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.
Licencias obligatorias para exportación: operacionalización en el orden jurídico argentino
Por Valentina Delich
En el año 2017, entró en vigor la enmienda del Acuerdo sobre los Derechos de Propiedad Intelectual relacionados con el Comercio (ADPIC), por la cual se incluyó el artículo 31 bis en su texto. Esta disposición permite las licencias obligatorias para exportación a terceros países sin o con insuficiente capacidad de producción local. El objetivo es paliar las dificultades de los países sin infraestructura de producción de medicamentos para que puedan hacer un uso efectivo de las licencias obligatorias y así fortalecer el acceso a los medicamentos a un menor precio. Argentina es un país que tiene infraestructura de producción de medicamentos y potencialmente podría devenir en un exportador eficiente. Este documento explora la posible instrumentación del art. 31 bis en la legislación de Argentina, proponiendo incorporar en la ley de patentes nacional el instituto de la licencia obligatoria humanitaria.
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.
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.
