Regulatory Focus™ > News Articles > UK Formally Launches Early Access Pathway for Neediest Patients

UK Formally Launches Early Access Pathway for Neediest Patients

Posted 07 April 2014 | By Alexander Gaffney, RAC

The UK's Medicines and Healthcare products Agency (MHRA) has announced that it had formally opened a new regulatory program intended to allow severely ill consumers earlier access to potentially lifesaving medicines.


The program, known as the Early Access to Medicines Scheme (EAMS), was first announced in March 2014. As described by the UK's Department of Health, EAMS is intended to make the UK "one of the best countries in the world to capitalize on breakthroughs in medical care."

At present, medicines approved by UK or EU regulators must first be approved by cost regulators at the National Institute for Health and Care Excellence (NICE) before they are allowed to be sold to consumers.

Under EAMS, as soon as a "promising and innovative medicine" (PIM) is granted approval by MHRA, the drug will be made available to a limited population of UK patients for whom there are no suitable alternative licensed treatments. The scheme, which will be paid for by participating companies and not by the National Health Service (NHS), is also intended to allow companies to better assess the real-world values of their drugs and to support additional regulatory approvals.

For more on EAMS, please read Focus' March 2014 story, "MHRA Launches its Own 'Breakthrough' Pathway to Allow for Early Access to Some Medicines."

EAMS Launched

At the time of EAMS' unveiling, MHRA officials said the program would be open for business in April 2014.

And, true to their word, the program is, as of 7 April 2014, open and able to receive and process applications.

"This is a significant step forward for the earlier availability of medicines in the UK and we look forward to receiving applications to the scheme," MHRA Chief Executive Ian Hudson said in a prepared statement.

Companies may submit for PIM designation and EAMS approval through MHRA's dedicated webpage, the regulator said.

MHRA Statement

EAMS Webpage

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