Bioscience Industry Recommends Revisions to the Clinical Trials Directive

LONDON, UK, October 3, 2007-The BioIndustry Association (BIA) today expressed its support for a revision of the Clinical Trials Directive 2001/20/EC at the European Commission-EMEA Conference on the operation of the Clinical Trials Directive. The conference offered stakeholder representatives a platform to provide feedback on the implementation of the Clinical Trials Directive and offer recommendations for the future.

The BIA believes that the Clinical Trials Directive should be reviewed in order to achieve harmonisation, transparency, and consistency in the approval and conduct of clinical trials across EU Member States, whilst ensuring public health protection. This will facilitate efficient development of biopharmaceutical products in Europe, which would in turn have a direct benefit of improving patient access to innovative medicines. It should be emphasised that the entire Directive does not need to be repealed and replaced by a different legal instrument.

The BIA, working EuropaBio, the European association for the bioscience industry, has identified five key areas for improving the Clinical Trials Directive:

• It is necessary to modify the language used to reduce the flexibility of the provisions in the Directive. Currently, the provisions are open to misinterpretation and misapplication of the law by Member States.
• The current regulatory and ethics review processes should be streamlined to accelerate the initiation of trials and allow patients faster access to innovative treatments.
• The roles and scope of responsibilities of National Competent Authorities (NCAs) and Ethics Committees need to be more clearly defined.
• Mutual recognition of assessments carried out by NCAs should be introduced.