Abstract
The orphan status of a medicinal product in Europe is regulated by Reg (EC) No 141/2000 and Reg (EC) No 847/2000 that states that:
“Persons suffering from rare conditions should be entitled to the same quality of treatment as other patients” but “the pharmaceutical industry would be unwilling to develop the medicinal product under normal market conditions” as “some conditions occur so infrequently that the cost of developing and bringing to the market a medicinal product … would not be recovered by the expected sales”.
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