Hospitals are forced to use unlicensed medicines to save millions

By Daniel Martin
Last updated at 8:05 AM on 27th September 2010

Rip-off: Some licensed drugs are up to 35 times more expensive

NHS hospitals are prescribing unlicensed drugs because they cannot afford sky-high prices for ‘branded’ versions, it emerged last night.

They are refusing to pay for medicines that cost up to 35 times more than the unlicensed versions.

But doctors are concerned that they could be left open to legal challenges from patients if something goes wrong and some NHS trusts have already sought legal advice on the issue.

The problem has arisen because of a European rule change two years ago that allows drug companies to license cheap medical preparations that have been in use for years.

They then slap a huge price tag on their branded drug – even though doctors say it is almost identical to the old one.

According to the Medicines and Healthcare products Regulatory Agency (MHRA), a doctor should always consider using a licensed product if one is available.

But hospitals, faced with having to make deep cuts, are continuing to use the much cheaper unlicensed version, potentially saving millions of pounds.

Papers seen by the Daily Mail show that

in at least one case, hospitals are giving patients an unlicensed drug costing £1,250 a year rather than buying the newly launched official version, which costs £44,000 a year – enough to pay for two people on dialysis.

The dilemma was revealed in a board paper from the East Sussex health economy medicines committee, and concerns drugs for the nerve disease Lambert Eaton Myasthenic Syndrome.

LEMS is rare, affecting up to 250 people in the UK, and in the past local hospitals prescribed a treatment called 3,4DAP, an unlicensed preparation made in four NHS hospitals.

But two years ago, the European Medicines Agency started allowing drug companies to apply for exclusive licenses for drugs for rare conditions, even if they are already

commonly produced. Recently, the EMA gave drugs company BioMarin authorisation to market a licensed version of 3,4DAP, called Firdapse, which is almost identical.

They are now charging £44,000 per year per patient – more than 35 times what the NHS had been paying. Nationwide, this is adding £9million to hospital costs.

Experts say the same dilemma is being faced by trusts for a range of other more common illnesses.

One consultant neurologist told the Daily Mail: ‘It’s daylight robbery. It is outrageous that a drug can cost this much, when it was so cheap before.’

Daphne Austin, of the UK Public Health Commissioning Network, said: ‘The NHS is being ripped off.

‘We have got two choices – either we can’t afford this drug, and

potentially we won’t get it any more, or we fund it, raid someone else’s budget and someone else misses out.’

The leaked NHS board report concluded: ‘To get this licence, the company used data already in the public domain and undertook no clinical research themselves – hence there is no indication that the licensed product is superior to the unlicensed in clinical terms.’

It added: The ruling not to allow the continued production of unlicensed products once a licensed version becomes available is being taken up with the Department of Health.’

The board advised that the NHS should use the cheaper drug, but warned: ‘There is a chance that using an unlicensed product over a licensed one, the PCT may open itself to legal challenge from either a patient or the licensed manufacturer.’

Treatment groups are preparing for potential legal challenges if they use unlicensed drugs.

A spokesman for BioMarin said that Firdapse is more stable than 3,4DAP and means patients can be sure they are always getting the right amount of the active substances in the drug.

The Department of Health declined to comment, saying it was a matter for the MHRA.

A spokesman for the MHRA said the cost of Firdapse was not a matter for them - only drug safety.

She said: ‘It is for doctors’ clinical judgement as to which medicinal products they prescribe for their patient.

‘A doctor should always consider using a licensed medicinal product first if available. If the special clinical needs of the patient cannot be met by a licensed medicinal product then a doctor may consider using an unlicensed medicine.’

The revelation comes as the NHS faces the prospect of cuts over the coming years as it battles to deal with the higher costs of an ageing population, and the rising cost of drugs.

And it occurs amid the continuing furore over the banning by rationing watchdog NICE of a series of cancer drugs because they are not deemed cost-effective.

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