ABC Four Corners screening of Blood Business

28 August 2017

Statement

Australian Governments are committed to providing an adequate, safe, secure and

affordable supply of blood and blood products to meet the needs of Australian
patients.

Blood and blood products are a critical component of health care. The Australian Red
Cross Blood Service is funded by all Governments to collect whole blood and plasma
from voluntary, non-remunerated donors for use in Australia. All blood and blood
products are provided free of charge to patients based on clinical need and best
practice. The majority of Australian plasma is provided to CSL Behring for the
manufacture of plasma-derived products for Australian patients.

Plasma-derived products, such as clotting factors and immunoglobulin products, are

essential to ensure the survival and wellbeing of thousands of Australian patients. To
ensure security of supply, plasma-products are imported within a narrow range of
circumstances where there is an inability to meet clinical demand through the
domestic supply, or when the product is not manufactured in Australia. This happens
within a framework that:

ensures adequacy of supply to Australian patients in need;

minimises the supply security and product safety risks to patients;
ensures affordability of products to the Australian health sector; and
recognises the practicalities of production and distribution.

Without plasma donation, domestic production and the importation of supplementary

plasma-derived products, the current demand for therapies could not be met. This
would have ramifications for the health outcomes of many Australian patients.

Blood, blood components and plasma derivatives are regulated under the
Therapeutic Goods Act 1989. Plasma derivatives are prescription medicines subject
to full regulation under provisions requiring standards, licensing of their manufacture
and inclusion in the Australian Register of Therapeutic Goods after review of
manufacturing, pre-clinical and clinical data and physical inspection of their
manufacturing facilities. Imported products are subject to the same regulatory
standards as domestic products.
The Federal Minister for Health Greg Hunt has sought assurances from the National
Blood Authority (NBA) and the Therapeutic Goods Administration (TGA) that the
current arrangements for the safety and quality of imported blood product supply are
rigorous, fit for purpose and consistent with those that apply to domestic supply.

The Minister has been given that assurance from the NBA and the TGA.