UK expert group calls for earlier patient access to medicines

In a report published Friday (November 15) by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), the Expert Group on Innovation in the Regulation of Healthcare has called for greater uptake of existing legal flexibilities to accelerate patient access to innovative medicines to address areas of unmet medical need.

Establishment of the Group was one of the key commitments of the Prime Minister’s 2011 Strategy for UK Life Sciences. A key recommendation of the Expert Group is tasking the MHRA to press the European Medicines Agency to launch a call for adaptive licensing at the earliest opportunity, so that pharmaceutical companies can put forward pilot products to use these flexibilities.

The Expert Group supports the proposed UK early access scheme for unlicensed medicines and urges the government to launch the scheme as soon as possible. The Expert Group recommends that the government consider accommodating within the scheme a designation that a product was a potential candidate for the early access scheme.

MHRA chief executive Ian Hudson said: “We want to see improvement in the health of millions of people. There are a range of regulatory tools that can be appropriately used to allow innovative products to be developed in an optimal way for the benefit of public health. Organizations developing innovative products can come to us as a one stop shop for scientific legal and regulatory advice. The report is now being considered by Ministers at the Department of Health and the Department for Business, Innovation and Skills.”