§ Mr. Ron DaviesTo ask the Secretary of State for Health what controls on imported factor 8 are being applied to the factor 8 currently being supplied in the United Kingdom on named product basis by the German-based company Octapharnna Gmbh; and what implications such controls have for the health of British haemophiliacs.
§ Mr. Mellor[holding answer 18 April 1989]: Factor 8 is being supplied by Octapharnna Gmbh for use in a clinical 208W trial under the terms of the Medicines (Exemption from Licences) (Clinical Trial) Order 1981 (SI 1981/164). This states that this product can only be used in accordance with the conditions of the trial and with the informed consent of the patient.
In addition, any physician, on his own responsibility, can order this factor 8 for use on a named patient basis.
The Department is satisfied that the blood meets the requirements of both EC and WHO guidelines and the requirements specified in the BP (Addendum 1386) monograph for factor 8.