New judgment by the Court of Justice of the European Union on access to documents in the possession of the EMA

In the appeals case C-576/19 P, the appellants' submission that access to documents should be set aside as the disclosure would be undermining the protection of court proceedings was dismissed.

On 3 April 2018, the EMA informed Intercept Pharma that a law firm had sent it, on the basis of Regulation No. 1049/2001 of the European Parliament and of the Council regarding public access to European Parliament, Council and Commission documents, a request for access to several documents relating to the company's medicinal product OCALIVA. The EMA invited Intercept Pharma to submit its observations on that request for access. 

Intercept Pharma proposed the redaction of specific sections of a periodic benefit-risk evaluation report in respect of the medicinal product OCALIVA ("the report at issue"). The sections concerned information regarding the safety of the medicinal product. Intercept Pharma stated that it was likely that the request for access had been made by the law firm which represented the counterpart in a dispute with Intercept Pharma's parent company in the USA, and that the parties in the American case, by means of the request for access, would obtain access to information which the counterpart could not have obtained access on the basis of the American procedural rules governing those court proceedings alone. According to Intercept Pharma, compliance with the request for access would be undermining the company's commercial interests and the disclosure was not based on overriding public interest.

As legal basis for the dismissal of the request for access to documents, Intercept Pharma, inter alia, referred to Article 4(2)(2) of Regulation No. 1049/2001 according to which a request for access to documents can be denied if disclosure would be undermining the protection of court proceedings and legal advice, unless there is an overriding public interest in disclosure. 

The EMA did not allow Intercept Pharma's submission and granted access to the documents requested. Intercept Pharma Ltd. and Intercept Pharmaceuticals, Inc. appealed the EMA's decision and in that connection, the EMA agreed not to release the report at issue until the General Court had ruled. After the Court's judgment of 28 June 2019, in which judgment was given in favour of the EMA, Intercept Pharma appealed the judgment to the Court of Justice of the European Union.   

The Court of Justice of the European Union rejected the appeal and maintained the Court's decision. 

The Court of Justice referred to the report at issue being "a scientific document" which was presented to the EMA in preparation for an administrative procedure in which it was to be determined whether the benefit/risk balance of the specific medicinal product remained unchanged. Therefore, the report was neither a document drawn up for the purposes of specific court proceedings not had it been the subject of such proceedings.

Furthermore, the Court of Justice held that the only thing that is relevant for the determination of whether a document falls within one of the exceptions from the right of access to the documents stipulated in Article 4(1)-(3) is the content of the requested document. Neither the identity of the person requesting the document nor the use that person intends to make of the document, if its disclosure is obtained, could justify the application of one of these exceptions.

On the basis of, among other things, the above, the Court determined that irrespective of the identity of the person who requests access to a document, that document may only be protected under the exception laid down in Article 4(2)(2) of Regulation No. 1049/2001, if it was drawn up in the context of specific court proceedings before a court of the European Union, of a Member State, of an International Organisation or of a third state, or, if that is not the case, if, on the date on which that request is replied to, it has been produced in those court proceedings. 

The appellants also took the view that the Court made an error in law in finding that the appellants had not shown which part of the report at issue contained commercially sensitive information. 

The court also here dismissed the appellants' submission and pointed to the fact that the appellants had not identified the parts of the report at issue which, if they were disclosed, would be capable of harming the appellants' interest, as the only argument put forward in that respect before the Court being connected with the additional investment that the appellants were required to make because of the court proceedings initiated in the United States in connection with the medicinal product OCALIVA.

Read the judgment of the European Court of Justice dated 29 October 2020 

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