Abstract
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.
Highlights
For health innovations to have their full impact, they must reach those in need
product development partnerships (PDPs) have generally translated this vision into catalytic support both for global policy change and, in a limited number of countries, for activities which could lead to decisions on use, and support uptake and introduction of the resulting products
After defining country decision making, we investigate the various roles for PDPs, how those roles are prioritized geographically, the partnerships required, and the specific approaches used by a number of PDPs
Summary
For health innovations to have their full impact, they must reach those in need. This job of achieving access is a multifaceted endeavor [1,2,3] requiring consideration of issues such as financing [4], manufacturing [5], pricing [6], international policies [7], regulatory approval [8], translational research [9], end-user acceptance [10] and a strategic communication approach to decision makers [11]. Define a clear, step-wise and timely process for country decision-making in general (in a particular disease or intervention area) and for adoption of new products .
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