§ Mr. BellottiTo ask the Secretary of State for Health what plans the bio products laboratory has to import unlicensed high purity Factor VIII products from abroad for the treatment of haemophilia A patients; and if he will make a statement.
§ Mr. DorrellThe bio products laboratory—BPL—is responding to the demand from clinicians for high purity Factor VIII made from plasma provided by United Kingdom unpaid voluntary donors as recommended in World Health Organisation and EC guidelines. It has licensed the appropriate manufacturing technology and is modifying its production facility to manufacture the product locally. For a limited period while those modifications are carried out, and in the interest of meeting the demands as quickly as possible, the BPL has contracted Kabi of Sweden to undertake part of the manufacturing process from an intermediate material supplied by the BPL. This work will be undertaken under the supervision of BPL staff.
The BPL is not at present covered by the licensing requirements of the Medicines Act because of Crown immunity. However, some of its products and facilities are already so licensed and it will be seeking licences for other products, including high purity Factor VIII, under the arrangements leading to the removal of Crown immunity. For many years the BPL has been inspected by the medicines inspectorate and its product have been tested by the National Institute of Biological Standards and Control, as are similar licensed pharmaceutical products.
§ Mr. BellottiTo ask the Secretary of State for Health what recent guidelines he has issued with regard to treatment of haemophilia A patients; and what representations he has received.
§ Mr. DorrellSeveral representations have been received concerning the use of high purity factor VIII for the treatment of haemophilia A patients. The Department has not issued guidance on this matter; decisions whether this treatment is appropriate for individual patients rest with the clinicians within the arrangements and protocols set locally for determining priorities among patient services, including prescribing costs.