Stem Cell Research

European Court of Justice confirms presumption of confidentiality covering EU pilot procedure documents

The European Court of Justice has confirmed the existence of yet another category of documents that can be covered by a presumption of confidentiality. This means that requests for access to documents in a pilot procedure can be refused without the institution having to carry out a concrete examination of each document. This is particularly concerning in the context of pilot procedures, due to the Commission’s reluctance to publish any information at all on the existence of pilot procedures taking place. Analysis by Maximilian Kemp.

Case C-562/14 P, Sweden v Commission, Judgment of 11 May 2017, ECLI:EU:C:2017:356

The Court decided that a general presumption of confidentiality under the third indent of Article 4(2) of Regulation 1049/2001 covers the documents produced during an EU Pilot procedure.

The applicants at first instance had issued a complaint in March 2011 to the Commission’s Directorate-General for Health, alleging a violation of Regulation 1394/2007 on advanced therapy medicinal products by the German authorities which they claimed led to the death of their child. The Commission initiated an EU pilot procedure to determine whether the allegations could be verified.

The Applicants asked to have access to the documents containing information on the processing of their complaint. In particular, they asked to consult the requests for information that the Commission sent to the Germany Government, and its replies. The Commission refused both the initial request and the confirmatory application on the basis of Article 4(2) of Regulation 1049/2001, arguing that their disclosure would be liable to affect the investigation involving Germany. It also considered that partial access under Article 4(6) of the Regulation was not possible in this instance. Lastly, it stated there was no overriding public interest to justify disclosure.

In September 2012, the Commission then informed the applicants of the definitive closure of the EU pilot procedure.
The applicants challenged this decision in the General Court, which decided in favour of the Commission and established a new presumption of confidentiality over documents in an EU pilot procedure. Sweden, one of the supporting parties in the initial case, initiated an appeal before the ECJ.

In order to determine whether the general presumption of confidentiality could apply to the EU Pilot procedure, the ECJ referred to its judgment in LPN and Finland v Commission, in which it had held that documents relating to the pre-litigation stage of infringement procedures could be covered by such a presumption, as their disclosure would risk altering the nature of the investigation.

In this case, all the documents, including those drawn up in the informal stage of the procedure, were considered to be covered. Although that case predated the EU Pilot procedure, the Court nevertheless considered that it was applicable, given that the EU Pilot procedure merely formalised the exchanges of information between the Commission and the Member States during the informal stage of an inquiry into possible infringements of EU law.

The Court further determined that the risk to the investigation existed until the EU Pilot procedure is closed and there is a definitive decision not to open a formal infringement procedure against the Member State. The Court also rejected the argument according to which each document to which access is requested has to be examined specifically and individually, remarking that this would defeat the purpose of a general presumption of confidentiality.

In the present case, the Court considered that, although the Commission had informed the applicants of its intention to close the investigation in April, prior to the adoption of the contested decision, the final decision to close the EU Pilot procedure was only taken in September. The Court therefore considered that the presumption applied since, at the time the decision was made, the investigation was still officially ongoing, and rejected this ground of appeal.

Regarding the existence of an overriding public interest to justify disclosure, the Court determined that the onus was on the party claiming such an overriding public interest to show specific circumstances justifying disclosure, and that general considerations are insufficient in this regard. The Court therefore also rejected this ground of appeal, since the applicants had only referred to the protection of human health when requesting disclosure.

The last ground of appeal argued, in essence, that although the EU Pilot procedure was closed after the adoption of the contested decision, it should nevertheless have been taken into account by the General Court, in the light of Regulation 1049/2001. Indeed, Sweden argued that if new facts could be examined only in a new request for access to documents, this would lead to parallel procedures, prolongation of procedures and increased administrative burdens on the applicants. The Court dismissed this line of argument, pointing out that the legality of an EU measure must be assessed on the basis of the facts and the law as they stood at the time when the measure was adopted.

With this decision, the Court has added yet another category of documents to the general presumption of confidentiality it recognised for the first time in its judgment in Commission v Technische Glaswerke Ilmenau. This trend is concerning, as this presumption is nowhere to be found in Regulation 1049/2001, and should therefore be limited to exceptional cases. Furthermore, it is difficult in this instance to see how disclosure of the requested observations from Germany would be liable to negatively impact the EU Pilot investigation.

Indeed, no reference is made to the fact that Regulation 1049/2001 requires an institution refusing access to documents to provide adequate reasons for doing so. In contrast, the Court requires the party requesting documents to demonstrate specific circumstances constituting an overriding public interest, but this can be difficult if the precise content of the requested document is unknown. Lastly, given the context of the case, the overly formal approach of the Court with regards to the official closure of the EU Pilot procedure is regrettable.

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The U.S. Food and Drug Administration