On 23 March 2017, two interim orders were published prohibiting the disclosure of information by the Dutch Medicines Evaluation Board (MEB) to a third party under the Government Information Public Access Act (Wet Openbaarheid van Bestuur) (WOB). On 9 March, the Court of Utrecht granted the requests of Engelhard Arzneimittel GmbH and Kwizda Pharma GmbH to prohibit disclosure by the MEB of specific information related to the marketing authorisation procedures for their respective medicinal products, in particular the preliminary and final assessment report, the list of questions, the approved labelling and mock-ups, and the clinical overview.
A key question within these preliminary proceedings was whether the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has a derogatory effect on the application of the WOB. Applicants also argued that the MEB did not adequately apply the exclusion ground in the WOB preventing disclosure of commercially confidential information, and (in one of the proceedings) that disclosure was not in accordance with the HMA/EMA Guidance document on the identification of commercially confidential information and personal data within the structure of the marketing authorisation application.
The Court considered that the question of whether the information should be disclosed required more consideration than could be offered within the framework of preliminary proceedings, concluding that the question of whether the TRIPS agreement has a derogatory effect on the application of the WOB must be considered during the main proceedings. As the disclosure of information would have a definitive and irreversible effect, the Court in its interim order prohibited the disclosure by the MEB.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, March 2017 Issue (Thomson Reuters).