The European Medicines Agency: A public Health European Agency?

Aurélie Mahalatchimy (1) , Emmanuelle Rial-Sebbag (2) , Nathalie de Grove-Valdeyron , Virginie Tournay (3) , Anne Cambon-Thomsen (2) , Anne-Marie Duguet , Florence Taboulet

1 PACTE - Pacte, Laboratoire de sciences sociales
2 INSERM - Institut National de la Santé et de la Recherche Médicale
3 CEVIPOF - Centre de recherches politiques de Sciences Po (Sciences Po, CNRS)

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.

Keywords: European Medicines Agency; Assessment; Transparency; Precaution; Independence

Domains: Sociology; Political science

Aurélie Mahalatchimy, Emmanuelle Rial-Sebbag, Nathalie de Grove-Valdeyron, Virginie Tournay, Anne Cambon-Thomsen, et al.. The European Medicines Agency: A public Health European Agency?. Medicine and Law Journal, 2012, 31 (1), pp.25 - 42. ⟨hal-01560579⟩