Industry and Stakeholders Push on EU Clinical Trial Timelines

An alliance of pharmaceutical and biotechnology industry associations, researchers and patient groups have asserted that the Council of the European Union needs to maintain the competitive timelines for assessment set out in the European Commission’s proposed regulation on clinical trials if they want to keep Europe at the front end of biopharmaceutical innovation.

The alliance consists of the European Federation of Pharmaceutical Industries and Associations (EFPIA),  the European Association for Bioindustries (EuropaBio), the Association of Clinical Research Organizations (ACRO), Cancer Research UK and The Patients Network for Medical Research and Health (EGAN).

The request comes as the draft regulation to renovate the much-maligned clinical trials Directive, 2001/20/EC, approaches its ultimate hurdle, with European legislators estimated to reach an agreement on the proposed regulation before Christmas.

However, as noted by European Organisation for Research and Treatment of Cancer (EORTC), the 7th June report on the proposed regulation by the European Parliament’s Committee on Environment and Public Health reduced the emphasis on the challenging timelines for clinical-trial approvals in the Commission’s original draft.

Approval Deadline Changes

Under the risk-based approach predicted in the proposed regulation, the Commission set out “very competitive” timelines for clinical trial evaluation, with an approval deadline of 48 to 79 days maximum, depending on the type of clinical trial.

For low-risk clinical trials subject to a complete application, and with no grounds for delay or additional requests, a verdict could be delivered in less than 26 days, the original draft proposed.

In the Environment Committee’s version, EORTC pointed out that these “challenging” timelines were lengthened slightly, with an approval deadline of 58 to 88 days maximum and the shortest time changed to 30 days.

“Conscious of the complexity of many issues and their implications for Member States, EORTC acknowledges the effort made to maintain the competitiveness of timelines proposed by the legislation, including prioritisation for rare diseases (Amendments 7& 16) and maintaining tacit approval (Amendment 112),” the European Organisation for Research and Treatment of Cancer commented.

“However, given that under the current legal framework the maximum time for approval is 60 days and some member states are able to approve clinical trials in 28 days, the timelines should not be made any longer,” the organisation added.

Higher Costs and Fewer Clinical Trials

The coalition of EFPIA and other stakeholders have warned that the longer the regulatory process takes to approve a clinical trial, or to effect regulatory procedures surrounding a clinical trial, the higher the cost will be.

Higher costs can, in turn, “result in fewer trials being run, reducing our ability to understand treatments better,” the alliance argues.

Calling for harmonised and streamlined approaches, they have announced a strong support for “the path set out by the Commission as well as the European Parliament in ensuring competitive timelines for these authorisations,” while urging the European Council “to support this approach moving forward.”


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