U.K. joins the 'breakthrough' bandwagon with new fast-track program

MHRA Chief Executive Ian Hudson

After months of lobbying and speculation, the U.K. has unveiled its Early Access to Medicines Scheme, a program that will allow patients with serious diseases to get access to potentially lifesaving drugs before they're approved.

Starting next month, the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) will start taking applications from drugmakers who want to participate in the effort. Under the program, MHRA will first apply a so-called promising innovative medicines designation to successful applicants, and then, once it's satisfied with a drug's clinical data, the agency will green-light the treatment for preapproval use.

The program requires drugmakers to foot the bill for any and all early access administrations, a money-saving move for the U.K.'s National Health Service that isn't sitting very well with the industry. But Ian Hudson, head of MHRA, said pharma will be willing to shell out in exchange for the chance to cull real-world data and forge all-important physician relationships before a drug's proper launch.

"This is a major new development in medicines policy in the U.K.," Hudson said in a statement. "The scheme offers a way by which unlicensed medicines can be available to patients before approval of a licence to benefit public health. It will also enable companies to gain additional knowledge and experience of these medicines in clinical use."

Local trade groups have by and large cheered the effort, viewing it in part as an economic development boon for the country's biopharma industry. Despite housing global leaders like AstraZeneca ($AZN) and GlaxoSmithKline ($GSK), the U.K. has endured deep cutbacks in pharmaceutical R&D over the last few years. This initiative, however, could help establish the country as a world-class place to start and develop a biotech company, U.K. BioIndustry Association CEO Stephen Bates said in a statement, and it "shows the U.K. is committed to an 'all-hands-on-deck approach' to speedily progress promising innovative therapies to the patients who need them."

Bates' group is far less thrilled with the program's funding structure, and the association said it planned to work with MHRA to make sure the lack of government cash doesn't hamstring use of the scheme.

- read the MHRA announcement
- here's U.K. BioIndustry Association's statement

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