Ged Kearney (Cooper, Australian Labor Party, Assistant Minister for Health and Aged Care) Share this | Link to this | Hansard source

I move:

That this bill be now read a second time.

I am pleased to introduce the Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022.

This bill amends the Therapeutic Goods Act 1989 to implement a number of measures which support the delivery of the highest-quality health care for the Australian public by ensuring the continued access to critical prescription medicines and supporting the safe use of therapeutic goods by strengthening therapeutic goods post-market monitoring and compliance.

In particular, the bill supports the implementation of a scheme for the mandatory reporting by hospitals of adverse events associated with medical devices. Following the 2017 Senate inquiry into the number of women in Australia who have had transvaginal mesh implants and related matters, the inquiry made a number of recommendations designed to improve patient safety and better ensure the early detection of safety signals. Recommendation 1 from the inquiry noted the vital role of adverse event reporting in post-market surveillance. The bill introduces the legislative framework for a scheme involving the mandatory reporting of adverse events associated with medical devices by hospitals, reflecting that for many patients the hospital setting is where adverse events involving medical devices occur or are recognised. This measure supports the improved monitoring of safety concerns associated with medical devices through access to information held by hospitals that identifies serious adverse events, and facilitates the earlier detection of safety signals that may raise concerns about particular devices.

The bill encourages innovation and investment in biologicals in Australia by introducing a new dedicated pathway for marketing approval of biologicals that are for export only. This measure is designed to provide incentives for investment in the export of biologicals from Australia, and encourages development of this industry, by reducing the regulatory burden and supporting sponsors of such products to obtain marketing approval. It would also ensure consistency across the regulatory schemes for medicines, medical devices, and biologicals.

The bill addresses and alleviates the effects of medicine shortages, by amending the act to allow the Secretary of the Department of Health and Aged Care to approve the importation or supply of an unapproved medicine that could act as a substitute for medicine that was previously approved in Australia. This measure provides an important additional mechanism to help deal with critical medicine shortages, by allowing the importation or supply of an available overseas medicine that could act as a substitute for a medicine that was approved in Australia, but has since been cancelled or suspended. In some cases, this may be the only option to deal with a medicine shortage. Before exercising such a power, the secretary would consider the suitability of granting such an approval, including whether it is in the interest of public health.

The bill supports the safe use of therapeutic goods by strengthening monitoring and compliance activities through a number of measures. The bill removes review rights for decisions to require the production of information or documents which are critical in identifying and investigating potential contraventions of the act, detecting safety concerns, and potentially preventing adverse events, associated with therapeutic goods. The measure is designed to prevent avenues of review for such decisions being misused to impede and delay timely regulatory action to protect Australians.

The bill introduces a general information-gathering power to enable the secretary to request information from any person who may hold information relevant to a potential contravention of the act. This may include, for example, a financial institution which may hold records of transactions, contractors involved in the supply chain or persons who are involved with the supply of illegal therapeutic goods. This general information-gathering power is designed to support the comprehensive and timely investigation of possible contraventions of the act and enhance the protection of Australian consumers from poor quality, and potentially unsafe, therapeutic goods through access to relevant documentation about potential contraventions of the act. The bill also extends the time frame for holding seized goods to 120 days, to provide a more appropriate time frame for seized goods to be laboratory tested, analytically assessed and carefully examined, and for regulatory or compliance action to be instituted where appropriate.

The bill makes a couple of changes to the regulation of advertising of therapeutic goods. First, the bill provides that the advertising requirements do not apply to an updated list of persons, including certain health professionals (such as oral health therapists), persons purchasing therapeutic goods on behalf of registered charities or governments, or to purchasing officers or practice managers of healthcare practices. Second, the bill provides a mechanism for an approval of a restricted representation to be withdrawn where additional information about the efficacy of therapeutic goods becomes available. This ensures that therapeutic goods advertising only contains correct and accurate information, taking into account all relevant information known about the goods, and therefore reducing the risk of unsafe use by consumers.

The bill contains a measure to support compliance by enabling the secretary, on the secretary's own initiative, to extend the due date for payment of an infringement notice, supporting the early resolution of a contravention of the act where a person intends to pay the infringement notice, but does not do so before the expiry date. In so doing, this measure will support the early resolution of contraventions of the act by infringement notice rather than criminal or civil court proceedings.

The bill also makes a number of other amendments to improve the clarity and consistency of regulatory requirements, codify current practices, and make other more minor changes to remove redundant provisions and correct typographical errors. In particular, this includes amendments to: