Obtaining documents held by the European Medicines Agency - the Transparency Regulation in the Life Sciences Industry

The Transparency Regulation (Regulation EC 1049/2001, the “Regulation”) governs public access to European Parliament, Council and Commission documents. The Regulation applies to all EU institutions and their agencies, giving the right for third parties to access any documents of these institutions provided such disclosure would not undermine the commercial interest of a legal or natural person, including their intellectual property, unless there is an overriding public interest for disclosure. There is also an exception to disclosure if it would seriously undermine the institution’s decision-making process.

The Regulation came into force in December 2001, but it has been back in the news recently because of the General Court rulings on three appeals against the European Medicines Agency’s (“EMA”) disclosure of documents provided as part of Marketing Authorisation applications[1]. The parties argued that all of the disclosed documents should have been covered by a general presumption of confidence and so fell under the commercial interests exception preventing disclosure. The argument was that the EMA’s definition of confidential information namely of “any information which is not in the public domain or publicly available” was overly restrictive, failing properly to protect information such as trade secrets and adequately comply with the Regulation.

In all three cases the General Court dismissed the actions, agreeing with the EMA decisions to disclose the particular documents. However, it is worth noting that in each case the General Court only considered the specific documents before it and was not commenting on the EMA’s policy as a whole.

The documents considered by the General Court were reports from the EMA’s Committee for Medicinal Products for Human Use (“CHMP”), toxicology reports and clinical studies. In the case of the CHMP reports the General Court found that disclosure was overridingly in the public interest in order for the CHMP’s decision to be properly understood. With regards to both the toxicology reports and the clinical studies it was decided that most of the information contained within these was already in the public domain and that there was no novelty or additional value in the composition of the reports therefore the documents as a whole could not be protected from disclosure, although it was accepted that some of the information should be redacted.

The general conclusion appears to be that once a marketing authorisation application procedure has ended (even if only on the basis of an interim marketing authorisation) anything submitted as part of the application loses any general presumption of confidentiality and it is unlikely that entire documents would remain protected from disclosure. In the EMA press release about the cases, they said “the General Court noted that the companies failed to give any concrete evidence of how the release of the contested documents would undermine their commercial interests, and therefore it rejected their claims”. It may be that the door is open for documents to be protected from disclosure in future, if the parties provide fuller evidence.

Some limited examples were given as to the type of information that would be kept confidential, in particular:

• Start and end dates of treatment and further dates that could lead to the identification of the patients;
• The concentration range of the active substance and on the internal reference standard used for the analytical tests, as well as references to future development plans;
• Quantitative and qualitative description of the method for drug concentration measurement.

It is worth noting that the EMA set a policy on its approach to complying with the Regulation in 2010, but a consultation on the policy was launched last May, before these cases. No conclusions from the consultation have yet been published, but it is clear that companies believe that the policy as it stands is too wide.

In conclusion, the General Court appears to support the EMA’s view that the prevailing principle with regards to transparency is that the public should have the widest possible access to documents, and that this approach is to be applied strictly. In particular companies must be aware that there is no presumption of confidentiality in relation to documents submitted as part of a marketing authorisation application and that these documents may therefore be disclosed to any third party who requests to see them.