BLOOD PRODUCT IMPORTATION
The Hon. R. D. DYER: I refer to the question without notice from the Hon. Elaine Nile asked on 6 December 1995 concerning blood product importation. My colleague the Minister for Health has advised:
The Health Department advises that imported blood products or blood components may include the following;
(a) Foreign plasma for fractionisation by Commonwealth Serum Laboratories (CSL).
(b) The Commonwealth Therapeutic Goods Administration licensed selective specialised blood products.
(c) Fresh blood components
The Commonwealth Serum Laboratories fractionate foreign plasma from a number of overseas countries including Asian countries and New Zealand. When privatised in 1994 CSL underwent an audit by the Federal Auditor-General. That audit raised concerns relating to the quality and safety of plasma from foreign countries which was being fractionated by CSL for use in those countries. The Auditor General recommended a reappraisal of the CSL plant to ensure that there was no risk of contaminating Australian plasma with foreign plasma.
A meeting was held on 21 February 1996 with representatives from CSL, the Therapeutic Goods Administration, the Red Cross Blood Transfusion Service and the Australian Quarantine and Inspections Service (AQIS) to discuss the audit report. At this meeting it was agreed that all suppliers of plasma to CSL would conform to the Committee for Propriety Medicinal Products (European committee) guidelines which control the starting materials for the production of blood derivatives. Each consignment of imported plasma will be accompanied by a statement from the collection agency certifying that the plasma has been collected in accordance with the requirements of the British Pharmacopoeia Monograph entitled "Human Plasma for Fractionation". The meeting concluded that there was no need to amend the legislation and that the Australian plasma supply is at no risk of contamination with foreign plasma.
The Commonwealth Serum Laboratories conforms to the Australian Code of Good Manufacturing Practice for Therapeutic Goods. This code requires that foreign plasma is appropriately labelled, quarantined and processed separately from Australian plasma and then returned to the country of origin. The NSW Health Department advises that all foreign plasma and Australian plasma is retested by CSL for HIV, Hepatitis B and Hepatitis C and that all products from foreign plasma processed in Australia by CSL are returned to the sending country.
Selective specialised blood products manufactured overseas from plasma sourced overseas are available in Australia eg. Recombinant FVIII. Prior to being licensed by the Therapeutic Goods Administration, the product is fully scrutinised and evaluated for quality, safety and efficacy by the Administration.
The Health Department advises that no imported blood is being used in New South Wales.
In NSW the Human Tissue Act 1983 - Regulation provides that all donated blood must be tested for prescribed contaminants using approved tests including - Hepatitis B surface antigen, Hepatitis C antibody, Furman immunodeficiency virus antibody and Treponemo Palladium related antibody. If any blood is found by the tests to be positive for a prescribed contaminant, the blood must not be used for any therapeutic purpose without the approval of the Director-General of the Health Department and the container of the blood must be prominently labelled with the biohazard symbol.