Materials for HCPs

Part 5-1 of the Therapeutic Goods Act 1989 does not apply to advertisements directed exclusively to health practitioners and the other listed categories such as wholesalers and hospital purchasing officers (section 42AA), and the statutory Advertising Code likewise does not apply. What actually governs promotion of prescription medicines to health professionals beyond that exclusion is the industry's own self-regulatory instrument, the Medicines Australia Code of Conduct (Edition 20, adopted 30 October 2024, effective 30 March 2025). Its Scope section states that the Constitution of Medicines Australia binds member companies to the Code, and that 'the Therapeutic Goods Administration states that, as a condition of registration, prescription medicines must be promoted in accordance with this Medicines Australia Code of Conduct, whether the Company is a member or non-member'. Part B section 1 permits promotion of prescription products to health professionals so long as all information, claims and graphical representations are current, accurate, balanced, consistent with the approved product information and do not mislead directly, by implication or by omission; companies are responsible for referencing all promotional claims and for ensuring the cited references provide the appropriate level of evidence, reflect the body of evidence and allow health professionals to evaluate the validity of the results independently. Qualifying statements must be linked to the claim by a readily identifiable symbol, placed directly below or adjacent to it and be prominent; claims based on animal or laboratory data must be appropriately qualified; claims for clinical benefit must be of a magnitude generally accepted as clinically meaningful; and the statistical significance of comparative claims must be clearly indicated. Overarching Principle 8 in Part A requires all promotional claims, including claims about competitor products, to be consistent with the Australian Product Information. Sanctions are set out in Part F section 15.6: cessation of conduct and withdrawal of the promotional activity, corrective action including corrective letters and advertising approved by the Code Committee before release, and monetary fines with a schedule of maximums (minor A$100,000; moderate A$150,000; severe A$200,000; a severe breach where the activity was completed and there is no opportunity for corrective action, and a repeat of a previous breach, A$250,000; failure to complete corrective action within 30 calendar days A$50,000; failure to pay a fine within 30 days A$50,000), fines being imposable individually or cumulatively up to a maximum of A$300,000 per complaint.

治療用品法1989のPart 5-1（広告）は、医師・歯科医師等の医療従事者、卸売業者、病院の購買担当者等に専ら向けられた広告には適用されず（第42AA条）、法定の広告コードも同様に適用されない。この除外の先で実際に処方薬の医療従事者向け販促を規律しているのは、業界の自主規制である Medicines Australia Code of Conduct（第20版、2024年10月30日採択、2025年3月30日施行）である。同コードは自らの Scope において、Medicines Australia の定款により会員企業が同コードに拘束されること、及び「TGAは、登録の条件として、処方医薬品は会員・非会員を問わず本コードに従って販促されなければならないと述べている」ことを明記する。Part B 第1節は、情報・主張・図表が最新・正確・均衡がとれ、承認された製品情報と整合し、直接にも黙示にも不作為によっても誤導しないことを条件に、処方薬の医療従事者向け販促を認め、すべての販促上の主張に出典を付し、引用文献が当該主張に見合う水準のエビデンスを提供し、エビデンス総体を反映し、医療従事者が結果の妥当性を独立に評価できるものであることを企業の責任とする。限定条件は主張と識別可能な記号で結びつけ直下又は隣接に目立つ形で置くこと、動物実験・試験管内データに基づく主張はその旨を適切に限定すること、臨床的利益の主張は臨床的に意味があると一般に認められる大きさであること、比較主張は統計的有意性を明示することを求める。Part A の包括原則第8は、競争品に関する主張を含むすべての販促上の主張が Australian Product Information と整合することを求める。違反に対する制裁は Part F 第15.6節に定められ、行為の中止及び販促活動の撤回、訂正状・訂正広告等の是正措置、並びに罰金（軽微10万豪ドル、中程度15万豪ドル、重大20万豪ドル、是正の機会がない完了済みの重大違反及び違反の繰り返し25万豪ドル、30日以内に是正を完了しない場合5万豪ドル、罰金を30日以内に支払わない場合5万豪ドル）であり、1件の申立てにつき累積で最大30万豪ドルまで科すことができる。