Volume 186 - Issue 8
Potential impact of AUSFTA on Australia's blood supply
Authors: Hilary J Bambrick and Thomas A Faunce
Med J Aust 2007; 186 (8): 427-430. || doi: 10.5694/j.1326-5377.2007.tb00985.x
Published online: 16 April 2007
Published online: 16 April 2007
In reply: Turner and Farrugia highlight important issues about the safety and supply of Australia’s blood and plasma that constituted key findings of the recent Australian Government review of Australia’s plasma fractionation arrangements.1 These included the desirability of self-sufficiency and the need for a viable contingency plan in the event of local supply failing to meet demand, in the context of probable increased uncertainty in relevant security and supply circumstances.
The authors note the importance of a rapid regulatory response to new risks, and rightly emphasise the important role of our National Blood Authority and the Therapeutic Goods Administration in relevant safety assurance processes. However, a crucial issue highlighted in the review that they fail to address is the difficulty of relying on the application and enforcement of regulatory standards if the bulk of Australia’s fractionation occurs offshore.1
After an exhaustive study of arrangements in Europe and the United States, the review concluded that overseas fractionation of Australian plasma would involve significant costs in moving away from the current local arrangements ($75 million) and, because of yield considerations, there would be the potential for an ongoing shortfall in the supply of intravenous immunoglobulin (IVIg) and other plasma-derived products. The review also found that overseas fractionation was potentially associated with major risks to the supply chain, with increased distance and handling providing more opportunities for loss and error, while a doubling or tripling of the turnaround period would have implications for continuity of supply. The review recommended that the federal government maintain the reservation exempting plasma fractionation services from the government procurement provisions of Chapter 15 of the Australia–United States Free Trade Agreement.1
The review confirmed that volunteering for blood donation should be institutionally reinforced as an important exemplar and means of sustaining Australia’s national culture, and that donor payment endorsed a very different set of values and was unlikely to assure sustainability of supply.2 It did, however, suggest initiatives such as tax relief or other institutional ways to encourage donation.1
We fully endorse the summary assessment of the review that:
[T]he current structural arrangements, whereby domestically collected plasma is fractionated by CSL Bioplasma, are, subject to careful monitoring of prices, in Australia’s best interests. The present system is well entrenched in the “hearts and minds” of the Australian population and of the Australian medical community and, particularly, in the strategy, thinking and reliance of all end user groups.1
Competing interests
Hilary Bambrick is related to Philip Flood, Chairman of the Plasma Fractionation Review Committee. He has had no input into this letter. Thomas Faunce is Project Director of an Australian Research Council (ARC) grant investigating the impact of international trade agreements on Australian medicines policy. The ARC was not consulted about the preparation of this letter.
References
- Flood P, Wills P, Lawler P, et al. Review of Australia’s plasma fractionation arrangements. Canberra: Commonwealth of Australia, 2006. http://www.donateblood.com.au/admin%5Cfile%5 Ccontent1%5Cc5%5Creport-dec06.pdf (accessed Mar 2007).
- Jones RP, Prasad V, Kuruvatti J, et al. Remuneration for blood donation and attitudes towards blood donation and receipt in Leeds. Transfus Med 2003; 13: 131-140. 0_CBBBCEFJ