Third-party Access to Documents of the EU Medicines Agency (cepInput)


On the basis of the Transparency Regulation, the CJEU has for the first time decided on third party access to documents submitted to the European Medicines Agency (EMA) by pharmaceutical companies. A cepInput explains the background and relevance of the CJEU proceedings and deals with the three main grounds for the decision in the "PTC Therapeutics" judgement.


The CJEU sets a high bar for a refusal of access. In doing so, it judges in favour of the greatest possible transparency and thus supports general efforts to achieve greater legitimacy of European decision-making processes. It acknowledges the risk of misuse of the data disclosed but does not take the appropriate action. With its ruling, the CJEU has established a disproportionate "duty of disclosure" for marketing authorisation holders.