§ Mr. Bellotti
To ask the Secretary of State for Health what information the Medicines Control Agency has on the import of unlicensed high purity factor VIII products for the treatment of haemophilia A patients.
§ Mrs. Virginia Bottomley
Under the provisions of the Medicines Act 1968 a medicinal product cannot normally be imported for use with patients except under the authority of a product licence, a clinical trial certificate or under the clinical trial exemption scheme. The Medicines Control Agency holds licensing records in respect of all such products. There are, however, certain circumstances under which medicinal products may be imported without the above authority.
Medical and dental practitioners may import unlicensed medicinal products in order to perform their own clinical trials. In these cases the practitioner must notify the licensing authority by means of the doctors and dentists exemption scheme. The Medicines Control Agency maintains records of all such notifications.
A United Kingdom company may import an unlicensed product which is required by a doctor for a particular patient, under SI No. 673, the Medicines (Exemption from Licences) Importation Order 1984. The company is required to notify the licensing authority prior to each importation.
All information concerning licence and other applications, including notifications, is held in confidence by the Medicines Control Agency in accordance with section 118 of the Act.
Medical and dental practitioners may also import unlicenced products for administration to particular patients—"named patient" supply. Under the terms of this exemption the practitioner is not required to notify the Licensing authority. As a consequence the Medicines Control Agency does not maintain centralised records of this type of supply.
§ Mr. Bellotti
To ask the Secretary of State for Health what plans he has to visit the bio products laboratory; what plans he has for its privatisation; what is the cost of the laboratory to the national health service; and what charges it makes to health authorities for human blood and blood-derived products.
§ Mr. Dorrell
My noble Friend the Parliamentary Under-Secretary of State for Health will visit the bio products laboratory on 11 March. The planned visit is a routine one. There are no plans to privatise the laboratory.
The aggregate cost of the bio products laboratory to the NHS is not separately identified. The bio products laboratory supplies products derived from human blood and the charges are shown in the table. These charges do not include any element for the freely donated blood from which the products are derived. The prices paid by the health authorities are not necessarily those shown in the table as there are volume related discounts for some product lines.556W
Therapeutic product prices Price list code Product code Description Cash list Price 1. Coagulation Factors 9124 Factor VII 25p/u 9109 Factor VIII (8Y) 28p/iu 9144 Factor IX (with Heparin) 25p/iu 9125 Factor XI 25p/u 9126 Factor XIII 25p/u 9127 Antithrombin III 1000iu £100.00 2. Albumin 9101 Albumin 4.5 per cent 100m1 £10.00 9102 Albumin 4.5 per cent 250m1 £21.00 9103 Albumin 4.5 per cent 500m1 £33.00 9104 Albumin 10 per cent 2.5m1 £600 9105 Albumin 10 per cent 100m1 £21.00 9106 Albumin 20 per cent 5m1 £2.75 9107 Albumin 20 per cent 100m1 £32.00 3. Immunoglobulins 9112 Human Normal Immunoglobulin 250mg £3.10 9113 Human Normal Immunoglobulin 750mg £640 9115 Human Anti-D (RHo) Immunoglobulin 250iu £10.90 9116 Human Anti-D (RHo) Immunoglobulin 500iu £19.25 9117 Human Anti-D (RHo) Immunoglobulin 2,500iu £72.50 9118 Human Tetanus Immunoglobulin £12.50 9119 Human Varicella-Zoster Immunoglobulin £121.00 9146 Human Hepatitis B Immunoglobulin 200iu £41.00 9121 Human Hepatitis B Immunoglobulin 500iu £82.60 9122 Human Rabies Immunoglobulin £113.00