Written question asked by Ian Gibson (Labour) on Wednesday, 22 April 2009, in the House of Commons. It was due for an answer on Friday, 24 April 2009. It was answered by Baroness Primarolo (Labour) on Wednesday, 29 April 2009 on behalf of the Department of Health.

Orphan Drugs

Question: To ask the Secretary of State for Health what his Department's definition of (a) orphan and (b) ultra-orphan drugs is.

Answer: A medicinal product may be designated as an orphan medicinal product within the European Union if:"it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union at the time of submission of the designation application (prevalence criterion); or""it is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition and without incentives it is unlikely that expected sales of the medicinal product would cover the investment in its development; and""no satisfactory method of diagnosis, prevention or treatment of the condition concerned is authorised, or, if such method exists, the medicinal product will be of significant benefit to those affected by the condition."Guidance on the interpretation of these criteria is published on the European Medicines Agency website at:"www.emea.europa.eu/htms/human/orphans/intro.htm"There is no formal classification of 'ultra-orphan' drugs. The term has been used by the National Institute for Health and Clinical Excellence to refer to drugs for the treatment of conditions with a United Kingdom prevalence of less than one in 50,000.

Secondary information