University of Toronto, Suite 130, 155 College Street, Toronto, M5T 1P8, Canada.
The University of Sydney, Sydney, Australia.
Global Health. 2022 Mar 18;18(1):33. doi: 10.1186/s12992-022-00822-8.
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.
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.
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.
公共部门药品政策和实践的治理薄弱,限制了基本药物的可及性,推高了药品价格,浪费了稀缺的卫生系统资源。药品体系在技术上很复杂,涉及私营部门和公共部门之间的广泛互动。对于公共部门药品委员会的成员来说,与私营部门的关系可能导致利益冲突,这可能会使决策带有商业偏见,从而损害公共卫生目标和卫生系统的可持续性。我们在 2020 年 9 月至 2021 年 3 月期间对世卫组织东南亚区域(世卫组织东南亚区域)十个国家(孟加拉国、不丹、印度、印度尼西亚、马尔代夫、缅甸、尼泊尔、斯里兰卡、泰国和东帝汶)的公共制药部门的利益冲突政策和做法进行了描述性、定性研究。
我们确定了 45 份政策和监管文件,并将文件数据与 21 次专家访谈进行了三角剖分。主要知情人根据本国制药行业的特点、市场规模以及与国内制药行业相关的国家经济目标,表达了非常不同的治理重点和利益冲突关切。公共部门药品政策和法规一致规定,药品委员会成员须披露相关利益,但对应当申报哪些内容、何时申报以及申报频率、以及是否对申报进行评估以及由谁进行评估等问题,几乎没有详细规定。除了少数几个关键的采购流程外,预防或管理利益冲突的流程不如披露流程发达。在规定了管理利益冲突的流程的地方,主要策略是让有利益冲突的委员会成员回避相关工作。政策很少规定委员会成员应放弃或摆脱利益冲突。
强有力的利益冲突预防和管理流程可以确保决策的完整性,并建立公众对实现公共卫生目标的药品流程的信任。上游方法,包括支持性立法框架、建立监督机构和加强监管机构,也有助于建立透明、问责和信任的文化。