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15 January 2010
Summary:
A report, describing the key elements of a scheme to make available certain new medicines before they are formally licensed, has been produced by a Working Group co-chaired by the MHRA and ABPI. The Working Group suggest that such a scheme could provide treatments for life-threatening or seriously debilitating conditions around one year earlier than present. The MHRA will undertake a formal 12-week public consultation on the proposals early in 2010.
Action
Stakeholders, including those from the NHS, who may wish to comment upon these proposals, should monitor the MHRA website for an update on the timelines for the formal consultation process and how they may respond. This blog will be updated as new information becomes available.
N.B. In May 2011 the MHRA announced that the government have decided not to progress this initiative at the present time, given the other ongoing initiatives in the NHS. This decision does not affect existing mechanisms for access to unlicensed medicines such as clinical trials and named patient use
What is the background to this?
The Ministerial Industry Strategy Group (MISG) is a forum that brings together relevant government ministers and pharmaceutical industry chief executives to discuss strategic matters pertaining to the pharmaceutical industry within the UK. The MISG requested the Medicines and Healthcare products Regulatory Agency (MHRA) and the Association of the British Pharmaceutical Industry (ABPI) to establish a working party to explore the possibility of introducing a scheme to the UK in which certain new and promising medicines could be made available before they are formally licensed.
The report of this working group and associated documents are now available on the MHRA website. A 12-week public consultation on the scheme and its operation will be undertaken by the MHRA early in 2010 with a view to introducing the scheme later in the year.
What does the Working Group propose?
A framework has been developed for an Earlier Access scheme that will operate within the existing regulatory environment to provide benefit to patients suffering from life threatening or seriously debilitating conditions without adequate treatment options currently and for which medicines are being developed, but are not available as licensed treatments. It is envisaged that such medicines could be assessed for this scheme by the MHRA normally after Phase III trials are complete; hence making them available for approximately one year before a market authorisation is granted. An assessment report will be produced by the MHRA for each medicine made available in this manner. Data will be required to indicate a positive benefit: risk profile and that the product is likely to offer advantages over existing treatment options.
The scheme does not involve any NICE appraisal and it is not proposed that additional funding would be available for earlier access medicines. Primary Care Trusts (PCTs) would be responsible for finding the funding from existing budgets.
How does this relate to other initiatives?
This scheme should be seen within the context of a broader agenda to encourage innovation and achieve earlier patient access to new medicines. We recently wrote about proposals for an ‘Innovation Pass’ pilot. The aim of which is to make selected, licensed innovative medicines available in England for a time-limited period, prior to a NICE appraisal. A consultation on this is currently ongoing and comments can be made until 8th February.
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