The Vaccine Industry After the COVID-19 Pandemic: An International Perspective
By Felix Lobo
The purpose of this report is to analyze the impact that the COVID-19 pandemic has had on the vaccine industry from an international perspective. The objective is to learn from the experience and contribute to the design of better tools for future vaccine development and manufacturing, as we must be prepared for future emerging infectious diseases with the potential for global expansion. This industry makes fundamental contributions to global social welfare, but from a business point of view it is complex and difficult to manage, and from an economic point of view it is an industry that does not fit the paradigm of competitive market efficiency with notorious market failures.
We examine the impact of the pandemic on innovation and the scientific, technological and industrial development of vaccines and find that certain elements of the industry’s structure have changed, while others have remained. We also summarize the lessons learned from the deployment of some public policies to boost supply and drive demand, paying particular attention to the inequity in the global distribution of vaccines and to the COVAX program. We conclude that some of the policies have been very effective, while others have not fully achieved their objectives. From the achievements and limitations, lessons can be drawn for the reformulation and expansion of global public policies that would stimulate R&D, manufacturing, distribution and access.
Compulsory Licensing as a Remedy Against Excessive Pricing of Life-Saving Medicines
By Behrang Kianzad
The COVID-19 crisis intensified decade-long debates on the interaction between intellectual property rights (IPRs), competition law and access to affordable life-saving treatments and vaccines. Compulsory licensing of patented medicines is a tried-and-tested method to expand access, particularly in a situation of “national emergency or other circumstances of extreme urgency” within the meaning of Article 31(b) of the TRIPS Agreement. Some legislations, such as European competition law, offer a toolbox for curbing the exercise of IPRs if they would be found in conflict with certain competition rules, such as rules prohibiting excessive pricing by dominant undertakings. The paper analyses the interface between intellectual property law and competition law in general, moving on to the settled case law of the Court of Justice of the European Union (CJEU) on this matter. It provides a general overview of legal and economics arguments related to excessive pricing prohibition and the main case law of European competition law on the matter and discusses whether compulsory licensing as a remedy against excessive pricing of patented life-saving pharmaceutical products can be a viable and appropriate remedy. Finally, the paper offers policy recommendations relating to compulsory licensing based on excessive pricing.
Leveraging the Potential of South-South and Triangular Cooperation for the Decade of Action
A joint publication by Islamic Development Bank (IsDB), South Centre, United Nations Trade and Development (UNCTAD) and United Nations Office for South-South Cooperation (UNOSSC)
This document was prepared for a Side Event to the 19th Non-Aligned Movement (NAM) Summit and Third South Summit, held in Kampala, Uganda in January 2024.
This joint initiative is meant to provide a detailed look at the current state of South-South and Triangular Cooperation (SSTrC) and consider how international development cooperation and the role of developing countries can be enhanced in the future.
The paper aims to, inter alia, explore the landscape of SSTrC uncovered by the COVID-19 pandemic and recent global events; look at how the pandemic acted as a stress test for international cooperation; consider the national institution building necessary for effectively engaging in SSTrC; and suggest different ways forward for leveraging SSTrC towards building resilient societies and achieving national development priorities, the 2030 Agenda for Sustainable Development and the Sustainable Development Goals (SDGs). It considers the possibilities of leveraging SSTrC for enhancing the transfer of knowledge, experiences and technologies within the Global South and increased capacity building in developing countries.
Proposal for a new Article 11bis in the WHO Pandemic Accord: a Pandemic Technology Transfer Mechanism
by Olga Gurgula and Luke McDonagh
The COVID-19 pandemic demonstrates the failure of voluntary mechanisms during global emergencies and exemplifies the need for effective involuntary technology transfer tools. The WHO Pandemic Accord offers an opportunity to provide an effective mechanism to build upon existing TRIPS flexibilities in the specific pandemic context. We propose a new provision (Article 11bis) that outlines a mechanism on cross-border procedure of non-voluntary technology transfer during a pandemic. This procedure could be invoked in a pandemic scenario in which voluntary technology transfer mechanisms have failed to provide sufficient supplies of a needed pandemic product.
South Centre Statement at the 9th session of the Intergovernmental Negotiating Body to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response
March 2024
The South Centre underscores the imperative for an international binding pandemic treaty to prevent the recurrence of past failures like those witnessed during the COVID-19 crisis.
¿Adónde va el tratado internacional vinculante negociado en la OMS contra futuras pandemias?
Por Germán Velásquez
La idea de un tratado internacional sobre pandemias es evitar que se repitan los fracasos que se produjeron durante la crisis del COVID-19. Muchas cosas no funcionaron, pero el fracaso más flagrante fue la desigual distribución y acceso a las vacunas, diagnósticos y tratamientos. Se necesita un tratado internacional basado en los principios de equidad, inclusión y transparencia para garantizar un acceso universal y equitativo.
El actual proyecto de texto del “tratado pandémico” está lejos de responder adecuadamente los retos planteados durante la crisis de COVID-19. Los países desarrollados han debilitado el texto inicial. Los países desarrollados han debilitado la versión inicial del borrador, y el texto está ahora lleno de matices innecesarios. La expresión “cuando proceda” y otras formulaciones típicas de las disposiciones voluntarias aparecen ahora repetidamente. Se trata de proteger y garantizar el interés público y la salud de los ciudadanos como un derecho, o de defender los intereses de una industria que pretende enriquecerse sin límites. El tratado contra futuras pandemias será uno de los temas centrales de la próxima Asamblea Mundial de la Salud de la Organización Mundial de la Salud (OMS) en mayo de 2024. Si los países del Sur, que representan la mayoría de los miembros de la OMS, se unen con una visión clara y fuerte de la salud pública y los países del Norte actúan con lucidez, siguiendo las pruebas científicas al tiempo que persiguen la seguridad para todos, el tratado contribuirá al bienestar de las generaciones futuras. Si al final un pequeño grupo de países se opone a un tratado con disposiciones significativas, no debemos olvidar que la OMS es una institución democrática donde existe la posibilidad de votar.
Où va le traité international contraignant négocié à l’OMS pour lutter contre les futures pandémies ?
Par Germán Velásquez
L’idée d’un traité international sur les pandémies est d’éviter de répéter les échecs qui se sont produits lors de la crise du COVID-19. Beaucoup de choses n’ont pas fonctionné, mais l’échec le plus flagrant a été la distribution inégale des vaccins, des diagnostics et des traitements, ainsi que l’accès à ces derniers. Un traité international fondé sur les principes d’équité, d’inclusion et de transparence est nécessaire pour garantir un accès universel et équitable.
Le projet de texte actuel du “traité sur les pandémies” est loin de répondre de manière adéquate aux défis rencontrés lors de la crise du COVID-19. Les pays développés ont affaibli la version initiale du projet, et le texte est maintenant plein de nuances inutiles. L’expression « le cas échéant » et d’autres formulations typiques des dispositions volontaires apparaissent désormais à plusieurs reprises. Il s’agit soit de protéger et d’assurer l’intérêt public et la santé des citoyens comme un droit, soit de défendre les intérêts d’une industrie qui cherche à s’enrichir sans limites. Le traité contre les futures pandémies sera l’un des sujets centraux de la prochaine Assemblée mondiale de la santé de l’Organisation mondiale de la santé (OMS) en mai 2024. Si les pays du Sud, qui représentent la majorité des membres de l’OMS, s’unissent autour d’une vision claire et forte de la santé publique et que les pays du Nord agissent avec lucidité, en suivant les preuves scientifiques tout en recherchant la sécurité pour tous, le traité contribuera au bien-être des générations futures. Si, en fin de compte, un petit groupe de pays s’oppose à un traité contenant des dispositions significatives, nous ne devons pas oublier que l’OMS est une institution démocratique où il est possible de voter.
Where is the Binding International Treaty Negotiated at the WHO Against Future Pandemics Going?
by Germán Velásquez
The idea of an international pandemic treaty is to avoid repeating the failures that occurred during the COVID-19 crisis. Many things did not work, but the most glaring failure was the unequal distribution of, and access to, vaccines, diagnostics and treatments. An international treaty based on the principles of equity, inclusiveness and transparency is needed to ensure universal and equitable access.
The current draft text of the “pandemic treaty” is far from adequately responding to the problems faced during the COVID-19 crisis. Developed countries have weakened the initial version of the draft, and the text is now full of unnecessary nuances. The expression “where appropriate” and other such wordings, typical of voluntary provisions, now appear repeatedly. It is a question of either protecting and ensuring the public interest and the health of citizens as a right, or of defending the interests of an industry that seeks to enrich itself without limits. The treaty against future pandemics will be one of the central topics at the next World Health Assembly of the World Health Organization (WHO) in May 2024. If the countries of the South, accounting for the majority of the WHO membership, unite with a clear and strong public health vision and the countries of the North act lucidly, follow scientific evidence while pursuing safety for all, the treaty will contribute to the well-being of future generations. If in the end a small group of countries oppose a treaty with meaningful provisions, we must not forget that the WHO is a democratic institution where there is the possibility to vote.
How Should the WHO Pandemic Treaty Negotiations Tackle Intellectual Property?
By Viviana Muñoz Tellez
The WHO pandemic instrument should commit the Parties to limit the exclusionary effects that government-granted patents and other IPRs may have during pandemics in support of rapid diffusion of new vaccines, diagnostics, medicines and other tools and facilitate collaboration and freedom to operate. The current draft text of Article 11 would not make any change to the status quo.
This Policy Brief discusses issues concerning trade, intellectual property, and technology transfer that are most relevant for consideration at the 13th World Trade Organization (WTO) Ministerial Conference (MC13) in February 2024 and inclusion in its outcomes.
The following recommendations are proposed:
TRIPS non-violation and situation complaints: MC13 Decision on the scope and modalities of non-violation and situation complaints under the Agreement on Trade related Aspects of Intellectual Property Rights (TRIPS). A second option is to extend the moratorium.
TRIPS, diagnostics and therapeutics for COVID-19: MC13 Decision that extends the MC12 TRIPS waiver Decision (only applicable to vaccines) to diagnostics and therapeutics
Relationship between TRIPS and the Convention on Biological Diversity: to be addressed in the MC13 Outcome Document
Follow up to the MC12 Declaration on the WTO Response to the COVID-19 Pandemic and Preparedness for Future Pandemics: to be addressed in the MC13 Outcome Document
Relationship of trade and technology transfer: include in the MC13 Outcome Document to reinvigorate and give direction to the Working Group on Trade and Technology Transfer (WGTTT) and increase attention in all relevant bodies on how the WTO can promote technology transfer
Desafíos actuales y posibles escenarios futuros de la salud mundial
By Germán Velásquez
Hace cuatro décadas los principales actores en la salud global eran la Organización Mundial de la salud (OMS), el Fondo de las Naciones Unidas para la Infancia (UNICEF) y los Estados Unidos de América y los países de Europa del Norte (mediante cooperación bilateral). Hoy asistimos a la proliferación de actores en este campo si bien con diferentes roles , ámbito de acción y niveles de influencia: La OMS, UNICEF, el Programa Conjunto de las Naciones Unidas sobre el VIH/SIDA (ONUSIDA), UNITAID, la Organización Mundial del Comercio (OMC), la Organización Mundial de la Propiedad Intelectual (OMPI), el Programa de las Naciones Unidas para el Desarrollo (PNUD), la Organización de las Naciones Unidas para la Agricultura y la Alimentación (FAO), el Fondo Monetario Internacional (FMI), el Banco Mundial, el G7 y el G20, el G77+China, el Movimiento de No Alineados, los BRICS (Brasil, Rusia, India, China y Sudáfrica), el Fondo Global, GAVI, COVAX, la industria farmacéutica, Bill & Melinda Gates y otras fundaciones y organizaciones no gubernamentales (ONGs) sin o con ánimo de lucro.
Este documento de investigación analiza el papel de los múltiples actores (públicos, privados y filantrópicos) en la salud global y, con base a ello, procura esbozar posibles escenarios futuros. En particular, examina el papel de la OMS bajo cuyos auspicios los países miembros están, desde hace dos años, negociando una reforma del Reglamento Sanitario Internacional (RSI) del 2005 y la posible adopción de un nuevo instrumento internacional para prevenir y dar una respuesta a futuras pandemias como la del COVID-19. La aplicación de estos instrumentos, si se adoptaran, estaría en manos de la OMS, uno de los principales actores de la salud mundial.
TRIPS Waiver Decision for Equitable Access to Medical Countermeasures in the Pandemic: COVID-19 Diagnostics and Therapeutics
By Nirmalya Syam and Muhammad Zaheer Abbas, PhD
The Marrakesh Agreement Establishing the World Trade Organization (WTO) allows WTO Members to agree to temporarily waive obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). However, the TRIPS Decision adopted by the 12th WTO Ministerial Conference in June 2022, after lengthy and protracted negotiations lasting for 20 months in the middle of a pandemic, allowed only a fragment of the waiver proposal submitted by India and South Africa. Moreover, since the adoption of the Decision there has been an impasse in the WTO about extending the Decision to COVID-19 diagnostics and therapeutics even though the WTO Members were mandated by the Decision to decide on this matter within six months of the Decision. This research paper analyses the current state of play and concludes that there is a need to immediately and unconditionally extend the Decision to COVID-19 diagnostics and therapeutics. Moreover, the paper suggests options for how the TRIPS flexibilities can be optimally utilized in a pandemic situation without developing countries being resigned to the vagaries of negotiations on a waiver which is supposed to be an urgent emergency solution. In this regard, the paper also suggests options that could be considered for reforming the process of decision-making on a waiver proposal to ensure that decisions on waivers are taken in a timely and expedited manner without being negotiated for an extensive period of time in the midst of an emergency.
