November 17th, 2010
By Rebecca Smith
Rules that were intended to encourage drug companies to research and develop new medicines for rare diseases that are being misused, the 20 consultants said in the British Medical Journal.
Instead of developing new drugs they are obtaining licenses for existing ones and hiking up the price by up to 700 per cent, they said.
Some NHS hospitals are now refusing to fund drugs that were previously available cheaply while the NHS faces paying millions of pounds extra a year for the same, or very similar, medicines.
The open letter, which is also addressed to Health Secretary Andrew Lansley and David Cameron, said: “Once a company has obtained a licence, the legislation then gives the company sole rights to supply the drug.
“This in turn allows the company to set an exorbitant price for this supply and effectively to bar previous suppliers of the unlicensed preparation from further production and distribution.
“We believe that this behaviour is not in the best interests of patients or the NHS but is undoubtedly significantly advantageous to drug companies.”
The doctors said they had already written to the Department of Health for England and the Medicines and Healthcare Products Regulatory Agency about the issue.
“In reply we have simply been quoted the rules, and no one seems willing to investigate the issues we are raising or to consider whether the system should be changed.
“We urge you to instruct urgent review not only for the sake of our particular patients but also for the many other patients who are likely to be affected in the near future as other drug companies take advantage of this loophole.
“Legislation on orphan drugs, far from encouraging the development of new treatments for orphan diseases, is severely limiting the availability of existing treatments.”
The doctors provide several examples of price hikes, including a drug to treat rare muscle diseases which used to cost £800 to £1,000 per patient per year.
After obtaining a licence and slightly modifying the drug, the drug company now charges £40,000 to £70,000 per patient per year, the doctors said.
They added: “In the present economic situation it seems vital to ensure that systems are in place to prevent excessive commercial profits being made at the expense of patients and public spending.”
In a BMJ investigation, also published today, Dr Sam Richmond, a consultant neonatologist at Sunderland Royal Infirmary, and a signatory of the open letter, said: “If drug companies are undertaking research where nobody else was interested – and some are – then a monopoly may be justified.
“But if it’s a product already in use, they should clear off, or sell at a price comparable with the existing price.”
Professor Timothy Cox and colleagues at the University of Cambridge also argue the issue may warrant an investigation under competition rules.