Therapeutic Goods (Medicinal Cannabis Products) (Information) Specification 2021

The instrument rests on a small set of statutory and definitional building blocks drawn from the Therapeutic Goods Act and the Regulations. The core concepts are:

• Therapeutic goods information: the term is referenced to subsection 61(1) of the Act by the Definitions section (section 4). The instrument does not redefine the phrase; it specifies particular kinds of that information for release under subsections 61(5C) and 61(5D).

• Relevant product: the instrument defines relevant product to mean a medicinal cannabis product that is the subject of one of four specified application/notification/report types: an authorised prescriber application, an authorised prescriber report, a SAS A notification, or a SAS B application (section 4). The instrument therefore limits its scope to medicinal cannabis products tied to those pathways rather than to registered or listed goods more broadly.

• Authorised prescriber pathway and reports: authorisation is the device under subsection 19(5) of the Act; the instrument uses the term authorised prescriber application for that application and authorised prescriber report for the reports provided to the Secretary under regulation 47B of the Regulations (section 4). Those references locate the data sources in the Act and existing Regulations.

• SAS A and SAS B: the instrument uses the defined terms SAS A notification and SAS B application (section 4). It notes that SAS A notifications are statements made under subparagraph 12A(2)(a)(iii) and sent under subregulation 12A(3) (section 4 note), and that SAS B applications are applications under subsection 19(2) for approvals under paragraph 19(1)(a) of the Act. Thus the data covered are those arising from special access scheme pathways exempting or approving non-registered goods.

• Release mechanism: the instrument specifies kinds of information "for the purpose of subsection 61(5C) of the Act" (section 5). The statutory architecture is that subsection 61(5D) permits the Secretary to specify kinds of therapeutic goods information, and subsection 61(5C) then permits release to the public the kinds so specified (section 5 Note). The instrument therefore converts that statutory permission into a concrete list of releasable categories relating to medicinal cannabis.

• Aggregate, categorical metrics: the Schedule lists counts and categorical breakdowns rather than named or individual-level identifiers. The Schedule focuses on numbers of submissions, counts of practitioners, states/territories, practitioner speciality, patient counts by age range and gender, indications, dosage forms, active ingredient name and strength, Poisons Standard schedule and repeat approval counts (Schedule 1, Column 2). These are structured metrics suitable for aggregation and public reporting.

Together, these concepts produce a unit of public information that is statistical in character, derived from existing administrative pathways for access to medicinal cannabis. The instrument ties the data to specific legal authorities and specified submission types, so that the content and provenance of the eventual published information is unambiguous in statutory terms.

The specification affects a small set of actors directly and broader groups indirectly. The text itself identifies the primary subjects of the data (practitioners and patients) and the decision-maker (the Secretary).

• The Secretary/Department of Health: the Secretary is the statutory decision-maker empowered to release therapeutic goods information under subsection 61(5C) of the Act and is the addressee of the specification (section 3 authority; section 5 specifying kinds). The instrument places an operational burden on the Secretary to collate, classify and, if the Secretary chooses, publish the specified categories of information drawn from authorised prescriber applications and reports, SAS A notifications and SAS B applications (Schedule 1).

• Medical practitioners and health practitioners who submit applications/notifications/reports: the Schedule’s data categories are derived from submissions that practitioners make under existing statutory/regulatory processes. The specification therefore affects practitioners in that their aggregate behaviours (numbers of submissions, practice location, speciality) and the patient counts associated with their submissions may appear in public statistics (Schedule 1 subitems referring to number of practitioners, states/territories, specialty and patient counts by age/gender). The instrument does not, however, create new individual reporting obligations; it relies on already-existing authorised prescriber and SAS reporting and application mechanisms (see section 4 definitions).

• Patients receiving medicinal cannabis products: patients are affected indirectly because counts and categorical data derived from their treatment episodes (age bands, gender, indications) are among the specified releasable kinds (Schedule 1). The instrument does not specify individual-level identifiers, but it does permit public release of aggregated demographic and clinical categories tied to medicinal cannabis access pathways.

• Pharmaceutical industry, manufacturers and suppliers of medicinal cannabis products: the Schedule specifically includes active ingredient name and strength and dosage forms (Schedule 1). Public release of such product-level activity data can be used by market participants to assess demand, prevalence of use patterns and repeat approvals. The instrument therefore affects commercial actors who monitor or respond to data on product usage.

• Researchers, journalists, policy-makers and state/territory regulators: the Schedule includes geographic breakdowns (states and territories) and practitioner specialty that are of direct use for research, reporting and regulatory oversight. These groups are indirectly affected because the instrument permits public access to the specified categories.

• Entities handling the Poisons Standard: the Schedule explicitly references the schedule to the current Poisons Standard (SUSMP Schedule) for substances contained in relevant products (Schedule 1). That ties releaseable metric categories to classification status in the Poisons Standard, which is of interest to those who monitor scheduling decisions.

Who pays: the instrument does not impose new fees but does allocate operational work and resource burdens. The Department must extract and prepare the specified categories for public release if it chooses to do so. Practitioners do not incur new statutory reporting duties created by this instrument; their routine submissions remain the source material. Patients incur no new direct obligations under this text, though their de-identified characteristics may be included in publicly released aggregates.

Who decides: the Secretary decides whether, when and how to publish the specified kinds of information under subsection 61(5C); the instrument only specifies the kinds that may be released (section 5 and Note).

This instrument does not create new duties, rights, or offences for private persons; instead it specifies the kinds of therapeutic goods information that the Secretary may publicly release. The key legal consequences follow from the interaction between this specification and the relevant subsections of the Therapeutic Goods Act 1989.

• Duty of the Secretary to observe statutory limits: the specification operates under subsection 61(5D) and for the purpose of subsection 61(5C) of the Act (section 3 authority; section 5). The Secretary has the ability, within that statutory framework, to release public information of the kinds listed. The instrument does not itself say the Secretary must publish; it sets out what the Secretary may disclose under the Act. The Secretary therefore has the right and discretion to publish these categories but not a statutory duty to do so arising from this instrument alone (section 5 and Note).

• No new reporting duties on practitioners or patients: the instrument refers to existing submission types , authorised prescriber applications and reports, SAS A notifications and SAS B applications , that are created by the Act and Regulations (section 4). The instrument does not add reporting obligations or change the content of those submissions. Practitioners’ obligations remain those in the Act and the Regulations (see references to subsection 19(5), regulation 47B, Regulation 12A and subsection 19(2) in section 4 notes). The instrument does not amend those provisions or prescribe new fields to be collected.

• Right to aggregate information release: the Schedule specifies categories of aggregated information , counts by time period, pathway, status, practitioner numbers, practitioner jurisdiction and specialty, patient counts by age range and gender, indications, dosage forms, active ingredient name and strength, Poisons Standard schedule, and repeat approval patient counts (Schedule 1, Column 2). The Secretary is authorised to publish these kinds of aggregated metrics, subject to the wider statutory provisions governing release in subsection 61(5C) and any other applicable law.

• Interaction with confidentiality and privacy frameworks: the instrument does not itself specify privacy safeguards, suppression thresholds, or de-identification standards. It specifies categories that are generally statistical and aggregate in nature, but it does not, for example, prohibit small-cell reporting. Therefore any duty to protect personal information when publishing will derive from other legal instruments, policies or practices, not from this specification text. The instrument’s silence on privacy is a material point: it sets out the categories without prescribing how to aggregate or anonymise them.

• No novel remedies or penalties: the instrument contains no penalty, enforcement or remedy provisions. It does not create a private right to compel disclosure; instead it enables the Secretary to release the specified kinds under the Act. Any rights of access or complaint about published information will look to other statutory frameworks (the Act, the Regulations, and privacy/FOI regimes) and are not created by this instrument.

• Defined scope limits duties and rights to medicinal cannabis access pathways: the specified categories apply to medicinal cannabis products that are the subject of the listed application/notification/report types (section 4 definition of relevant product). That limits the Secretary’s authorised release under this instrument to statistics arising from those pathways, not to broader datasets on registered or listed therapeutic goods unless those are captured through the listed submission types.

In sum, the specification modifies the universe of therapeutic goods information that the Secretary may publish by delineating specific, categorical metrics. It places no new statutory obligations on practitioners or patients but creates an authorising ground for public release of certain aggregated metrics by the Secretary.

The instrument contains no penalty provisions and does not alter enforcement regimes in the Act or Regulations. There are three relevant points to note from the instrument itself.

First, the specification does not create offences. Its operative content is descriptive , it identifies kinds of therapeutic goods information authorised for public release , and it contains no clauses establishing contraventions or civil penalties. The absence of penalty provisions in this instrument means that no enforcement mechanism is introduced by the instrument itself.

Second, enforcement of any duties related to the underlying submissions (authorised prescriber applications, authorised prescriber reports, SAS A notifications, SAS B applications) remains governed by the Act and the Regulations referenced in the Definitions (section 4). The specification references those instruments (for example, subsection 19(5) of the Act, regulation 47B, Regulation 12A and subsection 19(2) of the Act) but does not modify compliance obligations or sanctions associated with those provisions.

Third, the instrument enables the Secretary to release information (section 5) but does not set out a statutory obligation to publish, nor does it prescribe a process for rectification, confidentiality protections, or appeal rights in relation to published material. If a person sought a remedy for a misuse of published information or for an incorrect or privacy-invasive release, any enforcement mechanism or legal remedy would need to be sought under other applicable laws, such as privacy legislation, the general powers of the Secretary under the Act or possibly administrative law avenues. Those pathways are not created or modified by this specification.

Consequently, from the text of the instrument: there are no new penalties to be enforced; the Secretary remains the decision-maker on release; and compliance and enforcement questions arising from the handling of underlying submissions or from the publication of the specified categories are governed by the existing statutory and regulatory framework rather than by this instrument.

The instrument is tightly integrated with the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990 by design. It also references the Poisons Standard. The instrument’s own notes and definitions point to specific provisions and instruments that determine both its scope and practical application.

• Therapeutic Goods Act 1989: the instrument is expressly made under subsection 61(5D) of the Act (section 3). Section 5 states the specified kinds are for the purpose of subsection 61(5C) of the Act, and a Note in section 5 explicitly states that kinds specified under subsection 61(5D) may be released by the Secretary under subsection 61(5C). The instrument therefore functions as an implementing specification within the Act’s information-release architecture.

• Therapeutic Goods Regulations 1990: the Definitions section (section 4) imports multiple Regulation references. It adopts the Regulations’ meaning for active ingredient, medicinal cannabis products, SAS A notification, and SAS B application; it references regulation 47B as the provision under which authorised prescriber reports are provided to the Secretary. The instrument relies on these regulatory definitions to delimit what counts as a relevant product and what sources the Secretary may draw on for the specified categories.

• Poisons Standard (SUSMP): Schedule 1 requests that one of the data dimensions be the "schedule to the current Poisons Standard...in which a substance contained in the relevant products is included" (Schedule 1). That creates an explicit line between therapeutic goods statistics and the scheduling framework used for poisons and controlled substances. Any public information released under this specification must map active ingredients in products to the relevant Poisons Standard schedule in effect at the time.

• Privacy and confidentiality laws: the instrument does not reference privacy legislation or FOI. The specification lists aggregate categories (counts by age range, gender, practitioner location etc.), and these categories are statistical in nature. However, the instrument does not stipulate anonymisation standards, small-cell suppression thresholds or statutory protections against releasing identifying information. Therefore publication decisions will intersect, but are not harmonised here, with the Privacy Act 1988 and any departmental privacy policies or other statutory protections. The instrument is silent on these interactions; any operational obligations under privacy law will continue to exist independently of the specification.

• Existing authorised prescriber and SAS regimes: the instrument draws data from regimes governed by other parts of the Act and Regulations (such as subsection 19(5), regulation 47B, Regulation 12A and subsection 19(2)). It does not change the rules governing access via those pathways, nor does it change their compliance or enforcement mechanisms. It instead allows statistical outputs from those regimes to be released publicly under the Act’s information-release powers.

• Administrative law and record-keeping obligations: while the specification does not amend record-keeping or administrative obligations explicitly, it assumes that data required to produce the specified categories are captured in the course of existing submissions. If the Secretary or the Department chooses to publish these categories regularly, that decision may impose operational record-keeping burdens consistent with other statutory obligations, but those burdens arise from the practical need to prepare data rather than from new statutory record-keeping requirements in the instrument itself.

Overall, this instrument sits within the Act/Regulations ecosystem as a definitional and authorising specification for public release of certain aggregated statistics derived from existing authorised prescriber and SAS pathways, and it must be read in conjunction with the Act (s 61), the Regulations (reg 47B, reg 12A, and other cited provisions), and the Poisons Standard for correct interpretation and implementation.

The instrument includes limited amendment-history information within its own commencement section. The text indicates:

• Instrument identity and date: the instrument is the Therapeutic Goods (Medicinal Cannabis Products) (Information) Specification 2021 and is dated 4 August 2021 (front matter and signature block).

• Commencement timing: section 2(1) sets the commencement of the whole instrument as the day after the instrument is registered. The commencement table is the only operative commencement detail; it also contains a note that the table relates only to provisions of the instrument as originally made and will not be amended to reflect later amendments (section 2(1) Note).

• Non-substantive editorial note: section 2(2) states that any information in column 3 of the commencement table is not part of the instrument and that such information may be inserted or edited in any published version. That is an administrative clarification about the published instrument’s metadata and does not affect substance.

• Authority: section 3 states the instrument is made under subsection 61(5D) of the Therapeutic Goods Act 1989. The instrument therefore records its enabling provision.

• No subsequent amendments recorded in the text provided: the instrument as supplied contains no amendment schedule, amending instrument references, or later dates. There is no recorded later amending instrument or versioning within the supplied text. The instrument’s own note that the commencement table will not be amended to reflect later amendments indicates the drafter’s intent regarding how the printed commencement table should be treated in the future, but does not itself record any amendments.

• Schedule and operative content: Schedule 1 is presented as the instrument’s specified kinds of information. There is no separate clause altering or reserving rights to amend Schedule 1 in future; any change to the kinds of information would be effected by a later specification made under subsection 61(5D) or by amendment to this instrument, but no such amendment is contained in the instrument provided.

In short, within the supplied document the amendment history consists of its original making on 4 August 2021 and the commencement note that it commences the day after registration. There are no later amendments, repeals, or historical variations recorded in this text.

The instrument itself contains no litigation history, and it does not name any court decisions or judicial consideration. The text makes no reference to past or pending litigation in its notes, preamble or operative provisions. It is a specification made under subsection 61(5D) that defines kinds of information the Secretary may release; such administrative specifications are not, in the instrument, accompanied by references to cases or litigation.

Therefore, based solely on the text provided, there is no litigation history to report, and no judicial authorities are cited or invoked in the instrument. Any legal disputes concerning the specification’s operation, interpretation or subsequent use of the released information would be matters arising after publication and are not recorded in this instrument.

The specification is concise, but several practical issues arise from what it says and what it does not say. These are points that practitioners, departmental officials, researchers and industry observers should note, grounded in the instrument’s text.

• The Secretary’s power to release is permissive, not obligatory: the instrument specifies kinds of information "for the purpose of subsection 61(5C)" (section 5). It does not compel publication or set a timetable, frequency, or format for publication. The Secretary retains discretion whether and how to publish the specified categories.

• The specification lists aggregate categories but does not specify privacy safeguards: Schedule 1 requests counts broken down by age ranges, gender, practitioner location and speciality, indications, and product-level details such as active ingredient name/strength. The instrument does not include rules about anonymisation, minimum cell sizes, suppression of small counts or other privacy-protecting measures. The absence of those instructions means publication practice must be reconciled with privacy obligations that exist outside this instrument.

• Undefined granularity for "time period" and "age range": Schedule 1 allows breakdowns "by reference to one or more of the following: a time period; ... the numbers of patients ... by age range" (Schedule 1). The instrument does not define the granular units of time or the specific age bands to be used. That lack of precision creates potential inconsistency and administrative choice about how to bin data for public release.

• No format, frequency or methodology mandated: the instrument does not require how the statistics should be compiled, standardised or updated. It also does not specify whether the counts are cumulative, annual, quarterly, or otherwise. This gap may lead to variation over time in how the Secretary chooses to report the categories.

• Potential for small-number identification: Schedule 1 asks for breakdowns by state/territory and practitioner speciality in conjunction with practitioner counts and patient counts. In jurisdictions or specialties with small numbers of practitioners or patients, granular reporting could risk re-identification. The instrument does not address this risk.

• Product-level commercial sensitivity: Schedule 1 includes active ingredient name and strength and dosage form as permitted categories. Such information, when paired with counts and repeat-approval counts, has potential commercial value to manufacturers and competitors. The instrument does not frame how commercial-in-confidence considerations are to be managed.

• Scope limited to specified access pathways: the specified kinds relate only to medicinal cannabis products that are the subject of authorised prescriber applications/reports, SAS A notifications or SAS B applications (section 4 definition of relevant product). The instrument therefore omits statistics on registered or listed medicinal cannabis products or other pathways unless those happen to be captured in the specified submission types.

• Dependence on data quality of existing submissions: the categories to be published will be as reliable as the source data in authorised prescriber applications/reports and SAS notifications/applications. The instrument assumes those submissions capture the relevant fields (indication, age range, gender, active ingredient nomenclature, dosage form, practitioner specialty), but does not amend or standardise those forms. Data completeness and coding consistency risks may affect the usability of published statistics.

• No cross-references to privacy or FOI: the instrument is silent on how it interacts with privacy or Freedom of Information regimes. That silence does not override those regimes, but it does leave operational questions unresolved within this text.

These "gotchas" are concrete, text-based observations: the instrument authorises public release of particular categories of data (Schedule 1) but does not resolve key methodological, privacy or publication practice questions that will determine how the data are actually presented and interpreted.

Compliance, in the context of this specification, splits into two operational streams: what practitioners and applicants should continue to do, and what the Secretary/Department will need to do in order to produce the permitted public outputs.

For practitioners and applicants (medical practitioners, authorised prescribers, and those using SAS A/B pathways)

• Continue to make authorised prescriber applications, authorised prescriber reports and SAS A and SAS B submissions in accordance with the Act and Regulations. The specification draws its data from those existing submissions and does not add new statutory reporting obligations (see section 4 definitions and section 5).

• Ensure submissions accurately capture the fields that are likely to be aggregated and published: Schedule 1 anticipates reporting by indication, dosage form, active ingredient name and strength, age range and gender of patients, and practitioner speciality and location. Practitioners should therefore ensure those fields are complete and coded consistently on authorised prescriber forms and SAS submissions, to the extent those forms already collect the information.

• Maintain careful record-keeping and privacy compliance: because the instrument contemplates public release of aggregated patient demographics and clinical indications, practitioners should ensure they comply with existing privacy obligations when preparing reports and submissions under the Act and the Regulations. The instrument itself does not change privacy obligations, but published aggregates will be derived from practitioners’ submissions.

For the Secretary and Departmental data teams

• Identify source fields and data provenance: map fields from authorised prescriber applications, authorised prescriber reports (regulation 47B), SAS A notifications (subparagraph 12A(2)(a)(iii) and subregulation 12A(3)) and SAS B applications (subsection 19(2) and paragraph 19(1)(a)) to the categories set out in Schedule 1. This includes establishing standard lists for practitioner speciality, dosage form, indications coding and mapping active ingredients to the Poisons Standard schedules.

• Decide publication frequency, format and time-period bins: the Schedule allows breakdowns "by reference to one or more of the following: a time period" and "numbers of patients ... by age range". Decide and document the time unit(s) (e.g. quarterly, annual) and the age bands to be used consistently across releases. The instrument does not mandate these choices, so an explicit methodology should be adopted and published.

• Implement de-identification and small-cell suppression policies: because the Schedule requests demographic and geographic breakdowns, the Department should adopt and disclose a privacy-protecting policy for statistical releases (minimum cell sizes, aggregation thresholds, or other suppression rules). The instrument does not dictate such safeguards, but they are a practical compliance step given existing privacy obligations external to the instrument.

• Establish product classification and mapping procedures: Schedule 1 calls for the name and strength of active ingredients and the Poisons Standard schedule for substances in relevant products. Build a process to normalise active ingredient nomenclature (e.g. standardised names and strength units), map product formulations to dosage form categories, and link substances to the current Poisons Standard schedule, ensuring updates when the Poisons Standard changes.

• Capture repeat-approval counts for SAS B: the Schedule specifically requires the number of patients for whom repeat approvals for a SAS B application have been granted. Departmental systems must therefore be able to track approvals and repeat approvals at the patient level in an aggregated, non-identifying way.

• Publish methodology alongside statistics: because the instrument does not fix definitions for time periods or age ranges, publish a methodology note with each release explaining definitions, data sources, processing steps, suppression rules, update cadence, and known data limitations. This improves transparency and reduces misinterpretation of the figures authorised by the instrument.

• Assess commercial and regulatory sensitivities: active ingredient and dosage-form level counts may have commercial significance. Develop a policy for handling commercially sensitive information that remains consistent with the Act’s public release powers and with other legal obligations. The instrument does not provide carve-outs for commercial-in-confidence information.

• Maintain governance and audit trails: ensure there are documented audit trails for the data extracts and processing steps used to produce public statistics, so published figures can be traced back to source applications/notifications/reports should questions arise.

By following these steps, practitioners will remain compliant with the submission regimes from which the Secretary may draw data, and the Secretary/Department will be positioned to publish the categories specified in Schedule 1 in a manner that addresses privacy, methodological consistency and operational accuracy. The instrument itself does not prescribe these detailed compliance steps; it defines the permissible categories (section 5 and Schedule 1). Implementing them responsibly requires operational choices in line with broader legal obligations.