EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods Information Specification 2009
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) is responsible for administering the Act.
Section 61 of the Act lists a number of persons or organisations to whom the Secretary may release specified kinds of therapeutic goods information, such as the World Health Organisation or State or Territory authorities that have functions relating to therapeutic goods.
Therapeutic Goods Information Specification 2009 (the Specification) is made by 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.
The Specification has the effect of permitting the Secretary to release therapeutic goods information of a kind mentioned in the Specification to the public (under subsection 61(5C) of the Act).
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
Until recently, section 61 of the Act only provided for the release of a limited range of therapeutic goods information to the public generally.
In June 2009, the Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009 (the Amendment Act) introduced a range of changes to the Act including, at Schedule 5 to the Amendment Act, a number of changes in relation to the release of therapeutic goods information. Schedule 5 of the Amendment Act commenced on 18 June 2009.
These changes were to have been included in legislation underpinning the establishment of the proposed Australia New Zealand Therapeutic Products Agency (ANZTPA). However, in July 2007 the New Zealand Government announced that it was not proceeding with the necessary legislation in the New Zealand Parliament as it would not be passed, and further work on ANZTPA was suspended.
The Australian Government decided to proceed with amendments relating to, among other matters, information disclosure.
The Amendment Act added new subsections 61(5C) and 61(5D) to 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.
Subsection 61(5D) of the Act empowers the Minister, by legislative instrument, to specify kinds of therapeutic goods information for the purposes of subsection 61(5C) of the Act.
Subsections 61(5C) and 61(5D) of the Act are intended to give effect to the Government’s commitment to provide public access to a wider range of information held by the TGA.
The purpose of the Specification is to support this commitment by, under subsection 61(5D) of the Act, identifying some kinds of therapeutic goods information which the Secretary may release to the public under subsection 61(5C) of the Act.
Examples of the kinds of therapeutic goods information that the Specification would permit the Secretary to release to the public include documents prepared by the Secretary for the purpose of evaluating the quality, safety and efficacy of a therapeutic good for possible registration on the Australian Register of Therapeutic Goods (the ARTG), resolutions or recommendations or parts of those resolutions or recommendations of expert committees established by the Therapeutic Goods Regulations 1990 and details of the cancellation of the registration or listing of a therapeutic good.
The kinds of therapeutic goods information that the Secretary will be able to release to the public are set out at Schedule 1 to the Specification.
CONSULTATION
The TGA has been consulting with industry on the disclosure of a wider range of information since 2005. Public consultation on this matter was an important component of the consultation undertaken by the TGA in relation to ANZTPA. Consultation has continued throughout this year via industry working groups with representatives from Medicines Australian, Generic Medicines Industry Association of Australia and the Consumer Health Forum. Guidance information supporting this initiative has been available on the TGA website since August 2009.
The Specification is a legislative instrument for the purposes of the Legislative Instruments Act 2003.