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Presentation: Advertising therapeutic goods to consumers
The document outlines the regulatory framework for advertising therapeutic goods in Australia, describing the complaints handling process, categorization of complaints based on risk levels, and enforcement actions. It introduces a new complaints handling model aimed at improving compliance and education while detailing tools available for advertisers to manage their advertising practices. Additionally, it highlights the penalties for non-compliance, including fines, injunctions, and potential civil or criminal actions.
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Presentation: Advertising therapeutic goods to consumers
- 1. Advertising therapeutic goodsto consumers Complaints framework Advertising Education and Assurance Section Regulatory Education and Compliance Branch Regulatory Practice and Support Division 1 May 2019
- 2. Complaints Resolution Panel Complaintsabout advertising in specified media (including internet) for goods that can be advertised to public If compliance not achieved - referred to TGA TGA Complaints about advertising of S4s to public, advertising in other mediums & CRP referrals Limited compliance tools to gain compliance Industry bodies Complaints generally about advertising to health professionals & public “below the line” ads Can impose fines on members and require other actions to be taken Other bodies Some government based – ACCC, ACMA, state/territory government Some self-regulatory - e.g. Advertising Standards Bureau Previous complaints handling model 1
- 3. Issues under previousscheme • Prior to 1 July 2018, complaints were made to the Complaints Resolution Panel (CRP) or TGA. • CRP could refer complaints to TGA outright or recommend TGA order an advertiser to comply with the CRP’s findings • Three possible outcomes of the recommendations: – the advertiser agreed to comply and publish a retraction or correction (where required) – TGA ordered the advertiser to take an action, such as withdraw an advertisement or publish a retraction or correction (Reg. 9) Only useful where advertiser was also product sponsor as the penalty for failure to comply was removal of the product from the ARTG – the complaint was closed • Significant effort required over a long period to negotiate compliance, lack of enforcement powers • Advertising remains available to consumers – avg 200 (approx.) days to CRP decision • Only the details of the complaint were investigated • Advertising Code subjective, limited focus on education and assurance 2
- 4. New complaints handlingmodel • Single complaints handling body • Streamlined complaints handling processes • New and enhanced sanctions and penaltiesTGA • Pre-approvals cease 1 July 2020 • Support member compliance through education Industry and other bodies 3
- 5. Our approach tohandling complaints • Consultation was conducted on how we should handle advertising complaints • See ‘Complaints handling for the advertising of therapeutic goods to the Australian public’ on our website • Principles: – We provide tools & education resources to advertisers to aid them in managing their compliance – We focus our resources on alleged non-compliance that has the highest public safety risks – We consider the perceptions of & impact on ‘reasonable consumer’ when assessing advertising – Our compliance and enforcement actions are evidence-based and depend on the types of behaviours identified, including demonstrated willingness of the advertiser to be compliant – Our processes support consistent compliance and enforcement outcomes and provide clarity for the public and advertisers about what is and what is not acceptable in advertising. 4
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- 7. Categorising complaints • Weconsider a range of factors, including: – Whether reliance on the claims are likely to result in harm or injury – Safe and appropriate use of the good for their intended purpose – Action taken by the advertiser, willingness to comply with requirements, and their awareness of their obligations – Advertiser prior history and conduct • Complaints within jurisdiction are categorised as Low, Medium, High or Critical • Some may be outside our jurisdiction, and may be referred to another regulator • An assessment may not identify any advertising non-compliance 6
- 8. Risk based regulatoryaction 7
- 9. Low Risk Likely action •One off or isolated non-compliance • Low risk of harm • Advertiser has not previously come to the TGA’s attention • Obligations letter with education material Example: Advertisement promotes therapeutic goods in a manner that is misleading as to their proper use or effect, but the product has low to no risk of harm, and the advertiser is unaware their claim is in breach Outcome published: Yes. However for reasons of natural justice, TGA reporting of closed low matters will not specify the details of the advertiser or the goods involved because the TGA has not investigated nor made a formal finding in relation to the advertising. 8
- 10. Medium Risk Actions • Ongoingadvertising breaches, or where an advertiser has been made aware of their obligations in the past • Advertisement encourages unnecessary use • Warning • Directions notice • Infringement notice • Guidance • Education and training Example: Where a Schedule 3 medicine is being advertised to the public in a way that encourages unnecessary use but there are no other public health concerns Outcome published: Yes Including the name of the advertiser and goods involved 9
- 11. High Risk Activity • Continuednon-compliance despite evidence that the advertiser is aware of their obligations • Non compliance that is more serious in nature and may include prohibited or restricted representations • Advertising likely to lead to excessive use, or impact on the ability to use the therapeutic goods safely, in line with intended use • Infringement notice • Substantiation notice • Directions notice • Cancellation or suspension of the goods • Civil or criminal court action may be considered Example: Where a reference is made to a serious medical condition where choosing the product over conventional medical treatment may have a significant effect on the consumer’s prognosis Outcome published: Yes Including the name of the advertiser and goods involved 10
- 12. Critical Risk Activity • Involvesadvertising of therapeutic goods that claim to treat serious or very serious conditions that require diagnosis/ongoing treatment from a medical practitioner • Advertising to vulnerable or disadvantaged consumers • Risk that use may result in or is likely to result in harm or injury • Advertising may cause harm to a large group of consumers or particular individuals • Undermining public health campaigns • Investigate with view to prosecution of a civil or criminal penalties provision • Directions notice • Apply to Federal Court for injunction • Publish a public warning notice • Enforceable undertaking • Cancellation or suspension of the goods Example: Advertising a product for the treatment of cancer where the product has not been evaluated by the TGA, or is a listed complementary or registered over the counter medicine Outcome published: Yes Including the name of the advertiser and goods involved 11
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- 14. What’s in ourcompliance toolkit? Voluntary compliance • Education program (further information about this later in the afternoon) • Enquiry services • Advertising pre-approvals remain until June 2020 Assisted compliance • Obligations Notice – informs advertisers that their advertising may not be compliant and advises them of their obligations • Warning - informs advertisers that their advertising is non-compliant and advises them of regulatory action that may be taken if they fail to respond/comply – requires a written response 13
- 15. What’s in ourcompliance toolkit? (2) Regulatory Compliance • Substantiation Notice • Directions Notice • Cancellation or suspension of the therapeutic good from the ARTG • Public Warning Notice • Injunction from the Federal Court or Federal Circuit Court • Infringement Notice • Enforceable Undertaking • Prosecution of a civil penalty provision • Referral to the Commonwealth Director of Public Prosecutions for criminal prosecution 14
- 16. Enforcement discretion • Pragmaticapproach taken to non-compliance where a complaint is received after 1 January 2019 about an advertisement that would have been compliant with the 2015 Code. January – June 2019 June – December 2019 The action taken (in the absence of other non-compliance) will be a reminder about the advertising requirements of the 2018 Code. We will seek information about what is being done to correct the advertising, including the date corrective action commenced before determining whether to apply enforcement discretion. 15
- 17. Obligations letter • Foraddressing low priority complaints using an education based approach • If you receive one: – read it carefully – assess your advertising for compliance – get help if you need it • The TGA will generally only issue this letter to an advertiser once • Future complaints are likely to be given a higher priority 16
- 18. Warning • Often usedfor addressing medium priority complaints in the first instance • If you receive one: – read it carefully – get help if you need it – assess your advertising for compliance – respond within the required timeframe – address compliance issues ASAP • Failure to address advertising issues may result in escalating action 17
- 19. Substantiation notice –s.42DR • Used to obtain further information for management of the case • For example to identify: – the advertiser responsible, or – whether the advertising claims are substantiated • If you receive one, read it carefully and respond as outlined in the notice • Failing to reply or providing false or misleading information is an offence 18
- 20. Directions – s.42DKB& s.42DV • Generally won’t be issued without prior contact with advertiser • Used to direct an advertiser to: – cease using a particular claim or advertisement – issue a retraction or correction, and/or – destroy the advertisement and recover any ads still in circulation • If you receive one: – read it carefully and consider how you will address the notice – respond to the notice within the specified timeframe • Failing to comply with a direction is an offence 19
- 21. Publication of Directions TheTGA has published one Direction: • Advertising of Gumby Gumby capsules • Advertiser complied with the direction to: Cease making claims or representations for Gumby Gumby capsules outright or in the form of testimonials that: – They have or may have an effect on cancer of any sort, location or grade – They have or may have an effect on arthritis, chronic fatigue syndrome, or skin diseases – They have or may have any other therapeutic use whatsoever while ever the capsules are not included in the Australia Register of Therapeutic Goods (ARTG) – You can or are able to arrange the supply of these therapeutic goods which are not included in the ARTG and not excluded or exempted from that requirement 20
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- 23. Direction notice reviews •Direction notice includes consequences of non-compliance and rights for review • Advertiser may request a review of the ‘initial’ decision to issue a direction • The initial decision remains in effect unless and until it is revoked or substituted by a new decision 22
- 24. Public warning notice– s.42DY • TGA may publish a notice to alert consumers to a suspected contravention of the advertising requirements • Must be in the public interest • Key consideration - is there an imminent need to inform consumers so they can avoid suffering detriment from advertisements about therapeutic goods? – an actual or a perceived risk to public health from advertising non-compliance – advertising from persons who persistently or deliberately operate outside the TGA regulatory scheme • Can also be issued if a person fails to respond to a substantiation notice and it is in the public interest to alert the public 23
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- 26. Infringement notices –Part 5A-2 of the Act • Infringement notices are administrative fines - an alternative to: – criminal prosecution for a strict liability criminal offence, or – litigation for contravention of a civil penalty provision. • TGA can now issue infringement notices for non-compliance with – the advertising requirements, and – other requirements in the Act (wherever there is a strict liability offence) • TGA will publish the details of infringement notices issued 25
- 27. Impact of infringementnotices on advertisers • Amount for an infringement notice: – 12 penalty units (individual) or 60 penalty units (company) – multiple notices can be issued (e.g. for multiple contraventions) • Payment of an infringement notice: – pay by the due date to prevent further legal action – does not amount to an admission or finding that the advertiser has contravened the Act • Advertiser still needs to make advertising compliant - further instances of non-compliance may escalate regulatory or legal action 26
- 28. ACCC infringement notices Tworetailers of adjustable beds and mobility products pay $20,400 each in penalties See https://www.accc.gov.au/media-release/two-retailers-of-adjustable-beds-and- mobility-products-pay-20400-in-penalties 27
- 29. Cancellation/suspension from ARTG •Once a therapeutic good is cancelled or suspended from the ARTG, it cannot be supplied • The TGA may cancel or suspend goods from the ARTG where the sponsor of those goods: – fails to ensure compliant advertising, and – does not adequately respond to other regulatory tools (such as directions) • Cancellation or suspension may also occur to address other compliance issues • Cancellations and suspensions are published on the TGA website • There are different provisions for cancellation and suspension depending on the type of good 28
- 30. Act provisions forcancellation/suspension Type of good Suspension Immediate cancellation Cancellation with notice Medicine/OTG s.29D ss.30(1) ss.30(2) Biologicals s.32FA s.32GA s.32GC Medical device s.41GA s.41GL s.41GN • Advance notice of suspension of goods is generally given unless there is potential for death, serious illness or injury as a result of the goods • Failure of a sponsor to comply with an advertising direction notice is grounds for immediate cancellation 29
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- 32. Injunctions – Part5-4 of the Act • The Secretary can approach the Federal Court for an injunction to: – restrain a person from contravening the legislation, or – to compel compliance with the legislation • The injunction may be permanent or interim • The injunction may be pursued in conjunction with other enforcement actions (e.g. civil penalties) 31
- 33. Enforceable undertakings –Part 5A-3 • When dealing with a matter about non-compliant advertising, TGA may accept an offer from an advertiser to enter into a written undertaking as an alternative to court action • If the TGA accepts the undertaking, the advertiser would be bound by the terms agreed to in the undertaking • Terms of undertakings may include training requirements, compliance requirements • A breach of the terms can result in the matter being referred to the Federal Court who can order the advertiser to comply with the undertaking, pay damages • Details of undertakings are published on the TGA website 32
- 34. Criminal and civilpenalties • Can only be imposed by a Court • Such action would not be a surprise to an advertiser: – the TGA would have tried other avenues to achieve compliance first • Court action may be taken against: – a recipient of a substantiation notice that has not responded to the notice or has provided false/misleading information in a response – a recipient of a direction/infringement notice that doesn’t comply with the notice – advertisers that promote goods in a way that raises public safety concerns and/or has been unwilling to comply with previous compliance actions • TGA will not publish details of matters proceeding to court until after final outcome 33
- 35. Key advertising offenceprovisions Type of good Requirement Criminal offence Civil penalty Medicines, OTGs Prohibits promotion of off-label use ss.22(2), (3) & (5) ss.21B(4) Biologicals Prohibits promotion of off-label use ss.32BJ(2A)-(4) s.32BL Medical devices Prohibits promotion of off-label use s.42ML s.41MLB All Pre-approval offences s.42C N/A All General advertising offences s.42DL s.42DLB All Non-compliance with Code s.42DM s.42DMA All Failing to comply with/misleading info in reply to a substantiation s.42DS s.42DT All Failing to comply with direction notice s.42DW s.42DX 34
- 36. Three-tier criminal offenceprovisions Tier Condition Penalty 1 the use of the goods in reliance on the advertisement has resulted in, will result in, or is likely to result in, harm or injury to any person imprisonment for 5 years or 4,000* penalty units or both 2 harm not necessarily demonstrable but intent evident imprisonment for 12 months or 1,000* penalty units, or both 3 Strict liability (intent doesn’t need to be demonstrated) 100*+ penalty units * As at 1 July 2017, 1 penalty unit = $210. Offences by body corporates attracts 5x multiplier on penalty units + Infringement notices are an alternative to strict liability offences 35
- 37. New civil penaltyprovisions for advertising • Corresponding civil penalties added to complement most criminal offences applying to advertising non-compliance – 5,000 penalty units – individual – 50,000 penalty units – body corporate • Lower burden of proof than criminal offences 36
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- 39. Cooperating with otherregulators • TGA works cooperatively with state/territory and other Commonwealth regulators • If we receive a complaint outside our jurisdiction, we will refer it on – practice issues – AHPRA or state/territory government – pricing and unconscionable conduct issues – ACCC or state/territory government – sole traders operating intra-state - state/territory government • We will collaborate with other regulators to achieve a better outcome 38
- 40. Be contactableby the TGA If you receive correspondence from the TGA, read it Reply to TGA correspondence within specified timeframe Have robust procedures in your business for dealing with correspondence and checking advertising compliance Address compliance issues expeditiously Don’t wait for a complaint to collate supporting evidence for ads Top 5 tips to prevent compliance action 39
- 41. Further information • Weprovide a range of tools to assist advertisers and in managing their compliance, including: – E-learning modules – Advertising hub: https://www.tga.gov.au/advertising-hub – Fact sheets – Webinars – Roadshows – Subscribe to TGA website updates – Facebook, Twitter – Contact: advertising.education@tga.gov.au 40
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Editor's Notes
- #3 The TGA reviews all the material considered by the Panel and provides the advertiser the opportunity to make a submission as to why an order under regulation 9 should not be issued. This material is considered with a fresh pair of eyes and an independent decision is made. This provides for the admin law principle of ‘procedural fairness’ (or natural justice). Through this process the TGA is primarily seeking resolution of the advertising complaint by achieving compliance and assurances of ongoing compliance from the Advertiser. Ongoing compliance with the Panel’s requests is also examined Having considered the Panel’s findings and where the advertiser is still non-compliant, the delegate may decide under regulation 9 to order to the advertiser to withdraw the advertisement and publish a retraction or corrective statement, where required. The formal notice also draws the advertiser’s attention to the consequences of failing to comply with the Reg 9 order. This may also include cancellation of the good from the ARTG. The Advertising Standards Board also has a place in the complaints handling model – generally complaints about taste, community standards etc Where there has been a contravention of the advertising requirements, the Panel can request advertiser in writing to - withdraw an advertisement withdraw claim or representation publish a retraction or corrective statement Where requests are made by the Panel in relation to an advertising complaint, the advertiser is required to comply within 14 days as set out under regulation 42ZCAI. If an advertiser fails to reply or indicate a willingness to fully comply (100%) or ignores the requests in the Panel’s determination, this usually results in the Panel making a recommendation to the Secretary of the Department of Health under regulation 42ZCAI(3) of the TG Regulations Therefore, if you have a complaint before the CRP, it is in your company’s best interests to co-operate and actively participate in the process so that you have an opportunity to be heard. ‘Opting out’ of the proceedings is really not an option. 39 out of 119 (33%) determinations made in FY 14/15 were referred to the TGA (ie 67% of advertisers complied fully with the Panel’s requests
- #4 An unusual system – quite unlike other regulatory compliance activities undertaken at the Federal level Focus on non-compliance rather than enhancing voluntary compliance Limited focus on education and assurance Lack of efficiency Significant effort over a long period of time to resolve an advertising complaint Limited powers to enforce Perceptions of advertising may be nuanced. With multiple bodies handling complaints, there was capacity for like cases to be treated differently by different complaints handling bodies. Most significant power was Reg. 9 re advertiser – publish a retraction or withdraw and advertisement. Limited deterrence impact where the advertiser is not the sponsor. There are plenty of other products that they may sell. Where product is the sponsor there was a power to remove the product from the ARTG.
- #5 There is a very strong policy foundation for the new complaints handling model – the health and safety of Australian consumers is at the heart of this change TGA is now the single complaints handling body This allows for a more streamlined complaints handling process. Both complainants and advertisers only have to deal with one entity and provides clarity to both parties about how complaints will be handled Allows for a consistent policy approach to be taken to the handling of complaints Brings our complaints handling process into line with other commonwealth regulators. Trend towards decisions by delegates, expert advice sought where required. Gives greater certainty as the process moves quicker Provides greater policy consistency, ensures like cases are treated alike, procedural fairness New and enhanced sanctions and penalties are available to the TGA to pursue non-compliant advertising, which allows us to better protect the health and safety of Australian consumers. This also helps to provide a level playing field for industry – all advertisers of therapeutic goods are subject to the same rules, being applied consistently and with the TGA having sufficient compliance and enforcement tools to appropriately sanction those who intentionally flout the rules
- #6 To ensure procedural transparency, we have published our approach to complaints handling Document titled “Complaints handling for the advertising of therapeutic goods to the Australian public” is available on our website through the Advertising Hub. This document is essentially a framework for how we deal with advertising complaints (I’ll refer to this as the framework) It outlines the set of principles that we apply in addressing advertising non compliance.
- #7 Think of the complaint as a signal. We are not limited to dealing with just the subject matter complained of. Initiate risk based action – we have a number of administrative and regulatory actions that we may undertake based on the way we have categorised the complaint
- #8 The framework sets out the sorts of things we will consider in categorising a complaint. Each case will turn on its own facts, based on what evidence is provided by the complainant and what evidence we identify We articulate key factors and provide some examples in the framework There are some factors that are particularly important: Whether reliance on the claims are likely to result in harm or injury Safe and appropriate use of the good for their intended purpose Action taken by the advertiser, willingness to comply with requirements, and their awareness of their obligations Advertiser prior history and conduct
- #9 This pyramid is our “Risk based activity model” Published in the Framework – something we will examine in more detail What is critical to remember: WE ASSESS THE RISK – CATEGORISE THE COMPLAINT – CATEGORY DICTATES THE ACTION AVAILABLE TO US This is what ensures that like cases are treated alike (within our regulatory powers). The case categorisations operate as guidance for how we will treat a case. There is a sliding scale of risk. Some cases may sit on the cusp
- #10 Categorisation will be informed by whether the advertising is misleading as to the content or proper use or identification of the therapeutic goods. An example of this category includes promotion of therapeutic goods in a manner that is misleading as to their proper use, but where the product is ineffectual in its use for a minor or self-limiting condition and therefore highly unlikely to cause harm. Imagine a new multivitamin company – producing vitamin C products – claiming that the product is TGA approved. Only product they manufacture and advertise. Not come to the attention of the TGA before. Dosage information is accurate. Claims are not misleading. Breach of the code but unlikely to pose a risk to consumer health and safety. Will be categorised as low. Advertiser is sent a letter, but not required to respond. Can refute letter content if they wish to. No adverse finding These outcomes are not published. They are not published because they have not been investigated. No adverse finding is made. Not adverse action taken.
- #11 Categorisation will be informed by the likelihood of the advertisement encouraging excessive or inappropriate use of the therapeutic good being advertised, the type of therapeutic good and the condition the product purports to treat. Examples include where a Schedule 3 (pharmacist-only medicine) is being advertised to the public in a way that encourages unnecessary or excessive use. Medium cases usually involve advertisers who have previously come to our attention through their conduct. They may have received an obligations letter, and failed to rectify the advertising issue that it identified and we receive later complaints that signal to us to that the advertiser remains non-compliant EG1. Our new vitamin C company – we have engaged with them, sent them a letter reminding them of their obligations, maybe we have advised them over the phone about their advertising breach. We receive a subsequent complaint about their facebook page, stating that the product is TGA approved. EG2 – We see a fairly large number of cases where advertisers are targeting consumers who are often termed “the worried well”. Higher dosage forms of Vit D are schedule 3. A complaint about Vit D that included images where a consumer is pictured engaging in a range of outdoor/sun worshipping activities. This would may encourage unnecessary use, by a person whose lifestyle factors make it unlikely that they would be suffering a vit d deficiency (and where they had not sought advice from their doctor). PUBLICATION
- #12 High category cases include alleged non-compliance that we consider more serious in nature such as advertising containing prohibited or restricted representations around the indications (conditions) that the product is claimed to treat or manage. This category could also include advertising that is likely to lead to excessive use, or impact on the ability of consumers to use the therapeutic goods safely or appropriately in line with the good’s intended therapeutic use. These types of cases might involve continued non-compliance despite the TGA taking time to ensure that the advertiser is aware of their obligations Or, the advertising may involve the unapproved use of restricted or prohibited representations. I.e. a complementary medicine making claims that it assists in the treatment of a form of type 2 diabetes, leading that consumer to use the product rather than seek conventional medical treatment. Treats plantar faciitis (and does not include the statement ‘medically diagnosed’) PUBLISHED
- #13 This categorisation may also be assigned to advertising clearly directed to vulnerable or disadvantaged consumers with a risk that use may result in or is likely to result in harm or injury due to reliance on the claims made or because of the indications advertised. It may also be assigned where the advertising may cause harm or injury to a large group of consumers, or particular individuals. These are the most serious cases – cases requiring urgent attention. Sometimes they involve events where there is a time critical element. I.e. handing out of samples to a large group of consumers where there is no due diligence on their health concerns, the population may include children, the elderly. PUBLISHED
- #15 Voluntary compliance – these are the advertisers who want to comply. We want to help advertisers who want to comply to do so. The bulk of advertisers fit within this category. This is why we are rolling out an advertising roadshow (and participating in a range of industry events) Further events are planned until December. Further events to support embedding the new code are planned. Keep an eye on our website Assisted compliance – where advertisers may be unaware of, or fail to understand how to comply with the advertising requirements, we inform and/or warn them of the consequences of failing to comply.
- #16 Regulatory compliance Where we use the powers provided in the Act to ensure compliance. Large list of tools at our disposal to ensure advertiser compliance in more serious cases. Compliance assurance We undertake a compliance assurance program to ensure that advertisers who come to our attention maintain their compliance.
- #17 Advertisers are working hard to update systems and processes For some companies, it the internal approval process goes through strong governance processes Stakeholders have queried what action we will take in relation to advertising that complies with the 2015 Code but not the 2018 Code, particularly around the prominent display of mandatory information (such as health warnings) PRE APPROVAL – any ad pre-approved based on the 2015 Code – any complaints will be considered against the 2015 Code.
- #18 COPY of this available on the website
- #21 42DKB Certain representations not to be advertised (1) If a representation in an advertisement about therapeutic goods is false or misleading, the Secretary may, by notice given to a person apparently responsible for: (a) advertising the therapeutic goods; or (b) causing the advertising of the therapeutic goods; prevent that person from advertising the therapeutic goods, or causing the advertising of the therapeutic goods, in circumstances where the advertisement contains that representation (whether in express terms or by necessary implication) 42DV Directions about advertisements or generic information Advertisements (1) If, in relation to the advertising of therapeutic goods, the Secretary is satisfied that there has been a contravention of this Act or the regulations, the Secretary may, in writing, direct a person apparently responsible for advertising the therapeutic goods, or for causing the advertising of the therapeutic goods, to do one or more of the following: (a) cease the advertisement; (b) make a retraction; (c) make a correction; (d) recover any advertisement that is still in circulation; (e) destroy the advertisement; (f) cease making a particular claim or representation made by the advertisement. Generic information (2) If, in relation to the dissemination of generic information about therapeutic goods to the public or a section of the public, the Secretary is satisfied that there has been a contravention of this Act or the regulations, the Secretary may, in writing, direct a person apparently responsible for the dissemination, or for causing the dissemination, to do one or more of the following: (a) withdraw the generic information; (b) make a retraction; (c) make a correction; (d) recover any generic information that is still in circulation; (e) destroy the generic information; cease making a particular claim or representation made by the generic information. Conditions (3) A direction under subsection (1) or (2) may be subject to conditions specified in the direction. (4) Without limiting subsection (3), the conditions may relate to one or more of the following: (a) the period for doing a thing the subject of the direction; (b) in relation to the making of a retraction or correction, either or both of the following: (i) the form and manner of the retraction or correction; (ii) the period for which the retraction or correction must be made publicly available; (c) the reporting to the Secretary of compliance with the direction.
- #22 The delegate making a direction MUST publish it Directions are published in the Regulatory decisions and announcements section of the advertising hub
- #23 This is an example of a retraction ordered under the previous complaints handling arrangement for Invisible Zinc advertising. Retractions under the new complaints system won’t be identical to this but there will be similarities – e.g. prominence
- #24 A direction is an “initial decision” under the TG legislation. Advertisers may request a review of the decision under section 60 of the Act The decision remains in effect unless it is revoked by the Minister of their delegate as a result of a review under section 60, is set aside, varied or remitted by the Administrative Appeals Tribunal or is otherwise overturned by a court. Where the advertiser fails to comply with the direction, there are a range of other regulatory tools that may be used to achieve compliance, including: issuing a notice under s.30 (medicine) or s.41GN (devices) of the Act, proposing to cancel the registration and / or listing of the goods from the ARTG making further supply of the product unlawful Infringement notices Court proceedings to pursue civil or criminal action Past experience has shown that it is generally only the minority of sponsors who end up with a direction/order, which is a direct result of their own business decisions.
- #25 A public warning notice may be issued if the TGA reasonably suspects non-compliant advertising or dissemination of generic information about therapeutic goods to the public or a section of the public and is satisfied it is in the public interest to issue that notice. A public warning notice may also be issued if a person who has been given a substantiation notice fails to comply with it and the TGA is satisfied that it is in the public interest to do so. An example includes where the advertiser fails to provide evidence in response to a substantiation notice, in circumstances where there is a public safety risk, a public warning notice may be issued. EG – ADVERTISING ABOUT THE USE OF HUMAN PLACENTA INJESTION There is currently no evidence to support the claims of health benefits associated with consuming human placenta, and the broader risks are unknown. Human placenta is a biological material and is capable of containing and transmitting infectious agents, including bacteria and viruses. In addition, preparation may inadvertently introduce infectious agents. The risk of transmission may be even greater if your placenta is ingested by another person or you ingest another person's placenta.
- #26 This is an example of a consumer alert that was issued before the a specific power was added to the Act to enable It provides an example of how public warning notices might look The ACCC also issue similar alerts
- #27 An infringement notice may be issued where a person has, within 12 months contravened a strict liability offence or civil penalty provision of the Act. The person can choose to pay an amount to the Commonwealth as an alternative to having court proceedings brought against them in relation to the contravention.
- #28 1 penalty unit = 210 = 12600 for a company. Can issue multiple. Adds up quickly.
- #29 The ACCC has (following TGA intervention) issued two infringement notices to retailers of adjustable beds as they made false or misleading representations about their adjustable beds and associated mobility equipment. Each paid $20,400 in penalties. One of the retailers used the Commonwealth Coat of Arms accompanied by the words “Australian Government”, “Department of Health and Ageing” and “Therapeutic Goods Administration”. The words “TGA Approved products” were used elsewhere in the brochures. The other retailer claimed that their products had been awarded a certificate by the TGA. The ACCC considered that the materials represented that the goods were sponsored or approved by the TGA, when this was not the case. Such false representations can mislead elderly or other vulnerable consumers when they are choosing to make what can be very significant purchases.
- #30 We may Cancel or Suspend the relevant therapeutic goods from the ARTG.
- #32 SensaSlim was cancelled from the ARTG from 1 December 2011 for failing to comply with advertising requirements following a review of the product by the (then) Office of Complementary Medicines. This is one of the more interesting cases that the TGA has worked on. The product was said to help people lose weight without any change in diet or exercise. The Complaints Resolution Panel received a number of complaints in 2011 about the product and the TGA also became involved in the matter. The SensaSlim Solution Business model was problematic: Involved Peter Foster (commonly described in the media as a ‘conman’ that has been jailed on 3 different continents). Financed by “underworld” figure Mick Gatto. used a non-existent Swiss research institute and non-existent research to back claims. Retirees targeted to purchase $60,000 franchises but being ripped off. Peter Foster, after a year on the run, was eventually arrested at Byron Bay and served a year in jail for a contempt charge relating to SensaSlim. In May 2016, Peter Foster was also fined $660,000.00 for his role in SensaSlim and permanently banned from being a company director or having any business in the diet or health industry.
- #33 The TGA may seek an injunction in the Federal Court or Federal Circuit Court to stop or prevent a person from contravening the Act or compel a person to comply with the Act. An example of the circumstances where the TGA would seek an injunction is where advertising is planned for a defined event (e.g. a promotion at a particular major rock concert), there is a risk to public health and safety posed and it is time critical.
- #34 An advertiser may choose to give an enforceable undertaking, a promise able to be enforced by a court. An example includes where the advertiser undertakes to establish, review or improve their advertising processes to be compliant with the requirements in the Act and to make regular reports to the TGA for the period of the undertaking.
- #35 The TGA may commence prosecution of a civil penalty provision. This can result in large fines being imposed and recovered. The most serious matters may be referred to the Commonwealth Director of Public Prosecutions for criminal prosecution of offences under the Act.
- #36 Not an exhaustive list of advertising related criminal offences (e.g. claiming to be able to supply provisions omitted).
- #39 This is an example of how a civil court action can turn out. In March 2015, the ACCC brought a case in the Federal Court of Australia against Reckitt Benckiser Pty Ltd, the sponsor of Nurofen products, alleging it misled customers over claims its range of Nurofen “specific pain” products were each formulated to treat a specific kind of pain despite containing the same active ingredient (ibuprofen lysine 342mg). They are the same formulation, and have the same approved indications included on the ARTG. There are four products in the range: Nurofen Back Pain, Nurofen Period Pain, Nurofen Migraine Pain and Nurofen Tension Headache. On 11 December 2015, the Federal Court declared by consent that Reckitt Benckiser’s conduct was, or was likely to be, misleading to consumers by claiming on the packaging and on its website that each product in the Nurofen "specific pain" range of products was specifically formulated to treat, and solely or specifically treated, the particular type of pain specified on the product packaging. As such, each product is equally effective as the others in the range in treating the types of pain described on the packaging. The Federal Court ordered Reckitt Benckiser to cease any further distribution and sale of all Nurofen “specific pain” range products with this packaging within 4 weeks of the order, and to remove the products from retail shelves within 3 months. The Court also ordered that Reckitt Benckiser publish website and newspaper corrective notices, implement a consumer protection compliance program, and pay the ACCC’s court costs. A hearing to resolve pecuniary penalties resulted in a $1.7 million fine, however, on 23 May 2016, the ACCC announced that they would be appealing this penalty as too lenient given the sales of 5.9 million units of the products. In December 2016, the Federal Court increased the fine to $6 million.
- #42 I’ve also listed the TGA’s Twitter handle. The TGA tweets summaries and links to website information on recalls, safety alerts, medicine shortages, consultations and information for new sponsors (including advertising aspects).
- #43 Before I ask for questions, I’ve included the email address for the Advertising Education on the slide if you have any questions in the future.