UK Government to load Pharmaceutical Companies with taxpayers money for dangerous drugs

Drug firms lifted by ‘fast medicines’ deal

Pharmaceutical sector to welcome Government plans which could see patients may get treatments up to 10 years earlier

By Denise Roland9:00PM GMT 08 Mar 2014CommentsComments

Britain’s pharmaceutical industry is to be given a major boost by “revolutionary” government plans to fast-track breakthrough drugs to seriously ill patients.

A new scheme designed to accelerate the pace at which innovative medicines are made widely available in the UK is to be announced imminently, The Telegraph can reveal.

The plans will cut the time lag between early clinical research and widespread use to as little as five years, compared with the current industry average of 10 to 15 years.

The programme, detailed in official policy documents seen by this newspaper, is aimed at innovative drugs for serious illnesses for which there is no existing treatment or where the current medicines are inadequate.
It follows two years of consultation after David Cameron pledged in 2011 to introduce an early access scheme as part of the Coalition’s Life Sciences Strategy.

The scheme, which is still subject to final sign off, according to a Department of Health source, includes plans to grant promising new drugs a special “breakthrough” status.

This would pave the way for an early recommendation by the UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), provided the drug is safe and the benefits to patients outweigh the risks.

The Government envisages that a new drug could be given the green light for use with specific patient groups – subject to their consent and doctor approval – as soon as the data show safety and benefit advantages to the target users. This could bring drugs to patients anything from two to 10 years earlier than would otherwise be the case.
At present, the regulator will only assess drugs that have completed the full, “four stage” spread of clinical trials.

The Government hopes the scheme will especially benefit smaller “specialty pharma” companies, which typically only have one “niche” drug and lack the resources available to larger pharmaceutical businesses to complete the usual 10–15 year development programme which can often cost as much as £1bn.

Larger businesses, such as GlaxoSmithKline, Astra Zeneca and Shire, are also likely to find the development of drugs easier.

Programmes that win breakthrough status will benefit from lower costs and a shorter time to market and are likely to secure stronger investor support since it would provide an early indicator of the candidate drug’s likely success.

“If you can get a product through to wide use earlier, it dramatically changes the economics. Time is money for investors,” said Glyn Edwards, chief executive of Summit, which is developing a series of drugs to treat the childhood disease Duchenne muscular dystrophy (DMD), which typically leads to death in the mid-20s.

Mr Edwards said Summit’s most advanced treatment, which has already been tested for safety in a small group of patients at Great Ormond Street Hospital and shown to work in mice, would be “first in line” to apply for the early access scheme.

“It’s big for companies like us and diseases like this where there’s no cure. It really is revolutionary,” he said.
Alex Johnson, whose six-year-old son Jack has DMD, said she would be “elated” if the Government announces an early access scheme. She and her husband, Andy, a former rugby league player, have raised hundreds of thousands of pounds for research into the condition.

“It’s what I’ve wanted to hear,” she said. “We’ve developed a pipeline for potential treatments and my biggest fear was that due to regulations he wouldn’t be able to get a drug.”

The scheme is also expected to attract investment to the UK from foreign biotech companies, by providing an incentive to carry out clinical research in Britain.

Britain’s pharmaceutical and biotech industry has been calling for an early access scheme for years.
“The regulatory process is inefficient,” according to one leading biotech investor.

“From a business side of things these products stop being developed in the UK when they get into later stage because the UK is not a very good market for pharmaceuticals.”

Drug companies have also criticised the National Institute for Health and Care Excellence (Nice), the UK pricing regulator, which they believe is blocking new and innovative medicines by complicated approval processes and a heavy emphasis on cost control.

Steve Bates, chief executive of the Biotech Industry Association, said: “It’s fantastic and very important that there is a new designation and an ‘all hands on deck’ approach. I look forward to reading the details.”

George Freeman, the Conservative MP and former biotech venture capitalist, who was appointed by the Prime Minister in 2011 to help to co-ordinate the Government’s Life Sciences Strategy, said the new scheme will bring the UK in line with 21st century medicines discovery, which “is going to be all about designing drugs around patients”.

He added: “Instead of industry and patients complaining about the NHS being a slow adopter of new drugs, we become the laboratory of new medicines, with major benefits to NHS patients.”

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