The European Medicines Agency (EMA) will not be publishing a definitive policy on the disclosure of clinical-trial data for newly licensed medicines until at least next March, the agency has confirmed.

The original aim was to finalise the disclosure policy before the end of this year, in time for the planned implementation on 1 January 2014. 

Last month, though, the EMA announced that it might have to push back these dates, citing the volume and level of detail in comments received during its public consultation on the proposals.

The Agency now says it will continue working with stakeholders, including industry, academia and civil societies, “to further clarify and fine-tune the proposed rules to achieve the broadest possible consensus”.

This process will be guided by a set of key principles agreed with the EMA’s Management Board on 12 December 2013.

Management Board meeting

The policy on publication of, and access to, clinical-trial data, as well as an implementation plan for the new procedures, will be discussed at the EMA Management Board meeting in March 2014, the agency added.

The three-month consultation on the draft policy, which includes a tiered system of access to clinical study reports and raw trial data for products approved centrally in the European Union, concluded at the end of September.

More than 150 individuals and organisations submitted over 1,000 comments during the consultation period. 

Key principles

The key principles agreed by the EMA include a “stepwise approach” to implementation.

The first step, the agency explained, would be to prepare for the publication of Clinical Study Reports, with redactions where appropriate; develop a methodology for de-identifying patients who have taken part in the relevant clinical trials; and define a standard format for data submission.

The principles also foresee introducing “preliminary steps prior to data access” that would address “the risk of possible unfair commercial use of data while ensuring proactive and non-selective access (‘use control’ not ‘access control’)”.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has raised a number of objections to the draft policy, in particular relating to commercially confidential information, patient privacy, informed consent, and the need for a robust review-and-appeal system before clinical-trial data are released.

Large support

The EMA has now reviewed all of the comments received on its draft disclosure policy, and while these showed “large support” for the agency’s plans to widen access to clinical-trial data, they also highlighted a need for “further analysis and clarification of certain aspects”, it noted.

The agency said it would also continue to monitor “progress in the Court cases brought by two pharmaceutical companies against the Agency and the on-going discussions on the new European clinical-trials legislation”.

It recognised the “need for consistency in the general approach to access to documents by EU institutions and bodies”, while at the same time underlining “the specificity of documents in the possession of the EMA and the Agency’s primary duty to protect and foster public health”.

Clinical trials regulation

The European Parliament is currently negotiating with the EU Member States on a final version of the European Commission’s proposed regulation on clinical trials, which includes a number of data-transparency provisions.

Earlier this week, the AllTrials transparency campaign publicised a message from the office of MEP Glenis Willmott, who is rapporteur in Parliament’s Committee on Environment and Public Health (ENVI) for the Commission’s proposals to overhaul the clinical trial Directive, 2001/20/EC.

According to AllTrials, Willmott and her supporters have tentatively agreed, subject to endorsement by the Member States, the ENVI committee and the whole of Parliament, the following transparency measures:

  • A publicly accessible EU database, set up and run by EMA and incorporating:
    • A register of all trials carried out in the EU
    • A summary of results for all trials, uploaded at the latest one year after a clinical trial is completed
    • An additional summary understandable to a layperson
    • Clinical Study Reports for all trials used in a request for marketing authorisation, whether this is approved, rejected or withdrawn.               
  • A statement that Clinical Study Reports should “in general” not be considered commercially confidential.
  • Fines to be imposed by Member States for non-compliance with the transparency requirements.
  • A requirement for all trials to be registered or published so they can be used to back up a new clinical-trial authorisation (i.e., to encourage the retrospective registering/publication of old trials).
  • The Clinical Trial Master File should be retained for at least 25 years.

Legal challenges

The legal challenges to the EMA’s existing policy of releasing, on request, Clinical Study Reports (CSRs) and other information from marketing authorisation applications (MAAs) remain in flux, following two orders handed down late last month by the Vice-President of the European Court of Justice.

The EMA had appealed against the General Court’s interim ruling on 30 April instructing the agency not to release data (including CSRs) submitted in MAAs by AbbVie and InterMune, which had taken legal action to block disclosure on the grounds of commercial confidentiality.

On 28 November, the Vice-President of the European Court of Justice set aside the General Court’s decision to grant interim relief to AbbVie and InterMune in their efforts to prevent the EMA from releasing clinical-trial data on Humira (adalimumab) and Esbriet (pirfenidone) respectively.

The Vice-President has referred these orders back to the General Court for further consideration of the underlying arguments.

The reasoning was that the General Court had failed to establish with sufficient weight that the disclosure of commercially confidential information in the documents provided by AbbVie and InterMune to the EMA would result in “serious and irreparable harm” to the companies.