EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods Information (Joint Recalls Portal) Specification 2013
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 a division of the Department of Health and Ageing, 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 may release specified kinds of therapeutic goods information.
The Therapeutic Goods Information (Joint Recalls Portal) Specification 2013 (the Specification) is made by the Minister under subsection 61(5D) of the Act and specifies the kinds of therapeutic goods information that the Secretary may release 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 (FRLI).
BACKGROUND
In June 2011 the Australian and New Zealand Governments agreed to proceed with a joint scheme for the regulation of therapeutic products. The creation of a joint regulatory scheme applying in both countries will safeguard public health and safety, while encouraging economic integration and benefitting industry in both countries. The scheme will be administered by a single regulatory agency, the Australia New Zealand Therapeutic Products Agency (ANZTPA).
To that end, the Australian and New Zealand Governments agreed that the TGA and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) within the New Zealand Ministry of Health would undertake a program of joint projects. One of the projects is the establishment of a joint portal of recall actions relating to therapeutic goods in both Australia and New Zealand.
For that purpose both the TGA and Medsafe have made available on their respective websites a publicly accessible database that contains information about recall actions undertaken in their respective countries.
In the case of the TGA, information about Australian recall actions is currently available to the public in the form of the System for Australian Recall Actions (SARA) database on its website at www.tga.gov.au/safety/sara.htm, which has been operational since March 2013. In the case of Medsafe, information about New Zealand recall actions is currently available to the public in the form of the Medsafe Online Recalls Database (MORD) on its website at www.medsafe.govt.nz, which has been operational since July 2012. Both the SARA and MORD databases contain information about recall actions undertaken in Australia and New Zealand, respectively, from the period 1 July 2012 onwards.
The final stage of the project is to provide a publicly accessible joint recalls portal (JRP) containing information about both Australian and New Zealand recall actions for particular therapeutic goods (including medicines and medical devices) on the ANZTPA website at www.anztpa.org. The JRP combines the information about recall actions taken in relation to particular therapeutic goods in the SARA and MORD databases in the one place.
The JRP is expected to provide a number of benefits for health-related industries, consumers, patients and health care professionals, by permitting the reviewing of recall actions relating to particular therapeutic goods (including medicines and medical devices) in Australia and New Zealand.
The purpose of the Specification is to provide a legal basis under the Act to support release to the public of therapeutic goods information in the JRP.
Subsection 61(5D) of the Act empowers the Minister to, by legislative instrument, specify kinds of therapeutic goods information that may be released to the public 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.
The Specification made under subsection 61(5D) identifies a number of different kinds of information about recall actions that the Secretary can then release by way of publication in the JRP under subsection 61(5C) of the Act.
The kinds of information that will be released by the Secretary in this manner are listed in Schedule 1 to the Specification, and will be in either of two forms:
- a list of recalls – this search return will show a list of recall actions that match the search criteria used, from which a specific recall can then be selected by the user to view more information about that recall; or
- recall details – this search return will show summary information about a specific recall action that has been selected from a list, and provides greater detail than that which is viewable in the list of recalls.
A search in the JRP will return information about any Australian and New Zealand recall actions matching the search criteria. The JRP also provides the option of searching for information about recall actions in Australia or New Zealand only.
Recall action is defined in the Specification as action taken by the Australian Responsible Entity or New Zealand Responsible Entity (being the person who is responsible for taking the recall action as set out in the relevant definitions) to resolve a problem with therapeutic goods supplied in the market that have, or may potentially have, deficiencies relating to safety, quality, efficacy or presentation. The definition also sets out a non-exhaustive list of examples of types of recall action.
CONSULTATION
In December 2012 and January 2013, the TGA contacted a number of bodies that the TGA took the view would be in a position to provide useful feedback about a publicly accessible database of recall actions and invited them to participate in the testing of a prototype of the SARA database.
The stakeholders that were contacted included bodies representing specific industries relating to therapeutic goods, medical practitioners and consumers including Medicines Australia, the Generic Medicines Industry Association of Australia, the Australian Self Medication Industry Incorporated and the Complementary Healthcare Council of Australia, the Australian Medical Association and Consumers Health Forum of Australia.
A full list of these stakeholders is set out at Schedule 1 of the Therapeutic Goods Information (Stakeholder Consultation on the System for Australian Recall Actions) Specification 2013 which was registered on FRLI on 30 January 2013. This earlier specification authorised release under the Act of therapeutic goods information to these bodies for the purposes of facilitating this testing and obtaining feedback from the bodies about the functionality, suitability (in terms of informing the public about Australian recall actions) and presentation of the prototype database, including any impacts on industry that might result from its launch.
Feedback from stakeholders on the prototype of the SARA database was considered in the finalisation of the SARA database and thus in the development of the JRP.
As noted above, the JRP is the final stage of the project to establish a joint portal of recall actions relating to therapeutic goods in both Australia and New Zealand. This stage follows on from the release of publicly accessible databases containing information about Australian recall actions in the form of the SARA database and information about New Zealand recall actions in the form of MORD database. The information in the JRP will remain available in the SARA and MORD databases about recall actions in Australia and New Zealand, respectively with the JRP combining this information in the one place in preparation for the establishment of ANZTPA.
As the information that will be contained in the JRP is already publicly accessible (via the SARA and MORD databases) the legislative instrument is considered to be minor and machinery in nature.
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 attached.
ATTACHMENTS
1. Statement of compatibility for a legislative instrument that does not raise any human rights issues (Therapeutic Goods Information (Joint Recalls Portal) Specification 2013).