Raff Ciccone (Victoria, Australian Labor Party) Share this | Hansard source

At the request of Senator O'Neill, I move amendment (1) on sheet 1540:

(1) Schedule 1, page 6 (after line 37), after item 10, insert:

10A At the end of Division 1 of Part 2

Add:

9A Minimum data required before clinical practice stage

Before the Governor-General makes regulations declaring a mitochondrial donation technique for the purposes of the definition of permitted technique in section 8, the Minister must be satisfied that:

(a) there is sufficient clinical evidence that the technique has been used on at least 20 trial participants; and

(b) the outcomes of the use of the technique on the trial participants have been published.

This amendment proposed by Senator O'Neill will introduce a threshold where outcomes on 20 trial participants are required and published before the mitochondrial donation clinical licences are granted. The lack of data from the United Kingdom, the only jurisdiction where these practices are legal, should impel us to raise the threshold on these experimental gene editing techniques before we proceed in granting them a licence. The impacts and efficacy of these proposed techniques are still in theory, and thus a large number of trials should be undertaken and the results should be shared before these techniques are permitted to go ahead.