Early access to medicines scheme

On 5 December 2011 the Prime Minister announced that the MHRA would be consulting on an earlier access to medicines scheme as part of a strategy for UK life sciences. The MHRA launched a public consultation on the scheme on 17 July 2012 and responses are invited no later than 5 October 2012.

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.


Public engagement initiatives

Report on earlier access to medicines consultation with children and young peoplePDF file (opens in new window) (197Kb)

Report of qualitative researchPDF file (opens in new window) (203Kb)

Report of the deliberative event hosted by National Voices for the MHRAPDF file (opens in new window) (150Kb)

Earlier access to medicines phase III clinical trialsPDF file (opens in new window) (41Kb)


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

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


Page last modified: 17 July 2012