Drug developers deeply concerned

28.11.2013

European Biotechnology News

Published 28 November 2013

EU industry associations urge EU legislators: Don’t make the regulatory process too long, putting Europe’s competitiveness at risk.

Just before Christmas, the European Commission, European Parliament and the EU Council are expected to finalise the Clinical Trials Regulation. However, drug developers and manufacturers are deeply concerned. They believe that the compromise could fail to meet the original goal of the Regulation which was to reverse decreasing numbers of clinical trials carried out in the bloc.

In a joint statement EuropaBio, the European Federation of Pharma Industry Associations (EFPIA), the Association of Clinical Research Organisations (ACRO), Cancer Research UK, and the Patients Network for Medical Research and Health (EGAN) have urged the legislators not to dilute the original aim of the regulation: "It is imperative to build on Europe’s innovative edge – not just for competitive reasons, but because innovation is the tool needed to deliver new and improved medicines to patients,“ they stress. "The longer the regulatory process takes to approve a clinical trial, or process regulatory procedures around it, the greater the cost of the trial. Higher costs can result in fewer trials being run, reducing our ability to understand treatments better. Towards this end, we strongly support the path set out by the Commission as well as the European Parliament in ensuring competitive timelines for these authorisations, and urges the Council to support this approach moving forward.“

The full article is available here.