Potential impact of AUSFTA on Australia's blood supply

To the Editor: Bambrick et al1 suggest that the importation of overseas plasma products or the processing of Australian plasma overseas may pose a threat to the safety and security of Australia’s supply of plasma products. The National Blood Authority (NBA) and the Therapeutic Goods Administration (TGA) would like to respond to these issues to ensure that clinicians have confidence in the safety of products currently available in Australia and a better understanding of current blood processing and supply arrangements.

Australia is largely self-sufficient in plasma products, a position supported by all Australian governments.2 The governments also agree to the supply arrangements for imported plasma products when demand exceeds domestic supply (as in the case of intravenous immunoglobulin [IVIg]), and for products not supplied by Australian manufacturers (eg, fibrin sealant and other coagulation products). All these products are purchased by the NBA on behalf of Australian governments. Standards applied in Australia ensure that all products on the Australian market are derived from sources — in Europe, the United States and Australia — approved by the relevant authorities. The TGA regulates all plasma products to ensure that they meet international standards of safety, quality and efficacy, irrespective of their source.3 No centres sourcing blood from countries in the developing world, as cited by Bambrick et al, are used.

National health systems around the world strive to attain degrees of self-sufficiency that suit their particular economic and policy objectives. However, as the US supplies 60%–70% of global plasma (while consuming only 40% of products sourced from this plasma4), many patients outside the US are dependent on the system of both compensated and uncompensated donors operating in the US. It is worth noting that definitions of “remuneration” vary across countries. The Commission of the European Communities reported in 2006 that “the principle of voluntary and unpaid donations does not exclude compensation for donors, if it is limited to making good the expenses and inconveniences related to the donation”.5 Examples of compensation that this article cites include tax relief of up to €70 per annum in the Czech Republic, an expense allowance of up to €25 for a whole blood donation in Germany, and up to €50 for an apheresis donation in Austria. Thus, the boundary between compensated and non-compensated donors is not distinct globally.

Bambrick and colleagues’ contention that products manufactured from paid donors may be less safe is not supported by evidence. The history of blood safety clearly demonstrates that there were major safety issues with both fresh blood and blood products in the 1980s. These problems were more a result of pathogen epidemiology and governments’ blood safety policies than whether donors were paid or unpaid. For example, the Canadian and French blood systems relied entirely on volunteer donors, but the delayed implementation of safety measures and good governance measures led to pathogen risks that exceeded those of the US.6,7 In Australia, the incidence of HIV/AIDS in people with haemophilia exposed to only one type of product in the 1980s approached that of the same patient group in the US, despite the product being sourced entirely from domestic voluntary donors.8

Currently, robust plasma product safety measures in the US have proved to be effective in minimising contamination from both known and emerging pathogens, such as West Nile virus. This virus did not infect the recipients of plasma products from compensated donors, but did infect the recipients of (uncompensated) fresh blood transfusions.9 The equivalence in safety between plasma products sourced from compensated and uncompensated donors has been confirmed by the European Medicines Agency.10

Ensuring the security of supply is central to Australia’s plasma fractionation arrangements. The NBA’s contracts include provisions to ensure product supply security and product safety, including compliance with TGA requirements. Under Australia’s emergency response plans, plasma could be supplied from fresh stock, while the inventory of product in the system and the national reserve of products (funded by the NBA to cover contingencies) could provide fractionated products. A range of other supply security measures is implemented by the NBA on behalf of Australian governments, including secondary suppliers for critical products. These measures take into account the fact that Australian plasma used to manufacture fractionated products is not produced in sufficient quantities to permit storage of excess. Thus, Bambrick and colleagues’ concern that geographical factors may restrict access to Australian plasma has limited relevance in an emergency situation.

In summary, Australia has a comprehensive system that draws on international best practice and national jurisdictional arrangements to ensure the supply of high-quality, safe, efficacious plasma products, irrespective of their source.