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

EXPLANATORY STATEMENT

Therapeutic Goods Act 1989

The Therapeutic Goods Act 1989 (“the Act”) provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in, or exported from, Australia. The Act is administered by the Therapeutic Goods Administration (“the TGA”) within the Australian Government Department of Health and Aged Care (“the Department”).

Section 61 of the Act provides that the Secretary may release specified kinds of therapeutic goods information to the public, and to certain organisations, bodies or authorities. Subsection 61(1) of the Act provides that ‘therapeutic goods information’ means, for the purposes of the section, information relating to therapeutic goods, which is held by the Department and relates to the performance of the Department’s functions.

Subsection 61(5AA) provides that the Secretary may release to a specified person, body or authority (or one that is of a specified kind), specified kinds of therapeutic goods information, for a specified purpose. Subsection 61(5AB) relevantly provides that, for the purposes of subsection 61(5AA), the Minister may, by legislative instrument, specify a person, body or authority, the kinds of therapeutic goods information and the purposes for which the information may be released under such arrangements.

The Therapeutic Goods (Advisory Committees—Information Sharing) (Information) Specification 2023 (“the Specification”) is a legislative instrument made under subsection 61(5AB) of the Act. It repeals and replaces the Therapeutic Goods Information (Sharing of Committee Information) Specification 2017 (“the former Specification”) with the principal purpose of updating the list of persons and bodies to whom the Secretary may release information relating to advisory committee meetings. In particular, following the Department’s reforms to the Prostheses List governance and committee arrangements which take effect on 1 July 2023, the Specification:

removes the references to the “Panel of Clinical Experts for neurosurgical, plastic and reconstructive, ear/nose/throat, and general and miscellaneous prostheses” and the “Urogenital Prostheses Clinical Advisory Committee”, which were established under the former “Prostheses List Advisory Committee”; and
replaces the reference to the “Prostheses List Advisory Committee” with the “Medical Devices and Human Tissue Advisory Committee (MDHTAC), and any subcommittee of MDHTAC”, to reflect the change to the name of that committee and enable the release of information to any subcommittee established under the MDHTAC.

The Specification does not otherwise introduce any substantive changes to the former Specification with respect to the kinds of therapeutic goods information that the Secretary may release to specified bodies, and the purposes for which that information may be released to those bodies, under subsection 61(5AA) of the Act.

Background

Part 6 of the Therapeutic Goods Regulations 1990 (the Regulations) provides for the establishment of a number of important expert advisory committees to provide advice and make recommendations to the Minister or the Secretary on a range of matters relating to therapeutic goods.

These advisory committees include:

the Advisory Committee on Biologicals (ACB);
the Advisory Committee on Complementary Medicines (ACCM);
the Advisory Committee on Medical Devices (ACMD);
the Advisory Committee on Medicines (ACM); and
the Advisory Committee on Vaccines (ACV).

From time to time, the advice or recommendations provided by one of these advisory committees is needed by another committee or body established to provide specialist advice to the Commonwealth on particular matters in their consideration of matters before them. For example, advice provided by the ACV about the safety of a vaccine proposed to be included as part of the National Immunisation Program may be shared with the National Immunisation Committee (which is responsible for overseeing the development, implementation and delivery of the National Immunisation Program), the Australian Technical Advisory Group on Immunisation and the National Centre for Immunisation Research and Surveillance (which undertakes research aimed at reducing the incidence of vaccine preventable diseases and improving vaccine uptake in adults and children).

The Specification specifies a number of persons and bodies that are responsible for advising the Commonwealth on matters relating to public health and safety, including the supply of therapeutic goods under the Act, entitlements under benefits schemes administered by the Department, and public funding for medical services.

The Specification authorises the release of therapeutic goods information relating to the advisory committees established under the Regulations for the purpose of facilitating the sharing and consideration of information that is in the interest of public health and safety, including information relating to the safety, or efficacy or performance, of therapeutic goods.

Consultation

No consultation was undertaken in relation to the Specification as the purpose of the instrument is simply to update the list of persons and bodies to whom the Secretary may release information relating to advisory committee meetings). The Specification has the same effect as the former Specification, and does not alter existing arrangements.

An Impact Analysis was not required in relation to the development of the Specification, as the matter of specifying kinds of therapeutic goods information under section 61 of the Act is the subject of a standing exemption from the requirement to prepare an Impact Analysis (OBPR ID 15070).

Details of the Specification are set out in Attachment A.

The Specification is compatible with human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in Attachment B.

The Specification is a disallowable legislative instrument for the purposes of the Legislation Act 2003 and commences on 1 July 2023.

Attachment A

Details of the Therapeutic Goods (Advisory Committees—Information Sharing) (Information) Specification 2023

Section 1 – Name

This section provides that the name of the instrument is the Therapeutic Goods (Advisory Committees—Information Sharing) (Information) Specification 2023 (“the Specification”).

Section 2 – Commencement

This section provides that the Specification commences on 1 July 2023.

This is to align with the commencement of the Department’s reforms to the Prostheses List governance and committee arrangements, including the commencement of amendments in the:

Private Health Insurance Legislation Amendment (Medical Device and Human Tissue Product List and Cost Recovery) Act 2023;
Private Health Insurance (Prostheses Application and Listing Fees) Amendment (Cost Recovery) Act 2023;
Private Health Insurance (National Joint Replacement Register Levy) Amendment (Consequential Amendments) Act 2023.

Section 3 – Authority

This section provides that the legislative authority for making the Specification is subsection 61(5AB) of the Therapeutic Goods Act 1989 (“the Act”).

Section 4 – Definitions

This section notes that certain terms used in the Specification, e.g. ‘Secretary’, are defined in the Act. Other terms have been defined for the purposes of the Specification, including ‘advisory committee’, ‘advisory committee advice’, ‘meeting statement’ and ‘relevant persons or bodies’.

Relevantly, the definition of ‘relevant persons or bodies’ includes the “Medical Devices and Human Tissue Advisory Committee (MDHTAC), and any subcommittee of MDHTAC”. The MDHTAC replaces the former “Prosthesis List Advisory Committee” as part of the Department’s reforms to the Prostheses List governance and committee arrangements.

This section also provides that ‘therapeutic goods information’ has the same meaning as in subsection 61(1) the Act.

Section 5 – Release of therapeutic goods information

This section provides that, for subsection 61(5AA) of the Act, in relation to each item of the table in Schedule 1 to the Specification, the kinds of therapeutic goods information specified in column 2 may be released to a person, body or authority (or kinds of persons, bodies or authorities) specified in column 3, for the purposes specified in column 4.

Section 6 – Repeals

This section provides that each instrument that is specified in Schedule 2 is repealed as set out in the applicable items in that Schedule.

Schedule 1 – Therapeutic goods information

This Schedule specifies that therapeutic goods information relating to an advisory committee established under the Therapeutic Goods Regulations 1990, contained in advisory committee advice, agenda papers, meeting statements and minutes of meetings, may be released to relevant persons or bodies.

The purpose of releasing such information is to facilitate the sharing and consideration of information that is in the interest of public health and safety, including information relating to the safety, or efficacy or performance, of therapeutic goods.

The information that may be released under the Specification may contain personal information, within the meaning in the Privacy Act 1988. This would include the names and possibly the contact details of advisory committee members and TGA officers that arrange and attend advisory committee meetings. It may also include the names of guest experts that attend committee meetings as special advisors.

The release of this information is considered to be reasonable, necessary and proportionate in the circumstances. In relation to committee members or guest experts, the release of their details will be consistent with information already published on the TGA website about committee members (with committee members’ consent) or subject to the specific consent of the attendee. In relation to TGA officers, the release of the officers’ details is necessary to enable the bodies to whom the committee information is being provided to contact the TGA for further information or discussion if necessary (for example, to seek clarity on a particular point of advice or recommendation made by a committee). The release of personal information (i.e. the use and disclosure) would be consistent with the Privacy Act 1988.

Schedule 2 – Repeals

This Schedule provides that the Therapeutic Goods Information (Sharing of Committee Information) Specification 2017 is repealed.

Attachment B

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

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

This disallowable legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of legislative instrument

The Therapeutic Goods (Advisory Committees—Information Sharing) (Information) Specification 2023 (“the Specification”) is a legislative instrument made under subsection 61(5AB) of the Act. It repeals and replaces the Therapeutic Goods Information (Sharing of Committee Information) Specification 2017 (“the former Specification”) with the principal purpose of updating the list of persons and bodies to whom the Secretary may release information relating to advisory committee meetings. In particular, the Specification replaces the reference to the “Prostheses List Advisory Committee” with the “Medical Devices and Human Tissue Advisory Committee”, to reflect the change to the name of that committee following the Department’s reforms to the Prostheses List governance and committee arrangements which take effect on 1 July 2023.

The Specification does not otherwise introduce any substantive changes to the former specification with respect to the kinds of therapeutic goods information that the Secretary may release to specified bodies, and the purposes for which that information may be released to those bodies, under subsection 61(5AA) of the Act.

Background

These advisory committees include:

the Advisory Committee on Biologicals (ACB);
the Advisory Committee on Complementary Medicines (ACCM);
the Advisory Committee on Medical Devices (ACMD);
the Advisory Committee on Medicines (ACM); and
the Advisory Committee on Vaccines (ACV).

Human rights implications

The Specification engages:

the right to health in Article 12 of the International Covenant on Economic, Social and Cultural Rights (“ICESCR”); and
the right to protection against arbitrary and unlawful interferences with privacy in Article 17 of the International Covenant on Civil and Political Rights (“ICCPR”).

Right to health

Article 12 of the ICESCR promotes the right of all individuals to enjoy the highest attainable standards of physical and mental health. In General Comment No. 14: The Right to the Highest Attainable Standard of Health (Art. 12) (2000), the United Nations Committee on Economic, Social and Cultural Rights states that health is a ‘fundamental human right indispensable for the exercise of other human rights’, and that the right to health is not to be understood as the right to be healthy, but includes the right to a system of health protection which provides equal opportunity for people to enjoy the highest attainable level of health.

The Specification supports the right to health by ensuring that the Therapeutic Goods Administration (“the TGA”) can provide important information regarding the safety, or efficacy or performance, of therapeutic goods to persons and bodies that are responsible for advising the Commonwealth on matters relating to public health and safety.

Right to the protection against arbitrary and unlawful interferences with privacy

Article 17 of the ICCPR provides for the right of every person not to be subjected to arbitrary or unlawful interference with privacy. The prohibition on interference with privacy prohibits unlawful or arbitrary interferences with a person’s privacy, family, home and correspondence. It also prohibits attacks on a person’s reputation. Limitations on the right to privacy must be according to law and not arbitrary, that is limitations must be reasonable and necessary in the particular circumstances, as well as proportionate to the objective the limitations set to achieve.

Conclusion

This Specification is compatible with human rights because it supports the right to health in Article 12 of the ICESCR and any engagement with the right to privacy in Article 17 of ICCPR is reasonable, necessary and proportionate.

Administered by Department of Health, Disability and Ageing

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