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March 2020

On 22 January 2020, the Court of Justice of the European Union (CJEU) rendered judgment in two similar cases on the right of access of third parties to documents submitted to the European Medicines Agency (EMA).¹ The appellants had filed documents with the EMA when applying for a market authorisation for a medicinal product for human use and a veterinary medicinal product.

In both cases, the CJEU confirmed the right of the public to access the documents submitted to the EMA. The CJEU emphasised the importance of the principle of openness. Furthermore, it clarified who has the burden of proof to demonstrate that access to the information should be refused.

The claimants had submitted a marketing authorisation (MA) application to the EMA. In one case, this was for a medicinal product for the treatment of Duchenne Muscular Dystrophy; in the other, it was for a veterinary medicinal product for the treatment of tick and flea infestations in dogs.

The EMA granted an MA in both cases. Later, the EMA informed the applicants that a third party was seeking access to documents in their respective MA files. In the first case, access was requested to a clinical study report, and in the second case, to five preclinical toxicology reports.

The EMA notified the appellants and they each requested their entire reports be treated as confidential. These requests were not granted by the EMA, and it granted access to the full reports (with some redactions) in both instances. The appellants brought action to annul the decisions and introduce interim measures to suspend the EMA's decisions. The General Court dismissed the actions, and the appellants subsequently appealed their cases at the CJEU, without success.

The appellants claimed that the EMA (as an EU agency) must apply a general presumption of confidentiality to this type of document. The CJEU does not follow this reasoning. It emphasises the principle of openness or accessibility. Article 15(1) Treaty on the Functioning of the European Union (TFEU) provides that the institutions, bodies, offices and agencies of the EU are to conduct their work as openly as possible.

There are exceptions, which must be interpreted and applied strictly; reference is made to article 4 of Regulation 1049/2001 on public access to European Parliament, Council and Commission documents. These exceptions include situations where disclosure would undermine public security, privacy and integrity of the individual, and where it would undermine commercial interests (including intellectual property), unless there is an overriding public interest in disclosure (article 4(1) and (2)). Another exception relates to documents regarding an ongoing decision-making process of an EU institution (article 4(3)).

The CJEU confirms EU institutions, bodies and agencies have recourse to a general presumption of confidentiality for certain types of documents, but they always have the option to carry out specific and individual examination of the documents, to see whether they are covered by one of the exceptions in Regulation 1049/2001. The CJEU finds the EMA carried out a specific and individual examination of each of the reports at issue and removed certain passages.

The appellants argued the reports contained commercially confidential information which had not been redacted. The burden of proof rested on the appellants to demonstrate how the document could specifically and actually undermine the interest protected by the exception. The risk of the interest being undermined must be reasonably foreseeable and must not be purely hypothetical.

The CJEU found that the appellants did not substantiate that the EMA disclosed commercially confidential information. The EMA had redacted certain passages in the documents, such as those containing references to:

• protocol design discussions with the FDA
• materials and equipment
• data that could lead to the identification of patients, and
• composition and manufacturing of the medicinal product.

The appellants argued another exception should have been applied, as disclosure would undermine the decision-making process of the EMA. They argued that a third party could use the information needed to carry out studies and trials to develop rival medicinal products and obtain marketing authorisation from the EMA.

The CJEU ruled that the decision-making process does not extend to the entire period of market exclusivity. The fact that the data may be reused in connection with new MA applications does not mean the exception of the undermining of an ongoing decision making process is applicable. The MA procedure concerning the products in question was closed when the requests for access were filed – this is the relevant decision-making process.

The CJEU did not follow the opinion of Advocate General Hogan², who found that grounds of appeal on the presumption of confidentiality and the protection of commercial interests were successful. Ultimately, both of these CJEU judgments have confirmed the EMA's decisions to grant third parties access to the redacted documents.

If you have any questions on this article or would like to propose a subject to be addressed by Synapse please contact us.

1 CJEU C-175/18 22 January 2020, PTC Therapeutics/ EMA (medicinal product for human use); CJEU C-178/18 22 January 2020, MSD, Intervet/ EMA (veterinary medicinal product)

2 Opinion AG Hogan 11 September 2019 C-175/18 and C-178/18

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