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18/11/2010
PM Urged To Act On "Massive" Rise In Drug Prices
An open letter from 20 consultants and a patient group published on bmj.com today, calls on the Prime Minister to take action over a legal loophole that allows drug companies to make easy profits by licensing existing treatments for rare or orphan diseases.
It is argued that the current situation concerning orphan drugs is not in the best interests of patients or the NHS and that the cost to the NHS is likely to be above £10m a year. The original purpose of this legislation was to encourage drug companies to conduct research into rare diseases and develop new treatments. But, as the rules are currently enacted, many companies simply modify existing drugs and obtain a licence for one or more orphan diseases. This then gives the company sole rights to supply the drugs and to charge what many consider “exorbitant” prices.
One example of the effect of these rules is the drug 3,4-diaminopyridine (3,4-DAP), which doctors have been using for over 20 years to treat two rare muscle diseases at a cost of £800 to £1,000 per patient per year. The company BioMarin has now been issued with a licence to supply the drug (marketed as Firdapse) throughout Europe and charges £40,000 to £70,000 per patient per year - a 50-fold to 70-fold increase.
Oral ibuprofen for analgesia costs £0.08 per gram, but intravenous ibuprofen for patent ductus arteriosus (a congenital heart disorder) costs £6,575 per gram, tens or even hundreds of times more than the cost of producing sterile ibuprofen solution for intravenous injection in an NHS facility.
"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," say the signatories. They add: "Legislation on orphan drugs, far from encouraging the development of new treatments for orphan diseases, is severely limiting the availability of existing treatments. We believe that the Medicines and Healthcare Products Regulatory Agency and Department of Health should not just state the rules but should act now to progress the issue of unfairness upwards, so as to instigate change."
Authors Robin Ferner and Dyfrig Hughes believe the NHS “could, and should, make and distribute ‘specials’ (unlicensed medicines) for rare diseases” and that the GMC “should allow doctors to prescribe a drug that meets the individual patient’s needs, but is not licensed for the specific indication, even if a licensed medicine exists for the same indication.”
In an accompanying analysis, Timothy Cox and colleagues at the University of Cambridge argue that pricing for orphan drugs hinders access to treatment and may warrant a competition law investigation. They add that current high pricing contravenes the aim of the Orphan Regulation, which states: “Patients suffering from rare conditions should be entitled to the same quality of treatment as other patients.”
(BMcN/GK)
It is argued that the current situation concerning orphan drugs is not in the best interests of patients or the NHS and that the cost to the NHS is likely to be above £10m a year. The original purpose of this legislation was to encourage drug companies to conduct research into rare diseases and develop new treatments. But, as the rules are currently enacted, many companies simply modify existing drugs and obtain a licence for one or more orphan diseases. This then gives the company sole rights to supply the drugs and to charge what many consider “exorbitant” prices.
One example of the effect of these rules is the drug 3,4-diaminopyridine (3,4-DAP), which doctors have been using for over 20 years to treat two rare muscle diseases at a cost of £800 to £1,000 per patient per year. The company BioMarin has now been issued with a licence to supply the drug (marketed as Firdapse) throughout Europe and charges £40,000 to £70,000 per patient per year - a 50-fold to 70-fold increase.
Oral ibuprofen for analgesia costs £0.08 per gram, but intravenous ibuprofen for patent ductus arteriosus (a congenital heart disorder) costs £6,575 per gram, tens or even hundreds of times more than the cost of producing sterile ibuprofen solution for intravenous injection in an NHS facility.
"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," say the signatories. They add: "Legislation on orphan drugs, far from encouraging the development of new treatments for orphan diseases, is severely limiting the availability of existing treatments. We believe that the Medicines and Healthcare Products Regulatory Agency and Department of Health should not just state the rules but should act now to progress the issue of unfairness upwards, so as to instigate change."
Authors Robin Ferner and Dyfrig Hughes believe the NHS “could, and should, make and distribute ‘specials’ (unlicensed medicines) for rare diseases” and that the GMC “should allow doctors to prescribe a drug that meets the individual patient’s needs, but is not licensed for the specific indication, even if a licensed medicine exists for the same indication.”
In an accompanying analysis, Timothy Cox and colleagues at the University of Cambridge argue that pricing for orphan drugs hinders access to treatment and may warrant a competition law investigation. They add that current high pricing contravenes the aim of the Orphan Regulation, which states: “Patients suffering from rare conditions should be entitled to the same quality of treatment as other patients.”
(BMcN/GK)
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