Key points

• The Bill proposes amendments to the Therapeutic Goods Act 1989 (the Act) that include:
  • imposing a new reporting requirement on CEOs of healthcare facilities for adverse events involving medical devices
  • establishing a new ‘export only’ pathway for biologicals
  • expanding the Therapeutic Goods Administration’s information gathering powers
  • enabling the withdrawal of restricted advertising approval for therapeutic goods if concerns arise following the release of new efficacy information
  • expanding the list of exempt persons who may receive direct therapeutic goods advertising and for whom the Act’s advertising requirements do not apply
  • expanding existing powers to enable the importation or supply of (unapproved) substitutable medicines in the event of a medicine shortage where no appropriate alternative is available in the Australian Register of Therapeutic Goods and it is in the interests of public health.
• Several of these amendments build on ongoing therapeutic goods reforms and are in response to stakeholder feedback.
• Elements of the new adverse events reporting requirements will be set out in regulations, with further consultation anticipated, and are intended to avoid doubling-up on existing reporting obligations to state or territory health departments or the Australian Commission on Safety and Quality in Health Care.
• Certain provisions contained in the Bill (particularly the provisions in Schedules 3 and 10) which will impact a person’s administrative law remedies may be of interest to the Senate Standing Committee on the Scrutiny of Bills.

Introductory Info

Date introduced: 1 December 2022
House: House of Representatives
Portfolio: Health and Aged Care
Commencement: See details under the subheading ‘Commencement details’ in this Digest.

Purpose and Structure of the Bill

The purpose of the Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022 (the Bill) is to amend the Therapeutic Goods Act 1989 (the Act), which sets out the legal requirements for the import, export, manufacture and supply of therapeutic goods in Australia.

The Bill is comprised of 12 schedules:

• Schedule 1 introduces new mandatory reporting requirements for chief executive officers of healthcare facilities to report to the Secretary serious adverse events involving a medical device in certain circumstances
• Schedule 2 enables a new pathway for marketing approval for export only biologicals
• Schedule 3 removes merits review rights in instances when the Secretary requires information or documents to be provided for post-marketing monitoring and compliance activities
• Schedule 4 enables the Secretary to extend the period a person can pay an infringement notice
• Schedule 5 expands the Secretary’s information gathering powers to provide a broad power enabling them to require information or documentation that are relevant to alleged contraventions of the Act or the Regulations
• Schedule 6 extends the period things seized under Part 6–2 of the Act can be retained from 90 days to 120 days
• Schedule 7 modifies the list of people who may receive direct therapeutic goods advertising based on their role
• Schedule 8 enables the Secretary to withdraw an approval for the use of a restricted representation in relation to a therapeutic good, based on efficacy data
• Schedule 9 enables the Secretary to grant approval for a person to import or supply a specified therapeutic good as a substitute medicine when another is in short supply
• Schedule 10 specifies that the Secretary does not need to observe the natural justice hearing rule when releasing information under section 61 of the Act
• Schedule 11 specifies sponsor responsibilities in notifying and keeping the Secretary up to date on medicine shortages
• Schedule 12 makes other minor amendments.

As the matters covered by each of the schedules are generally independent of one another, for the purpose of this Bills Digest the relevant background information and analysis of key provisions are grouped together by topic, noting that not all schedules are discussed.

Commencement details

• Sections 1 to 3 commence on Royal Assent
• Schedule 1 commences on the earlier of a day to be fixed by Proclamation, or 24 months after Royal Assent
• Schedule 2 commences 3 months after Royal Assent
• Schedules 3 – 10 commence the day after Royal Assent
• Schedule 11 commences 6 months after Royal Assent
• Schedule 12 commences the day after Royal Assent.

Committee consideration

The Bill has yet to be referred to any committees for inquiry and report.

Senate Standing Committee for the Scrutiny of Bills

The Senate Standing for the Scrutiny of Bills (Scrutiny of Bills Committee) has not reported on the Bill at the time of writing.

Financial implications

There are no anticipated financial implications for the Government’s budget, as the implementation of the proposed measures will be funded through the Therapeutic Goods Administration’s existing cost recovery mechanisms.[1]

Statement of Compatibility with Human Rights

As required under Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011, the Government has assessed the Bill’s compatibility with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of that Act.

The Government considers that the Bill is compatible with human rights, noting that ‘it promotes the right to health, and to the extent that it may limit human rights, those limitations are reasonable, necessary, and proportionate’.[2]

Parliamentary Joint Committee on Human Rights

The Committee has not reported on the Bill at the time of writing.

Schedule 1: Mandatory reporting of adverse events involving medical devices

Schedule 1 amends the Act to require the chief executive officer (CEO) of a healthcare facility to report adverse events involving reportable medical devices in some circumstances to the Secretary of the Department of Health and Aged Care (the Secretary). This is intended to enhance patient safety and enable earlier detection of potential issues with a medical device.

What is a medical device?

Therapeutic goods are defined in the Act and are health-related products that can be used for a range of reasons, including managing illness or injury, altering bodily processes or replacing or modifying parts of the body.[3] The Therapeutic Goods Administration (TGA) is responsible for ensuring that therapeutic goods available in Australia are safe and fit for their intended purpose. Medical devices are a type of therapeutic good, alongside other goods such as medicines and biologicals.

The term medical device is defined in section 41BD of the Act and, in brief, refers to an instrument, apparatus, appliance, software, implant, reagent, material or other article intended for human use for purposes such as diagnosis, treatment, support of conception or in vitro examination. In addition, a medical device cannot achieve its primary intended action through pharmacological, immunological or metabolic means, although its function can be assisted by these means. The term medical device covers a wide range of products and includes items such as bandages, hip replacement implants, COVID-19 tests and personal protective equipment.

Current adverse events reporting obligations

At this stage, under the Act and the Therapeutic Goods (Medical Devices) Regulations 2002 (Medical Device Regulations), only manufacturers and sponsors of medical devices are required to report adverse events for medical devices to the Secretary. This must occur within the specified timeframe, which is defined in the Medical Device Regulations, and varies based on the type of risk, ranging from 48 hours to 60 days. There are some types of incidents that are exempt from the notification requirements.

Adverse events can be reported on a voluntary basis by health professionals, individuals (for example, a patient) and health services. People can report an adverse event and search for adverse event reports for medical devices through the Database of Adverse Event Notifications – medical devices.

The TGA publishes annual performance reports, which indicate that for 2021–22 it received 8,737 medical device incident reports.[4] The TGA aims to process these reports within 90 working days.[5] The outcomes of these incident reports for 2021–22 are summarised in Table 1.

Table 1      Medical device incident report outcomes^a

Source: Therapeutic Goods Administration (TGA), Performance Report 2021–22, (Canberra: Department of Health and Aged Care [DoHA], 2022), 78.

Post-market monitoring reforms

The TGA is continuing to refine how it regulates medical devices and, in 2019, released ‘An action plan for medical devices’ containing 3 strategies:

• strategy 1: Improve how new devices get to the market
• strategy 2: Strengthen monitoring and follow-up of devices already in use
• strategy 3: Provide more information to patients about the devices they use.
• Four areas for action were identified under strategy 2 to strengthen post-marketing monitoring of devices:
• scope the introduction of unique device identifiers
  • the Therapeutic Goods Amendment (2020 Measures No. 2) Act 2021 includes provisions to allow the establishment and maintenance of a unique device identification database. The Act received Royal Assent on 19 February 2021.
• enhance inspections and reviews to confirm ongoing quality and safety
• explore removing reporting barriers which may include mandatory reporting of adverse events by healthcare facilities
• greater data analysis, information sharing and joined up systems with hospitals.[6]

The TGA has published progress report cards for the action plan and publishes updates on its medical devices reforms projects, including enhancements to post-marketing monitoring and devices of concern reviews (with a focus on surgical mesh devices).[7]

Position of major interest groups

In 2021, the TGA undertook public consultation on the Potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia. The TGA provided the following summary of the feedback it received:

Submissions were received from 56 stakeholders representing healthcare, industry, and consumers. Almost three quarters of respondents were in favour of introducing mandatory reporting of medical device related adverse events by healthcare facilities in Australia, providing a range of comments about implementation, with safety and accountability as key drivers. Some respondents felt mandatory reporting by healthcare facilities was long overdue and that without it, the current underreporting of medical device adverse events does not support the early identification of emerging safety and performance issues. Those not in favour of introducing mandatory reporting raised valid concerns and issues including data duplication and integrity, and the burden that would fall to staff. These concerns require further discussion. Most respondents indicated that if mandatory reporting was introduced, all healthcare facilities should be included, however a small number raised concerns about smaller facilities such as general practices being included due to limited resources to manage additional administrative requirements.

Data integrity was a key concern of stakeholders both for and against the introduction of mandatory reporting, with an overall desire expressed by all stakeholders for a better understanding of the risk-benefit profile of medical devices generally. Stakeholders also raised concerns that additional reporting requirements may be burdensome, duplicative, and of little benefit to patient outcomes.

Based on feedback received, it is evident that if mandatory reporting were to be introduced, work would need to be undertaken with healthcare facilities, their existing systems, and information collection points to facilitate accurate and timely reporting. Additional work would also be needed to increase awareness of the scope of benefits of mandatory reporting, including through education and communication materials. This outcome would need to be supported by significant effort to change clinical practice to incorporate mandatory reporting requirements.

The Australian Commission on Safety and Quality in Health Care (ACSQHC) indicated their willingness to take a leadership role in working with the TGA and other stakeholders to incorporate mandatory reporting within the existing frameworks for hospital quality assurance and accreditation processes thus minimising any additional regulatory burden. They highlighted that other activities, including further education, encouragement and support given to patients and practitioners to report adverse events are complementary, but do not replace the importance of mandatory reporting.[8]

Key provisions

Chapter 4 of the Act provides requirements intended to ensure the safety and appropriate performance of medical devices and includes offences and civil penalty provisions. Item 4 will insert proposed Part 4-8A—Mandatory reporting of adverse events by healthcare facilities, which will introduce a requirement for the CEO of a ‘healthcare facility’[9] to report to the Secretary an adverse event that involves a ‘reportable medical device’ (to be defined in regulations made under the Act) in instances where:

• the device is used in the facility and has resulted in the death or serious health deterioration of a person (proposed subsection 41JM(2))
• the facility does not use the device due to an intervention by a person in the facility and the use of the device would, or is likely to, result in a person’s death or serious health deterioration (proposed subsection 41JM(3))
• a health practitioner provides treatment to a person in the facility for serious health deterioration caused by the device (proposed subsection 41JM(4)).

According to the Explanatory Memorandum, defining reportable medical devices in the regulations will not only allow flexibility for adding or removing devices from the list but also means that the reporting requirements will not come into force until the regulations are updated following a period of consultation and after hospitals have been made aware of these new obligations.[10]

Failure to comply with the reporting requirements could expose the CEO of the facility to a civil penalty of up to 30 penalty units (proposed subsection 41JM(8)).[11]

Proposed subsection 41JM(7) will introduce some reporting requirement exemptions. The CEO will not be required to provide a report to the Secretary if they have already reported the adverse event to one of the following:

• the CEO of the Australian Commission on Safety and Quality in Health Care
• the head of a state or territory department responsible for health-related matters or
• any other person prescribed in the regulations.

Schedule 2: Export only biologicals

Schedule 2 amends the Act to enable the establishment of a new pathway for export only biologicals to be included in the Australian Register of Therapeutic Goods (ARTG).

What is a biological?

Section 32A of the Act defines a biological to mean a thing that is either comprised, contains or derived from human cells or tissues or is specified by the Secretary (in a legislative instrument) and that is used for:

• preventing or treating a disease, condition or injury
• screening or diagnosing a person
• changing a person’s physiological processes or
• changing parts of a person’s anatomy.

Examples of biologicals include:

• ocular tissue used, for example, in corneal transplants
• human stem cells used, for example, to treat graft-versus-host disease
• genetically modified cells from the immune system to, for example, treat some types of lymphoma.

Biologicals are classified into different classes based on the risk they may pose to people when used. There are 4 classes, as defined in the Therapeutic Goods Regulations 1990 (TGA Regulations) with Class 1 biologicals having a low risk with sufficient oversight and Class 4 biologicals being ones of high risk. Some items may meet the definition of a biological but are not regulated by the TGA or may not be regulated as a biological (for example, assisted reproductive technologies, viable organs, plasma derivatives and vaccines).

Can biologicals currently be exported?

Yes, but there is no dedicated ‘export only’ pathway and as such, the product that is exported must be the same as the one on the ARTG (i.e., the one approved for use in Australia by the TGA).

Export only medicine and medical device pathways already exists in Australia, as set out in the Act and the TGA Regulations, and, unless subject to some form of exemption, these items must be included on the ARTG. These export only products must not be supplied in Australia.[12] When the changes were introduced to enable export only medicines and medical devices, ‘exported human cell and tissue (HCT) products were not envisioned during the development of the regulatory mechanism that governs biologicals’.[13]

In 2021, the TGA undertook sector consultation on whether an export only pathway should be available for biologicals, and if so, what form it should take:

The TGA recognises that countries importing Australian manufactured biologicals may have different standards to Australia. The imposition of current Australian regulatory requirements on export only biologicals may be onerous or inappropriate and inhibit local biological export industries… The aim is to provide more flexibility to export only biological manufacturers while still maintaining an appropriate level of regulatory oversight. [14]

In a joint submission made to the Inquiry into the Australian Manufacturing Industry in 2021, 4 organisations highlighted that existing legislation is not responsive to the regenerative medicine (RM) industry in Australia. The submission referenced the TGA consultation being undertaken at the time and suggested that changes to legislation:

… can ensure an open and accessible export market for RM therapies. This will encourage large “big pharma” clients to establish Australian manufacturing programs that can rely on Australia’s reputable production of safe complex medical products, therefore establishing Australia as the manufacturing hub for the region.[15]

Key provisions

Item 3 of Schedule 2 defines an export only biological to mean a biological that is either manufactured or imported into Australia for the purpose of being exported.  

Item 7 inserts proposed subdivision BA–Export only biologicals into Division 4 of Part 3-2A of the Act, which provides for the new pathway for export only biologicals to be included on the ARTG:

• a person must apply to apply to the Secretary for inclusion of an export only biological in the ARTG (proposed subsection 32DCA(1))
• as part of that application, the applicant must certify that, among other things, the biological:
  • is safe for its intended purpose
  • complies with all prescribed and relevant quality and/or safety criteria
  • does not contain substances that have been prohibited from import into Australia or export from Australia (proposed subsection 32DCA(4))
• if any of the manufacturing steps have been carried out outside of Australia, the Secretary must certify (or refuse to certify) that the manufacturing and quality control is acceptable (proposed subsection 32DCA(5)).
  • The Secretary may take into account several factors outlined in proposed subsection 32DCA(6), including, for example, if the applicant has provided an EC/EFTA attestation of conformity (within the meaning of the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement)
• the biological will remain on the ARTG until the entry is cancelled by the Secretary (proposed subsection 32DCB(5))[16]
• if the Secretary refuses the application, they must, as soon as practicable, give the applicant notice of the refusal and the reason behind it (proposed section 32DCC)
  • this decision can be reviewed under section 60 of the Act.

Schedule 3 – Removal of merits review for certain decisions

Schedule 3 amends the Act to provide that a decision by the Secretary to require the production of information or documents will no longer be subject to independent merits review by the Minister or the Administrative Appeals Tribunal (AAT).

What is merits review? 

Merits review is the process by which a person or body:

• other than the primary decision-maker
• reconsiders the facts, law and policy aspects of the original decision and
• determines what is the correct and preferable decision.[17]

Key provisions

Currently under section 60 of the Act, a number of decisions made by the Secretary are subject to merits review by the Minister. This includes decisions made by the Secretary to require a person to provide information or documents in relation to possible contraventions of the Act.[18] Where a person is dissatisfied with the decision of the Minister, they can then appeal to the AAT to review the Minister’s decision.

The provisions in Schedule 3 of the Bill will amend section 60 of the Act to clarify that merits review and the right to appeal to the AAT will no longer apply to a decision by the Secretary to require the production of information or documents.

Justification for the removal of merits review

The Scrutiny of Bills Committee has advised that where merits review is being excluded, the Explanatory Memorandum to the Bill should address ‘the characteristics of the relevant decision/s which justify the omission of merits review, by reference to the Administrative Review Council's guide, What decisions should be subject to merit review?’.[19]

The Explanatory Memorandum provides:

The exercise of merits review rights in relation to decisions to require the provision of information or documents under the Act may delay, and in so doing potentially undermine, the timely investigation of potential contraventions of the Act and subsequent regulatory action if appropriate, including where there may be significant concerns about the safety and suitability of therapeutic goods for use by consumers and users. There is also a risk that the exercise of such review rights in relation to a requirement to provide information or documents under the Act, may be undertaken by a person in order to frustrate or delay an investigation into a potential contravention.

Removing merits review rights specifically in the context of such decisions is designed to strengthen and improve the post-market monitoring of therapeutic goods and better ensure compliance with the regulatory scheme, by reducing the risk of delays that can impact the investigation of contraventions and related safety concerns.[20]

The former Administrative Review Council's guide, What decisions should be subject to merit review?, provides for a number of grounds on which merits review can be excluded, including ‘preliminary or procedural decisions’.[21] Whether a decision is considered to fall into this category will appear to depend on whether the decision will have substantive consequences for the person affected versus the cost of potentially frustrating the making of substantive decisions.[22]

Schedule 5 – Expansion of information gathering powers

Schedule 5 amends the Act to expand the Secretary’s existing information gathering powers to allow the Secretary to require information or documents relevant to an alleged contravention of the Act.

Key provisions

As noted in the Explanatory Memorandum, the Secretary already has the power to obtain information or documents from certain parties:

Under the Act, the Secretary may, in specified circumstances, require the production of information or documents from specified persons, including in particular sponsors and manufacturers of therapeutic goods, and applicants for marketing approval. The Act also provides for more onerous powers relating to searches of premises and seizure of things from premises with consent or under a warrant. Further, the Act empowers the Secretary to require a person to provide all reasonable assistance to the Secretary in relation to an application for a civil penalty order if that person can give information relevant to that application.[23]

Schedule 5 will insert proposed Part 6-1A to introduce a general information gathering power. Proposed section 45AB will allow the Secretary to give a written notice to a person requiring them to produce information or give the Secretary any document relevant to a contravention or possible contravention of the Act or the regulations. Failure to comply with the notice is an offence, which may attract a maximum penalty of 500 penalty units (equivalent to $137,500 (proposed subsection 45AC(1)).

The Explanatory Memorandum argues that this additional power is necessary to facilitate the gathering of information from third parties who are not covered by the existing provisions in the Act (for example, financial information held by banks or information about unlawful goods held by persons involved in the supply of the goods).[24]

Schedule 10 – Clarification of application of natural justice hearing rule when releasing information

Schedule 10 amends the Act to clarify that the Secretary is not required to comply with the natural justice hearing rule when releasing information under section 61 of the Act.

What is the natural justice hearing rule?

The common law recognises a duty to accord a person natural justice (or procedural fairness) when a decision is made that affects a person’s rights, interests or legitimate expectations[25]:

The obligation of procedural fairness has two aspects: the ‘hearing rule’ which requires that a person be given an opportunity to present their case with knowledge of any adverse material that might be taken into account by the decision-maker, and the ‘rule against bias’ which requires the decision-maker to be neither biased nor one who might be reasonably apprehended to be biased.[26]

What information is released under section 61 of the Act?

Section 61 of the Act allows the Secretary to release information about therapeutic goods to a number of third parties, in certain circumstances, including:

• the World Health Organization
• international regulators of therapeutic goods or
• Commonwealth, state or territory health authorities or law enforcement authorities.[27]

Subsection 61(5A) of the Act specifically provides that the Secretary may also release to the public therapeutic goods information relating to any decision or action taken under the Act or the regulations.

Key provisions

Schedule 10 of the Bill will amend the Act to provide that the Secretary is not required to observe the natural justice hearing rule when releasing information under section 61 of the Act (proposed subsection 61(13)).

Justification for limiting the natural justice hearing rule

The Scrutiny of Bills Committee is generally concerned with Bills which seek to exclude or limit procedural fairness.[28] Where a Bill limits or excludes the right to procedural fairness the Committee expects the Explanatory Memorandum to the Bill to address the following matters:

• the nature and scope of the exclusion or limitation and
• why it is considered necessary and appropriate to restrict a person's right to procedural fairness.[29]

The Scrutiny Committee has also previously noted that ‘the courts have consistently interpreted procedural fairness obligations flexibly based on specific circumstances and the statutory context’ and that the Explanatory Memorandum to the Bill should include an explanation ‘as to why the level of flexibility traditionally applied by the courts in relation to natural justice is not sufficient in this instance’.[30]

The Explanatory Memorandum to the Bill states that the TGA has already been administering the Act ‘on the basis that the Secretary is not obliged to observe the natural justice hearing rule when releasing information under section 61 of the Act’.[31]

The Government states that the amendments contained in Schedule 10 are ‘crucial because of the importance of ensuring that important information that is critical to ensuring the safe use of therapeutic goods is able to be communicated in a timely manner and without delay, given its nature and significance and the associated risks to public health’.[32] The amendments in Schedule 10 will provide statutory authority to support the TGA’s current practice.

Schedules 9 and 11: Approval of importation or supply of substitutable medicines; and reporting medicine shortages

Schedule 9 amends the Act to expand the Secretary’s power to approve the importation or supply of specified therapeutic goods in instances when there is no medicine in the ARTG that could act as a substitute and where the approval is in the interests of public health.

Schedule 11 makes minor amendments to sponsor’s requirements for reporting medicine shortages.

What happens when medicines are unavailable or in short supply?

As identified by the Productivity Commission, some goods, such as medicines, are essential for people’s wellbeing and people could not live without them for even a few weeks.[33] As such, there are a range of safeguards and initiatives in place to respond to anticipated and actual medicine shortages, some of which are briefly outlined below.

Under the Act, there is a medicine shortage at a particular time:

… if, at any time in the 6 months after that particular time, the supply of that medicine in Australia will not, or will not be likely to, meet the demand for the medicine for all of the patients in Australia who take, or who may need to take, the medicine.[34]

Not all medicine shortages need to be reported to the TGA, with reportable medicines being medicines that are:

• registered Schedule 4 (prescription only) medicines
• registered Schedule 8 (controlled drug) medicines[35]
• determined by the Minister by legislative instrument as being reportable medicines.[36]

In addition, the TGA maintains a publicly available medicines shortage reports database.

Mandatory reporting for sponsors

A sponsor is required to notify the Secretary of a reportable medicine shortage within legislated timeframes:

• for shortages that will have a critical impact: within 2 working days of when the person knows or ought to have reasonably known of the shortage
• in any other case: within 10 working days.[37]

A medicine shortage with a critical impact occurs when the shortage could have a life-threatening or serious health impact on a person and either:

• there is no registered good that could be reasonably substituted for the medicine
• while there are other registered goods that could be substituted, it is anticipated that there would not be sufficient quantities available to meet demand.[38]

Shortages of medicines included on the Therapeutic Goods (Medicines Watch List) Determination 2018 (a determination made by the Minister or their delegate) are automatically deemed to have a critical shortage impact rating.[39]

Sponsors are also required to notify the Secretary of the permanent discontinuation of a medicine in Australia:

• if the discontinuation is likely to be of critical impact, at least 12 months before the discontinuation occurs, or as soon as practicable following the decision
• in other cases, at least 6 months before the discontinuation, or as soon as practicable.[40]

Serious Shortage Medicines Substitution Notice

In May 2020, in response to the COVID-19 pandemic, new arrangements were introduced to allow pharmacists to substitute medicines in instances when a patient’s medicine had been identified as being in ‘serious scarcity’. This approach was considered in instances when alternative mechanisms were anticipated to be unable to meet demand, such as accessing a medicine through section 19A of the Act.

What is section 19A of the Act?

Section 19A of the Act enables the Secretary to approve the importation or supply of a medicine that is not in the ARTG in particular instances. Among the requirements is that the medicine must be of a type listed in Schedule 10 of the Regulations or as specified by a determination made by the Secretary. Figure 1 is a flow chart summarising the considerations for section 19A approval.

Figure 1    Summary of considerations for section 19A approval

Note: section 23 relates to applications to the Secretary for registration or listing of a therapeutic good on the ARTG. Subsection 19A(3) enables the Secretary to make written determinations to specify foreign countries for the purposes of subsection 19A(1).

Source: TGA, Section 19A: guidance for industry – supplying substitute medicines when registered medicines are unavailable or in short supply, 11.

The TGA maintains a public database of medicines that have been approved under section 19A, as these medicines are not included in the ARTG.

Interests of public health

The Secretary must consider, among other things, that the approval is necessary in the interests of public health. In its guidance for industry, the TGA outlines the types of matters that may be considered for this criterion:

• availability of alternative treatments
• whether available treatments meet the therapeutic needs of patients
• whether substitute/s are suitable for patients
• the anticipated consequences of ceasing or changing treatment
• any other health risks associated with the proposed medicine
• the projected demand for the medicine and whether current supply can meet it.[41]

Key provisions – Schedule 9

Section 19A of the Act currently enables the importation or supply of substitutable medicines listed in the ARTG. The proposed amendments will enable the substitution of medicines that have been cancelled or have been suspended from the ARTG.

Proposed subsection 19A(2A) will enable the Secretary to approve the importation or supply of specified therapeutic goods when the Secretary is satisfied that:

• there is no registered good in the ARTG that could be used as a substitute
• a suitable substitute medicine has either previously been registered or has its registration suspended
• the substitute is registered or approved for general marketing in a foreign country specified by the Secretary in the relevant determination (specified foreign country)
• the substitute is a type of good identified in Schedule 10 of the Therapeutic Goods Regulations 1990
• the approval is necessary in the interests of public health.

Proposed subsection 19A(2B) is drafted in similar terms to the requirements outlined above, with one key difference regarding the condition for approval for general marketing in a foreign country, in which:

• all of the following must apply:
  • the substitute is not registered or approved for use in a specified foreign country
  • the substitute is registered or approved for use in at least one foreign country that is not a specified foreign country
  • the manufacturing and quality control processes used to manufacture the substitute are acceptable (proposed paragraph 19(A)(2B)(c)).

Key provisions – Schedule 11

Schedule 11–Reportable medicine shortages will define the period of a medicine shortage (proposed section 30EIA) and introduce some additional requirements for sponsors for notifying the Secretary of medicine shortages, including:

• sponsors will be required to notify of any changes to the period of the shortage (proposed subsection 30EFA(1))and when the shortage has been resolved (proposed subsection 30EFA(2))
• notification of a change or resolution of a shortage will need to be in a form approved by the Secretary (proposed subsections 30EFA(3) and (4)).