Senate debates

Thursday, 9 March 2023


Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022; In Committee

11:04 am

Photo of Jordon Steele-JohnJordon Steele-John (WA, Australian Greens) Share this | Hansard source

HN () (): I want to thank the minister and the shadow minister for their responses. I'll ask a couple of clarifying questions of the minister. Before I do so, I want to place on record a particularly compelling piece of evidence given to the inquiry into this issue four years ago. It's the evidence of a woman in relation to her experience with transvaginal mesh and the current reporting system. They said:

… no-one knows about reporting it. I don't understand why it's our responsibility to report it to the TGA when the doctors, who we go back to with our complaints and complications, don't.

I found out via the mesh support group online about the TGA and what its purpose is. I contacted my surgeon to ask if he had reported my erosion and issues along with the partial removal of the … sling. I also sent him the TGA link with the alert advising Drs they should be reporting any adverse affects. He had not reported anything. So I did it myself.

This is the situation that 150,000 Australian women found themselves in when potentially exposed to this device. They had to follow-up with their surgeons. They had to share the link to the regulator's statements about this and then their surgeons didn't follow it up. The government may well say, 'As we've defined it here, it's medical facilities, it's hospitals.' The problem with that is that if the relevant healthcare practitioner does not work within a facility they don't fall under those requirements, and we go back to the inadequate voluntary system.

The minister, in their statement, talked about the 'complexity' and the 'difficulty'. I think they were referring potentially to the system of voluntary reporting, the system of reporting more broadly, and the way in which that has been updated. The TGA have told us on three separate occasions that they are working right now to improve their systems and they expect that work to be completed in reasonably short order. If there's a problem with resourcing the TGA so they can do that, the government can solve that problem. I think that has been addressed comprehensively in relation to the responses from the TGA in the course of negotiations over this bill.

The question of burden on medical practitioners is a reality. I do want to talk to this because I have heard, as many of us have heard, from the representative peak bodies of general practitioners and other professions in relation to the stresses and strains that they are under. But I would also caution that we need balance in this conversation. We need to take a clear-eyed look at what the burden may reasonably be expected to be.

Now I would hope that there is not, in fact, a great multitude of faulty medical devices circulating in the Australian community. I would really hope that's the case after these scandals. But even if there were, this is a situation that a general practitioner would be reasonably expected to actually experience—a patient presenting to them in those circumstances where there is a serious resulting illness. They would see these kinds of issues once or twice in their practice life. It isn't every day that somebody's going to be coming in with these circumstances saying, 'Oh, my God, I'm in this situation and I've just had this device in.' These will hopefully be very rare situations but, when they occur, they must be reported.

We need to balance that potential rare burden with the burden borne by the patient. If they have implanted within them a medical device which is faulty, fails, causes them harm and then that is not reported to the regulator, then we have a situation where thousands of people's lives are adversely affected. Because that's what happened here. It wasn't in the sixties, it wasn't in the seventies; it was in modern, contemporary Australia.

Before this became more widely known, before transvaginal mesh and its healthcare impacts became more widely known, the TGA had recorded hundreds—just hundreds—of cases. A couple of hundred here; a couple of hundred there.

When Professor Skerritt gave evidence to the inquiry in 2018, if I remember his submission correctly, he said that at one point they'd had 12 reports to the TGA of faults. He specifically stated that one of the challenges with the system was that if the regulator doesn't get the information then they can't issue the red alert. That's why it is so important for that data to be gathered from everywhere it exists, not simply the data that it is easy for the government currently to access.

Finally, my question to the minister: they reference a 'potential legal barrier' to this amendment. I would genuinely like to inquire of the minister what they are referring to there. My read of the act is that 29AA gives the TGA the ability to issue penalty notices to individuals who fail to comply. However, if the government is in possession of other understandings, other pieces of legal advice, I'd really welcome the opportunity to hear the minister's perspective on what they exactly mean in relation to 'potential legal barriers'.


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