Simplified system will boost R&D and save €800m a year says Dalli
The European Commission (EC) has published proposals to simplify the rules governing the testing of medicines in humans, 11 years after the introduction of the Clinical Trials Directive (CTD) in the EU.
The new proposals follow a public consultation of the CTD in 2009 and 2010 that found that it had fallen short in a number of areas, with sponsors claiming that the operating environment for clinical research has become significantly more bureaucratic, particularly for trials carried out in multiple sites across Europe.
One consequence has been the publication of numerous ad hoc guidelines in recent years to try to improve the interpretation and application of the CTD, and critics have suggested that the excess red tape has been a driver behind the shift in clinical research to non-EU countries.
The latest proposal "significantly facilitates the management of clinical trials, while maintaining the highest standards of patient safety and the robustness and reliability of trial data," said John Dalli, European Commissioner for Health and Consumer Policy.
The new approach could save €800m per year in regulatory costs and "boost research and development in the EU, thus contributing to economic growth," he added.
Speaking ahead of the publication of the proposals, Dalli noted there had been a 25 per cent decline in the number of clinical trials conducted in the EU between 2007 and 2011, although he stressed the CTD was just one factor in that decline.
Others include the emergence of clinical capacity in low-cost economies, the reduction in productivity in pharmaceutical R&D and a lack of access to capital for biopharma ventures.
The proposals (pdf) will set up a new regulation to ensure the rules governing trials are harmonised across Europe, with a particular focus on easing the conduct of multicentre clinical trials, but will also give the Commission more powers to ensure trials are being properly supervised in the EU and elsewhere.
A regulation is preferred to a Directive because it allows less room for differences in interpretation and implementation among member states, which was one reason the CTD failed in its objectives.
The regulation will feature a streamlined, centralised authorisation process for trials and simplified reporting procedures that avoid duplication of effort, as well as greater transparency on the results and recruitment status of studies.
Industry has long complained that the cost of conducting trials in Europe has been impacted by delays, the workload required to negotiate national review processes and rising insurance costs.
European Federation of Pharmaceutical Industries & Associations (EFPIA) director general Richard Bergström said he welcomed the reform, saying it provided an opportunity "to create a competitive European medical research environment for the next 20 years."
The UK's BioIndustry Association (BIA) also responded warmly to the move, with chief executive Steve Bates noting that the proposed regulation "will save time, money and paperwork for companies wishing to run clinical trials across Europe, thus making it easier to develop innovative medicines for patients."
The Association of the British Pharmaceutical Industry (ABPI) also welcomed the plans: "The number of clinical trials in Europe and in the UK has been declining in recent years, in part because of the complexity of the EU environment; we now have an opportunity to address the decline, improve patients' access to the latest clinical research, while encouraging inward investment into the UK.”
However, while welcoming the attempt to reduce bureaucracy, there are still concerns about how the proposals will emerge from the co-decision procedure. The draft will now be discussed in Parliament and the Council and could come into effect in 2016.
Bergström said "a workable administrative and scientific cooperation for large scale clinical trials is the key to make the new system effective."
"We call on the European Parliament and Member States to take a responsible, ambitious and pragmatic approach when debating the Commission's proposal," he added.