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.
The South Centre carries out multiple activities to support developing countries with policy-oriented research, inputs and advice for negotiations and capacity building. See a summary of the South Centre’s activities in the Annual Report 2023.
New US Policy on Exercise of March-In Rights to Curb High Drug Prices: Lessons for the Global South
By Nirmalya Syam
In response to soaring prescription drug costs, the United States government recently announced proposed changes to the exercise of march-in rights under the Bayh-Dole Act, allowing federal agencies to license taxpayer-funded inventions to other parties based on factors such as accessibility and affordability. This article explores the implications of the US policy shift on global pharmaceutical pricing and access, particularly for developing countries. Drawing parallels between the US approach and flexibilities under intellectual property laws such as compulsory licensing and government use authorizations that are allowed under the WTO TRIPS Agreement, the article suggests that similar strategies could be employed by developing nations to address public health needs and economic considerations.
Régimen de licencias obligatorias y uso público no comercial en Argentina
Por Juan Ignacio Correa
Con la adopción del Acuerdo sobre los Aspectos de Propiedad Intelectual relacionados con el Comercio (ADPIC), la Argentina debió adaptarse a las nuevas reglas internacionales en materia de derecho de patentes. Uno de los puntos centrales del Acuerdo es la posibilidad de establecer diferentes formas de licencias obligatorias y uso gubernamental no comercial. Este documento analiza las condiciones previstas en el artículo 31 del ADPIC con ese fin y examina en detalle las diferentes causales de licencias obligatorias contempladas en la legislación argentina y las condiciones aplicables a cada una de ellas, así como para el uso de patentes por parte del gobierno con fines no comerciales. Finalmente, con base en el margen normativo del ADPIC y la legislación vigente, el documento discute el posible contenido de una reglamentación de licencias obligatorias y uso público no comercial que permita a la Argentina utilizar de manera efectiva esas herramientas cuando se presente alguna de las circunstancias previstas en la actual regulación.
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.
Implementation of TRIPS Flexibilities and Injunctions: A Case Study of India
by Shirin Syed
The proponents of intellectual property (IP) have increasingly utilized injunctions with indiscriminate propensity as a strategic tool for IP enforcement, resulting in adverse socio-economic implications, including the enjoyment of human rights. This trend has eclipsed the flexibilities provided in the Doha Declaration on the TRIPS Agreement and Public Health. Although a substantial volume of the literature focuses on the flexibilities of compulsory license or scope of patentability, little attention has been given to the flexibilities related to IP enforcement. Discussing the implications of IP enforcement on public interest, the paper examines the gaps in the articulation of flexibilities of intellectual property rights (IPRs) enforcement, with special reference to injunctions in India. It examines how far the courts consider the implications on the enjoyment of fundamental rights while granting injunctions on patents. This paper argues that the Indian courts have deviated from the cautious approach provisioned under the TRIPS flexibilities that allows the courts to consider the public interest aspect and human rights implications while granting injunctions in patent litigation. Moreover, it asserts that the courts should exercise prudence in granting injunctive relief in cases involving patent infringement, and take into account the potential impact of such relief on the exercise of human rights. This suggests a need for a careful examination of the potential implications of injunctive remedies in such cases.
South Centre Statement to the 7th meeting of the WHO Working Group on Amendments to the International Health Regulations (2005)
6 February 2024
The South Centre urges the WGIHR to ensure that equity issues are substantially addressed in the process of amendments to the IHR in accordance with decision EB150(3) which mandates the WHGIHR to “… address clearly identified issues, challenges, including equity …” in this process. To that end member States have submitted important textual proposals that seek to advance equity concerns in the IHR. As the WGIHR negotiations advance towards their culmination, it is critical that these proposals on equity, in particular articles, 13, 13A, 44 and 44A, are prioritised and treated on an equal footing with the other amendment proposals. Textual proposals on equity provisions should not be deferred to be addressed only in the INB negotiations, noting that while the INB negotiations concern an international instrument on pandemic prevention, preparedness and response, the IHR is an instrument that is different in scope and deals with public health emergencies of international concern. Equity issues are critical in both instruments.
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.
Pautas para el examen de patentes sobre anticuerpos monoclonales
Por Juan Correa, Catalina de la Puente, Ramiro Picasso y Constanza Silvestrini
La investigación tiene como objetivo conocer el estado de las solicitudes de patente en materia de anticuerpos monoclonales (mAbs). El documento analiza las distintas estrategias en materia de reivindicaciones que utilizan los solicitantes con el fin de obtener protección por derecho de patentes. Se utilizó como fuente de información la base de datos construida y descrita en el Documento de Investigación No. 186 de South Centre. Se indaga sobre las principales reivindicaciones utilizadas en el campo de los mAbs, el tipo de clasificación CIP y el tipo de invención (producto o proceso) más frecuente en las patentes concedidas vigentes o caducas en Argentina. Finalmente, se analiza la utilización de las directrices de patentamiento argentinas en el caso de mAbs y se hacen recomendaciones respecto de posibles reformas a dichas directrices.
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.
