E-drug: EU loophole sends drug prices soaring
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[Reprinted under the fair use doctrine of international copyright law:
http://www4.law.cornell.edu/uscode/17/107.html\]
Guardian Weekly June 27-July 3 2002
EU loophole sends drug prices soaring
Companies profit from treatments for rare diseases
Sarah Boseley
The prices of cheap, life-saving treatments for rare children's diseases are
being increased by drug companies to levels where hospitals can barely
afford them.
The companies are exploiting European Union regulations concerning 'orphan
drugs' - drugs that are of benefit to fewer than five per 10 000 people -
despite the rules being put in place to encourage the invention of new
medicines.
Two children in Middlesbrough were hospitalised and put on drips after
supply of a cheap chemical that was necessary to keep them alive ran out.
The chemical manufacturer can no longer provide the hospital with carbamyl
glutamate because a drug company is in the process of securing licence and
sole marketing rights to the compound under what is known as the orphan drug
regulations passed by the EU.
The drug company, Orphan Europe, based in Paris but with a branch in Henley,
Oxfordshire, has increased the price of carbamyl glutamate from around �700
to �1 500 a year to �80 000 to �106 000 (depending on dosage) and will soon
have a 10-year monopoly on its supply.
The orphan drug regulations were passed in Europe in 1999, following similar
legislation in the United States. They were intended to reward companies
that invested in research leading to new drugs for rarer diseases that would
normally have a big market. But companies such as Orphan Europe are taking
commonly used products through the licensing system and reaping the benefits
even though they have not invented the drugs and have spent nothing on
original research.
'It's a scam and it should not be exposed as such' said Sam Richmond,
consultant neonatologist at Sunderland district general hospital.
Orphan Europe has obtained a licence to produce other compounds that have
been used for years. The price has risen steeply in each case.
Orphan Europe denies that it has done nothing to justify the increases.
Pierre Mambrini, a pharmacist employed by the company responsible for the
development of carbamyl glutamate, said that researching the drugs and
formulating ways to purify the compound had cost money.
The price was justified, in his view, by the 'quality and safety of the
medicine his company was producing'.
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Kirsten Myhr, MScPharm, MPH
Head, RELIS Ost Drug Information Centre
Ulleval University Hospital
0407 OSLO, Norway
Tel: +47 23 01 64 11 Fax: +47 23 01 64 10
kirsten.myhr@relis.ulleval.no (w)
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