Request for information regarding EMA authorised pharmaceutical product refused in The Netherlands

02 March 2010

Machteld Hiemstra

The Dutch Medicines Evaluation Board (CBG), responsible for issuing marketing authorisations for medicinal products, has rejected a request under the Dutch Freedom of Information Act to provide information, such as internal memorandums, correspondence and minutes of meetings concerning the expedited authorisation procedure to authorise H1N1 vacines to the market by the EMEA under the centralised procedure laid down in Regulation 726/2004.

CBG was of the opinion that the request to obtain information about centrally authorised medicinal products should not be decided on the basis of national legislation, but on the basis of the legal regime implemented across the EU by Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents. CBG decided that this Regulation allows them to refer an applicant on the basis of Article 5 of this Regulation to EMEA directly, without taking any decision themselves. CBG substantiates their decision by referring to “Rules for the implementation of Regulation 1049/2001, where it is said that: “Whereas Article 73 of Regulation (EC) No 726/2004 foresees that Regulation (EC) No 1049/2001 (…) will apply to the Agency”.

Importantly, the CBG specifically notes that insofar as the request seeks to provide insight into internal documents and correspondence of the members of the Committee for Medicinal Products for Human Use, the CBG will treat such information as confidential, both during as well as after a marketing authorisation procedure is finalised, as they contain personal interpretations of policy. This is in line with the general view expressed by the CBG that information contained in product dossiers, as well as communications with the CBG or other regulatory authorities in the EU during the marketing authorisation process, is of a confidential nature in order to safeguard the confidential and/or commercially sensitive information of marketing authorisation holders. It is therefore advisable to substantiate in other ways any request relating to information that might be contained in a product dossier, as a requestor will have to overcome the CBG’s very strict operating rules in this regard.