The evolution of the EMA’s approach towards transparency has probably been one of the biggest policy changes within the institution in the last decade. Conscious of what was at stake, the industry soon embraced the changing times and evolved towards improved openness and data sharing. The breeding ground of the evolution, which can be classified as a paradigm shift in the EMA, was a more active involvement of patients in their care, the increasing role of patient associations, the growth of research in academia, a general societal trend towards transparency, together with the enactment of Regulation (EC) 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (the “Transparency Regulation”).
The Court of Justice has recently had the chance to rule on the application of the Transparency Regulation in two cases which raised almost identical issues concerning the right of third parties to access documents held by the EMA. In Appeals C-175/18 P and C-178/18 P the Court of Justice upheld the decisions of the General Court and, in turn, those of the EMA to release documents which were submitted as part of marketing authorisation applications, despite the diverging Opinion of Advocate General Hogan.
Both PTC Therapeutics International Ltd (“PTC”) and MSD Animal Health Innovation GmbH and Intervet International BV (together “Merck”) argued, before the EMA and the Court of Justice of the European Union, that documents submitted as part of their respective marketing authorisation applications (a case study report in the case of PTC and a toxicology report in the case of Merck) should be presumed to be confidential in their entirety and, for that reason, should not be released in response to a third party application to access said documents under the Transparency Regulation.
In its two judgments of 22 January 2020 the Court of Justice clarified that:
- The principle of the widest possible public access to documents has some exceptions (article 4 of the Transparency Regulation). In this regard, the right to access is subject to certain limits based on reasons of public or private interest such as the undermining of the protection of commercial interests of the proprietor of the document. As an exception, the above mentioned provision should be interpreted strictly.
- For a proprietor to benefit from the abovementioned exception, it must explain how access to that document could “specifically and actually undermine the interest protected by that exception” and “the risk of the interest being undermined must be reasonably foreseeable and must not be purely hypothetical”. The Court of Justice agreed with the Advocate General that the test set by the General Court that any disclosure had to “seriously” undermine the protection of the proprietor’s commercial interest for the purposes of bringing the exception into play is too elevated a standard. The Court of Justice concluded that “any undermining of the interests concerned is capable of justifying the application, as the case may be, of one of the exceptions” in article 4 of the Transparency Regulation.
- Contrary to the Opinion of the Advocate General, the Court of Justice has ruled against a general presumption of confidentiality. Indeed, the recourse to a general presumption of confidentiality is merely an option for the EU institution or agency concerned and the latter always retains the possibility of carrying out a specific and individual examination of the documents in question to determine whether they are protected, in whole or in part, by one or more of the exceptions of article 4 of the Transparency Regulation, including the one related to commercially confidential information.
Conclusion and implications
Unsurprisingly the CJEU broadly supports the EMA’s approach towards the Transparency Regulation. There is one useful takeaway from the decisions for proprietors of documents held by the EMA which are subject to a third party request to access them: when presented with the opportunity to express their views on the possible confidentiality of certain information contained in the document, proprietors should not provide a mere unsubstantiated claim to a general risk of misuse. On the contrary, they must precisely and specifically identify the part or parts of the document which, if disclosed, would harm their commercial interests. Only if proprietors explain how access to a document could specifically and actually undermine their interest and are able to convey that the risk of undermining said interests is reasonably foreseeable (as opposed to purely hypothetical) will they have chances of succeeding with the redaction of those parts of the document which are truly commercially confidential.
Notwithstanding the above, these cases will be of little value, other than historical, once Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“Clinical Trials Regulation”) becomes applicable. Indeed, the culmination of the shift towards transparency is enshrined in the legal obligation of applicants of marketing authorisation to make publicly available, via the EU database to be set up by the EMA, the clinical study report within 30 days after the day the marketing authorisation is granted, the procedure for granting the marketing authorisation is completed, or the application is withdrawn. The application of the Clinical Trials Regulation will put an end to most of the litigation around the disclosure of clinical study reports, as the legislature considered that in general the data included in said report should not be considered commercially confidential once a marketing authorisation has been granted.
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 According to the information provided by the EMA in March 2020, the Clinical Trials Regulation will not become applicable before 2021