AUSTRALIA Law and Practice Contributed by: Greg Williams and Sheena McKie, Clayton Utz
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation The primary legislation that governs the importation, exportation, manufacture and supply of therapeutic goods in Australia – including pharmaceuticals and medical devices – is the Therapeutic Goods Act 1989 (Cth). The Therapeutic Goods Act establishes Austral- ia’s national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods, and provides the framework for the states and territories to adopt a uniform approach to the safe handling of poisons (including medicines). The Therapeutic Goods Act is supported by a number of regulations, including the following two key sets of subordinate regulations: • the Therapeutic Goods Regulations 1990, which provide detailed rules around manufacturing, sup- ply, advertising, labelling and post-market surveil- lance of medicines; and • the Therapeutic Goods (Medical Devices) Regula- tions 2002, which set out the requirements for reg- istration, classification and conformity assessment of medical devices specifically. The Therapeutic Goods Administration (TGA) is Aus- tralia’s principal regulatory authority for therapeutic goods. The TGA’s remit includes all aspects of the supply, importation, exportation, manufacturing and advertising of therapeutic goods, while also main- taining the Australian Register of Therapeutic Goods (ARTG). A therapeutic good cannot be supplied in Australia unless it is listed, registered or included on the ARTG (as applicable). The TGA is not an independent statutory authority and operates as a division of the Department of Health, Disability and Ageing, in its Health Products Regula- tion Group (HPRG). At a practical level the TGA is can be described as “semi-autonomous”, with broad day-to-day operational independence, its own organi- sational identity and its own head (who also holds the title of Deputy Secretary of the HPRG). State and territory laws govern the storage, handling, retail and wholesale of poisons, including medicines.
In addition, the National Health Act 1953 (Cth) and its delegated legislation establish the Pharmaceutical Benefits Scheme (PBS), which is Australia’s Common- wealth (federal) Government scheme to subsidise the cost of drugs and medicinal products (primarily pre- scription medicines). There is also a Prescribed List (formerly known as the Prostheses List), which sets a minimum list and associated benefit for certain medi- cal device and human tissue products that must be covered by health insurers in respect of private health insurance. 1.2 Challenging Decisions of Regulatory Bodies Three-Tiered System Australia’s therapeutic goods regime has a three- tiered system for challenging regulatory decisions, the availability of which will depend on the decision and decision-maker in question. Internal merits review by the Minister The Therapeutic Goods Act provides (in Section 60) that certain “initial decisions” made by the Secretary of the Department of Health, Disability and Ageing or their delegate may be eligible for reconsideration, which is a form of merits review. A person whose inter- ests are affected by an initial decision of the TGA may request that the Minister review the decision within 90 calendar days. The Minister may confirm or revoke the initial decision, and may make a decision in substitu- tion for the initial decision. The Minister is not limited to checking whether the original decision-maker made an error in the making of the decision. External merits review (ART) The Minister’s decision on reconsideration becomes a “reviewable decision”, and a person whose interests are affected by the decision may apply to the Austral- ian Review Tribunal (ART) (which replaced the AAT on 14 October 2024) for review of that decision. The ART considers all evidence before it and seeks to make the “correct or preferable decision”. An application to the ART must be filed within 28 days of being notified of the Minister’s decision (and reasons for that decision). Judicial review (Federal Court) A person aggrieved by certain administrative deci- sions made by a public authority may seek judicial
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