Lessons from COVID-19: Pharmaceutical Production as a Strategic Goal
By Dr. Carlos M. Correa
As often said, major crises bring about challenges but also opportunities. The strategic importance of a local pharmaceutical industry has been growingly recognized as a result of the COVID-19 crisis. Developing countries should take advantage of this opportunity to strengthen their pharmaceutical industry, including biological medicines. Industrial policies would need to be reformulated under an integrated approach so as to expand value added & create jobs while addressing public health needs. South-South cooperation may also play an important role in increasing the contribution of developing countries to the global production of pharmaceuticals.
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.
Intellectual Property, Innovation and Access to Health Products for COVID-19: A Review of Measures Taken by Different Countries
By Nirmalya Syam
The rising incidence of COVID-19 will require all countries, particularly developing and least developed countries, to be able to procure and manufacture the products required for the diagnosis, prevention and treatment of COVID-19. Intellectual property (IP) rights over such products can constrain the ability of countries to rapidly procure and produce and supply the products required at a mass scale. This Policy Brief describes the measures and actions taken by different countries to address potential IP barriers to access to the products required for COVID-19. A number of countries, both developed and developing, have adopted measures to enable governments to take action to overcome IP barriers in case they constrain access to the products required for COVID-19. In addition to these measures, the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) also allows considerable flexibility to adopt a number of other possible measures which can be considered by developing countries where necessary.
Making Covid-19 Medical Products Affordable: Voluntary Patent Pool and TRIPS Flexibilities
By Sudip Chaudhuri
The proposal of Costa Rica to create a voluntary pool mechanism for medical products and technologies for COVID-19 has evoked huge interest and optimism. The World Health Organization (WHO) and Costa Rica have followed it up through a Solidarity Call emphasizing the need for voluntary licensing on non-exclusive basis to the Medicines Patent Pool (MPP). The success of a voluntary pool critically depends on the willingness of the patentees to join the pool. In a public health crisis, boundaries of public policy must not be determined by the patentees. MPP will work much better if the patentees are compelled or induced to join the pool. International cooperation is important in this regard. Highlighting the virtues of voluntary measures and promoting MPP without adequate emphasis on the use of compulsory licensing and other TRIPS flexibilities, actually weakens the MPP. In the light of the experience of MPP, the basic objective of this paper is to analyze to what extent voluntary pool mechanisms can be relied upon to make COVID-19 medical products affordable and accessible. It is important to appreciate the achievements of MPP. But the constraints under which it operates, and its limitations must also be kept in mind.
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.
Articles 7 and 8 as the basis for interpretation of the TRIPS Agreement
By Thamara Romero
Articles 7 and 8 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) play a central role in assuring the members of the World Trade Organization (WTO) the right to implement public health measures. The Doha Declaration on the TRIPS Agreement and Public Health is also an important element for the interpretation of any provision of the TRIPS Agreement that may have public health implications. The most recent and prominent example of the use of articles 7 and 8 for interpretation in WTO law can be found in the WTO Panel decision of 2018 on the Australia – Tobacco Plain Packaging dispute.
Message from the South Centre at the launch of the “Solidarity Call To Action” by the President of Costa Rica and the Director-General of the WHO
The architecture for access to medicines and vaccines, which is already complex to manage in normal times, requires even more structured actions in times of a pandemic by the scale of the demand and the urgency in meeting it. This call for solidarity to bring together the technologies and treatments related to COVID 19 is part of the necessary solution. It complements other available instruments for States to facilitate access to prevention and treatment for the population, including through the use of the flexibilities of the WTO TRIPS Agreement.
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.
