Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what assessment he has made of the potential merits of adaptive licensing or early access schemes (a) in the UK and (b) across the EU; and if he will make a statement.

The potential merits and impact of adaptive licensing and early access to medicine schemes were considered by the Expert Group on innovation in the regulation of healthcare that was established in June 2012 following the Prime Minister's 2011 Life Science Strategy. The Expert Group was composed of a range of experts from government, industry, patient and health professional stakeholders.

In their 2013 report, the group welcomed the proposal for the Early Access to Medicines Scheme (EAMS), for highly promising unlicensed medicinal products in areas of high unmet medical need, and urged the Government to introduce it as soon as possible. The Medicines and Healthcare products Regulatory Agency launched the EAMS on 7 April 2014.

On adaptive licensing, the group saw opportunities for more use of the existing legal flexibilities to facilitate patient access to innovative products. The Group urged for the pilot on adaptive licensing by the European Medicines Agency (EMA) to be launched at the earliest opportunity.

The EMA published its adaptive licensing pilot project on 19 March. The Government sees this pilot as a test for current licensing flexibilities and the methodology of adaptive licensing. We welcome the pilot and will continue to be actively engaged in the debate in Europe.

A copy of the report of the Expert Group on innovation in the regulation of healthcare has been placed in the Library.