EMA clinical study report disclosures policy backed

Catherine Drew of Pinsent Masons, the law firm behind Out-Law, said this approach is now necessary after the Court of Justice of the EU (CJEU) ruled that no general presumption of confidentiality applies to CSRs, and upheld the EMA's decision to disclose a CSR with only minor redactions in one case.

"The EMA’s policy of transparency has effectively been endorsed and so those submitting such CSRs with their marketing authorisation applications should not expect the documents to be withheld from disclosure on the basis of a blanket exception, should a third party request access" Drew said. "If those submitting the document consider that real damage could accrue to it through disclosure of the document to third parties then it must fully particularise what that damage would be, and this may form the basis for redactions to the released document or refusing its disclosure in its entirety."

CSRs are prepared by businesses undertaking clinical trials to support the development of new medicines. They often contain a vast amount of detail relating to the nature of the trials, the methodology underpinning them and the results achieved. CSRs will be submitted by those businesses to regulators to support their application for marketing authorisation for the new products developed. The data contained in the CSR supports the positive risk:benefit for the product.

In two cases before it, the CJEU was asked to determine, principally, whether the commercial interests of pharmaceutical companies expressed in CSRs are protected by a general presumption of confidentiality. The court was also asked to consider circumstances in which pre-clinical or clinical documents are not protected by a presumption of confidentiality but where exceptions to the disclosure may still arise.

In its rulings, the CJEU upheld earlier rulings by the EU's General Court. It confirmed that the application of a general presumption of confidentiality is "always optional" for an EU institution like the EMA, which is the body responsible for considering applications for European marketing authorisation for medicines.

In one of the cases, the CJEU dismissed claims raised by Dublin-based company PTC Therapeutics International (PTC) that the General Court had failed to apply the protection of commercial interests set out in EU disclosure laws. The EMA had made a redacted copy of clinical documents PTC had submitted to it available to others upon their request.

EU 'freedom of information' (FOI) laws, which concern public access to documents held by EU institutions, mandate disclosure upon request subject to exemptions applying. A further EU regulation requires the EMA, on the one hand, to ensure the widest possible access to documents it holds and, on the other, to refuse access to a document where disclosure would undermine protection of commercial interests.

The CJEU said PTC had failed to precisely identify to either the EMA or General Court which parts of its reports could harm its commercial interests if disclosed.

"A mere unsubstantiated claim relating to a general risk of misuse cannot lead to those data being regarded as falling within the scope of the [commercial interests] exception … where the person seeking the application of that exception by the institution, body, office or agency in question has not adduced, prior to it taking a decision in that respect, additional details, concerning the nature, purpose and scope of the data, that are capable of enabling the courts of the European Union to understand how disclosure of those data would be likely concretely and reasonably foreseeably to undermine the commercial interests of the persons concerned thereby," the CJEU said.

The EMA welcomed the ruling.

"Transparency is an important feature of the Agency's operations," said EMA executive director Guido Rasi. "We welcome [the] judgments and will continue to work to secure transparency on medicinal products in the EU, in the interest of patients and public health."

Catherine Drew said that identifying confidential commercial information is not always easy.

"Pre-clinical documents being requested can vary in form, format and content," Drew said. "The CJEU also indicated that for data to be considered confidential commercial information the party resisting disclosure would be required to explain how their commercial interests would be harmed by the release of the information and for this to be real, rather than a merely hypothetical assertion. It is therefore for those submitting the documents to provide evidence of the real harm that would result to its commercial interests should the information be disclosed."

"It will be interesting to see how this judgment interplays with forthcoming requirements in the Clinical Trials Regulation, where those conducting clinical trials will be obliged to prepare and summaries of their activities which will then be published. Proactive publishing of those summaries may reduce the number of requests such as that considered in this case," she said.