Regulation & Government

Gov to plan legal framework for Early Access to Medicine Scheme

The new legal framework will aim to improve legal certainty and reduce regulatory burdens

The UK government is reportedly planning to introduce a legal framework for the Early Access to Medicine Scheme (EAMS) and has now launched a consultation on it, with responses to be submitted by 17 September 2021.

The EAMS is one way through which a patient with a life threatening or seriously debilitating condition can gain access to a medicine before it has gained approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 

The proposed legal framework will seek to clarify the legal basis for the EAMS, to enhance the flexibility of the scheme and to ensure it remains an “attractive mechanism” for companies to provide medicines to patients prior to licensing.

Life sciences expert Helen Cline of Pinsent Masons, the law firm behind Out-Law, said: “The Early Access to Medicines Scheme is an important existing regulatory flexibility to ensure that UK patients are some of the first in the world to access new treatments, effectively delivering a scientific opinion which supports clinicians and patients when prescribing an unlicensed medicine.

“The proposal suggests introducing provisions that simplify supply, provide a framework for collection of real world data, provide clarity around liability for prescribing and set out pharmacovigilance obligations.”

Sarah Taylor, also of Pinsent Masons, added: “One of the driving forces behind the proposed changes to the scheme is to ensure that it, and therefore the UK market, remains relevant and attractive to companies following Brexit.”

The government said: “Since there is no legislative provision that covers or specifically mentions EAMS, there are some aspects that would benefit from clarification in law, providing a legal basis for the delivery of EAMS.” 

It added that the new legal framework is aimed at improving legal certainty and reducing regulatory burdens.

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