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.
Assessing the State of Play in the WHO Pandemic Instrument Negotiations
By Viviana Muñoz Tellez
This Policy Brief discusses the state of play of the negotiations of the pandemic instrument at the World Health Organization. The Intergovernmental Negotiating Body (INB) is increasing its meetings as the target deadline for completion in the first half of 2024 draws closer. To advance, the political will needs to be scaled up in the next months. The expectations should not be lowered to focus on the lowest common denominator. Real progress needs to be made in priority areas of concern for developing countries to keep momentum.
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 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.
Summary of the intervention by Carlos Correa, Executive Director of the South Centre,at the UN General Assembly – Pandemic Prevention, Preparedness and Response Multi-Stakeholder Hearing, New York, May 9th, 2023
The response to COVID-19 revealed serious shortcomings in the multilateral system. Despite solemn declarations, it was unable to ensure equity in addressing its health, economic and social impacts. See a summary of the South Centre’s intervention at the UN General Assembly – Pandemic Prevention, Preparedness and Response Multi-Stakeholder Hearing below.
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.
El debate sobre la exención de los derechos de propiedad intelectual en tiempos de pandemia
Descripción:
El 11 de marzo de 2020 la Organización Mundial de la Salud (OMS) comunicó que la enfermedad por coronavirus de 2019 (COVID-19), podía ser considerada una pandemia. A medida que el contagio de la enfermedad aumentaba se hizo evidente la insuficiencia de los recursos sanitarios, vacunas y métodos de diagnóstico y tratamiento para enfrentar con éxito la pandemia. En este contexto, en la Organización Mundial del Comercio (OMC) se reavivó la tensión entre las reglas de propiedad intelectual y la salud pública.
Como consecuencia de ello, el 2 de octubre de 2020, Sudáfrica e India, presentaron ante la OMC una propuesta para que ciertas disposiciones del Acuerdo sobre los ADPIC no resultaran de aplicación para cualquier producto o procedimiento destinado a la prevención, contención y tratamiento de la COVID-19. Esta propuesta de exención (waiver), contó con la férrea oposición de la Unión Europea que presentó una propuesta alternativa. Para intentar llegar a un acuerdo se formó una comisión cuadrilateral conformada por Sudáfrica, India, la Unión Europea y EEUU. Finalmente, luego de dos años de negociaciones y en el marco de la 12ª Conferencia Ministerial (MC12) celebrada en Ginebra el 17 de junio de 2022, se aprobó un proyecto de exención de los derechos de propiedad intelectual que dista mucho de la propuesta original de 2020.
El presente trabajo, analiza detalladamente el proceso de discusión – en torno al tema del “waiver” – dado en el Consejo de los ADPIC de la OMC: estudia los antecedentes de la propuesta de exención, analiza los documentos presentados por las partes en pugna, revisa los argumentos esgrimidos a favor y en contra del waiver, los instrumentos propuestos y, asimismo, muestra cómo se desenvolvieron las distintas posiciones hasta alcanzar el acuerdo final.
Autores: Alejandra Aoun, Juan Correa, Martín A. Cortese, Vanesa Lowenstein, Sandra C. Negro, Guillermo E. Vidaurreta
Leading and Coordinating Global Health: Strengthening the World Health Organization
By Nirmalya Syam
The World Health Organization (WHO) should act as the directing and coordinating authority in global health but it has been steadily marginalized over time by design, through criticism as an inefficient organization, the reduction of assessed contributions and consequent impoverishment, and the proliferation of “new” international health agencies to which WHO has been compelled to cede operational space. This paper discusses how such marginalization of the WHO is in the interest of the dominant actors in global health, and leads to the neglect of health as a development issue. Today the global health system is more fragmented than it was when the WHO was established in 1948. Rich donor countries and corporations dominate multistakeholder governance structures in health partnerships, marginalizing most of the WHO membership and, notably, the Global South, in their decision-making. A consequence of this fragmentation in global health governance is that the space of the only multilateral organization where developing countries have an equal presence in terms of participation and decision-making as sovereign States –WHO– has been marginalized. Consequently, the development dimension of health is also marginalized and only the development assistance aspects of it receive major attention through vertical programmes and agencies addressing limited health needs without effectively addressing the basic need of strengthening health systems. Therefore, for developing countries it is imperative that WHO is effectively retooled to act as the leading and coordinating authority on global health with adequate legal powers, as well as institutional and financial capacities to do so without undue influence from donor countries and entities that have interests in the private sector. This would enable WHO to ensure that the interests of all countries are fairly addressed in its normative and operational activities. Such a transformation of WHO would require action both within and outside the organization. The paper proposes some suggestions in this regard.
Descripción: