Unit of Medicines and Health Technologies, Health Systems and Services, Pan American Health Organization/World Health Organization, Washington, District of Columbia, USA.
BMJ Glob Health. 2020 Mar 2;5(2):e001912. doi: 10.1136/bmjgh-2019-001912. eCollection 2020.
Countries should ensure equitable access to quality medicines. Regulatory systems for medicines and other health technologies are an essential part of well-functioning health systems and are a requisite for achieving Universal Health and the Sustainable Development Goals. The Pan American Health Organization, the World health Organization (WHO) regional office for the Americas, has assessed national regulatory capacities using a precursor of WHO Global Benchmarking Tool, and conducted an analysis of the data which suggests an association of regulatory capacity with population and the size of the economy. Regulatory capacity tends to decrease as population and gross domestic product decreases. This predominantly impacts the Caribbean sub-region in the Americas, which includes many states with small populations and economies. This paper will use the World Bank's term 'small states' to refer to countries with 1.5 million people or less and other larger countries that face similar challenges. The regulatory challenges of small states include small markets and limited human and financial resources. However, small states can build regulatory systems with a narrower scope that are less resource intensive and still ensure appropriate regulation and oversight. The approach should be tailored to accomplish a subset of WHO recommended essential functions, including marketing authorisation, licensing of establishments and postmarket surveillance/pharmacovigilance, depending on the need to oversee local manufacturing, which requires a comprehensive system. The approach should also include adoption of efficiencies, such as regionalisation and reliance. This model is currently being put in practice in the small states of the Caribbean Community and Pacific Islands and can inform other small states around the world.
各国应确保公平获得高质量的药品。药品和其他卫生技术的监管体系是健全卫生系统的重要组成部分，也是实现全民健康和可持续发展目标的必要条件。泛美卫生组织（美洲世界卫生组织区域办事处）使用世界卫生组织全球基准工具的前身评估了各国的监管能力，并对数据进行了分析，表明监管能力与人口和经济规模之间存在关联。监管能力往往随着人口和国内生产总值的减少而下降。这主要影响到美洲的加勒比次区域，其中包括许多人口和经济规模较小的国家。本文将使用世界银行的术语“小国”来指代人口在 150 万或以下的国家和面临类似挑战的其他较大国家。小国的监管挑战包括市场规模小、人力资源和财力有限。然而，小国可以建立监管范围较窄、资源密集度较低的监管系统，仍然可以确保适当的监管和监督。这种方法应根据监督本地生产的需要进行调整，以实现世界卫生组织推荐的一系列基本功能，包括营销授权、机构许可和上市后监测/药物警戒，这需要一个全面的系统。该方法还应包括采用效率，如区域化和依赖关系。这种模式目前正在加勒比共同体和太平洋岛屿的小国家中实施，并可以为世界各地的其他小国家提供借鉴。
