The European Medicines Agency (EMA) released a draft policy on access to clinical trial data as it tries to strike a balance between transparency and confidentiality of sensitive information.
The publication of the policy statement comes at a time when the agency has committed to proactive disclosure of data from trials submitted in support of marketing authorisation applications, once a verdict on the submission has been delivered.
The EMA has said it intends to release clinical trial data on all newly-approved pharmaceutical drugs in a bid to foster transparency, promote faster innovation and establish “trust and confidence in the system”.
The shift to greater openness seems inevitable in the wake of the recent European Parliament Environment, Public Health and Food Safety (ENVI) committee vote to amend the Clinical Trial Directive (CTD), but there is still plenty of debate to be had, and the EMA is accepting comments on the draft policy until September 30, 2013.
Provisionally starting in January 2014, the policy separates clinical data into three categories of access: commercially confidential information; open-access data that does not contain patients’ personal information; and controlled-access data that may include personal data and will only be accessible after the requester fulfils certain requirements.
Commercially-confidential information would include details of the investigational medicinal product itself, such as in vitro studies or bioanalytical data that characterises it, according to the EMA.
Open-access data would include any clinical-trial data, information or documents that do not reveal patient data, and it is envisaged that this would be downloadable from the EMA website from the time the European public assessment report (EPAR) is published, regardless of the outcome of the review.
The third category – controlled access – is likely to be the most difficult to handle as it includes trial data and other information that contain patient information, such as individual patient data sets and case reports.
The EMA expects that controlled access will only be granted if the data is ‘de-identified’ to protect patient confidentiality, while the requester will have to meet criteria including the signing of a data-sharing agreement.
‘Undermine industry competitiveness’
Reacting to the draft policy, Sanofi chief executive Chris Viehbacher immediately went on the record to claim the proposal would undermine the competitiveness of the pharma industry.
On his election as president of the European Federation of Pharmaceutical Industries & Associations (EFPIA) yesterday, Viehbacher said that the stance taken by the European regulator threatens to impose a ‘data dump’ that will make commercially confidential information available to competitors around the world.
He said the industry is amenable to changing the way it operates, but any change has to be carried out “intelligently” to avoid damaging the sector. In 2012 alone, the R&D-based pharmaceutical industry in Europe generated 700,000 jobs, and created a positive trade balance of an estimated €80bn, he pointed out.
Meanwhile, the EMA itself concedes that its plans could be undone if ongoing court cases that challenge its access-to-documents policy and seek to clarify the definition of commercially confidential information change go against the agency’s position.
AbbVie and InterMune filed suit against the EMA earlier this year to block the release of clinical data on their drugs and won an injunction from the General Court of the EU a few weeks ago.
The EMA also noted that the ongoing legislative process to replace the current European CTD framework may diverge from the ENVI committee’s current position that was put to the vote at the end of May 2013.