I do think there is a need for an arms-length regulator for techniques that are very novel and revolutionary. I would posit that even those who are passionately in favour of this bill understand how revolutionary the techniques we are talking about are. The techniques involve transferring, for the first time, genetic material between two human cells for the purposes of reproduction. This is at the cutting edge, in the world, of these techniques. We have heard through this debate that the United Kingdom is the only country that has legalised this approach to date, and to date there has not been a successful live birth emerging from mitochondrial donation in that country. So it is something that we should ensure has a significant level of oversight and regulation. I know that some have raised the point that the Office of the Gene Technology Regulator may not be the appropriate body to regulate human gene therapy. Indeed, there was a review of the National Gene Technology Scheme in 2018, which did conclude that the definition of GMO in that act be amended to exclude a human being from the definition. That’s consistent with those who have argued against this amendment. However, that amendment has not been made. That recommendation has not been acted on. What no-one else has put forward in this debate at this stage is that that review also said:
The Review notes that this amendment may result in the need for another existing, or new, regulatory body to expand its scope of regulatory activity, to ensure that appropriate regulatory oversight is provided in this area.
The National Health and Medical Research Council is a great body and a fantastic institution in this country. It is not a regulator. It is a provider of health advice and research to governments and other organisations. It is not an arms-length regulator of an activity. I say that without casting any aspersions on the people who work in the NHMRC or the persons that would be part of the Embryo Research Licensing Committee that this bill would form. I’m sure they are all very good people, but they are people that are directly involved in the provision of these techniques and therefore cannot themselves sit at arm’s length. That has been admitted to me in discussions where there has been the admission that many people on the ERLC will have conflicts of interest. They will be disclosed, I’m sure, in the appropriate manner, but just the mere fact of having those conflicts of interest means they will not be an arms-length regulator.
In my view, not proceeding with this amendment would be inconsistent with the recommendations of the recent review of the National Gene Technology Scheme. We do not yet have a separate regulator established. That has not been considered. The Gene Technology Act has not been amended in the way recommended by that review in 2018. So we are putting cart before the horse here in excluding regulation from the OGTR before a proper consideration of the recommendations of that review—unless we move this amendment.
