What is the value of including vulnerable people in risk regulation decision-making in the European Union (EU)? This article examines a distinctive approach employed by the European Medicines Agency (EMA): public hearings integrated within safety reviews of medicinal products. The article presents findings from a case study of the EMA’s public hearing on Quinolone antibiotics, which was included by the EMA as part of a review process that led to significant tightening of regulatory restrictions on the prescribing of this class of antibiotics. The article argues that the public hearing enabled a group of patients who had been victims of a debilitating toxicity syndrome associated with Quinolone antibiotics to criticise the existing scientific evidence base around the safety of Quinolone. Deploying the quantitative Discourse Quality Index and an interpretive analytical approach, the article shows how patients challenged the evidence base in a manner that was efficacious in advancing knowledge in this area of risk regulation. When physically staged alongside interventions by professional experts, the article argues that patients facilitated a process of “negotiation” of expertise, leading professional representatives to propose methods of coordination in order to integrate the patients’ qualitative evidence of their suffering with the toxicity syndrome. Ultimately, this process led to the EMA proposing more stringent future guidelines for the prescription of Quinolone antibiotics in the EU.

将弱势群体纳入欧盟 (EU) 的风险监管决策有何价值？本文探讨了欧洲药品管理局 (EMA) 采用的一种独特方法：将公开听证会纳入医药产品的安全审查中。这篇文章介绍了 EMA 关于喹诺酮类抗生素的公开听证会的案例研究结果，EMA 将其纳入审查过程，导致对此类抗生素处方的监管限制显着收紧。文章认为，公开听证会使一群患有与喹诺酮类抗生素相关的衰弱性毒性综合症的患者能够批评围绕喹诺酮类抗生素安全性的现有科学证据基础。本文采用定量话语质量指数和解释性分析方法，展示了患者如何以有效推进这一风险监管领域知识的方式挑战证据基础。当与专业专家的干预一起进行物理分期时，文章认为，患者促进了专业知识“谈判”的过程，引导专业代表提出协调方法，以便将患者的痛苦与毒性综合症的定性证据结合起来。最终，这一过程导致 EMA 为欧盟的喹诺酮类抗生素处方提出了更严格的未来指南。这篇文章展示了患者如何以一种有效地推进风险监管领域知识的方式挑战证据基础。当与专业专家的干预一起进行物理分期时，文章认为，患者促进了专业知识“谈判”的过程，引导专业代表提出协调方法，以便将患者的痛苦与毒性综合症的定性证据结合起来。最终，这一过程导致 EMA 为欧盟的喹诺酮类抗生素处方提出了更严格的未来指南。这篇文章展示了患者如何以一种有效地推进风险监管领域知识的方式挑战证据基础。当与专业专家的干预一起进行物理分期时，文章认为，患者促进了专业知识“谈判”的过程，引导专业代表提出协调方法，以便将患者的痛苦与毒性综合症的定性证据结合起来。最终，这一过程导致 EMA 为欧盟的喹诺酮类抗生素处方提出了更严格的未来指南。领导专业代表提出协调方法，以整合患者的中毒综合症痛苦的定性证据。最终，这一过程导致 EMA 为欧盟的喹诺酮类抗生素处方提出了更严格的未来指南。领导专业代表提出协调方法，以整合患者的中毒综合症痛苦的定性证据。最终，这一过程导致 EMA 为欧盟的喹诺酮类抗生素处方提出了更严格的未来指南。