Regulating the advertising of therapeutic goods A legislative overview Advertising Education and Assurance Section Regulatory Compliance Branch Regulatory Practice and Support Division CHP Australia -Therapeutic Goods Advertising Code Seminar March/April 2020
Before we begin… We have assumed that: • You are familiar with the Poisons You need to know that: Standard and scheduling of medicines • The information in this session is not • You know how to locate the comprehensive Therapeutic Goods Act and • You should not rely on this Advertising Code presentation to determine the • You have a basic level of knowledge compliance of your advertising about the Code • The content is not binding on the TGA • You know the definitions for ‘therapeutic good’ and ‘therapeutic use’ 1
Three levels of advertising controls • Legislation administered by Regulation the TGA • Advertising pre-approvals Co-regulation (shared with industry) Self-regulation • Industry Codes 2
Therapeutic goods advertising legislation • The advertising requirements are set out in the: – Therapeutic Goods Act – Therapeutic Goods Regulations – Therapeutic Goods Advertising Code • Advertising is also subject to the Competition and Consumer Act (Australian Consumer Law) • Australian Health Practitioner Regulation Agency law may also apply 3
Therapeutic Goods Act 1989 4
Definition of ‘advertise’ – s.3 of the Act “... includes make any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design: (a) is on the label of the goods; or (b) is on the package in which the goods are contained; or (c) is on any material included with the package in which the goods are contained.” Very broad definition Captures advertising irrespective of the medium (e.g. online, print, TV, radio) 5
The therapeutic goods advertising requirements • The advertising requirements are specified in the form of criminal offence and civil penalty provisions in the Act – Offences specific to particular types of therapeutic goods – General advertising offences • The TGA doesn’t necessarily take court action against advertising that contravenes these offences – we may use other tools: – Administrative tools – cancellation/suspension from ARTG – Compliance tools – Enforcement tools 6
Key advertising offence provisions Civil Audience Type of good Offence for Criminal offence penalty Medicines, Promoting off-label use ss.22(2), (3) & (5) ss.21B(4) Any OTGs (including Biologicals Promoting off-label use ss.32BJ(2A)-(4) s.32BL health profs) Devices Promoting off-label use s.42ML s.41MLB All Pre-approval offences s.42C N/A Consumers All General advertising offences s.42DL s.42DLB only All Non-compliance with Code s.42DM s.42DMA 7
The Act – general advertising offence Section 42DL – prohibits advertisements: • for prescription medicines • for biologicals • for illegal (unapproved) products • with prohibited representations that have not been permitted by the TGA • with restricted representations that have not been permitted by the TGA • with government endorsement, references to the Act 8
Rationale for the Advertising Code • Therapeutic goods advertising legislation goes beyond the legal requirements for advertising ordinary consumer goods – because: they are not ordinary goods consumers seeking a therapeutic good may be vulnerable due to a health condition or concerns about a possible health condition • The Code exists so that advertisements: are truthful and give consumers adequate information on risks and cautions to enable informed health choices promote only the safe and proper use of therapeutic goods is ethical and does not mislead or deceive the consumer or create unrealistic expectations about product performance 9
Therapeutic Goods Advertising Code • Advertising must: – be accurate, balanced & verified – not mislead nor arouse unwarranted expectations not lead to self diagnosis and/or inappropriate treatment – – must match the indications for the product • Other specific requirements include: – must not advertise goods as ‘safe’, miraculous – no endorsements by health professionals or government – must not imply that other goods are harmful or ineffectual – certain mandatory statements must be included 10
Prohibited and Restricted Representations 11
Prohibited representations • Representations specified in (or through) the Regulations • Any representation regarding the treatment, cure, prevention, diagnosis (including screening), monitoring or susceptibility of, or pre-disposition to, the following diseases : – Neoplastic diseases Legislative definition: see s.42DJ of – Sexually Transmitted Diseases (STD) Act, read with Regulation 6B & Part 1 – HIV AIDS and/or Hepatitis C viruses of Schedule 2 of the Regulations and – Mental illness s.30 of the Code • Abortifacient action claims • Other claims – including for antiseptics & disinfectants 12
Restricted representations • Restricted representations must be approved or permitted by the TGA before being used in an advertisement • A representation in advertising that refers, expressly or by implication, to a serious form of a disease, condition, ailment or defect, as defined in s.28 of the Code, needs prior approval • Note exclusions for uncomplicated Legislative definition: see pregnancy and conditions that can s.42DD of the Act, read with be self-managed post-diagnosis s.28 of the Code 13
Applying for approval to use a restricted representation • Legislative requirements for applications: ‒ Set out in sections 42DD to s.42DK ‒ Includes the criteria TGA use to decide whether to approve an application • New online form contains checklists • Frame your application to address the criteria the TGA have to assess • Guidance and approvals also available on website - www.tga.gov.au/form/application- approval-use-restricted-representation-advertising 14
Unapproved prohibited and restricted representations - possible consequences 2. Cease making claims or represtntations for Gumby Gumby capsules outright or in the form of testimonials that: i. They have or may have an effect on cancer of any sort, location or grade; ii. They have or may have an effect on arthritis, chronic fatigue syndrome, or skin diseases. iii. The have or may have any other therapeutic use whatsoever while ever the capsules are not included in the Australia Register of Therapeutic Goods (ARTG); iv. You can or are able to arrance the supply of these therapeutic goods which are not included in the ARTG and not excluded or exempted from that requirement. See - https://www.tga.gov.au/direction-about-advertisement-gumby-gumby-capsules 15
Interface issues: services, foods, cosmetics and consumer goods 16
Interfaces with therapeutic goods regulation • The TGA does not ordinarily regulate the supply, provision or advertising of: • Health services • Foods • Cosmetics • Consumer goods • The way these things are promoted could result in the advertising or products being captured under the therapeutic goods legislation 17
Interface Issues - overview The definition of “therapeutic goods” EXCLUDES – • goods declared by the TGA to NOT be therapeutic goods; or • foods for which: ‒ there is a prescribed standard in ANZ Food Standards Code, or ‒ there is a tradition of use in ANZ as foods in the form in which they are presented 18
Interface issues: Foods Food or therapeutic good? 19
Food - Medicine interface guidance tool • Search “food medicine interface guidance tool” on TGA website 20
Interface issues - Cosmetics • Cosmetics are regulated under legislation administered by the National Industrial Chemicals Notification & Assessment Scheme: – the Industrial Chemical Notification Act 1990 (ICNA Act) • A cosmetic: ‒ must meet the definition of “cosmetic” in the ICNA Act ‒ cannot be a ‘therapeutic good’ within the meaning of the Therapeutic Goods Act 1989 i.e. must not be for preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons 21
Interface issues – Cosmetics https://www.nicnas.gov.au/cosmetics-and-soaps/is-my-product-a-cosmetic 22
Interface issues - Cosmetic products 23
Interface issues – Consumer products 24
Some top tips… Check if your advertisements need approvals Ensure claims are consistent with indications/intended purpose in ARTG Before advertising – is it a therapeutic good…or something else? Don’t advertise with prohibited or unapproved restricted representations 25
TGA’s advertising complaints handling: framework and insights
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