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CJEU rejects presumption of confidentiality of documents lodged as part of a marketing authorisation application

Jacqueline Bore

Senior PSL / Life Sciences


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23 January 2020

The Court of Justice has upheld two EMA decisions to release documents lodged as part of a marketing authorisation application to third parties. In doing so it has agreed with the EMA’s approach to transparency and disagreed with the opinion of its own Advocate-General Hogan that had surprised many observers when it was published last September.

The two cases before the Court raised almost identical issues. PTC Therapeutics had argued that a clinical study report submitted to support a marketing authorisation application for the product, Translarna, should be presumed to be confidential in its entirety and, therefore, should not be released in response to an application made by another pharmaceutical company pursuant to the EU’s Access to Documents Regulation No 1049/2001. MSD Animal Health and Intervet made the same argument in relation to a toxicity report submitted as part of an application for a marketing authorisation for a veterinary product.

The Court held that neither report should be presumed, by its very nature, to be confidential. The EMA was entitled to make a detailed and specific analysis of each document to determine whether it contained commercially confidential material. Only if all of the information in the reports could be considered to be confidential should they be withheld from the applicant requesting access. In order to determine whether any particular piece of information constituted commercially confidential information the EMA should apply the test of whether the undertaking resisting disclosure had identified a concrete and reasonably foreseeable risk that release of unpublished data could undermine its commercial interests. The Court rejected the argument that the collection together of published and unpublished data in a clinical study report or toxicity report could provide a competitor with a “roadmap” that would enable them to shortcut their own development time for a competing product.

The judgment of the Court of Justice confirms the approach that the EMA has been adopting in relation to transparency requests despite A-G Hogan’s Opinion to the contrary. It will continue to be very difficult to resist disclosure of most of the information in clinical study reports or other documents lodged as part of a marketing authorisation application unless the company which has submitted the document can produce detailed evidence of how this information could be used, for example, to gain a marketing authorisation in a country outside the EU. The EMA will continue to take a line by line, word by word approach to the redaction of such documents before disclosure.

The cases considered by the Court of Justice here did not take account of the permissive approach to the publication of clinical trial documents and data pursuant to the Clinical Trial Regulation. However, this confirmation by the Court of Justice of the approach taken by the EMA to assessing whether information is commercially confidential in the context of clinical trial disclosures could be seen to be a tacit approval of the EMA’s interpretation of the commercially confidential information exception in the context of laying down the disclosure rules under the Clinical Trial Regulation.

The pharmaceutical industry will start to see the effect of these new rules when the Clinical Trial Regulation is currently expected to become applicable once an audit of the Clinical Trials Information System has successfully completed, such audit currently scheduled to start in December 2020. Companies will need to start thinking how those disclosures could affect the protection of its patents as well as trade secrets and know-how.

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