EFPIA perspective Regulation EU 536/2014/CTIS – and its implications on new requirements – particularly those requirements that affect the publicly disclosed documents.

10:00 AM - 10:40 AM

The EU CTR became applicable in the European Economic Area on 31 January 2022 with aims at simplifying and harmonising clinical trial research in Europe, as well as providing improved transparency of relevant documents and processes as the clinical trial evolves. The level of transparency that is in scope under the EU CTR is unprecedented. As a default, all documents, except those relating to financial arrangements and quality, will be made public at the earliest opportunity.

EFPIA1 and its members are committed to ensure EU CTR compliance. We work with stakeholders to ensure that clinical trial information is shared responsibly taking into account patient anonymity, maintaining the integrity of regulatory systems worldwide, and continuing to support innovation with appropriate arrangements for commercial-in-confidence information.

To support the sharing of clinical trial data, EFPIA and its member companies published and implemented the EFPIA/PhRMA principles for responsible sharing of clinical trial data. Going beyond the legislative requirements, the principles bring new levels of access to clinical trial data (see link here).

An early publication of clinical trial information can prevent sponsors from securing Intellectual Property Rights on innovation arising from clinical trials. The EU CTR allows sponsors to protect their commercially confidential information (“CCI”) offering two distinct tools: (a) justified deferral from publication and (b) selective redaction of documents. However, the EU CTR itself does not provide details on the process for the request and assessment of such deferrals and redactions, these issues are addressed in the EMA guidance on the protection of personal data and CCI in documents submitted or uploaded via CTIS and also in Q&A documents issued by the EMA.

This presentation will provide an industry perspective from a legal standpoint on the implications of the EU CTR transparency requirements on the protection of IP rights and patents, with a particular focus on the redaction and deferral strategy.