In a long-running legal case challenging the European Medicines Agency’s approach to disclosure of clinical trial data, Advocate General Hogan has recommended that the Court of Justice find that such data are presumptively confidential when handling disclosure requests under the Transparency Regulation 1049/2001.

PTC Therapeutics International Limited (“PTC”) had argued before the General Court that a clinical study report it submitted to the EMA in support of marketing authorisation for its ultra-orphan drug Translarna was presumptively confidential and should not be disclosed to a competitor. However, this position was dismissed by the General Court of the EU in early 2018.

On appeal to the Court of Justice, however, PTC argued that the General Court had erred in arriving at that decision, raising a number of grounds, including that on a proper interpretation of the relationship between the Regulation No 726/2004 and Regulation No 1049/2001, the report at issue is covered in its entirety by a general presumption of confidentiality. In his opinion, AG Hogan disagreed with the General Court’s assessment of the relevant legislation, noting in particular that Article 39(3) of the TRIPs Agreement provides that data must be protected against disclosure unless steps are taken to ensure that such data are protected against unfair commercial use. On this point, the General Court stated in paragraph 91 of the judgment under appeal that ‘potential misuse of the report at issue by a competitor is not in itself a ground for considering that information is commercially confidential under Regulation No 1049/2001’. AG Hogan explained that while this statement is correct so far as it goes when it comes to considering the ‘commercial confidentiality’ exception in the first indent of Article 4(2) of Regulation No 1049/2001, it did not ensure that release of undisclosed data would not undermine the data and marketing exclusivity of the originator company, particularly in countries outside the EU.

As such, AG Hogan considered that the General Court had erred in law in so far as it concluded that there was no general presumption that CSRs should not be disclosed by reference to the first indent Article 4(2) of Regulation No 1049/2001. AG Hogan also considered that the General Court had erred in law in so far as it concluded that the disclosure of the report at issue would not compromise the appellant’s commercial interests for the purposes of the first indent of Article 4(2) of Regulation No 1049/2001. The AG added, however, that the EMA does not need to rely on the presumption of confidentiality. In practice, though, this would likely make a finding by the EMA that certain data are not commercially confidential more difficult in cases of detailed and individualised assessment of clinical study reports. The AG opinion is non-binding and it will now be for the Court of Justice to assess the case in light of this opinion.

The opinion can be accessed here.

Another appeal brought by a veterinary pharmaceutical company in relation to pre-clinical study reports was heard in parallel and AG Hogan reached the same conclusion. That case can be accessed here.