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

Chukwuemeka A Umeh,Veronika J Wirtz,Ovi Wagh,Richard Laing,Peter C Rockers

doi:10.1186/s40545-020-0204-z

Chukwuemeka A Umeh, Veronika J Wirtz + Show 3 more

Open Access

https://doi.org/10.1186/s40545-020-0204-z

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Abstract

BackgroundThere has been increased demand for greater public accountability and transparency of private sector-led global health partnership programs. This study critically reviews and pilot tests the World Health Organization (WHO) medicine program checklist as a framework for public reporting and assessing of programs.MethodsWe reviewed each question on the WHO checklist for clarity and usability. Next, we pilot tested the subset of checklist questions focused on program assessment. We extracted and analyzed publicly available information on one randomly selected program from each of the 20 largest research-based biopharmaceutical companies. For each program, we assessed whether publicly available information allowed for an assessment of each relevant question in the checklist.ResultsChecklist questions fit in four main categories: [1] national health and development plans, needs, capacity, laws and policies; [2] financial, performance, and public accountability; [3] risk management and mitigation strategies; and [4] long-term sustainability. Nearly all (21 of 22) questions in the checklist require information best provided by companies; one question requires information best provided by governments.Programs frequently reported on the public health needs of their programs (100%), program objectives and activities (100%) and the actual or expected program outputs (95%). There was less information on program alignment with country plans and capacity (50%), detailed program monitoring and evaluation plan (20%), risks mitigation strategies (5%), program needs assessment (5%), and additional resources required from or contributed by government (0%).ConclusionThe WHO checklist of key considerations for evaluating proposals for access to medicine programs could be a useful framework for public reporting of program information as most of checklist questions ask for data that should be available to those leading the program. Further revisions of the WHO checklist will help refine it to improve clarity and content validity.

Highlights

There has been increased demand for greater public accountability and transparency of private sector-led global health partnership programs
While private sector companies are traditionally accountable to shareholders and investors, and public sector organizations are accountable to the political structures, there has been lack of public accountability and transparency of global health public-private partnership programs [6, 7]
The World Health Organization (WHO) checklist has four domains and 23 questions of key considerations to be taken into account by companies when providing information on access to medicine programs

Summary

Introduction

There has been increased demand for greater public accountability and transparency of private sector-led global health partnership programs. The number and scope of public health programs implemented by biopharmaceutical companies to promote access to care and medicines for people in low- and middle-income countries has increased in recent years [1]. This increase has triggered wider discussions on the gaps in program performance monitoring and evaluation [2, 3], public policies on the roles of the private sector [4], and public accountability including the absence of an assessment tool to guide governments in their review of program development, implementation and regulation [5]. When programs are open and forthcoming with information on all aspects of the program, this allows program assessment by stakeholders which helps to build public trust in the program [10]

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