The European Court of Justice upholds the decision on interim suspension of access to clinical data, etc.

The European Court of Justice ("ECJ") upholds two decisions from the General Court, which determined that requests for access to documents should not be granted.

In the two cases, the EMA had granted access to clinical studies relating to the medicinal product TranslarnaTM (Ataluren) and to toxicological studies of the veterinary medicinal product, Bravecto® (fluralaner) pursuant to Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents. The studies were submitted as part of the application for marketing authorisation.

The marketing authorisation holders initiated accordingly an action for annulment before the General Court in order to have the decision on access to documents annulled. At the same time as the request of annulment, the Court was requested to prohibit the EMA from publishing the documents as the case was pending. The requests were granted by the Court, however, the EMA appealed the decision to the ECJ.

The ECJ has now upheld the Court's decision. Essentially, the ECJ referred to that the public's interest to have access to the documents did not counterbalance the claim for confidentiality as long as the case was pending.

The ECJ states that the Court did not make a mistake when grounding its decision on a general presumption on confidentiality regarding the studies in question. The ECJ will have to make a final decision on the question of access to documents later on.

The cases have to be seen in the light of EMA's new policy on publication of clinical data, after which the EMA proactively publishes clinical trials. A previous newsletter regarding EMA's new policy is attached to this email. In its policy on publication of clinical data, the EMA has, in accordance with the Regulation on Medicines, undertaken not to publish confidential information.

Therefore, it is of great importance whether there is a general presumption that the submitted documents are confidential or not. It will be interesting to follow how the cases develop before the ECJ.

Read the ECJ's decision regarding TranslarnaTM here

Read the ECJ's decision regarding Bravecto® here

Read the EMA's policy on publication of clinical data here

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