FLOORS AND CEILINGS: COORDINATION, COHERENCE AND CONSISTENCY IN THE RELATIONSHIP BETWEEN THERAPEUTIC GOODS REGULATION AND CONSUMER PROTECTION
Marco Rizzi1, Penny Gleeson2, Jeannie Marie Paterson3, University Of Western Australia Perth2, Melbourne Vic3, Vic Australia 1University Of Western Australia, Perth, WA, Australia2Deakin University, Melbourne, Vic, Australia3University of Melbourne, Melbourne, Vic, Australia
Abstract
This paper examines the tensions between the two Australian regimes that govern the regulation of therapeutic goods: the general consumer protection regime of the Australian Consumer Law and the more specific regime under the Therapeutic Goods Act 1989 (Cth) administered by the TGA. The TGA aims to ensure that therapeutic products are safe and effective when they go to market according to a range of scientific standards. The ACL complements this regime with a suite of market protections that aim to ensure that consumer products are accurately represented, meet baseline quality standards and are reasonably safe. The core regulatory approaches to determining whether therapeutic products should go to market and whether they meet community standards are themselves dynamic given that community expectations and demands of the health system change over time. What is unclear is whether and how the ACL and TGA regimes should and do interact with each other to ensure the best outcomes for patients and consumers. We develop three case studies of therapeutic products (hand sanitisers, vaccines, and medical implants) to illustrate the challenges of consistency and coherence that may arise between the two regimes. These challenges arise specifically when regulatory regimes respond to a public health crisis such as the COVID-19 pandemic. The more general point however is that the regimes should act in a complementary manner, as the ‘floor and ceiling’ of consumer and patient protection, which requires a coordinated, and dynamic, approach to regulation.
Biography
Dr Marco Rizzi is Associate Professor at UWA Law School where he teaches and researches in the areas of tort law, health law & policy, risk regulation, and law & technology. He holds a PhD from the European University Institute and is currently CI in two major MRFF projects.
Dr Penny Gleeson is a Lecturer at Deakin Law School. Her expertise is in public health law, regulation, public law, new health technologies and ethics. Her PhD examined the political legitimacy of the regulation of therapeutic goods. She holds a PhD from the University of Melbourne and an LLM from the University of Cambridge.