In the recent cases of PTC Therapeutics International v. EMA (C-175/18 P) and MSD Animal Health Innovation and Intervet International v. EMA (C-178/18 P), the Court of Justice of the European Union (CJEU) for the first time considered the question of access to European Union documents submitted - in this instance - to the European Medicines Agency (EMA) as part of a marketing authorisation (MA) application to third parties.
EU Regulation No 1049/2001 regulates public access to European Parliament, Council and Commission documents, and defines when grounds of public or private interest governing the right of access to such documents can prevail over the broad EU principle that there should be "the widest possible access to documents". Specifically, under article 4, access shall be refused to a document "where disclosure would undermine the protection of … commercial interests of a natural or legal person, including intellectual property".
However, in these judgments the CJEU dismissed the appeals brought by PTC Therapeutics and MSD Animal Health Innovation and Intervet International and upheld the EMA decisions to allow third-party access to documents contained in the file of MA applications, including toxicology and clinical study reports.
The two cases raised identical issues concerning the legality of the EMA's decision to grant, under Regulation No. 1049/2001, access to a number of documents submitted as part of MA applications. Both appellants claimed that the toxicology and clinical study reports should benefit from a general presumption of confidentiality and should not be disclosed to third parties.
Is there a general presumption that EU institutions and bodies must keep documents confidential?
As a general presumption, the CJEU held that the application of a general presumption of confidentiality is merely an option for the institution, body, office, or agency concerned. It is not obliged to keep documents confidential. The general presumption of confidentiality is optional rather than mandatory. Instead, the institution or body is entitled to carry out an analysis of each document to determine whether that document contains commercially confidential material that can be protected, in whole or in part, by one or more exemptions laid down in article 4 of Regulation No 1049/2001.
The CJEU noted that the EMA had undertaken a specific review of the documents in question, and redacted certain (confidential) information before releasing the documents publicly. The CJEU therefore agreed with the EMA that, apart from the information that had already been redacted before disclosure (such as protocol designs and methods of drug concentration measurement), those documents were not confidential.
Did disclosure undermine the owners' commercial interests?
The CJEU then considered whether the EMA's decision to release the toxicology and clinical study reports had (in the language of article 4) undermined the owners' commercial interests in continuing to preserve that confidentiality.
Three factors are critical in this analysis.
- When seeking to resist publication, the owner of the documents or data must provide specific explanations as to how access to those documents or data could specifically and actually undermine the relevant commercial interest protected by article 4.
This applies equally to the EU institution or body if it decides to refuse access to such documents or data.
- The existence of a risk of misuse of the data contained in a document to which access is sought must be established. Moreover, a mere unsubstantiated claim relating to a general risk of misuse will not lead to such data being treated as falling within the article 4 exception of "the protection of commercial interests".
It is incumbent on the owner of the data in question to provide the EU institution or body with relevant information concerning the nature, purpose, and scope of the data, sufficient to enable them to understand how disclosure of that data would be likely substantially and reasonably foreseeable to undermine the commercial interests of its owner.
- The passages in the reports at issue which had been disclosed did not constitute sufficiently confidential information capable of falling within the article 4 exception relating to the protection of commercial interests.
Had the owner been able to identify unpublished data that was not a matter of common knowledge in the pharma sector, then the CJEU accepted that that might constitute grounds for potential harm being caused to the owner's commercial interests.
This CJEU decision will concern innovator companies in the pharmaceutical and biotech industries. The right of access to documents contained in the MA file could provide a competitor with critical information to enable them to compete and, in certain cases, to use that information tactically in patent litigation. While it is too late to withdraw documents in granted MAs, companies making future applications should think carefully about what information is submitted as part of the MA application and whether it is worth holding back on some of the most confidential information contained in them. If such data needs to be disclosed, it should be flagged as confidential, and MA applicants should ensure that they are able to give a clear and precise explanation of what data in the file is confidential and why.
Please get in touch if you would like us to help you plan your MA application or to discuss any of the issues in more detail.
Client Alert 2020-029