EMA Consultation Response | 17 May, 2017 | Download PDF

As recalled in the proposed revised Policy 0043, openness and transparency are fundamental European Union values. In this regard, all efforts by the European Medicines Agency (EMA) to stick to these values are welcome.

For the purpose of enhancing transparency, we invite the EMA to set up and maintain a comprehensive public register of all documents it holds. As pointed out by the European Ombudsman, “the aim of a public register is to enable the public to gain detailed and up-to-date knowledge of the documents, or at least the type of documents, that an institution holds. This knowledge facilitates members of the public to exercise their fundamental right to request access to documents.

At line 51, it is noted that the consultation on EMA’s access to documents policy excludes requests for information from the scope of this policy because they are handled in accordance with the EMA Code of Conduct. However, later in the document, aspects relating to requests for information are outlined. This is confusing and should be… (read more)