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UK Fast-track plan for serious illness medicines


(Source: Financial Times 2014-3-14)

Drug companies have welcomed a move to accelerate the introduction of medicines for seriously ill patients as part of broader government efforts to promote investment in the UK life sciences sector.

Jeremy Hunt, health secretary, said the initiative – modelled on a similar fast-track scheme in the US – would allow cutting-edge drugs to be used years earlier than in the past.

The Early Access to Medicines scheme will be open to drugs targeting life-threatening and seriously debilitating illnesses where there is currently no good treatment.

Mr Hunt said it would help patients and encourage investment in medical research by allowing companies to develop drugs more quickly.

The government is under pressure to support the life sciences industry after decisions by Pfizer, AstraZeneca and Novartis to close big UK research and development centres over the past two years with the loss of thousands of jobs. Other measures have included the introduction of the “patent box” tax break on intellectual property.

Mr Hunt said the aim was to make Britain “the best place in the world for science, research and development”.

Under the scheme, doctors will be allowed to prescribe medicines as soon as the Medicines Products Regulatory Agency, the UK regulator, is convinced the benefits outweigh the risks.

This would allow some unlicensed treatments to be introduced while still in final clinical trials and before they have received approval from European regulators or the National Institute for Health and Care Excellence (Nice), which decides which drugs to adopt in the NHS.

Drug companies would not be paid for the medicines but the government hopes the early access to patients will encourage companies to conduct R&D in the UK.

Sally Davies, chief medical officer, said the scheme would allow drugmakers to demonstrate the value of unlicensed medicines – improving their chances of eventual approval by regulators and Nice.

“If you are a small innovative company it should help you go out and get investment and if you are a big company it opens a discussion with regulators and Nice earlier in the approval process,” she said.

Glyn Edwards, chief executive of Summit, a UK company developing drugs to treat the childhood disease Duchenne muscular dystrophy, described it as “a big step forward”.

It was also welcomed by the Bioindustry Association, which represents the UK biotech sector, but Steve Bates, chief executive, cautioned that lack of reimbursement for the unlicensed medicines risked deterring smaller companies.

Harpal Kumar, chief executive of Cancer Research UK, said the scheme could be “the difference between life and death” for some patients.

Drugmakers and patient groups have complained that the UK is slower to adopt treatments than some other European governments.

In another step to boost R&D, the government said it was creating a bank of 75,000 medical research volunteers to make it easier for researchers to recruit people with specific conditions or a family history of certain diseases.