Katy Gallagher (ACT, Australian Labor Party, Minister for the Public Service) Share this | Link to this | Hansard source

by leave—I move government amendments (1) to (3) on sheet UD159 together:

(1) Schedule 10, item 1, page 29 (lines 6 to 8), omit subsection 61(13), substitute:

(13) The Secretary is not required to observe any requirements of the natural justice hearing rule in relation to:

(a) releasing information under subsection (5C) if:

(i) the release of the information is in the interests of public health or safety; or

(ii) the information relates to the safety of one or more therapeutic goods; or

(b) releasing information under any other provision of this section.

(2) Schedule 10, item 1, page 29 (line 11), after "this Act", insert "(including this section)".

(3) Schedule 10, item 1, page 29 (after line 11), after subsection 61(14), insert:

(15) For the purposes of subparagraph (13)(a)(i), the release of information is not in the interests of public health or safety if the information:

(a) relates to the quality or efficacy of therapeutic goods; and

(b) does not relate to the safety of the therapeutic goods.

I table a supplementary explanatory memorandum relating to the government amendments moved to this bill.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

I want to indicate that the opposition will be supporting these amendments by the government, and I want to thank the government for working with us to resolve the concerns that had been expressed by many around the natural justice implications of the original bill with regard to the powers of the secretary to publish information outside of information that has public health and safety implications. I'd like to acknowledge the constructive way that we worked with the government to make sure that we dealt with the concerns, which were significant concerns raised by the sector.

Katy Gallagher (ACT, Australian Labor Party, Minister for the Public Service) Share this | Link to this | Hansard source

I acknowledge Senator Ruston's contribution, but if I could just speak quickly to the government amendments that are before the chamber. The bill included a measure to clarify that the natural justice hearing rules are not required to be observed in relation to the release of therapeutic goods information. An obligation to observe the natural justice hearing rule prior to releasing information could directly prevent or delay the release of health and safety information to the public or relevant stakeholders—for example, state and territory health departments—which could risk the health and safety of patients, frontline healthcare workers and the public. The government amendments mean this measure will limit the exclusion of the natural justice hearing rule in relation to the release of information to the public, under section 61(5C) of the act, to release of information that is in the interests of public health or safety, or where the information relates to the safety of one or more therapeutic good.

These amendments balance the provision of natural justice in relation to the release of information with the need to ensure the timely release of health and safety information to the public. If the amendments to this measure were to go further and only exclude the natural justice hearing rule in relation to the release of critical or urgent safety information, this would present a risk to the safety of Australian patients, health professionals and the public. The release of this information is necessary to prevent harm and even potentially death and would not be able to be released if it did not meet this threshold or if its release was delayed through courts. In some instances, TGA safety information would need to be combined with information from other sources—for example, state and territory health departments—in order to recognise that the information concerns health or safety issues.

Overall, the release of therapeutic goods information under the act is a critical element of Australia's regulatory framework for therapeutic goods as it underpins community and healthcare industry awareness of the safe use of therapeutic goods compliance and enforcement activities and cooperation with international regulators to bring new treatments to Australia as quickly as possible.

Deborah O'Neill (NSW, Australian Labor Party) Share this | Link to this | Hansard source

The question is that government amendments moved by Senator Gallagher be agreed to.

Question agreed to.

Jordon Steele-John (WA, Australian Greens) Share this | Link to this | Hansard source

by leave—I move amendments (1) to (11) on sheet 1806 revised 2 together:

(1) Clause 2, page 2 (table item 1), omit "3", substitute "4".

(2) Clause 2, page 2 (table item 2), omit the table item, substitute:

(3) Page 2 (after line 11), after clause 3, insert:

4 Reform of ICT systems for reporting of medical device incidents

(1) The Therapeutic Goods Administration must conduct a reform of the ICT system used by medical practitioners for the purposes of mandatory reporting of medical device incidents to the Therapeutic Goods Administration (known as the "medical device incident reporting and investigation scheme (IRIS)").

(2) The reform must be conducted in consultation with medical practitioners.

(3) The reform must be completed by 1 July 2024.

(4) The Therapeutic Goods Administration must, as soon as practicable after the reform is completed, prepare a report outlining the outcome of the ICT system reform and give a copy of the report to the Minister.

(5) The Minister must cause a copy of the report to be tabled in both Houses of the Parliament within 15 sitting days of that House after the report is given to the Minister.

(6) In this section:

healthcare facility has the same meaning as in the Therapeutic Goods Act 1989.

medical practitioner means a person who is registered, in a State or internal Territory, as a medical practitioner.

(4) Schedule 1, item 3, page 3 (line 26), after "facilities", insert "and medical practitioners".

(5) Schedule 1, item 4, page 4 (line 2), at the end of the heading to Part 4-8A, add "and medical practitioners".

(6) Schedule 1, item 4, page 4 (lines 5 and 6), omit "of a healthcare facility is", substitute "of a healthcare facility and a medical practitioner that provides treatment, other than at a healthcare facility, are".

(7) Schedule 1, item 4, page 4 (line 10), after "facility" insert ", or a medical practitioner,".

(8) Schedule 1, item 4, page 4 (lines 18 and 19), omit the heading to section 41JM, substitute:

41JM Requirement to report adverse events involving reportable medical devices — healthcare facility

(9) Schedule 1, item 5, page 6 (after line 17), after section 41JM, insert:

41JN Requirement to report adverse events involving reportable medical devices — medical practitioner

Report to be given to the Secretary

(1) A medical practitioner must give a report to the Secretary if subsection (2), (3) or (4) applies to the medical practitioner in relation to a reportable medical device and a person.

(2) This subsection applies to a medical practitioner if:

(a) a reportable medical device is used by the medical practitioner to treat a person, other than in a healthcare facility; and

(b) the use of the device has resulted in the death, or a serious deterioration in the health, of the person while the device is used.

(3) This subsection applies to a medical practitioner if:

(a) a reportable medical device is not used by the medical practitioner to treat a person, other than in a healthcare facility, because of the intervention of the medical practitioner or another person; and

(b) the use of the device, if the device were used, would result in, or would be likely to result in, the death, or a serious deterioration in the health, of the person.

(4) This subsection applies to a medical practitioner if:

(a) the medical practitioner provides treatment to a person, other than in a healthcare facility, for a serious deterioration in the health of the person; and

(b) the use of a reportable medical device has resulted in the serious deterioration in the health of the person.

Report requirements

(5) The report must include the following information about the reportable medical device and the person:

(a) the name, or a description, of the reportable medical device;

(b) a description of the matters covered in subsection (2), (3) or (4);

(c) any other information prescribed by regulations made for the purposes of this paragraph.

Note: For the release of information included in, or relating to, a report, see section 61.

(6) The report must be given to the Secretary:

(a) within the period prescribed by regulations made for the purposes of this subparagraph or such longer period as the Secretary allows in a particular case; and

(b) in the manner prescribed by regulations made for the purposes of this subparagraph.

Exceptions

(7) Subsection (1) does not apply if the medical practitioner has reported the matters covered by subsection (2), (3) or (4) to:

(a) the chief executive officer of the Australian Commission on Safety and Quality in Health Care; or

(b) the head (however described) of a Department of State of a State or Territory that has responsibility for matters relating to health; or

(c) any other person prescribed by regulations made for the purposes of this paragraph.

(8) Subsection (1) does not apply to a general practitioner if the general practitioner has referred a person to another medical practitioner for treatment in relation to the matters covered in subsection (2), (3) or (4).

Civil penalty

(9) A person contravenes this subsection if:

(a) the person is required to give a report to the Secretary in accordance with this section; and

(b) the person fails to comply with the requirement.

Maximum civil penalty: 30 penalty units.

(10) In this section:

general practitioner means a medical practitioner registered in the specialty of general practice.

medical practitioner means a person who is registered, in a State or internal Territory, as a medical practitioner.

(10) Schedule 1, item 5, page 6 (line 19), before "Section", insert "(1)".

(11) Schedule 1, item 5, page 6 (after line 28), at the end of the item, add:

(2) Section 41JN of the Therapeutic Goods Act 1989, as inserted by this Schedule, applies in relation to:

(a) a reportable medical device that is used, on or after 1 July 2024, by a medical practitioner; or

(b) a reportable medical device that is not used by a medical practitioner because of the of the intervention, on or after 1 July 2024, of the medical practitioner or another person; or

(c) treatment provided, on or after 1 July 2024, by a medical practitioner to a person for a serious deterioration in the health of the person.

In moving these amendments today I want to dedicate them to the 150,000 Australian women who received surgically implanted transvaginal mesh. Most commonly, these procedures were undertaken, these devices were sought, in relation to the treatment of pelvic prolapse, stress related urinary incontinence or, additionally, complications resulting from childbirth. These were things that people sought to access, devices that they sought to have implanted in order to treat conditions that were causing them great distress and having a profound impact on their lives. These devices were promoted to women as being safe, and they were not safe.

When women spoke up about the reality of what these devices were doing to them—the pain, the blood, the inability to engage in intimate relations with their partners—they were dismissed; they were ignored year after year. And women continued to suffer. This medical scandal resulted in the largest women's based health class action in Australian history—and rightly so, given that this was one of the most profound failures in medical regulation and one of the most dangerous products ever allowed into human bodies since thalidomide. Australian women led the world in holding manufacturers and regulators to account. Australian women, although they had experienced the most horrendous mistreatment at the hands of the manufacturers, at the hands of medical practitioners and at the hands of dismissive regulators, came forward to their parliament in 2018 and trusted their parliament, gave evidence to their parliament, went to their MPs and said, 'I am willing to talk, on the public record, about some of the most personal, some of the most intimate impacts of medical device failure—in the public and in the media—and I do this so that this may never happen again to anybody else.' That's what they did.

Four years ago the Senate inquiry handed down its recommendations as a result of that evidence. Finally, a government has coughed up a response to some of those recommendations. Yet what we see here today is the half-baked misimplementation of the very first recommendation of that inquiry. The very first recommendation of that inquiry was to create a mandatory reporting system that covered healthcare practitioners so that, if in the future such a device is in circulation, causing pain and harm, the regulator will have the data to alert the community, yet what the government has put forward is a mandatory reporting framework solely for hospitals, for healthcare facilities, missing the vital role of general practitioners in reporting. The reality is that when a device such as these malfunctions—and it relates particularly to gynaecological issues—people are not going to go straight to their ED; they're going to want to talk with somebody they have a relationship with. Because this is clouded in shame, in a context where women's pain is so often dismissed, people are going to want to talk to a person they have a built trust with, and that is often their GP.

The Greens recognise the absolute urgency of listening to women's voices and listening to the experts who gave evidence to the inquiry, putting forward a comprehensive mandatory reporting regime, and that is exactly what this amendment does, in line with the recommendations of the Senate inquiry. We recognise that there is a need to allow for a transition period and so we have crafted an amendment that enables hospitals to mandatorily report from the date of royal assent and, in a year's time, after the completion of the TGA's review of its systems and process, requires GPs to mandatorily report—after the system has been reviewed in consultation with GPs. We have made those allowances in this amendment. We also recognise that, in the rural and regional context, there may be times when the injuries that people are presenting with from the devices they've had implanted sit outside the GP's scope of practice, and so we have made an allowance that in such circumstances the GP is not required to mandatorily report if they refer the patient to a specialist.

These are reasonable exemptions and reasonable provisions that should enable a reasonable government that prides itself on centring women's voices to support this amendment to ensure that such medical harms are never again done to women. I urge the chamber to support these changes. In the absence of mandatory reporting, we are left with a voluntary reporting framework, which the inquiry heard over and over again was inadequate. It too often places the onus on the patient that has been harmed to follow up with the regulator or to follow up with the practitioner to ensure that the report has been made. This is not acceptable.

Finally, in closing, I urge the chamber—and I make these comments as a cis man sitting in this place—to acknowledge the role that misogyny and sexism have played in the fact that we are four years down the line and still have not implemented these recommendations. I say this with no desire to create mock shock or outrage. If this had been a medical device that had affected men in the same way, if it had affected men's ability to engage in intimacy with their partners, if it had caused such a profound pain to men, this would have been dealt with immediately. It would have been numero uno on the health minister's agenda. Yet, because it related to women's pain, it has for too long been put in the hard basket, and then today we see a bill that doesn't do the job. Please, I urge the government: join with the Greens in accepting this very reasonable amendment.

Katy Gallagher (ACT, Australian Labor Party, Minister for the Public Service) Share this | Link to this | Hansard source

The government won't be supporting the amendment moved by the Greens, and I will take a few moments to say why. Recommendation 1, which Senator Steele-John referred to, noted the vital role of adverse reporting in post-market surveillance. The committee recommends that the Australian government, in consultation with states and territories and the Medical Board of Australia, review the current system of reporting adverse events to the TGA to implement mandatory reporting of adverse events by medical practitioners; provide guidance on what constitutes an adverse event for use by consumers, medical professionals and device sponsors; improve awareness of the reporting system; and examine options to simplify the reporting process. That recommendation has been implemented in the sense that the consultations referred to in the recommendation have been undertaken.

The former government accepted that recommendation in principle but did note through that recommendation there may be a number of policy and implementation constraints and the potential for administrative burden on healthcare professionals. I think, at the time, the response was, 'The government is aware of the heavy burden of care in reporting carried by some in the healthcare sector and is mindful to balance any proposed measures appropriately.'

I should also say throughout this process it was pointed out the TGA has no legal regulatory authority to mandate the reporting of medical practitioners. The chief medical officer wrote to the AMA, the Medical Board of Australia, the Australian Health Practitioner Regulation Agency and the Australian Commission on Safety and Quality in Health Care and respective professional colleges and societies to encourage reporting of adverse events to the TGA. And many healthcare professional bodies have adopted the Australian consensus framework for ethical collaboration, including the AMA, the RACS and the RACGP, which requires their members to demonstrate ethical behaviour, including reporting obligations.

In terms of the next step, the former and current governments, so our government and the previous government, have supported the TGA to work closely with healthcare facilities and state and territory health departments to implement rapid sharing about medical device safety and effectiveness.

An action plan for medical devices released in 2019 and public consultation papers in 2020 and 2021, seeking feedback on mandatory reporting, focused on reporting by healthcare facilities. The TGA also reviewed its adverse event reporting forms and improved its internal systems.

I think it is important that some of the relevant information is around the TGA's role. It does not regulate individual medical practitioners or healthcare professionals themselves. Therefore, compliance of mandatory reporting of individuals would be difficult and potentially outside the legal powers of the TGA. The approach of healthcare facilities reporting aligns with their existing role, that they have to report to health state departments, and the role of the Australian Commission on Safety and Quality in Health Care in being a standards and accreditation body for facilities rather than individual doctors.

I have a couple of other points. Medical devices will be proposed to be in scope of the mandatory reporting scheme by a facility and are a device that is used in the facility, has resulted in the death or serious deterioration in health and/or has resulted in treatment for a serious deterioration in health, or would have likely resulted in the death or serious deterioration in health. The government would argue that this is the mandatory process that should be put in place via the facilities themselves, which of course would have contacts with those individual medical practitioners who operate within them.

Pauline Hanson (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

With the indulgence of the Senate, I would like clarification on a comment that Senator Steele-John made in relation to his amendment. That is, when he made reference to the fact that, if I have this right, if you have a regional doctor that can't report to the reporting body, then the patient must be referred to a specialist.

That is the case. My concern with that is, if you're in a regional area, if the patient has to be referred to a specialist who will pay for that? People will not be able to travel or go to see a specialist. I have a concern about that.

Jordon Steele-John (WA, Australian Greens) Share this | Link to this | Hansard source

Just briefly, in relation to Senator Hanson's question, the amendment as drafted does not address the question of the patient's funding to travel to the specialist; you're right. The intent of the amendment is particularly around the device that had malfunctioned being inserted or provided to the patient, in some way, by a specialist. The device has malfunctioned and they have presented to their general practitioner. The general practitioner may be of the view that what the patient is experiencing, and its harm to the patient, is beyond their scope of practice. The GP would be freed of their mandatory reporting obligation if they take the step of referring the patient to the specialist that implanted the device. That's an example. I hope that's useful.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

The opposition has sympathy with the intent of the amendment that Senator Steele-John has moved, in this place, and is before us at the moment. Everybody would agree that patient safety must always be at the forefront of our thinking when we deal with issues in relation to the health and welfare of Australians.

We are very mindful of the technical aspects of the implementation of the effects of this particular amendment, many of which have been outlined by the minister. But we also recognise that medical practitioners are under significant pressure due to serious workforce shortages. This is particularly significant for medical practitioners and general practitioners working in rural, regional and remote Australia. We know that's where workforce shortages are hitting the hardest at the moment.

Before we seek to make these sorts of changes, we need to make sure, first and foremost, that reporting processes are as easy as possible. The simplification of reporting systems is something that, when in government, we were very keen to continue as a work in progress, and, as indicated by the minister, the government is intent to continue that process as well.

We would certainly say to the government, and to the Greens and Senator Steele-John, that we are absolutely committed to working to make sure the simplification of reporting systems is absolutely maximised, but before making any changes at all, in this place, they need to be well consulted and well considered. Any changes need to be fit for purpose and able to be implemented, but they also need to be able to deliver the effect that they're intending to deliver in the first place.

The opposition is happy to support an ongoing effort to make sure that the health and safety of all Australians is maximised. There are a number of recommendations that we would like to see continue to be pursued. For example, there is recommendation 22 of the medicines and medical devices review, which called on the establishment of a registry of high-risk implantable devices with a view to facilitating timely identification of emerging safety concerns.

While the opposition is opposing this amendment, for the reasons that I have stated, I want to put on the record that patient safety is absolutely first and foremost; however, we must recognise that we need to make sure that the implementation mechanism and method is appropriate and timely and doesn't have any unintended consequences.

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

Minister, the way I've been advised on this bill is that, No. 1, it strips fundamental legal rights and legal principles that have been fundamental for centuries. No. 2, it is sneaky. It's been introduced very sneakily, and I'll ask you questions about that in a minute. No. 3, I have significant problems with the provisions, and I'll ask you questions about that.

The pelvic mesh disaster is nothing short of a cruel, inhuman disaster. People have been neglected and they need this help. You've had two other bills on pelvic mesh, which we supported, but this one is a baloney sandwich. While it does have some good material on pelvic mesh and alleviating that crippling problem, it has been sneakily bundled in with big changes in a bill that's supposed to support pelvic mesh but really goes to freeing up and giving complete control with limited accountability to bureaucrats.

There's been no committee inquiring into this bill—none at all. The changes are sneaky. They give one bureaucrat unprecedented power to approve medicines that are not tested in Australia and immunity from accountability. I want to read some parts of the report from the Scrutiny of Bills Committee, Scrutiny digest 1 of 2023, because that's where I'd like to go with my first questions. I'll start with the reversal of evidential burden of proof. I'm not a lawyer, but I understand you are, Minister. I quote item 1.176 in the Scrutiny digest:

As the explanatory materials do not address this issue—

that is, reversal of evidential burden of proof—

the committee requests the minister's advice as to why it is proposed to use a defence of reasonable excuse (which reverses the evidential burden of proof) for proposed subsection 45AC(3). The committee's consideration of the appropriateness of a provision which reverses the burden of proof is assisted if it explicitly addresses relevant principles as set out in the Guide to Framing Commonwealth Offences.

What is your response to that, Minister?

Katy Gallagher (ACT, Australian Labor Party, Minister for the Public Service) Share this | Link to this | Hansard source

I thank Senator Roberts for the question. I'd like to make clear, on the record, that I am not a lawyer. There are plenty in this place, but I am not one of them.

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

I withdraw my assertion.

Paul Scarr (Queensland, Liberal Party) Share this | Link to this | Hansard source

Your personal reflection!

Katy Gallagher (ACT, Australian Labor Party, Minister for the Public Service) Share this | Link to this | Hansard source

That's right—your adverse reflection on me! In relation to the reversal of evidential burden of proof, section 45AC would create an offence for failing to comply with a notice from the secretary requiring the production of information for documents, and the proposed new subsection 45AC(3) provides a defence of reasonable excuse for the offence of failing to comply with a notice from the secretary requiring the production of information or documents that are relevant to a contravention or possible contravention of the act or regulations. Therefore, the offence does not apply if a person has a reasonable excuse, but the defendant has to prove this.

The note to the subsection provides that the defendant bears an evidential burden in relation to this matter. A reasonable excuse defence is appropriate because the matters comprising the offence would generally be known only to the defendant. For example, they did not comply because they were in hospital, they were dealing with an emergency or a natural disaster, or something to that effect. It would be significantly more difficult for the prosecution to prove that. The proposed defence only involves an evidential burden for the defendant to point to evidence that suggests a reasonable possibility that the matter comprising the excuse exists, rather than a legal burden of proof.

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

I'd like to go to the next topic: stripping fundamental legal practices and principles. Strict liability: my understanding of that is that it means no trial, no evidence of defence—just strictly liable. Documents are not required under a court order, just a bureaucrat. I read item 1.183 from the Scrutiny digest. I'm not going to take up too much time, because I'm not going to read two pages of this:

The committee draws its scrutiny concer ns to the attention of senators, and leaves to the Senate as a whole the appropriateness of imposing a strict liability offence under proposed subsection 45AD(2), noting that the penalties imposed under that offence are above what is recommended in the Gui de to Framing Commonwealth Offences .

Do you have a response to the scrutiny of bills report?

Katy Gallagher (ACT, Australian Labor Party, Minister for the Public Service) Share this | Link to this | Hansard source

I agree. Strict liability offences should only be used in particular circumstances throughout legislation. They are used in circumstances where there is a public interest ensuring that the regulatory schemes are observed and it can be reasonably expected that the person was aware of their duties and obligations.

The inclusion of the strict liability offences and the maximum of 100 penalty units is justified in the particular context of the regulatory scheme for therapeutic goods, given the potentially significant consequences for public health and safety in the event of noncompliance. For instance, a failure to provide information or documents could delay the investigation of a contravention of the act with patients suffering harm before the contravention is identified, and the provision of false and misleading information could lead TGA to conclude that a therapeutic good is safe for use by patients when it may not be.

It is an exception to the offence if a person has a reasonable excuse, such as being unable to answer for a reason such as being in hospital and unable to reply for not complying. In your second reading address, you raised comments about an automatic fine of $27,000. It's important to note that the penalty of 100 penalty units is a maximum penalty for natural persons and that the amount of any penalty would be for a court to determine in accordance with sentencing principles.

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

Regarding procedural fairness, we have the reversal of evidential burden of proof, strict liability, and now we have procedural fairness. The bureaucrats don't even have to make a case. Let me read 1.190 from the scrutiny of bills report:

In light of this, the committee requests the minister's advice as to:

• why it is considered necessary to provide a broad exclusion to procedural fairnes s within the bill—

A 'broad exclusion', 'sweeping' would be another word—

noting the flexibility that is already applied by the courts when considering the extent to which procedural fairness obligations might apply in a particular circumstance; and

• whether, at a minimum, the amendment can be narrowed to exclude procedural fairness to circumstances where disclosure is required for urgent public safety reasons.

What was the minister's response?

Katy Gallagher (ACT, Australian Labor Party, Minister for the Public Service) Share this | Link to this | Hansard source

On the last bit of that question, the Senate just agreed to a government amendment around that section of the bill, so I think that probably has addressed in the second part of your remarks, Senator Roberts. Under the section 61 amendment, the therapeutic goods information is released by the TGA under the act for health, safety and transparency purposes. This measure supports the timely release of therapeutic goods information by the TGA, which is vital for protecting the health and safety of patients, frontline healthcare workers and the public. The amendment to this measure, which we just passed, appropriately balances the provision of natural justice with the need to ensure the timely release of health and safety information.

The amendment does so by limiting the circumstances in which the natural justice hearing rule is excluded for releases of information to the public under section 61(5C) of the act. A natural justice hearing rule is not excluded for information released under the provision unless there is a safety related issue, and, in some circumstances, the secretary may still observe the requirements of the natural justice hearing rule. The amendment effectively codifies the TGA's current practice as delaying or preventing the release of information would be contrary to the public interest.

Jordon Steele-John (WA, Australian Greens) Share this | Link to 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'.

Katy Gallagher (ACT, Australian Labor Party, Minister for the Public Service) Share this | Link to this | Hansard source

Senator Steele-John, your approach through this is that there is no other regulation around the behaviour, conduct and standards of medical practitioners, which is incorrect. The TGA's role is not to regulate the conduct, capability and standards of medical practitioners.

Well, that's the answer. In relation to the powers of the TGA to issue penalties and things like that, that is in relation to manufacturers, not medical practitioners. So, that is the legal barrier. It's not in the TGA's role. There's the Australian Health Practitioner Regulation Authority, APRA, that does that, in relation to the standards of medical practitioners. I think that's at the heart of your amendment. You obviously disagree with us around a mandatory scheme, as opposed to the TGA being able to have the information available to it through the facilities where women—and others; it's not just women, because it's not just about the mesh devices—present with issues relating to that device, which is likely to be in a health facility. It's not necessarily going to be a GP practice where that device may have been implanted. That is the idea—having the mandatory scheme by the health facilities. And it's not the TGA's role to issue penalties against medical practitioners. It's not the TGA's role, and that is the legal barrier that I referred to earlier in my contribution.

Ralph Babet (Victoria, United Australia Party) Share this | Link to this | Hansard source

by leave—I move amendments (1) and (2) on sheet 1849 together:

(1) Schedule 9, item 5, page 27 (lines 30 and 31), omit the item, substitute:

5 Subsection 19A(11)

Repeal the subsection, substitute:

(11) An approval under subsection (1), (1A), (2), (2A) or (2B) is a legislative instrument.

(2) Schedule 9, page 27 (after line 31), after item 5, insert:

5A At the end of section 19A

Add:

(12) If the Secretary intends to grant an approval under this section, then prior to granting the approval, the Secretary must:

(a) give a notice (a ministerial notice) to the Minister in accordance with the requirements in subsection (13); and

(b) receive the agreement of the Minister.

(13) The ministerial notice must:

(a) be in writing; and

(b) include:

(i) the reasons for granting the approval; and

(ii) the conditions (if any) that are to be specified in the notice of approval; and

(iii) the period to be specified in the notice of approval; and

(c) seek the agreement of the Minister to the approval; and

(d) request that the Minister agree to, or object to, the approval before the end of 14 days beginning on the day the ministerial notice is given to the Minister.

(14) If the Minister does not agree to, or object to, the approval within 14 days, then at the end of that period the Minister is taken to have agreed to the notice of approval.

My intent in proposing these two amendments is as follows. Amendment (1) amends subsection 19A(11) of the TGA Act 1989 to provide that approvals made by the secretary are legislative instruments and will therefore be subject to disallowance under section 42 of the Legislation Act 2003. Quite simply, we're seeking to ensure proper oversight and political accountability for decisions made by the secretary as a result of proposed amendments. I believe that in the bill as it is written right now there appears to be a lack of accountability and too much power placed in one person's hand.

Amendment (2) is designed to serve two functions. It will ensure that there is ministerial oversight and that, before giving notice of approval, the secretary must first give notice to the minister and seek their agreement. We have proposed that the minister be asked to provide their agreement or objection within 14 days or otherwise is considered to have been given.

Progress reported.