EXPLANATORY STATEMENT
Subject: Therapeutic Goods Act 1989
Poisons Standard Amendment No.2 of 2010
The Therapeutic Goods Act 1989 (the TG Act) provides for the establishment and maintenance of a system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The TG Act also provides for a framework for the States and Territories to adopt a uniform approach to control the availability and accessibility, and to ensure the safe handling, of poisons (medicines and chemicals) in Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the TG Act and associated Regulations under the Act.
Subsection 52D(2) of the TG Act authorises the Secretary to the Department of Health and Ageing, or a delegate of the Secretary, to amend the current Poisons Standard or prepare a document (a new Poisons Standard) that includes schedules containing the names or descriptions of substances, in substitution for the current Poisons Standard. This authority had previously been provided to an independent statutory committee established under the TG Act, the National Drugs and Poisons Schedule Committee (NDPSC), which no longer exists due to the implementation of amendments to the TG Act that commenced on 1 July 2010.
Part 6-3 of the TG Act provides for the basis for a uniform system of access controls for goods containing scheduled substances. The scheduling of substances allows restrictions to be placed on their supply to the public, in the interest of public health and safety. The scheduling of substances is aimed at minimising the risks of poisoning from, and the misuse or abuse of, scheduled substances. The TG Act also establishes two expert advisory committees, the Advisory Committee on Medicines Scheduling (section 52B) and the Advisory Committee on Chemicals Scheduling (section 52C). These statutory committees provide advice and make recommendations to the Secretary (or a delegate of the Secretary) on matters relating to medicines and chemicals scheduling decisions and in relation to any other matters referred to them by the Secretary. Part 6-3 of the TG Act also provides for the constitution of those committees and other administrative arrangements in relation to the carrying out of their functions in accordance with the regulations.
The Poisons Standard consists of decisions of the Secretary, or a delegate of the Secretary, regarding the classification of poisons into nine different Schedules signifying the degree of control recommended to be exercised over their availability to the public.
The purpose of this instrument is to amend the Poisons Standard 2010. The amendments to the Poisons Standard 2010 set out in Schedule 1 of this instrument consist of decisions made by a delegate of the Secretary. These amendments commence on 1 January 2011.
The statutory procedures set out under the TG Act and the Therapeutic Goods Regulations 1990 (the Regulations) allow the delegate of the Secretary to consider applications under section 52EAA of the TG Act to amend the current Poisons Standard, or to initiate an amendment or the making of a new document to substitute the current Poisons Standard on the Secretary’s (or a delegate of the Secretary) own initiative (see subsection 52D(3) of the TG Act). Regulation 42ZCZU of the Regulations allows the Secretary, or her delegate, to make a final scheduling decision in response to an application under section 52EAA to amend the current Poisons Standard, if the decision aligns with the proposal in the application and without referring the matter for consideration by an expert advisory committee.
The decisions set out in this instrument were in regard to a number of new substances that have not been previously included in the Poisons Standard, as well as a number of editorial and/or errata amendments, which the delegate of the Secretary decided did not require referral to an expert advisory committee.
The Poisons Standard is a legislative instrument for the purposes of the Legislative Instruments Act 2003 (the LIA). However, section 42 (disallowance) of the LIA does not apply (refer to subsection 52D(4A) of the TG Act).
The Schedules contained in the Poisons Standard are referred to under State and Territory legislation for regulatory purposes. The Commonwealth also takes into account the scheduling and classification of substances in the Poisons Standard for regulatory and enforcement purposes under the TG Act. For example, the TG Act and Regulations prohibit the publication of advertisements to consumers about prescription medicines included in Schedule 4 or 8 of the Poisons Standard or over the counter medicines included in Schedule 3 and not included in Appendix H of the Poisons Standard. The advertising of substances included in Schedule 9, or Appendix C of the Poisons Standard is also prohibited.
A regulatory impact statement does not accompany this instrument as the amendments to the
Poisons Standard set out in this instrument are regarded as having minimal regulatory impact in general and are necessary public health measures to allow consumers appropriate and safe access to the substances contained in the amendments.
These amendments did not involve public consultation as most of the amendments relate to substances that have never been entered in the Australian Register of Therapeutic Goods for the purposes of registration under the Act and have never been listed in the Poisons Standard. For the medicines set out in this instrument, consultation was only undertaken with the sole sponsor of the medicine and expert advisory committees as they relate to the registration of the medicine.
Medicines containing these new substances have never been supplied to the general public in Australia and have been classified as high risk medicines used for the treatment of serious conditions. They are therefore required to be registered under the Act. For these medicines to be lawfully supplied in Australia, they have to undergo a stringent process for registration that requires the evaluation of the medicine against the criteria set in subsection 25(1). In general, the registration criteria are science based and input from the public is not necessary for their evaluation.
Although registered medicines containing these substances can be lawfully supplied in Australia, the States and Territories have responsibility for controls over the access to these high risk medicines. These controls include that these medicines can only be prescribed by a registered medical practitioner or other authorised prescribers when included in Schedule 4 or 8 of the Poisons Standard. It is therefore required that these new high risk medicines be included in the Poisons Standard prior to commencing supply. This arrangement is consistent with the approach recommended in the Galbally Report, that is that the registration of medicines be better integrated with the scheduling of substances contained in these medicines. This arrangement is consistent with procedural requirements set out under the Regulations.