British Medical Journal: "Neurologists and paediatricians call for action on “massive” rises in the prices of orphan drugs.
"We are writing to you as a group of clinicians treating patients with so called “orphan” diseases (and one representative of a patients’ group) to express our concern at an unintended effect of the European Union’s regulations on orphan drugs. The original purpose of this legislation, passed in 1999, was to encourage drug companies to conduct research into rare diseases and develop novel treatments. However, as the rules are currently enacted, many drug companies merely address their efforts to licensing drugs that are already available rather than developing new treatments. 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.
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