In particular for commercial reasons, pharmaceutical companies have an interest in the confidentiality of documents submitted in connection with the marketing authorization for medicinal products vis-á-vis its competitors as well as vis-á-vis the public.
The Court of Justice of the European Union (“CJEU”) ruled in its decision of June 28, 2019 (Case T-377/18), that a pharmaceutical company cannot invoke the exceptions of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (the “Regulation”) to prohibit public access to a periodic benefit-risk evaluation report submitted in the context of a marketing authorization of a medicinal product. The exceptions to the Regulation for protection of court proceedings or commercial interests must be interpreted and applied strictly, as such exceptions derogate from the Regulation’s objective of ensuring the widest possible access to documents.
Background to the Dispute
In the context of a communication of the Food and Drug Administration (FDA, United States) concerning the safety of a medicinal product and a drop in the share price followed by a lawsuit filed by shareholders in the U.S. against the pharmaceutical company manufacturing the medicinal product (the “DeSmet lawsuit,” a so-called stock drop lawsuit), a law firm requested access to several documents from the European Medicines Agency (“EMA”) relating to the marketing authorization of the medicinal product in question. Despite the fact that the pharmaceutical company proposed redactions of specific sections of the report relating to the safety of the medicinal product with regard to the disclosure request, EMA decided to disclose the report without the proposed redactions. The pharmaceutical company challenged EMA’s decision.
Decision of the CJEU
The CJEU approved EMA’s decision to grant access to documents submitted in the context of a marketing authorization of the medicinal product, and found that the exceptions of the Regulation did not apply in this case.
Exception to publication applies to documents relating to court proceedings (second indent of Art. 4(2) of the Regulation)
The CJEU ruled that this exception only applies to documents drawn up in the context of specific pending court proceedings (e.g., pleadings in pending court proceedings) or, exceptionally, documents that contain legal positions that subsequently become the subject of such proceedings and whose disclosure would be likely to compromise the defense of the documents’ author in the context of such proceedings. However, the contested report is a scientific document that was submitted to EMA in the context of an administrative procedure (in order to establish whether the risk-benefit balance remained unchanged), and not a document that met the conditions set forth by the CJEU. (N.B.: The term “court proceedings” also covers non-European court proceedings.)
The exception to publication for protection of court proceedings is necessary to ensure observance of the principles of equality of arms. Contrary to the claimant’s opinion, disclosure of the report would not lead to circumvention of the protections conferred by U.S. legislation in proceedings relating to preliminary investigation. The main purpose of that legislation is characterized by the intention to limit abusive class actions, given that such actions have a negative impact on the U.S. capital markets. Accordingly, that legislation is not concerned with the protection of court proceedings as interpreted by the EU courts and, consequently, does not affect the principle of equality of arms.
Exception to publication applies to documents where disclosure undermines the protection of commercial interests (first indent of Art. 4(2) of the Regulation)
The CJEU ruled that pharmaceutical companies have to show that the requested documents contain commercially sensitive information, e.g., with regard to commercial strategies of the undertakings involved or to their customer relations or where that document contains information particular to that undertaking that reveals its expertise. Arguments such as a greater financial investment in the context of the court proceedings pending in the U.S. or the scientific nature of the complex, detailed, or specialized report are not sufficient to constitute a ground for non-disclosure.
To invoke the exception of “court proceedings,” the document must be drawn up in the context of specific court proceedings or contain internal positions of a legal nature. To invoke the exception of “commercial interest” successfully, pharmaceutical companies have to show that the requested documents contain sensitive commercial information. The mere fact that a document concerns an interest protected by an exception is not sufficient to justify the application of that exception. Furthermore, the risk of such interest being undermined by disclosure of the document must be reasonably foreseeable and must not be purely hypothetical. Otherwise, these exceptions do not apply and disclosure of the documents cannot be prohibited.
Note that other EU Regulations, such as the Trade Secrets Directive, in particular its rules for preservation of confidentiality of trade secrets in the course of legal proceedings, do not affect the rules on public access to documents or on the transparency obligations set forth in the Regulation (recital 11 of the Trade Secrets Directive).