11 / 02 / 2020 - 13:10

The CJEU: no presumption of confidentiality for pharmaceutical companies’ clinical and toxilogical data in applications for marketing authorisations

News type
On 22 January 2020, the CJEU issued a decision on a fundamental question regarding the confidentiality of data (and the right of access to documents containing such data) submitted by pharmaceutical companies when applying for marketing authorisations for pharmaceutical products.

The Court’s decisions concerned two cases in which two pharmaceutical companies had initially complained to the European General Court that the European Medicines Agency (EMA) had unlawfully granted right of access to clinical and toxicological trials submitted by the two pharmaceutical companies in connection with their applications for marketing authorisations. 

The General Court reached the decision that there was no general presumption of confidentiality. Furthermore, the General Court found that the applicants had not specifically demonstrated that the access to the documents could “seriously” undermine the commercial interests of the applicants.

On 11 September 2019, the Advocate General gave his proposal for a decision in which he suggested that a presumption of confidentiality should apply.

As opposed to the Advocate General, the CJEU ruled in both decisions that the EMA and the General Court were not required to apply a general presumption of confidentiality in their decisions on access to documents. The EMA’s approach in assessing whether access to the specific documents should be granted was therefore correct, and the applicants’ view that the reports were covered by a general presumption of confidentiality was rejected. It should be mentioned that the EMA had, on its own initiative, made certain extractions of passages which the EMA considered to be confidential.

The CJEU also held that it is the responsibility of the person requesting the information to be kept confidential to specifically and precisely identify the passages that would allegedly harm commercial interests. This means that it is not enough to indicate that there is a general risk of abuse. On the other hand, it is not a requirement that it can be proven that such damage to commercial interests is "serious" as otherwise stated by the General Court.

Lundgrens believes that the decisions can be of great importance for the pharmaceutical companies' practical handling of applications for marketing authorisations. It is important that pharmaceutical companies assess which documents are considered confidential and provide the EMA with specific, precise, and reasoned grounds for confidentiality when applying for a marketing authorisation.