Promoting the personal importation of therapeutic goods: recent legislative amendments to advertising regulations may impact consumer access and understanding
Christopher Rudge
A * and Narcyz Ghinea B
+ Author Affiliations
- Author Affiliations
A Faculty of Law, Sydney Law School, University of Sydney, Rm No 523, New Law Building, NSW 2006, Australia.
B Philosophy Department, Faculty of Arts, Centre for Agency, Values and Ethics, Macquarie University, North Ryde, NSW 2109, Australia.
* Correspondence to: christopher.rudge@sydney.edu.au
Australian Health Review 47(2) 182-191 https://doi.org/10.1071/AH22209
Submitted: 10 October 2022 Accepted: 23 January 2023 Published: 13 February 2023
© 2023 The Author(s) (or their employer(s)). Published by CSIRO Publishing on behalf of AHHA.
Abstract
Objective The personal importation scheme is a legislative mechanism that allows health consumers to import unapproved medicines under certain conditions. This article analyses the legal and policy basis for the scheme and considers how reforms to advertising laws for therapeutic goods may restrict communications about it. The article represents the first published analysis of the personal importation scheme’s interaction with the communications of health professionals and buyer’s clubs. It considers how these communications may be affected by legal amendments, particularly where unapproved medicines may be accessed through the scheme.
Methods An examination of Australian therapeutic goods law concerning the personal importation scheme was conducted, including both the historical law and recent regulatory reforms. Illustrative tables were prepared to identify scheme-related advertising that may contravene therapeutic goods law. Risk estimates were allocated to several new legal rules to indicate whether health professionals or buyer’s clubs would contravene these laws when promoting the scheme to health consumers for unapproved medicines.
Results Representations made directly to the public by health practitioners or on buyer’s clubs websites about accessing unapproved therapeutic goods through the personal importation scheme are likely to contravene one or more advertising laws.
Conclusions The Therapeutic Goods Administration has very strong powers to initiate compliance or enforcement action for advertising breaches in Australia for many promotional practices. Arguably, in the age of the internet and in the context of emerging expensive medicines, these powers should not be used to restrict health practitioners or buyer’s clubs from sharing information about the lawful personal importation scheme to health consumers in need. Nevertheless, the study finds that health practitioners who promote or refer to the availability of unapproved medicines through the personal importation scheme outside of a consultation are likely to contravene the law and may be subject to disciplinary or enforcement action.
Keywords: access to medicines, advertising, buyers’ clubs, health regulation, medical practitioner law, personal importation, unapproved medicines.
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