§ Mr. BellottiTo ask the Secretary of State for Health, pursuant to his answer of 19 February,Official Report, column 86, (1) from what date the imported unlicensed high purity product from Kabi will be available to the National Institute of Biological Standards and Control for testing; and what is the anticipated release date for patient treatment using this product;
(2) on the Bio Products Laboratory, what assurances have been given by the Medicines Control Agency as to the safety of the unlicensed product due to be imported from Sweden relative to the licensed product available for the United Kingdom;
(3) what assurance has been given that the Medicines Control Agency will be provided with full details of the 448W patients and doctors involved in the name-patient import of the unlicensed high purity factor VIII produce from Sweden.
§ Mr. DorrellIn my reply to the hon. Member of 19 February at column86, I explained that the Bio Products Laboratory's high purity product will be covered by arrangements leading to the removal of Crown immunity and is currently the subject of a full licensing application. The Medicines Control Agency will be considering this application. The product has already been tested by the National Institute for Biological Standards and Control and is now available to clinicians under these arrangements and not on a named patient basis.
§ Mr. BellottiTo ask the Secretary of State for Health what actions are in place to ensure that when Crown immunity ceases the Bio Products Laboratory will have to conform in all respects to the same controls of the Medicines Act and to the same fair trading and free competition practices as currently apply to the commercial plasma industry in the United Kingdom.
§ Mr. DorrellOfficials of the Medicines Control Agency have for some months provided guidance and advice not only to Bio Products Laboratory, but to others in the NHS affected by the cessation of Crown immunity and the controls of the Medicines Act. This advice service will continue after Crown immunity ceases, and subject to the transitional arrangements for the removal of Crown immunity, the BPL will be treated under the Medicines Act in the same way as other pharmaceutical manufacturers.
§ Mr. BellottiTo ask the Secretary of State for Health, pursuant to his answer of 19 February,Official Report, column 86, on the Bio Products Laboratory if he will indicate which products and facilities are currently licenced under cover of the licensing requirements of the Medicines Act.
§ Mr. DorrellThe information requested in respect of Bio Products Laboratory is confidential by virtue of the restrictions on disclosure contained in section 118 of the Medicines Act 1968.
In accordance with article 12 of the EC directive 65/65, the licensing authority publishes any grant of marketing authorisation in the Official Gazettes.