The CJEU rules on access to documents submitted when applying for marketing authorization

In two recent rulings, the Court of Justice of the European Union ruled that the public has a right to access documents submitted in the context of marketing authorization applications for a medicinal product. The rulings arguably pave way for more transparency, but also have important implications for pharmaceutical companies, in particular when it comes to the confidentiality of documents submitted with an MA application using the centralized procedure.

Background

Three pharmaceutical companies had submitted marketing authorization (MA) applications to the European Medicines Agency (EMA). After the EMA had granted the authorizations, a third party had requested access to some of the documents included in the MA application files. In the first case, the third party had requested access to a clinical study report, and, in the second case, five toxicology reports.

The request for access raised the question of public access to European Parliament, Council and Commission documents.  According to the exceptions listed in the Article 4(2) of EU Regulation No 1049/2001, commercial interests of a legal person are protected and consequently the EU institution has an obligation to refuse access to a document where disclosure would undermine the protection.

In both cases, the pharmaceutical companies had requested the EMA to treat reports as wholly confidential, taking the view that the reports should be protected by a presumption of confidentiality. Therefore, the documents should not be disclosed to a third party. It should be noted that, according to established EU case law, under specific conditions the relevant EU institution has the option of basing its decision on a general presumption instead of having to explain in detail how access to the documents could specifically and actually, not just hypothetically, undermine protected interests.

The EMA did not accept these views; instead, it granted access to the documents, although they were partially redacted. In both cases, the companies ended up bringing an action for the annulment of the EMA’s decision to the General Court. The actions were dismissed by the General Court and the rulings were appealed to the CJEU.

Proceedings before the CJEU

On 22 January 2020, the CJEU handed down its rulings (case C‑175/18 P PTC Therapeutics International Ltd v European Medicines Agency; case C-178/18 P MSD Animal Health Innovation GmbH and Intervet International BV v European Medicines Agency) in which it confirmed the right for the public to access the documents.

As for the general presumption of confidentiality, the CJEU viewed it as merely an option for an EU institution. The EU institution concerned can always carry out a specific and individual examination of the documents to determine whether they are protected, in whole or in part, by one or more of the exceptions laid down in Article 4 of Regulation No. 1049/2001.

A second point the CJEU considered was whether the appellants’ commercial interests were undermined by granting access to the documents. The CJEU held that the appellants should have specifically and precisely identified the parts of the document which could harm their commercial interests if they were disclosed. Simply claiming that there is a general risk of misuse does not lead to data in the document being regarded as falling within the scope of the exception listed in Article 4(2). This was especially the case where no additional details concerning the nature, purpose and scope of the data were provided.

In addition, the appellants claimed that the General Court had infringed Article 4(3) of the above-mentioned Regulation. The provision makes it possible to refuse access to a document which relates to a matter where the decision has not yet been taken by the institution, if disclosure of the document would seriously undermine the institution’s decision-making process. According to the appellants, this disclosure during the data exclusivity period could lead to the EMA’s decision-making process becoming seriously undermined.

The CJEU, however, rejected this argument. First, the decision-making processes in question were noted to be separate from decision-making processes relating to potential MA applications. In short, arguing that the data could potentially be reused in in the context of further MA applications was considered a mere hypothetical argument. Secondly, the relevant decision-making processes were already closed by the time the third party had requested access. Hence, access could not be refused on this basis.

Conclusions and implications

In the rulings, the CJEU highlighted the importance of public access to documents. It also restated its holding from earlier case law that exceptions must be interpreted and applied strictly. The accountability and legitimacy of the EU institutions were also highlighted as important values.

In light of these rulings, documents submitted with an MA application are not automatically considered confidential. Companies wishing to oppose a request for access to documents related to MA applications would do well to take note of the importance of showing that the relevant data tangibly could undermine the commercial interests of the undertaking.

Furthermore, it should be noted that, although these rulings may add transparency when it comes to the centralized procedure, the question of which information is public is still subject to national law in each EU country when it comes to MA applications submitted to the national authority.

 

Author

Vilhelm Schröder 
Senior Associate
Helsinki