Hasnida Amalia, Bal Roland, Manninda Reise, Saputra Stanley, Nugrahani Yunita, Faradiba Faradiba, Kok Maarten Olivier
Department of Health Care Governance, Erasmus School of Health Policy and Management, Erasmus University Rotterdam, Rotterdam, The Netherlands.
Faculty of Pharmacy, Pancasila University, Jakarta, Indonesia.
Health Res Policy Syst. 2025 Feb 19;23(1):21. doi: 10.1186/s12961-025-01286-z.
Tackling falsified and substandard medicines requires intersectoral collaboration, impact-oriented research and the effective application of research findings. However, the best way to organize research and involve stakeholders from different sectors to ensure that results are used, remains unclear. We aimed to assess how intersectoral stakeholder engagement in research on medicine quality in Indonesia evolved, influenced the research processes and participants, and affected the uptake of the results.
For this prospective case study, we adopted an abductive approach inspired by contribution mapping and collaborative governance. We conducted 37 interviews with key informants, observed 24 meetings and analysed 121 documents to systematically map the engagement of stakeholders in a study on medicine quality, focusing on processes, influences and research-related contributions.
From the outset, it proved feasible, but challenging, to effectively engage stakeholders in research into falsified and substandard medicines in Indonesia. After a cautious start and persistent efforts, stakeholders, such as the national medicine regulatory authority, became increasingly involved and developed a shared understanding of the need for intersectoral collaboration to tackle problems with medicine quality. While the research findings did not lead to a different estimate of the magnitude of the problem, the involvement of stakeholders was beneficial. After formalizing the collaboration, stakeholders provided data needed to study potential risk factors, product varieties and sales volumes, and contributed to decisions during the research and interpretation of the findings. Owing to frequent personnel changes and diverging priorities, stakeholder engagement required more effort than anticipated, and necessitated a strategic and adaptive approach. This approach had to account for the varying priorities and interests of stakeholders, the evolving framing of the problem, the implications of the findings and the nature of the field, where regulators must operate cautiously, balance interests and respond to critical incidents.
Intersectoral stakeholder engagement in medicine quality research is challenging but beneficial. Engagement contributed to building trust and relationships between researchers and stakeholders, helped forge an intersectoral network focused on medicine quality, exposed the medicine regulator to new methods, inspired stakeholders to take on new roles and make better use of existing data and furthered a research-policy partnership forum on pharmaceutical topics.
应对假药和劣药问题需要跨部门合作、以影响为导向的研究以及研究结果的有效应用。然而，组织研究并让不同部门的利益相关者参与以确保结果得到应用的最佳方式仍不明确。我们旨在评估印度尼西亚跨部门利益相关者参与药品质量研究的情况是如何演变的，如何影响研究过程和参与者，以及如何影响研究结果的应用。
对于这项前瞻性案例研究，我们采用了一种受贡献映射和协作治理启发的溯因方法。我们对关键信息提供者进行了37次访谈，观察了24次会议，并分析了121份文件，以系统地梳理利益相关者在一项药品质量研究中的参与情况，重点关注过程、影响和与研究相关的贡献。
从一开始就证明，要有效地让利益相关者参与印度尼西亚假药和劣药的研究是可行的，但具有挑战性。在谨慎起步并持续努力之后，国家药品监管机构等利益相关者越来越多地参与进来，并对跨部门合作解决药品质量问题的必要性形成了共同理解。虽然研究结果并未导致对问题严重程度的不同估计，但利益相关者的参与是有益的。在合作正式确定后，利益相关者提供了研究潜在风险因素、产品品种和销量所需的数据，并在研究过程和结果解读过程中为决策做出了贡献。由于人员频繁变动和优先事项不同，利益相关者的参与比预期需要更多努力，因此需要一种战略和适应性方法。这种方法必须考虑到利益相关者不同的优先事项和利益、问题框架的演变、研究结果的影响以及该领域的性质，在该领域中监管机构必须谨慎行事、平衡利益并应对重大事件。
跨部门利益相关者参与药品质量研究具有挑战性，但有益处。这种参与有助于在研究人员和利益相关者之间建立信任和关系，有助于形成一个专注于药品质量的跨部门网络，使药品监管机构接触到新方法，激励利益相关者承担新角色并更好地利用现有数据，并推动了一个关于制药主题的研究 - 政策伙伴关系论坛。
