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Wednesday, 19 September 2007
Page: 64

Mr ABBOTT (Minister for Health and Ageing) (1:48 PM) —in reply—I do not want to further detain the House other than in ways that are absolutely necessary. I thank both the member for O’Connor and the member for Gellibrand for their contributions in the debate on the Health Legislation Amendment Bill 2007. I particularly thank the member for Gellibrand for the time she has taken to delve into this and to assess it. I will not repeat what was covered in the second reading speech but, in considering the Pharmaceutical Benefits Scheme amendments in this bill—and I think this will help the member for Gellibrand—I want to clarify the process which underpins the flagging of a pharmaceutical benefit in the PBS to show that it can be substituted for another equivalent pharmaceutical benefit or benefits. The practice for determining equivalence is that a sponsor has submitted evidence to the Therapeutic Goods Administration that a medicine has demonstrated bioequivalence or therapeutic equivalence against another medicine. The Therapeutic Goods Administration may also conclude bioequivalence between two medicines on the basis of the route of administration and the formulations of the products concerned. Bioequivalent and therapeutically equivalent medicines can be expected to produce the same clinical effects and to have the same safety. This is a technical assessment, and it is my intention that this practice will continue in effecting the provisions outlined in the bill. I commend it to the House.

Question agreed to.

Bill read a second time.