Clarification on Patient Facing Document from ACT EU Q&A

On 31Jan24, the "Q&A on the protection of Commercially Confidential Information and Personal Data while using CTIS, Question and Answers, version 1.4" was released on ACT EU web site. To promote its visibility, the document was announced in the Key updates section of the "CTIS newsflash – 9 February 2024" released by EMA today.

https://www.ema.europa.eu/en/documents/newsletter/ctis-newsflash-9-february-2024_en.pdf

The only update to the document was the addition of the following Q&A 3.4 on patient facing documents disclosure:

"3.4 Is it possible not to disclose patient facing documents publicly?

In some cases, written agreements between the sponsor and the third-party service provider expressly establish that patient facing documents (e.g. patient questionnaires) cannot be disclosed publicly. In those cases, it is possible for the sponsor to upload in the ‘for publication’ placeholder a document where a justification for not disclosing the patient facing document is provided. In the placeholder ‘not for publication’ the document with its full content should be uploaded to allow the Member State(s) assessment".

The answer above is actually reopening to door for discussions about the publication of patient facing documents (e.g. patient questionnaires) in the CTIS Public web site as part of EU CTIS submission.

Going back to the 2015 Appendix, on disclosure rules, to the “Functional specifications for the EU portal and EU database to be audited - EMA/42176/2014”, it should be repeated that:

• "The Regulation sets out requirements for increased transparency of EU clinical trials".
• Article 81(4) of the Regulation states that the EU database shall be publicly accessible unless, for all or part of the data and information contained therein, confidentiality is justified on any of the following grounds:
• a) ?protecting personal data in accordance with Regulation (EC) No 45/2001;
• b) ?protecting commercially confidential information, in particular through taking into account the status of the marketing authorisation for the medicinal product, unless there is an overriding public interest in disclosure;
• Point c) protecting confidential communication between Member States & Point d) ensuring effective supervision by Member States are out of scope here.

https://www.ema.europa.eu/en/documents/other/appendix-disclosure-rules-functional-specifications-eu-portal-and-eu-database-be-audited_en.pdf

Clearly, the question is to know if patient facing documents (e.g. patient questionnaires) cannot be disclosed publicly because of a written agreement to protect "commercially confidential information".

We can oppose the fact that a lot of patient facing documents (e.g. patient questionnaires) were initially publicly published in scientific journals, to facilitate their visibility to the scientific or medical communities.

Some were then made publicly accessible, some were protected by Copyright.

Patient facing documents (e.g. patient questionnaires) that cannot be used freely because of a Copyright, are protected by the Copyright itself, not by the fact these will not be visible in the CTIS Public web site.

The main exception to this rule that can be covered by the Q&A 3.4 on patient facing documents disclosure, will probably be for the ones that are in development (not made public in scientific journals) and for which there is clearly a legitimate commercially confidential information aspect for the development entity.

Additional clarifications may be generated later.

Clear practical issues for the Sponsors (who will decide not to disclose patient facing documents in their submission package) will be:

• To have justification for not disclosing the patient facing document ready;
• To have all translated versions ready in case of requests by some NCAs or Ethics Committees (not accepting the justification for not disclosing) at the Validation or Assessment Phases.

As a reminder, Decision on the clinical trial (Article 8) is Member State specific. We may see interesting situation where a translated Patient facing document (e.g. patient questionnaires) is accepted not to be disclosed in one country, and the justification is not accepted in another one which will request submission & the associated publication in CTIS Public Web site.

https://accelerating-clinical-trials.europa.eu/system/files/2023-11/ACT%20EU_Q%26A%20on%20protection%20of%20Commercially%20Confidential%20Information%20and%20Personal%20Data%20while%20using%20CTIS_v1.3.pdf