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28 Jan 2020

Documents disclosed to the EMA as part of an MA application process are not presumed to be confidential

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On 22 January 2020 the CJEU handed down two decisions in which it decided that the European Medicines Agency (EMA) was entitled to disclose to third parties the study reports submitted to it by applicants for marketing authorisations (MAs), despite the applicants claiming confidentiality over the reports.

The PTC v EMA (C-175/18 P) and MSD v EMA (C-178/18 P) decisions both grappled with the tension between the principle of transparency of EU institutions and the desire to incentivise pharmaceutical companies by preventing competitors from gaining access to documents submitted during the MA application process.

The arguments of the appellants

The appellants argued that:

  1. There should be a presumption that documents submitted to the EMA during the MA application process are confidential.

  2. Study reports constitute a category of commercially sensitive documents which should be excepted from the general rule that documents submitted to EU institutions are disclosable to the general public. In the alternative, the appellants argued that these specific reports were commercially sensitive and should not have been disclosed by the EMA. They argued that the EMA and the General Court had applied too high a threshold of commercial sensitivity.

  3. The disclosure of study reports prejudiced the EMA’s decision-making process by inviting third party interference.

  4. The EMA and the General Court gave undue weight to the public interest in transparency.

The CJEU decision

In both cases the CJEU declined to follow the Opinion of the Advocate General (who had advised the CJEU to allow the appeals on the second, third and fourth grounds above). A number of points of general applicability can be taken from the CJEU’s decisions: 

  1. There is no mandatory presumption of confidentiality in the case of documents submitted during an application for an MA. On the contrary, EU jurisprudence is clear that there is a general principle of transparency which is subject to limited, narrowly-interpreted exceptions. In any case, EU institutions are not bound to follow a general presumption and are able to conduct a specific analysis on a case-by-case basis.

  2. An applicant seeking to fall within an exception to the general principle of transparency must adduce evidence at an early stage (before the EMA makes its decision) which identifies specifically and precisely why an exception applies and to what information (rather than relying on general, principle-based arguments).

  3. There is no “seriousness” threshold to be applied when determining whether information is “commercially sensitive” and therefore excepted from disclosure.

Points to consider

Although the CJEU found that there is no general presumption of confidentiality in relation to documents submitted as part of an MA application process, that does not mean that the whole or part of such a document cannot be exempted from the transparency principle on a case-by-case basis. However, persuading the EMA to treat a document (or part thereof) as confidential may be a difficult and time-consuming task. In the present cases, after the EMA made its intital decision both applicants submitted witness statements which sought to explain why the relevant reports were commercially sensitive (indeed, the Advocate General described PTC’s witness to have “provided very clear and thorough explanations as to how the appellant’s commercial interests would be undermined if the report at issue were to be disclosed. It is, frankly, difficult to see how he could have been any more specific than he was”). Despite this, in both cases the CJEU confirmed that the General Court did not have to take the witness statements into account because the CJEU deemed them to be too general as they did not explain why “specific passages” of the reports were commercially sensitive by reference to the “nature, purpose and scope” of the data contained therein. The witness statements were also found to have been submitted too late as they all post-dated the EMA’s initial decision.

From now on applicants for centralised MAs will have to provide specific and precise explanations as to why a disclosure exemption applies to each part of any document which an applicant seeks to maintain as confidential. Applicants will have to provide that explanation before the EMA makes its initial decision as to disclosure.

Beyond claims of confidentiality, MA applicants and holders will continue to be able to rely on other rights (to the extent that these exist), such as copyright, database rights, and data- and market-exclusivity rights, to protect their first-mover investment.

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