House debates

Wednesday, 17 June 2020


Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020; Second Reading

10:21 am

Photo of Julian HillJulian Hill (Bruce, Australian Labor Party) Share this | | Hansard source

I want to make some remarks—this is a non-controversial bill; I'll say that at the outset, as you can tell by the fact that I don't think anyone else is speaking on it—but I want to firstly make some remarks about schedule 5, which piqued my interest. It gives medical practitioners greater flexibility to prescribe unapproved therapeutic goods. In response to that, I asked some questions. The minister's office—and I thank them for this—set up a discussion with Professor Skerritt, the head of the TGA, which was very informative.

What I discovered—which is not apparent from the bill, because it's incredibly arcane, technical, pharmaceutical regulatory architecture—is that in essence this is a very sensible schedule but it introduces a form of off-label prescribing. That is when a drug has not been approved by the TGA for a purpose for which it's prescribed by a medical practitioner, with very clear requirements for informed consent. I want to spend a little bit of time talking about this. In essence, just to explain the schedule, there's a group of medications, I think they're called special access C medications. They're often either: old drugs that have been taken off by the sponsor because they don't want to pay the annual fee, because there's only a few of them prescribed each year and it's not commercial; or they're drugs which, for whatever reason—usually because they have very small markets and are very rarely used—might have been approved in larger markets such as the United States or the EU, but have never actually been approved for use in Australia. But they have, importantly, been approved somewhere else in the world in a comparable country with similar oversight to the TGA.

What this bill does is, effectively, tidy up the arrangements whereby medical practitioners can get access to these drugs. Currently, a doctor can just prescribe them, but the authorised prescriber scheme doesn't allow for it. What the bill does is allow an authorised prescriber for a certain patient group. They still have to go through ethics committee approvals in their respective specialist colleges and apply to the college. They can go to the TGA and then get an authority, effectively, to prescribe these rarely-used drugs for a particular patient group. But, importantly, the requirement then is that the patient—or, in the case of children, their parents—has to provide written informed consent, which stays on the file of the medical practitioner. I think it lasts for about three years, or something of that order. That all seems quite sensible. It cuts red tape, effectively, for the prescriber, who currently has to fill in a special access form for each individual patient. So that all makes sense.

However, what it raises for me is a really important example of the government actually acting on the requirement for informed consent for off-label prescribing. So I use this opportunity to renew my call to the House for an inquiry into off-label prescribing. Off-label prescribing is, in essence, when you go to the doctor and the doctor gives you a script for a drug for a condition. You might have something wrong with you, whatever it may be, and they're recommending a drug for you for a purpose other than that which the TGA has approved it for. It happens every day, and it's enormously beneficial to many patients. There's no fundamental concern about clinical discretion. But it's also clear that there is a higher risk—I confirmed this with the head of the TGA and I've seen scientific studies—in aggregate where there's no rigorous scientific proof that's been undertaken for the drug to treat a particular condition. The medical negligence lawyers know this and they've been warning medical practitioners for years that they run a high risk of medical negligence in the case of off-label prescribing. There was a study of adverse drug reactions on off-label uses without strong scientific evidence of benefit with over 45,000 patients which found high rates of harm with off-label use compared to on-label use. In one sense it's a small difference—around 20 people per 10,000 versus 13 per 10,000—but when you scale up that to a population level it's very material. Indeed, the TGA's own warnings in Australia say very clearly that they recognise off-label prescribing may be appropriate in some circumstances but recommends that such use only be considered where 'other options are unavailable, exhausted, not tolerated or unsuitable'. The TGA has written to me a number of times confirming that off-label prescribing is not endorsed by the TGA, yet anyone and everyone knows that it's widespread.

My point is not to restrict clinical discretion, despite what some of the response to this in the media has been. I'm not hunting the doctors. My dad was a doctor. I think it's great we don't have lawyers sitting in doctors' surgeries like we do in America and that we've got a pretty high bar. Doctors don't set out to harm people. I get that. But I do believe we should look at a requirement for informed consent in Australia. In essence, with an off-label prescription, a patient in Australia is being subjected to an experiment by their doctor. There have never been any scientific rigorous tests. Drug companies have not run the gauntlet of the TGA to get a drug approved for a particular purpose. The doctor is conducting an experiment on them. It may be an experiment they've conducted many times or that doctors across the country have conducted many times, but it is still not approved, and I believe that Australian patients have a right to be told when that experiment is being conducted on them. That's all. There should be a positive duty on a clinician to tell a patient, 'The script I'm giving you now is for a purpose other than which the drug's been approved in Australia.' I've spent a lot of time with medical practitioners, with the Pharmaceutical Guild, with the PSA, with Medicines Australia and with others, and I think in many quarters there's quiet support for this proposition to at least be tested through a proper inquiry into off-label prescribing. That would promote better quality conversations between medical practitioners and patients. It would allow the patient to decide whether they want to accept that risk and, particularly, to look at the side effects.

I got into this issue in a personal way. My daughter almost died three years ago from a near-fatal blood clot from her ankle to her hip from an off-label drug. I've spoken previously about this and I won't repeat it at length. It was a drug called Diane-35. She'd been prescribed it—and she's asked me to talk publicly about this; I'm not disclosing her medical history—to regulate irregular periods. It's a very common issue for young women. She was prescribed this drug which is only approved for excessive acne and to treat excessive body hair in the case of androgyny, but its side effect is as a contraceptive. It would never be approved as a contraceptive in Australia because it's got a higher risk of blood clots than other more modern contraceptives, but it's widely prescribed by doctors. Anyway, I've spoken elsewhere about that.

More recently, there's the case of antidepressants and youth suicide. There was a study released Monday last week, which I spoke on in the Federation Chamber and which was reported on in the media last week. In essence, it points out that not one antidepressant is approved in Australia to treat depression in children—kids under 18 in effect—yet nearly two per cent of Australian kids are now taking an antidepressant. Correlation is not causation, but in the case of that massive epidemic of off-label prescribing we see over 100,000 Australian kids taking antidepressants, none of which have been approved, and over the last 10 years we've seen the suicide rate per capita in young Australians rise by 49 per cent correlated with a rise in antidepressant prescribing of 66 per cent. The US FDA in 2004 and 2007 looked at the risk of suicidality and suicide ideation and behaviours in antidepressants, and they issued their highest form of warning, black box warnings, in 2004 and 2007 for antidepressants prescribed for young people. In Australia, the TGA decided to not take that action, and they took much softer action in 2005. I think this is a problem. I think after 10 years of data heading in the wrong direction, it's time that we actually had a proper inquiry into this.

For the first time, actually, in the decade or so, this issue has been raised by some—and it's quite controversial; it's disputed within the mental health community of Australia. The paper was co-authored by the professor of psychiatry from the University of South Australia. These are not fringe dwellers or nutters. They have a fundamentally different view of this issue to the doyens, the mental health establishment professors McGorry and Hickey, and Beyond Blue, headspace and Suicide Prevention Australia—all the people who've been recommending this epidemic of prescribing. And that's fine; the scientists should contest it. I'm not an expert. But the point is that, with 10 years of data heading in the wrong direction, the suicide rate going up and the prescribing rate going up, to the point where Australia now has the second-highest rate of antidepressant use across the whole population of any country in the world—second only to Iceland—it's time that we had a proper look at this.

In that regard, I'm really pleased with the health minister's response to the speech that I made last week and to the paper. The health minister indicated to The Sydney Morning Herald that he'd asked his department to review the results of the study and have an inquiry into this matter, though the extent of that inquiry is as yet unclear. The study raised issues not just in regard to the dispute about prescribing; it also raised significant issues in regard to the quality of prior research that had influenced the TGA's response to the issues raised in the FDA warnings and challenged the veracity of the advice of the prominent Australian suicide prevention experts and mental health organisations.

So I welcome the health minister's inquiry, but I would also welcome his advice, whether to the House or shortly, as to what the terms of reference for this review are, what the time frame of the review is, what age demographic is to be analysed, and whether antidepressant use and suicide data is to be analysed. Since I made the speech and since the media reporting last week, I've been contacted by many people across Australia from all age groups reporting concerns around this issue. Will the review consider the quality of research that informed the prior TGA responses to the FDA warnings? Will the review consider the veracity of the advice of prominent Australian suicide prevention experts and prominent mental health organisations? Who will be conducting the review? Will there be an opportunity for public submissions to the review? How, if at all, will the authors of the study be consulted in the review? They stand ready to assist, contribute their views and explain their paper. I note that it was a peer reviewed paper in a proper psychiatric journal. What's the reporting deadline for the review, and will the review report be made publicly available? I'd welcome the minister's advice on that.

I've previously outlined other examples of off-label prescribing which are of concern. Shamefully for this nation, one example of off-label prescribing is the use of sedatives in aged-care settings. I understand the difficulties around informed consent with dementia patients and emergency settings and all that kind of stuff, and of course you can provide for sensible exemptions, but there have been calls for some time for this kind of examination of off-label prescribing and of whether we can do a better job of regulating it. Given that the minister announced in, I think, November last year that medicines would be the ninth or 10th national health priority, this broader issue of off-label prescribing is an important issue that could easily be looked at through an expert inquiry.

In closing, I make the point that I welcome the minister's commitment to review the issues raised about suicide in young people and the link, or possible link, with antidepressants. But I do think there's a broader issue around the regulation and oversight of off-label prescribing in Australia. Ultimately, I don't think the TGA is responsible for this. It goes to an issue of clinical practice, and current clinical practice. Before I spoke about this in the previous parliament, I actually consulted with former member Dr Kerryn Phelps, who was in cautious agreement with some of the propositions I was putting forward but did agree that they should be tested through an inquiry and that there was enough of an issue to merit a proper examination.

Current clinical practice in Australia encourages doctors to discuss medication risks, but, as I said, there is no duty to tell patients when they're being given an off-label prescription. I think this is wrong. I think Australians should have the right to be told. That's what I would want to be told if I went in to see a doctor. What I think most people would like to be told is that the drug they're being offered or asked to take is not approved by the TGA for the purpose for which it's being prescribed. In that regard, one approach would be to have AHPRA, the Australian Health Practitioner Regulation Agency, look at the basic medical law and strengthen the requirement on clinicians to provide that informed consent. Other countries do this. It's important to note that several European countries, including France, Spain, the Netherlands and Sweden, require doctors to advise patients when they're being given off-label drugs so that they get that informed consent and, I would hope, have those better-quality conversations. I don't see any reason why we couldn't adopt a similar model here in Australia. As I said, you've got to carve out sensible things for emergencies, although there are particular issues with paediatrics because of the difficulties in getting ethical approval to conduct clinical trials on children. But, for example, in the case of the antidepressants, you've got 10 years of real-world data. If you're collecting the right data, after some years you can do a retrospective analysis which goes close to approximating a clinical trial. I spoke to Medicines Australia about that, and they agreed that, if the right data was there, that real-world data can be looked at.

My colleague the member for Dobell is a pharmacist, and pharmacists have a critical role also in that chain of events before a person actually takes a medication. They're often the last check in that chain, and so, as part of a proper look at off-label prescribing, I would suggest that we consider a requirement to notify pharmacists when a prescription is off-label, at least for the first time, so that at the pharmacist's counter they can have that extra minute or so talking about the side effects. I know that if my daughter had had the opportunity to be warned about the higher risks—she's like Saffy from AbFab: she's very sensible; far more sensible, they say, than her parents—I think she would have made a different decision about whether to put that drug in her body before getting on a long-haul flight, and she'd be in a very different situation now.

10:36 am

Photo of Lucy WicksLucy Wicks (Robertson, Liberal Party) Share this | | Hansard source

I rise to speak in support of the Morrison government's amendments to the Therapeutic Goods Act 1989 contained in this bill, the Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020. The coalition government has a proud record of prioritising the health and wellbeing of all Australians, which has been particularly evident in our response to the COVID-19 pandemic. The government has also listed over 2,400 new medicines, worth around $11.6 billion, on the Pharmaceutical Benefits Scheme. This has only been possible because of the coalition's prioritisation of the health of Australians and our responsible economic management since 2013. The fact that 30 new or amended medicines are listed each month is indicative of the coalition's focus and commitment to improving the health of all Australians, including people in my electorate of Robertson. This bill strengthens Australia's ability to list medicines on the PBS.

(Quorum formed) It strengthens Australia's ability to list medicines on the PBS, reducing delays for Australians who are trying to access new medicines and navigate regulatory hurdles.

One of the key features of this bill is the harmonisation of the key medical device definitions in Australia with those recently adopted by the European Union. These changes will assist in minimising the delay for Australian consumers in accessing new medical devices as our standards will now be in line with the EU. This means Australians can access world-class and affordable health care sooner. In April 2017 the EU introduced significant reforms for medical devices and in-vitro medical devices. These reforms better address technological and scientific advances in the medical industry over the past 20 years. In considering these new regulations, the Department of Health's expert panel for the review of medicines and medical devices regulations recommended that the regulation of medical devices in Australia should align whenever possible with the EU framework. This bill will support the expert panel's recommendation by updating key medical device definitions, which will clarify regulatory requirements for industry sponsors and manufacturers.

Another significant change this bill will make is to allow the secretary of the Department of Health to provide early, non-binding specific advice to sponsors of medicines about the safety, quality or efficacy of their products. These registerable medicines are typically classified as higher-risk medicines, which are mostly dispensed by prescription and over the counter. As there may not be enough guidance available on these complex medical products, this bill provides a mechanism for sponsors to seek early scientific advice about certain aspects of a medicine before they formally apply to register the medical product on the PBS. This will mean that the time taken to register higher-risk medical products on the PBS, some of which will assist Australians with complex medical needs, will be reduced. It will also provide greater certainty and clarity for sponsors looking to list a promising new medicine.

The bill will also introduce a targeted data-protection regime for access listed medicines, to encourage innovation in Australia's complementary-medicines industry. This provision supports another recommendation of the Department of Health's expert panel. This recommendation suggested that incentives be introduced for medicine sponsors to invest in innovation, which will in turn increase the competitiveness of complementary medicines in Australia.

In my electorate of Robertson I've witnessed firsthand how the Morrison government's strong economic management has benefited those suffering from medical conditions, with them able to access new medicines listed on the PBS. I've also seen why it's important for us to make it easier for Australians to access the medicines they desperately need and to reduce the barriers for sponsors of medicines by applying for their registration on the PBS.

In August last year I was pleased to welcome the Minister for Health, the Hon. Greg Hunt, to the Central Coast to announce the delivery of a third linear accelerator at the Central Coast Cancer Centre. During the minister's visit there we met with a patient receiving treatment for brain cancer. He told us how the Morrison government's listing of Avastin on the PBS dramatically reduced his treatment costs. This is a medication that blocks a cancer cell protein which allows cancers to grow in blood vessels. It starves the protein. Over 900 Australians living with this aggressive form of brain cancer now benefit from Avastin being listed on the PBS. Without the subsidy, it would cost up to $31,200 per course of treatment. Instead, cancer patients like the one that the minister and I met at the Central Coast Cancer Centre now receive prescriptions at the cost per script of only $6.60 for concession card holders and $41 for general patients.

The coalition government's strong record on the economy to date has ensured the continued investment in lifesaving medicines on the PBS. This stands in stark contrast to the last time that Labor was in office, when they deferred listings of new medicines on the PBS. This bill will make it easier for medicines to be listed on the PBS and to ensure Australians receive access to new medical devices sooner. In concluding, I would like to thank the Minister for Health, who I notice is in the chamber, for his ongoing support for the people in my electorate of Robertson who are suffering from severe health conditions. I particularly commend him for his leadership in strengthening Australia's healthcare sector, especially during the current global pandemic.

In closing, this bill makes important amendments to the Therapeutic Goods Act 1989 to support the delivery of the highest quality health care for Australians. This bill will assist in decreasing the waiting times for Australians to receive new medical devices as well as reduce the regulatory barriers for medicine sponsors in listing promising new products on the Pharmaceutical Benefits Scheme. I commend this bill to the House.

10:45 am

Photo of Greg HuntGreg Hunt (Flinders, Liberal Party, Minister for Health) Share this | | Hansard source

I want to thank all of those who have spoken on the Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020. The member for Bruce made important points about antidepressants, and I have referred that matter to the TGA, and I also look forward to receiving the response. It's about making sure that people have access to medicines that can help protect them and help them through what can be the most difficult of times in a way that is safe and not merely a default which avoids the necessary therapy, cognitive behavioural support and mental health support necessary to deal with so many cases. It's about getting the appropriate treatment for the appropriate condition.

I also want to thank the member for Robertson. She, in particular, has been a great advocate for the Pharmaceutical Benefits Scheme. As she noted, over 2,400 medicines—approximately one per day—have been listed on the PBS during our time in government. They're medicines such as Avastin and Tecentriq. They're medicines for spinal muscular atrophy. They're life-saving medicines for conditions. These have been immensely important. She mentioned Avastin, which would have cost up to $31,000 per treatment over the course of time. It's now available for $6.60. We will continue to list all of the medicines that the PBAC approves.

One of the things which I do want to highlight to the House is that from time to time there will be companies that seek to astroturf. Astroturfing is where a company refuses to abide by the legal requirements and conditions set out by the PBAC. They will attempt to support a patient group with funds to try to pressure the government to bypass the legal requirements. The government cannot bypass the legal requirements. One such case that I do want to call out is the improper practice of Eli Lilly. Their practice has been improper and inappropriate. They are denying patients access to Emgality, a medicine for migraines. This is Migraine Awareness Week. Their behaviour is improper and inappropriate, and they're seeking to avoid the legal requirements. Today I am calling on that company to stop denying patients access to this medicine and to meet the legal requirements, which are mandatory. They are mandatory because of safety. They are mandatory because of efficacy. On this day, this company must abide by the legal requirements and should stop their practice of denying their patients access to a medicine which has been approved by the PBAC but for which they refuse to meet the legal requirements. It is, in my view, unethical and inappropriate and we are calling it out.

Against that background, this is landmark legislation. This bill amends the Therapeutic Goods Act to implement a range of fundamental measures to support the health and wellbeing of Australians. In particular, the bill introduces measures to improve access to therapeutic goods for Australians, encourage innovations, reduce regulatory burden and enhance patient safety by removing barriers to efforts to alleviate medicine shortages.

In relation to improving access to therapeutic goods, the bill amends a number of medical device definitions to more closely align Australia's regulatory framework for devices with the European Union framework. As most devices supplied in Australia are manufactured overseas, reducing differences between the two frameworks is designed to minimise delays in device sponsors and manufacturers seeking marketing approval in Australia after European approval.

The bill enables the secretary to provide early scientific advice to sponsors of registrable medicines, mainly prescriptions and over-the-counter medicines, about prescribed aspects of the medicines' safety, quality or efficacy—exactly the things which I referenced in relation to the work of the PBAC in approving medicines for the PBS—to assist sponsors to understand the level of information needed to support a successful application for marketing approval. This measure will reduce delays in access to new medicines that stem from industry uncertainty about aspects of supporting information for such products, particularly for generic medicines in relation to bioequivalence studies. The advice will guide sponsors and help them reduce the incidence of rejections and the time and cost of developing evidence that is not needed.

The bill also removes a barrier for promising new medicines to access the new provisional registration pathway, which was introduced in 2018 to provide access to medicines that provide a major therapeutic advance over existing treatment options for very serious conditions. Other measures in the bill address issues of delay and interruption for operators of clinical trials who need to make variations to the terms of their approvals and improve flexibility for authorised prescribers seeking to supply unapproved goods to their patients, and the measures encourage investment through the introduction of a targeted data protection regime for the clinical trial data for assessed listed medicines.

It is my view that, in addition to the legislative amendments, we have a unique opportunity in Australia. Australians have done it hard through the course of the COVID-19 pandemic, but they have been magnificent. As a result of those successes in helping to flatten the curve, not only have we saved lives and protected lives in Australia but we have still further enhanced the standing of Australia's medical system, health system and medical research system. As a consequence, there is a unique opportunity for Australia to further advance our clinical trial capacity. The world wishes to practise clinical trials in Australia whenever possible. So we are seeking to work with the states on a one-stop-shop for clinical trial approvals. If we can expedite that pathway, we can give more Australians earlier access to breakthrough new therapeutic medicines, build jobs in Australia and build the medical sector still further.

The bill also enhances patient safety by removing a criminal offence that has been the subject of concern that it may be a disincentive to sponsor some potential alternative products to a medicine that is in shortage by identifying if they are able to arrange for the supply of their products to help alleviate the effects of the shortage. It is part of the general process of making drugs, devices, medicines, therapeutic procedures and implantables available to more Australians at an earlier time. It wouldn't have happened without the work of the TGA, the department, the Medical Technology Association of Australia, Medicines Australia and my office. I particularly want to thank my medicines adviser, Sam Develin; my budget adviser, Belinda McEniery; and my legislative adviser, Chantal D'argaville. Altogether, they've played a very important role. I thank the members for their contribution to the debate on this bill, and I commend the bill to the House.

Photo of Tony SmithTony Smith (Speaker) Share this | | Hansard source

The original question was that this bill be now read a second time. To this the honourable member for Dobell has moved as an amendment that all words after 'That' be omitted with a view to substituting other words. The immediate question is that the words proposed to be omitted stand part of the question.