The European Medicines Agency (EMA) will now move ahead with drafting a policy on proactive access to clinical-trial data for medicines that have completed their marketing-authorisation process.
Having published on its website the final advice from the five multi-stakeholder advisory groups set up to consider various aspects of clinical-data transparency, the EMA aims to have its draft policy out for consultation at the end of June 2013, in line with its previous timetable.
The public consultation will last until the end of September 2013, after which a final policy will be published at the end of November 2013, for planned implementation on 1 January 2014.
A possible complicating factor is the interim ruling by the General Court of the European Union (EU) on 30 April, instructing the EMA not to release data (including clinical study reports) submitted in marketing-authorisation applications by AbbVie and InterMune, which are claiming commercial sensitivity.
However, the EMA is weighing up whether to appeal the interim relief granted in the court cases brought by AbbVie and InterMune. The agency also intends to continue granting access on a case-by-case basis to documents similar to those contested by AbbVie and InterMune, pending a final judgment from the General Court.
Commenting on this issue in relation to its evolving policy on clinical-data transparency, the EMA stated: “A number of court cases are currently ongoing which will bring the opportunity for legal clarification of the concept of commercially confidential information”.
The outcomes of these court cases “will be taken into account in the finalisation of the policy”, the agency added.
Must not delay
Steve Bates, chief executive officer of the UK-based BioIndustry Association, has warned that the General Court’s interim ruling “must not delay the timetable for introducing a modernised Clinical Trial Regulation for Europe”.
Data transparency has become a primary focus of the European Commission’s proposals to overhaul the EU Clinical Trials Directive (2001/20/EC), which are now before the European Parliament.
As the EMA noted, more than 200 people from the full range of stakeholder groups applied to participate in one or more of the advisory groups on clinical-data transparency, which met via teleconference between January and April 2013.
Final advice has been published at www.ema.europa.eu from advisory groups on:• protecting patient confidentiality;
• clinical-trial-data formats;
• rules of engagement;
• good analysis practice; and
• legal aspects of transparency.The EMA said it was aware of patients’ concerns about protecting personal data and would take these into account in its final policy.
It would also address issues around the analysis of clinical-trial data by independent parties, which was “not always equivalent to it being free of conflicts of interest and of high quality”.The final policy would ensure transparency in the best interests of public health without impinging on individual companies’ intellectual property rights, or otherwise acting as a disincentive to future investment in research and development, the EMA promised.