What pharmacies need to know about advertising therapeutic goods in 2019 Advertising Workshop for Banner Groups - The Pharmacy Guild of Australia

Advertising Education and Assurance Section Regulatory Education and Compliance Branch Regulatory Practice and Support Division

20 November 2018

The new landscape for therapeutic goods advertising

Advertising legislation, including

new Code

New advertising complaints handling

system

New sanctions and penalties for non-

compliant ads

TGA educational activities

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The therapeutic goods advertising legislation

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Therapeutic Goods Advertising Legislation

• The advertising requirements are set out in the Ø Therapeutic Goods Act Ø Therapeutic Goods Regulations Ø Therapeutic Goods Advertising Code Ø Price Information Code of Practice

(part of the 2018 Code from 1 January 2019)

• Advertising is also subject to the Competition and Consumer Act (Australian Consumer Law)

Definition of ‘advertise’ “... 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.”

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Advertising to the public • Therapeutic Goods Act 1989 requirements for advertising to the public:

– Comply with the Therapeutic Goods Advertising Code – Must not advertise indications other than those included on ARTG – Must not promote or mention prescription medicines or biologicals – Must not advertise illegal therapeutic goods – Must not mention cancer (except skin cancer in some cases), HIV/AIDS, mental illness –

Prohibited Representations – Pre-approval for references to serious diseases (Restricted Representations, like references

to asthma, diabetes etc) – Pre-approval for medicine ads in ‘specified media’

• Applies to sponsors AND advertisers (e.g. retailers, practitioners)

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Advertising approvals needed 1. Restricted representations

– TGA must approve use of restricted representations (e.g. asthma, diabetes) before they are used in advertising

– There are public interest criteria that must be considered – To be approved, the use must be accurate, balanced and not misleading

2. Advertising pre-approval – Advertising for medicines in ‘specified media’ (TV, radio, newspapers,

magazines, billboards etc) needs pre-approval under Regulation 5G – Applications assessed and decided by industry bodies – To be approved, delegate must be satisfied that ad complies with Code and

other requirements

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The 2018 Advertising Code

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The Advertising Code • Advertising to the public for therapeutic goods MUST comply with the

Advertising Code • Requirement to comply with the Code is specified through a criminal offence

and civil penalty provision in the Act: – Section 42DM – criminal offence for non-compliant ads – Section 42DMA – civil penalties for non-compliant ads

• For an ad to be approved, the delegate must be satisfied that it complies with the Code

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About the 2018 Code

• The 2018 Code was made on 31 October 2018, to take effect on 1 January 2019

• Principles underpinning 2015 and 2018 Codes are similar

• The 2018 Code is supported by specific guidance

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Code version for pre-approvals

• For pre-approval decisions made: – On or after 1 January 2019: 2018 Code applied – On or before 31 December 2018: 2015 Code applied

• You must allow time for the process, any revisions and Christmas shut downs

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Code version applied in compliance

• For ads with current approval: version of Code approved under

• For ads (other than pre-approved ads) that occurred:

Advertising occurred Assessed against On or after 1 January 2019 2018 Code

Before 1 January 2019 and is no longer occurring

2015 Code

Before 1 January 2019 and is still occurring 2018 Code

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Structure of the 2018 Code • Part 1 – Preliminary – definitions, object, application • Part 2 - General requirements for advertising therapeutic goods • Part 3 – Specific rules relating to particular therapeutic goods • Part 4 – Prohibited & restricted representations • Schedule 1 – Medicines with specific health warnings • Schedule 2 – Advertising to children • Schedule 3 – Samples • Schedule 4 – Price information • Schedule 5 – Repeals

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The new compliance framework

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

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What’s in our compliance 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

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Person responsible for advertising • We will look to deal with the person responsible for the advertising

• We have tools to identify who is responsible for the advertising, including substantiation notices

• We can examine corporate relationships to identify primary responsibility for advertising: – Social media influencers – Testimonials – Banner groups and sponsor/promoters

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New complaints handling model

• Single complaints handling body • Streamlined complaints handling processes • New and enhanced sanctions and penalties TGA

• Pre-approvals cease 1 July 2020 • Support member compliance through

education

Industry and other bodies

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Complaints handling process

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Categorising complaints • We consider 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

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Risk based regulatory action

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Enforcement discretion • Pragmatic approach 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.

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Complying with the legislation when you advertise

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Using advertising provided by sponsors • Many therapeutic goods ads used by retailers are provided by the manufacturer or supplier of the

goods (the sponsor)

• Have processes in place to record when you received advertising from sponsors and what the advertising was

• Take care in placing advertising: Ø the total context in which advertising occurs can alter the consumer take-out message Ø your business could be liable for breaches arising from the context

• Action requests from sponsors to remove or replace advertising for compliance purposes promptly – whether online or in other forms of ads Ø Record when you actioned the request

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Case study – Bowel health month display • Rod’s Pharmacy receives a shipment of

Bean’s Tonic (for the relief of medically diagnosed IBS symptoms) and advertising from Bean’s Inc.

• Pharmacy staff know there is a world bowel health week coming up and decide to produce a window display using the Bean’s advertising and some public health materials

• What might a consumer with recent onset diarrhoea and/or constipation make of the window display?

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Creating your own advertising content • You will need to ensure the advertising complies with the Act and Code

• Be careful about the placement of material as it can produce a different take out message for consumers than the one you intend

• Don’t make therapeutic claims about cosmetics or ordinary consumer goods - refer to the definition of ‘therapeutic use’ in the Act, which includes:

– preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons, and

– influencing, inhibiting or modifying a physiological process in persons

• Undertake due diligence to ensure there is sufficient proof of claims

• Remember to check if you need pre-approval

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Catalogues and inserts • Catalogues and inserts about therapeutic goods are promotional in nature – so the Code applies

• Important Code provisions to consider when preparing these: – Definition of ‘health warnings’ – see section 4 and Schedule 1 of Code – Definition of ‘prominently displayed or communicated’ – you may need to repeat information to

ensure it is likely to be noticed by the viewer

– Section 13 of the Code – mandatory information needed in advertising for all products Ø Note picture/price/point of sale catalogues exempt from some requirements here, provided

no therapeutic claims present

– Part 3 of the Code – mandatory information for certain types of products

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Social media • You are responsible for the content of any page you create/manage

• Advertisers need to monitor their social media feeds for non-compliant posts from third parties

• Consider having an ‘acceptable use policy’ that tells third parties that there are requirements and you may remove non-compliant posts

• Be careful about what you are tagged in and remove inappropriate tags

• Do not tag the TGA or a government entity in product-specific posts

Ø Express or implied government endorsement of therapeutic goods is prohibited

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Professional articles in the public domain • We know that pharmacists engage with their patients online, and want to share their knowledge to

ensure the best consumer health outcomes

• Some pharmacists publish blogs and social media articles (including on LinkedIn)

• The Code prohibits health professional endorsement of therapeutic goods Ø Articles written by health professionals for the public must not be promotional

• An article that singles out particular products or a range of products is more likely to be promotional

• Be careful about the context in which the article appears – can also promote Ø E.g. pharmacist writes a blog article dedicated to the symptoms of ankylosing spondylitis.

Blog surrounded by banner ads of products that assist with managing plantar faciitis and back pain.

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Prescription medicine price lists • It’s illegal for therapeutic goods advertising to contain a reference to a prescription medicine

(s.42DL(10) of the Act) Ø Exception for references authorised by the Government Ø Basis of the prohibition on advertising prescription medicines to public

• Prescription price lists that comply with Schedule 4 of the Code are considered ‘authorised’ by Government – i.e. they would not be an offence under the Act

Ø Requirements are there to ensure the medicines listed are not promoted

• Schedule 4 of the Code replaces the Price Information Code of Practice Ø Now allows for online price lists

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Education and finding more information

Further information • See the Advertising hub: https://www.tga.gov.au/advertising-hub

• Attend a training session or webinar – details on Hub

• Subscribe to TGA website updates

• Follow us on Facebook, Twitter - @TGAgovau

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

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Education activities • Face to face training and webinars for advertisers

• New Advertising hub, containing: – Access to complaints and inquiry online forms, complaint outcomes – Guidance and education tools for advertisers (including online training module) – Consumer-focused information § Consumer guide to therapeutic goods advertising requirements § 10 things to look out for in medicine advertisements (fact sheet) § How to make a complaint (fact sheet) § 6 stages of complaint handling (fact sheet)

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Advertising guidance • Australian Regulatory Guidelines for Advertising Therapeutic Goods Ø Guidance on the advertising framework generally

• Guidance on the Advertising Code Ø Specific guidance on the interpretation and application of the Code

• Fact sheets, including: – Consumer fact sheets – Advertising therapeutic goods: Requirements for pre-approval – Pharmacy-specific fact sheet - coming soon

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Education program for 2018

Date Location Event 13 Nov 2018 Melbourne Advertising therapeutic goods in 2019: The Code basics 15 Nov 2018 Sydney As above 20 Nov 2018 Webinar As above 21 Nov 2018 Melbourne CMA Therapeutic Goods New Advertising Code & Complaints System

Seminar 22 Nov 2018 Adelaide As above 28 Nov 2018 Sydney As above 29 Nov 2018 Brisbane As above

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