We discussed at length last night the fact that, as drafted, this bill has only minimal regulatory oversight of these processes. Indeed, there isn’t really a regulator as such—certainly not a solely devoted regulator—in charge of issuing the licences associated with mitochondrial donation. It is governed completely by the NHMRC and the minister, neither of whom are themselves a dedicated regulator. That would have been ideal from the perspective of myself and others in this chamber; ideally we would have preferred to have independent arm’s-length regulation through the OGTR, as we discussed last night. Those amendments have failed. It would seem, in that environment, to be prudent to put some quantitative hurdles before proceeding to a widespread clinical practice.
Just like our amendments last night, none of the amendments here stop, prevent or slow down the provision of mitochondrial donation services. Of course we’ll need to have participants go through these trials, which will include, potentially, live births. There are clinical trial licences that can be issued before reaching this 20-participant threshold, so we can have real outcomes for parents going through the trials in terms of not passing on mitochondrial defects to children, if these processes work. That can happen all through the trial period; there’s no limitation, through this amendment, on that occurring. We can still do all of that.
If this amendment is accepted, we just have to do 20 trials before we would proceed to widespread clinical application outside of a more monitored trial framework. We think that is a more than reasonable number. I dismiss the arguments put by the government, through Senator Birmingham, that somehow this would be an artificial hurdle. It seems a pretty weak argument that somehow, just because we reach 20, everybody thinks we have to go to stage 2. There’s nothing in this amendment which would suggest that at all. Indeed, this amendment does not get rid of the provision that Senator Birmingham highlighted which requires successful trial applications to occur before moving to stage 2. So, just because we have 20 trial participants, if none of those are successful, there are other provisions in this bill which would prevent stage 2 from occurring.
I am concerned, though, that the term ‘successful’ that Senator Birmingham is relying on is not defined in the bill. Potentially it could mean just one success would be sufficient to meet that hurdle before proceeding to stage 2. It doesn’t need to be plural. We know from the evidence received through the Senate committee that there is a risk through these processes of so-called off-target genetic modifications, which may not become apparent through simply one, two or a small number of mitochondrial donation processes. So it would make sense to do some larger number. The number 30 is normal in statistics. Thirty participants tends to get you a low-confidence interval when you’re dealing with risk and uncertainty. We haven’t gone quite as high as 30, but 20 seems like a reasonable number of participants to go through this trial, so that we have clear, risk-adjusted data on whether or not these donation processes can succeed in the broad, before proceeding to the stage 2 process.
