Promoting the personal importation of therapeutic goods: recent legislative amendments to advertising regulations may impact consumer access and understanding.

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. What is known about the topic?. The personal importation scheme has not been studied extensively. This paper investigates whether recent updates to the advertising laws will affect the operation of the personal importation scheme and health practitioners' ability to refer to it in public. What does this paper add? This paper represents the first ever analysis of the way in which the personal importation scheme interacts with health practitioners' statements, buyer's clubs, and the internet. What are the implications for practitioners ? The study finds that health practitioners who promote the availability of unapproved medicines through the personal importation scheme outside professional consultations are likely to be liable to enforcement action from the Therapeutic Goods Administration. [ABSTRACT FROM AUTHOR]