Table 1 Examples of country decision making activities

Background information

• Define national health priorities.

• Conduct research to understand priority of disease area, generally, and likely desire for proposed product, specifically.

• Obtain information on the future products that are likely to become available.

• Disseminate product and pipeline information.

Process and people

• Ensure a decision-making body (or person) is identified, active, and has members empowered to make decisions based upon available evidence.

• Facilitate awareness raising and transparent information sharing among appropriate stakeholders.

• Define a clear, step-wise and timely process for country decision-making in general (in a particular disease or intervention area) and then for adoption of new products specifically.

Evidence base

• Define the specific evidence base required for decision making, including local data requirements.

• Determine what information is expected to be needed for national decision-making (e.g., what efficacy endpoints).

• Make plans to generate this required local evidence base.

• Integrate consideration of these information needs into R&D activities. This affects, for example, clinical trial planning, development of regulatory strategies, and post-introduction strategies to monitor safety and impact.

• Assist countries to define data needs and gaps, including clarifying if the information (e.g., on program and budget impact) should be generated in a country or internationally.

• Gather and disseminate a standard evidence package informing decision making, or see that others do so. The data should come from a source or partnership that is credible to countries.

• Train key personnel to respond to questions about the data or lack thereof.

• Address concerns that are common across countries (e.g., price, cost-effectiveness, ease of use, source and geography of manufacturing, and impact on supply chain and existing program delivery).