UK sees need for EU to revise medicines regulation

Life sciences minister George Freeman intends to lead a delegation to press the European Union to adopt a revised model of regulation for medical treatments.

Freeman told the House of Commons on 4 December that he was “exercised by the danger of the EU putting in place a regulatory framework that does not support 21st-century leadership in regenerative medicine, in stem cells, and in the use of data”. He said that in 2015 he would highlight to the European Commission the type of regulatory framework that he felt was needed. Such a framework would reflect the fact that more personalised treatments are now being developed for smaller numbers of patients.

The body responsible for regulating the licensing of most types of treatments in Europe is the European Medicines Agency. Granting of a Marketing Authorisation by the agency allows the manufacturer to market the treatment in all member states of the EU, as well as countries in the European Economic Area. In England, The National Institute for Health and Care Excellence then assesses the effectiveness and cost of a drug to determine whether it should be made available on the NHS.