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UK to fast-track some drugs under early access scheme

By Ben Hirschler

LONDON (Reuters) - Britain is to accelerate access to ground-breaking drugs for serious conditions under a new early-access plan that the government hopes will benefit both patients and pharmaceutical companies.

The initiative, which has similarities with a U.S. scheme that has speeded the development of so-called "breakthrough" medicines, follows criticism that Britain's state-run healthcare system is too slow to adopt new medical treatments.

The Early Access to Medicines scheme, which was unveiled on Friday, will mean that patients with life-threatening and debilitating diseases may get access to novel medicines months or even years before they are officially licensed for sale.

Doctors will be able to prescribe promising new drugs as soon as the Medicines and Healthcare Products Regulatory Agency - the country's drugs watchdog - signals that the benefits outweigh the risks, following an initial scientific assessment.

The program will be funded by drug companies. That is a bonus for the country's National Health Service, will which not bear any extra costs, but it is a bone of contention for the industry, even though companies overall applauded the plan.

Health minister Jeremy Hunt said the scheme would help make Britain a leading location for life sciences and drug development, and should create more jobs by encouraging firms to carry out more work in the country.

Pharma has traditionally been a key plank of the British economy, thanks to the presence of local groups such as GlaxoSmithKline and AstraZeneca, and the presence of laboratories operated by several international players.

But recent cutbacks, including Pfizer's decision three years ago to close its large R&D site in Sandwich, southern England, have dealt a blow to the sector and worried the government. That prompted a pledge by Prime Minister David Cameron in 2011 to improve early access to key new drugs.

The new scheme will be launched in April. Medicines deemed suitable for inclusion will be given a Promising Innovative Medicine designation, which could occur several years before licensing.

Although companies will have to fund early access out of their own pockets, they will gain valuable experience about drug use and be able to build up awareness of new medicines among prescribing doctors.

The Association of the British Pharmaceutical Industry welcomed the initiative. However, trade body said the lack of central funding was a concern and it asked that the scheme be reviewed after the first year to look at funding options.

(Reporting by Ben Hirschler. Editing by Jane Merriman)

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