Therapeutic Goods (Information Specification—Medicine Shortages and Availability Data) Instrument 2024

The instrument introduces or relies upon several defined concepts that structure how information may flow. An individual data set means any data provided to the TGA by a data source about a medicine that is in shortage, at risk of shortage, or permanently discontinued. This includes data on supply, demand, current and expected availability, quantity, and expected availability dates. A data source is defined broadly to include a pharmacy, a State or Territory department or authority, a sponsor or peak body representing sponsors, a wholesaler or peak body representing wholesalers, and a private hospital or peak body for the private hospital sector. This captures virtually every entity that holds meaningful supply chain information. An aggregated data set means data that is an aggregate of the individual data sets for a medicine from all data sources that provided data to the TGA for that medicine. This is distinct from an aggregated visual, which means the medicine availability modelling forecast (in report form, live modelling form or any other form) created by the TGA or an expert adviser in the MAWG through running the aggregated data set through a dynamic modelling process to obtain estimates of expected medicine availability. The distinction is important because Schedule 1 treats these categories differently regarding who may receive them and for what purposes. MAWG (Medicine Availability Working Group) is coordinated by the TGA and comprised of representatives of State and Territory health departments, and may include an expert adviser. MSAG (Medicine Shortage Action Group) is convened and coordinated by the TGA for a medicine or group of related medicines that are or are anticipated to be in shortage or discontinued, and includes healthcare professional peak bodies, consumer representative groups and other key stakeholders. National demand means the expected demand for a medicine for all patients in Australia who take or may need to take the medicine. Supply deficit means the shortfall in supply of a medicine as a percentage of expected demand over a specific period. An alternative treatment means a medicine that may be used as an alternative for another medicine that is in shortage, at risk of shortage, or permanently discontinued. The instrument also incorporates defined terms from the Therapeutic Goods Act including medicine, Secretary, shortage and sponsor. Several government departments are defined for release purposes: the Foreign Affairs Department, Home Affairs Department (including the Australian Border Force), and the Industry Department responsible for manufacturing and commerce, biotechnology and supply chain resilience policy coordination.

The instrument directly affects several categories of entities. Data sources are the most directly impacted because the information they provide to the TGA about medicine supply, demand and availability (their individual data sets) may now be released by the Secretary to specified government bodies and, in aggregated or summary form, to the public. This includes sponsors (the entities responsible for the medicine on the Australian Register of Therapeutic Goods), wholesalers, pharmacies (both community and hospital), private hospitals, State and Territory health departments, and peak bodies representing any of these categories. For sponsors, the commercial sensitivity of their supply data is particularly significant. Release of information about stock levels, production capacity, anticipated supply dates and supply deficits could affect their negotiating position with buyers, their competitive position relative to other sponsors, and their relationships with overseas parent companies or manufacturing sites. Government departments and agencies are affected as recipients of the information. The PBS administration branch receives individual and aggregated data sets and aggregated visuals to facilitate consideration and analysis of medicine availability data to support management of shortages and discontinuations including securing alternative treatments. The MAWG, MSAGs, Foreign Affairs Department, Home Affairs Department, Industry Department and NEMA receive the aggregated visual for similar purposes. These bodies gain access to modelling forecasts that they may not have previously received, enabling them to take actions such as coordinating international supply responses, managing border controls, supporting domestic manufacturing, or activating emergency management protocols. Healthcare professional peak bodies and consumer representative groups may be affected through their participation in MSAGs where they receive aggregated visual data. The public is affected through Schedule 2, which authorises release of information about medicine availability, shortage predictions, impact assessments and alternative treatments. This includes patients, prescribers, pharmacists and the broader community who rely on timely information about medicine shortages to make treatment decisions. The instrument does not directly affect individual patients or healthcare professionals by imposing obligations on them, but it affects their access to information about medicine availability that was previously held confidentially within the TGA and limited government circles.

The instrument does not impose duties directly on regulated entities. It confers a right or authority on the Secretary to release specified therapeutic goods information to specified recipients for specified purposes. The key legal effect is to provide a shield against claims that release of the information would breach statutory confidentiality provisions in the Therapeutic Goods Act. Under subsection 61(5AA) of the Act, the Secretary may release information if it is of a kind specified under subsection 61(5AB) to a person or body of a kind specified for a purpose specified. This instrument provides that specification. Similarly, under subsection 61(5C), the Secretary may release information to the public if it is of a kind specified under subsection 61(5D). This instrument provides that specification for public release. The rights conferred on recipients of the information are implied rather than express. Recipients such as the MAWG, MSAG, PBS administration branch, Foreign Affairs Department, Home Affairs Department, Industry Department and NEMA are authorised to receive the information for the specified purpose: to facilitate the consideration, analysis and communication of medicine availability data to support the management of medicine shortages and discontinuations, including the securing of alternative treatments. The instrument does not expressly restrict those recipients from further disclosing the information, but the purpose limitation may provide some constraint. For data sources who provide individual data sets, the instrument does not confer any right to be notified before their information is released, nor any right to object to release, nor any right to review the aggregated data set or aggregated visual before publication. Sponsors and other data sources do not have a right under this instrument to challenge the accuracy of the information that the TGA proposes to release. The instrument also does not create any right for the public or for healthcare professionals to request particular information; it simply authorises the Secretary to release information of the specified kinds. There is no obligation to release any particular information on request. The instrument does not create a right of access to information analogous to freedom of information. For the PBS administration branch, the instrument facilitates consideration and analysis of medicine availability data to support management of shortages and discontinuations including securing alternative treatments. This implies a right to use the data for those purposes, though the instrument does not expressly authorise further disclosure or commercial use.

The instrument itself does not create any penalties or enforcement mechanisms. It is a specification instrument made under enabling provisions of the Therapeutic Goods Act 1989, and its legal effect is to define what information may be released. The consequences of non-compliance with the instrument would depend on the provision of the Act under which the information is released. If the Secretary releases information that does not fall within the specified kinds, or releases it to a person or body not specified, or for a purpose not specified, then the release may not be authorised by subsections 61(5AA) or 61(5C) of the Act. This could expose the Secretary or the TGA to legal challenge, including potential claims for breach of statutory confidentiality, breach of confidence at common law, or judicial review of the decision to release the information. For recipients of the information, the instrument does not impose any penalty for misuse of the information. However, recipients who are government agencies or employees may be subject to their own statutory secrecy provisions, codes of conduct or employment obligations that restrict how they handle confidential commercial information. For data sources that provide inaccurate or misleading data to the TGA, the instrument does not itself impose penalties, but the underlying Act and other provisions may apply. The instrument deals with release of information, not with the accuracy of the underlying data. If a sponsor provides inaccurate supply data and the TGA releases that data (whether as an individual data set to a government body or as part of an aggregated public release), the sponsor may face reputational harm, but the instrument does not create liability for that outcome. There is no enforcement mechanism in the instrument for ensuring that recipients use the information only for the specified purpose. The purpose limitation in column 4 of the Schedules is a condition on the Secretary's authority to release, not a prohibition on the recipient. If a recipient uses the information for another purpose, that may not invalidate the release, and the instrument provides no remedy for the data source. The practical enforcement risk falls on the TGA: if the TGA releases information outside the specification, it may be acting beyond power, and affected parties could seek injunctive relief or damages, though the instrument provides no private right of action.

The instrument is made under the Therapeutic Goods Act 1989, specifically subsections 61(5AB) and (5D). Section 61 of the Act deals with disclosure of therapeutic goods information and contains a general prohibition on disclosure subject to exceptions. The instrument provides one such exception by specifying kinds of information that may be released. The instrument interacts with the confidentiality provisions in the Act. Subsection 61(5AA) allows release to persons, bodies or authorities if the information is of a kind specified under subsection 61(5AB), to a person or body of a kind specified, for a purpose specified. This instrument provides that specification. Without this instrument, the Secretary would not have statutory authority to release individual data sets or aggregated data sets to the PBS administration branch or aggregated visuals to the various government departments listed in Schedule 1. The instrument also interacts with the PBS provisions in the National Health Act 1953 and related legislation. The PBS administration branch receives the information to facilitate consideration and analysis of medicine availability data to support management of shortages including securing alternative treatments. This may involve decisions about PBS listing of alternative products, authority requirements, special supply arrangements or price determinations. The instrument may interact with the Biosecurity Act 2015 through the involvement of the Home Affairs Department and NEMA, particularly if medicine shortages are linked to biosecurity risks or emergency management responses. The instrument may interact with the Privacy Act 1988 if released information includes personal information. However, the instrument deals with information about medicines and their availability, not about individual patients, so this interaction is likely limited. The instrument may interact with competition and consumer laws. Public release of information about medicine availability, supply deficits and alternative treatments could affect markets for medicines. Sponsors may be concerned about release of commercially sensitive information that could affect their competitive position, pricing strategies or contractual relationships with overseas suppliers. The instrument does not include any confidentiality protections or mechanisms for sponsors to contest release of their data. The instrument may interact with freedom of information laws under the Freedom of Information Act 1982. If information is publicly released under this instrument, it may reduce the scope for FOI exemptions based on confidentiality or commercial sensitivity. Conversely, if the TGA chooses not to release information that the instrument authorises, a party could potentially seek access under FOI, though the instrument does not compel release. The instrument may interact with State and Territory health legislation through the MAWG, which includes representatives of State and Territory health departments who receive aggregated visual data.

This instrument was made on 13 June 2024 by Nicholas Henderson, First Assistant Secretary, Medicines Regulation Division, as delegate of the Minister for Health and Aged Care. It commenced on the day after registration, which given the making date would have been 14 June 2024. As at the date of the instrument, there are no amendments recorded. It is a relatively new instrument and has not been amended since its commencement. The instrument is a legislative instrument for the purposes of the Legislation Act 2003 and is registered on the Federal Register of Legislation. It is a standalone specification instrument that does not amend any other instrument. It is made under specific enabling provisions in the Therapeutic Goods Act 1989 that allow the Minister or delegate to specify kinds of therapeutic goods information that may be released. The instrument's amendment history going forward will depend on whether the TGA or the Department determines that additional categories of information should be released, additional recipients should be added, additional purposes should be specified, or restrictions should be placed on existing authorisations. Given the instrument's purpose to facilitate management of medicine shortages, amendments could be expected if new government bodies become involved in shortage management, if new categories of information become relevant, or if experience reveals that the current specification is too broad or too narrow. The instrument does not contain a sunset or review provision, so it will remain in force unless revoked or amended. Any amendment would need to be made by the Minister or a delegate with authority under subsections 61(5AB) and (5D) of the Act, and would be subject to registration and tabling requirements under the Legislation Act 2003. The instrument could also be disallowed by either House of Parliament within the prescribed disallowance period, which would have the effect of revoking it.

As at the making date of this instrument (13 June 2024), there is no litigation history associated with it. The instrument is a new legislative instrument that has not been the subject of any court proceedings, administrative review or judicial consideration. This is expected given its recent commencement. The absence of litigation history does not mean that litigation will not arise in the future. Potential sources of litigation include challenges by sponsors or other data sources to the release of their commercial supply data, particularly if they consider that the information released contains confidential commercial information that goes beyond what the instrument authorises, or that the release causes competitive harm. Such challenges could be brought as judicial review proceedings under the Administrative Decisions (Judicial Review) Act 1977 or as original jurisdiction proceedings in the Federal Court, arguing that the Secretary exceeded the authority conferred by the instrument or that the instrument itself is invalid because it exceeds the scope of the enabling provisions in the Act. Another potential source of litigation is if a data source claims that the TGA released inaccurate data about their medicine, causing reputational or commercial damage. The instrument does not create any duty of care or standard of accuracy for released information, but a data source might seek to argue that the TGA owed a duty to take reasonable care in releasing information that could cause economic loss. A further potential source is if a competitor or member of the public claims that the TGA should have released information but failed to do so, though the instrument does not mandate release it only authorises it so such a claim would be difficult to sustain. The instrument could also be relevant in proceedings under the Therapeutic Goods Act if the Secretary relies on this instrument to defend a claim that information was unlawfully disclosed. In such proceedings, a court would need to consider whether the released information falls within the kinds specified, whether the recipient is within the specified class, and whether the purpose is within the specified purpose. The instrument is likely to be subject to a narrow construction given that it creates exceptions to statutory confidentiality protections. Any litigation would need to address the interaction between this instrument and the primary provisions of the Act, the scope of the definitions, and the extent of the delegate's power.

Several aspects of this instrument warrant close attention from regulated entities and their advisers. First, the definition of data source is broad and inclusive. It captures not only sponsors and wholesalers but also pharmacies (including presumably individual community pharmacies), State and Territory departments, and private hospitals. Any entity that provides data to the TGA about medicine supply, demand or availability becomes a data source whose individual data set may be released to the PBS administration branch under Schedule 1 item 1. A pharmacy that provides stock level data in response to a TGA request may not expect that its individual data set could be shared outside the TGA. Second, the instrument does not require the TGA to notify a data source before releasing its individual data set to the PBS administration branch. There is no consultation obligation, no opportunity to contest the accuracy of the data, and no mechanism to seek redaction of commercially sensitive information. Third, the aggregated data set and aggregated visual definitions are broad. The aggregated visual may be in report form, live modelling form or any other form. This means the TGA could publish a dynamic, interactive model showing predicted medicine availability over time, built from underlying individual data sets. The aggregated visual is available to a wide range of government bodies including Foreign Affairs, Home Affairs, Industry and NEMA, for the broadly stated purpose of facilitating consideration, analysis and communication of medicine availability data to support management of shortages. Fourth, the public release provisions in Schedule 2 are very broad. Item 1 includes information about predicted future supply and availability of the medicine over time, and estimated supply deficit. This could include forward-looking projections that are inherently uncertain but may be relied upon by competitors, buyers or media as definitive statements. Item 1(d) includes the estimated proportion of the usual or expected supply of the medicine that is available. This could reveal production volumes or capacity utilisation rates that a sponsor considers commercially sensitive. Fifth, the instrument does not limit the form or timing of public release. It does not require the TGA to present the information in a way that protects the identity of individual data sources, though the aggregated nature of much of the information may provide some de facto anonymisation. However, if only one sponsor supplies a particular medicine, an aggregated data set for that medicine effectively reveals that sponsor's data. Sixth, the alternative treatment provisions in Schedule 2 items 3 and 4 include information about the sponsor of the alternative treatment and its predicted future supply and availability. This means that a sponsor of a product that is not itself in shortage may have its supply data publicly released because it has been identified as an alternative to a product that is in shortage. That sponsor has no right to contest that characterisation or the release of its data. Seventh, the instrument does not contain any provision for review, appeal or complaint by affected data sources. If a sponsor believes that released information is inaccurate, misleading or commercially damaging, its only recourse is to seek judicial review or to request that the TGA correct or withdraw the information, which the TGA is not obliged to do under this instrument.

The instrument imposes no direct compliance obligations on regulated entities. It is an authorising instrument for the Secretary, not a regulatory instrument that imposes duties on data sources or other parties. However, entities that provide data to the TGA about medicine supply, demand and availability should take several practical steps to manage the risks arising from this instrument. First, data sources should ensure that the data they provide to the TGA is accurate and up to date. Once the TGA releases information derived from that data to government bodies or the public, correcting any errors becomes difficult and may cause reputational or commercial harm. Data sources should implement internal verification processes before submitting supply data to the TGA. Second, data sources should understand what information they are providing and how it may be used. The instrument authorises release of individual data sets to the PBS administration branch. Data sources should consider whether the data they provide contains information beyond what is necessary for shortage management, such as pricing information, customer details, or manufacturing process details. If so, they may wish to limit the data they provide to the minimum required, or to seek guidance from the TGA about how such information will be treated. Third, data sources should monitor what information the TGA releases to the public under Schedule 2. There is no notification obligation, so data sources should regularly check the TGA website or other public channels for information about their medicines. If a data source considers that publicly released information is inaccurate or misleading, it should contact the TGA promptly to request correction. Fourth, sponsors of medicines that may be identified as alternative treatments should be aware that their supply data may also be released under Schedule 2 items 3 and 4, even if their medicine is not in shortage. They should ensure they are prepared for this possibility and have accurate supply forecasts available. Fifth, recipients of information under Schedule 1 (government bodies, MAWG members, MSAG members, expert advisers) should ensure that they use the information only for the specified purposes. While the instrument does not impose penalties for misuse, using the information for other purposes may breach other statutory obligations or common law duties of confidence, and may affect the willingness of data sources to provide data in the future. Sixth, government bodies that receive information should have appropriate information security and handling protocols in place to prevent unauthorised access or disclosure, particularly given the commercial sensitivity of the data. Seventh, peak bodies that act as data sources should ensure their members are aware that individual data sets provided by the peak body may be released to the PBS administration branch. Member entities may not expect that data provided through a peak body could be shared with government in identifiable form.