On 2 October 2014 the European Medicines Agency (EMA) adopted a new policy, effective from 1 January 2015, on publication of clinical data for medicinal products for human use[1].  It represents a shift from reactive to proactive publication of clinical data for centralised marketing authorisation (MA) applications.  The EMA’s intention is to increase transparency to enable non-commercial use of the data while ensuring the protection of personal data and commercially confidential information (CCI).

Development of clinical data transparency

While an enormous amount of data is generated by clinical trials conducted in support of applications for MAs, to date relatively little has been made readily available to the public.

Since November 2010, the EMA’s policy has been to provide access to clinical trial reports, and other documents submitted as part of an application, on request once the decision-making process is complete.  To protect sensitive data, both personal data and CCI may be redacted.  The originator of the data will be notified of the request but will only be consulted where there is doubt in relation to potentially confidential information contained in the report. 

Following extensive consultation, its new policy adopts a proactive approach so that clinical data from MA applications submitted under the centralised procedure will automatically be published once the procedure has been finalised.  The new policy is also applicable to post-authorisation procedures for existing centrally authorised medicinal products, procedures under Article 58 of Regulation (EC) No 726/2004[2] and any other submissions in response to requests from the EMA for additional clinical data for these applications or procedures.  The new policy will not apply retroactively, nor will it cover clinical data not held by the EMA or pharmacovigilance data based on individual case safety reports.

The new policy will come into force on 1 January 2015 pre-empting the new EU Clinical Trials Regulation[3], which will require publication of data in an EU database.  The current policy of providing documents on request will continue alongside the new. 

The goals of the EMA’s policy shift are two-fold: to establish greater trust and confidence in the MA applications system through transparency and to provide wider access to third parties to enable secondary analyses of the data for the benefit of public health.  However, elements of clinical trial data remain inherently sensitive.  Personal data and CCI need to be protected so as to respect the privacy of patients and avoid undermining the legitimate economic interests of companies that invest in the research and development of new medicines.  The EMA’s new policy aims to strike a balance between the benefits of transparency and these rights.

Scope of the EMA’s new policy

The data to be published under the new policy will encompass both the clinical reports (i.e. clinical overviews, clinical summaries and the clinical study reports (CSR), together with some appendices to the CSRs) and individual patient data (IPD).  While the information in clinical reports is generally not considered confidential, there will be occasions when they will contain CCI which, if placed in the public domain, would undermine the economic interests or the competitive position of the MA applicant. To encourage continued investment in drug development, given the considerable sums involved, such CCI needs to be protected and accordingly a procedure will be put in place to assess whether information qualifies as CCI and whether redaction is justified.

The right to privacy and the protection of personal data is a fundamental right in EU law,[4] and IPD in clinical data contains sensitive personal data that relates to an identifiable individual with the risk of identification increasing for sufferers of rare diseases. While there are methods to anonymise data, the rapid evolution of technologies in data mining and database linkage requires the EMA to ensure that patients are protected from both direct and indirect identification.  For these reasons, the new policy is being introduced in a step-wise fashion, beginning with the publication of clinical reports from applications made from 1 January 2015 (and 1 July 2015 for extensions), followed by IPD at a later date once there is sufficient protection to ensure that individuals cannot be identified.

To further protect the data and promote responsible use, users will have to register to obtain a username and password, and abide by terms of use.  There will be two sets of terms depending on what the user intends to do with the data.  A simple, limited registration process will provide clinical reports in a searchable format, but will only allow on-screen viewing.  Where the intended use of the data is for academic and non-commercial research purposes, users must provide further identification details in order to download or print the data.  The terms will also require users to confirm that they will not make any attempt to identify individuals or use the data for unfair commercial uses, and that any such use would breach intellectual property rights of the originator of the data.  The terms also specify that the clinical reports may not be used to support MA applications by the recipient(s) of the data.

Implications of the EMA’s new policy

By making clinical data more readily available the new policy is likely to result in it reaching a wider audience than under the current policy, particularly amongst organisations which previously may not have had the resources or the inclination to make disclosure requests.  The greater accessibility has the potential to make the development of medicines more efficient through sharing of information, allowing researchers to learn from past successes and failures.  A further public health benefit may arise from researchers applying novel questions and analyses to the data.

Although the policy carries a greater risk to MA applicants of CCI being disclosed, knowing that their clinical trial data will be published automatically should encourage them to engage in the redaction process at an early stage.  But how effective this process will be in meeting confidentiality concerns will depend on how the new policy is implemented in practice, and is likely to lead to further consultation in the future.