Disclosure, transparency, and accountability: a qualitative survey of public sector pharmaceutical committee conflict of interest policies in the World Health Organization South-East Asia Region

Abstract

Background Weak governance over public sector pharmaceutical policy and practice limits access to essential medicines, inflates pharmaceutical prices, and wastes scarce health system resources. Pharmaceutical systems are technically complex and involve extensive interactions between the private and public sectors. For members of public sector pharmaceutical committees, relationships with the private sector can result in conflicts of interest, which may introduce commercial biases into decision-making, potentially compromising public health objectives and health system sustainability. We conducted a descriptive, qualitative study of conflict of interest policies and practices in the public pharmaceutical sector in ten countries in the World Health Organization (WHO) South-East Asia Region (SEAR) (Bangladesh, Bhutan, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand, and Timor-Leste) between September 2020 and March 2021. Results We identified 45 policy and regulatory documents and triangulated documentary data with 21 expert interviews. Key informants articulated very different governance priorities and conflict of interest concerns depending on the features of their country’s pharmaceutical industry, market size, and national economic objectives related to the domestic pharmaceutical industry. Public sector pharmaceutical policies and regulations consistently contained provisions for pharmaceutical committee members to disclose relevant interests, but contained little detail about what should be declared, when, and how often, nor whether disclosures are evaluated and by whom. Processes for preventing or managing conflicts of interest were less well developed than those for disclosure except for a few key procurement processes. Where processes for managing conflicts of interest were specified, the dominant strategy was to recuse committee members with a conflict of interest from relevant work. Policies rarely specified that committee members should divest or otherwise be free from conflicts of interest. Conclusions Robust processes for conflict of interest prevention and management could ensure the integrity of decision-making and build public trust in pharmaceutical processes to achieve public health objectives. Upstream approaches including supportive legislative frameworks, the creation of oversight bodies, and strengthening regulatory institutions can also contribute to building cultures of transparency, accountability, and trust.

International comparison of pharmaceutical industry payment disclosures in the UK and Japan: implications for self-regulation, public regulation, and transparency

“…Corresponding with IFPMA’s declared emphasis on increasing transparency [ 49 , 51 , 93 ], the JPMA and ABPI presented transparency as disclosure’s primary aim. Nevertheless, it was unexplained how transparency was to be achieved; for example, how disclosures were expected to be used, by whom, and to what purpose [ 20 ]. Limited attention given to “transparency relations” [ 146 ] is also common in European public regulation, as evidenced by a lack of granular and easily interpretable disclosures in many countries [ 24 ].…”

“…Any legislation should be premised on a comprehensive international evaluation of disclosure rules , practices and data [ 24 , 46 , 55 , 175 ], including their unintended consequences [ 23 , 176 , 177 ]. One structured way of embedding the perspectives of HCPs, HCOs, patients, and members of the public into the policy proposals would involve developing a “theory of change” [ 178 ] capturing multifaceted relationships between disclosure, transparency, as well as the economic power of the industry and the state’s regulatory power [ 18 – 20 ]. In so doing, it is important to consider a range of potential goals of transparency, such as increasing the industry’s accountability to the public revealing potential FCOIs [ 21 , 24 , 26 , 55 , 106 ] and protecting the integrity of healthcare research or policymaking [ 20 , 146 , 179 ].…”

“…No less important are solutions addressing the underlying problem of financial dependency of healthcare actors on drug company funding [ 18 , 117 , 181 ]. Some of the available options include FCOI management policies such as limiting or banning certain forms of financial relationships [ 18 , 20 , 26 , 182 ].…”

“…However, these collaborations may generate financial conflicts of interest (FCOIs) biasing healthcare practice, research, education, and policy [ 15 – 17 ]. The main global response to these concerns is disclosure of drug company payments – including for consultancies, sponsorships, and grants – to healthcare professionals (HCPs) and organisations (HCOs) [ 18 – 20 ]. Payment disclosure involves different “transparency provisions”: (1) self-regulation, primarily voluntary codes of conduct developed and enforced by industry trade groups; (2) public regulation, typically sunshine legislation mandating drug companies to disclose certain payments to some recipient categories; or (3) their combination [ 18 , 21 – 25 ].…”