Early risers: life-changing medical scheme given legal revitalisation

After an analysis of the six-week Medicines and Healthcare Regulatory products Agency (MHRA) consultation – which was launched last year – key legislative changes have been outlined for the UK’s Early Access to Medicines Scheme (EAMS).

The scheme gives patients with life-threatening or seriously debilitating conditions access to medicines not yet authorised for marketing, helping to address significant unmet medical needs in the UK.

The legislative changes to EAMS will help to maximise its impact, accelerating availability of medicines for patients, reducing the burden on manufacturers supplying medicines for the scheme and facilitating the collection of real-world data.

This data may then be used as evidence to support regulatory decision-making and future authorisation, allowing more patients to benefit indirectly from the scheme further down the line and ensuring the UK remains internationally competitive in the pre-market access landscape.

Dr June Raine, chief executive of the MHRA said: “This is a ground-breaking move, demonstrating our commitment to ensuring that patients can have fast access to promising new treatments ahead of normal licensing time frames. This life-changing scheme, which has remained running throughout the pandemic, gives patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need.”

The scheme has been running since 2014 and to-date has granted 100 medicines a Promising Innovative Medicine status. Meanwhile, over 40 Scientific Opinions have been awarded in a variety of therapeutic areas with significant unmet patient need.

Dr Raine added: “We have seen positive support for these new changes in the responses to our consultation and a clear indication that patients, clinicians and industry are supportive of introducing a bespoke EAMS provision within the UK medicines legislation.

“We will now take the steps needed to provide a legislative framework for EAMS. This comprehensive framework will not only benefit patients in need of innovative and cutting-edge treatments but will also provide detailed real-world evidence for our future regulatory decisions.”