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24 January 2020Big PharmaEdward Pearcey

CJEU upholds EMA’s right to publish drug firms’ clinical trial data

The Court of Justice of the European Union (CJEU) has rejected two appeals that would have restricted the European Medicines Agency’s right to publish a pharmaceutical company’s clinical trial data, as it relates to their applications to market their products within the EU.

The court confirmed the “right of access to documents contained in the file of a marketing authorisation application for a medicinal product”, after being asked to examine the question of access to EU documents submitted in this context.

Two appeals, brought by PTC Therapeutics International and MSD Animal Health Innovation and Intervet International, were dismissed after the CJEU found the rejected the appellants’ claim that that the “reports at issue were covered by a general presumption of confidentiality”, whereby access to documents can be refused without the institution or body involved needing to carry out an in-depth examination of the documents requested, as way to protect sensitive information.

The court argued that the EMA was not obliged to apply such a presumption to those reports.

According to statement released by the court, both cases concern “the legality of the EMA’s decisions to grant, under Regulation No 1049/2001, access to a number of documents, namely toxicology reports and a clinical study report, submitted by the appellants in the context of their MA applications relating to two medicinal products, one for human use (Case C-175/18 P) and the other for veterinary use (Case C-178/18 P).”

After authorising those medicinal products, the EMA decided to disclose the content of those reports to third parties, subject to some redactions.

The court thus concluded that the “application of a general presumption of confidentiality is merely an option for the institution, body, office or agency concerned and the latter always retains the possibility of carrying out a specific and individual examination of the documents in question to determine whether they are protected, in whole or in part, by one or more of the exceptions laid down in Article 4 of Regulation No 1049/2001,” said a statement from the court.

The CJEU also said an objection to access must explain the nature, purpose and scope of the data whose disclosure would undermine commercial interests.

The CJEU concluded, upholding the reasoning of the General Court, that the “passages in the reports at issue which had been disclosed did not constitute information capable of falling within the exception relating to the protection of commercial interests”.

The original 2018 ruling was passed by the EU General Court, and upheld the EMA’s open data policy. The EMA oversees the evaluation and supervision of medicinal products within the EU.

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