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Improving basic capacities for regulation of medicines and health technologies through regulatory systems strengthening is particularly challenging in resource-constrained settings. "Regionalization"-an approach in which countries with common histories, cultural values, languages, and economic conditions work together to establish more efficient systems-may be one answer. This report describes the Caribbean Regulatory System (CRS), a regionalization initiative being implemented in the mostly small countries of the Caribbean Community and Common Market (CARICOM). This initiative is an innovative effort to strengthen regulatory systems in the Caribbean, where capacity is limited compared to other subregions of the Americas. The initiative's concept and design includes a number of features and steps intended to enhance sustainability in resource-constrained contexts. The latter include 1) leveraging existing platforms for centralized cooperation, governance, and infrastructure; 2) strengthening regulatory capacities with the largest potential public health impact; 3) incorporating policies that promote reliance on reference authorities; 4) changing the system to encourage industry to market their products in CARICOM (e.g., using a centralized portal of entry to reduce regulatory burdens); and 5) building human resource capacity. If implemented properly, the CRS will be self-sustaining through user fees. The experience and lessons learned thus far in implementing this initiative, described in this report, can serve as a case study for the development of similar regulatory strengthening initiatives in resource-constrained environments.

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Improving basic capacities for regulation of medicines and health technologies through regulatory systems strengthening is particularly challenging in resource-constrained settings. “Regionalization”—an approach in which countries with common histories, cultural values, languages, and economic conditions work together to establish more efficient systems— may be one answer. This report describes the Caribbean Regulatory System (CRS), a regionalization initiative being implemented in the mostly small countries of the Caribbean Community and Common Market (CARICOM). This initiative is an innovative effort to strengthen regulatory systems in the Caribbean, where capacity is limited compared to other subregions of the Americas. The initiative’s concept and design includes a number of features and steps intended to enhance sustainability in resource-constrained contexts. The latter include 1) leveraging existing platforms for centralized cooperation, governance, and infrastructure; 2) strengthening regulatory capacities with the largest potential public health impact; 3) incorporating policies that promote reliance on reference authorities; 4) changing the system to encourage industry to market their products in CARICOM (e.g., using a centralized portal of entry to reduce regulatory burdens); and 5) building human resource capacity. If implemented properly, the CRS will be self-sustaining through user fees. The experience and lessons learned thus far in implementing this initiative, described in this report, can serve as a case study for the development of similar regulatory strengthening initiatives in resource-constrained environments.

El mejoramiento de la capacidad básica para la reglamentación farmacológica mediante el fortalecimiento de los sistemas de reglamentación plantea un reto especialmente difícil en contextos de escasos recursos. Una posible solución radica en la “regionalización”, proceso según el cual países con un mismo legado histórico, cultural y lingüístico y con situaciones económicas semejantes colaboran entre sí con objeto de establecer sistemas más eficientes. En el presente informe se describe el Sistema de Reglamentación del Caribe (SRC), iniciativa de regionalización que se está poniendo en marcha en los países de la Comunidad y el Mercado Común del Caribe (CARICOM), pequeños en su mayoría. La iniciativa representa una medida innovadora por fortalecer los sistemas de reglamentación en el Caribe, donde la capacidad existente es más modesta que en otras subregiones de las Américas. En el concepto y diseño de la iniciativa hay elementos y pasos destinados a fomentar la sostenibilidad en contextos de escasos recursos. Estos consisten en aprovechar las plataformas ya existentes para la cooperación, gobernación e infraestructura centralizadas; fortalecer las capacidades de reglamentación que puedan tener la mayor incidencia sobre la salud pública; incorporar políticas que fomenten la confianza en los organismos de reglamentación; modificar el sistema para alentar a la industria a comercializar sus productos en el CARICOM (por ejemplo, utilizando un punto de entrada centralizado para aligerar las cargas reglamentarias); y fortalecer la capacidad en materia de recursos humanos. Si se pone en práctica adecuadamente, el SRC se financiará a sí mismo con las cuotas de los usuarios. La experiencia y las enseñanzas extraídas hasta el momento con la puesta en marcha de esta iniciativa, que se describen en el presente informe, pueden ser útiles como estudio de caso para la formulación de iniciativas afines orientadas a fortalecer la capacidad de reglamentación en entornos de pocos recursos.

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In the Region of the Americas, access to medicines and other health technologies constitutes a priority for countries as they continue to move towards universal access to health and universal health coverage. Ensuring the availability of affordable medicines and health technologies within health services is required as part of the comprehensive approach to disease prevention and control. Through the adoption of pharmaceutical policies and strategies at the national level, governments establish the framework that will ensure equitable access and affordability of medicines and health technologies, while promoting their rational use. Core to such policies and strategies is the principle of quality, safety and efficacy. The pharmaceutical and health technology sector plays a critical role in the health promotion and protection by ensuring that those products and technologies made available through the health systems respond to international norms of quality and safety. The role of the government, and in particular the ministry of health, jointly with interested stakeholders, is to create a regulatory environment that guarantees the quality of the product throughout its life cycle, to ensure patient safety and optimize health outcomes. As globalization continues, with an ever increasing flow of people and products across borders, product quality and safety becomes a co-responsibility between countries and interconnected regulatory systems—nationally, regionally and globally. The regulatory landscape for medicines and health technologies is complex, given the multiple different types of product (medicines, biologicals, medical devices, etc.), the co-existing of single, limited and multiple source products within the market, the increasing technological complexity of new products entering the market (genomic, biotechnical products, etc.), and the critical array of regulatory functions (clinical studies, manufacturing, distribution, post marketing surveillance, etc.)...

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En la Región de las Américas, el acceso a los medicamentos y otras tecnologías sanitarias constituye una prioridad para los países en su avance hacia el acceso universal a la salud y la cobertura universal de salud. Es necesario asegurar la disponibilidad de medicamentos y tecnologías sanitarias asequibles dentro de los servicios de salud como parte del abordaje integral de la prevención y el control de las enfermedades. Mediante la adopción de políticas y estrategias farmacéuticas a nivel nacional, los gobiernos establecen el marco que garantizará el acceso equitativo y la asequibilidad de los medicamentos y las tecnologías sanitarias, al tiempo que promueve su uso racional. El principio de calidad, seguridad y eficacia ocupa un papel central en tales políticas y estrategias. El sector farmacéutico y de la tecnología sanitaria desempeña una función crucial en la promoción y protección de la salud al asegurar que los productos y tecnologías que se ponen a disposición de las personas por intermedio de los sistemas de salud respondan a las normas internacionales de calidad y seguridad. La función del gobierno y en particular del ministerio de salud, conjuntamente con los interesados directos, es crear un entorno de regulación que garantice la calidad del producto a lo largo de toda su vida útil, garantizar la seguridad para el paciente y optimizar los resultados en materia de salud...

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The Caribbean's long history of cooperation in health now focuses on noncommunicable diseases (NCDs), given that Caribbean Community (CARICOM) countries have the highest NCD burden in the Americas. The heads of government convened a first in the world one-day summit on NCDs, largely due to advocacy by George Alleyne and others, on the health, social, and economic impact of NCDs; the need for upstream multisectoral interventions to address the common, multifactoral risks; and the need for increased global attention to NCDs. Implementation of the NCD Summit Declaration mandates was most effective in larger countries with greater capacity, but countries of all sizes performed well, when they had regional or global support. Progress was limited in regional approaches to food security, labeling, and elimination of trans fats. Inadequate funding stymied several resource-dependent interventions. Monitoring mechanisms were established, but more concrete goals are needed, especially for actions of nonhealth government agencies.

La larga trayectoria de cooperación de los países del Caribe en materia de salud se centra ahora en las enfermedades no transmisibles (ENT), puesto que los países integrantes de la Comunidad del Caribe (CARICOM) soportan la mayor carga de estas enfermedades en la Región de las Américas. Los jefes de gobierno convocaron una cumbre de un día, la primera del mundo, sobre las ENT, en gran parte gracias a la tarea de concientización llevada a cabo por George Alleyne y otros, con objeto de tratar las repercusiones sanitarias, sociales y económicas de las ENT; la necesidad de intervenciones multisectoriales tempranas para abordar los riesgos comunes y multifactoriales; y la necesidad de que se conceda mayor atención a las ENT a escala mundial. La ejecución de los mandatos de la Declaración de la Cumbre sobre las ENT fue más eficaz en los países más grandes y con mayor capacidad, pero países de distintos tamaños actuaron satisfactoriamente cuando contaron con la ayuda regional o mundial. En los enfoques regionales, el progreso se limitó a la seguridad alimentaria, la rotulación y la eliminación de las grasas trans. El financiamiento insuficiente obstaculizó diversas intervenciones que dependían del aporte de recursos. Se establecieron mecanismos de vigilancia, pero es preciso establecer metas más concretas, especialmente en lo referente a las actividades de los organismos gubernamentales de ámbitos ajenos a la salud.

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Approximately 55% of malaria infections in the Guyana Amazon region are attributed to Plasmodium falciparum while the other 45% are attributed to non-falciparum, mostly Plasmodium vivax. However, little is known about the P. vivax strain types circulating in the region. Using PCR for Plasmodium detection and two genetic markers specific to P. vivax to detect the polymorphic circumsporozoite protein (CSP) and the conserved 19-kDa region of the merozoite surface protein-1 (MSP-1), we investigated the overall Plasmodium strain distribution and population diversity within P. vivax in isolates collected from the blood of infected individuals in the interior Amazon region of Guyana, South America. Out of a total of 250 samples positive for Plasmodium, P. vivax was detected in 30% (76/250) and P. falciparum was detected in 76% (189/250). Mixed infections containing both P. falciparum and P. vivax constituted 6% (15/250) of the total positive samples. Further analysis of P. vivax strains showed that 92% (56/61) of the P. vivax samples hybridized with a probe specific to type VK210, 39% (24/61) hybridized with a probe specific for type VK247, and 25% (15/61) hybridized with a probe specific for the P. vivax-like CS genotype. DNA sequencing of the 19-kDa C-terminal domain in block 13 of MSP-1 amplified from 61 samples from patients infected with P. vivax demonstrated that this region is highly conserved, and all samples were identical at the nucleotide level to the Belem and Salvador-1 types. No synonymous or nonsynonymous mutations were observed in this region of the gene, indicating that current vaccine-development efforts based on the MSP-1(19) fragment would be applicable in Guyana.

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