The Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021, as senators would realise, establishes five different types of licences. It effectively establishes two stages to introduce mitochondrial donation into our laws. As has been described, this will be a new and revolutionary form of human gene therapy that is prohibited under our laws today. Because of that, the bill seeks to establish some trial and research licences in the first stage. There are three of those that are particularly specified in this bill. Then, following the research and trials, the bill outlines two additional licences—a clinical research licence and a clinical practice licence—that would then be allowed for to provide for widespread adoption of mitochondrial services to the broader population, outside of research and trials.
I am a little concerned here that the approach adopted in this bill continues some of the deficiencies we have seen emerge in the Senate on the use and overuse of delegated legislation. This bill establishes a regulatory framework for mitochondrial donation. However, at the conclusion of the research and trial phase—the so-called stage 1 in this approach—there are no specific conditions to be placed on the licences that will apply to clinical practice trials.
Senator Steele-John: Point of order, Mr Temporary Chair.
The TEMPORARY CHA IR ( Senator O’Sullivan ): Yes, Senator Steele-John?
Senator Steele-John: Mr Temporary Chair, I draw your attention to Senator Antic, who is moving about the chamber without a mask. I would ask that you request that he wear one in line with the rules.
The TEMPORARY CHAIR: Senators are aware of the rules, and I would remind them of that.
Senator CANAVAN: As I was saying, in this so-called stage 2 of the bill, moving to clinical practice trials, the conditions that would apply to those licences are not set or outlined in this bill because, of course, we haven’t done the research and the trials, so, understandably, the government cannot at this stage outline in detail those particular regulations. For example, the explanatory memorandum to this bill says:
… organisations will not be able to apply to the ERLC—
the Embryo Research Licensing Committee—
for either of the two clinical practice related licences until a particular technique is specified in the Regulations for this purpose.
The explanatory memorandum goes on to say:
… Stage 2 would commence only after mitochondrial donation techniques suitable for use in clinical practice have been prescribed in the Research Involving Human Embryo Regulations 2017.
Keep in mind what we are doing if we do not amend this approach. We will continue the trends we have seen whereby the parliament delegates enormous power to the executive, and to ministers within that executive, to effectively make laws in the future that are not subject to the full oversight and scrutiny of this parliament.
I want to recognise the fantastic work that Senator Fierravanti-Wells, Senator Carr and others on the Senate Standing Committee for the Scrutiny of Delegated Legislation have done in this space. They have produced two groundbreaking reports—reports that I’m sure will stay on the shelves of many in this place for decades—about the overuse and risks of delegated legislation. Indeed, Senator Concetta Fierravanti-Wells, in tabling the final report in this place last year, commented that:
In theory, delegated legislation should only deal with purely technical or administrative matters, but this is no longer the case. In practice delegated legislation now often deals with matters of policy significance. An already unsatisfactory situation is becoming intolerable.
I couldn’t agree with those words more—that, as senators in this place, we should be the house of review, we should be holding up standards that hold the executive to account on matters of policy significance. And this is clearly a matter of significance in terms of setting the conditions that would apply to a unique, novel and revolutionary form of human gene therapy. And, in that comment, Senator Fierravanti-Wells succinctly summed up that delegated legislation should be there for technical administrative matters—stuff that is urgent and cannot necessarily go through a full parliamentary process. The bill and explanatory memorandum said that the stage 1 process will take 10-plus years. So the delegated legislation that we would be approving without the bill being amended would not necessarily be exercised for another three federal elections. A completely different Senate would be here, and they would have no direct parliamentary oversight, apart from the disallowance process, to deal with the new regulations that may be set at that point.
Another good point that was made by Senator Fierravanti-Wells’s committee is that we should have sunset clauses on delegated legislation. If we approve this bill, there will be more sunlight to the executive than would exist in Nordic countries in summer. It will be 10 years before they even consider it! We don’t know what developments there will be in human gene therapy. We don’t know what will happen in the UK and other countries. We will give a blank cheque to an executive in 10-plus years to write their own regulations then. I admit that we can disallow them, but we all know that’s inadequate. It doesn’t go through the committee process properly, it doesn’t have to go through both houses, there are very rarely any public hearings associated with a disallowance, and it’s an up-and-down vote. We can’t have this process. There is no Committee of the Whole in a disallowance process. We can’t amend the regulation. We have our hands tied somewhat when it comes to dealing with delegated legislation, even in a disallowable sense.
In the amendments that I will be moving tonight, I will propose that we should seek to remove the stage 2 licences from this bill. These amendments would not stop mitochondrial donation research and trials from continuing. As I’ve outlined, they’ve got 10 years of those to go—at least. These amendments would not stop that from occurring and the progression of this technology happening. All that agreeing to this amendment would mean is that, at the conclusion of those trials and research, the government of that day, or members and senators at that time, would put forward additional legislation which would then govern the regulatory framework for clinical practice trials.
In my view, these amendments become even more important given the fact that we did not agree to the regulatory oversight of the Office of the Gene Technology Regulator. I accept the decision of the Senate that has occurred here—that we will have scrutiny through the National Health and Medical Research Council. That body, as I’ve outlined, is not a regulatory body. There are at least some question marks here about gaps in the regulatory process. Surely, before we proceed with clinical practice trials, we should ensure that a full parliamentary process occurs. If these gaps remain—the gaps that I perceive, and plenty of other senators perceive; it was a very tight vote—then we could seek to look at how we fix those and fill those gaps at that point.
These are commonsense amendments that I would encourage all senators to adopt. They do not stop, slow down or in any way prevent the progression of mitochondrial donation technologies. They simply make sure that the scrutiny of this parliament and its integrity is maintained and we do not continue the trend of the executive of this country taking more and more power and authority from the parliament, where it should reside.
