On 5 February 2018, the General Court delivered three key judgments regarding the understanding and scope of transparency of clinical trial data under the Transparency Regulation.
In all three judgments, the General Court of the Court of Justice of the European Union upheld the European Medicines Agency’s (EMA) decision to release documents included in the marketing authorization (MA) application dossier for a centrally approved medical product. The MA holders fruitlessly argued that the documents contained commercial confidential information.
The judgments mark the first time the Court of Justice of the European Union has had the chance to comment on the merits of the so-called Transparency Regulation ((EC) No 1049/2001) in relation to documents held by the EMA.
In all three cases, a competing pharmaceutical company or third party had requested the EMA to release documents included in an MA application dossier of another pharmaceutical company. All three requests were based on the Transparency Regulation together with EMA’s own policy on access to documents.
With the three judgments, the General Court clarifies the scope of the commercial confidentiality defence, as set out in article 4 of the Transparency Regulation, in relation to data included in the MA application dossier for centrally approved medicinal products.
The General Court noted that no specific evidence was given on how the release of the documents would compromise the commercial interests of the MA holder. Accordingly, the claims of commercial confidentiality were rejected.
The specific cases concerned the disclosure of a) similarity and superiority reports on an orphan medicinal product (prepared by the Committee for Medicinal Products for Human use(CHMP)), b) a clinical study report, and c) toxicology study reports for a veterinary medicinal product.
While every request to the EMA for the release of documents must, naturally, undergo a specific assessment, the three judgments clearly demonstrate that the General Court of the Court of Justice of the European Union interprets the commercial confidentiality defence in the Transparency Regulation narrowly. Going forward, pharmaceutical companies wishing to challenge the release of documents under the Transparency Regulation must carefully evaluate whether adequate specific evidence supports a claim for commercial confidentiality.