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Adoption of new health products in low and middle income settings: how product development partnerships can support country decision making

机译：在中低收入环境中采用新的保健产品：产品开发伙伴关系如何支持国家决策

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摘要

When a new health product becomes available, countries have a choice to adopt the product into their national health systems or to pursue an alternate strategy to address the public health problem. Here, we describe the role for product development partnerships (PDPs) in supporting this decision-making process. PDPs are focused on developing new products to respond to health problems prevalent in low and middle income settings. The impact of these products within public sector health systems can only be realized after a country policy process. PDPs may be the organizations most familiar with the evidence which assists decision making, and this generally translates into involvement in international policy development, but PDPs have limited reach into endemic countries. In a few individual countries, there may be more extensive involvement in tracking adoption activities and generating local evidence. This local PDP involvement begins with geographical prioritization based on disease burden, relationships established during clinical trials, PDP in-country resources, and other factors. Strategies adopted by PDPs to establish a presence in endemic countries vary from the opening of country offices to engagement of part-time consultants or with long-term or ad hoc committees. Once a PDP commits to support country decision making, the approaches vary, but include country consultations, regional meetings, formation of regional, product-specific committees, support of in-country advocates, development of decision-making frameworks, provision of technical assistance to aid therapeutic or diagnostic guideline revision, and conduct of stakeholder and Phase 4 studies. To reach large numbers of countries, the formation of partnerships, particularly with WHO, are essential. At this early stage, impact data are limited. But available evidence suggests PDPs can and do play an important catalytic role in their support of country decision making in a number of target countries.
机译：当有新的保健产品问世时，各国可以选择将该产品纳入其国家保健体系，或采取替代策略来解决公共保健问题。在这里，我们描述了产品开发合作伙伴关系（PDP）在支持此决策过程中的作用。 PDP致力于开发新产品，以应对中低收入环境中普遍存在的健康问题。这些产品在公共部门卫生系统中的影响只能在国家政策流程之后才能实现。 PDP可能是最熟悉有助于决策的证据的组织，通常转化为参与国际政策制定，但是PDP进入流行国家的机会有限。在少数几个国家中，可能会更广泛地参与跟踪收养活动并生成当地证据。 PDP的本地参与始于基于疾病负担，在临床试验期间建立的关系，PDP国内资源以及其他因素的地理优先级。 PDP采取的在流行国家建立办事处的策略从开设国家办事处到聘用兼职顾问或与长期或特设委员会合作不等。 PDP承诺支持国家决策后，方法会有所不同，但包括国家磋商，区域会议，组建区域性，针对特定产品的委员会，为国内倡导者提供支持，制定决策框架，向以下组织提供技术援助帮助修订治疗或诊断指南，以及进行利益相关者和第四阶段研究。为了覆盖众多国家，特别是与世卫组织建立伙伴关系至关重要。在此早期阶段，影响数据有限。但是现有证据表明，PDP可以并且确实在支持许多目标国家的国家决策中发挥重要的催化作用。

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