AbbVie has withdrawn its legal challenge to the European Medicines Agency’s (EMA) policy of releasing, on request, Clinical Study Reports (CSRs) and other information from marketing authorisation applications (MAAs).
The EMA said it had reached a compromise with AbbVie over “very limited” redactions to data in the disputed CSRs, removing what AbbVie considered to be commercially confidential information (CCI).
A parallel court case brought against the EMA by InterMune on CCI grounds is still awaiting resolution.
If the agency can reach a similar compromise with InterMune over data disclosure from CSRs on request, it should lend some momentum to the EMA’s efforts to introduce a proactive policy on the disclosure of clinical-trial data for newly licensed medicines.
Clinical trials and CCI
The agency’s draft disclosure policy, which is still being fine-tuned to accommodate a flood of comments from interested stakeholders, raised industry hackles by stating that “in general”, clinical trials “cannot be considered CCI” and are outweighed by public-health considerations.
This was the position taken in rapporteur Glenis Willmot’s amendments to the European Commission’s proposed Regulation on clinical trials, which will overhaul the much-maligned Clinical Trials Directive, 2001/20/EC.
A compromise version of the regulation, approved last week in a plenary vote by the European Parliament, states that “in general” the data included in a CSR “should not be considered commercially confidential once a marketing authorisation has been granted, the procedure for granting the MA has been completed, [or] the application for MA has been withdrawn” (see separate story in today’s clinical e-lert).
However, the regulation goes on to state that discretion may be 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”.
Need for change
The EMA’s announcement came just one day after the Parliament’s plenary vote and was greeted by Willmott as further evidence that opponents of transparency “are now realising the need to change”.
In Willmott’s view, the regulation as approved “includes a clear statement that Clinical Study Reports should not be seen as commercially confidential. This is vital in supporting the European Medicines Agency as they try to publish the data they hold on old trials”.
It is “great to hear that one pharmaceutical company has backed down and I hope the one remaining legal challenge will also be dropped”, Willmott commented. “Access to clinical trial data is essential for patient safety, scientific progress and public trust in medicine.”
Redacted documents
The EMA explained that it was asked to “consider an entirely new set of redacted documents” on AbbVie’s anti-inflammatory blockbuster Humira (adalimumab), as well as 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 .
“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. “Therefore, a decision accepting that new set of documents was notified to the company.”
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 had withdrawn its lawsuits in the European court.
According to Dirk Van Eeden, AbbVie’s senior director, public affairs, this means a “significant portion” of the Humnira data will be disclosed “while protecting the information that is commercially sensitive”.
AbbVie will continue to work with regulators and other stakeholders “to provide scientists with the information they need to weigh the risks and benefits of medicines, while protecting the identities of patients and commercially sensitive information”, Van Eeden added.
ECJ ruling
The General Court’s interim rulings had instructed 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.
In November 2013, however, 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 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.
CSRs on request
The EMA has been releasing CSRs on request since 2010, in line with a recommendation from the European Ombudsman – which itself had come under pressure from the Nordic Cochrane Centre over data disclosure.
According to the agency, its open-data policy already includes provisions for redaction to protect CCI and patient privacy, although the extent to which this policy is applied has been unclear.
It had been hoped that, in addressing the legal challenges from AbbVie and InterMune, the General Court would arrive at some firm definition of what constitutes CCI and how it might be protected.
Proactive policy
These issues, as well as the pending Clinical Trials regulation, have muddied the EMA’s plans to introduce a proactive policy for disclosing clinical-trial data.
Last December, the EMA confirmed 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.
The original aim was to finalise the disclosure policy before the end of last year, in time for the planned implementation on 1 January 2014.
