§ Mr. Michael MorrisTo ask the Secretary of State for Health what provision there is to abate or reduce the fees of the Medicines Control Agency for orphan drugs.
§ Mrs. Virginia BottomleyA reduced fee (currently £13,600 instead of £68,000) is payable for a major product licence application covered by paragraph 5 of chapter III of part 3 of the annex to EC directive 75/318.
The term "orphan drug" is of United States origin and has no direct counterpart in United Kingdom or EC legislation. It is considered that the above directive provision (which deals with situations where comprehensive data on therapeutic safety and efficacy cannot be provided) covers the concept of "orphan drugs".