Mahalatchimy Aurélie, Rial-Sebbag Emmanuelle, De Grove-Valdeyron Nathalie, Tournay Virginie, Cambon-Thomsen Anne, Duguet Anne-Marie, Taboulet Florence
Pacte Politique - Organisations Department Umr 5194, Institut D'etudes Politiques/F-38040 Grenoble Cedex 9.
Med Law. 2012 Mar;31(1):25-42.
The European Medicines Agency (EMA) is a European Agency as it is a decentralized body governed by European public law; it has its own legal personality and is also distinct from the European Union institutions (Council, Parliament, Commission, etc.). The EMA presents itself, and is commonly recognised, as a public health agency. This is notably supported by its recent transition from the Regional Direction of Research to the Regional Direction of Public Health. Four recognized principles of public health can be identified as such: assessment, transparency, precaution and independence. These principles appear to be closely linked to those forming the basis of good European governance regarding agencies: efficacy, coherence, openness, participation and responsibility. Thus, it is interesting to study how these principles are applied by the EMA in order to assess the reality of its qualification as a Public Health European Agency. The principles of assessment and transparency seem to be largely applied whereas the principles of precaution and independence are more problematic.
欧洲药品管理局（EMA）是一个欧洲机构，因为它是一个由欧洲公法管辖的分散型机构；它拥有自己的法人资格，并且也有别于欧盟各机构（理事会、议会、委员会等）。EMA自称为并且通常被公认为是一个公共卫生机构。其最近从研究区域司向公共卫生区域司的转变尤其支持了这一点。可以确定有四项公认的公共卫生原则：评估、透明度、预防和独立性。这些原则似乎与构成欧洲有关机构良好治理基础的原则紧密相连：效力、一致性、开放性、参与性和责任性。因此，研究EMA如何应用这些原则以评估其作为欧洲公共卫生机构资格的实际情况是很有意思的。评估和透明度原则似乎得到了广泛应用，而预防和独立性原则则更成问题。
