Jordon Steele-John (WA, Australian Greens) Share 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.