Involving patients and consumers in Swissmedic’s regulatory processes: From information sharing to participation

Gabriela Zenhäusern, Lukas Jaggi
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Abstract

The COVID-19 pandemic has highlighted the value of public engagement as a way of building confidence in innovative treatments, diagnostics, and vaccines for coronavirus-induced disease that have been brought to market readiness within a very short space of time. Developing public trust and engagement extends beyond providing transparent research results and evidence-based information to creating a framework for a dialogue that includes patients’ perspectives. Whereas frameworks exist in the US, the UK, the Netherlands, and Germany, systematic patient involvement in Switzerland’s healthcare system is still taking root. Even though Swiss policymakers acknowledge the importance of stakeholder involvement in healthcare, tangible, overarching forms and systems of participation are only gradually being rolled out. Swissmedic, the Swiss Agency for Therapeutic Products, is also tackling the issue of how to integrate patients and the public into its regulatory processes. As it responds to this issue, Swissmedic aims to not only adopt current approaches but also actively create solutions that give patients a voice and incorporate their experiences and concerns into regulatory processes wherever possible.
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让患者和消费者参与瑞士医疗监管流程:从信息共享到参与
2019冠状病毒病大流行凸显了公众参与的价值,公众参与是建立信心的一种方式,可以在很短的时间内将针对冠状病毒引起的疾病的创新治疗方法、诊断方法和疫苗推向市场。发展公众信任和参与不仅要提供透明的研究结果和基于证据的信息,还要建立一个包括患者观点的对话框架。尽管美国、英国、荷兰和德国都有相关框架,但瑞士医疗保健系统中系统性的患者参与仍在生根发芽。尽管瑞士政策制定者承认利益相关者参与医疗保健的重要性,但具体的、总体的参与形式和体系只是逐步推出。瑞士药品管理局(Swiss Agency for Therapeutic Products)也在解决如何将患者和公众纳入其监管流程的问题。在应对这一问题时,Swissmedic的目标不仅是采用当前的方法,而且还积极创造解决方案,让患者发出自己的声音,并尽可能将他们的经验和关切纳入监管过程。
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The PES-SLEEP project: A practical approach to the categorisation challenge for studies with medical devices Challenges facing Switzerland’s medical technology industry following the 2021 changes to medical device legislation Swissmedic’s experience with the regulatory changes for clinical investigations with medical devices implemented in 2021 Patient input into medical device development: A missed opportunity Regulatory developments in the medical devices sector: A long and difficult journey
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