On 1 December 2022, the Federal Government introduced the Therapeutic Goods Amendment (2022 Measures No 1) Bill 2022 (Bill), which will amend the Therapeutic Goods Act 1989 (TG Act) to implement a raft of reforms across the therapeutic goods lifecycle.
If the Bill is passed, the reforms will expand the powers of the Secretary of the Department of Health and Aged Care (Secretary) and equip the Therapeutic Goods Administration (TGA) with additional monitoring and compliance tools.
The Bill also introduces a mandatory scheme for reporting adverse events associated with medical devices in healthcare facilities, codifies some existing practices of the TGA and plugs gaps that had previously been identified in the regulations.
In this Alert, we survey the proposed changes. Anyone active in the healthcare and life sciences sectors should consider their compliance position in advance of the likely passing of the Bill.
Expanded information gathering powers
The Bill proposes to considerably expand the TGA’s information gathering powers.
Currently, the TG Act enables the Secretary to request the production of information or documents from specified persons and in specific situations. For example, the Secretary can issue notices to applicants, manufacturers and or sponsors of therapeutic goods in relation to features of their therapeutic goods (such as their formulation, quality, safety and efficacy).[1] The Secretary may also require the production of information by advertisers about advertisements for therapeutic goods.[2]
While these existing powers are fairly broad, the Bill introduces a general information gathering power that will enable the Secretary to require any person (including parties other than the sponsor of a therapeutic good) to provide information or produce documents that are relevant to a contravention or possible contravention of the TG Act or related regulations. The new power is “designed to be used in situations where the Secretary has reason to believe a person has information or documents that would be peculiarly within their knowledge or possession …or information … relating to the business arrangements for distribution and retail sale of illegal therapeutic goods (for example supply chains for illegal nicotine vaping products).”
The new power also aims to improve the TGA’s ability to investigate possible contraventions in an efficient and timely manner. In particular, the new powers aim to avoid potential offenders being given notice of investigations into potential non-compliance by enabling information gathering from third parties.
Parties will have at least 14 days to provide the information or documents and will face significant penalties for failing to produce requested material or providing false or misleading information.
These new powers would apply to any notice given on or after commencement of the Bill, regardless of the date of the contravention or possible contravention. That is, the powers would be able to be exercised in relation to historical contraventions (or possible contraventions) of the TG Act prior to the introduction of the new power.
The Bill also removes the right to seek review of a decision to require a person to give information or produce documents to the Secretary.
Participants in the health sector should be aware that, if passed, the Bill will mean that they are subject to broad investigatory powers in respect of therapeutic goods, even if they are not the Australian sponsor.
Mandatory Reporting of Adverse Events Involving Medical Devices
The Bill will introduce a new scheme for the mandatory reporting of adverse events relating to the use of medical devices in public and private healthcare facilities.[3]
In short, the Bill would require the Chief Executive Officer (CEO) of a healthcare facility to report adverse events involving particular medical devices (that will be set out in further regulations), including where:
- use of the device in the facility has resulted (or could result) in the death or serious deterioration in the health of a person; and
- a health practitioner provides treatment to a person in the facility for a serious deterioration in the health of the person caused by the use of the device.
Should the Bill pass, the types of medical devices to which the mandatory reporting scheme will apply will be prescribed by further regulations. We understand that hospitals and the States and Territories will be consulted in relation to the form of those regulations.
Failure to comply would expose the CEO of a healthcare facility to a maximum fine of $6,660.
The amendment follows consultation undertaken by the TGA with hospitals arising out of the 2017 Senate Inquiry into the Number of women in Australia who have had transvaginal mesh implants and related matters. The Inquiry recognised the importance of adverse event reporting in post-market surveillance of the safety of medical devices.
We recommend operators of healthcare facilities follow these developments closely to ensure they are aware of the new mandatory reporting requirements when implemented.
Withdrawing restricted representations
The Bill also broadens the Secretary’s power to withdraw an approval to use a restricted representation in the advertising of therapeutic goods.
Restricted representations are representations about a serious form of a disease, condition, ailment or defect.[4] For example, the following claims are restricted representations because they refer to serious conditions: ‘Do not use this product if you have diabetes’, ‘we proudly support Osteoporosis Australia’ and ‘may help relieve pain associated with arthritis’.[5]
Restricted representations must not be used without TGA approval, that can be for an individual advertiser (i.e. for particular products) or advertisers generally (i.e. for particular product categories). Currently, the Secretary can withdraw an approval to use a restricted representation (only) if the Secretary is satisfied that:
- additional information about the safety of the therapeutic goods has become available; and
- if that information had been available at the time of the approval, the Secretary would not have approved the use of the restricted representation.[6]
The Explanatory Memorandum recognises that “[t]his mechanism is an important safety measure to ensure that advertisements for therapeutic goods only contain information that is correct and do not contribute to the risk of the use of unsafe therapeutic goods by consumers. However, concerns have arisen that the Act does not currently provide a similar mechanism if additional information about the efficacy of therapeutic goods becomes available.”
The Bill bridges this gap by empowering the Secretary to withdraw an approval for the use of a restricted representation where additional information about the efficacy of goods becomes available. This information may come from further clinical trials or post market surveillance.
If passed, advertisers will need to ensure that any restricted representations made in relation to their products are consistent with the current data relating to both efficacy and safety.
Carve out for advertising directed exclusively to certain persons
The Bill broadens the circumstances in which advertising requirements under the TG Act will not apply.
Currently, advertisements that are directed exclusively to medical practitioners and other specified professionals are excluded from requirements that apply to the advertising of therapeutic goods, including compliance with the Therapeutic Goods Advertising Code and regulations that apply to the use of restricted representations. These exceptions reflect that it is not necessary to control advertisements directed to appropriately qualified and experienced health professionals to the extent that is required for advertising directed at consumers.
The Bill contemplates updating the class of exempted individuals to add those who are:
- registered to practice oral health therapy and paramedicine;
- purchasing therapeutic goods on behalf of a registered charity;[7]
- purchasing therapeutic goods on behalf of a government or government authority;[8] and
- purchasing officers or practice managers of health practices/facilities (other than retail pharmacists).[9]
If these amendments are passed, it will be good news for advertisers of therapeutic goods, and particularly pharmaceutical manufacturers and distributors, who will have greater freedom and liberty to promote and market pharmaceutical products to health professionals.
Approval of importation or supply of substitutable medicine
The Bill proposes to broaden powers to approve the importation or supply of medicines where there are critical shortages in Australia.
The TG Act currently provides that the Secretary can approve the importation into, or the supply in, Australia of specific therapeutic goods if the Secretary is satisfied that registered goods that could act as a substitute for goods that are unavailable or in short supply (amongst other matters). However, the current provision does not enable the Secretary to approve unapproved medicines that could act as a substitute where the medicine has been cancelled or suspended from the ARTG.
The proposed amendment would address this gap, and allow the Secretary to approve the importation or supply of an unapproved medicine that is, or is similar to, a medicine previously approved in Australia but that has since been cancelled or suspended. Before exercising this power, the Secretary must be satisfied of certain matters, including that quality control procedures are acceptable and that the approval is necessary in the interests of public health.
The reform will provide the TGA a welcome additional avenue for dealing with critical medicine shortages in Australia.
Reporting medicine shortages
The Bill proposes amendments designed to fine tune the scheme for the mandatory reporting of medicines shortages.
In short, sponsors of medicines that have already been reported to the TGA as being affected by a shortage must report any change to the duration of the shortage (including any resolution of the shortage) within a specified time after the sponsor knew, or ought reasonably to have known, of the change.
- While most sponsors report shortages of medicines, the lack of formal protocols has created inefficiencies. The proposed amendments are intended to formalise and streamline the reporting process.
Sponsors should be prepared for the increased formality of reporting requirements in respect of medicines shortages.
Release of Information
The Bill would also introduce an amendment to codify current regulatory practice in respect of the release of urgent or critical information about the safety of therapeutic goods to the public, patients and other affected persons.
Under section 61 of the TG Act, the Secretary has discretion to release ‘therapeutic goods information’[10] to the public or to specified recipients (including, for example, the World Health Organisation or Australian law enforcement authorities).
The TGA and the Secretary currently administer the TG Act on the basis that rules of procedural fairness do not need to be followed when this power to release information is exercised because of the importance of being able to provide critical public health and safety information quickly.
The Bill would amend the TG Act to reflect current TGA practice and formally exempt the Secretary from the obligation to provide procedural fairness (for example, to sponsors) when releasing information about therapeutic goods.
Next steps
Debate on the Bill was adjourned on 1 December 2022. As there are no more sitting weeks left this year, debate in the House of Representatives will take place in the new year.
The KWM team will monitor developments relating to the Bill closely and provide further updates as it progresses through Parliament.
The Authors wish to acknowledge the contribution of Luke Hawthorne, Tim Craven, Vicky Zhang, Joe Ko, Jess Horn, Rosie Rand, Zak Vidor Staub, and Jane Spencer in the preparation of this Alert.
TG Act, s 31.
TG Act, s42DR.
Healthcare facility means: (a) a public hospital; or (b) a private hospital; or (c) any other facility prescribed by regulations.
Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, s28.
See TGA guidance at https://www.tga.gov.au/restricted-representations
Section 42DI(1)(b) also contains other circumstances in which the Secretary may withdraw an approval.
Note that this only applies to charities that are registered under the Australian Charities and Not-for-profits Commission Act 2012 as an entity for the purpose of advancing health.
Including foreign governments and government authorities.
That is, purchasing officers or practice managers for health practitioners (including doctors, nurses, optometrists, physiotherapists, podiatrists), chiropractors, dentists, osteopaths and paramedics (other than pharmacists in retail pharmacies.
‘Therapeutic goods information’ includes information in relation to therapeutic goods that is held by the Department of Health and Aged Care (Department) and relates to the performance of the Department’s functions.
