UK to adopt fast market access scheme for 'breakthrough' medicines
Further details of the UK government's Early Access to Medicines scheme emerged in a press report on Monday, including a system that will grant "breakthrough" status for badly-needed novel drugs.
According to the article published in The Daily Telegraph, the scheme could allow patients access to new medicines within five years, instead of the 10-15 year wait for the R&D process to be completed under existing regulations.
Quoting official policy documents, the Telegraph reported the scheme is aimed at innovative drugs for serious illnesses for which there is no existing treatment, or where standard of care is inadequate.
The scheme follows two years of consultation after a pledge to introduce such a measure by the Prime Minister, David Cameron, in 2011.
According to the article, new drugs fitting this description could be given "breakthrough" status and then approved for use with specific patient groups as soon as data show safety and benefit advantages to target users, instead of using the conventional trial system.
A spokesperson for the Medicines and Healthcare Products Regulatory Agency (MHRA) confirmed to APM that it was working with the Department of Health to develop the scheme.
In a statement the MHRA said the Early Access to Medicines scheme will enable UK patients to have access to highly promising medicines before they are licensed, adding that policy development is "advanced", with an announcement due as soon as discussions are complete.
An MHRA spokesperson said in a statement: "At the request of the expert group on innovation in the regulation of healthcare which reported last year, government is also considering the possibility of adopting a scheme that will provide companies with an indication on whether a product will be accepted as a candidate for the early access to medicines opinion, based on results from early clinical development studies."
"The Early Access to Medicines scheme has been designed to enable earlier UK patient access to highly promising medicinal products before they are licensed."
The Daily Telegraph reported that the government hopes the scheme will benefit small specialist companies, perhaps with only one niche drug and lacking the resources to fund the full 10-15 year development programme, which can cost around a billion pounds.
Larger businesses such as the UK's GlaxoSmithKline, AstraZeneca and Shire are likely find development of drugs easier under the scheme, according to The Daily Telegraph.
The system as outlined resembles the "breakthrough therapy" designation developed by the U.S. Food and Drug Administration.
On its website the FDA says this allows medicines for diseases where treatments are non-existent or limited to be approved on the basis of Phase II data, using surrogate endpoints that predict efficacy, or endpoints other than irreversible mortality or morbidity, if manufacturers conduct post-marketing monitoring.
It was unclear from the press report the kind of endpoints accepted in the UK system and the UK Department of Health would not provide further information when contacted by APM.
A DH spokesperson told APM: "We will announce our plans in due course."