The Medicines and Healthcare products Regulatory Agency (MHRA) is conducting a public consultation on a proposal to introduce a scheme that will provide access to certain new medicines before they receive a marketing authorisation. The consultation document proposes that "promising new medicines that treat, diagnose or prevent life threatening, chronic or seriously debilitating conditions without adequate treatment options" would be made available at the end of Phase III trials but before licensing (with the possibility of earlier access in exceptional circumstances where justified by the available data).
The MHRA is seeking the views of stakeholders (including patients, healthcare professionals, academics, regulators and industry) on a range of issues including the likely value of the scheme to patients, the types of illnesses which should be within the scope of the scheme, the stage of development at which a medicine would become eligible, safety monitoring, pricing and any other aspects of the proposal on which respondents wish to submit comments.
A consultation on the early access scheme was one of the commitments made under the Government's Strategy for Life Sciences paper published at the end of last year (see the November/December 2011 edition of our newsletter). Although procedures for allowing early access do currently exist in the UK, these tend to be locally based, ad-hoc in nature and perceived as overly bureaucratic. The introduction of a new early access scheme will be welcomed by industry and patients, although some are likely to be pressing the authorities to grant access to drugs at an earlier stage of development than has been proposed in the consultation.
Comments on the proposals are invited by 5 October 2012 at the latest and the MHRA will make a decision on implementing the scheme in the autumn. The consultation documents and information on how to respond can be found on the MHRA website.