New policy on publication of clinical data for medicinal products for human use

18 February 2015

In October 2014, a new policy on publication of clinical data for medicinal products for human use was unanimously approved by the management board of the EMA. The adoption of this policy forms an important milestone in the on-going debate on access to clinical research, data sharing and transparency.

1. Introduction

The new policy governs publication of clinical trial data for medicines that have received a Marketing Authorization (MA) under the centralized procedure as from 1 January 2015. Indeed, applicants for a MA routinely submit such data, composed of clinical reports and Individual Patient Data (IPD) to the EMA under the centralized marketing authorization procedure.

The new policy clarifies the extent to which the EMA will proactively publish these data and under what conditions. It deals with the main concerns relating to the concept of Commercial Confidential Information (CCI) and the protection from unfair commercial use, protecting patient confidentiality as well as the concept of raw data.

This policy is without prejudice to Regulation No 1049/2001 regarding public access to documents. The result of this is that any natural or legal person may continue to submit a request for access to documents to the EMA independently of the proactive publication mechanism established in this new EMA policy.

Importantly, the EMA developed this policy in the absence of any specific legal provision mandating that the EMA must publish such data. Hereby taking into account the views and concerns of a broad range of stakeholders (including patients, healthcare professionals, pharmaceutical industry representatives, researchers, transparency campaigners, academic and public institutions, health technology assessment bodies, and national medicines regulators) and European bodies, who all contributed actively to the development of this new policy.

2. Scope of the new policy

The EMA's new policy will only cover clinical data of new MA applications and Article 58 applications of Regulation (EC) No 726/2004 (medicines that are intended exclusively for markets outside the European Union) submitted to the EMA after 1 January 2015 and does not apply to clinical data that the EMA holds for applications received under the centralized procedure before that date.

For post-authorization procedures for existing centrally authorized medicinal products, the effective date will be 1 July 2015 for extension of indication and line extension applications that have been submitted as of that date.

Therefore, according to this policy, data will only start to become accessible once the final decision on a given procedure has been reached by the European Commission, which implies a timeframe of approximately 18 months.

3. Main features of the new policy

In accordance with the policy, the EMA will provide access to clinical reports primarily redacted by the Marketing Authorization Holder (MAH). In limited circumstances these reports may be redacted prior to publication, the objective being a publication of the documents around the time of the Commission decision granting or refusing the MA/post-authorization submission outcome.

The redaction mechanism foresees that the reports may only be subject to redaction when needed to protect specific elements which qualify as CCI. The EMA will have the final say in case of disagreement on what will be redacted, following a consultation with the MAH. Importantly, the new policy provides an extended list of documents potentially containing CCI for partial redaction.

The policy is accompanied by newly developed Terms of Use (ToU) and access rules. The Annexes of the policy contain (i) copies of the ToU, (ii) details of information contained in clinical reports that may be CCI and (iii) the process for publishing clinical reports.

Two sets of ToU are available depending on the intended use of the information contained in the clinical reports:

- Any user may have view-only access to the clinical reports for general information purposes (non-commercial, including non-commercial research purposes) following a simple and limited registration process; or

- Formally identified users to the EMA may download clinical reports solely for academic and non-commercial research purposes. These data may not be used to support a MA application or extensions or variations to a MA nor to make any unfair commercial use of the clinical reports.

A Q&A document was published together with the final policy.

4. Stepwise implementation of the new policy

The first stage of implementing the new policy will involve the publication of clinical data relating  to clinical reports only. There will be no access to so called raw data. This will however, be reviewed by the EMA in a second phase in which various aspects in relation to IPD, including finding the most appropriate way to make IPD available in compliance with privacy and data protection laws, will be analyzed.