TheCouncil of the European Union must preserve the competitive timelinesfor assessment set out in the European Commission's proposedregulation on clinical trials if it wants to keep Europe at thecutting edge of biopharmaceutical innovation, a coalition ofpharmaceutical and biotechnology industry associations, researchersand patient groups insists.

Thecall from the European Federation of Pharmaceutical Industries andAssociations (EFPIA), the European Association for Bioindustries(EuropaBio), the Association of Clinical Research Organizations(ACRO), Cancer Research UK and The Patients Network for MedicalResearch and Health (EGAN) comes as the draft regulation to overhaulthe much-maligned clinical trials Directive, 2001/20/EC, approachesits final hurdle.

Europeanlegislators are expected to reach a compromise on the proposedregulation before Christmas.

Asthe European Organisation for Research and Treatment of Cancer(EORTC) has noted in a position paper, though, the 7 June report onthe proposed regulation by the European Parliament's Committee onEnvironment and Public Health watered down somewhat the challengingtimelines for clinical-trial approvals in the Commission's originaldraft.


Underthe risk-based approach envisaged in the proposed regulation, theCommission set out “very competitive” timelines for trialevaluation, with an approval deadline of 48 to 79 days maximum,depending on the type of trial.

Forlow-risk trials subject to a complete application, and with nogrounds for delay or additional requests, a decision could come inunder 26 days, the original draft suggested.

Inthe Environment Committee's version, EORTC pointed out, these“challenging” timelines were extended slightly, with an approvaldeadline of 58 to 88 days maximum and the shortest time for low-risktrials softened to 30 days.

Consciousof the complexity of many issues and their implications for MemberStates, EORTC acknowledges the effort made to maintain thecompetitiveness of timelines proposed by the legislation, includingprioritisation for rare diseases (Amendments 7& 16) andmaintaining tacit approval (Amendment 112),” the Organisationstated.

However,given that under the current legal framework the maximum time forapproval is 60 days and some member states are able to approveclinical trials in 28 days, the timelines should not be made anylonger. "

Highercosts, fewer trials

Thecoalition of EFPIA and other stakeholders picks up on these points,warning that the longer the regulatory processtakes to approve a clinical trial or to effect regulatory proceduresaround a trial, the greater the cost.

Highercosts can, in turn, “result in fewer trials being run, reducing ourability to understand treatments better.”, the coalition argues.

Callingfor harmonised and streamlined approaches in this area, it declaresstrong support for “the path set out by the Commission as well asthe European Parliament in ensuring competitive timelines for theseauthorisations”, while urging the Council “to support thisapproach moving forward”.

EFPIAreiterated in particular the need:

  • To ensure that timelines defined in the regulation are predictable and no longer than the timelines already established in the clinical trial Directive.

  • To streamline the process for assessing applications to conduct a clinical trial across the European Union, by ensuring clear and competitive timelines.

  • To support a robust legislative mechanism ensuring compliance with these timelines.

  • For the Commission to ensure support for Member States during the implementation phase to make certain the timelines in the legislation are met.

Timelinesare achievable

Thetimelines set out by the Commission are achievable – we can look toBelgium and the United Kingdom as examples for best practice,”commented EFPIA director general Richard Bergstrom.

Whereadjustments to national regulatory systems are required, “theseshould be regarded as investment in the future”, he added.

Mymember companies invest around €20 billion every year on clinicalresearch in Europe, and clinical trials contribute to economicgrowth, attract high-skilled jobs and foster an innovative Europeanresearch community.”