On 2 October 2014, the European Medicines Agency (EMA) adopted its long awaited policy on the publication of clinical data for medicinal products (the Policy). Under the Policy, the EMA will proactively publish on its website clinical data submitted as part of an application for marketing authorization for medicinal products through the centralized procedure. The clinical data shall be published following completion of the decision-making process.

1. Background

The Policy was developed by the EMA as part of its overall initiative to increase transparency of information on medicinal products.

A draft policy was published for public consultation by various stakeholders in June 2013. The draft policy was revised to reflect the comments received as a result of the public consultation.

2. Application and Scope

From 1 January 2015 clinical data composed of clinical study reports and individual patient data that was submitted as part of an application for centralized marketing authorization of a medicinal product will be publicly disclosed in accordance with the Policy.

From 1 July 2015, clinical data submitted as part of an application for extension of a therapeutic indication and line extension applications will also be subject to the disclosure requirements of the Policy. The effective date for publication of clinical data submitted as part of all other post-authorization procedures will be communicated by the EMA in due course.

The following clinical data will not be disclosed under the Policy:

  • Clinical data submitted as part of an application for marketing authorization submitted to the EMA prior to 1 January 2015.
  • Clinical data submitted to the EMA concerning medicinal products subject to a national authorization procedure.

According to the Policy, the new procedure is intended to complement the new Clinical Trials Regulation (EU) No. 536/2004 (Regulation). The EMA does not expect the first clinical trial results to become publicly available under this Regulation before 2019/2020.

Moreover, the Policy confirms that the new disclosure requirements will not replace the existing EMA policy on access to documents. As such, any entity or individual is still permitted to submit a request for access to documents to the EMA independently of the proactive publication mechanisms established by the new Policy. The Policy, therefore, aims to serve as a complementary tool to the access to documents policy prior to implementation of the Clinical Trials Regulation. The EMA does not discuss the future of the Policy and its relationship with the Clinical Trials Regulation following the implementation of the Regulation.

3. Clinical Data to be Published

From 1 January 2015, or from 1 July 2015 in the case of applications for extension of indications and line extensions for medicinal products, the EMA will publish the following information on its website:

  • Module 2.5 (clinical overview);
  • Module 2.7 (clinical summary);
  • Module 5 (clinical study reports and appendices 16.1.1 (protocol and protocol amendments), 16.1.2 (sample case report form) and 16.1.9 (documentation of statistical methods)).

The EMA intends to make individual patient data available in the future. This disclosure shall, however, be preceded by consultation with stakeholders and an assessment of the most appropriate way to make disclosure of such information compliant with applicable data protection laws.

4. Mode of Publication

Clinical data containing commercially confidential information will not be proactively disclosed. Prior to any publication of clinical data containing such commercially confidential information there will be a consultation between the marketing authorization holder and the EMA regarding proposed redactions of any commercially confidential information.

Commercially confidential information is defined as:

“Any information contained in the clinical reports submitted to the EMA by the applicant/marketing authorization holder that is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the applicant/marketing authorization holder.”

The EMA’s assessment of commercially confidential information will be the same as that conducted as part of its current access to documents policy.

When submitting applications for marketing authorization, Applicants are required to identify the clinical data which they consider to constitute commercially confidential information. In accordance with the Policy, the EMA considers that much of the information in clinical study reports is not commercially confidential information. The EMA did, however, acknowledge that the following sections of the clinical study report may contain commercially confidential information:

  • Introduction;
  • Study objectives;
  • Efficacy and safety variables;
  • Determination of sample size;
  • Study information appendices.

The final decision concerning whether or not to redact certain clinical data will lie with the EMA.

5. Access to the Clinical Data

Access to the clinical data will be conditional on acceptance by visitors of “terms of use”. There will be two separate terms of use for individuals or entities wishing to access the data:

  • The first terms of use will govern access for general information purposes. The users must complete a simple registration process and agree to the related terms of use. The clinical data will be subsequently available as a “view-on-screen-only” mode.
  • The second terms of use concern access for academic and non-commercial research purposes. The user will be required to agree to the terms of use and provide their identification during the registration process. Individuals will be requested to provide information such as their name, date of birth, and passport details. Where relevant, the user will be required to provide their position within their employer organization. The users will be able to download, save, cut and paste, and print the data. The clinical data accessed under these terms of use may be used for academic and non-commercial research purposes.

No clinical data accessed under either terms of use may be used to support an application for marketing authorization for a medicinal product or an application for an extension or variation to a marketing authorization. Furthermore, the Policy prohibits the re-identification of trial subjects whose clinical data is part of the documentation accessed and any unfair commercial use of the clinical data. The EMA questions and answers document on the Policy describes “commercial purposes” as including selling, trading or supplying the data to a third party that has not agreed to the appropriate terms of use.