On 22 January 2020, the European Court of Justice (ECJ) issued a key ruling related to third parties' rights of access to clinical study reports, on the basis of the EU regulation.This is the first time that the ECJ addressed this question as it relates to the pharmaceutical sector and especially to the clinical study report. This document is one of the most significant documents contained in marketing authorisation applications and includes explanations of the critical design features, the plan methods and conduct of the study, individual patient data and details of analytical methods.
In the specific context of the case, a competitor wished to access the clinical study report originally used by another pharmaceutical company in its MA application, which was filed with the EMA. The EMA agreed to this request and released the documentation, thus giving access to potentially sensitive commercial information. This decision was challenged by the pharmaceutical company at the origin of the clinical study report, before the EU Court. The company notably argued that documents submitted in a procedure for the granting of an MA, and in particular clinical study reports, were protected by a general presumption of confidentiality.
Both the EU Court, in its judgement dated 5 February 2018, and the ECJ in its present ruling dated 22 January 2020, found that no general presumption of confidentiality covers the clinical study report, although they did not deny that this document may indeed contain commercially confidential data. Surprisingly, the Court did not follow the Advocate General in its reasoning with regard to the application of a general presumption of confidentiality in the context of clinical trial data. Indeed, in the Advocate General's opinion, the application of such a general presumption in this context would be consistent with the market exclusivity granted to the pharmaceutical company identified as the "first mover" on the market vs. the pharmaceutical company that develops its medicine through the "generic approval route", afterwards.
Some may think that this ECJ decision is particularly unfavourable to innovative pharmaceutical companies, while others, such as generic companies, may see an opportunity, as suggested by the Advocate General. In any event, there is no doubt that this ruling addressing very complex issues, will give rise to some tricky questions. Some of them are already popping up as we think of the impact of this case law on (i) the application of the rules set in the EMA Policy 0070 on the publication of clinical data for medicinal products for human use that was developed by the European Medicines Agency (EMA), in accordance with Article 80 of Regulation (EC) No 726/2004; and also (ii) on its articulation with the clinical trials regulation (EU) no. 536/2014. Will the ECJ confirm this case law once the clinical trials regulation come into force?