Rudge Chris, Ghinea Narcyz, Munsie Megan, Stewart Cameron
Department of Anatomy and Neuroscience, The University of Melbourne, Victoria 3010, Australia. Email:
School of Public Health, Faculty of Medicine and Health, University of Sydney, NSW 2006, Australia. Email:
Aust Health Rev. 2021 Aug;45(4):507-515. doi: 10.1071/AH20217.
Objective This paper provides an update and overview of the law governing direct-to-consumer (DTC) advertising of autologous stem cell interventions (ASCIs) in Australia. It follows significant changes to the advertising regulations made in 2018. Methods The paper reviews the three primary sources or 'centres' of law regulating ASCIs in Australia, together with the relevant guidance documents that supplement these sources. It provides analysis of how the post-2018 advertising regulations, contained in the Therapeutic Goods Act 1989 (Cwlth), apply to all 'biologicals', including ASCIs. It demonstrates how these three sources of law interact with one another and outlines the new tiered offence regime that applies to contraventions of these prohibitions. Results The analysis demonstrates that DTC advertising of ASCIs in Australia is strictly controlled, with primary legislation prohibiting the advertising of biologicals altogether. Conclusions The polycentric legal regime regulating biologicals in Australia clearly makes DTC advertising of ASCIs unlawful. Health practitioners who promote ASCIs, either online, in print or in other media forms, may be penalised in different ways and by different authorities. What is known about the topic? Although several analyses have examined the regulation of ASCIs in Australia, no analysis has studied the reforms made in 2018 relating to the advertising of biologicals. As such, this analysis contributes a fresh examination of these relatively recent reforms. What does this paper add? This analysis clarifies the effects of these new advertising regulations, providing clear guidance on the relevant legal provisions for the benefit of health practitioners and health professionals more generally. What are the implications for practitioners? Health practitioners, especially those who offer ASCIs, should be aware that civil and criminal penalties are likely to be imposed on individuals who promote biologicals in Australia by any means.
目的 本文对澳大利亚自体干细胞干预措施（ASCI）面向消费者直接广告（DTC）的相关法律进行更新和概述。这是继2018年广告法规发生重大变化之后。方法 本文回顾了澳大利亚规范ASCI的三个主要法律来源或“中心”，以及补充这些来源的相关指导文件。分析了1989年《治疗用品法》（联邦）中2018年后的广告法规如何适用于所有“生物制品”，包括ASCI。展示了这三个法律来源如何相互作用，并概述了适用于违反这些禁令行为的新分层犯罪制度。结果 分析表明，澳大利亚对ASCI的DTC广告进行严格管控，主要立法完全禁止生物制品广告。结论 澳大利亚规范生物制品的多中心法律制度明确规定ASCI的DTC广告违法。通过网络、印刷品或其他媒体形式推广ASCI的医疗从业者可能会受到不同方式、不同当局的处罚。关于该主题已知哪些内容？尽管已有多项分析研究了澳大利亚对ASCI的监管，但尚无分析研究2018年与生物制品广告相关的改革。因此，本分析对这些相对较新的改革进行了新的审视。本文补充了什么内容？本分析阐明了这些新广告法规的影响，为医疗从业者及更广泛的健康专业人员提供了关于相关法律规定的明确指导。对从业者有何影响？医疗从业者，尤其是那些提供ASCI的从业者，应意识到在澳大利亚以任何方式推广生物制品的个人可能会面临民事和刑事处罚。
