The European Medicines Agency (EMA) has once again extended its deadline for publishing a definitive policy on the disclosure of clinical-trial data for newly licensed medicines.
The EMA is, nonetheless, moving towards the final stages of introducing a proactive disclosure policy, with particular emphasis on resolving the vexed issue of data in clinical study reports (CSRs) that trial sponsors say is commercially confidential.
At the beginning of May, the agency will launch a “final round of targeted consultations” with key stakeholders on its draft policy for proactive publication of, and access to, clinical trial data following publication of the EMA’s European public assessment report on an application for centralised marketing authorisation.
This will give key stakeholders and the agency the opportunity to address any outstanding issues before the final policy is presented to the EMA’s Management Board for endorsement in June 2014, the agency explained.
Redaction principles
The targeted discussions will focus on “the presentation by the EMA of the principles set for the possible redaction of the clinical-study reports to be published”, it noted.
If applied, these redactions will be “based on the criteria identified by the agency for those parts of clinical-trial data that exceptionally contain commercially confidential information”.
These intentions are in line with the compromise reached by the agency last week with AbbVie over releasing historical CSRs on request for the company’s blockbuster anti-inflammatory blockbuster Humira (adalimumab).
They also chime with the limited exemptions for commercially confidential information included in the EU Clinical Trials Regulation that was approved by the European Parliament last Wednesday.
The targeted consultations will further try to clarify how “concerned data-owners”, such as marketing-authorisation holders, will be consulted before their CSRs are published.
Also up for discussion are “user-friendly” technical measures to make the relevant data accessible under the new policy, including terms of use.
Final round
The EMA says it will liaise shortly with organisations representing patients, academia, the pharmaceutical industry and European Union (EU) institutions on the final round of consultations
These are aimed at clarifying and fine-tuning specific aspects of the draft policy, while achieving “the broadest possible consensus and understanding” of the agency’s proactive strategy for data transparency.
The original aim was to finalise the disclosure policy before the end of 2013, to meet the planned implementation date of 1 January 2014.
Last November, though, the EMA announced that it might have to push back these deadlines, citing the volume and level of detail in comments received during its public consultation on the proposals.
The agency subsequently confirmed in December that it would not be publishing a definitive policy on the disclosure of clinical-trial data for newly licensed medicines until at least March 2014.
Clinical Trials Regulation
As the EMA pointed out, its disclosure policy runs parallel to other initiatives aimed at increasing the transparency of clinical trials in the EU – most notably the new Clinical Trials Regulation, which “received a strong vote in favour” from the European Parliament on 2 April 2014.
Under the Regulation, clinical-trial sponsors will need to submit a results summary, regardless of the study outcome, to a publicly accessible EU database within one year of the trial ending, as well as an additional summary understandable to lay people.
Where the purpose of the trial is to obtain a marketing authorisation (MA), the applicant will also have to file the CSR to the EU’s database 30 days after the MA is granted, the decision-making process on the MA application completed, or the application withdrawn by the sponsor.
The text approved by the European Parliament in its plenary vote states that “in general” the data included in a clinical-study report “should not be considered commercially confidential once a MA has been granted, the procedure for granting the MA has been completed, [or] the application for MA has been withdrawn”.
However, it provides for an exemption from public access in cases where confidentiality is justified on grounds of “protecting commercially confidential information, in particular through taking into account the status of the marketing authorisation for the medicinal product, unless there is an overriding public interest in disclosure”.
AbbVie compromise
The Clinical Trials Regulation will not apply retroactively to study data for medicines already on the market, which is a particular bugbear for the AllTrials transparency campaign.
However, the EMA gave some pointers to future policy on this front when it reached a compromise – involving limited redaction of commercially sensitive data – in its legal dispute with AbbVie over releasing CSRs and other information from approved marketing authorisation applications on request.
The EMA was asked to “consider an entirely new set of redacted documents” on Humira, as well as the related justification for redaction proposed by the company, following the agency’s successful appeal against the interim rulings handed down by the European Union’s General Court in April 2013.
Very limited
“The very limited redactions proposed by AbbVie were consistent with the Agency’s redaction practices and also had no significant impact on the readability of the reports,” the EMA stated.
AbbVie confirmed that the EMA had accepted the redacted documents, along with the company’s rationale for removing “certain commercially confidential information from the clinical study reports that are at the centre of the litigation”.
As a result, AbbVie has withdrawn its lawsuits against the agency in the European court, although a parallel case brought against the EMA by InterMune on CCI grounds is ongoing.
According to Dirk Van Eeden, AbbVie’s senior director, public affairs, the compromise reached with the EMA means a “significant portion” of the Humira data will be disclosed “while protecting the information that is commercially sensitive”.
