Nicholas Soames: To ask the Secretary of State for Business, Innovation and Skills what recent assessment he has made of the effect of the Clinical Trials Directive on the competitiveness of the life sciences industry in the UK; and if he will make a statement. [98177]

David Willetts MP; Minister of State: In November 2010, the Government launched the healthcare and life sciences growth review. The review involved the Department for Business, Innovation and Skills working closely with the Department of Health, and with business, in an intensive programme of work to identify and remove barriers to life sciences investment.

This led to the publication of the growth review alongside the 2011 Budget http://cdn.hm-treasury.gov.uk/2011budget_growth.pdf and set out an ambitious package of measures to strengthen UK competitiveness, including a commitment to influence the Commission to bring forward soundly based proposals to reduce regulatory burdens in the European Clinical Trials Directive.

The European Commission has announced proposals to revise the directive. The draft of the final Commission proposals is expected during 2012 when formal negotiations can take place.

The Government believe that clearer definitions of the terms used in the directive, together with the adoption of a risk adapted approach to the regulation of trials, will reduce the scope for differing interpretations in member states, and inconsistencies in their application across the EU and ensure that regulatory oversight of all clinical trials is proportionate to risk. Greater consistency across the EU will also help to remove barriers to conducting multi-state clinical trials.