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Therapeutic Goods Advertising Compliance Education Plan 2021

18 August 2021

Our commitment is to educate advertisers, consumers, health professionals and industry to promote voluntary compliance with the advertising requirements of the Therapeutic Goods Act 1989.

We will increase compliance with the advertising requirements in a way that optimises public health and safety and builds community trust.

The table below outlines the compliance education priorities. Activities against these priorities are provided in the following tables. The education activities are consulted on with the Therapeutic Goods Advertising Consultative Committee at each meeting and will be adjusted as appropriate to meet demand for specific products.

Education priorities

  1. Plan for and develop communication and education products as part of the Compliance Plans for the agreed advertising compliance priorities.
  2. Timely communications on regulatory changes and emerging issues.
  3. Publish information on compliance and enforcement actions for transparency of compliance activities and as a deterrent to non-compliance.
  4. Maintain and enhance fit for purpose educational resources, and participate in training and education opportunities.
  5. Engage with key stakeholders, including members of the TGACC, as partners in education and communication activities.
  6. Maintain and enhance an advertising enquiry management function.

This plan should be read in conjunction with the Therapeutic Goods Advertising Compliance Education Strategy 2021.

Education Priority 1: Activities related to Advertising Compliance Priorities
Topic Education activity Status/key messaging
Compliance Priority - COVID-19 products

COVID-19 vaccines

Fact sheet

Guidance on the use of Government materials to promote COVID-19 vaccines

COVID-19 vaccines

Direct engagement and education

Current and continued - phone calls and emails to discuss and clarify guidance on promoting COVID-19 vaccines

COVID-19 vaccines

Fact sheet update

Update to guidance on advertising COVID-19 vaccines

COVID-19 vaccines

Web updates

Information on matters arising from compliance activities

Hand sanitisers

Case study

(drafted) for consultation, endorsement and publication

Test kits on ARTG

Case study

(drafted) for consultation, endorsement and publication

Self-test kits

Case study

(drafted) for consultation, endorsement and publication

Compliance Priority - Stem Cells

Stem cell therapies

Guidance

Advertising guidance targeted at this sector

Stem cell therapies

Media release

Media release advising of the TGA's compliance focus on advertising of stem cell therapies

Stem cell therapies

Case study

(drafted) for consultation, endorsement and publication

TBA

TBA

Additional education activities to be determined through the compliance plan

Compliance Priority - Medicinal Cannabis

Guidance for businesses involved with medicinal cannabis

Guidance document

Guidance for businesses involved with medicinal cannabis to assist them to promote their business without promoting medicinal cannabis (a prescription medicine)

Guidance for businesses involved with medicinal cannabis

Direct engagement and education

Direct communications including emails

TGA, MCIA and AMCA

Webinars x 2

Joint presentations, hosted by the TGA, to clarify the advertising rules and responsibilities

Supply of unapproved products - compliance with 'direct control'

Direct engagement via letter

Targeted letters regarding 'direct control' (Schedule 5A Therapeutic Goods Regulations) and how to comply with the rules for supply of unapproved products

Case study

Case study

Case study of a Facebook post (drafted) for publication

TBA

TBA

Additional education activities to be determined through the compliance plan

Compliance Priority - Performance and image enhancing drugs

Sports supplements

Webinar x 2

Clarify advertising requirements following the section 7 declaration

Advertising prescription only medicines (SARMs)

Case study

(drafted) for publication

Compliance Priority - Therapeutic goods used in beauty industry

Unregistered sunscreens

Case study

(drafted) for publication

Schedule 4 Botox

Case study

(drafted) for publication

Guidance re cosmetic/therapeutic goods interface

Guidance/fact sheet

To be developed

Education Priority 2: Activities related to regulatory changes and emerging issues
Topic Education activity Status/key messaging
Changes to the advertising complaints handling framework

New reporting process

Web information

Update to website information regarding 'how to report non- compliant advertising' in conjunction with new system implementation

New process

Web information

Update to website information regarding how we manage advertising compliance

Tips

Fact sheet

(update to previous publication) 10 things to look out for in advertising

Reporting process

Fact sheet

Overview of advertising compliance management for consumers, including how to lodge report

Medical device reforms

Changes to legislation

Fact sheet

Advertising basics fact sheet focusing on medical devices

Changes to legislation

Guidance document

Addressing personalised medical devices, equipment and Software as Medical Devices

Changes to legislation

Fact sheet

Addressing personalised medical devices, equipment and Software as Medical Devices

Changes to the Advertising Code

Code Review

Direct engagement

TGACC updates

Code Review

Public engagement

Public consultation on proposed changes to the Advertising Code

Code Review

Webinars

Public consultation on proposed changes to the Advertising Code

Code implementation

Web statements and direct engagement

To inform stakeholders about the new Advertising Code

Code implementation

Guidance and fact sheets

Updates to guidance and fact sheets

Sports supplements

S7 declaration

Webinar

Section 7 declaration – certain supplements are therapeutic goods

Essential Oils

Direct Sellers

Guidance document

Guidance document produced for advertisers (direct sellers) of essential oils

General advertising

Advertising directed to health professionals

Fact sheet

Clarify the regulatory interpretation of what is meant by advertising exclusively to health professionals

Use of 'TGA approved' in advertising

Fact sheet

How to include reference to ARTG registration/listing/inclusion in advertising and not breach the government endorsements prohibition

Education Priority 3: Publish information on compliance and enforcement actions for transparency of compliance activities and as a deterrent to non-compliance
Status / Key messaging

Publish the outcome of advertising investigations

Publish media releases when higher level enforcement actions are taken, as appropriate

Publish Therapeutic Goods Advertising Compliance Annual Report 2020-21

Education Priority 4: Maintain and enhance fit for purpose educational resources, and participate in training and education opportunities
Topic Education activity Status / key messaging
Annual Education Plan

Annual Education Plan

Working document

Working document to set education activities linking to the Therapeutic Goods Advertising Compliance Education Strategy. TGACC feedback on education requirements continues to inform and update the plan

Advertising Hub improvements

Central repository for Fact Sheets

Fact sheets

To consolidate all fact sheets into a central location for ease of access and use

Publication of new case studies

Case Studies

Ensuring suite of case studies are published and located centrally for ease of access and use

Identify and update broken links

General updates

To ensure content is current

ARGATG

General improvement

For consideration - work with Regulatory Guidance team to improve the way the ARGATG is presented on the TGA website (currently any updates to the guidance require removal and republication of entire document)

Development of educational materials to support ongoing advertising compliance

Code guidance

Align with amended Code

Code guidance to be amended to reflect any changes made to the Advertising Code

ARGATG

Additional content

Continue to add content to the ARGATG, with a focus on providing additional guidance on conducting information sharing activities (e.g. ASX announcements, conferences) without being promotional.

ASX announcements

Additional content

Requirements and obligations for writing ASX announcements

Various, emerging, as required

Case Studies

Case studies to support advertising requirements related to emerging and compliance topics

Various, emerging, as required

Guidance documents

Guidance on application of the legislation

Various, emerging, as required

Fact sheets

Summary documents to highlight advertising issues and provide tips and advice

Various, emerging, as required

Web pages

To alert audience to new topics or emerging issues

Various, emerging, as required

Webinars, training materials

Information sharing and training

Various, emerging, as required

Social media

Alerts, advice. Promotion of call to action

TGA stakeholder survey

Stakeholder survey

Planning

Include agreed advertising questions in the TGA Stakeholder Survey in support of KPI reporting

Reporting

Therapeutic Goods Advertising Compliance Annual Report

Reporting

The annual report includes an analysis of advertising compliance during the year and promotes transparency by providing information about the TGA's compliance and enforcement work throughout the year

TGA annual reporting

Reporting

Information provided as part of the TGA's annual performance reports

Education and training

Topics as identified

Education and training

Educational activities for external audiences

Topics as identified

Training

Training for TGA staff in line with the Regulatory Compliance Branch Training Framework

Education Priority 5: Engage with key stakeholders, including members of the TGACC, as partners in education and communication activities
Status / key messaging

When preparing education activities we will ensure that the audience for each activity is identified, that suitable channels of communication are selected and that activities cover a relevant range of topics.

Industry membership of the Therapeutic Goods Advertising Consultative Committee (TGACC) reflects representation from key sectors of the therapeutic goods industry. The TGACC will take a pivotal role in helping to guide and shape the education activities for 2021, as well as in the distribution of education content and messaging.

Education Priority 6: Maintain and enhance an advertising enquiry management function
Status / key messaging Anticipated completion by

We are committed to maintaining an effective enquiry management function.

Trends seen through our enquiry management function, informed by reporting from our new IT system (go live late July 2021), will be used to inform our education work.

Ongoing