{"id":122544,"date":"2025-12-09T12:40:25","date_gmt":"2025-12-09T12:40:25","guid":{"rendered":"https:\/\/my.legal500.com\/guides\/?post_type=comparative_guide&#038;p=122544"},"modified":"2025-12-12T13:56:12","modified_gmt":"2025-12-12T13:56:12","slug":"australia-pharmaceutical-advertising","status":"publish","type":"comparative_guide","link":"https:\/\/my.legal500.com\/guides\/chapter\/australia-pharmaceutical-advertising\/","title":{"rendered":"Australia: Pharmaceutical Advertising"},"content":{"rendered":"","protected":false},"template":"","class_list":["post-122544","comparative_guide","type-comparative_guide","status-publish","hentry","guides-pharmaceutical-advertising","jurisdictions-australia"],"acf":[],"appp":{"post_list":{"below_title":"<div class=\"guide-author-details\"><span class=\"guide-author\">Maddocks<\/span><span class=\"guide-author-logo\"><img src=\"https:\/\/my.legal500.com\/guides\/wp-content\/uploads\/sites\/1\/2022\/11\/PNG-LOGO-MADDOCKS-CHARCOAL-2000PX.jpg\"\/><\/span><\/div>"},"post_detail":{"above_title":"<div class=\"guide-author-details\"><span class=\"guide-author\">Maddocks<\/span><span class=\"guide-author-logo\"><img src=\"https:\/\/my.legal500.com\/guides\/wp-content\/uploads\/sites\/1\/2022\/11\/PNG-LOGO-MADDOCKS-CHARCOAL-2000PX.jpg\"\/><\/span><\/div>","below_title":"<span class=\"guide-intro\">This country specific Q&amp;A provides an overview of Pharmaceutical Advertising laws and regulations applicable in Australia<\/span><div class=\"guide-content\"><div class=\"filter\">\r\n\r\n\t\t\t\t<input type=\"text\" placeholder=\"Search questions and answers...\" class=\"filter-container__search-field\">\r\n\t\t\t<\/div>\r\n\r\n\t\t\t\r\n\r\n\r\n\t\t\t<ol class=\"custom-counter\">\r\n\r\n\t\t\t\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What laws are used to regulate advertising on medicines in your jurisdiction?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The Therapeutic Goods Act 1989 (Cth) (TG Act) and its associated instruments including the Therapeutic Goods Regulations 1990 (Cth) (Regulations) and Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (Cth) (Code) are the main laws regulating advertising of medicines in Australia. The TG Act and the associated legislative instruments are administered by the Therapeutic Goods Administration (TGA). The TGA has published guidance on complying with the Code (including a guidance note on advertising medicines on social media platforms and a recent note on how to advertise medicines exclusively to health professionals). We understand from Complementary Medicines Australia that the TGA has established a Therapeutic Goods Advertising Consultative Committee to, among other things, review and update the Code.<\/p>\n<p>Australia\u2019s competition and consumer laws also apply to the advertising of medicines, in particular the Australian Consumer Law (ACL) (which is set out in Schedule 2 to the Competition and Consumer Act 2010 (Cth) together with the Competition and Consumer Regulations 2010 (Cth)). The ACL is administered by the Australian Competition and Consumer Commission (ACCC).<\/p>\n<p>Additionally, while not the focus of this guide, the Health Practitioner Regulation National Law (as is in force in each State and Territory) (National Law) applies to the advertisement of regulated health services (in particular, advertising by pharmacists). The National Law is administered by the Australian Health Practitioner Regulation Agency (AHPRA) (in partnership with the National Health Practitioner Boards (National Boards)) who have developed guidelines for advertising a regulated health service. Further, the National Health Act 1953 (Cth) regulates advertisements related to the Pharmaceutical Benefits Scheme (being the medicine subsidy program funded by the Australian Government).<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there any self-regulatory or other codes of practice which apply to the advertising of medicines? a) If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)? b) What is the legal status of the self-regulatory codes?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Yes.<\/p>\n<p><strong>\u00a0a. <\/strong><strong>If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)?<\/strong><\/p>\n<p>These self-regulatory codes apply to the members (who are usually pharmaceutical or other healthcare companies) falling within the target area of focus for each organisation. These include:<\/p>\n<table>\n<tbody>\n<tr>\n<td>Code<\/td>\n<td>Focus<\/td>\n<\/tr>\n<tr>\n<td>Medicines Australia Code of Conduct<\/td>\n<td>Prescription medicines.<\/td>\n<\/tr>\n<tr>\n<td>Generic and Biosimilar Medicines Association Code of Practice (GBMA Code)<\/td>\n<td>Generic and biosimilar medicines.<\/td>\n<\/tr>\n<tr>\n<td>Complementary Medicines Australia Code of Practice and Industry Guidelines<\/td>\n<td>\u2018Complementary medicines\u2019, including products referred to as complementary or alternative medicines (e.g. herbal medicines, homoeopathic medicines), traditional medicines (e.g. Indigenous Australian, Chinese and Ayurvedic medicines) and therapeutic dietary supplements (e.g. vitamins, minerals and amino acids).<\/td>\n<\/tr>\n<tr>\n<td>Complementary Medicine Association Code of Ethics and By-laws<\/td>\n<td>Complementary medicines\u2019 including Chinese Herbal medicine and Western Herbal Medicine.<\/td>\n<\/tr>\n<tr>\n<td>Pharmaceutical Society of Australia Code of Ethics for Pharmacists<\/td>\n<td>Pharmacy services.<\/td>\n<\/tr>\n<tr>\n<td>Consumer Healthcare Products Australia Code of Practice<\/td>\n<td>Non-prescription consumer healthcare products (including schedule 2 and schedule 3 medicines).<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>(together, the Codes of Practice).<\/p>\n<p><strong>b. What is the legal status of the self-regulatory codes?<\/strong><\/p>\n<p>The Codes of Practice are not legally binding, but may include internal disciplinary mechanisms that members have agreed to. Such disciplinary mechanisms may include requiring cessation of certain conduct\/withdrawal of materials, corrective actions, monetary fines and suspension\/expulsion from the relevant association. Compliance with the relevant Code of Practice may also be a condition of membership of the relevant association. Breaches of codes or complaints made about members of an industry body may be forwarded to the TGA or ACCC for further investigation, and failure to take corrective action may be publicised.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Is there a statutory or generally accepted definition of \u201cadvertising\u201d? a) What does the definition cover? \u2013 does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example? b) Does the definition apply equally to all target audiences?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Yes, the TG Act defines advertising for therapeutic goods.<\/p>\n<p><strong>(a) What does the definition cover? \u2013 does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example?<\/strong><\/p>\n<p>Under the TG Act, \u2018advertise\u2019 has a broad meaning and includes making any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods. This includes where the statement, pictorial representation or design is on the label, packaging or other material included with the package in which the goods are contained <sup style=\"font-size: 9px\">(1)<\/sup> .<\/p>\n<p>Material that is purely factual and which is not, directly or indirectly, intended to promote the use or supply of the goods (e.g. scientific\/medical information, provided there is no promotional claim, including price promotion claims) is unlikely to be considered advertising. However, if factual material is presented in close proximity to advertising material (e.g. the factual material and the advertising material are on a website and appear close to each other), the TGA may consider both the actual advertising material and the factual material to together comprise advertising for the purposes of the TG Act.<\/p>\n<p>The test is an objective test which considers the likely impact on a reasonable person to whom the advertisement is directed<sup style=\"font-size: 9px\">(2)<\/sup>. This test involves considering whether the material or format on its face appears to be designed to draw public attention to and promote the supply, sale, or use of the particular therapeutic good (the actual intention of those concerned is irrelevant). The total presentation and content of the advertisement (including the words, images, claim, advertising medium) will be considered. If members of the public would reasonably consider the information to be intended to promote the use or supply of a product, then the TGA will be likely to consider it an advertisement.<\/p>\n<p>Catalogues from retail pharmacies (and certain others) are permitted to include limited price information regarding medicines included in Schedule 3 (pharmacist-only medicines), Schedule 4 (prescription-only medicines) or Schedule 8 (controlled drugs) to the current Poisons Standard (and which are not included in Appendix H of the current Poisons Standard). Otherwise, unless authorised, these medicines must not be included in advertising.<\/p>\n<p>The Code does not apply to:<br \/>\n\u2022 An advertisement directed exclusively to certain health professionals (see (b) below).<br \/>\n\u2022 An advertisement that is part of, or comprises, a public health campaign. Otherwise, the advertising of therapeutic goods cannot be inconsistent with any such public health campaigns (see below).<br \/>\n\u2022 An advertisement relating to COVID-19 vaccines (made in accordance with the Therapeutic Goods (Restricted Representations\u2014COVID-19 Vaccines) Permission 2022 (Cth)).<br \/>\n\u2022 Genuine news published or broadcast by a broadcaster, datacaster, the SBS, or the publisher of a print edition of a magazine or newspaper for purchase in Australia.<\/p>\n<p>Pharmaceutical companies may undertake disease awareness campaigns to educate the public about diseases or conditions that require diagnosis, monitoring, treatment or management by a health professional. The campaigns may make reference to a range of treatment options, however if the information provided is likely to encourage consumers to seek to obtain a particular medicine, then the campaign will be considered advertising and must comply with the requirements under the TG Act and the Code.<\/p>\n<p>(b) Does the definition apply equally to all target audiences?<br \/>\nSubject to our comments below, the definition of \u2018advertising\u2019 under the TG Act applies equally to target audiences.<\/p>\n<p>Advertisements that are directed exclusively to the following persons are exempt from the application of the Code, provided that such advertisements are not accessible by the public and clearly target the following health professionals:<sup style=\"font-size: 9px\">(3)<\/sup><br \/>\n\u2022 health practitioners (who are registered health professionals in their professions);<br \/>\n\u2022 certain other health professionals (including chiropractors and dentists);<br \/>\n\u2022 persons engaged in the wholesale of therapeutic goods or purchasing of therapeutic goods on behalf of a hospital, charity, government or government authority; and<br \/>\n\u2022 herbalists, homoeopathic practitioners, naturopaths, nutritionists or practitioners of traditional Chinese medicine registered under a law of a State or Territory.<br \/>\nHowever, the Therapeutic Goods (Vaping Goods\u2014Advertising) Authorisation 2024 (Cth) provides a more limited list of health professionals for which advertisements of notified vaping goods can be exclusively directed: a medical practitioner, nurse practitioner, pharmacist or a practice manager or purchasing officer for any of the above persons.<br \/>\nPhysical advertisements for health professionals must not be able to be accessed by or seen by members of the public. Online content must also be secured (e.g. with secure log in information, statutory declarations and other confirmations of health professional status and restrictions on IP addresses and applications or programs).<\/p>\n<p>Generally, advertisements of medicines must not be directed to children under 12. However, certain advertisements can be directed to children over the age of 12<sup style=\"font-size: 9px\">(4)<\/sup>, including for:<br \/>\n\u2022 sunscreens with SPF 15+;<br \/>\n\u2022 acne preparations;<br \/>\n\u2022 condoms;<br \/>\n\u2022 lip balm; and<br \/>\n\u2022 cold sore preparations<sup style=\"font-size: 9px\">(5)<\/sup> .<\/p>\n<p>\u2022 <u>Footnote(s):<\/u><\/p>\n<p><sup style=\"font-size: 9px\">(1)<\/sup> <span style=\"font-size: 12px\">( TG Act s 3, definition of \u2018advertise\u2019.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(2)<\/sup> <span style=\"font-size: 12px\">(Code pt 2, s 5(2).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(3)<\/sup> <span style=\"font-size: 12px\">(Code pt 2, s 6(1)(a).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(4)<\/sup> <span style=\"font-size: 12px\">(Products containing substances included in Schedule 2, Schedule 3, Schedule 4, or Schedule 8 of the Poisons Standard may not be advertised to children of any age unless specifically approved by the TGA for use in products such as those specified above (e.g. in acne preparations). )<\/span><br \/>\n<sup style=\"font-size: 9px\">(5)<\/sup> <span style=\"font-size: 12px\">(Code, Annexure 1.)<\/span><\/p>\n<p>&nbsp;<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are press releases regarding medicines allowed in your jurisdictions, and if so what are the restrictions on these (bearing in mind the target audience)?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Yes, product-specific media statements are allowed in certain situations, subject to meeting certain requirements.<\/p>\n<p><strong>TG Act<\/strong><\/p>\n<p>The TG Act does not specifically regulate press releases regarding medicines. Press releases are subject to the same restrictions that apply to advertisements of medicines to the public as set out above. Please see our comments above regarding the proximity of promotional material with factual material.<br \/>\nThe TGA has published guidance for companies who are also listed on the Australian Stock Exchange (ASX) and who must comply with disclosure obligations under the ASX Listing Rules, reminding them of the prohibition against advertising in relation to regulated medicines<sup style=\"font-size: 9px\">(6)<\/sup>. ASX announcements must therefore be factual and not seen as promoting any particular medicines.<\/p>\n<p>As noted above, the Code does not apply to genuine news that is broadcast or published by any medium by a broadcaster, datacaster, the SBS<sup style=\"font-size: 9px\">(7)<\/sup> or any person that is a publisher of a print edition newspaper or magazine that is or was available to the public by way of purchase in Australia. Please see our comments above regarding any proximity of news items to advertising or promotional material.<\/p>\n<p><strong>The Medicines Australia Code of Conduct<\/strong><\/p>\n<p>The Medicines Australia Code of Conduct confirms that it is appropriate for members to provide current, accurate and balanced information about prescription products approved for use in Australia if the product-<\/p>\n<p>specific media statement is required to meet the \u2018information needs\u2019 of the general public<sup style=\"font-size: 9px\">(8)<\/sup> . The scope of whether a media statement meets the \u2018information needs\u2019 of the Australian public is limited, and may include:<\/p>\n<ul>\n<li>an announcement of a new product or new indication registration (however this media statement must not be made known to the general public until the product or indication has been registered in Australia, and the company has taken reasonable steps to inform healthcare professionals of the availability of the product or indication)<sup style=\"font-size: 9px\">(9)<\/sup> ;<br \/>\n\u2022 new public fundings (e.g. a new PBS listing); or<br \/>\n\u2022<\/li>\n<li>a change to public funding.<br \/>\nA product-specific consumer media statement must contain all of the following specific requirements:<\/li>\n<li>the brand name of the product;<\/li>\n<li>the Australian Approved Name(s) of the active ingredient(s) in the product;<\/li>\n<li>its approved indications, relevant to the product-specific media statement;<\/li>\n<li>therapeutic class<\/li>\n<li>public finding status and restrictions, or a notation fi the product is not publicly funded;<\/li>\n<li>a summary of the side effect profile, product\u2019s precautions, adverse effects, warnings, contraindications, and interactions; and<\/li>\n<li>a copy of, or link to, the product\u2019s Consumer Medicine Information<sup style=\"font-size: 9px\">(10)<\/sup> .<\/li>\n<\/ul>\n<p>A product-specific consumer media statement may include:<\/p>\n<ul>\n<li>a non-comparative description of the mechanism of action;<\/li>\n<li>the price of the product to the patient; and\/or<\/li>\n<li>the date of product\/ indication availability<sup style=\"font-size: 9px\">(11)<\/sup> .<\/li>\n<\/ul>\n<p>A product-specific consumer media statement must not include any of the following:<\/p>\n<ul>\n<li>promotional claims or statements;<\/li>\n<li>comparison with other products;<\/li>\n<li>quotes that are promotional or comparative in nature (e.g. from experts, opinion leaders or patients);<\/li>\n<li>an image of the product packaging;<\/li>\n<li>reference to a Company product access program.<\/li>\n<\/ul>\n<p>The product-specific consumer media statement must not be accompanied by any material which encourages, or is designed to encourage, the use of any prescription product<sup style=\"font-size: 9px\">(12)<\/sup> .<\/p>\n<p>A company may only issue each product-specific consumer media statement once, though this may be a single coordinated release across several channels (eg consumer medica, patient organisations or through the company\u2019s digital channels). In specific circumstances, a company may issue a media statement in consultation with the TGA about issues including product safety, shortages, recalls or withdrawal<sup style=\"font-size: 9px\">(13)<\/sup> .<\/p>\n<p>More broadly, any interactions between a member and the consumer media must enhance the quality use of medicines by providing appropriate, non-promotional information that is relevant to the Australian public. A company may respond to media enquiries or provide comment to a journalist or editor in situations where a published article contains factually incorrect information, provided that this is educative and non-promotional. General media articles concerning specific prescription products must not be initiated by companies, and companies should not seek to encourage the publication of general media articles or its content with the aim of promoting products. Companies may, on request, provide educational material or review a copy of general media articles to ensure accuracy<sup style=\"font-size: 9px\">(14)<\/sup> .<\/p>\n<p>While an ASX listed company must not initiate comments or statements regarding any product that is not registered in Australia (but is available overseas), it may issue a non-promotional product specific media statement in line with its continuous disclosure requirements<sup style=\"font-size: 9px\">(15)<\/sup> .<\/p>\n<p><u>Footnote(s):<\/u><\/p>\n<p><sup style=\"font-size: 9px\">(6)<\/sup> <span style=\"font-size: 12px\">(Complying with advertising rules for therapeutic goods when making an ASX announcement published 1 September 2022 and last updated 31 October 2024; see also the Code of Best Practice for Reporting by Life Sciences Companies, Second Edition published by AusBiotech in collaboration with the ASX and the Victorian State Government.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(7)<\/sup><br \/>\n<sup style=\"font-size: 9px\">(8)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct, s 10.1.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(9)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 10.1(d).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(10)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 10.1(e).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(11)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 10.1(f).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(12)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 10.1(g).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(13)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 10.1(b).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(14)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 10.1(j).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(15)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 10.1(h). )<\/span><\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there any processes prescribed (whether by law or Codes of Practice) relating to the approval of advertising of medicines within companies?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The TG Act does not specifically regulate the processes that companies must put in place internally concerning the approval of advertising of medicines. However, Codes of Practice may require members to comply with requirements for employees involved in the development, review and approval of promotional materials and educational materials for the general public, including minimum training requirements. Some of these requirements are outlined at Question 11 below.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Do companies have to have material approved by regulatory bodies prior to release?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Generally, the approval of the TGA, ACCC or any other regulatory body is not required for the release of any advertising material. However, under the TG Act there are certain representations which are either \u2018prohibited\u2019 or \u2018restricted\u2019 in the advertising of medicines and do require approval.<\/p>\n<p>Advertisers are prohibited from making representations regarding the treatment, cure, prevention, diagnosis (including screening) or monitoring of, or the susceptibility or pre-disposition to, sexually transmitted diseases, HIV or AIDs, Hepatitis C Virus, mental illness or neoplastic disease (i.e. conditions that cause tumour growth). These prohibited representations can only be used if the TGA has permitted them<sup style=\"font-size: 9px\">(16)<\/sup> , either because they are necessary for the appropriate use of the goods or are necessary in the interests of public health. This is a high standard.<\/p>\n<p>A representation in an advertisement about medicines that refers to a serious form of disease, condition, ailment or defect (i.e. one that usually requires diagnosis and \/ or management by a health practitioner and is not a prohibited representation) is a restricted representation. A restricted representation can only be used with prior approval or permission from the TGA<sup style=\"font-size: 9px\">(17)<\/sup> . Notices of restricted representations that the TGA has approved or permitted the use of are available on the TGA website.<\/p>\n<p>Otherwise, as noted in response to Question 4, there are also specific circumstances where a company must consult with the TGA to issue a media statement about issues including product safety, shortages, recalls or withdrawal<sup style=\"font-size: 9px\">(18)<\/sup> .<\/p>\n<p><u>Footnote(s):<\/u><\/p>\n<p><sup style=\"font-size: 9px\">(16)<\/sup> <span style=\"font-size: 12px\">(TG Act s 42DK)<\/span><br \/>\n<sup style=\"font-size: 9px\">(17)<\/sup> <span style=\"font-size: 12px\">(TG Act s 42DL.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(18)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 10.1(b).)<\/span><\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Is comparative advertising for medicines allowed and if so, what restrictions apply?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Comparative advertising (i.e. identifying a competing product and making or implying certain claims about it) is permitted under the Code, however advertising must not:<br \/>\n\u2022 suggest that the comparator goods are harmful or ineffectual<sup style=\"font-size: 9px\">(19)<\/sup> ;<br \/>\n\u2022 make broad comparisons like \u2018higher strength\u2019 or \u2018better absorbed\u2019; or<br \/>\n\u2022 use superlatives in describing the product such as \u2018the best\u2019, \u2018the fastest acting\u2019, or \u2018most effective\u2019.<\/p>\n<p>Where product comparisons are made, they should be factual, fair, and should not undermine the comparator goods. This is consistent with the requirements under the ACL which includes the requirement that advertisements not be misleading or deceptive to consumers. Any comparative claim should not be used unless there is clear evidence to substantiate the relevant claims. The advertising must not discredit other products, whether directly or by implication.<\/p>\n<p>If a company is making a comparative claim about a prescription product in advertising directed at healthcare professionals, the statistical significance of the comparative claim must be clearly indicated. \u2018Hanging\u2019 comparative claims should not be used (e.g. claims that a product is better, stronger, or more widely prescribed)<sup style=\"font-size: 9px\">(20)<\/sup><\/p>\n<p><u>Footnote(s):<\/u><\/p>\n<p><sup style=\"font-size: 9px\">(19)<\/sup> <span style=\"font-size: 12px\">(Code s 9(3)(f).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(20)<\/sup> <span style=\"font-size: 12px\">(Medicines Code of Conduct s 1.)<\/span><\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Is it possible to provide information on unauthorised medicines or unauthorised indications? Is it possible to provide information on unauthorised medicines or unauthorised indications during a scientific conference directed at healthcare professionals, or to send information to healthcare professionals?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p><strong>Information about unauthorised medicines<\/strong><\/p>\n<p>In Australia, medicines that are not registered or listed on the Australian Register of Therapeutic Goods cannot be \u2018advertised\u2019 \u2013 see our response to Question 3 for the definition of \u2018advertise\u2019 for the purposes of the TG Act. The same prohibition applies to advertising unauthorised indications. Any statement promoting a new product (e.g. new treatment for eczema is coming in 2026\u2019) is considered promotional, even if it doesn\u2019t mention the name of the product. A person or company that advertises an unregistered medicine, or includes an unauthorised indication in an advertisement for a medicine, could be subject to criminal and civil penalties<sup style=\"font-size: 9px\">(21)<\/sup> .<\/p>\n<p><strong>Providing material about unauthorised medicines \/ indications during scientific conferences<\/strong><\/p>\n<p>As stated above, providing information about unauthorised medicines or unauthorised indications is permitted where the information is purely factual as an exchange of scientific and medical information between medical professional or an independent clinical opinion, and is not proximate to any form of advertising. The Medicines Australia Code of Conduct provides further guidance on this, stating that members who have initiated or managed an educational event must ensure that healthcare professionals speaking at those events understand their obligation not to promote unapproved pharmaceutical products or indications. Companies should be able to produce documentary evidence showing that the healthcare professional was briefed on this obligation<sup style=\"font-size: 9px\">(22)<\/sup> .<\/p>\n<p>It is acceptable to display or supply information regarding an unregistered product or indication in the case of international or Australasian congresses held in Australia that are purely for health care professionals, provided any material used clearly identifies that it refers to a product or indication not approved in Australia, and that the product or indication (as appropriate) is approved overseas. Information provided must be consistent with the product information in the country where it is approved or registered<sup style=\"font-size: 9px\">(23)<\/sup> .<\/p>\n<p><strong>Providing material about unauthorised medicines \/ indications to healthcare professionals<\/strong><\/p>\n<p>Under the Medicines Australia Code of Conduct, only the \u2018medical department\u2019 personnel of pharmaceutical companies (rather than sales personnel) may engage in exchanges with healthcare professionals about unregistered products or off-label uses<sup style=\"font-size: 9px\">(24)<\/sup> . In some instances, non-promotional roles (such as market access or regulatory affairs) may also be permitted to engage in this exchange. Such exchanges must be non-promotional in intent, content, and nature<sup style=\"font-size: 9px\">(25)<\/sup> . Any information relating to unregistered products or off-label uses must be clearly identified as such and must meet the requirements of the Medicines Australia Code of Conduct. These materials must be approved by the Company\u2019s medical director or their delegate<sup style=\"font-size: 9px\">(26)<\/sup> .<\/p>\n<p>Information about unapproved products and their uses may be provided to healthcare professionals through digital medical information applications if the information is only viewable after the healthcare professional executes a search that includes specific search terms relating to the unapproved product or use<sup style=\"font-size: 9px\">(27)<\/sup> .<\/p>\n<p><u>Footnote(s):<\/u><\/p>\n<p><sup style=\"font-size: 9px\">(21)<\/sup> <span style=\"font-size: 12px\">(TG Act ss 21B(4), 22(2)\u2013(5).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(22)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 4.1)<\/span><br \/>\n<sup style=\"font-size: 9px\">(23)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 4.3.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(24)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 7(c).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(25)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 7(c).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(26)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 7(e).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(27)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 7(f).)<\/span><\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please provide an overview of the rules that apply to advertising to the general public for prescription only medicines and over the counter medicines, and include the information that must or must not be included.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The TG Act prohibits the advertising of prescription-only medicines (i.e. Schedule 4 and Schedule 8 medicines) and Schedule 3 medicines (other than those listed in Appendix H to the Poisons Standard) to the general public<sup style=\"font-size: 9px\">(28)<\/sup> . The sole exception is the provision of price information by retail pharmacies and certain others<sup style=\"font-size: 9px\">(29)<\/sup> .<\/p>\n<p>Non-prescription medicines (e.g. over the counter medicines) and certain permitted Schedule 3 (pharmacist-only) medicines can be advertised to the public.<\/p>\n<p>Under the TG Act, companies should ensure that any advertisements for pharmacy-only (Schedule 2) or permitted pharmacist-only (Schedule 3) medicines complies with the TG Code and:<\/p>\n<ul>\n<li>are accurate and balanced;<\/li>\n<li>do not represent that the medicine is safe, without harm or side effects, effective or a guaranteed cure, or infallible, magical or miraculous;<\/li>\n<li>do not cause, or be likely to cause, undue alarm, fear or distress;<\/li>\n<li>minimise misuse of their products and promote safe usage;<\/li>\n<li>are not misleading to the consumer as to the nature or performance of the product;<\/li>\n<li>support informed choices about healthcare;<\/li>\n<li>only contain information that is substantiated by the advertiser;<\/li>\n<li>are consistent with listed indications \/ intended purposes for the goods in the ARTG, if applicable;<\/li>\n<li>do not exaggerate efficacy and encourage excessive use;<\/li>\n<li>include warnings where specific ingredients are present;<\/li>\n<li>only contain easily understood scientific or clinical terminology;<\/li>\n<li>comply with TGA guidance as to restricted and prohibited representations (see Question 6 above);<\/li>\n<li>must not be directed to children under 12 years old (unless exempt);<\/li>\n<li>only contain compliant testimonials and endorsements;<\/li>\n<li>are not inconsistent with current public health campaigns; and<\/li>\n<li>contain relevant mandatory statements and other required information<sup style=\"font-size: 9px\">(30)<\/sup> .<\/li>\n<\/ul>\n<p><u>Footnote(s):<\/u><\/p>\n<p><sup style=\"font-size: 9px\">(28)<\/sup> <span style=\"font-size: 12px\">(TG Act s 42DL; s 42DLB.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(29)<\/sup> <span style=\"font-size: 12px\">(Code pt 9.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(30)<\/sup> <span style=\"font-size: 12px\">(Code pt 3, 4, 5, 6 and 8.)<\/span><\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there any restrictions on interactions between patients or patient organisations and industry (e.g., consultation, sponsorship)? If so, please describe those briefly.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Restrictions on interactions between patients or patient organisations and industry are governed by the Codes of Practice rather than the TG Act, in particular the Medicines Australia Code of Conduct.<\/p>\n<p><strong>Guidelines concerning interactions with patients<\/strong><\/p>\n<p>Members of Medicines Australia can make available to patients (and their families) information about a product that is a credible and non-promotional source of information, such as \u2018Consumer Medicine Information\u2019, risk management materials, and \u2018Product Information\u2019 about their products. These materials must be provided in their entire form and not be amended, abridged or shown in a promotional manner<sup style=\"font-size: 9px\">(31)<\/sup> .<\/p>\n<p>Product-specific programs, product information, and patient aids should only be provided to patients already prescribed the product<sup style=\"font-size: 9px\">(32)<\/sup> . These items must not be promotional in any way. Where an item is likely to be used outside of the home and therefore be visible to the public, a company may include their company name and\/or logo only on such materials<sup style=\"font-size: 9px\">(33)<\/sup> .<\/p>\n<p>Companies are also permitted to conduct patient support programs, with or without a patient organisation. Patient support programs aim to increase patient compliance with a prescribed medical treatment, in turn increasing health outcomes<sup style=\"font-size: 9px\">(34)<\/sup> . Patient support programs must be designed to address a legitimate need and must have a clearly documented clinical rationale<sup style=\"font-size: 9px\">(35)<\/sup> . Advertisements of patient support programs are bound by the TG Act and Medicines Australia Code of Conduct.<\/p>\n<p><strong>Guidelines concerning interactions with patient organisations<\/strong><\/p>\n<p>The Medicines Australia Code of Conduct specifies that companies may enter into relationships with patient organisations with the objective of enhancing the quality use of medicines and supporting better health outcomes for the Australian community<sup style=\"font-size: 9px\">(36)<\/sup> .<\/p>\n<p>The Medicines Australia Code of Conduct provides the following guidance:<\/p>\n<ul>\n<li>companies should refer to the Medicines Australia a guide titled \u2018Working Together: A guide to relationships between health consumer organisations and pharmaceutical companies\u2019 when entering into relationships with patient organisations;<\/li>\n<li>companies should conduct a case by case consideration of whether any offer or proposal to collaborate with, or provide support for, a patient organisation will withstand professional and public scrutiny;<\/li>\n<li>the selection criteria for sponsorship to enable patients and representatives from a patient organisation to attend third-party scientific and medical conferences should be based on their specific interest in a therapeutic area; and<\/li>\n<li>companies may share information with patient organisations and their representatives, including information about prescription medicines if there is a genuine need for the information, the content is relevant to their specific expertise and interest in the therapeutic area, and is non-promotional<sup style=\"font-size: 9px\">(37)<\/sup> .<\/li>\n<\/ul>\n<p>More broadly, communications with patient organisations (who may be consulted regarding a therapeutic good) is allowed provided the disclosure of information is limited to information that may assist that organisation with their role and is not promotional in nature<sup style=\"font-size: 9px\">(38)<\/sup> . It is also appropriate for pharmaceutical companies to solicit information to assist in understanding relevant aspects of the healthcare environment relating to their products<sup style=\"font-size: 9px\">(39)<\/sup> . Communications cannot be promotional in nature, should only be conducted by appropriately qualified and selected company personnel, and cannot be made with the intention to influence patient-level prescribing or any other clinical decision-making relevant to individual patients<sup style=\"font-size: 9px\">(40)<\/sup> .<\/p>\n<p><u>Footnote(s):<\/u><\/p>\n<p><sup style=\"font-size: 9px\">(31)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 12(a).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(32)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 12(d).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(33)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 12(d). )<\/span><br \/>\n<sup style=\"font-size: 9px\">(34)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 13.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(35)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 13(a).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(36)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 11.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(37)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 11.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(38)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 10.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(39)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 10(c).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(40)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 10(a)-(b).)<\/span><\/p>\n<p>&nbsp;<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Which information must advertising directed at healthcare professionals contain, and which information is prohibited? For example, can companies provide information about clinical trials, or reprints of scientific journal articles?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>As noted in response to Question 3(b) above, therapeutic goods advertisements directed exclusively to certain healthcare professionals do not need to comply with the TG Act and Code<sup style=\"font-size: 9px\">(41)<\/sup> . The Codes of Practice provide guidance on the kind of information that is required or prohibited in such advertisements.<\/p>\n<p><strong>General requirements<\/strong><\/p>\n<p>The Medicines Australia Code of Conduct requires that<sup style=\"font-size: 9px\">(42)<\/sup> :<\/p>\n<ul>\n<li>information must be current, accurate, balanced, consistent with the approved product information, and must not mislead directly, by implication, or by omission;<\/li>\n<li>members must ensure that all promotional claims are substantiated; i.e. that they are referenced with the appropriate level of evidence for the claim (including any statistical data);<\/li>\n<li>substantiating data should consist of more than just posters, abstracts, personal communication, and unpublished data \u2013 however, such data can be used as secondary resources to support claims;<\/li>\n<li>comparative claims based on studies reporting clinically important differences must include sufficient detail to enable the reader to understand the significance of the data;<\/li>\n<li>if qualifying statements are used with a promotional claim, they should be linked to the relevant claim with a readily identifiable symbol and appear directly below or adjacent to the claim. Qualifying statements must be prominent;<\/li>\n<li>any claims for clinical benefit need to be of a magnitude that is generally accepted as clinically meaningful and supported by the body of evidence.<\/li>\n<\/ul>\n<p><strong>Specific requirements<\/strong><\/p>\n<p>The Medicines Australia Code of Conduct also specifies requirements for all promotional material of a product, whether or not the material contains a promotional claim. Such material must include, or provide access to, sufficient prescribing information for a healthcare professional to appropriately prescribe the product for a person consistent with its approved use<sup style=\"font-size: 9px\">(43)<\/sup> . All types of promotional materials, across all media, must include<sup style=\"font-size: 9px\">(44)<\/sup> :<\/p>\n<ul>\n<li>the product\u2019s brand name;<\/li>\n<li>Australian Approved Name(s) of the active ingredient(s) placed next to the most prominent presentation of the brand name;<\/li>\n<li>Any boxed warnings and\/or black triangle statement(s) as required by the TGA;<\/li>\n<li>A statement directing healthcare professionals to review product information before prescribing. This should include the means to access the product information immediately (in electronic or other form, or the telephone number for the company medical information service);<\/li>\n<li>a statement indicating the public funding or reimbursement status of the product (with or without details of listing, or a direction to where the relevant information is available);<\/li>\n<li>name of the supplier, and the city, town or locality of the registered office; and<\/li>\n<li>date that the material was prepared or last revised.<\/li>\n<\/ul>\n<p>Separately, as noted above, information that is purely factual and that would not be considered \u2018advertising\u2019 for the purposes of the TG Act may be provided to healthcare professionals. It will depend on whether the clinical trial information or journals are considered to be advertising as to whether they need to comply with the Codes of Practice rules.<\/p>\n<p><u>Footnote(s):<\/u><br \/>\n<sup style=\"font-size: 9px\">(41)<\/sup> <span style=\"font-size: 12px\">(Code s 42AA)<\/span><br \/>\n<sup style=\"font-size: 9px\">(42)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 1.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(43)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 2.1.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(44)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 2.1.)<\/span><\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">May pharmaceutical companies offer gifts to healthcare professionals and are there any monetary limits?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>This is governed by the Codes of Practice rather than the TG Act. For example, the GBMA Code prohibits members from providing personal gifts to healthcare professionals<sup style=\"font-size: 9px\">(45)<\/sup> , whereas the Medicines Australia Code of Conduct prohibits members from offering items or gifts which may inappropriately influence the prescribing of a product<sup style=\"font-size: 9px\">(46)<\/sup> . However, certain company-branded items of low monetary value relevant to the conduct of an educational meeting to health care professionals attending that educational meeting, or otherwise company-branded educational material are permitted<sup style=\"font-size: 9px\">(47)<\/sup> .<\/p>\n<p>Companies may also provide hospitality, travel and\/or accommodation to healthcare professionals who are participating in the event or providing a service subject to the principles outlined in the Medicines Australia Code of Conduct (any hospitality must be moderate and reasonable and subject to monetary limits set out in the Medicines Australia Code of Conduct \u2018tool kit\u2019)<sup style=\"font-size: 9px\">(48)<\/sup> . Companies may not provide entertainment to healthcare professionals<sup style=\"font-size: 9px\">(49)<\/sup> or provide the hospitality, travel and accommodation to the healthcare professional\u2019s or non-healthcare professionals practice staffs\u2019 guests, spouses, relatives or companions<sup style=\"font-size: 9px\">(50)<\/sup> . Doing so would be considered a gift or inducement.<\/p>\n<p>Companies providing items as permanent loans to a medical practice or health-related organisation could be regarded as offering gifts<sup style=\"font-size: 9px\">(51)<\/sup> . See also the response to Question 14 below.<\/p>\n<p><u>Footnote(s):<\/u><\/p>\n<p><sup style=\"font-size: 9px\">(45)<\/sup> <span style=\"font-size: 12px\">(GBMA Code s 6.9.5.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(46)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 3.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(47)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 3. )<\/span><br \/>\n<sup style=\"font-size: 9px\">(48)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 4.5(c).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(49)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 4.5(e).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(50)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 4.5(i).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(51)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 5.2(e).)<\/span><\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are pharmaceutical companies allowed to provide samples to healthcare professionals?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The Code permits the limited distribution of samples to the general public for certain specified goods (which generally do not include pharmaceuticals, other than oral rehydration products)<sup style=\"font-size: 9px\">(52)<\/sup> . Where samples are permitted they must comply with the labelling requirements under Therapeutic Goods Orders 91 and 92 (prescribing standards for labelling of prescription and related medicines and non-prescription medicines).<\/p>\n<p>Providing samples of other types of medicines to healthcare professionals is governed by State and Territory legislation. For example in South Australia, samples of certain medicines can be provided to registered health practitioners and veterinary surgeons provided that they comply with requirements of the Controlled Substances Act 1984 (SA) including manufacturing and packaging. However, nothing in the SA legislation empowers any person to give a sample of a Schedule 8 poison (i.e. a drug of dependence).<\/p>\n<p>The Codes of Practice may also impose further requirements for samples. For example, the Medicines Australia Code of Conduct provides that members can provide samples (i.e. product starter packs) at no cost or reduced cost to healthcare professionals only when formally requested by written request from a healthcare professional<sup style=\"font-size: 9px\">(53)<\/sup> . The supply must only be for the purpose of enhancing patient access or enabling prescribers to gain experience with the product to improve patient care<sup style=\"font-size: 9px\">(54)<\/sup> . They can only be supplied by representatives employed by the holder of a manufacturer\u2019s licence or wholesale dealer\u2019s licence, or by authorised Company representatives<sup style=\"font-size: 9px\">(55)<\/sup> .<br \/>\nA record of delivery, including the quantity and nature of the starter pack, should be kept for a minimum of 2 years by the company<sup style=\"font-size: 9px\">(56)<\/sup> .<\/p>\n<p><u>Footnote(s):<\/u><\/p>\n<p><sup style=\"font-size: 9px\">(52)<\/sup> <span style=\"font-size: 12px\">(Code s 25; annexure 2.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(53)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 6.1(e).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(54)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 6.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(55)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 6.1(d).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(56)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 6.1(e).)<\/span><\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are pharmaceutical companies permitted to sponsor scientific meetings or congresses and\/or attendance by healthcare professionals to these events?  If so, which restrictions apply?  Do additional restrictions apply to events taking place abroad?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The TG Act does not specify any requirements in relation to sponsorship or attendance at events, however the Medicines Australia Code of Conduct specifies the following:<\/p>\n<ul>\n<li>Sponsorship including hospitality (being costs for food or beverages), travel, and accommodation may be provided to enable a healthcare professional to attend an educational event, provided the meeting is directly related to the healthcare professional\u2019s area of expertise\u00a0<sup style=\"font-size: 9px\">(57)<\/sup> . The sponsoring company must establish clear guidelines in relation to the awarding of the sponsorship, which can be publicly disclosed if required.<\/li>\n<li>A sponsoring company must adhere to certain rules in relation to costs, flights and accommodation in connection with any event<sup style=\"font-size: 9px\">(58)<\/sup> .<\/li>\n<li>Where the member initiates and manages the event, the member should:<\/li>\n<\/ul>\n<p>o be able to produce objective evidence of the educational value of the event (for example an invitation or agenda) that clearly describes the purpose, content, and meeting start and finish times;<\/p>\n<p>o review and approve the educational program through an internal company process; and<\/p>\n<p>o brief healthcare professionals speaking at the event about their obligation to not promote unapproved company products or indications. An exception to this are events where an independent scientific faculty has chosen the topics and speakers<sup style=\"font-size: 9px\">(59)<\/sup> .<\/p>\n<ul>\n<li>A member can sponsor educational events organised by a society, university, or other healthcare professional organisation<sup style=\"font-size: 9px\">(60)<\/sup> .<\/li>\n<li>Members may host a trade display provided the audience is solely healthcare professionals. Where the primary audience is broader than healthcare professionals, the member should carefully consider whether the promotional trade display or the information from a trade display involves the promotion of products to the general public which may contravene the TG Act<sup style=\"font-size: 9px\">(61)<\/sup> .<\/li>\n<\/ul>\n<p>Where an event takes place in countries other than Australia, the Medicines Australia Code of Conduct specifies that:<\/p>\n<ul>\n<li>A member can sponsor international travel in either economy or business class, though travel to and from New Zealand is by economy class only. The most direct route should be booked without the allowance of more time at the destination than is reasonably justified to enable the healthcare professional to effectively participate in the events<sup style=\"font-size: 9px\">(62)<\/sup> .<\/li>\n<li>Any meal provided in another country should comply with the monetary limit set by the industry association in that country. Where there is no monetary limit in that country, the Medicines Australia Code of Conduct principles should apply<sup style=\"font-size: 9px\">(63)<\/sup> ; any spend on food and beverages must be moderate and reasonable, as judged by Australian standards. In Australia, the capped maximum spend per person is $140 per person per meal (excluding gratuities and GST<sup style=\"font-size: 9px\">(64)<\/sup> )<\/li>\n<\/ul>\n<p><u>Footnote(s):<\/u><\/p>\n<p><sup style=\"font-size: 9px\">(57)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 4.4.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(58)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 4.5.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(59)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 4.1.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(60)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 4.2.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(61)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 4.3.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(62)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 4.5.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(63)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 4.5.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(64)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct Code Resource Toolkit, Capped Maximum Hospitality Spend.)<\/span><\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What are the restrictions on the organisation of cultural, sports or other non-scientific events in relation to scientific conferences by pharmaceutical companies?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The TG Act does not specify any restrictions on the organisation of cultural, sports or other non-scientific events in relation to scientific conferences by pharmaceutical companies.<\/p>\n<p>However, a member of Medicines Australia must comply with the Medicines Australia Code of Conduct guidelines concerning company-initiated or sponsored events, and the Medicines Australia Code of Conduct\u2019s overarching principles such as ensuring all activities have the purpose of supporting the quality use of medicine<sup style=\"font-size: 9px\">(65)<\/sup> .<\/p>\n<p>The Medicines Australia Code of Conduct states that pharmaceutical companies cannot provide entertainment to healthcare professionals<sup style=\"font-size: 9px\">(66)<\/sup> . Previous versions of the Medicines Australia Code of Conduct specified that entertainment includes the provision of tickets to cultural, sporting or artistic events, including a band as a featured attraction at a dinner meeting or an invitation to a corporate box at a sporting event<sup style=\"font-size: 9px\">(67)<\/sup> . While the current version of the Medicines Australia Code of Conduct no longer expressly specifies this, it is highly likely that cultural, sporting, and other non-scientific events at scientific conferences would still be classified as entertainment.<\/p>\n<p>The Medicines Australia Code of Conduct also states that a facility selected as part of the travel, accommodation and\/or hospitality of the healthcare professional must be selected for its appropriateness to enable the activity to be conducted, and should not be chosen or utilised for the purpose of leisure, sporting or recreational activities<sup style=\"font-size: 9px\">(68)<\/sup> .<\/p>\n<p><u>Footnote(s):<\/u><\/p>\n<p><sup style=\"font-size: 9px\">(65)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct pt A, principle 1.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(66)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 4.5.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(67)<\/sup> <span style=\"font-size: 12px\">(Edition 18 of the Medicines Australia Code of Conduct version 2, October 2016, s 9.5.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(68)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 4.5.)<\/span><\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Is it possible to pay for services provided by healthcare professionals and if so, which restrictions apply?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The TG Act does not specifically deal with payments by pharmaceutical companies to healthcare professionals.<\/p>\n<p>However, in accordance with the Medicines Australia Code of Conduct, members can pay healthcare professionals for legitimate expertise and services provided to the pharmaceutical industry. This includes payment for:<\/p>\n<ul>\n<li>speaking at educational events or meeting;<\/li>\n<li>consultancy or advisory services;<\/li>\n<li>renumeration or sponsorship of a healthcare professional in accordance with the Medicines Australia Code of Conduct (excluding any payments to consultants for research and development work, such as the conduct of clinical trials);<\/li>\n<li>payment for the purpose of market research only where he identify of the healthcare professional is known to, or becomes known by, the Company.<\/li>\n<\/ul>\n<p>These fees must be reported to Medicines Australia (with the exception of fees for market research if the company contracting the market research is not involved in selection of healthcare professionals and is not aware of the identity of those participating in the market research)<sup style=\"font-size: 9px\">(69)<\/sup> . Details about the reporting requirements are included in response to Question 18 below.<\/p>\n<p>There should be a clearly identified legitimate need for the services prior to the pharmaceutical company approaching prospective healthcare professionals for services<sup style=\"font-size: 9px\">(70)<\/sup> . Remuneration for the services rendered should not exceed an amount commensurate with the services supplied and must be reasonable, appropriate, and balanced when considered in context<sup style=\"font-size: 9px\">(71)<\/sup> . Any payment made to a healthcare professional must not be made as an incentive or in return for their attendance at an educational event or trade stand, and must not be conditional on the use of a specific product by the health professional<sup style=\"font-size: 9px\">(72)<\/sup> .<\/p>\n<p><u>Footnote(s):<\/u><\/p>\n<p><sup style=\"font-size: 9px\">(69)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 14.1.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(70)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 5.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(71)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 5.1.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(72)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 5.1.)<\/span><\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are pharmaceutical companies permitted to provide grants or donations to healthcare professionals or healthcare institutions? Does it matter if the grant or donation is monetary or in kind?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The TG Act does not deal with grants or donations made by pharmaceutical companies.<\/p>\n<p>Under the Medicines Australia Code of Conduct, Medicines Australia members can provide grants, financial support, or in-kind support to healthcare professionals or health-related organisations in specific circumstances, being:<\/p>\n<ul>\n<li>to implement a Quality Use of Medicine program;<\/li>\n<li>for educational, training or academic purposes;<\/li>\n<li>for medical research; or<\/li>\n<li>to improve patient outcomes<sup style=\"font-size: 9px\">(73)<\/sup> .<\/li>\n<\/ul>\n<p>The Medicines Australia Code of Conduct recommends that financial support be paid to a healthcare institution rather than directly to an individual healthcare professional as payments to individuals may create an impression that the purpose is not related to the specific approved circumstances above<sup style=\"font-size: 9px\">(74)<\/sup> .<\/p>\n<p>A grant of financial support must not be provided to underwrite a commercial business, generate income for the practice \/ institution, or to pay for an employee\u2019s salary in part or full<sup style=\"font-size: 9px\">(75)<\/sup> .<\/p>\n<p>The member may temporarily loan a piece of equipment to a medical practice or health-related organisation, provided it facilitates the quality use of medicines and has a mechanism to retrieve the equipment. Where an item is provided on permanent loan, this may be regarded as a gift<sup style=\"font-size: 9px\">(76)<\/sup> . Gifts for the personal benefit of healthcare professionals are prohibited, and companies are not to offer any items or services that could be considered to be a gift (see Question 12 above)<sup style=\"font-size: 9px\">(77)<\/sup> .<\/p>\n<p><u>Footnote(s):<\/u><\/p>\n<p><sup style=\"font-size: 9px\">(73)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 5.2.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(74)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 5.2. )<\/span><br \/>\n<sup style=\"font-size: 9px\">(75)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 5.2.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(76)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 5.2.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(77)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct Code Resource Toolkit, Gifts, Offers and Company Branded Items. )<\/span><\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are pharmaceutical companies required to disclose details of transfers of value to healthcare professionals or healthcare institutions? If so, please indicate whether this is a legal requirement or not, and describe briefly what the companies must report and how. Do these transparency requirements apply to foreign companies and\/or companies that do not yet have products on the market?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The TG Act does not deal with disclosure and transparency requirements in relation to payments between pharmaceutical companies and healthcare professionals or institutions.<\/p>\n<p>However, under the Medicines Australia Code of Conduct, members are required to report on transfers of value to healthcare professionals, third-party educational meetings and symposia, and health consumer organisations<sup style=\"font-size: 9px\">(78)<\/sup> . These reports must be publicly available for three years from publication<sup style=\"font-size: 9px\">(79)<\/sup> . This is irrespective of whether the member has products on the Australian market. Reporting of each individual transfer of value for each healthcare professional is required, indicating the:<\/p>\n<ul>\n<li>date of the event or provision of service;<\/li>\n<li>healthcare professional\u2019s name;<\/li>\n<li>type of healthcare professional;<\/li>\n<li>healthcare professional\u2019s principal practice address;<\/li>\n<li>description of the service<\/li>\n<li>description of the event<\/li>\n<li>whether the payment was made to the healthcare professional or to a third-party;<\/li>\n<li>the amount of the payment or transfer of value, subdivided into registration fees, travel and accommodation, and fees for service (where relevant)<sup style=\"font-size: 9px\">(80)<\/sup> .<\/li>\n<\/ul>\n<p>Transparency reporting is not a legal requirement, but breaching the Medicines Australia Code of Conduct may lead to sanctions being imposed and fines of up to $300,000 per complaint<sup style=\"font-size: 9px\">(81)<\/sup> . Companies must also comply with Australian privacy legislation (the Privacy Act 1988 (Cth) and associated Australian Privacy Principles) regarding reporting of individual healthcare professional data.<\/p>\n<p>Support provided to health consumer organisations including financial support or significant direct or indirect non-financial support should also be reported.<\/p>\n<p>The Medicines Australia Code of Conduct is only concerned with payments made to Australian healthcare professionals by Australian companies. This means:<\/p>\n<ul>\n<li>if a global company with no Australian legal entity pays or provides support to an Australian healthcare professional, this is not a reportable transfer of value;<\/li>\n<li>if an Australian company pays or provides support for an Australian healthcare professional to undertake a global activity, this is a reportable transfer of value;<\/li>\n<li>if a global company pays or provides support for an Australian healthcare professional, but then the global company subsequently bills or invoices an Australian company, this is a reportable transfer of value<sup style=\"font-size: 9px\">(82)<\/sup> .<\/li>\n<\/ul>\n<p>Further practical guidance on reporting procedures, especially pre-reporting procedures, can be found in Medicine Australia\u2019s Transparency Reporting Quick Guide and Transparency Reporting FAQs.<\/p>\n<p><u>Footnote(s):<\/u><\/p>\n<p><sup style=\"font-size: 9px\">(78)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 14.1.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(79)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 14.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(80)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 14.1.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(81)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 14; s 15.6.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(82)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct Code Resource Toolkit, Transparency Reporting FAQs.)<\/span><\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there any restrictions (whether by law or Codes of Practice) on advertising for medicines on social media directed to healthcare professionals or directed to the general public?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Advertising of medicinal products on social media is subject to the same regulation as traditional forms of advertisement under the TG Act. Accordingly, the requirements outlined in Question 9 remain applicable to advertisements on social media.<\/p>\n<p>Social media advertisements for Schedule 2 and 3 medicines must include relevant mandatory statements and health warnings which are visible at all times and not \u2018collapsed\u2019 within a social media post. Any non-compliant comments must be removed from the social media page. The TGA recommends businesses to adopt an \u2018acceptable use policy\u2019.<\/p>\n<p>The TGA has also noted that if a business becomes aware of misinformation in relation to its product (even on social media channels for which it is not responsible), they should provide corrective information.<\/p>\n<p>The Medicines Australia Code of Conduct confirms that activities on social media are considered in the same way as traditional recommends that companies have policies and procedures in place which describe the roles and responsibilities of employees and contractors when interacting on social media to ensure compliance with the Medicines Australia Code of Conduct<sup style=\"font-size: 9px\">(83)<\/sup> .<\/p>\n<p><u>Footnote(s):<\/u><\/p>\n<p><sup style=\"font-size: 9px\">(83)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 10.2.)<\/span><\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Is advertising on the internet for medicinal products regulated, and if so, how? Should companies include access restrictions on websites containing advertising or other information intended for healthcare professionals?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The advertising of medicinal products on the internet is highly regulated where that advertising is directed towards members of the Australian public for products available for supply in Australia. When considering advertisements on the internet, it is critical for companies to ensure that any content with promotional claims about prescription medicines are not accessible to the general public.<\/p>\n<p>Any advertising or information intended for health professionals should have access restrictions to ensure the information is only accessible to a verified healthcare professional audience. For example, companies can ensure that such material is hosted on a secure server that is restricted though password protection (as set out in Question 3 above).<\/p>\n<p>When a consumer is leaving the Company\u2019s site \/ being directed to a third party site (e.g. to the webpage of a distributor), a \u2018pop up\u2019 statement should be displayed before the page can be accessed disclaiming the accuracy of information displayed on that third party webpage e.g. \u201cT<em>he information a reader is about to be referred to may not comply with the Australian regulatory requirements. Further information relevant to the Australian environment is available from the Company or via the Product Information<\/em>.\u201d<sup style=\"font-size: 9px\">(84)<\/sup><br \/>\nThe Codes of Practice also provide further guidance for promotional claims directed at healthcare professionals.<\/p>\n<p><u>Footnote(s):<\/u><\/p>\n<p><sup style=\"font-size: 9px\">(84)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s2.2(c). )<\/span><\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there any anti-bribery rules that apply to communications between pharmaceutical companies and healthcare professionals or healthcare organisations?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Commonwealth anti-bribery legislation prohibits the offering of inducements to \u2018Commonwealth public officials\u2019<sup style=\"font-size: 9px\">(85)<\/sup> . This may be relevant to pharmaceutical companies who interact with Commonwealth health organisations (or employees of those organisations).<\/p>\n<p>Anti-bribery legislation at the State \/ Territory level also applies to interactions between private parties. For example, the Crimes Act 1900 (NSW) prohibits agents (including employees) from receiving or soliciting (from another person) any benefit as an inducement or reward for doing or not doing something; individuals can be liable for 7 years imprisonment for contraventions<sup style=\"font-size: 9px\">(86)<\/sup> .<\/p>\n<p>The Codes of Practice are also relevant. For example, the Medicines Australia Code of Conduct imposes fines on members of up to $200,000 for any activity that discredits or reduces confidence in the pharmaceutical industry<sup style=\"font-size: 9px\">(87)<\/sup> .<\/p>\n<p><u>Footnote(s):<\/u><\/p>\n<p><sup style=\"font-size: 9px\">(85)<\/sup> <span style=\"font-size: 12px\">(Criminal Code Act 1995 (Cth) pt 7.6.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(86)<\/sup> <span style=\"font-size: 12px\">(Crimes Act 1900 (NSW) s 249B.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(87)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 15.6. )<\/span><\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What are the rules (whether statutory or self-regulatory) which govern the offering of benefits or inducements to healthcare professionals?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p><strong>Statutory rules<\/strong><\/p>\n<p>Under the Health Practitioner Regulation National Law Act 2009 (Qld) (National Law), a recommendation by a practitioner that a person use a health product constitutes unprofessional conduct if the practitioner has a pecuniary interest in giving that recommendation, unless the practitioner discloses the nature of that interest to the person before or at the time of giving the referral or recommendation<sup style=\"font-size: 9px\">(88)<\/sup> . Queensland is the host jurisdiction for the National Law, with each other jurisdiction applying changes to the National Law through local legislation, with local variations. Accordingly, each Australian jurisdiction has legislation which governs the offering of benefits or inducements to healthcare professionals, though this varies slightly according to jurisdiction.<\/p>\n<p>For example, in New South Wales, a registered health practitioner who accepts a benefit from a product supplier as inducement, consideration or reward in return for referring or recommending other people to use that product would be engaging in unsatisfactory professional conduct, regardless of whether the practitioner discloses the nature of any interest when giving the product recommendation<sup style=\"font-size: 9px\">(89)<\/sup> . Such conduct could attract complaints and disciplinary measures from AHPRA, and National Boards<sup style=\"font-size: 9px\">(90)<\/sup> .<\/p>\n<p>Under the Code, an advertisement about a therapeutic good must not offer any personal incentive or commission to a pharmacy assistant, or any retail salesperson who is not a health professional, in exchange for recommending or supplying the goods<sup style=\"font-size: 9px\">(91)<\/sup> . Incentives to the pharmacists themselves are governed by the National Law as noted above.<\/p>\n<p><strong>Self-regulatory rules<\/strong><\/p>\n<p>The National Boards for each health profession such as the Medical Board of Australia and the Pharmacy Board of Australia have developed their own codes and guidelines under the National Law that cover the offering of benefits \/ inducements to their respective members. The case is the same for any state-based health professional councils.<br \/>\nThe Codes of Practice also contain rules regarding the offering of benefits or inducements to healthcare professionals. For example, the Medicines Australia Code of Conduct governs sponsorships to events (along with hospitality, travel, and accommodation) (see Question 14) and grants (financial or in-kind support) to healthcare professionals (see Question 17). The Medicines Australia Code of Conduct also imposes sanctions on any activity that discredits or reduces confidence in the pharmaceutical industry.<sup style=\"font-size: 9px\">(92)<\/sup>  It would be considered a gift or inducement if a Medicines Australia member provided hospitality, travel or accommodation to spouses, relatives, guests or companions of healthcare professionals and non-healthcare professional practice staff when they are accompanying a healthcare professional<sup style=\"font-size: 9px\">(93)<\/sup> .<\/p>\n<p><u>Footnote(s):<\/u><\/p>\n<p><sup style=\"font-size: 9px\">(88)<\/sup> <span style=\"font-size: 12px\">(Health Practitioner Regulation National Law Act 2009 (Qld) s 5, definition of \u2018unprofessional conduct\u2019.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(89)<\/sup> <span style=\"font-size: 12px\">(Health Practitioner Regulation National Law 2009 (NSW) s 139B(1)(h) and (i).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(90)<\/sup> <span style=\"font-size: 12px\">(Health Practitioner Regulation National Law 2009 (NSW) s 144(b).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(91)<\/sup> <span style=\"font-size: 12px\">(Code s 26.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(92)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 15.6.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(93)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 4.5)<\/span><\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Which bodies are responsible for enforcing the rules on advertising and the rules on inducement? Please include regulatory authorities, self-regulatory authorities and courts.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The TGA is responsible for enforcing contraventions of the TG Act and its associated legislative instruments. The TGA can issue infringement notices requiring the payment of a penalty or, for repeated or more egregious breaches, it can commence actions in the Federal Court of Australia against any person or company who breaches the legislation. We understand from the CMA that the TGA has established a \u2018Targeted Advertising Compliance Team\u2019 within the TGA\u2019s Regulatory Compliance Branch to specifically address contravention of the advertising laws.<\/p>\n<p>The ACCC may hold advertisers liable for contraventions of the ACL such as misleading and deceptive conduct. It can similarly commence actions in the Federal Court of Australia against any person or company who breaches the legislation.<\/p>\n<p>AHPRA is the body responsible for enforcing rules concerning the conduct of healthcare professionals, including in relation to advertising and inducements. Similarly, the Health Care Complaints Commission deals with complaints against health service providers and health care professionals in NSW.<\/p>\n<p>Industry bodies such as Medicines Australia administer their own codes of conduct, including in respect to advertising and inducement.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">On what basis and before which bodies or courts can companies initiate proceedings against competitors for advertising infringements?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The primary regulatory bodies for advertising compliance regarding pharmaceutical goods are the TGA and the ACCC.<\/p>\n<p>Individuals can anonymously report any infringements or suspected infringements of the Code to the TGA, who may then initiate proceedings where necessary. The TGA also undertakes surveillance of advertising, including on websites. It has a range of enforcement powers including initiating proceedings before the Australian Federal Courts (see Question 23).<\/p>\n<p>The self-regulatory bodies have processes for reporting and investigating suspected breaches of their codes of conduct. For example, Medicines Australia receives complaints (either from member companies about other member companies, or from health professionals or other members of the public) and considers them through their Code of Conduct Committee (Code Committee), and Appeals Committee when necessary.<\/p>\n<p>Companies submitting complaints against competitors to Medicines Australia must provide evidence of intercompany dialogue and demonstrate that they have made a meaningful effort to resolve the issue prior to submitting the complaint.<\/p>\n<p>Companies have also initiated proceedings against competitors in relation to advertising under the Australian Consumer Law \u2013 generally on the grounds of the advertising constituting misleading or deceptive conduct or representations. See for example AFT Pharmaceuticals (AU) Pty Limited (AFTP) v Reckitt Benckiser (Australia) Pty Limited (Reckitt) [2020] FCAFC 45. This case involved comparative advertising of over-the-counter pain relief products. Reckitt brought proceedings against AFTP alleging that its comparative advertising which claimed to have a more effective product than Reckitt amounted to misleading and deceptive conduct. ATFP subsequently cross-claimed on similar grounds against Reckitt, claiming that Reckitt breached ACL in claiming its product was superior.<br \/>\nAt first instance, the Federal Court held that AFTP had breached ACL by making misleading representations about the product without evidence to substantiate the claims. The use of charts, percentages and footnotes in representations implied that the statements were \u2018in the realm of science\u2019, which the Court determined was not the case. Similarly, the Federal Court found that Reckitt had also made misleading representations. Accordingly, both parties were held to have breached ACL.<\/p>\n<p>Following several appeals, the Federal Court of Australia found that there was an adequate scientific foundation for the comparative claims which AFTP\u2019 made in its advertisements, highlighting the importance of having strong scientific support to support any claims of superior efficacy<sup style=\"font-size: 9px\">(n94)<\/sup> . In April 2022, the High Court rejected Reckitt\u2019s application to appeal the judgment.<\/p>\n<p><u>Footnote(s):<\/u><\/p>\n<p><sup style=\"font-size: 9px\">(94)<\/sup> <span style=\"font-size: 12px\">(AFT Pharmaceuticals (AU) Pty Ltd v Reckitt Benckiser (Australia) Pty Ltd [2021] FCAFC 222.)<\/span><\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What are the penalties, sanctions or measures that regulators or courts can impose for violating medicines advertising rules and rules on inducements to prescribe in your jurisdiction?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p><strong>TGA<\/strong><\/p>\n<p>The TGA undertakes intelligence led, risk-based compliance and enforcement activities to ensure compliance with the TG Act. It uses a number of compliance and enforcement tools ranging from education and the issue of warning letters for low compliance risks to suspensions, issuing infringement notices (requiring the payment of a penalty), enforceable undertakings, fines and seeking injunctions from the Federal Court of Australia or court proceedings for more severe risks or ongoing or repeated noncompliance. The TGA focuses on those matters that concern public safety, allege serious breaches of the TG Act and involve repeated or wilful non-compliance.<\/p>\n<p>The TGA also seeks to make sponsors liable for any advertising carried out by third parties on behalf of a business where the sponsor has directed or influenced that advertising.<br \/>\nACCC<\/p>\n<p>The ACCC may investigate misleading and deceptive conduct which can lead to an action for injunctions, damages, or compensation orders in court. False or misleading representations about goods or services can also attract civil penalties for a company, being the maximum of the greater of the following:<\/p>\n<ul>\n<li>$50,000,000;<\/li>\n<li>if Court can determine &#8220;reasonably attributable&#8221; benefit obtained, 3 times that value; or<\/li>\n<li>if Court cannot determine benefit, 30% of annual turnover in preceding 12 months from the month that the offence was committed<sup style=\"font-size: 9px\">(95)<\/sup> .<\/li>\n<\/ul>\n<p>Where an offense is committed by a person other than a body corporate, the offence on conviction is punishable by a fine of not more than $2,500,000.<\/p>\n<p><strong>AHPRA \/ National Boards<\/strong><\/p>\n<p>A health practitioner who accepts inducements from a product supplier may be fined up to 250 penalty units (currently $27,500)<sup style=\"font-size: 9px\">(96)<\/sup> . Disciplinary measures can also include cancelling registration or imposing conditions on registration.<\/p>\n<p><u>Footnote(s):<\/u><\/p>\n<p><sup style=\"font-size: 9px\">(95)<\/sup> <span style=\"font-size: 12px\">(ACL s 151(5).)<\/span><br \/>\n<sup style=\"font-size: 9px\">(96)<\/sup> <span style=\"font-size: 12px\">(Health Practitioner Regulation National Law 2009 (NSW) s 149B.)<\/span><\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What is the relationship between procedures before or measures taken by the self-regulatory authority and the procedures before or measures taken by courts\/government competent authorities?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>There is no specific relationship between the procedures taken by a self-regulatory authority (e.g. Medicines Australia Code of Conduct) and the procedures taken by the government or courts (e.g. by the TGA). However as noted above, the self-regulatory authorities may refer conduct which they become aware to the TGA or the ACCC, where relevant.<\/p>\n<p>When the TGA issues infringement notices for breach of the therapeutic goods advertising law, payment of the associated penalty will mean that the TGA will not initiate court proceedings for that specific alleged breach.<\/p>\n<p>Generally, any procedures before or measures taken by the self-regulatory authority are in addition to the normal rights of the parties under applicable laws (e.g. ACL and TG Act) and are not intended to restrict a party from referring a complaint to a court \/ tribunal \/ government competent authorities. For example, the Medicines Australia Code of Conduct notes that where substantially the same subject matter is, at the same time, subject to review by the TGA, or is the subject of legal proceedings between the same parties in an Australian court or Administrative Tribunal, Medicines Australia has the discretion to either not accept a complaint, or accept and delay referring a complaint to the Code Committee<sup style=\"font-size: 9px\">(97)<\/sup> .<\/p>\n<p>The Medicines Australia Code of Conduct also states that where a complaint is made to Medicines Australia against a non-member, Medicines Australia invites the non-member to have the complaint adjudicated by the Code Committee, subject to the non-member agreeing to abide by the Committee\u2019s decision and any sanctions imposed. If the non-member declines the invitation, Medicines Australia has the right, but not the obligation, to forward the complaint to the TGA or ACCC<sup style=\"font-size: 9px\">(98)<\/sup> .<br \/>\n<u>Footnote(s):<\/u><br \/>\n<sup style=\"font-size: 9px\">(97)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 15.1.)<\/span><br \/>\n<sup style=\"font-size: 9px\">(98)<\/sup> <span style=\"font-size: 12px\">(Medicines Australia Code of Conduct s 15.3.)<\/span><\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there any recent enforcement trends in relation to pharmaceutical advertising in your jurisdiction? Please report any significant (publicly known) enforcement actions in the past two years.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The TGA is an active regulator. Recent enforcement trends involving pharmaceutical advertising have focused on:<\/p>\n<ul>\n<li>the unlawful advertising of prescription-only medicines directly to consumers, including medicinal cannabis and weight loss injections;<\/li>\n<li>the use of restricted or prohibited representations in advertisements; and<\/li>\n<li>references to products being recommended or approved by the TGA.<\/li>\n<\/ul>\n<p>On 1 August 2024, the TGA published that it had issued over 70 infringement notices totally over $1million to 19 entities for alleged unlawful advertising of prescription medicines. Of this amount, $300,000 related to weight loss medicines such as Ozempic and Saxenda. This trend has continued. Most recently, on 29 September 2025 the TGA issued 10 infringement notices (totalling $198,000) and accepted an enforceable undertaking in relation to unlawful advertising of prescription-only weight loss medications by Midnight Health Pty Ltd.<\/p>\n<p>In a significant Federal Court decision in October 2023, Vapor Kings Pty Ltd and its Director were fined a total of over $5 million for unlawful advertising of prescription-only nicotine vaping products. The company had been warned about alleged unlawful advertising but continued to advertise and sell the products following the warning, which led to the proceedings being initiated. Since then, there have been several other enforcement actions in relation to illegal vapes. Since 1 January 2024, more than 13.6 million illicit vaping products with an estimated street value of approximately $684 million have been seized and kept out of the community by the TGA and the Australian Border Force. On 24 October 2025, the TGA reported that in a coordinated crackdown with Queensland Health, the TGA seized more than $5.8 million of illegal cigarettes and loose tobacco in southeast Queensland, in an operation enforcing vaping laws under the TG Act.<\/p>\n<p>Advertising of medicinal cannabis continues to be an area of significant enforcement action for the TGA. Medicinal cannabis products are generally not registered or listed on the Australian Register of Therapeutic Goods, and so are unapproved. They may only be supplied through limited channels. In recent years, several civil proceedings have been commenced by the TGA and numerous infringement notices have been issued relating to unlawful advertising of medicinal cannabis.<\/p>\n<ul>\n<li>In December 2023, the TGA initiated Federal Court proceedings against CDA Clinics QLD Pty Ltd and its former director for alleged unlawful advertising of medicinal cannabis. Similarly, in April 2024, the TGA commenced proceedings against Montu Group Pty Ltd, its subsidiary Alternaleaf Pty Ltd and their common director. In May 2024, the TGA worked with the Dolphins National Rugby League club to remove Alternaleaf branding from rugby jerseys and signage at stadiums, highlighting that advertising can be any content that promotes the use or supply of a therapeutic good to the public.<\/li>\n<li>Also in May 2024, 11 infringement notices were issued to Better Leaf Pty Ltd and an individual for allegedly unlawfully advertising medicinal cannabis including by making prohibited and restricted representations that it would treat conditions such as epilepsy and PTSD. The TGA emphasised that medicinal cannabis products are prescription-only, so cannot be directly or indirectly advertised to Australian consumers including through abbreviations or acronyms (such as \u2018THC\u2019 or \u2018CBD\u2019) or through the use of colloquialisms (such as \u2018plant medicine\u2019).<\/li>\n<li>In June 2024, the TGA issued 35 infringement notices totally $627,252 to several companies and individuals for the alleged unlawful advertising of medicinal cannabis on their websites and social media platforms. In some cases, these advertisements implied that medicinal cannabis was approved or recommended by the TGA, and promoted products that were not entered on the ARTG.<\/li>\n<li>In June 2025, the TGA initiated proceedings in the Federal Court against AG Therapeutics Pty Ltd (trading as Atlus), AG Therapeutic\u2019s sole director, Mamamia.com.au Pty Ltd, News Life Media Pty Ltd and Straight Up PR Pty Ltd for alleged unlawful advertising of medical cannabis (a prescription only medicine). The TGA alleges Atlus made prohibited and restricted representations that promoted the use of medical cannabis for the treatment of serious diseases, conditions or disorders. The TGA also alleges that Mamamia and News Life published online articles marketing medicinal cannabis that included testimonials and endorsements. The TGA is seeking declarations and pecuniary penalties. The matter remains before court.<\/li>\n<li>In September 2025, 6 infringement notices totalling $118,800, and a direction notice, were issued to Dispensed Pty Ltd for the alleged unlawful advertising of prescription only medicinal cannabis on third party websites and social media platforms. The advertising included indirect references to medicinal cannabis such as \u2018plant medicine\u2019 and \u2018cannabinoid-based therapies\u2019. The direction notice requires Dispensed to cease all advertising of medicinal cannabis (including on platforms managed by third parties), recover printed advertising material still in circulation and report evidence of compliance with the direction of the TGA.<\/li>\n<\/ul>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\r\n<div class=\"word-count-hidden\" style=\"display:none;\">Estimated word count: <span class=\"word-count\">12592<\/span><\/div>\r\n\r\n\t\t\t<\/ol>\r\n\r\n<script type=\"text\/javascript\" src=\"\/wp-content\/themes\/twentyseventeen\/src\/jquery\/components\/filter-guides.js\" async><\/script><\/div>"}},"_links":{"self":[{"href":"https:\/\/my.legal500.com\/guides\/wp-json\/wp\/v2\/comparative_guide\/122544","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/my.legal500.com\/guides\/wp-json\/wp\/v2\/comparative_guide"}],"about":[{"href":"https:\/\/my.legal500.com\/guides\/wp-json\/wp\/v2\/types\/comparative_guide"}],"wp:attachment":[{"href":"https:\/\/my.legal500.com\/guides\/wp-json\/wp\/v2\/media?parent=122544"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}