francisco Colman Sercovich
Sars-CoV-2, a novel pathogen, submits a stern warning, a clarion call, on the huge human costs of shortsightedness, inaction and lessons lost in the face of common predicaments at the global level. Yet, a number of key actors remain oblivious, including ethically-challenged politicians seeking to elbow their way to the front of the queue at the expense of the poorest and most vulnerable nations and communities. Contrary to expectations being formed, a safe and effective vaccine for the Covid-19 strain once, if ever, attained, is the best way out but unlikely to do as a silver bullet in the midst of the complexities and unknowns at play.
As a result of the harmful impact of the pandemic and ensuing policy aftermath, the world runs the risk of squandering the gains barely made in the fight against poverty over the last few decades – a looming scenario of egregious global governance failure, in view of the eight close calls recently received (three flu epidemics or near-flu epidemics, two Sars episodes, one Mers episode, Zika & Ebola). A promptly and universally distributed vaccine promises to prevent future disease outbreaks. However, many scientific, economic and distributional hurdles stand in the way. Whilst each day counts, the survival of hundreds of millions of lives hangs in the balance as health issues and those pertaining to livelihoods, nutrition, schooling and deprivation are so closely interdependent. Can we rule out the need to resort to internationally sanctioned legal remedies as an inescapable response?
Examining antimicrobial resistance in the light of the COVID-19 pandemic
By Mirfin Mpundu, Caline Mattar and Mirza Alas
The COVID-19 pandemic provides an opportunity to strengthen the capacity of health systems not only to be better prepared for the next pandemic but also to address ongoing crises such as antimicrobial resistance. The unfolding crisis due to antimicrobial resistance is, unfortunately, similar to the current health crisis due to the COVID-19 pandemic, albeit at a slower pace. As countries address the pandemic, there is a need to identify interlinkages between the pandemic and antimicrobial resistance and to continue strengthening the actions needed to slow down the emergence of antimicrobial resistance.
The UN General Assembly Resolutions on COVID-19: Solemn Assurances for Access to Health Technologies without an Action Plan
By Nirmalya Syam
The United Nations (UN) has the mandate under the Charter of the United Nations to promote solutions to international health problems, such as the global COVID-19 pandemic. While the UN secretariat, led by the Secretary-General, has undertaken a number of initiatives in response to COVID-19, member State initiatives in the UN has so far been limited to two resolutions adopted by the UN General Assembly. Member States are currently negotiating an omnibus resolution of the General Assembly on COVID-19. This policy brief analyzes the extent to which the General Assembly addresses the issue of timely, equitable and affordable access to health technologies, particularly for developing countries who have greater vulnerability to COVID-19. The adopted resolutions make very broad pledges for global solidarity but lack specific commitments to guide actions by member States. The omnibus resolution currently under negotiation should provide specific guidance to member States on actions to be taken based on the principles of solidarity and multilateral cooperation in diverse aspects impacted by COVID-19.
Equitable Access to COVID-19 Related Health Technologies: A Global Priority
By Dr. Zeleke Temesgen Boru
Since COVID-19 was first identified, infections from the virus and the death toll have spiked abysmally. The pandemic has also paralyzed the economies (particularly, global trade, tourism and transport) of many countries. The dire social and psychological ramifications associated with the pandemic are also immense. The threat posed by COVID-19 on global health and the economic downturn resulting thereof necessitates the development of health technologies (such as medicines and vaccines). A global effort to invent new health technologies or the likely application of existing technologies is also underway since the outbreak of the pandemic. Even though the race to develop these technologies can be hailed as a pivotal undertaking, the development of health technologies alone may not expedite equitable access to the outcome of such development. Particularly, the lack of access to health technologies may befall if the conventional model of health technology pricing, which is derived from monopoly rights created by IP protection, is set. However, legal as well as policy tools can be used to overcome such hurdles and ensure global access to health technologies. In this sense, this paper discusses plausible legal and policy options that can help to accelerate access to health technologies targeting COVID-19.
COVID-19 Crisis and Developing Countries: Digital Health Perspective
By Ambassador Fauzia Nasreen, Dr. Azeema Fareed, Ms. Huma Balouch
Commission on Science and Technology for Sustainable Development in the South (COMSATS)
Technology and Innovation are quintessentially relevant especially in dealing with the multiple threats posed by COVID-19. Most developing countries are already under tremendous stress because of financial constraints, enormous development challenges and technology innovation and knowledge deficiencies. COVID-19 which has disrupted every walk of life is having a multiplier effect on many countries, posing difficult governance choices. Reform and reorientation of the health system and structure is fundamentally important in dealing with the public health issues in the post COVID-19 period, and digital health could help in providing solutions.
The COVID-19 Pandemic: Intellectual Property Management for Access to Diagnostics, Medicines and Vaccines
Developing countries and LDCs in particular in Africa are especially vulnerable to the unfolding effects of the COVID-19 pandemic. A priority area for global collaboration is to ensure that diagnostics, vaccines and medicines are made available, affordable and accessible worldwide. There is currently no vaccine and no proven safe and effective direct therapy for COVID-19. There is also the need to accelerate testing capacity and tools in developing countries and LDCs with increased access to low-cost diagnostics. The approach to the management of intellectual property rights by research institutions, pharmaceutical and biotech companies and R&D funders will decisively affect availability and access, as well as the transfer of technology and know-how. Governments must ensure that they have legislative and procedural frameworks in place to enable them to over-come, consistently with the TRIPS Agreement, any patent, data exclusivity and trade secret barriers to procure and produce COVID-19 diagnostics, vaccines, medicines and other therapeutics.
The 73rdWorld Health Assembly and Resolution on COVID-19: Quest of Global Solidarity for Equitable Access to Health Products
By Nirmalya Syam, Mirza Alas and Vitor Ido
The annual meeting of the World Health Assembly (WHA) of the World Health Organization (WHO) held virtually on 18-19 May 2020 discussed the global response to COVID-19 and adopted Resolution WHA73.1 on “COVID-19 Response”. The Resolution reaffirms the role of WHO as the directing and coordinating authority on international health work and it recognizes that all countries should have timely and affordable access to diagnostics, therapeutics, medicines and vaccines as well as to essential health technologies and equipment to respond to COVID-19. However, the Resolution does not define concrete actions to address the pandemic. Though the Resolution makes a commitment of ensuring access to medical products, vaccines and equipment for all countries in a timely manner, there are no concrete actions defined. In order to ensure global equitable access, WHO Members should make full use of the flexibilities of the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) and also enhance transparency of costs of research and development (R&D), openness and sharing of data, tools and technologies, and build more capacity through technology transfer.
La pandemia de COVID-19: el fomento de la I+D y la gestión de la propiedad intelectual para acceder a diagnósticos, medicamentos y vacunas
PorViviana Muñoz Tellez
La rápida difusión actual de COVID-19 está poniendo a prueba la capacidad de los gobiernos y de la Organización Mun-dial de la Salud (OMS) para poner en marcha una respuesta mundial coordinada a la pandemia. Los países en desarrollo y los países menos adelantados (PMA), en particular los de África, son particularmente vulnerables a los efectos de la crisis de salud pública. Una esfera prioritaria para la colaboración mundial es el fomento de la investigación y el desar-rollo de vacunas y medicamentos que estén disponibles, sean asequibles y accesibles en todo el mundo. En la actualidad no existe una vacuna ni una terapia directa segura y eficaz probada para COVID-19. También es necesario acelerar la capacidad y los instrumentos de ensayo en los países en desarrollo y los países menos adelantados con un mayor acceso a diagnósticos de bajo costo. El enfoque de la gestión de los derechos de propiedad intelectual por parte de las instituci-ones de investigación, las empresas farmacéuticas y biotecnológicas y las entidades de financiación de la investigación y el desarrollo afectará de manera decisiva a la disponibilidad y el acceso, así como a la transferencia de tecnología y conocimientos técnicos. Los gobiernos deben asegurarse de que disponen de marcos legislativos y de procedimiento que les permitan superar cualquier barrera de patentes, de exclusividad de datos y de secretos comerciales para adquirir y producir diagnósticos, vacunas, medicamentos y otros productos terapéuticos de COVID-19.
Compilation of Extracts from Selected Country Statements during 73rd World Health Assembly supporting Access to Health Products on COVID-19
The compilation below was done on the basis of published statements on the WHO website (https://apps.who.int/gb/statements/WHA73/) and the speeches delivered orally for those delegations which have not submitted their statements. This is a non-official document for information only.
La pandémie de COVID-19 : R&D et gestion de la propriété intellectuelle pour l’accès aux tests diagnostiques, aux médicaments et aux vaccins
Par Viviana Muñoz Tellez
La propagation rapide actuelle du COVID-19 met à l’épreuve la capacité des gouvernements et celle de l’Organisation mondiale de la santé (OMS) à apporter une réponse mondiale coordonnée à la pandémie. Les pays en développement et les pays les moins avancés (PMA), en particulier en Afrique, sont particulièrement vulnérables aux effets de la crise de santé publique. Un domaine prioritaire de collaboration mondiale consiste à faire progresser la recherche et le développement (R&D) de vaccins et de médicaments qui soient disponibles, abordables et accessibles dans le monde entier. Il n’existe actuellement aucun vaccin et aucune thérapie directe pour COVID-19 dont l’innocuité et l’efficacité ont été prouvées. Il est également nécessaire d’accélérer les capacités et les outils d’essai dans les pays en développement et les PMA en leur donnant un accès accru à des diagnostics peu coûteux. L’approche de la gestion des droits de propriété intellectuelle par les institutions de recherche, les entreprises pharmaceutiques et biotechnologiques et les organismes de financement de la R&D aura une incidence décisive sur la disponibilité et l’accès, ainsi que sur le transfert de technologie et de savoir-faire. Les gouvernements doivent s’assurer qu’ils disposent de cadres législatifs et procéduraux leur permettant de surmonter les obstacles liés aux brevets, à l’exclusivité des données et aux secrets commerciaux afin de se procurer et de produire des diagnostics, des vaccins, des médicaments et d’autres produits thérapeutiques pour le COVID-19.