EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods Information (Sharing of Committee Information) Specification 2014
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 Therapeutic Goods Administration (the TGA), which is part of the Department of Health, is responsible for administering the Act.
Section 61 of the Act lists a number of persons or organisations, such as the World Health Organisation and State and Territory authorities that have functions relating to therapeutic goods, to which the Secretary of the Department of Health can release specified kinds of therapeutic goods information. Section 61 also allows the Minister for Health to make a legislative instrument setting out other circumstances in which the Secretary can release therapeutic goods information under that section.
The Therapeutic Goods Information (Sharing of Committee Information) Specification 2014 (the Specification) is made by the Minister under subsection 61(5AB) of the Act and specifies kinds of therapeutic goods information that can be released, bodies and kinds of persons to whom that information can be released, and the purposes for which it can be released, by the Secretary under subsection 61(5AA) of the Act.
The making of the Specification has the effect of permitting the Secretary to release therapeutic goods information of a kind mentioned in the Specification to the bodies and the kinds of persons mentioned in the Specification, for the purposes set out in the Specification.
Therapeutic goods information in this context is defined in subsection 61(1) of the Act as, relevantly, information in relation to therapeutic goods that is held by the Department and which relates to the performance of the Department’s functions.
The Specification commenced on the day after it was registered on the Federal Register of Legislative Instruments.
BACKGROUND
A number of important expert advisory committees are established under Divisions 1-1EB of Part 6 of the Therapeutic Goods Regulations 1990 (the Regulations) to provide advice and make recommendations to the Minister or the Secretary on a range of matters relating to therapeutic goods.
These include, for example, the Advisory Committee on Prescription Medicines (Division 1A of Part 6 refers), and the Advisory Committee on the Safety of Vaccines (Division 1EB refers).
The Specification has the effect of permitting the Secretary to release to those bodies listed in it, and to their employees, members or agents, therapeutic goods information relating to the TGA advisory committees established under Divisions 1-1EB of Part 6 of the Regulations.
These committees are the: Therapeutic Goods Committee, Advisory Committee on Prescription Medicines, Advisory Committee on Non-prescription Medicines, Advisory Committee on the Safety of Medicines, Advisory Committee on Medical Devices, Advisory Committee on the Safety of Medical Devices, Advisory Committee on Complementary Medicines, Advisory Committee on Biologicals and Advisory Committee on the Safety of Vaccines.
The kinds of information that will be able to be released by the Secretary regarding these committees include the advice and/or recommendations provided by an advisory committee, committee agenda papers and minutes of committee meetings and brief descriptions of any outcomes arising from such meetings.
From time to time, the advice or recommendations provided by one of these committees is needed by another committee or body established to provide specialist advice to the Government on particular matters, in their consideration of matters before them.
For example, advice provided by the Advisory Committee on the Safety of Vaccines 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 bodies to whom the Secretary will be able to provide committee information are principally entities established to advise the Government on matters relating to human health including, for example, the Drug Utilisation Sub Committee of the Pharmaceutical Benefits Advisory Committee, which assesses estimates of the projected usage and financial cost of medicines in Australia.
The purpose of releasing the information to other bodies and advisory committees is to facilitate the sharing of information in the interest of public health and safety.
The kinds of therapeutic goods information that the Secretary can decide to release, the bodies and kinds of persons to whom the Secretary can decide to release that information and the purposes for which the Secretary can decide to release that information, are set out in Schedule 1 to the Specification.
CONSULTATION
Consultation was not undertaken in relation to the Specification as the provision of committee information as set out in the instrument is considered to be of a minor and machinery nature and is not considered to substantially alter existing arrangements.
This is because the provision of the information concerned to the bodies listed in the Specification reflects an administrative practice that has occurred from time to time of providing such information to those bodies to strengthen collaboration between the TGA and its advisory committees and those other bodies.
The Specification is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
In relation to compatibility with human rights, it is considered that the Specification 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, and a Statement of Compatibility setting that out in further detail is set out below.
Statement of Compatibility with Human Rights for a legislative instrument that raises human rights issues
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Therapeutic Goods Information (Sharing of Committee Information) Specification 2014
This 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 the Bill/Legislative Instrument
The Therapeutic Goods Information (Sharing of Committee Information) Specification 2014 (the Specification) is made by the Minister for Health under subsection 61(5AB) of the Therapeutic Goods Act 1989 (the Act). The effect of making the Specification is that it will permit the Secretary of the Department of Health to release information that relates to the committees established under Divisions 1-1EB of Part 6 of the Therapeutic Goods Regulations 1990 to the bodies or kinds of persons specified in the instrument, in the interests of public health and safety. For example, the Specification will allow the Secretary to provide advice of the Advisory Committee on the Safety of Vaccines to the National Immunisation Committee, or the National Centre for Immunisation Research and Surveillance.
Human rights implications
The information authorised to be released under the Specification will contain a small amount of personal information within the meaning of the Privacy Act 1988 – engaging the right to privacy in article 17 of the International Covenant on Civil and Political Rights (the ICCPR).
This will principally be in the form of:
- the names and, on occasion, contact details, of committee members and TGA staff as part of the agenda papers for committee meetings;
- the names of a small number of TGA staff members as contact points for further information as part of the meeting statements; and
- the names of attending committee members and the names and positions of attending TGA staff members as part of the minutes of those meetings.
The release of this information is considered to be justified in relation to the engagement of article 17:
- in relation to committee member information, the release will be either consistent with information about such committee members already present on the TGA’s website (with committee members’ consent), or its release will be subject to the specific consent of the relevant members; and
- in relation to the staff member details, because this information is necessary to allow the bodies to whom the committee information is being provided to be able to contact the TGA for further information or discussions if necessary (e.g. to clarify a particular point of advice or a recommendation made by a committee).
Both of the above points ultimately relate to supporting the protection of public health.
Conclusion
This legislative instrument is compatible with human rights because, to the extent that it may limit human rights, those limitations are reasonable, necessary and proportionate.
Professor John Skerritt, delegate of the Minister for Health