Documento de Análisis proceso Resolución CD58/6 (2020) Asamblea Organización Panamericana de la Salud

Considerando que: 

1. Históricamente, la OPS ha jugado un papel muy relevante para promover la acción coordinada de los países miembros ante las emergencias y las prioridades de salud pública, así como para fortalecer  la capacidad de negociación en las adquisiciones de vacunas, medicamentos y otras tecnologías en salud . Esto ha sido notable en los programas ampliados de inmunización, en las negociaciones conjuntas de medicamentos para el VIH-SIDA, y en la oferta de medicamentos esenciales para hepatitis C, entre muchas otras,  mediante el Fondo Estratégico.

Sin embargo, ante esta pandemia, la peor emergencia en años, las propuestas contenidas en la resolución se limitan al apoyo a las respuestas nacionales, dejando de lado una larga historia de solidaridad y apoyo mutuo. Tratándose de una organización regional, resulta llamativo que en lugar de proponer alternativas a los peligros en la respuesta a la pandemia (nacionalismo, autoritarismo, aislacionismo, falta de transparencia en las negociaciones, profundización de las inequidades etc) la resolución sólo contenga elementos de apoyo técnico a cada país, sin tomar en cuenta  las brechas entre países grandes y pequeños, entre países desarrollados y en desarrollo, entre países ricos y países pobres.

2. El mundo está mirando a las opciones que se ofrecen desde los mecanismos de asociación-negociación global que muestran  una  falta de liderazgo,  privilegiando las pretensiones  de algunos países y de grandes empresas farmacéuticas con confusos mecanismos de compensación de las desigualdades sostenidas  por la filantropía. Los llamados a una respuesta global coordinada y solidaria, a compartir el conocimiento y la ciencia y a fortalecer las capacidades locales de respuesta han sido desestimados. Las opciones de utilizar al máximo las flexibilidades del ADPIC,  construidas para emergencias como esta pandemia, son  ignoradas.

3. El Presidente de Costa Rica, ha presentado una propuesta en ésa línea, que no ha tenido la trascendencia que merece a nivel global, pues han primado intereses políticos y comerciales de grandes países y grandes firmas. No es  aceptable que nuestros países se sumen al silencio y desestimen  una propuesta arraigada en nuestra tradición de solidaridad regional.

4. Existen hoy en muchos países capacidades importantes para la producción y el desarrollo de vacunas y terapias para enfrentar esta pandemia. Hay  esfuerzos para hacer un mapeo de capacidades en la región que no se han consolidado y que la OPS podría culminar y completar, para tener más elementos que apunten a la respuesta coordinada y compartida ante la pandemia. Sin embargo, se están privilegiando las negociaciones individuales limitando el papel de la OPS al apoyo técnico a cada país por separado.

5. Una de las instituciones más golpeadas por la pandemia, ha sido el multilateralismo, consecuencia de las decisiones políticas de los que, en el pasado, lo impulsaron con entusiasmo en la medida en que se alineaba con sus intereses. Esta resolución debilita severamente a la organización más antigua del planeta en materia de salud pública; sin embargo,  son los países miembros los que deciden su futuro y su papel en esta crisis  que podría ser mucho más activo y contribuir a la reducción de las brechas e  inequidades.

6. Las patentes y otros Derechos de Propiedad Intelectual (DPI) han sido cuestionados  por sus consecuencias como la fragmentación y descoordinación en el desarrollo de terapias y vacunas y por sus consecuencias  en el acceso derivadas de los altos precios. Se ha puesto sobre la mesa opciones como la ciencia abierta, la suspensión temporal de los DPI y su  cesión  a un Pool administrado por la OMS.  ONGs como REDLAM, consideran que los DPI aplicados a vacunas y medicamentos han significado  la profundización de enormes y crecientes desigualdades, inaceptables desde la perspectiva de los derechos humanos. Consecuentemente han  sugerido la renegociación del ADPIC y la eliminación de patentes y otros DPI para medicamentos esenciales , vacunas y otras tecnologías sanitarias, propuesta que ya ha sido discutida por el Panel de Alto Nivel del SG de las Naciones Unidas en 2015 y 2016.

Tomando en cuenta estas consideraciones, se desprenden una serie de acciones a seguir para que esta resolución sea un marco político importante que impulse cambios urgentes a fin de que  las poblaciones latino-americanas tengan garantizado el ejercicio pleno del derecho a la salud  que tiene en su base el compromiso solidario de los países.

Situation Analysis

32. Since the beginning of the COVID-19 pandemic, countries and territories in the Region have experienced challenges in accessing essential health technologies for the response, such as in vitro diagnostics, ventilators, and PPE. Some manufacturing countries have imposed export restrictions on PPE, ventilators, and diagnostics, and manufacturers are prioritizing certain markets above others. Border closures and limited flights have further hindered access and increased the costs of essential supplies. The restrictions imposed also affected the provision of independent humanitarian response in the region, either regarding the lack of PPE and other supplies or the limitation of movement of humanitarian personal, either by the border closures or by the lack of flight options. The involvement of multiple intermediaries is also affecting the transparency and timeliness of the acquisition process, as well as the ability to monitor the quality of products. These restrictions have further aggravated disruptions to the supply chain for essential health supplies, triggered by the pandemic’s impact on manufacturing. The challenges experienced in accessing medical supplies due to increased demand during the current pandemic may predict a similar struggle to access COVID-19 therapeutics and vaccines once these become available.

Actions Necessary to Improve the Situation 

43. Initiate preparatory activities for immunization in anticipation of a COVID-19 vaccine in the next 24 months. These include expert consultations (in particular, meetings of the regional Technical Advisory Group on Vaccine-Preventable Diseases and of the National Immunization Technical Advisory Committees) to recommend immunization strategies and best practices. Actions should be taken to train national stakeholders (in particular in countries with little or no experience with established seasonal influenza immunization programs); evaluate and strengthen cold chain capacities; develop or update regional and national vaccine deployment plans; strengthen information systems for immunization registries and vaccination coverage; and develop social and risk communication capacities and initiatives. Additionally, participation in regional networks for vaccine safety surveillance should be ensured. Finally, a mapping of existing vaccine production capacity should be carried out by PAHO, including facilities that require additional investments to comply with GMP and other regulatory requirements to become regional or global suppliers. 

46. Establish and implement policies and programs that mitigate the negative consequences faced by populations in vulnerable situations whose pre-existing adverse conditions have worsened as a consequence of the public health measures. They include, among others, workers without social protection or health insurance, people living in crowded spaces, people living in institutions and in shelters, people deprived of liberty, migrants and refugees, the homeless, and indigenous, and Afro-descendant and traditional people and communities living in precarious conditions or with limited access to health. For many populations in the Region, the implementation of and adherence to public health measures has been challenging. Among them are workers in the informal economy, dependent on a daily income, who must comply with stay-at-home orders; families living in overcrowded housing with increased risk of interfamily violence and little space for social distancing; and persons without access to running water and soap to practice frequent hand washing, despite no access to sanitation.

47. Develop rigorous guidance to advance justice and equity in the global and regional allocation of COVID-19 therapeutics and vaccines. Policy practices that facilitate access to medicines, vaccines and other medical goods, such as the adoption and full use of TRIPS flexibilities in a “holistic” manner (including the full scope of IPRs), should also be incentivized across the region.

53. Strengthen event-based surveillance to address the challenges of early detection in populations in vulnerable situations, including indigenous, traditional and Afro-descendant populations, whose lack of access to healthcare, water and sanitation, communication, and transportation services increases their vulnerability to SARS-CoV-2 virus, further guaranteeing community approach actions to stop the chain of infection. 

58. Identify access barriers and implement strategies to provide coverage to populations in conditions of vulnerability or with specific vulnerabilities during the pandemic, with due attention to specific and differentiated needs, like people affected by neglected diseases. Implementation of mechanisms for community engagement and intersectoral action is critical to respond to the health needs of the population during COVID-19.

63. Ensure that financial and political commitments are in place to provide timely access to diagnostics, medical devices, new vaccine, and therapeutics for all Member States. This will require engaging in global discussions and supporting (politically and financially) initiatives such as the Access to COVID-19 Tools (ACT) Accelerator, the United Nations COVID-19 Supply Task Force, the COVAX facility, the Technology Access Pool (C-TAP) and others, while ensuring that any investments of public funds are attached to transparency, access and affordability clauses. 

64. Contribute to the adoption of transparent criteria for equitable access and allocation of essential health technologies. Use of the pooled procurement and technical cooperation capacities available through the Revolving Fund for Access to Vaccines and the Strategic Fund could help improve the affordability, availability, and appropriate use of these technologies in Member States, as well as the use of joint negotiation strategies by countries in the region with PAHO as the core facilitator.

68. Develop capacity in the Region for the development, fabrication and manufacturing of essential supplies and technology, including more substantive financial support from governments and international agencies and initiatives, both to indigenous/local/regional/autochthonous projects and technology transfer agreements. 

69. Recalling the resolutions CD45.R7: Access to medicines (2004); CD48.R15 Public Health, Innovation and Intellectual Property: a Regional Perspective (2008); CD50/20: Strengthening National Regulatory Authorities for Medicines and Biologicals (2010);  CE148/INF/5: Implementation of the Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property (2011); CD53.R14: Universal Access to Health and Universal Health Coverage (2014); 2015 CD54.R8: Plan of action on immunization (2015); and CD55.R12: Access and rational use of strategic and high-cost medicines and other health technologies (2016); adopt a collaborative regional strategy to ensure universal access and sustainable prices for health technologies over the existing and future pandemics and explore the suspension of IPRs and the adoption of mandatory open sharing innovation policies.

Resolution

(OP)1. To urge all Member States, considering their contexts, needs, vulnerabilities, and priorities, to:

Initiate preparatory activities for immunization in anticipation of the availability of a safe, efficacious, and accessible COVID-19 vaccine; define prioritization policies based on public health and Human Rights criteria, taking into account the most vulnerable populations. 

Provide sustainable funding to the Pan American Health Organization so that it can fulfill its mandates while responding to, mitigating the impact of, and recovering from the COVID-19 pandemic.

Add:

Make full use of TRIPS Flexibilities to ensure universal access in the region and to supply other countries in need. Expand the reach of TRIPS Flexibilities beyond patents to also include trade secrets, copyrights, industrial designs, know-how and data relevant for the production of Covid-19 related technologies.

Adopt public interest conditions attached to R&D supported with public funds, including mandatory transparency norms for companies benefiting from such resources, accessibility and affordability clauses, non-patentability of the end-result products and a non-exclusive licenses policy. Push for similar norms in the scope of multilateral initiatives that are pooling public funds for R&D and production investments on COVID-19 related health technologies, such as the COVAX.

Support the further development of the C-TAP platform to facilitate the pooling of intellectual property and information on diagnostic tests, devices, medication or vaccines, with free access or licensing on reasonable and affordable terms, and open sharing of rights in regulatory test data, knowhow, cell lines, copyrights and blueprints for manufacturing, including for vaccine candidates under negotiation by the COVAX mechanism. 

Contribute to global price reductions through regional joint procurement strategies, effective use of TRIPS flexibilities, meaningful and transparent technology transfer agreements aimed at expanded supply and wide geographical coverage, influence over pricing decisions taken at multilateral level and setting affordable prices on locally produced health goods.

Apply transparency principles over the bilateral deals signed for the trialing, development and/or production of essential health tools, such as diagnostics, drugs and vaccines, in accordance with WHA resolution “Improving the transparency of markets for medicines, vaccines, and other health products”.

Strengthen local production capacities by investing on public institutions and supporting them in the fulfilment of technical and regulatory requirements to become alternative sources of supply for national, regional and global needs. 

(OP)2. To request the Director to: 

Maintain the regional network for the surveillance of influenza and other respiratory viruses, and expand them through the creation of a Regional Genomic Surveillance Network;

Conduct and publish a mapping report of existing vaccine manufacturing capacity in the region to identify opportunities for further expansion of local production initiatives.

Identify investment needs for existing and potential new projects, and to repurpose existing projects towards the platforms/products found to be more effective.  

Support countries in the establishment of regulatory pathways that facilitate the review and market authorization of vaccines produced by non-originator companies, building upon the existing best practices in the region for approval of biosimilar products and avoiding that trade secret become a barrier at the regulatory level

Support Member States through the Bureau’s technical areas, the Revolving Fund for Access to Vaccines (Revolving Fund), and the Regional Revolving Fund for Strategic Public Health Supplies (Strategic Fund) to improve equitable access to, and appropriate use of, affordable, safe, efficacious and quality vaccines, therapeutics, diagnostics, biomedical equipment, and personal protective equipment that can improve health outcomes and reduce the impact of the pandemic;

support Member States in engaging with global initiatives, such as the Access to COVID-19 Tools Accelerator, for vaccines, diagnostics and therapeutics, the Solidarity Call to Action and all other relevant initiatives for the development and access to essential health technologies for COVID-19;

inform Member States on a regular basis on advances in the research and development of COVID-19 vaccines, therapeutics and diagnostics, as well as recommendations for use, principles for access and allocation, regulatory requirements, and actions that the Revolving Fund and the Strategic Fund have initiated to ensure access to vaccines and products for COVID-19;