Radio Interview with Minister Butler and Patricia Karvelas, ABC RN Breakfast - 22 May 2024

Read the transcript of Minister Butler's interview with Patricia Karvelas on banning pharmacy compounding of replica weight loss medicines; ICC independence; social media ban for children.

The Hon Mark Butler MP
Minister for Health and Aged Care

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PATRICIA KARVELAS, HOST: Following a Four Corners investigation, the federal government will close a loophole which allowed replica versions of popular diabetes drugs like Ozempic to be manufactured. Prompted by safety concerns, the government has announced a ban on compound pharmacists from making these replicas and the Health Minister, Mark Butler, of course, is responsible for all of this. And he joins us. Minister, welcome.
KARVELAS: What are the dangers you're aiming to protect people from?
BUTLER: A whole series of adverse events that are effectively off the radar. I mean, Australians take millions and millions of medicines every single day, in the confidence, I hope, that we have a terrific safety system that gives them a surety about what the medicine contains and also the conditions under which they were manufactured – very strict conditions about manufacturing operations. There's always been this carve out, if you like, called compounding that would allow a doctor and a pharmacist to decide that their patient needed something, a medicine or an ointment that wasn't commercially available, and as a one-off that is compounded or made up and provided on prescription to the patient. And that's an important part of our system. But what we've seen over the last several months is a whole lot of business models develop that are using this carve out, effectively abusing this exception, to put in place some large-scale manufacturing operations. And we have no oversight about what these medicines contain. They're used through injection, so that adds another element of risk. And there's no ability to gather adverse event reporting. So there's no line-of-sight that the regulators have about what's happening out there. This is something that the American authority, the FDA, has also expressed concern about. So over the last several months, we've been working with authorities to gauge their views about what we should do. And the clearest advice to me from the TGA was that we should remove this exemption.
KARVELAS: The ban will come into effect from October. You've given the industry a four-month transition period. Why do they need that time period? Why can't it happen immediately?
BUTLER: I certainly don't see it as giving the industry a four-month transition period. What I'm giving is patients a transition period. For better or for worse, there are some thousands of patients who are accessing these products, and I want to give them the time to go and see their doctor and to work through an alternative and give them the time to move to that alternative. I thought about this carefully. I took advice on this. And I thought that, given the number of patients who've been lured onto these arrangements, it was important not to shut it down overnight and have a whole lot of patients left high and dry. So we think four months is an appropriate balance.
KARVELAS: Some pharmacy groups, including telehealth company Eucalyptus, have warned that a ban on these compounded medicines will basically make it harder for people, right? Because there's a global shortage of, if I can be blunt, the legit stuff. So what are you going to do about that? Because some people will inevitably have to wait, won't they?
BUTLER: The first thing I'd say, Patricia, is that every stakeholder we consulted supported this ban, with the exception of the businesses that are in the market. So we consulted all of the Chief Pharmacists at state level, the Pharmacy Board, the Medical Board, the doctors’ groups, consumer groups like Diabetes Australia, the Eating Disorders Alliance. They all supported this ban. They're all concerned about the safety risk. But obviously everyone, frankly, not just in Australia but around the world, is concerned about the global shortage of supply for these medicines that currently are recognised as diabetes medicines in Australia, but have taken off as their use in weight loss has skyrocketed across the world. So we are concerned about this. The TGA has been working with the relevant companies for Ozempic and also Mounjaro, which is the other diabetes medicine that's increasingly being used for weight loss, to try to get a sense of when these global shortages will resolve. Unfortunately, they are not likely to resolve this year. The companies effectively have to build new factories to make more of this stuff. And that's again why I've given a transition period for patients to go away and talk to their doctors about this. What we have been clear about, though, for some time now, through the authorities to doctors, is that they should prioritise prescription of these medicines for diabetes patients. They are often very, very important treatments for people with diabetes conditions. And so diverting supply of these drugs, when they're in short supply, for alternative purposes is something we're strongly trying to discourage among doctors.
KARVELAS: How widespread do you think it is that this medicine is being diverted to those, you know, who have different motives, like weight loss rather than its primary purpose?
BUTLER: In the formal market, we think it's come down substantially. We've had a good response from doctors about this as we've been communicating directly with them and also working with the College of General Practitioners that has been very supportive of this. In the informal market, these so-called replica products, it's been difficult for us to know. I mean, the report from Elise Worthington and Four Corners was some really terrific public interest journalism that did try to draw out some numbers here. But in a formal sense, it's hard to get a sense of these numbers because they're not reporting through Medicare, they're not reporting through the PBS. And that's really why I was so concerned about it. An exception that's intended to be used on a one-off basis had essentially been abused to create a large-scale manufacturing and prescribing market that poses very real risks to public safety.
KARVELAS: On another issue this morning, the Shadow Foreign Minister, Simon Birmingham, joined us and accused the Prime Minister of “wilful inconsistency” after he said he would not comment on the ICC Chief Prosecutor's pursuit of Hamas and Israeli leaders. He said in the same press conference he was happy to talk about Assange, for instance, and that obviously is, you know, court-related as well. Is there an inconsistency?
BUTLER: No, there's not. What we've seen over the last very little while, 24 hours or 48 hours perhaps, is the ICC take a decision and the Australian Government has, essentially, voiced a longstanding position that that court is independent, and it will go through its usual procedures. I mean, I think one of the disturbing things out of these reports has been a sense that there's some equivalence between Hamas and Israel, and I think we all, certainly I reject that, the Government rejects that. Hamas is a vile terrorist organisation. It's been recognised as a terrorist organisation in Australia for some time. But the point that the PM has made, and I know the Foreign Minister has made, is that the ICC is part of the sort of global architecture that Australia, as a middle power, has always supported. And so decisions by the ICC to do one thing or another are a decision for them. We don't seek to interfere in that.
KARVELAS: No, but the Prime Minister of Israel, Benjamin Netanyahu, obviously have been targeted. Israel is now calling for countries to boycott any potential arrest warrants. Should we boycott any potential arrest warrants?
BUTLER: Patricia, I'm the Health Minister, the Prime Minister and the Foreign Minister –
KARVELAS: I know. You're a senior minister, though.
BUTLER: The Foreign Minister and the Prime Minister talk on these issues. As I said, we've got a longstanding position as a country - not as a party, but as a country - to recognise the ICC as part of an important global architecture. And so they will take their decisions and proceed with them. You know, I think as I said, our Government's been clear that any sense out of this decision that there's some equivalence between Hamas and Israel, though, should be rejected by all reasonable people. And this is a vile terrorist organisation that precipitated this devastating conflict in Israel and Palestine through some truly awful, heinous acts and still haven't released hostages -
KARVELAS: Well, Simon Birmingham says that equivalence has now been made, and that's why we should boycott and should be taking a position against this. Do you disagree?
BUTLER: Look, I can only say it a third time, Patricia. Australia and our Government has had a longstanding position that the ICC is an independent part of the global apparatus. It’s an important part of the global apparatus, and it makes its decisions independently. We don't seek to interfere in those.
KARVELAS: Just finally, your portfolio - and it is your portfolio, it does encompass mental health, of course – and this week, a number of state Premiers and the Prime Minister called for stronger age limit restrictions on social media. Anthony Albanese wants kids under 16 banned from social media. Do you agree? Do you think that's actually achievable?
BUTLER: From a technological point of view, I'm no expert. But I can tell you, as a Health Minister, I think this has been a really important debate over the last little while. And I think there is a growing sense of outrage among parents and now among community leaders as well, about what social media is doing to young people. We've seen this inexorable increase in levels of mental distress among young people, not just here in Australia, but around the world for the last 20 years. And the only thing, really, that can explain it is the explosion of social media and what it's doing to their lives and their sense of place in their community. So I really welcome this. We obviously need to work through the process of deciding where the age should be and how we actually implement something like that. You know, Patricia, I certainly do as a parent, that young people are very good at getting around some of these restrictions, so we’ve got to be careful -
KARVELAS: That's why I wonder if it's achievable because I live in like the real world, and I have teenagers and I just think it's, you know, great for adults to walk around and people in power saying “16 sounds about right, let's do that”. Is it actually achievable or are we just building expectations that can't be achieved?
BUTLER: And that's the point the Prime Minister has made, and others have made, is we’ve got to step through this in a way that makes sure that whatever we decide can actually make a difference to the lives of young people. But I can't say enough how much I welcome this debate. I've been watching this space, youth mental health, for a couple of decades now, and it just gets worse and worse and worse. And the role that social media plays in their lives is a big driver of that.
KARVELAS: Why did it take us so long to have this debate? It's not like it just happened. This has been getting worse and social media has been with us for a long time?
BUTLER: That's right. I think, you know, sometimes these things feel like a bit of a boiling frog situation, where, you know, parents have been struggling with this in their own households and where the community have been struggling with something that's just sort of grown and grown, in front of our face. But sometimes with these things, they get to a point where the community just says “enough - we're sick of watching our young people in such levels of distress and young people considering taking their own lives, taking their own lives, such higher rates of a whole range of disorders, as well”. So I really welcome the point we've got to. Now, whether we should have got to it 12 months ago or five years ago is, you know, an interesting academic debate. But we're here now. So let's work out how we can make the lives of our young people better
KARVELAS: Yeah, absolutely. Mark Butler, many thanks for joining us.
BUTLER: Thanks, PK.

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