Federal Register of Legislation - Australian Government

Primary content

Specifications as made
This instrument specifies kinds of therapeutic goods information that the Secretary may release to the public under subsection 61(5C) of the Act.
Administered by: Health
Registered 29 Apr 2014
Tabling HistoryDate
Tabled HR13-May-2014
Tabled Senate14-May-2014

EXPLANATORY STATEMENT

Therapeutic Goods Act 1989

Therapeutic Goods Information (Information about Advisory Committee Meetings) 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 or Territory authorities that have functions relating to therapeutic goods, to which the Secretary of the Department of Health may 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 (Information about Advisory Committee Meetings) Specification 2014 (the Specification) is made by the Minister under subsection 61(5D) of the Act and specifies kinds of therapeutic goods information that the Secretary may release to the public under subsection 61(5C) 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 public.

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 provision to the public of a wider range of information about the TGA’s advisory committees addresses recommendation 8 of the ‘Review to improve the transparency of the TGA’ (released on 21 July 2011) that:

The TGA provide clear information on the role of its statutory advisory committees, and adopt a consistent and transparent approach to the publication of information from those committees”.

The Government agreed to the implementation of the recommendation in December 2011.

The Specification has the effect of permitting the Secretary to release to the public a number of kinds of therapeutic goods information relating to meetings of 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 to the public by the Secretary regarding meetings of these committees are:

 

·                information about the nature or content of any discussion about matters or items considered by the committee at a committee meeting, or that summarises that discussion.

 

This may include, for example, a brief overview of the matters in relation to which the Committee has been asked by the Minister or the Secretary to provide advice or make recommendations about, a brief outline of other matters considered by the Committee at the meeting and any subcommittee updates.

Subsection 61(5D) of the Act empowers the Minister to, by legislative instrument, specify kinds of therapeutic goods information for the purposes of subsection 61(5C) of the Act.  Under subsection 61(5C) of the Act, the Secretary may release to the public therapeutic goods information of a kind specified by the Minister under subsection 61(5D) of the Act.

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.

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 (Information about Advisory Committee Meetings) 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 (Information about Advisory Committee Meetings) Specification 2014 (the Specification) is made by the Minister for Health under subsection 61(5D) 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 to the public certain kinds of information about meetings of a number of the committees established under the Therapeutic Goods Regulations 1990 – that is, information about the nature or content of any discussion about matters or items considered by the committee at a committee meeting, or that summarises that discussion. This may include, for example, a brief overview of the matters in relation to which the committee has been asked by the Minister or the Secretary to provide advice or make recommendations, and a brief outline of any other matters the committee has considered at the meeting. 

Human rights implications

The information authorised to be released under the Specification may 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 of a small number of TGA staff members as contact points for the public to obtain further information from the TGA about the committee or any of its meetings.

The release of this information is considered to be justified in relation to the engagement of article 17, because this information is necessary to allow the public to be able to contact the TGA for further information (e.g. to clarify a recommendation of a committee).

 

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