EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods Information Specification 2015
The Therapeutic Goods Act 1989 (the Act) provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy/performance 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 to the public under that section.
The Therapeutic Goods Information Specification 2015 (the Specification) is made by a delegate of the Minister under subsection 61(5D) of the Act and specifies the kinds of therapeutic goods information that may be released to the public by the Secretary under subsection 61(5C) of the Act. It replaces the Therapeutic Goods Information Specification 2009 (the 2009 Specification) which is being revoked by the Therapeutic Goods Information Specification 2009 Revocation Specification 2015.
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 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
Amendments to section 61 of the Act made in 2009, including the introduction of subsections 61(5C) and (5D), facilitate a more extensive release of therapeutic goods information by the Secretary. These amendments supported the making of the 2009 Specification which allows the Secretary to release to the public a range of information, primarily relating to registered therapeutic goods.
The 2009 Specification supported the publication on the TGA website of product information and consumer medicines information in relation to registered medicines. These documents can be found at https://www.ebs.tga.gov.au/.
The 2009 Specification also supported the publication on the TGA website of Australian Public Assessment Reports (AusPAR). AusPARs provide information about the evaluation of medicines for which registration on the Australian Register of Therapeutic Goods (the Register) has been sought and include (where relevant) information such as the considerations that led to the TGA to approve, or not approve, the registration of the medicine. Currently published AusPARs can be found at http://tga.gov.au/browse-auspars-active-ingredient.
The purpose of the Specification is to replace the 2009 Specification, principally in order to update a number of references to the names of expert committees established by the Therapeutic Goods Regulations 1990 (the Regulations) and to update references to provisions of the Act which have changed since 2009.
The kinds of therapeutic goods information that the Specification will continue to permit the Secretary to release to the public include the following:
- product information approved by the Secretary under subsection 25AA(1) or 25AA(4) of the Act in relation to a medicine and information required by the Regulations to be supplied with certain therapeutic goods (Consumer Medicine Information);
- information in documents prepared for the purpose of evaluating therapeutic goods under subsection 25(1) or subsection 9D(3) of the Act;
- information in relation to post-market pharmacovigilance requirements imposed as a condition on registration under the Act in relation to therapeutic goods, or by a regulation made for the purposes of paragraph 28(5)(e) of the Act;
- information in documents relating to assessments made as part of evaluation of the pharmacovigilance system, quality and non-clinical and clinical data of therapeutic goods under section 25 of the Act;
- information in documents included in a request of the Secretary for advice from the Advisory Committee on Prescription Medicine or its sub-committees (including the Pharmaceutical Subcommittee), the Advisory Committee on the Safety of Medicine or its sub-committees or the Advisory Committee on the Safety of Vaccines, seeking advice in relation to the evaluation of a medicine under section 25 of the Act or for the purposes of subsection 9D(3) of the Act, including in relation to post-market pharmacovigilance requirements;
- information in the minutes or outcomes of those committees or subcommittees, about those matters, or of any other expert committee established by the Regulations about the suitability for registration or inclusion of therapeutic goods in the Register; and
- information in decisions of the Secretary under section 25 of the Act in relation to the registration of therapeutic goods, including the reasons for the decision.
The Specification also includes a reference to information in any written decision under section 60 of the Act on a review of a decision under subsection 25(3), subsection 9D(3) or subsection 25AA(1) or (4) of the Act. This will ensure that the Secretary can include information in an AusPAR about any decision under section 60 of the Act reviewing a decision about the registration of therapeutic goods, the variation of an entry in the Register in relation to registered therapeutic goods or a decision to approve product information in relation to registered goods.
The kinds of therapeutic goods information that the Secretary will be able to release to the public under the Specification are set out at Schedule 1 to the Specification.
CONSULTATION
The nature of the Specification is such that consultation was not considered to be necessary as the Specification is of a minor nature and does not substantially alter existing arrangements.
The Specification is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Statement of Compatibility with Human Rights for a legislative instrument that does not raise any human rights issues
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Therapeutic Goods Information Specification 2015
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 Legislative Instrument
The Therapeutic Goods Information Specification 2015 is made under subsection 61(5D) of the Therapeutic Goods Act 1989 (the Act) by a delegate of the Minister for Health. It replaces the Therapeutic Goods Information Specification 2009 and updates references to the statutory committees established under the Therapeutic Goods Regulations 1990 and references to provisions in the Act.
It will continue to permit the Secretary of the Department of Health to release to the public under subsection 61(5C) of the Act therapeutic goods information held by the Therapeutic Goods Administration (TGA) in the form of Product Information, Consumer Medicine Information and Australian Public Assessment Reports (AusPAR) for prescription medicines, all currently published on the TGA website.
Human rights implications
As this instrument does not include any measures other than providing for the release to the public of information outlined above, it does not engage any of the applicable rights or freedoms.
Conclusion
This legislative instrument is compatible with human rights as it does not raise any human rights issues.
Professor John Skerritt, delegate of the Minister for Health