Regulatory Focus™ > News Articles > UK Proposes Reimbursement-based Accelerated Approvals Process

UK Proposes Reimbursement-based Accelerated Approvals Process

Posted 17 July 2012 | By Alexander Gaffney, RAC 

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is calling for comments on a newly-released proposal that would see some patients receiving medicines faster under an approval pathway focused more on reimbursement than on the complete assessment of a product's safety and efficacy.

The pathway, called the Early Access to Medicines Scheme, "would provide a scientific opinion on the benefits and risks of medicines" from MHRA, which would in turn form the basis of a National Health Service (NHS) decision on whether to make the medicines available to patients and for reimbursement.

Unlike an overhaul of European regulations, MHRA regulators said this proposal would "operate within the current legislative framework and could be in place before the end of 2012."

"It will be for NHS purchasers to decide whether such treatments should be funded" based on its scientific opinions, said MHRA. The medicines would "remain unlicensed until fully assessed and authorized according to existing EU requirements."

Similar schemes are already in place on a small-scale basis across the country, but MHRA said the new scheme would provide standardized, nation-wide coverage for UK citizens.

Patients to See Earlier Products

MHRA said patients with "life threatening, chronic or debilitating conditions" would stand to benefit the most from the proposal.

"We expect that in most cases the scheme would be available for medicines at the end of Phase 3 trials although in exceptional cases it could apply to medicines at an earlier stage of development such as the end of Phase 2," MHRA said in a statement posted to its website.

The proposed Early Access to Medicines Scheme was first proposed in 2007, and later developed into draft format between 2009 and 2010, said MHRA in their formal consultation notice. The notice also mentioned MHRA's potential interest in considering "adaptive licensing" methods such as limited approvals.

MHRA said in a statement it is planning on receiving comments for the next 12 weeks.

Read more:

MHRA - MHRA asks for views about giving patients earlier access to medicines

MHRA - Consultation on a Proposal to Introduce an Early Access to Medicines Scheme in the UK

MHRA - Earlier Access to Medicines Scheme : Application Guidance

MHRA - Public consultation (MLX 376): Proposal to introduce an early access to medicines scheme in the UK

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