advertising therapeutic goods to consumers...miracle mineral solution . prohibited and restricted...

Advertising therapeutic goods to consumers Complying with the legislation

Advertising Education and Assurance Section Regulatory Education and Compliance Branch ASMI Advertising Seminar

29/30 October 2018

Before advertising laws… Very serious diseases

Implies no other treatment is needed Endorsement by experts Questionable risk/ benefit profile More serious diseases

Sure cure, miraculous outcomes

Misleading if doesn’t actually contain radium

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Three levels of advertising controls

• Legislation administered by the TGA Regulation

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

• Industry Codes Self-regulation

The TGA’s role • Administers the legislation that underpins

the advertising framework • Advertising complaints handling body • Initiates regulatory action to obtain

advertising compliance • Oversees the shared regulatory

arrangement with industry organisations • Observer on some industry complaints

panels

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

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

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Therapeutic Goods Act 1989

Changes to the Act – March 2018 • Amendments to implement some reforms • Key changes:

–3 tier criminal offences & corresponding civil penalties –Improved powers for advertising directions –Additional sanctions – infringement notices, injunctions,

substantiation notices, enforceable undertakings, public warning notices

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The Act – Chapter 1 - Overview

• Section 4 - Objects of the Act – to provide: – a national system of controls for the quality, safety,

efficacy and timely availability of therapeutic goods – a framework for states & territories for a uniform

approach to control the availability and accessibility of therapeutic goods (poisons scheduling)

• Section 3 - Important definitions

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Definition of ‘therapeutic goods’ • Therapeutic Goods includes ‘goods’ for

Ø therapeutic use

Ø use as an ingredient or compound used in the manufacture of therapeutic goods

Ø use as a container or part of a container • There are some exclusions – more on this later

Ø preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury

Ø influencing, inhibiting or modifying physiological processes

Ø Testing of susceptibility to a disease or ailment Ø influencing, controlling or preventing conception

Ø testing for pregnancy

Ø replacement or modification of parts of the anatomy

Definition of ‘therapeutic use’

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.”

Which of these are advertising? A. A flyer from a particular pharmacy advising that a commonly used

cold medicine is 20% off normal price this week

B. A stock exchange announcement by a medical device company

C. An Instagram post from a complementary medicine company announcing that their new topical treatment for psoriasis is now available from a specific chain of health food stores

D. A website for a physiotherapist listing the services that they offer, including massage and manipulation

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The therapeutic goods advertising requirements • The advertising requirements are specified in the form of criminal

offences provisions in the Act – Offences specific for the particular types of therapeutic goods – General advertising offences

• Advertising that contravenes these offences is not necessarily prosecuted – the TGA may use other tools – Administrative tools – cancellation/suspension from ARTG – Compliance tools – Enforcement tools

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The Act - Chapter 3 - Medicines

• ss.22(5): General offence

– Advertising an indication not included in ARTG in relation to the good

– Applies to ads for all audiences (not just consumers)

• ss.28(5)(ab): Conditions of registration or listing – Must not, by any means, advertise goods for an indication other

than those accepted in the ARTG

The Act - Chapter 3 - Biologicals • ss.32BJ(2A): Offence for biologicals

– Advertising an indication not accepted in relation to the inclusion of the biological in ARTG

– Applies to ads for all audiences (not just consumers)

• ss.32EA(9) – Conditions applying automatically – The inclusion of a biological in the ARTG is subject to a

condition that advertising material relating to the biological is consistent with the indication accepted in relation to the ARTG entry

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The Act - Chapter 4 – Medical devices • s.41ML: Offence for Medical Devices

– Advertising an intended purpose not accepted in relation to the inclusion of the device in ARTG

– Applies to ads for all audiences (not just consumers)

• ss.41FN(5) – Conditions applying automatically – The inclusion of a kind of medical device in the Register is

subject to a condition that advertising material relating to medical devices of that kind is consistent with the intended purpose as certified under section 41FD.

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The Act – Part 5-1 – Advertising to consumers Provides for:

–exemption for advertisements directed exclusively to health professionals

–other advertising definitions –establishes the Advertising Code –prohibited and restricted representations –offences

The Act – Part 5-1 – Advertising to consumers General advertising offences for:

• Section 42C - unapproved advertisements or those that differ “in any respect” from what was approved

• Section 42DL – advertisements with: ‒ prohibited representations that have not been permitted ‒ unapproved restricted representations ‒ illegal products ‒ government agency recommendations

• Section 42DM – advertising that does not comply with the Code

Generic information • Generic information is information about the composition, properties

or other characteristics of therapeutic goods, but does not include: ‒ an ad about the goods; or ‒ generic information included in an ad about the goods; or ‒ bona fide news

• Generic information is subject to separate offences to advertising • Generic information must comply with specific requirements in the

Advertising Code • True generic information is very rare

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Therapeutic Goods Regulations 1990

Therapeutic Goods Regulations 1990 • Part 2

‒ Division 2 - establishes approval scheme for certain “specified media” advertisements

‒ Division 3 - specifies further information on the Act provisions

‒ Division 4 – prescribes the sections of the Code that apply to generic information

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Therapeutic Goods Advertising Code

Therapeutic Goods Advertising Code • The Code is a legislative instrument made under section 42BAA of the Act

• The Code is consistent with the WHO Ethical Criteria on Medicinal Drug Promotion

Therapeutic Goods Advertising Code 2018 Section 5 - Object The Object of this Code is to ensure that the advertising of therapeutic goods to consumers is conducted in a manner that: (a) promotes the safe and proper use of therapeutic goods by minimising their misuse, overuse or underuse; and (b) is ethical and does not mislead or deceive the consumer or create unrealistic expectations about product performance; and (c) supports informed health care choices; and (d) is not inconsistent with current public health campaigns.

Interface issues: foods, cosmetics and

consumer goods

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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

Interface Issues - Food Products

Regular food advertisement?

Interface Issues - Food Products

Food or therapeutic

good?

Interface Issues - Food Products

Interface Issues - Food Products

Food

or therapeutic good?

Inappropriate Food Product Claims Food products with health claims on such as:

‒ prevent or decrease the risk of cancer

‒ prevent or decrease the risk of heart disease

‒ treatment of influenza

are illegal and a matter for the relevant state/territory food authority

Food-Medicine Interface Guidance Tool

See - https://www.tga.gov.au/food-medicine-interface-guidance-tool-fmigt

Solgar ABC Dophilus powder

Interface Issues - Cosmetic Products

• “Cosmetic” products are not intended to be “therapeutic goods”

• Cosmetics are regulated under legislation administered by the National Industrial Chemicals Notification & Assessment Scheme (NICNAS):

–the Industrial Chemical Notification Act 1990 (ICNA Act) –Cosmetics Standard 2007 (made under ICNA Act)

• Further information see www.nicnas.gov.au

Interface Issues – Cosmetic Products

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

Interface Issues - Cosmetic Products

• 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

Ø i.e. must not be for preventing, diagnosing, curing or

alleviating a disease, ailment, defect or injury in persons

Interface Issues - Cosmetic Products

Regular cosmetic advertisement?

Interface Issues - Cosmetic Products

Interface Issues - Cosmetic Products

Cosmetic or therapeutic good?

Interface Issues - Cosmetic Products

Interface Issues – Consumer Products

ACCC Corrective Advertisements

ACCC Warning Notice

Miracle Mineral Solution

Prohibited and Restricted

Representations

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Prohibited Representations Offence: Subsection 42DL(5) of the Act Definition: Section 30 of the Code

• An advertisement must not contain representations (express or implied) regarding any representation regarding the treatment, cure, prevention, diagnosis (including screening), monitoring or susceptibility of, or pre-disposition to, the following diseases: – Neoplastic diseases – Sexually Transmitted Diseases (STD) – HIV AIDS and/or Hepatitis C viruses – Mental illness

• Abortifacient action claims also prohibited

Offence: Subsection 42DL(5) of the Act Definition: Section 30 of the Code, Schedule 2 of Regulations

• This definition captures: –prevention of skin cancer through the use of sunscreens –devices used in contraception or in the prevention of

transmission of disease between persons • The use of these representations will be permitted under

s.42DK of the Act

Prohibited Representations

Offence: Subsection 42DL(7) Definition: Section 42DD of the Act and Section 28 of the Code

• Restricted representations must be approved by the TGA before being made 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

Restricted Representations

Restricted Representations Offence: Subsection 42DL(7) of the Act Definition: Section 42DD of the Act and Section 28 of the Code

• For the purposes of section 42DD of the Act, a form of a disease, condition, ailment or defect is a serious form if: (a) it is medically accepted that the form requires diagnosis or treatment or supervision by a suitably qualified health professional, except where the form has been medically diagnosed and medically accepted as being suitable for self-treatment and management; or (b) there is a diagnostic (including screening), preventative, monitoring, susceptibility or pre-disposition test available for the form (including a self-administered test), which requires medical interpretation or follow-up.

• Subsection 42DL(7) – offence for using unapproved restricted representations in advertising

Applying for approval to use a Restricted Representation • Legislative requirements:

‒ Set out in Division 3 of Part 5-1 of the Act

Ø specifically, sections 42DD through to s.42DK

• Guidance and application form online: https://www.tga.gov.au/advertising-guidance-advertisers#restricted

Approve or Refuse an application?

• Section 42DF – to approve application, must be satisfied that the representation is: üaccurate and balanced; and ünot misleading or likely to be misleading

• Required to take into consideration: üany advice of the ACM, ACCM, ACMD or ACV (if sought) üthe public interest criteria

Approval notice example

Unapproved restricted representation

Getting more information about

advertising requirements

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Advertising education materials • New “Advertising hub” – www.tga.gov.au/advertising-hub

– Easier to locate from homepage – Access to education, guidance, fact sheets, complaint form, inquiry

form etc – An e-learning module (more under development)

• Australian Regulatory Guidelines for Advertising Therapeutic Goods • Consumer-specific materials:

– Fact sheets – lodging complaints, identifying non-compliant ads – Short video on advertising requirements

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Consumer education materials

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Online training module

Online training module

Top advertising tips þ Check if your advertisements need pre-approval

þ Ensure claims are consistent with indications/intended purpose in ARTG

þ Before advertising – is it a therapeutic good…or something else?

ý Don’t advertise with prohibited or unapproved restricted representations

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The benefits of compliant advertising • A robust and effective system of advertising controls • Promotes responsible advertising • Reinforces quality use of therapeutic goods • Supports consumer confidence and trust • Enhances health outcomes for all Australians • Level playing field for business

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Questions? Email: Advertising.Education@tga.gov.au

Online form: https://compliance.tga.gov.au/advertising-enquiry/

Twitter: @TGAgovau

Facebook: TGAgovau