Court of Justice of European Union Confirms General Court's Judgments Regarding Access to Medicine Marketing Authorisation Files

• 23/01/2020
• Articles

The Court of Justice of the European Union (“CJEU”) delivered on 22 January 2020 two judgments which confirm the judgments handed down by the General Court on 5 February 2018 with regard to the right of access to documents that form part of a marketing authorisation application for a medicinal product (Case C-175/18 P, PTC Therapeutics International v EMA, and Case C-178/18 P, MSD Animal Health Innovation and Intervet International v EMA – judgments attached).
 
Both cases concern the legality of the decisions of the European Medicines Agency (“EMA”) pursuant to Europe’s transparency rules contained in Regulation No 1049/2001 to grant access to toxicology reports and a clinical study report. These reports had been submitted to EMA as part of applications for marketing authorisations for two distinct medicines, one for human use (in Case C-175/18 P) and the other for veterinary use (in Case C-178/18 P).
 
The EMA decided to disclose redacted versions of these reports to third parties on the grounds that these reports were not confidential (with the exception of the redacted parts). By contrast, the applicants (PTC Therapeutics, MSD Animal Health Innovation and Intervet International) contended that the reports at issue should benefit in their entirety from a presumption of confidentiality.
 
The CJEU sided with the EMA. In relevant part, it held, first, that the EMA was not obliged to apply a confidentiality presumption to the reports at issue, especially because it had made the effort to carry out a specific and individual examination of the reports which had resulted in the creation of redacted versions. For example, in PTC Therapeutics, the CJEU noted that EMA had “redacted the references to protocol design discussions with the Food and Drug Administration, batch numbers, materials and equipment, exploratory assays, the quantitative and qualitative description of the method for drug concentration measurement, and the start and end dates of treatment and further dates that could lead to the identification of the patients”.
 
Second, the CJEU rejected the notion that the decision to grant access to the reports had hurt the applicants’ commercial interests, which is an exception to the general access principle (Article 4(2), first indent of Regulation No 1049/2001). According to the CJEU, the applicants had failed to demonstrate how the access decision had concretely and reasonably foreseeably undermined their commercial interests. It specified that the applicants had not shown any novelty in the models, assays or methodologies included in the clinical study report at issue. In so doing, it confirmed the EMA’s assessment that the models and methodologies used in the clinical study in question were based on know-how that is ‘widely available in the scientific community’. The CJEU concluded that the disclosed passages did not amount to information capable of falling under the category of commercial interests.
 
Third, the CJEU also analysed another exception to the right of access to documents, namely the exception relating to the protection of the decision-making process (Article 4(3), first subparagraph of Regulation No 1049/2001). The appellants maintained that disclosure of the reports at issue during the data exclusivity period would seriously undermine the decision-making process relating to potential applications for marketing authorisations of generic medicinal products during that period. However, the CJEU noted that these decision-making processes are separate from the decision-making processes concerning the marketing authorisations for the original medicinal products. These processes were already closed on the date of the request for access to the reports at issue and could therefore no longer be compromised.
 
Predictably, reception of the judgments was mixed. Industry representatives expressed disappointment, while the EMA, the office of the European Ombudsman and transparency advocates hailed the outcome of the proceedings. In truth, while the bar for keeping medicine marketing authorisation files confidential has been raised, the judgments, and indeed EMA’s transparency policy, still leave room for keeping confidential information, including know-how and personal data, out of the limelight.