Bloom Gerald, Henson Spencer, Peters David H
Institute of Development Studies, University of Sussex, Brighton, East Sussex BN1 9RE, UK.
Global Health. 2014 Jun 24;10:53. doi: 10.1186/1744-8603-10-53.
The rapid evolution and spread of health markets across low and middle-income countries (LMICs) has contributed to a significant increase in the availability of health-related goods and services around the world. The support institutions needed to regulate these markets have lagged behind, with regulatory systems that are weak and under-resourced. This paper explores the key issues associated with regulation of health markets in LMICs, and the different goals of regulation, namely quality and safety of care, value for money, social agreement over fair access and financing, and accountability. Licensing, price controls, and other traditional approaches to the regulation of markets for health products and services have played an important role, but they have been of questionable effectiveness in ensuring safety and efficacy at the point of the user in LMICs. The paper proposes a health market systems conceptual framework, using the value chain for the production, distribution and retail of health goods and services, to examine regulation of health markets in the LMIC context. We conclude by exploring the changing context going forwards, laying out implications for future heath market regulation. We argue that the case for new approaches to the regulation of markets for health products and services in LMICs is compelling. Although traditional "command and control" approaches will have a place in the toolkit of regulators, a broader bundle of approaches is needed that is adapted to the national and market-level context of particular LMICs. The implication is that it is not possible to apply standard or single interventions across countries, as approaches proven to work well in one context will not necessarily work well elsewhere.
健康市场在低收入和中等收入国家（LMICs）的迅速演变和传播，促使全球与健康相关的商品和服务供应量显著增加。而监管这些市场所需的支持机构却滞后了，其监管体系薄弱且资源不足。本文探讨了与低收入和中等收入国家健康市场监管相关的关键问题，以及监管的不同目标，即医疗质量与安全、性价比、公平获取和融资方面的社会共识以及问责制。许可、价格管制和其他传统的健康产品及服务市场监管方法发挥了重要作用，但在确保低收入和中等收入国家用户端的安全性和有效性方面，其效果存疑。本文提出了一个健康市场系统概念框架，利用健康商品和服务生产、分销及零售价值链，来审视低收入和中等收入国家背景下的健康市场监管。我们通过探讨未来不断变化的背景得出结论，阐述对未来健康市场监管的影响。我们认为，在低收入和中等收入国家采用新的健康产品及服务市场监管方法的理由很充分。尽管传统的“命令与控制”方法在监管机构的工具包中仍将占有一席之地，但需要一套更广泛的、适应特定低收入和中等收入国家国情及市场层面情况的方法。这意味着不可能在各国应用标准或单一干预措施，因为在一种情况下被证明有效的方法在其他地方不一定有效。
