Dr Stewart Jessamine, New Zealand
The New Zealand safety provisions for blood products are: standard donor selection and screening tests, NAT (nucleic acid testing) for HIV and hepatitis C, first-pass donor testing for HTLV, adoption of FDA donor deferral criteria for new variant Creutzfeldt Jakob disease (nvCJD), universal leukodepletion, and implementation of CPMP/OIE/WHO guidelines on TSE and pharmaceutical products.
Fractionated products are supplied under contract, but there are certain risks for product supply. One of them is that New Zealand has a small regulatory agency and the country needs only small volumes of product (approximately six batches fractionated per year). In this situation, if one batch is contaminated, the stocks of the product available on the market will be significantly reduced.
One of the specific safety issues in New Zealand is risk management in relation to nvCJD. However, risks are defined by other countries contracting with the fractionator, and it is possible that standards will be driven by the most risk-averse client, with significant impact on costs.