On the eve of a pivotal committee meeting on proposed changes to the EU’s clinical trial regulations, the UK’s BioIndustry Association (BIA) has warned that political compromises could undermine the reforms.
The EU Committee of Permanent Representatives (COREPER) is due to discuss the proposals – designed to make it easier to conduct trials in the EU and protect patients being harmed in studies – at a meeting later today (December 20).
COREPER’s role is to set the agenda for discussions in the European Council on new legislation and try to arrive at a negotiation position that balances the positions of the European Parliament and the EU Commission.
Among the proposals in the new regulations is the creation of a public, EU-wide database for all clinical trials of new medicines, a simplified trial application procedure via a single web portal and streamlined protocols for review and authorisation of studies.
Alan Morrison, chair of the BIA’s regulatory affairs advisory committee, expressed concern yesterday about reports that the timeframe for decisions on trial authorisations could be extended to over 100 days, pointing out that this “is a worse position than the UK consistently achieves at present”.
Such a move could mean that other EU countries may be able to delay decision making and slow down the process for multinational trials, making Europe a less attractive location for clinical research, added Morrison.
The fear is that longer review periods could discourage trial sponsors from choosing to run trials in a region where they would face higher costs.
International competition for clinical trials is already increasing because this type of research creates jobs and stimulates the economy, drives R&D progress and helps bring innovative medicines to patients more quickly, but there are concerns Europe’s competitiveness in this area is on the wane.
The recent SAT-EU study – published in the British Medical Journal (BMJ) – found that applications to run clinical trials in Europe fell by a quarter between 2007 and 2011, with bureaucracy, slow decision-making and disparities in national regulations cited as reasons for the decline.
“The EU Clinical Trials Regulation must deliver what it set out to do: provide a simplified and efficient regulatory framework for clinical trials in the EU,” said BIA chief executive Steve Bates. “The BIA calls for the Permanent Representatives to take this into account.”
Many of the overarching themes in the proposed regulation are strongly supported by industry, but certain other elements – including a drive towards increased transparency on the results of studies – have not been welcomed.
However, Morrison voiced his support for plans for practical checkpoints to ensure the regulation only becomes applicable if the IT systems crucial to its operation are in place.