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Table 1 Description of program information that would fulfil the requirements of the corresponding checklist question

From: Public reporting on pharmaceutical industry-led access programs: alignment with the WHO medicine programs evaluation checklist

 WHO checklistDescription of program information from companies that align with the checklist
Alignment with countries’ national health and development plans, needs, capacity, laws and policies
1The program serves a public health need.A description of the health problem the program is trying to solve.
2The policy objective is clear.Program objectives are clearly stated.
3The program aligns with health strategic plans and the general development agenda.aA description of how the program aligns with the country’s health strategic plan and/or development agenda. For multi-country programs, a description of how the program aligns with the Sustainable Development Goals or World Health Organization health goals might meet this requirement.
4The program is suitable for the existing infrastructure, capacity, environment and local context.a bA description of the design or implementation of programs in accordance with country laws, policies and practices might meet this requirement, e.g. treating patients using national treatment guidelines.
Just mentioning that the government and local stakeholders made inputs to the program design might not meet this requirement.
5Additional government resources (infrastructure, human resources or funding) that are required have been identified and are available.aA description of additional resources that are required from government e.g. human resources and infrastructure.
6The program does not divert resources away from other public health priorities.Information on how the additional resources that might be required from government will not adversely affect other public health priorities.
7The program has been compared to other approaches/programs/ programmes and has been found to be the most suitable.aA formal needs assessment should provide information on the suitability of the program.
Strong mechanisms to ensure financial, performance, and public accountability
1Roles and responsibilities for all stakeholders involved are clear.A description of the roles and responsibilities of all named stakeholders meets this requirement.
2The mechanisms for how the program will be carried out are clear.A description of program activities might meet this requirement.
However, a more detailed work plan showing the program activities, and the responsible party and timeline for each activity will be ideal.
3Those responsible for overseeing and monitoring the program have been identified.A mention of the party responsible for monitoring or evaluating the program might meet this requirement.
4The process for monitoring and evaluation has been established.A description of the process for monitoring and evaluation of the program. This may include a description of the performance indicators and data collection and processing strategies.
5Allocation, disbursement and utilization of financial resources have been defined.aThe program should provide information on the allocation, disbursement and utilization of financial resources. Reporting the amount that a program has spent or plan to spend might meet this requirement.
6Performance targets, outputs and results are defined.aReporting the performance targets and/or program outputs/outcomes meets this requirement e.g. number of persons the program plans to treat. For programs that are already being implemented, reporting both the performance target and the actual outputs and results is ideal.
7There is sufficient support for the program amongst political parties, unions, and civil society organizations.Government should provide this information.
8Measures to disclose information to the public, including procurement information, contractual obligations, evaluation criteria, progress reports, fund flows, commitments and timelines have been established.A description of the plan to make program information publicly available.
Providing program information through webpages, program reports, annual company reports, etc. might meet this requirement.
Strong risk management and mitigation strategies
1Risks have been identified.A description of the potential strategic, implementation, and sustainability risks, harm or unintended consequences might meet this requirement.
2Mitigation strategies for each risk, have been developed.A description of how to mitigate any potential strategic, implementation, and sustainability risks, harm or unintended consequences might meet this requirement.
3Due diligence on industry partner has been conducted (including financial, managerial and implementation capacity assessments).Company provides information on how it assessed and selected its partners.
4Potential conflicts of interest have been identified.A description of any potential conflict of interest meets this requirement such as potential conflicts between business interests and social interests (program goals).
Clear transitioning plans for long-term sustainability
1The program is or will be integrated into the health system.A description of how the program will be integrated into the health system meets this requirement e.g. incorporating the program’s training curriculum for midwives into the national training curriculum. A program that is supporting an existing government program might meet this requirement.
2A clear transition plan for when the program ends has been developed.A description of how the program will transition to the local community/government or made self-sustaining when the funding has ended meets this requirement. For example, having training participants pay a training fee to sustain the program.
3A strategy to ensure sustainability of health gains has been developed.A description of how the program will ensure sustainability of the health gains meets this requirement e.g. training local health providers to train other providers who will continue to provide care after the program has ended.
A program that ensures local ownership of the program might meet this requirement.
A pricing scheme where patients pay part of the cost of the medicine might meet this requirement.
A licensing agreement that leads to lower prices for patients might meet this requirement.
  1. aDouble- or multi-barreled questions (questions that had two or more concepts in a single question)
  2. b We combined two questions: “The initiative can be implemented under existing legislation and it adheres to national regulations, procurement procedures, treatment guidelines, and standards of care, quality and safety requirements, remuneration scales and hiring practices” and “The program is suitable for the existing infrastructure, capacity, environment and local context” into one question because of their similarity. Only if both statements applied, we checked this item
  3. Note: “The policy objective is clear”: for the purposes of this study, we considered program that provided information on their program objectives as having answered the question