Hacia una Agencia Latinoamericana y del Caribe de Medicamentos (AMLAC)
Por Germán Velásquez
El 26 de abril de 2023 en Acapulco, México, las Autoridades Reguladoras de Medicamentos de Colombia (INVIMA), Cuba (CECMED) y México (COFEPRIS) firmaron la “Declaración de Acapulco” para la creación de la Agencia Latinoamericana y del Caribe de Regulación de Medicamentos y Dispositivos Médicos (AMLAC). Esta declaración fué confirmada en Bogotá, Colombia el 16 de junio de 2023 en una reunión titulada “Convergencia regulatoria” por los responsables de las agencias reguladoras de medicamentos de Argentina, Brasil, Chile, Colombia, Cuba y México que acordaron la creación progresiva de una Agencia Latinoamericana y del Caribe de Medicamentos -AMLAC-.
La AMLAC fué creada para contribuir a la integración regional a través de la armonización y convergencia en materia de regulación sanitaria, la creación de un mercado regional de medicamentos en busca del acceso a medicamentos y dispositivos médicos seguros, eficaces y de calidad.
Towards A Latin American and Caribbean Medicines Agency (AMLAC)
By Germán Velásquez
On 26 April 2023 in Acapulco, Mexico, the Medicines Regulatory Authorities of Colombia (INVIMA), Cuba (CECMED) and Mexico (COFEPRIS) signed the “Declaration of Acapulco” for the creation of the Latin American and Caribbean Medicines and Medical Devices Regulatory Agency (AMLAC). This declaration was confirmed in Bogota, Colombia on 16 June 2023 in a meeting called “Regulatory convergence” by the heads of the medicines regulatory agencies of Argentina, Brazil, Chile, Colombia, Cuba and Mexico who agreed on the progressive creation of a Latin American and Caribbean Medicines Agency (AMLAC).
AMLAC was created to contribute to regional integration through harmonisation and convergence in health regulation, the creation of a regional medicines market in pursuit of access to safe, effective and quality medicines and medical devices.
South Centre Statement to the 64th WIPO General Assembly (2023)
The South Centre, the intergovernmental organization of developing countries, actively promotes balancing public and private interests in the IP system. In accordance with the mandate of the 2007 Development Agenda (DA) and the Sustainable Development Goals (SDGs), which WIPO as a UN specialized agency must contribute to, development, sustainability and human rights should be at the core of WIPO’s activities. WIPO should remain a Member State-driven, development-oriented organization.
The South Centre remains available to all developing countries’ delegations to provide further information and support on these matters, during and after the Assemblies.
Health, Intellectual Property and Biodiversity Programme, South Centre
The following matrix provides a factual overview and analysis of the standing and non-standing agenda items of the regular session of the WTO TRIPS Council. The matrix also discusses the TRIPS Implementation issues as part of the WTO Doha Development Round of negotiations.
South Centre Statement to the Resumed session of the fifth meeting of the Intergovernmental Negotiating Body (INB) to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response
12 June 2023
The South Centre appreciates the opportunity to address this INB. We remain available, here in Geneva or online, to present our views on specific draft provisions.
We recognise the work advanced so far.
In the Bureau text, not all options are yet on the table. All Member State proposals, existing and new ones as they come, should receive proportionate consideration, inclusion and discussion.
The consolidated text of February should remain complementary to the Bureau text.
There must be balance in providing options under various articles and in the approach for legal language under them. The Bureau text as it stands now would not deliver on equity.
The INB is moving towards consensus on principles of equity, solidarity, common but differentiated responsibilities, transparency and respect for human rights. We also support the proposal for a principle on global public goods. The INB needs now to better translate these principles into concrete legal provisions in the text.
The drafting group during this session of the INB could focus discussion on Articles 9 to 13 of the Bureau text, also drawing from the consolidated text.
A Response to COVID-19 and Beyond: Expanding African Capacity in Vaccine Production
By Carlos M. Correa
The unequal global distribution of vaccines against the deadly COVID-19 virus has cast a spotlight on the lack of access to vaccines on the African continent, and the vulnerability that such a lack places on both the economies of African nations and the health of their people. Various initiatives have been launched to overcome the dependence of African nations on vaccines produced elsewhere. If implemented in timely and effective ways, those initiatives will contribute to the diversification of African economies and strengthen the capacity of nations on the continent to address their public health needs during pandemics and at other times. While establishing a viable vaccine industry on the continent presents serious challenges, the African Continental Free Trade Area (AfCFTA) can provide the framework for leveraging economies of scale to stimulate the production of needed vaccines across the region.
Where Does Global Health Funding Come From and Where Does It Go?
By Germán Velásquez
In theory, the World Health Organization (WHO) is the coordinating agency for global health. Influential private and public actors have claimed the relevance and central role of this United Nations (UN) agency. In practice, paradoxically, the money budgeted for health goes largely to other institutions and not to the WHO. New institutions and mechanisms have been created to which funds are channeled (GAVI, The Global Fund, Act-A, CEPI, COVAX, etc.). These institutions or mechanisms are, in most cases, public-private partnerships where the pharmaceutical industry is usually present. Official Development Assistance is important but represents only 1 per cent of what developing countries’ expenditure on health. How much is spent to promote global health and where this money goes is the subject of this paper. After the experience with COVID-19, a fundamental question that must be addressed is how the global public interest can be preserved by creating common public goods and protecting human rights in the prevention, preparedness, and response to present and future pandemics.
De dónde viene y a dónde va el financiamiento para la salud mundial
Por Germán Velásquez
En teoría la OMS es la agencia coordinadora de la salud mundial, y los grandes actores, privados y públicos, revindican la relevancia y el rol central de esta agencia de Naciones Unidas. En la práctica, paradójicamente, los dineros para la salud van en gran parte a otras instituciones y no a la OMS o incluso se crean nuevas instituciones o mecanismos donde se canalizan los nuevos fondos (GAVI, Fondo Mundial, Act-A, CEPI, COVAX etc.) Estas instituciones o mecanismos son, en la mayoría de los casos, partenariados público-privados donde está presente la industria farmacéutica. La Ayuda Oficial para el Desarrollo es importante pero sólo representa el 1% de lo que invierten los países en desarrollo en salud. En qué se gasta para promover la salud global y a dónde va este dinero es el objeto de este documento. Una de las preguntas que debemos hacernos tras la experiencia con COVID-19 es cómo vamos a preservar el interés público global mediante la creación de bienes públicos comunes y la protección de los derechos humanos en las actividades de prevención, preparación y respuesta a las pandemias presentes y futuras.
Read the South Centre Annual Report 2022 for an analysis of the situation faced by our members & other developing countries & for a summary of the Centre’s activities in 2022.
Experiencias internacionales sobre la concesión de licencias obligatorias por razones de salud pública
Por Catalina de la Puente, Gastón Palopoli, Constanza Silvestrini, Juan Correa
El presente estudio tiene como objetivo analizar los regímenes de licencias obligatorias (LOs) en países seleccionados, en particular los elementos económicos de la concesión de las LOs, la determinación y negociación de regalías al titular del derecho. Para ello se realizó un análisis descriptivo y exploratorio de experiencias de concesión de LO en países seleccionados, con foco en las experiencias de los países en vías de desarrollo por su proximidad al caso argentino.
En particular se discuten los ejemplos de experiencias de emisión de medidas de LOs o de UG en países en vías de desarrollo. Con especial foco en Latinoamérica, donde sólo dos países han hecho uso de dichas medidas por razones sanitarias (Ecuador y Brasil). Además se examina la eficacia del empleo de LO o de UG en la reducción de precios donde se evidencian ahorros significativos Como conclusión se propone elaborar una metodología en relación a las regalías para Argentina mediante un rango de pago que tome en consideración criterios de accesibilidad y asequibilidad poblacional a la tecnología licenciada, así como la sustentabilidad de los presupuestos de los agentes financiadores.
Submission by the South Centre to the USITC hearing on Covid-19 diagnostics and therapeutics
India, South Africa and co-sponsors made a proposal for a waiver to certain provisions of the provisions of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) in March 2020. In June 2022, the WTO Ministerial Decision on the TRIPS Agreement provided a partial waiver to obligations in Article 31, namely an exception to the 31.f export restrictions, in relation to patents for Covid-19 vaccines. No decision has yet been made with respect to diagnostics and therapeutics for Covid-19.
In this context, the U.S. Trade Representative (USTR) requested the U.S. International Trade Commission (USITC) to prepare a report on Covid-19 diagnostics and therapeutics.
Read below the submission by the South Centre to the USITC investigation: COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities (Inv. No. 332-596).
