Earlier access to new medicines in the UK

The Ministerial Industry Strategy Group (MISG), an initiative that brings together relevant UK government ministers and pharmaceutical industry chief executives, asked the MHRA and the Association of the British Pharmaceutical Industry (ABPI) to explore the feasibility and desirability of introducing a scheme in the UK to make certain new and promising medicines available to patients before they are formally licensed.
A working group co-chaired by the MHRA and ABPI – which also sought views from the public and healthcare professionals - developed a framework for an earlier access scheme to operate within the existing regulatory regime and this was reviewed and approved by MISG in late November 2009.

The report describing the key elements of the scheme, the reports of the work undertaken to gauge the views of the public and healthcare professionals and the minutes of the working group are published below. The minutes have been redacted as necessary in line with our obligations under the Freedom of Information Act.

The MHRA has prepared an outline on how Earlier Access to Medicines might work in practice. No decision has yet been made on whether the scheme will go ahead at this time. If the concept of the scheme is approved, then it will be subject to a 12-week public consultation.

MISG report on earlier access to medicines (70Kb)

Public engagement initiatives

Report on earlier access to medicines consultation with children and young people (197Kb)

Report of qualitative research (203Kb)

Report of the deliberative event hosted by National Voices for the MHRA (150Kb)

Earlier access to medicines phase III clinical trials (41Kb)

Minutes of MISG Earlier Access Forum (February to December 2009)

10 February 2009 (45Kb)
26 March 2009 (46Kb)
14 May 2009 (44Kb)
2 July 2009 (41Kb)
13 August 2009 (26Kb)
1 October 2009 (38Kb)
27 October 2009 (23Kb)
2 December 2009 (18Kb)