The European Court of Justice dismisses general presumption of confidentiality for clinical and toxicological study reports
In the parallel cases C-175/18, PTC v EMA, and C-178/18, MSD v EMA, the European Court of Justice has considered the general question whether there is a general presumption of confidentiality for clinical and toxicological study reports submitted to the European Medicines Agency as part of an application for a marketing authorisation.
These decisions by the European Court of Justice refer back to 2015 when the European Medicines Agency ("EMA") in a number of cases granted access in data from clinical study reports in connection with the pharmaceutical companies' application for marketing authorisation. In all the cases, the marketing authorisation had been granted at the time of the application for access.
EMA's decision on right of access was subsequently submitted to the General Court, which in February 2018 decided on the question in three cases. In its judgments, the General Court based its decision on there being no presumption of confidentiality and also held that it must be up to the proprietor of the individual documents to prove that they should not be subject to access due to confidentiality. Consequently, the General Court refused to dismiss EMA's decisions granting access.
Two out of the three decisions made by the General Court were subsequently appealed, and the European Court of Justice has now decided on the question of right of access. In the autumn of 2019, the first declaration was issued in the form of the Advocate General's proposal for a decision, in which he argued in favour of a general presumption of confidentiality and ever since the European Court of Justice's final judgment in the matter has been eagerly awaited.
The judgment of the European Court of Justice has just been given and it is clear that the European Court of Justice has chosen not to follow the Advocate General's opinion. Instead, the European Court of Justice confirms the assumption of the General Court that there is no general presumption of confidentiality for clinical and toxicological study reports. In its judgment, the European Court of Justice states that neither EMA nor the General Court are bound by a general presumption of confidentiality in their assessment of whether access should be granted to clinical and toxicological study reports. Consequently, EMA and the General Court had not been wrong in assessing confidentiality for each individual document, and on that basis redacting potentially compromising information.
Regarding the actual assessment of the requests for access, the European Court of Justice found that access can only be denied if it will "seriously undermine the commercial interests of a legal person"; a definition which was criticized by the Advocate General as being too narrow. Furthermore, the European Court of Justice stated that the natural or legal person that argues for dismissal of access and disclosure of documents is responsible for providing sufficient information on the relevant passages and on how access to these specific passages constitute a risk of misuse and may undermine the protectable commercial interests of the persons concerned. According to the European Court of Justice, the risk of the interest being undermined must be reasonably foreseeable and must not be purely hypothetical.
The European Court of Justice also dismissed the argument that disclosure of data from clinical and toxicological study reports would provide the appellants' competitors with a "road map" on how to file a marketing authorisation application for a competing product. In the case C-175/18 PTC v EMA, the European Court of Justice also dismissed that access in the data from the clinical and toxicological study reports would give competitors a competitive advantage as EMA had redacted the information on composition and production of the appellant's medicinal product, so the competitors would have to perform their own study to obtain the relevant knowledge. The appellants' arguments that the disclosure of the data concerned during the data protection period would cause serious damage to the decision process concerning any applications for marketing authorisations for generic medicinal products during this period were also dismissed on the grounds that the procedure for the marketing authorisation application was completed at the time of the application for access.
After considering the above, the European Court of Justice dismissed the two appeals; in case No. C-175/18 P because the appellant did not prove that access to the material would involve risk of misuse; and in case No. C-178/18 P because the appellants had not specified which passages in the material might be misused.
The two judgments of the European Court of Justice show that the consideration for publicity and transparency weigh heavily in relation to EMA's treatment of applications for access, including access to documents and data concerning clinical and toxicological study reports. The judgments also confirm that EMA will still assess the possibility of access to data from clinical and toxicological study reports word for word and line by line.
The judgments of the European Court of Justice must be seen in light of Regulation No. 536/2014 on clinical trials and the future EU database (CTIS) which will store and publish data on clinical trials. With the decisions of the European Court of Justice and the future CTIS database, pharmaceutical companies should consider, going forward, how they publish information in their trial documents, including information on patent rights, knowhow and trade secrets, as there is a risk that the information will be disclosed through applications for access or published via CTIS. At the same time, the pharmaceutical companies must expect that the fight against applications for access to clinical and toxicological study reports must he handled with specific arguments, as the companies cannot rely on a general presumption of confidentiality.
See Plesner's comment on the judgments of the General Court here (Danish)
See Plesner's comment on the opinion of the Advocate General here (Danish)
See the European Court of Justice's judgments here (C175/18, PTC v EMA) and here (C178/18, MSD v EMA)