Simon Birmingham (SA, Liberal Party, Minister for Finance) Share this | Hansard source

I urge senators to vote against this amendment. This bill already effectively requires successful clinical outcomes from the clinical trial phase before moving to stage 2, the use of mitochondrial donation techniques in clinical practice. As outlined in the revised explanatory memorandum, stage 2 will only commence after the clinical trial has demonstrated success over a number of years and the results have been evaluated by experts. Over that period of time it is expected that significantly more data than the minimum data proposed in this amendment will be acquired.

Proponents of this amendment may say, 'Then why not put a minimum requirement in?' However, that may create the false impression that it would be appropriate to move to clinical practice once this minimum threshold has been reached and raise misplaced expectations in stakeholders. It is an important area in which we should rely upon expert assessment of the appropriateness of movement from the clinical phase of trials into clinical practice, and that we have that expert assessment of all available data, whatever is deemed to be required, to make sure there is confidence in that regard.

In addition this amendment could also create further legal uncertainty, as it might be that this would be the only consideration that could legally be taken into account when deciding whether to move to stage 2, with an implication that the broader range of factors intended to be taken into account couldn't be considered. I urge senators to oppose this amendment. The bill as drafted sets out very clearly the high standards required to move from trial to practice and that it is, rightly, for scientific experts to make sure those standards have been met.