On 6 February 2018, the General Court delivered three very carefully considered judgments in cases brought by companies who objected to the disclosure in their entirety of documents submitted to the European Medicines Agency (EMA) for the purposes of gaining a marketing authorisation or additional market exclusivity (see our previous update (see our previous blog post “EU General Court rules on transparency of clinical trial data”). The Court dismissed all three cases as it considered that the companies had failed to provide any concrete evidence of how the disclosure of the contested documents would undermine their commercial interests.
The cases concerned are Case T-235/15, Pari Pharma v EMA, in relation to the disclosure of similarity and superiority reports on an orphan medicine, Case T-718/15, PTC Therapeutics International v EMA, in relation to the disclosure of a clinical study report, and Case T-729/15, MSD Animal Health Innovation and Intervet International, in relation to toxicology study reports for a veterinary medicine.
Between 2015 and 2016, the CJEU issued interim orders in all three cases suspending EMA’s decision to disclose the relevant documents requested by third parties.
These cases – for the first time – tested the controversial application by the EMA of its 2010 Policy 0043 on access to documents (the Policy) in the context of Regulation (EC) No 1049/2001, the so-called “Transparency Regulation”. Under the Policy, documents which companies had assumed were submitted on a confidential basis began to be made available by the EMA on application by any EU citizen, personal or corporate. However, until now, the legality of the EMA’s approach to transparency had never been examined by an EU court on the merits. Two other companies – AbbVie and InterMune – had earlier filed legal challenges against the EMA, but subsequently withdrew their requests.
The EMA had judged that the balance of interests between the commercial interests of the company submitting documents and the interests of the general public and public health should dictate disclosure as a default except where it could clearly be demonstrated that disclosure would undermine the commercial interest of the company concerned. The irony, of course, is that most requests were submitted by commercial competitors which may, in itself, be thought to carry the presumption that the documents had some commercial value.
The EMA formulated a redaction regime which has allowed most requests for disclosure to be met after consultation with the company whose documents were sought. But the EMA resisted claims that entire documents should be protected from disclosure, especially where some of their contents were available in the public domain, rejecting the argument of innovator companies that the compilation of public and non-public data in a particular form and its analysis could constitute a “strategic roadmap” that would enable competitors unfairly to formulate their own development plans more quickly and more cheaply.
The Court’s rulings
The claimants put their cases in a number of ways but each failed to convince the Court that the documents in question should be protected from disclosure in their entirety. In Pari Pharma the General Court began by rejecting the proposition that there exists a general presumption of confidentiality of the CHMP reports drawn up in the context of the marketing authorisation procedure in this case pursuant to Regulations Nos 726/2004 and 141/2000. Such documents could be subject to a presumption of confidentiality if there existed on-going judicial or administrative proceedings but in this case there were none. Pari Pharma’s product had been granted orphan status, and disclosure of the documents could not alter that procedure. So it was up to the EMA to satisfy itself “by means of each document in the administrative case file, whether the document is covered by commercial secrecy” for the purposes of Article 4(2) of the Transparency Regulation, as reflected in Policy 0043.
Pari Pharma argued that the CHMP similarity and superiority reports, containing proprietary confidential raw data, compilation of publically accessible clinical data and their analysis, constituted its own proprietary know-how and strategic trade secrets, giving it an advantage over its competitors who do not have this strategic know-how.
The Court proceeded on the basis that, since Article 4(2) provides an exception to the general principle that the public must have the widest access to the documents, it must be interpreted and applied strictly. It must be shown that the documents at issue contain elements which may, if disclosed, seriously undermine the commercial interest of a legal person. This could include commercially sensitive information relating to the business strategies of an undertaking or documents revealing its expertise. This could include a new scientific conclusion or an inventive strategy.
Pari Pharma was unable to meet this evidential test. They failed to show that performing searches on public scientific data and the assembly of those data reflected an inventive strategy and provided added value. The Court remained unconvinced that the public and non-public data and analysis in the reports constituted an inseparable whole, although it was open to an alternative plea that particular parts of the reports could be withheld from disclosure as commercially confidential. Ultimately, Pari Pharma failed to make the case, in the alternative, that any individual pieces of information sought should be protected from disclosure.
Pari Pharma then tried to argue that there was no overriding public interest in disclosure as the public interest, particularly in promoting effective pharmacovigilance, was already served by the European Public Assessment Report, the EPAR. But again the Court disagreed. First, it said that, having concluded that the contested information was not commercially confidential, the EMA did not need to determine whether there was or was not an overriding public interest in disclosure. In any event, however, the information in the reports could be interesting from a pharmacovigilance perspective so that plea failed as well.
To conclude a comprehensive demolition of Pari Pharma’s case, the Court considered and dismissed pleas that the EMA’s decision to disclose the CHMP reports infringed Article 339 of the Treaty on the Functioning of the European Union, the Charter of Fundamental Rights and Freedoms and Article 8 of the European Convention on Human Rights and the TRIPS Agreement. None of these arguments could succeed once it was determined that the reports were not commercially confidential in their entirety. A final attempt by Pari Pharma to argue that Policy 0043 was being exercised in a manner inconsistent with Article 15 TFEU, which says that only regulations govern the right of access to documents, and that the definition of trade secrets was being applied more restrictively than the definition contained in the proposed Trade Secrets Directive was also dismissed by the Court.
The judgments in PTC Therapeutics and MSD Animal Health Innovation, given by a subset of the expanded Second Chamber that heard Pari Pharma, applied the same principles to their analysis of whether a clinical study report and animal toxicology reports could be confidential and, therefore, protected from disclosure in their entirety. They concluded that neither type of report was confidential in principle or on the individual facts of these cases and the applications to annul the decisions of the EMA to disclose them were dismissed.
The pharmaceutical industry and the EMA have by now settled into an uneasy truce on the issue of disclosure. Companies argue for maximum redaction and the EMA counters with evidence that information is already in the public domain. The process has become rather distracting, expensive and time consuming for both parties.
In the meantime, and also in light of EMA’s Policy on publication of clinical data for medicinal products for human use (the so-called Policy 0070) which mandates proactive disclosure of clinical study reports submitted in the context of a centralised marketing authorisation application, companies have refined their approach to the submission of evidence to the EMA to limit inadvertent disclosure of what they consider to be trade secrets. The EMA stated that the court cases did not impact its Policy 0070, which indeed becomes apparent from recently released statistics that it has rejected 76% of the proposals by pharmaceutical companies to redact what they claimed as commercially confidential information (CCI) in clinical study reports.
The rather lengthy Court judgments, while validating the EMA’s approach to transparency in principle, nevertheless provide some guidance on what could constitute “commercial confidential information”. This is not only relevant to prevent disclosure under the EMA Policies but also one of the exception grounds for information in the EU Clinical Trial Regulation (CTR) database not to be made public. According to the Court, disclosure of, for instance, “new scientific conclusions” or “an inventive strategy” could “seriously undermine the commercial interest of a legal person” and thus justify non-disclosure.
Importantly, the Court imposes a high standard of proof on companies seeking to prevent disclosure by requiring that they “describe in specific terms the professional and commercial importance of the information […] and the utility of that information for other undertakings which are liable to examine and use it subsequently”, for example “to show specifically and actually how, once the documents have been disclosed, competitors would be able to enter the market.”
Companies should take these guidelines into account when redacting documents in the context of both EMA Policies 0043 and 0070, e.g. by underlining and providing clear evidence of innovative elements and strategies, even though this may often prove challenging in practice. The EMA, from its side, has in any event confirmed that “based on the guidance issued […] by the General Court, [it] will continue to diligently assess each individual request for access to documents […] in accordance with its policy on access to documents.”
However, despite the Court’s rubber stamp of the EMA’s approach to transparency, one cannot help but wonder – especially on the brink of even more, and different, transparency requirements under the CTR, whether the EMA should not take a step back and reflect on whether these developments – imposing significant bureaucracy and thus adding to the development costs of innovative medicines – are really in the interest of public health?