Kim Daria
Max-Plank Institute for Innovation and Competition, Munich, Germany.
Med Law Rev. 2017 Aug 1;25(3):456-483. doi: 10.1093/medlaw/fwx002.
This article reflects on the state of play as regards access to non-summary clinical trial data in the European Union (EU). In particular, it examines the scope of access under the recent transparency policies of the European Medicines Agency (EMA) that attempt to break away from the presumptively confidential treatment of clinical trial data. In light of the emerging case law of the Court of Justice of the European Union on clinical trial data disclosure, it remains highly uncertain what data, and under what conditions, can be lawfully released by the EMA. Under the applicable regulations, the scope of the accessible data depends on the interpretation of commercially confidential information-the notion derived from the exception to the fundamental right of access to documents. Accordingly, the analysis focuses on the application of this exception, taking into account the specifics of clinical data, the context in which disclosure occurs, and the interests that are at stake. The main complexity is found in defining the scope of the relevant and legitimate interests to be balanced when applying the exception. Overall, it is argued that the current regulatory framework does not provide a sufficient legal basis to support the objectives pursued by the EMA's policies.
本文反思了欧盟（EU）获取非摘要临床试验数据的现状。特别是，它审视了欧洲药品管理局（EMA）近期透明度政策下的获取范围，这些政策试图摆脱对临床试验数据假定的保密处理方式。鉴于欧盟法院关于临床试验数据披露的新判例法，EMA能合法发布哪些数据以及在何种条件下发布仍极不确定。根据适用法规，可获取数据的范围取决于对商业机密信息的解释，这一概念源自获取文件基本权利的例外情况。因此，分析聚焦于这一例外情况的适用，同时考虑临床数据的具体情况、披露发生的背景以及利害攸关的利益。主要的复杂性在于确定适用该例外情况时要平衡的相关和合法利益的范围。总体而言，有人认为当前的监管框架没有提供充分的法律依据来支持EMA政策所追求的目标。
