The EMA Management Board meeting will consider a draft policy on the publication of clinical trial data. The draft policy arises from the agency’s commitment to increase access to clinical trial data and has been shaped by the many comments received during the consultation phase.
The EMA was faced with an unprecedented level of response and range of divergent interests during its public consultation. Many stakeholders made their views known, including pharmaceutical industry, academia, patients and healthcare professionals, health-technology-assessment bodies and national medicines regulators. At the E.U.-level, contributions also came from members of the European Parliament, the European Ombudsman and European Commission.
Some parties argued the agency’s policy would encourage unfair commercial use of data outside of the E.U., that it would provide a disincentive to innovation in Europe and risk companies moving their R&D activities outside of the E.U., and even that it could endanger international agreements on intellectual property protection.
On the other side, some saw the policy as limiting the ability of researchers and academics to carry out meaningful re-analysis of data on medicines, as offering limited benefit for public health, even as restricting rights to access documents and going against the principles of transparency and openness.
The agency stands by its commitment to increase access to clinical trial data and continues to believe that this will benefit the research-based pharmaceutical industry. In a July 2013 article published in the New England Journal of Medicine, the agency argued that it would “help to increase the efficiency of drug development, improve cost-effectiveness, improve comparative-effectiveness analysis and reduce duplication of effort among trial sponsors.”
The EMA also has publicly recognized the potential benefits for public health of independent re-analysis of data by independent academics and researchers after a medicine has been approved, and acknowledged that regulators do not have a monopoly on science.
The draft policy is a compromise approach that takes into account different stakeholders’ competing interests, in the absence of any specific current legal provision mandating the EMA to publish documents submitted by third parties. If agreed, the policy will serve as a useful complementary tool ahead of the implementation of the new clinical trials regulation when it comes into force no sooner than May 2016. The policy is without prejudice to citizens’ rights under existing access to documents legislation and the future clinical trials regulation.
The agency welcomes the debate that has been generated since the launch of its initiative in November 2012 and recognizes that stakeholders have been willing to shift their position towards greater transparency. The policy takes the agency beyond its legal obligations and is an ambitious step forward towards achieving increased transparency in the regulation of medicines in Europe.
The agency has aimed to find a workable solution for all its stakeholders. A second round of consultation that took place in May showed broad support for the policy, but highlighted concerns over the proposed view-on-screen-only access. Guido Rasi, EMA executive director, said, “I remain open-minded and will explore with the board possible alternative approaches, especially more user-friendly ways of providing access to data and meeting the reasonable expectations of academics and researchers.”