Therapeutic Goods (Advisory Committees—Information Sharing) (Information) Specification 2023

The instrument rests on several tightly specified concepts drawn partly from the Act and partly defined within the instrument. Core concepts and how the instrument uses them are:

• Therapeutic goods information: The instrument uses the statutory term “therapeutic goods information” as defined by subsection 61(1) of the Act (see section 4). The specification does not restate that definition; it relies on the Act for its scope and meaning.

• Advisory committee and advisory committee advice: The instrument defines “advisory committee” as those committees established under Part 6 of the Regulations and as including previously established committees (section 4). “Advisory committee advice” is defined to mean advice or recommendations provided by an advisory committee to the Minister or the Secretary in relation to a matter or item considered at an advisory committee meeting (section 4). Schedule 1, column 2 explicitly lists “advisory committee advice” among the kinds of material that may be released.

• Kinds of material: Schedule 1, column 2 enumerates the authorised categories: (a) advisory committee advice; (b) agenda papers for advisory committee meetings; (c) meeting statements; and (d) minutes of advisory committee meetings. The instrument therefore authorises release of both formal outputs (advice, meeting statements) and internal or preparatory materials (agenda papers, minutes).

• Relevant persons or bodies: The instrument provides a specific list of recipients in section 4. That list includes the named advisory committees (ACB, ACCS, ACCM, ACMD, ACM, ACMS, ACV, MDHTAC, MSAC, PBAC), specified clinical advisory groups (for cardiac, cardiothoracic, hip, knee, ophthalmic, specialist orthopaedic, spinal, vascular prostheses), ATAGI, NCIRS, NIC, the AOANJRR, and related subcommittees and registries (see section 4). The instrument treats employees, members and agents of these bodies as within the class “relevant persons or bodies.”

• Permitted purpose: Schedule 1, column 4 narrowly frames the authorised purpose as facilitating sharing and consideration of information in the interests of public health and safety. It adds an illustrative scope “including information relating to: (a) the safety of therapeutic goods; or (b) the efficacy or performance of therapeutic goods.” The express purpose anchors authorised disclosure to public health and safety considerations tied to product safety, efficacy and performance.

• Permissive release power: The instrument repeatedly uses permissive wording. Section 5 authorises that “the kinds of therapeutic goods information specified in column 2 may be released” to persons or bodies in column 3 for purposes in column 4. The Secretary’s power to release therefore exists as an authorisation under subsection 61(5AA) and the instrument under subsection 61(5AB), but the text does not impose a mandatory duty to disclose.

• Repeal of earlier instrument: Schedule 2 repeals the 2017 specification in full. The new instrument supplants the earlier text from its commencement date (section 6, Schedule 2).

These concepts structure what is transferable, who the authorised recipients are, and for what public‑health purposes disclosure is authorised. The instrument ties the scope of disclosure to committee‑related materials rather than to a broader class of departmental records, and it identifies a bounded set of recipient organisations rather than open public disclosure.

The instrument affects several identifiable actors through its authorisation of disclosure. The affected groups and the nature of impact for each are set out below, with the instrument citations that establish their relevance.

• The Secretary of the Department of Health and Aged Care: The Secretary is the decision‑maker for release under subsection 61(5AA) as enabled by this specification. The instrument is made under subsection 61(5AB) of the Act (section 3) and section 5 explicitly connects to subsection 61(5AA). Practically, the Secretary holds the administrative authority to release the listed kinds of information to the listed recipients for the stated purposes.

• The Minister for Health and Aged Care: Advisory committee advice is defined as advice provided to the Minister or the Secretary (section 4). While the instrument does not change the Minister’s statutory decision‑making powers, the Minister is a recipient of advice whose content may be shared further with the listed bodies under the instrument.

• Advisory committees and their members: The instrument defines “advisory committee” to include the committees established under Part 6 of the Regulations and previously established committees (section 4). It expressly addresses material that relates to advisory committees, including agenda papers and minutes (Schedule 1, column 2). Members, employees and agents of advisory committees may be affected by the authorised disclosure of internal materials, as their deliberations and committee documents are the subject matter of authorised release.

• Named recipient bodies and their personnel: The instrument lists a comprehensive set of recipient bodies in section 4 as “relevant persons or bodies.” These include specific standing advisory committees (for example PBAC, MSAC, ATAGI), registries (AOANJRR), national immunisation bodies (NCIRS, NIC), and multiple clinical advisory groups for various prostheses and devices. Employees, members and agents of those listed bodies are treated as potential recipients for the specified materials (section 4, Schedule 1, column 3).

• Departmental and committee staff who prepare or hold agenda papers, minutes and meeting statements: Because agenda papers and minutes are defined as categories of material that may be released (Schedule 1, column 2), staff who generate and manage those records may see a change in how those records are handled administratively, including the potential for sharing beyond the immediate committee and departmental environment.

• Persons or entities relying on confidentiality or restricted access to committee deliberations: The instrument authorises release of internal committee documents to named bodies for public health and safety purposes. Although the instrument itself does not create new statutory obligations for private parties, persons who previously regarded certain advisory committee papers as confidential will find that the Secretary may lawfully disclose them to the specified recipients (section 5, Schedule 1).

• Holders or sponsors of therapeutic goods: The instrument frames permissible disclosure around information “in the interests of public health and safety,” including safety, efficacy or performance of therapeutic goods (Schedule 1, column 4). Sponsors and manufacturers whose products are the subject of committee advice or minutes could be indirectly affected if committee material concerning their products is shared with the listed bodies.

• Parties previously subject to the 2017 Specification: The prior specification named in Schedule 2 is repealed (section 6, Schedule 2). Entities that had adapted administrative processes under the 2017 instrument will be affected by that repeal and by the replacement structure set out in this 2023 specification.

The instrument therefore concentrates its direct effects on departmental decision‑makers (the Secretary), advisory committees and their records, and a closed list of national advisory bodies and registries that may receive committee materials for stated public health purposes. The authority does not extend a general public right of access, but it enlarges the universe of internal recipients beyond the Minister and the Secretary by naming specific external advisory and expert bodies.

The specification creates and clarifies a narrow set of administrative rights and permissive duties. It does not establish new civil or criminal penalties, nor does it create explicit private rights of action. The operative duties and rights arising from the instrument are as follows, with direct textual grounding.

• Right of the Secretary to release specified materials: Section 5 together with Schedule 1 authorises the Secretary to release the specified kinds of therapeutic goods information to the listed persons and bodies for the stated purposes. The instrument therefore creates an administrative right in the Secretary to disclose those materials, grounded in the Act under subsection 61(5AA) and made operative by the instrument under subsection 61(5AB) (see section 3 and section 5).

• Nature of the released materials: Schedule 1, column 2 specifies the kinds of information that may be released: advisory committee advice, agenda papers, meeting statements, and minutes. This defines the class of committee materials that fall within the Secretary’s authorised release power.

• Recipient classes and identities: Section 4 identifies the recipients (Schedule 1, column 3). The instrument treats employees, members and agents of those bodies as included. The named list is effectively the catalogue of entities that may lawfully be recipients under the instrument.

• Purpose restriction on release: Schedule 1, column 4 restricts the permitted purpose to facilitating sharing and consideration of information that is in the interests of public health and safety, including safety, efficacy or performance of therapeutic goods. This language qualifies the Secretary’s authorisation: release is authorised for those purposes.

• Permissive rather than mandatory disclosure: The specification uses permissive language , “may be released” (section 5). That wording means the instrument confers discretion rather than imposes a binding duty to disclose in every case where a listed item exists. The Secretary has the discretion whether to release a specified item to a specified recipient for a specified purpose but may do so lawfully if the conditions are met.

• Reliance on Act and Regulations for definitions and context: The instrument invokes definitions in section 3 of the Act (section 4) and treats advisory committees as those established under Part 6 of the Regulations (section 4). Where the instrument uses statutory terms (for example “therapeutic goods information”), the rights and duties depend on their statutory definitions.

What the instrument does not do, by its text:

• It does not create a new statutory right in recipients to demand disclosure. The authorised releases are at the Secretary’s discretion.

• It does not specify administrative procedures for release, such as steps for approval, redaction requirements, timings, or record‑keeping, within its text. Nor does it impose procedural obligations on advisory committees to produce different kinds of papers.

• It does not state any conditions extinguishing existing protections (for example confidentiality obligations or privacy requirements), nor does it refer to Freedom of Information processes, privacy legislation, or commercial confidentiality exceptions.

Users and advisers should therefore treat the specification as creating an executive discretion to disclose the listed categories of committee materials to the listed recipients for public health and safety purposes, rather than as imposing mandatory disclosure duties or conferring enforceable private rights to obtain those materials.

The specification contains no express penalties, sanctions, enforcement mechanisms, or statutory offences. The instrument is an authorising administrative specification and does not establish an enforcement regime within its text. The following points summarise the enforcement‑related features and the gaps that the instrument leaves:

• No express criminal or civil penalties: The instrument does not create any offence for failing to disclose, nor any penalty for unauthorised disclosure within its text. Section 5 authorises disclosure; it does not criminalise non‑disclosure or set out penalties for disclosure outside the authorisation.

• Secretary’s administrative control: The practical enforcement mechanism for compliance with the instrument is internal administrative control exercised by the Secretary and departmental staff. The Secretary holds the discretion to release material in accordance with the instrument (see section 5). Where particular releases are made, compliance will be measured against the specification’s categories and purposes.

• No external enforcement body named: The instrument does not name an external regulator or agency charged with enforcing compliance with the specification. There is no specified inspector, auditor, or statutory complaint mechanism within the text. Enforcement therefore remains within the ordinary departmental governance and legal frameworks applicable to the Secretary and the Department.

• Repeal of prior specification: The instrument repeals the 2017 specification in full (section 6, Schedule 2). Where the earlier instrument included any administrative or process detail, those would have been removed by repeal; the new instrument does not replace such detail within its text.

• Interaction with broader legal obligations not set out: The instrument does not purport to displace or clarify the interaction with other laws that provide enforcement mechanisms, such as privacy, confidentiality obligations or Freedom of Information legislation. The specification is silent on whether releases authorised under it are to be treated differently in those contexts.

• Administrative accountability: In the absence of statutory penalties, the principal accountability routes for the Secretary’s exercise of discretion would be the standard public law remedies available under general administrative law: review of administrative decisions, judicial review for jurisdictional error, or statutory complaint mechanisms outside the specification where available. The instrument itself does not establish or alter those remedies.

In short, enforcement in the context of this specification is administrative and internal. The instrument authorises action but does not create a parallel penalty or enforcement architecture within its text. Any question about unauthorised disclosure or the misuse of disclosed material would need to be addressed under other laws and departmental governance arrangements, which the instrument does not modify in its text.

The specification expressly situates itself within the Therapeutic Goods legislative framework and points to the Regulations for aspects of committee establishment and statutory definitions. The instrument’s own text makes the following interactions explicit and leaves other interactions unstated.

• Authority derived from the Act: The instrument is made under subsection 61(5AB) of the Therapeutic Goods Act 1989 (section 3). Section 5 refers to subsection 61(5AA) of the Act as the operative statutory provision enabling the Secretary to release therapeutic goods information to specified persons or bodies for specified purposes. Therefore the specification operates as an instrument under the Act and must be read together with subsections 61(1), 61(5AA) and 61(5AB) of the Act for full legal effect. The instrument also relies on section 3 of the Act for several definitions (section 4).

• Reliance on the Regulations for committee establishment: The instrument defines “advisory committee” by reference to committees established under Part 6 of the Regulations (section 4). This means the set of committees covered by the specification is coextensive with, or dependent on, the committees that exist under the Regulations. Any changes to committee structures in the Regulations will affect which bodies are within the ambit of the specification.

• Repeal of the 2017 specification: Schedule 2 repeals the Therapeutic Goods Information (Sharing of Committee Information) Specification 2017 (section 6). The repeal places this specification as the operative instrument for release of committee information under subsections 61(5AA) and 61(5AB) following commencement. Any transitional or process details formerly captured by the 2017 specification are not preserved in this text.

• No express interaction with privacy and confidentiality law in the text: The specification does not mention privacy laws, secrecy provisions, or how authorised disclosure under the specification interacts with other statutory protections such as privacy legislation, Protected Information provisions, or contractual confidentiality obligations. The absence of such cross‑references in the instrument means that any interaction must be resolved by reference to the Act, the relevant privacy and confidentiality statutes, contractual terms, or departmental policy, none of which are altered or addressed in the instrument itself.

• No express relation to Freedom of Information (FOI): The instrument does not provide that disclosures under the specification supplant FOI processes, nor does it declare that materials authorised for release are exempt or non‑exempt from FOI. The specification therefore leaves open the normal operation of FOI laws in relation to committee materials, subject to those laws and to any other statutory exemptions.

• Administrative law overlay: Because the instrument grants a discretionary power to the Secretary, the Secretary’s exercise of that discretion will remain subject to public law principles (for example reasonableness, absence of jurisdictional error) outside the instrument’s text. The instrument does not restrict or expand those principles; it simply sets the scope of authorised disclosure.

• Relationship with departmental governance and document handling: The specification does not amend departmental recordkeeping or document handling statutes. Practical interaction with record retention, classification, and release procedures will be managed within departmental policy frameworks that are external to the instrument.

Overall, the specification is tightly targeted to implement a statutory authorisation in the therapeutic goods legislative framework. It defines who may receive what committee materials and for what purposes, but it does not expressly address interaction with privacy, FOI, contractual confidentiality or other statutory regimes in its terms. Those interactions therefore require cross‑referencing with the Act, the Regulations, and other applicable laws and policies.

The specification contains a concise amendment and commencement record within its own text. The elements of amendment history and immediate predecessor instruments are:

• Date of instrument and making: The instrument is dated 7 June 2023 and was made by Chris Bedford, acting First Assistant Secretary, Regulatory Practice and Support Division, Health Products Regulation Group, Department of Health and Aged Care (cover page).

• Commencement: Section 2 contains the commencement table. The whole instrument commenced on 1 July 2023 (section 2(1) and the commencement table). The table notes that it represents the instrument as originally made and will not be amended subsequently in the instrument text.

• Authority and statutory basis: Section 3 records that the instrument is made under subsection 61(5AB) of the Therapeutic Goods Act 1989. The instrument therefore functions as the statutorily authorised specification referred to in that provision.

• Repeal of the 2017 instrument: Section 6 and Schedule 2 expressly repeal the Therapeutic Goods Information (Sharing of Committee Information) Specification 2017 in full. Schedule 2 itemises the repealed instrument and indicates that “The whole of the instrument” is repealed. The effect is that, from 1 July 2023, the 2017 specification is no longer in force.

• Definitions and continuity with the Act: Section 4 of the instrument notes that several expressions used are defined in section 3 of the Act, and it imports those definitions by reference. It also defines a number of instrument‑specific terms, and enumerates the “relevant persons or bodies.” This approach creates continuity with the Act while updating the list of recipients and the specific authorised materials.

• No subsequent amendments recorded in the instrument: The text contains no later amendment schedule or amendment history entries beyond the repeal noted in Schedule 2 and the commencement table. If the instrument were subsequently amended, that would appear in an amended version or in the Federal Register of Legislation as a separate amendment instrument; the instrument itself contains only its original making and repeal of its predecessor.

Taken together, the instrument is a single, self‑contained replacement for the 2017 specification, commencing 1 July 2023 and continuing the statutory authorisation under subsection 61(5AB) of the Act. The instrument does not itself indicate plans for future amendments, nor does it list transitional provisions beyond the repeal. Any subsequent change to the list of recipients, the categories of information, or the permitted purposes would require a further specification under the enabling Act.

The specification contains no litigation history, case citations, or references to judicial decisions within its text. The instrument is an administrative specification made under subsection 61(5AB) of the Act; it does not record or reference any legal proceedings, judicial interpretations, or precedent. The document’s text therefore provides no account of litigation, challenges, or judicial review relating to either this specification or the repeal of the 2017 instrument.

Practical implications of the absence of litigation history in the text:

• No statutory record of disputes: The instrument does not document prior disputes over the sharing of advisory committee information, nor does it attach interpretive guidance derived from case law within its text. Any legal questions about its meaning or application therefore would be resolved by applying the instrument and the Act to the facts, and, if contested, through ordinary administrative or judicial processes external to the instrument.

• Administrative discretion and potential for review: Because the specification authorises discretionary release by the Secretary and does not itself set out an enforcement or appeals mechanism, disputes about the exercise of that discretion (for example refusal to release material, or alleged unlawful disclosure) would be managed through existing administrative law remedies, which are not described in the instrument.

• No recorded judicial interpretation of defined terms: The instrument relies on statutory terms in the Act (for example “therapeutic goods information”) and on the Regulations for advisory committee definitions. The instrument does not indicate that those definitions have been the subject of litigation or that their scope has been judicially clarified in the context of committee information release.

• Absence of litigation entries means due diligence required: Parties needing to understand the legal effect of the specification must review the Act and Regulations, and where necessary consider seeking legal advice or pursuing statutory review routes if disputes arise. The instrument itself provides no procedural or authoritative litigation trail.

In short, the instrument contains no litigation history and no guidance drawn from litigation. Any litigated questions about the specification’s application will therefore need to be resolved by reference to the instrument together with the Act, the Regulations, and applicable administrative law principles.

The instrument appears simple at first reading, but several features create operational and legal pitfalls that advisers and practitioners should note. Each item below is grounded in the instrument’s text.

• “May be released” is discretionary, not mandatory (section 5). The Secretary’s power is permissive. That means recipients should not assume an entitlement to receive committee materials; instead the Secretary may, at their discretion, release them. A failure to receive materials is not a statutory contravention of the instrument because the instrument does not impose a mandatory disclosure duty.

• The specification authorises release of internal and preparatory materials (Schedule 1, column 2). Agenda papers and minutes are included alongside formal advice and meeting statements. These documents can contain substantive deliberations, draft assessments, or sensitive material. The instrument authorises release of those internal record types to the listed recipients, which broadens the set of internal materials that can lawfully circulate beyond the immediate committee and departmental environment.

• The recipient list is closed and specific, not open‑ended (section 4 and Schedule 1, column 3). The specification names particular committees, registries and advisory bodies as recipients, and includes employees, members and agents of those bodies. Materials are authorised to be released to those named entities or kinds of persons, but the specification does not authorise release to unlisted third parties. If a party seeks disclosure outside the listed recipients, the Secretary’s power under this specification will not, on its face, permit that.

• The permitted purpose is specific: public health and safety, including safety, efficacy or performance (Schedule 1, column 4). The instrument does not authorise release for broader purposes such as commercial advantage, litigation, or general research unless those purposes can be characterised as facilitating sharing and consideration of information in the interests of public health and safety and concern safety, efficacy or performance of therapeutic goods.

• The instrument is silent on privacy, confidentiality and FOI interactions (sections 4 and 5; Schedule 1). It does not state how disclosures authorised by the specification will be treated under privacy law or Freedom of Information law, or whether redaction or confidentiality protections apply. Parties should not assume that authorisation to release under the specification displaces privacy or contractual confidentiality obligations. The instrument’s silence on these interactions is a potential operational risk that requires administrative policies to manage.

• No procedural detail for release steps (section 5). The instrument identifies what can be released, to whom, and for what purpose, but it does not specify steps for authorisation, signatures, approvals, record‑keeping, timeframes, or redaction standards. Administrative practice will need to fill these gaps. Absent consistent departmental procedures, inconsistent application of the specification could occur.

• Repeal of the 2017 instrument without transitional detail (section 6, Schedule 2). The earlier instrument is repealed in full. If the 2017 instrument contained procedures or safeguards that personnel relied upon, those will not remain in force unless captured elsewhere. The repeal without transitional rules in the text can create immediate practical uncertainty about legacy handling of papers produced under the older regime.

• Reliance on external statutory definitions (section 4). The instrument depends on the Act’s definitions (section 3 of the Act) and on the Regulations for which committees are “advisory committees.” Advisers must check those sources to determine the precise scope of “therapeutic goods information” and which committees are covered. The instrument on its face does not define those statutory terms.

• Broad definition of “relevant persons or bodies” includes subcommittees, employees, members and agents (section 4). The inclusion of agents means contractual third parties engaged by those named bodies could be authorised recipients. That expands potential distribution chains for committee materials.

• No express limit on onward disclosure by recipients. The instrument authorises initial disclosure to particular recipients, but it does not set express limits or conditions on recipients’ further dissemination of the received materials. That absence may raise questions about the downstream handling of sensitive material after it leaves the Department’s control.

These features require administrative attention. The specification authorises release in a bounded way, but significant procedural and legal risks arise from its discretionary nature, the inclusion of internal papers, the closed list of recipients, and the instrument’s silence on privacy and onward dissemination rules.

Compliance with the instrument is primarily an internal administrative task for the Secretary and departmental staff responsible for advisory committee papers, together with the named recipient bodies and their personnel. The instrument itself prescribes what may be released, to whom, and for what purpose; it does not prescribe steps. The following compliance checklist derives directly from the instrument’s text and the operational gaps it leaves open.

• Confirm statutory basis and scope before any release: Any proposed release should be documented as authorised under subsection 61(5AA) and the Therapeutic Goods (Advisory Committees,Information Sharing) (Information) Specification 2023, made under subsection 61(5AB) of the Act (see section 3 and section 5). Ensure the material falls within the kinds listed in Schedule 1, column 2 (advisory committee advice; agenda papers; meeting statements; minutes).

• Verify recipient identity against the instrument’s list: Before release, confirm that the intended recipient is one of the “relevant persons or bodies” specified in section 4 and in Schedule 1, column 3. The instrument names specific bodies and includes employees, members and agents. If the recipient is not on that list, the instrument does not authorise release under its terms.

• Ensure purpose aligns with Schedule 1, column 4: The instrument authorises release only to “facilitate the sharing and consideration of information that is in the interests of public health and safety,” explicitly including material relating to safety, efficacy or performance. Document how the release advances that authorised purpose, so there is a clear administrative record linking the release to the instrument’s purpose test.

• Treat release as a discretionary administrative decision: The instrument states that materials “may be released” (section 5). Decision‑makers should therefore record the rationale for exercising the discretion, including consideration of competing legal obligations (for example privacy or contractual confidentiality) and the specific public health justification for release.

• Assess privacy and confidentiality issues before release: Although the specification does not address privacy or contractual confidentiality, compliance practice should require an assessment of applicable privacy laws, confidentiality obligations and any contractual or statutory restrictions on disclosure. Where privacy or confidentiality concerns exist, consider redaction, obtaining consents, or seeking legal advice before disclosure, even where the specification would otherwise authorise release.

• Document the release and maintain records: Because the instrument provides administrative authorisation rather than procedural steps, good governance requires documenting: the material released, the recipient, the statutory basis (reference to section 5 and Schedule 1), the purpose justification, any redactions made, and any approvals by authorised officers. This record will support accountability in the absence of internal statutory enforcement mechanisms in the instrument.

• Coordinate with recipient bodies on handling and onward dissemination: The specification is silent on downstream dissemination. Prior to release, consider obtaining assurances from recipients about confidential handling or restrictions on onward disclosure where appropriate, particularly for commercially sensitive or personal information. If recipients are agents under contractual arrangements, ensure their engagement terms permit and limit the handling of disclosed material consistent with the purpose set out in Schedule 1.

• Update internal policies and training: Departmental and committee staff who prepare agenda papers and minutes should be trained on the new scope of authorised release and any internal clearance procedures to ensure consistent application. The repeal of the 2017 instrument means that any previous practices based on that instrument should be reviewed and updated in departmental guidance.

• Check committee and regulatory definitions to confirm coverage: Because the instrument defines advisory committees by reference to the Regulations (section 4), verify which committees are covered by checking Part 6 of the Regulations. Ensure minutes and papers from committees that are not under Part 6 of the Regulations are not treated as automatically covered by the specification.

• Seek legal advice for borderline cases: If doubt exists about whether materials fall within the listed kinds, whether a recipient is properly included, or whether privacy/confidentiality law conflicts with a contemplated release, seek legal advice. The instrument itself does not provide conflict resolution mechanisms.

Applying these practical steps will align departmental action with the instrument’s text. The specification authorises release in specified cases but leaves procedural and inter‑statutory issues to administrative practice; compliance therefore depends on internal governance, documentation and legal assessment carried out in each case.