Submission Health innovation System reform and governance Clinical trials

Inquiry into the Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021

Research Australia 14 July 2021 2021 · Submission

In brief

Research Australia supported the Bill to legalise mitochondrial donation, starting with tightly regulated clinical trials. It recommended that the NHMRC committee overseeing licences be given enough resources and clinical expertise to make decisions quickly.

Abstract

This short letter to the Senate Standing Committees on Community Affairs responds to the inquiry into the Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021. Research Australia supports the Bill’s two-stage implementation approach, noting prior reviews by the Senate Community Affairs References Committee and the National Health and Medical Research Council (NHMRC), and the UK’s approval of mitochondrial donation in 2015 after ten years of review. It considers initial access through clinical trials appropriate to the technology’s stage of development, and the licensing requirements onerous but justified, with the NHMRC Embryo Research Licensing Committee (ERLC) the right oversight body. It recommends the Committee to recommend that the ERLC be adequately resourced, including with clinical expertise, to make timely decisions.