Preston Charles, Chahal Harinder S, Porrás Analia, Cargill Lucette, Hinds Maryam, Olowokure Babatunde, Cummings Rudolph, Hospedales James
Rev Panam Salud Publica. 2016 May;39(5):262-268.
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.
在资源有限的环境中，通过加强监管系统来提高药品和卫生技术监管的基本能力尤其具有挑战性。“区域化”——一种让具有共同历史、文化价值观、语言和经济状况的国家共同努力建立更高效系统的方法——可能是一个解决方案。本报告介绍了加勒比监管系统（CRS），这是一项在加勒比共同体和共同市场（加共体）多数小国实施的区域化倡议。该倡议是加强加勒比地区监管系统的一项创新举措，与美洲其他次区域相比，该地区的能力有限。该倡议的概念和设计包括一些旨在提高资源有限环境下可持续性的特点和步骤。后者包括：1）利用现有的集中合作、治理和基础设施平台；2）加强对公共卫生影响最大的监管能力；3）纳入促进依赖参考当局的政策；4）改变系统以鼓励行业在加共体销售其产品（例如，使用集中的进口门户以减轻监管负担）；5）建设人力资源能力。如果实施得当，CRS将通过用户收费实现自我维持。本报告中描述的到目前为止在实施该倡议过程中的经验和教训，可作为在资源有限环境中制定类似监管加强倡议的案例研究。
