On 3 February 2016 European Medicines Agency (“EMA’s”) introduced new External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use(“the New External Guidance”).

Background

EMA’s policy on the publication of clinical data for medicinal products for human use (“the Policy 0070”) was developed in accordance with Article 80 of Regulation (EC) No 726/2004. It was adopted by the EMA Management Board on 2nd October 2014.

Policy 0070 consisted of two phases. Phase 1, covering publication of clinical data reports, entered into force on 1st January 2015. Phase 2, covering the aspect of publishing of individual patient data. Clinical reports and individual patient data are collectively referred to as “clinical data”. This second stage will be implemented at a later stage, exact date is yet to be announced.

In order to implement provisions of Policy 0070, new approaches had to be developed. In order to implement objectives defined in Policy 0070 particular consideration was given to protecting personal data and protecting commercially confidential information (“CCI”). In this new External guidance document details on publication of clinical data will be provided.

EMA’s Policy 0070 applies to clinical reports contained in all marketing-authorisation applications submitted on or after this date. According to the new external guidance on the implementation of the EMA policy on the publication of clinical data for medicinal products for human use, the first reports will be made publicly in September 2016.

New Guidance for the publication of clinical data

The new guidance consists of the following four chapters:

  • First chapter: information on the scope and definitions used throughout the text;
  • Second chapter: External guidance on the procedural aspects related to the submission of clinical reports for the purpose of publication in accordance with EMA Policy 070, providing procedural guidance on submission of clinical reports;
  • Third chapter: External guidance on anonymisation of clinical reports for the purpose of publication in accordance with EMA Policy 0070, providing guidance to companies on how to anonymise clinical reports for the purpose of publication. EMA recognises that a number of methods are available to make sure the data is presented in a form that does not allow re-identifying individuals who have participated in clinical trials. Therefore the guidance does not single out one specific anonymisation method yet gives recommendations to companies on how to best balance data utility for researchers with a minimal risk of re-identification. Companies will need to provide a report explaining their approach to the anonymisation of the data, which will be reviewed and published by EMA;
  • The fourth chapter: External guidance on the identification and production of commercially confidential information in clinical reports submitted to EMA for the purpose of publication in accordance with EMA Policy 0070, which focuses on identification and redaction of commercially confidential information (-; information which is not in the public domain or publicly available and where disclosure may undermine the economic interest or competitive position of the owner of the information.”) in clinical reports submitted to EMA for the purpose of publication. The guidance states that vast majority of the information contained in clinical reports is not considered CCI. However, in the limited circumstances in which clinical reports might contain CCI, companies will need to submit to EMA for review a table justifying why such data has been redacted. The guidance clarifies which type of data EMA would typically refuse as being CCI and how the redaction of such data will be handled.

The New Guidance also includes templates for a “Redaction Proposal Document” package, Anonymisation Report, process flowcharts, workflow scheme, sample of justification table for CCI redactions, report structures and Redaction tool application letter for small and medium enterprises (“SME’s”).