Regulating the advertising of therapeutic goodsA legislative overview

Advertising Education and Assurance SectionRegulatory Compliance BranchRegulatory Practice and Support Division

CHP Australia -Therapeutic Goods Advertising Code SeminarMarch/April 2020

Before we begin…

You need to know that:• The information in this session is not

comprehensive• You should not rely on this

presentation to determine the compliance of your advertising

• The content is not binding on the TGA

We have assumed that:• You are familiar with the Poisons

Standard and scheduling of medicines• You know how to locate the

Therapeutic Goods Act and Advertising Code

• You have a basic level of knowledge about the Code

• You know the definitions for ‘therapeutic good’ and ‘therapeutic use’

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Three levels of advertising controls

• Legislation administered by the TGARegulation

• Advertising pre-approvals (shared with industry)Co-regulation

• Industry CodesSelf-regulation2

Therapeutic goods advertising legislation•

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The advertising requirements are set out in the:

Therapeutic Goods ActTherapeutic Goods RegulationsTherapeutic 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

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Therapeutic Goods Act 1989

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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 definitionCaptures advertising irrespective of the medium (e.g. online, print, TV, radio)

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The therapeutic goods advertising requirements•

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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 goodsGeneral 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 ARTGCompliance toolsEnforcement tools

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Key advertising offence provisionsAudience Type of good Offence for Criminal offence Civil

penalty

Any

(including health profs)

Medicines, OTGs Promoting off-label use ss.22(2), (3) & (5) ss.21B(4)

Biologicals Promoting off-label use ss.32BJ(2A)-(4) s.32BL

Devices Promoting off-label use s.42ML s.41MLB

Consumers only

All Pre-approval offences s.42C N/A

All General advertising offences s.42DL s.42DLB

All Non-compliance with Code s.42DM s.42DMA7

Section 42DL – prohibits advertisements:••••

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for prescription medicinesfor biologicalsfor illegal (unapproved) productswith prohibited representations that have not been permitted by the TGA with restricted representations that have not been permitted by the TGAwith government endorsement, references to the Act

The Act – general advertising offence

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Rationale for the Advertising Code•

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Therapeutic goods advertising legislation goes beyond the legal requirements for advertising ordinary consumer goods – because:

they are not ordinary goodsconsumers 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 choicespromote only the safe and proper use of therapeutic goodsis ethical and does not mislead or deceive the consumer or create unrealistic expectations about product performance

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Therapeutic Goods Advertising Code •

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Advertising must:be accurate, balanced & verifiednot mislead nor arouse unwarranted expectationsnot 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’, miraculousno endorsements by health professionals or governmentmust not imply that other goods are harmful or ineffectualcertain mandatory statements must be included

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Prohibited and Restricted Representations

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Prohibited representations••

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Representations specified in (or through) the RegulationsAny representation regarding the treatment, cure, prevention, diagnosis (including screening), monitoring or susceptibility of, or pre-disposition to, the following diseases

Neoplastic diseasesSexually Transmitted Diseases (STD)HIV AIDS and/or Hepatitis C virusesMental illness

Abortifacient action claimsOther claims – including for antiseptics & disinfectants

Legislative definition: see s.42DJ of Act, read with Regulation 6B & Part 1 of Schedule 2 of the Regulations and s.30 of the Code

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Restricted representations•

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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 approvalNote exclusions for uncomplicatedpregnancy and conditions that can be self-managed post-diagnosis

Legislative definition: see s.42DD of the Act, read with s.28 of the Code

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Applying for approval to use a restricted representation•

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Legislative requirements for applications:Set out in sections 42DD to s.42DKIncludes 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 assessGuidance and approvals also available on website - www.tga.gov.au/form/application-approval-use-restricted-representation-advertising

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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

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Interface issues: services, foods, cosmetics and

consumer goods

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Interfaces with therapeutic goods regulation•

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The TGA does not ordinarily regulate the supply, provision or advertising of:Health servicesFoodsCosmeticsConsumer goods

The way these things are promoted could result in the advertising or products being captured under the therapeutic goods legislation

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The definition of “therapeutic goods” EXCLUDES –••

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goods declared by the TGA to NOT be therapeutic goods; orfoods for which:

there is a prescribed standard in ANZ Food Standards Code, orthere is a tradition of use in ANZ as foods in the form in which they are presented

Interface Issues - overview

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Interface issues: Foods

Foodor therapeutic

good?

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Food - Medicine interface guidance tool

• Search “food medicine interface guidance tool” on TGA website

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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

Interface issues - Cosmetics

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Interface issues – Cosmetics

https://www.nicnas.gov.au/cosmetics-and-soaps/is-my-product-a-cosmetic 22

Interface issues - Cosmetic products

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Interface issues – Consumer products

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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

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TGA’s advertising complaints handling: framework and insights

Our approach to handling complaints•

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Our approach is published on the TGA website: https://www.tga.gov.au/publication/complaints-handling-advertising-therapeutic-goods-australian-public

Some key principles:We focus resources on alleged non-compliance with highest public safety risksWe consider the perceptions of & impact on ‘reasonable consumer’ when assessing advertisingCompliance/enforcement actions are evidence-based and depend on the types of behaviours identified, including willingness of advertiser to be compliantOur processes support consistent compliance and enforcement outcomes and provide clarity for the public and advertisers

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What’s in our compliance toolkit?Voluntary compliance•••

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Education program (further information about this later in the afternoon)Enquiry servicesAdvertising pre-approvals remain until June 2020

Assisted complianceObligations Notice – informs advertisers their advertising may not be compliant and advises them of their obligationsWarning - informs advertisers 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

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What’s in our compliance toolkit? (2)Regulatory Compliance•••••••••

Substantiation NoticeDirections NoticeCancellation or suspension of the therapeutic good from the ARTGPublic Warning NoticeInjunction from the Federal Court or Federal Circuit CourtInfringement NoticeEnforceable Undertaking Prosecution of a civil penalty provisionReferral to the Commonwealth Director of Public Prosecutions for criminal prosecution

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Trends in compliance•

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For the period 1 October 2019 – 31 December 201987% of the 358 complaints received were about advertising in social media and web-based platforms1,233 products featured in advertising complaints in this period – medicines (40%), medical devices (15%) and not on the ARTG (45%)79% of all cases were categorised as ‘low’; the remainder were ‘medium’ and ‘high’Of the ‘medium’ cases the following themes were identified:

Weight loss products, hangover products, memory enhancement (Ginkgo biloba), Benign prostatic hypertrophy (Saw Palmetto), muscle cramps (magnesium), heart health (CoQ10) and pain relief devices.

Coronavirus is an emerging issue – note published web statement

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Top tips to prevent compliance action Be contactable by 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

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The benefits of compliant advertising••••••

A robust and effective system of advertising controls Promotes responsible advertisingReinforces quality use of therapeutic goodsSupports consumer confidence and trustEnhances health outcomes for all AustraliansLevel playing field for business

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Further informationWe provide tools to assist advertisers and in managing their compliance, including:•

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On the advertising hub: https://www.tga.gov.au/advertising-hubAustralian Regulatory Guidelines on Advertising Therapeutic GoodsCode guidanceFact sheets and decision treesPresentations from seminars

Facebook, Twitter, InstagramAdvertising mailing list

• Contact: advertising.education@tga.gov.au

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