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 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)
