Regulatory Focus™ > News Articles > MHRA Launches its Own 'Breakthrough' Pathway to Allow for Early Access to Some Medicines

MHRA Launches its Own 'Breakthrough' Pathway to Allow for Early Access to Some Medicines

Posted 14 March 2014 | By Alexander Gaffney, RAC

The UK's Medicines and Healthcare Products Agency (MHRA) has announced that it will soon launch 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), has long been in the works at the regulator, and its launch was previewed last week in British newspaper The Telegraph.

As announced on 14 March 2014 by MHRA and the UK Department of Health, the scheme 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 an "innovative and promising" drug is approved by MHRA-and presumably the European Medicines Agency (EMA) as well-the drug will be made available to a limited population of UK patients.

"The scheme is an important addition to the pharmaceutical sector, providing a platform for drugs to be brought to patients at a much faster rate than ever before," DOH wrote in a statement. "The companies will be able to gain experience of their medicines being used in the NHS and work closely with regulators to look at the value of the drugs, gaining guidance and advice much earlier in the regulatory process."

MHRA said in a separate statement that companies will need to apply to have their medicines considered under EAMS, and will begin accepting applications in April 2014.

A two-step evaluation process is also planned involving the granting of a "promising innovative medicines (PIM)" designation, similar to an orphan drug designation, followed by a specific scientific opinion on the early access to medicines approval.

"The scientific opinion will describe the benefits and risks of the medicine, based on the information submitted to MHRA by an applicant after sufficient data have been gathered from the patients who will benefit from the medicine," MHRA wrote. "The opinion will support the prescriber and patient to make a decision on whether to use the medicine before its license is approved."

The scheme is intended to be similar in effect to the US' recently instituted Breakthrough Products Designation, according to analysts. It will be funded entirely by the pharmaceutical industry, with the intent being that evidence obtained through early access will inform subsequent discussions (i.e. NICE) about the value of medicines.


Early Access to Medicines Scheme

MHRA Statement

DOH Statement

BioIndustry Association Statement

Regulatory Focus newsletters

All the biggest regulatory news and happenings.