On 1 December 2022 the Therapeutic Goods Amendment (2022 Measures No 1) Bill 2022 was introduced to Commonwealth Parliament. Notably, the Bill introduces a scheme for the mandatory reporting by hospitals and healthcare facilities of adverse events associated with 'reportable' medical devices. The proposed changes follow the recommendations of the 2017 Senate Inquiry in relation to Transvaginal Mesh Implants.
Background
Currently, sponsors of medical devices and device manufacturers have obligations to report adverse events relating to medical devices to the Therapeutic Goods Administration (Regulator) as part of the Incident Reporting and Investigation Scheme (see Therapeutic Goods (Medical Devices) Regulations 2002 (Cth). But if passed, the Bill will also place a reporting obligation on healthcare facilities, including hospitals.
The centrepiece of the Bill is the proposed Part 4-8A, which would place a positive obligation on the 'chief executive officer' (CEO) of a healthcare facility to give a report to the Secretary about an 'adverse event involving a reportable device in certain circumstances'. The proposed Expanded Regime includes civil penalties for CEOs who fail to make such reports, equal to 30 Commonwealth penalty units (currently $6,660.00).
The Second Reading Speech explains that the primary purpose of the Expanded Regime is to 'monitor the safety and performance' of medical devices to 'improve patient safety and better ensure the early detection of safety signals' (Second Reading Speech, Ms Kearney, delivered 1 December 2022).
Notably, a number of hospital providers may already have contractual obligations to report adverse events to the manufacturer / sponsor as part of the medical device purchasing arrangement. However, the Bill will introduce a legislative obligation upon Hospitals to also report adverse events directly to the Regulator, under the threat of penalty.
Key features of the proposed Expanded Regime
The Expanded Regime will apply to healthcare facilities where:
- a reportable medical device is used, and its use has resulted in 'death or serious deterioration in the health, of a person while the medical device [was] used in the facility' (Bill, s 41JM(1) and (2)); or
- a reportable medical device is not used in the facility because of the intervention of a person in the facility, and the medical device, if used, would result in our would be likely to result in, the death or serious deterioration in the health of a person; or
- a health practitioner provides treatment to a person at the facility for the serious deterioration in the health of the person, and the use of a reportable medical device has resulted in the serious deterioration in the health of the person.
This means the mandatory reporting obligations would fall on both the hospital that provides the primary care, and any secondary facility where a person presents with serious deterioration as a result of use of a reportable medical device.
Other proposed changes in the Bill?
The Bill also proposes to expand the Secretary's information gathering powers by allowing the Secretary to give written notice requesting a third party "produce or give the Secretary any documents…relevant to a contravention or possible contravention" of a provision of the Therapeutic Goods Act or Regulations (Bill, s 45AB). Failure to comply could result in a finding the third party has committed an offence (Bill, s45AC).
Among other things the Bill also purports to address:
- the effects of medicine shortages, by allowing the Secretary to approve importation or supply of unapproved medicines that could act as a substitute for medicine that was previously approved in Australia; and
- reduce the regulatory burden for therapeutic goods advertises. Specifically, the Bill increases the classes of individuals that are exempt from the Therapeutic Goods Advertising Code. If introduced, the new measures could permit therapeutic goods advertisers to advertise directly to purchasing officers of charities, governments and other practice managers (Bill, s 42AA(1)(b)(ii)).
We will continue to monitor the Bill but in the meantime, if you would like assistance understanding how the proposed changes to the therapeutic goods regime could affect your hospital or business, please contact us.