Thursday, 9 March 2023
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022; In Committee
Katy Gallagher (ACT, Australian Labor Party, Minister for the Public Service) Share 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.