Transparency of the EMA remains intact
European Court of Justice rules on the transparency of clinical data for new drug approvals.
RB – 02/2020
On 22 January, the European Court of Justice confirmed the right of access to documents contained in
the file of an application for marketing authorisation for medicinal products.
This ruling confirms that the European Medicines Agency (EMA) has the right to operate in a
transparent manner and publish the
results of clinical trials of medicinal products submitted as part of the marketing
In July 2014, the manufacturer PTC Therapeutics International Ltd. was
granted marketing authorisation
for Translarna, a medicinal product for treating
the rare disease Duchenne muscular dystrophy (DMD). In October 2015, PTC
Therapeutics was notified by the EMA that a competing manufacturer had been
granted access to a clinical trial report on the drug from the marketing
PTC Therapeutics was of
the opinion that the clinical trial contained in the report is essential to the
granting of marketing authorisation and is subject to confidentiality. In
November 2015, the EMA rejected the request for confidentiality of the report
and took the decision
to grant third parties access to the entire disputed report, apart from their own redaction.
PTC Therapeutics filed the case on the decision to publish the clinical report in December 2015. The case
went through the stages of appeal to the European Court of Justice and was ruled in January 2020.
The judges based their ruling on the requirements of Regulation
1049/2001 to ensure transparent public access to European Parliament, Council and Commission documents as well as Regulation
536/2014 in conjunction with the ruling made
in 2018 on access to clinical trial documents.
The ECJ confirmed that the general presumption of
confidentiality is optional rather than mandatory. The judgment clarified that
a holder of a marketing
authorisation must demonstrate, in a reasonably foreseeable and concrete manner, how access
to documentation would
undermine its commercial interests. In this case, PTC
Therapeutics failed to demonstrate and identify specifically and precisely how
disclosure of the passages of the report at issue could harm its commercial interests. As a result, the
EMA was within its rights to disclose the information solely on the basis of the non-confidential nature
of the report without the need to weigh up the interests involved. The mere
unsubstantiated allegation of a risk of abuse by competing companies was not
sufficient in the eyes of the court, especially since PTC Therapeutics had the
opportunity to comment on the confidentiality of the documents but did not do