The Australian government's review of the plasma fractionation arrangements in Australia

Abstract

Australia has followed a single supplier policy for the provision of blood and blood products, with an oft-declared policy of self-sufficiency. Up to 2005, the mainstay of this policy in the public domain was a provision in the Australian Therapeutic Goods Administration's (TGA – the Australian regulator of therapeutic goods) Guidelines for the Registration of Drugs. This provision stated that overseas-sourced plasma products were required to demonstrate a clinical superiority over domestically sourced and manufactured products before they would be considered for approval on the Australian market. These domestic products have been historically supplied to the Australian community, through financial arrangements overseen by Australian governments, by CSL Ltd, a formerly government owned manufacturer of biological therapeutics which is now the world's largest private plasma products manufacturer. In 2004, a Free Trade Agreement between the United States and Australian governments included provisions, requested by the US government, which removed this requirement from the TGA's requirements. In addition, the Australian government committed to recommending an end to the current monopolistic arrangement to the other Australian jurisdictions, and to reviewing the whole area of plasma fractionation services. This review was conducted over 2006 and finalised its recommendations, which essentially advised the Australian government to maintain the current arrangements and recommended against the introduction of competition in domestic plasma fractionation services, in December 2006. Over the course of the review's work, intense public interest was evident in the issue, as shown by numerous media and other emanations. This work will review the background to Australia's blood system and, in particular, the convergent features which elicited the US FTA request and the reaction to it by the key stakeholders in the Australian blood economy. Some analysis will be offered to support an assessment of how these events can affect the status of recipients and donors in Australia's plasma product supply chain. Finally, opinion will be submitted on how these events can impact on international developments in blood safety and supply.