TGA Presentation: Therapeutic Goods Advertising Code (No. 2) 2018

Therapeutic Goods Advertising Code (No. 2) 2018
Advertising Regulation Update Workshop
Advertising Education and Assurance Section
Regulatory Education and Compliance Branch
Regulatory Practice and Support Division
3 April 2019

Therapeutic goods advertising legislation
• The advertising requirements are set out in the
 Therapeutic Goods Act
 Therapeutic Goods Regulations
 Therapeutic Goods Advertising Code
• Advertising is also subject to the Competition and
Consumer Act (Australian Consumer Law)

Therapeutic Goods Act 1989
• Act sets out a range of requirements for advertising to the public
– They apply to sponsors AND advertisers (e.g. retailers, practitioners)
• Prohibition on promoting ‘off-label’ use - s.22, s.32BJ, 41ML
• Requirement to seek pre-approval for medicine ads in ‘specified media’ – s.42C
• Other requirements – s.42DL
– Must not promote or mention prescription medicines or biologicals
– Must not advertise illegal therapeutic goods
– Must not mention cancer (one exception), HIV/AIDS, mental illness, hepatitis
C (prohibited representations)
– Pre-approval for references to serious diseases (restricted representations) 3

Compliance with advertising code
• Advertising to the public for therapeutic goods MUST
comply with the Code
• Requirement to comply with the Code is specified through
a criminal offence and civil penalty provision in the Act:
–Section 42DM – criminal offence
–Section 42DMA – civil penalty
• For an ad to be approved under the Regulations (5G), the
delegate must be satisfied that it complies with the Code
4

Role of the advertising code
• The Code is the cornerstone of the advertising framework
–Requires that advertising supports appropriate use of
therapeutic goods and does not mislead or deceive
• Advertising Code (No.2) 2018 took effect on 1 January
2019
• The Code was revised to provide clarity and more
objective tests to support sanctions and penalties 5

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.”
Very broad definition
Captures advertising irrespective of the medium (e.g. online, print, TV, radio)

Promotion v Information
• Use of language - factual vs compelling/call to action
• Inclusion of testimonials
• References to the product
• Comparison information
• Motivates a response
• Creates a sense of urgency
Does it make a consumer want to go out and buy the product?
8

Example 4
NOT PROMOTING
A THERAPEUTIC
GOOD
12

The Therapeutic Goods
Advertising Code 2018
in detail
13

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 14

Section 4 - Definitions
• It is important to read the Code in conjunction with the Act
and the Therapeutic Goods Regulations 1990
–Terms that are not defined in the Code may be defined in
the Act and Regulations (e.g. ‘advertise’)
• Most Code definitions straightforward but there are some
that we will explore in detail:
–Health warning
–Prominently displayed or communicated
16

What are health warnings?
• In some cases, health warnings need to be included in ads
• Concept of ‘health warning’ is defined in s.4 of the Code
• Purpose of health warnings:
to alert consumers to information that will be critical to their
assessment of whether the advertised product is right for
them before purchase
17

Health warning definition – devices/OTGs
…a statement that is required under the Act or Regulations or Medical Devices
Regulations to be included on the label or in instructions for use that warns that
a person who takes or uses the device or goods as intended may:
(i) die; or
(ii) require hospitalisation or a longer period of hospitalisation than would be
required if the person had not taken or used the device or goods; or
(iii) require a medical practitioner to treat or prevent injury, disability, incapacity
or impairment of any bodily function, organ or structure as a consequence of
taking or using the device or goods
18

Prominently displayed or communicated
‘prominently displayed or communicated’ is defined as:
(a) either:
(i) for a visual statement—standing out so as to be easily read
from a reasonable viewing distance for the particular media
type in the context in which the advertisement is intended to be
viewed; or
(ii) for a spoken statement—able to be clearly heard and
understood; and
(b) repeated as often as is necessary to ensure that it is likely to
be noticeable for a viewer or listener. 19

Section 5 – Object of the Code
“...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.“
20

Section 6 – Application
• Applies to:
–The advertising of therapeutic goods (ss.6(1))
–By any person advertising or causing advertising (ss.6(5))
• Does not apply to:
–Genuine news (ss.6(6)) by certain bodies (ss.6(7)) –
including broadcasters, datacasters and publishers
–Advertising directed exclusively to health professionals
(ss.6(2))
21

Application of specific sections of the Code
• Certain sections and parts of the Code do not apply to:
– Labels (as defined in s.3 of the Act)
– Consumer medicine information leaflets (CMIs) – (defined in
Regulations as ‘patient information documents‘)
– Patient information leaflets (PILs) - for implantable medical
devices (see Code - s.4 - Definitions)
• These exemptions are set out in the relevant sections of the Code
• These documents can still be considered promotional – if so, they
have to comply with all other relevant Code provisions
22

Section 6 – Application
How to apply the Code to a particular advertisement:
consider its likely impact on a reasonable person to
whom the advertisement is directed (ss.6(3))
the total presentation and context of the advertisement
is to be taken into account (ss.6(4))
23

Audience advertisement directed to
• Advertising may be directed to the public in general or a
sub-population
• A direction may be made in many forms, including:
–An overt statement e.g. “Do you suffer from cold sores?”,
“For the relief of psoriasis”
–An implied call to capture the attention of a sub-
population e.g. for the measurement of blood pressure
–The location of the ad e.g. in a magazine for diabetics
24

Total presentation & context
• Total presentation: the advertisement as a whole
• Context includes:
–What other information is provided around the
advertisement that could change the take-out message?
e.g. an editorial on a page opposite the advertisement
–Does the environment in which it is displayed have the
potential to alter the take-out message? E.g. a billboard
ad that is viewed when passing in a car at speed
25

Example – reasonable consumer
26

Section 6A & 6B – Repeals & transition
• Section 6A, by reference to Schedule 5, repeals the 2015
Code and the original 2018 Code
• Section 6B allows for a transition period for ads pre-
approved under the 2015 Code – i.e.
–Complaints about such ads will be assessed against the
2015 Code for the life of the approval
28

Section 7 - Price information
• Price information – definition in s.4 of Code – relates to
prescription medicines and pharmacist-only medicines only
• S.42DL(10) of the Act – advertising of prescription medicines to
the public prohibited “other than a reference authorised or
required by a government or government authority”
• Section 7 of the Code authorises the dissemination of price lists
that comply with Schedule 4 of the Code – i.e. not an offence
under the Act
• Schedule 4 replaces Price information code of practice 29

Part 2 - Requirements for
advertising all therapeutic
goods to the public
30

Section 8 – Approved ads
• Ads for medicines for ‘specified media’ (e.g. free-to-air
television, newspaper, billboard) require prior approval
under Regulation 5G
Offence under section 42C of Act
• S.8 requires ads appearing in print media and billboards to
display the approval number in the advertisement as set
out in ss.8(3) – must be legible
31

S.9 – Accuracy: validity & substantiation
Advertising for therapeutic goods must satisfy the following:
(a) any claims made in the advertising are valid and accurate,
and all information presented has been substantiated before the
advertising occurs
Example: An ad promotes a medical device for identifying allergies
from a non-invasive sample from the patient. The advertiser states
the claim is supported by a small clinical trial conducted in the
1960s. Subsequent larger studies failed to reproduce the positive
findings. The claims are not valid.
32

S.9 – Accuracy: truthful & not misleading
(b) it is truthful, balanced and not misleading or likely to mislead,
including in its claims, presentations, representations and
comparisons
Example: an imaging device is advertised as producing 5 times less radiation
than other devices but fails advise that the amount of radiation produced by
such devices is very small. It is likely to mislead consumers:
• into thinking other imaging devices are harmful
• as to the order of magnitude of the difference in radiation produced by the
devices – even if the claim is substantiated. 33

S.9 – Accuracy: comparisons
(c) any comparisons made in the advertising between
therapeutic goods or classes of therapeutic goods do not directly
or indirectly claim that the goods or class of goods being used as
the comparator are harmful or ineffectual;
Example: A nasal aspirator product is promoted as being able to
extract 100% more liquid than the leading brand. Unlike the leading
brand, it can be used in babies without any fear of injury or harm
34

S.9 – Accuracy: consistency with ARTG
(d) if the goods are included in the Register— it is consistent with
the entry for the therapeutic goods in relation to that
inclusion.
Example: A device included in the ARTG is promoted as made in
the United Kingdom. The ARTG entry for the device shows it is
manufactured in Belgium. The ad would contravene s.9(d).
Example: A dental dam included in the ARTG as a latex product is
promoted as latex-free. The ad would contravene s.9(d). 35

S.10 – Effect: support proper use
(a) Advertising for therapeutic goods must support the safe and
proper use of therapeutic goods by:
(i) presenting the goods in accordance with directions or
instructions for use; and
(ii) not exaggerating product efficacy or performance;
Example: An electromagnetic pulse machine claiming to assist with instances
of mild pain (as per ARTG entry) is marketed as suitable for use in reducing
inflammation and helping circulation.
Or: Made a claim that it provides ongoing relief/ends pain.
36

S.10 – Effect: delaying appropriate treatment
(b) Advertising for therapeutic goods must…not be likely to lead to
people delaying necessary medical attention or delaying the use of,
or failing to use, treatment prescribed by a medical practitioner;
Example: A kit is promoted as a first-aid essential for the
emergency treatment of venomous snake bites. The kit operates in
a way that conflicts with contemporary first aid protocols.
37

S.10 – Effect: encourage inappropriate use
(c) Advertising for therapeutic goods must not encourage
inappropriate or excessive use of the therapeutic goods
Example: A medical device for alleviating snoring is promoted for
alleviating sleep apnoea. The advertising would be likely to
encourage inappropriate use.
38

S.10 – Effect: safe or cannot harm
(d) Advertising for therapeutic goods must not contain any claim,
statement, implication or representation that:
(i) the therapeutic goods are safe or that their use cannot cause
harm, or that they have no side-effects
Example: A herbal medicine is promoted as having a safe mode of
action and that millions of people have bought it and there have
been no adverse reports.
39

S.10 – Effect: sure cure
statement, implication or representation that…
(ii) the therapeutic goods are effective in all cases of a condition
or that the outcome from their use is a guaranteed or sure
cure;
Example: A medical device is promoted as guaranteed to improve
lung function by 75% in COPD patients
40

S.10 – Effect: miraculous
(iii) the therapeutic goods are infallible, unfailing, magical or
miraculous;
Example: A testimonial on a website for a TENS machine stating
that the product provides complete relief for pain during the late
stages of labour.
41

S.10 – Effect: harmful consequences
(iv) harmful consequences may result from the therapeutic
goods not being used — unless the claim, statement, implication
or representation is permitted under section 42DK of the Act or
approved under section 42DF of the Act.
Example: An ad for orthotics implying that failure to wear them
would exacerbate the symptoms of scoliosis.
42

Sections 11 - 13
Mandatory information and
statements
43

Overview: application of sections
Section 11 Section 12 Section 13
Ad for S3 (App H) medicine

Ad for non-S3 therapeutic good
that allows purchase without
seeing the good
 
(selected
items only)
Any other ad for non-S3
therapeutic good

Note: other provisions in the Code, including Part 3, will still apply in each case 44

Overview of
Section 12 & 13
requirements Advertising
must
contain…
Basic info
about the
goods
Important
health
information (or
a prompt to
consumers to
read it) *
Advice to
follow
directions *
If there are
symptoms
claims in the ad
– an
appropriate
symptom
statement *
* information that needs to be
prominently displayed or
communicated
45

S.12: What must ads contain (goods not
available for inspection)
• This section is only for ads for goods that are not available for
physical examination by the consumer before or at the time of
purchase (e.g. internet, mail order marketing)
• Does not apply to:
– advertisements subject to section 11
– a label, consumer medicine information or a patient information
leaflet
46

Section 12 mandatories: devices
Type of information Provision and the information required in ad
Basic information about the
goods
• ss.12(4)(a) – (b) – an accurate description and a reference to EITHER the trade
name or another name for the device
• ss.12(4)(c) – the intended purpose or indications for the device as they appear on
label or primary packaging
• ss.12(4)(d) - a list of the ingredients if applicable
Important health
information *
• ss.12(4)(e) – an alert to the consumer to read the label, instructions or warnings
(as appropriate for the device)
Follow the directions
statement *
• ss.12(4)(f) – ‘Follow the directions for use’ or ‘Follow the instructions for use’
from ss.13(6) as appropriate for the device
Symptom statement * • ss.12(4)(g) - If there are symptoms claims in ad, include appropriate statement/s
from ss.13(7)
* Needs to be prominently displayed or communicated (as defined in s.4)
47

ss.12(4)(e): Important info for devices
Are there statements on the label or instructions
for use for the device that meet the definition of
‘health warning’ in section 4 of the Code?
Do you want to include the health
warnings upfront in the ad?
USE: ‘This product may not be right for you.
Read the warnings before purchase’
followed immediately by information about
where the health warnings can be found
USE: ‘Always read the
label/instructions for use’
and the health warnings
NoYes
No Yes
48

Section 12 mandatories: OTGs
Basic information
about the goods
• ss.12(5)(a) – (b) – an accurate description and a reference to
EITHER the trade name or another name for the goods
• ss.12(5)(c) – the intended purpose or indications for the goods
as they appear on label or primary packaging
• ss.12(5)(d) - a list of the ingredients where relevant
Important health
information
• ss.12(5)(e) – an alert to the consumer to read the label,
instructions or warnings (as appropriate for the goods)
statement
• ss.12(5)(f) – ‘Follow the directions for use’ or ‘Follow the
instructions for use’ from ss.13(6) as appropriate for the goods
Symptom statement • ss.12(5)(g) - If there are symptoms claims in ad, include
appropriate statement/s from ss.13(7)
49

ss.12(5)(e): Important info for OTGs
Are there statements on the label or instructions
for use for the goods that meet the definition of
‘health warning’ in section 4 of the Code?
warnings upfront in the ad?
Read the warnings before purchase’
followed immediately by information about
where the health warnings can be found
and the health warnings
NoYes
No Yes
50

Examples: Bean’s Tonic
internet marketing
51

Example 1 –
Bean’s Tonic
52

Example 2 –
Bean’s Tonic
53

Example 3 –
Bean’s Tonic
54

S.13: What must ads contain (general)
• This section is only for ads that:
–are for goods other than Schedule 3 medicines (see
s.13(1)(d) - section 11 applies to these)
–do not facilitate purchase of the goods without the
consumer being able to inspect them (see s.13(1)(e) -
section 12 applies to these)
• This section does not apply to labels, consumer medicine
information or a patient information leaflet (s.13(1)(a) & (b)) 55

S.13: What must ads contain (general)
• This section also does not apply to picture/price/point of
sale ads (see s.13(1)(c)) – i.e.:
–an advertisement displaying only the name or picture of
therapeutic goods or their price or point of sale, or any
combination of these, provided the advertisement does
not contain or imply a claim relating to therapeutic use,
or any other representation
56

Section 13 mandatories: devices
Basic information
about the goods
EITHER the trade name or another name for the device
• ss.13(3)(c) – the intended purpose or indications for the device
Important health
information *
• ss.13(3)(d) – an alert to the consumer to read the label,
instructions or warnings (as appropriate for the device)
statement *
• ss.13(6) – ‘Follow the directions for use’ or ‘Follow the
instructions for use’ as appropriate for the device
Symptom statement * • ss.13(7) - If there are symptoms claims in ad, include
appropriate statement/s
57

ss.13(3)(d): Important info for devices
Are there statements on the label or instructions for use for the
device that meet the definition of ‘health warning’ in section 4?
warnings in the ad?
USE: ‘This product may not be right for you. Read
the label/instructions for use before purchase’
depending on whether there is a label visible on
primary pack
label/instructions for
use’ and the health
warnings
NoYes
No Yes
58

What do I include in the health warnings?
Intended purpose:
Contraindications – Do not use if you have:
• A pacemaker or Automatic Implanted Cardiac Defibrillator (AICD) -
may interfere with operation of these devices and cause heart failure
and/or death
• 1st trimester of pregnancy – use may cause miscarriage
• Deep Vein Thrombosis – may lead to stroke, heart attack and/or death
• Epilepsy – may cause fitting
Other contraindications:
Talk to your doctor before using and do not use on any of the specific
body parts associated:
• Pregnant – do not use over abdomen
• Broken or bleeding skin – dress any open wound to ensure electrodes
to not come into contact with the area – to avoid a stinging sensation
• Eyes, Testicles – serious injury may follow from use in these areas
Beans
machine
The instructions for use state:
59

What would a compliant warning look like?
OPTION ONE:
This product may not be right for
you. Read the instructions for use
before purchase.
If symptoms persist talk to your
health professional.
OPTION TWO:
Always read the label. Do not use if
you have a pacemaker or automatic
implanted cardiac defibrillator
(AICD) , are in the first trimester of
pregnancy, have deep vein
thrombosis or epilepsy. Follow the
instructions for use.
If symptoms worsen or change
unexpectedly, talk to your health
professional.
60

Section 13 mandatories: OTGs
Basic information
about the goods
EITHER the trade name or another name for the goods
• ss.13(4)(c) – the intended purpose or indications for the goods
Important health
information *
• ss.13(4)(d) – an alert to the consumer to read the label or
instructions (as appropriate for the goods)
statement *
• ss.13(6) – ‘Follow the directions for use’ or ‘Follow the
instructions for use’ as appropriate for the goods
Symptom statement * • ss.13(7) - If there are symptoms claims in ad, include
appropriate statement/s
61

ss.13(4)(d): Important info for OTGs
Are there statements on the label or instructions for use for the
goods that meet the definition of ‘health warning’ in section 4?
warnings in the ad?
Read the label/instructions for use before
purchase’
depending on whether there is a label visible
on primary pack
label/instructions for
use’ and the health
warnings
NoYes
No Yes
62

Exemptions from parts of section 13:
short form ads
• “Short form ads” are:
–Radio commercials 15 seconds or less duration
–Text-only ads of 300 characters or less with no ability to
include pictures, logos or other imagery
• Short form ads are exempt from:
–Important info – ‘Always read the label’ etc
–Symptoms statement (ss.13(6)) 63

Applying prominently displayed
and communicated
64

Example 1 – Bean’s Tonic
An example of prominently displayed
mandatories for a medicine without health
warnings
65

Example 2 –
Bean’s Tonic
Will not be compliant
under the Code
66

Example 4 –
Bean’s
SUPERclean
68

Example 5 –
Bean’s clean
69

S.15: Scientific or clinical representations
• Ss.15(1) - this section does not apply to labels, CMIs or
PILs
• This section is in two parts:
–Requirements for use of scientific or clinical claims
(ss.15(2))
–Requirements for use of citations (ss.15(3))
70

S.15(2): Scientific or clinical claims
Where an advertisement makes a scientific or clinical claim:
• (a) any scientific or clinical terminology must be
appropriate, clearly communicated and able to be readily
understood by the audience to whom it is directed; and
• (b) any scientific or clinical representation must be
consistent with the body of scientific or clinical evidence
applicable to the advertised therapeutic goods.
71

S.15(3): Scientific citations
Where an advertisement contains a citation to scientific or
clinical literature, either explicitly or impliedly:
• (a) any research results must identify the researcher and
financial sponsor of the research, where the advertiser
knows, or ought reasonably to have known that
information; and
• (b) the study must be sufficiently identified to enable
consumers to access it. 72

Example Implied scientific
citation – reference
needs to be
provided
Scientific
information is
inappropriate and
won’t be readily
understood
These would need
to reflect the body
of evidence
available
73

Example
Provided these
claims reflect the
body of evidence
available about the
product or
ingredient, this
would likely
comply with s.15
74

S.16(1): Endorsements
• The endorsement provisions in section 16 do not apply to:
–Testimonials captured by section 17 (s.16(1)(a))
–Claimer for efficacy assessed non-prescription medicines
– as described in Regulations (s.16 (1)(b))
75

S.16(2) and (2A): Endorsements
• Endorsements (express or implied) from the following are prohibited:
(a) a government authority, hospital or healthcare facility; or
(b) an employee or contractor of a government agency, hospital or
healthcare facility; or
(c) a health practitioner, health professional, medical researcher or
a group of such persons.
• Health care facilities do not include community pharmacies
76

S.16(3): Endorsements
Subject to conditions, endorsements from the following are permitted:
(a) an organisation that:
(i) represents the interests of healthcare consumers; or
(ii) represents the interests of health practitioners, health
professionals or medical researchers; or
(iii) conducts or funds research into any disease, condition, ailment
or defect; or
(b) an employee or contractor of an organisation mentioned above,
other than an individual mentioned in paragraph (2)(b) or (c) 77

S.16: Endorsement conditions
• Endorsements made under s.16(3) are subject to the conditions
that the advertisement:
– names the organisation concerned; and
– discloses:
(i) the nature of the endorsement; and
(ii) whether the organisation or employee, has received, or
will receive, any valuable consideration for the
endorsement
• ‘Organisation’ defined in s.16(4) – any group, association etc 78

S.17: Testimonials
• Testimonial = a statement about a therapeutic good made by a person
that claims to have used that good (s.17(1))
• This section of the Code specifies three types of requirements:
– Characteristics of the person making testimonial (s.17(2)(a))
– Obligations of the advertiser before using testimonial in advertising
(s.17(2)(b) and (c))
– Information that must be disclosed in the ad about the testimonial
(s.17(3))
• When is a testimonial on social media considered to have been ‘used’
in an advertisement? 79

Who can make a testimonial for use in ads?
s.17(2)(a) - a person:
(i) whose details are verified prior to the advertising occurring; and
(ii) who has used the goods for their intended purpose; and
(iii) who is not:
(A) involved with the production, sale, supply or marketing of the goods;
or
(B) an employee or officer of a corporation that is involved with the
production, sale, supply or marketing of the goods; or
(C) a corporation; or
(D) mentioned in subsection 16(2) (e.g. health professionals, staff from
government agency, hospital or healthcare facility)
80

Advertiser obligations when using testimonials
s.17(2)(b) and (c) – the advertiser needs to ensure that they
have:
• verified as to the use of the goods and the claims made by
the person prior to the advertising occurring; and
• checked that the testimonial is typical of the results to be
expected from the use of the goods in accordance with the
directions for use, or purpose, of the goods.
81

Information re testimonials to be included in ads
s.17(3) – An ad containing a testimonial must:
(a) disclose whether the person providing the testimonial has
received, or will receive, any valuable consideration for the
testimonial;
(b) disclose where another person is taking the place in the
advertisement of the person providing the testimonial; and
(c) disclose where the person providing the testimonial is an
immediate family member of an individual who is involved with
the production, sale, supply or marketing of the goods.
82

Example acceptable use policy
We welcome your comments on our page but we ask that you help us comply with the Therapeutic Goods Advertising Code (the Code).Please
consider these guidelines before commenting. We will remove any comments that may result in us breaching the Code.
We love when you comment and tag your friends and family on our posts but we ask that you do not:
 endorse our product if you are:
o an employee or contractor of a government authority, a hospital or a healthcare facility
o a health practitioner, health professional or medical researcher
o involved with the production, sale, supply or marketing of our product
o not using your own name on this social media platform.
 imply that a government authority, a hospital or a healthcare facility endorse our product
 make comments about how a product works for you outside of its intended purpose, as these comments can be dangerous or
misleading.—our products are developed for particular purposes, as stated on the label and/or in our advertising, and these comments can
be dangerous and misleading
• make comments about serious conditions, diseases, ailments or defects, such as comments about how a product helped with your cancer
treatment or how it will relieve a tagged person’s rheumatoid arthritis pain
We also have an obligation to make sure any advertisements we make, including endorsements and testimonials, are not misleading. Therefore
we promise to disclose:
 where a person has been, or will be, compensated for making a testimonial
 where we have actors making the testimonial, such as in cases where the original person who made the testimonial does not want to
appear in our advertisement
 where the person making the testimonial is an immediate family member of anyone employed by our business 83

Example comments –
Facebook
85

S.18: Incentives
• Ads must not offer any personal incentive to a pharmacy
assistant, or any retail sales person who is not a health
professional, to recommend or supply therapeutic goods.
• Pharmacy assistants and other retail staff do not meet the
criteria for ‘health professionals’ for the purposes of the
advertising (s.42AA)
• Ads for these audiences must comply with the Code –
including this provision
86

S.19: Advertising to children
• Advertising must not be primarily directed to children
under the age of 12 years at all
• Advertising must not be primarily directed to children aged
12 years or over, EXCEPT for those products listed in
Schedule 2 of the Code, which include tampons and condoms
• Labels are excluded from this provision
• ‘primarily directed’ does not include incidental exposure
87

S.20: Samples
• An ad must not contain an offer of a sample EXCEPT for those
products listed in Schedule 3:
Condoms
Sunscreens
Stoma devices for self-management
Continence catheter devices for self-management
• Samples can in themselves be an ad – consider Act definition of
‘advertise’
• Some samples may also be subject to state and territory laws –
e.g. scheduled substances 88

S.20: Samples example
Have you been diagnosed with IBS recently?
Wondering if you will ever find anything to help your
symptoms?
You can feel better in just two weeks – take the
Bean’s challenge!
Sign up at www.beanstonic.com.au and we will
email you a voucher for a free one month
supply of Bean’s Tonic from your local
pharmacy 89

S.21: Consistency with public health campaigns
• If a relevant public health campaign of which the advertiser
knows, or ought reasonably to have known is or will be current
at the time of advertising therapeutic goods, the advertising must
not be inconsistent with the public health campaign
• Campaigns can be current but not necessarily active – e.g.
respiratory hygiene campaigns only run in cold & flu season
• Guidance contains more information on establishing current
public health campaigns
90

S.21: Consistency with public health campaigns
Example: There are a
range of current initiatives
in Australia to encourage
healthy eating and exercise
as a way to not only lose
weight but also stay
healthy
Bean’s Gastric Balloon
• Prevents fats, proteins and
carbohydrates from being
absorbed by your body
• Lose weight without losing the
taste and enjoyment of eating
your favourite takeaway
• Easily provided by your GP
91

Part 3 - Requirements when
advertising particular types of
therapeutic goods
92

S.26 – Goods for weight management
(1) An advertisement for therapeutic goods containing any claim
relating to weight management must balance the claims with
the need for a healthy energy-controlled diet and physical
activity.
(2) Advertising of therapeutic goods containing any claim relating
to weight management must not include any reference or
depiction suggesting that the therapeutic goods will correct or
reverse the effects of overeating or over-consumption of any
food or drink.
93

S.26 – Weight management
(3) An advertisement for therapeutic goods containing any claim
relating to weight management must not:
(a) feature individuals in images or visual representations;
or
(b) use individuals’ statistics or testimonials; unless the
results achieved by those individuals from the use of the
goods would be expected to be achieved on average by
users of the goods.
94

Part 4 – Restricted and
prohibited representations
95

Prohibited and Restricted Representations
• The Act makes it a criminal offence, and provides civil penalties,
where an advertiser makes reference certain conditions (explicitly,
or by implication) in advertising of therapeutic goods without prior
approval:
– S. 42DL(7) and 42DLB(4) – restricted representations
– S. 42DL(5) and 42DLB(2) – prohibited representations
• The Act also provides that the Secretary may approve the use of
these representations under certain circumstances (s.42DF and
s.42DK)
96

s.29(1)(a) – medically accepted
to be a form requiring
diagnosis, treatment or
supervision by a suitably
qualified health professional?
s.29(1)(a) - Once medically
diagnosed, is it medically
accepted to be suitable
for self-treatment and
management?
s.29(1)(b) - Is there a
diagnostic/screening, or other
kind of test for the form which
requires medical interpretation
or follow-up?
The form IS a
serious form
NOT a serious form
NO
YES YES
NO
NO
YES
97

Restricted representations
• A range of examples of what are and are not considered
serious conditions are provided in the Guidance.
• The conditions included in the Guidance make for a fairly
easy assessment of whether or not they need to be
medically diagnosed.
• Where the serious condition is implied by the
representation, this may be more difficult to assess
98

Permitted restricted representations
• TGA has permitted the use of certain restricted representations by
all advertisers of therapeutic goods, where the ad and product
meets the characteristics and requirements specified.
• Permitted restricted representations include:
– Neural tube defect risk reduction in pregnancy when advertising
medicines with at least 400µg folic acid/day
– representations about sleep apnoea, Obstructive Sleep Apnoea
(OSA) and Central Sleep Apnea/Apnoea (CSA) in relation to
Continuous Positive Airway Pressure (CPAP) equipment
99

Restricted
representation
approvals and
permissions
are published
on the TGA
website
100

S.30 - Prohibited representations
• Representations (express or implied) about the treatment, cure,
prevention, diagnosis (including screening), monitoring or
susceptibility of, or pre-disposition to:
– Neoplastic diseases (i.e. all types of cancer)
– Sexually transmitted disease
– HIV/AIDS
– Hepatitis C virus
– Mental illness
• Abortifacient action 101

Using prohibited representations
• The use of a prohibited representation may be authorised where it
is necessary for either:
– Public health interest; or
– The appropriate use of the goods (packaging & labelling only)
• There is no process for applying to use prohibited representations
– TGA will identify where it is needed
• Representations about preventing transmission of
STDs/HIV/AIDS and prevention of skin cancer through sunscreen
use are prohibited representations but will be permitted
102

What’s in our compliance 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
104

What’s in our compliance toolkit? (2)
Regulatory Compliance
• Directions 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
Administrative Action
• Cancellation or suspension of the therapeutic good from the ARTG
• Public Warning Notice
• Substantiation Notice
Compliance Assurance
• Confirming continued compliance by advertisers that come to our attention 105

Risk based regulatory action
106

Code version applied in compliance
• For ads (other than pre-approved medicine ads):
107

Compliance approach
• TGA statement on its approach to compliance and
enforcement discretion in the changeover to 2018 Code:
https://www.tga.gov.au/therapeutic-goods-advertising-
update-29-october-2018
• Details of the TGA’s advertising complaints handling
framework have been published:
https://www.tga.gov.au/publication/complaints-handling-
advertising-therapeutic-goods-australian-public
108

Top tips for compliant advertising
 Ensure ads contain the correct mandatory statements and
information with appropriate prominence
 Check advertising for complementary medicines, analgesics,
vitamins, weight loss products and sunscreens carefully to
ensure full compliance with the express provisions
 Don’t use advertising with references to diseases, conditions,
ailments or defects before checking if you need restricted
representation approval
109

Top tips for compliant advertising
 Ensure testimonials, endorsements and scientific representations
fully comply with clarified requirements.
 Don’t use advertising that is inconsistent with the product’s ARTG
entry, directions, or instructions for use
 Don’t use advertising that encourages people to delay seeking
medical advice or cease prescribed therapies
 Don’t use advertising that conflicts with public health campaigns
110

Top tips for compliant online advertising
 Include required warning statements prominently in all online advertising
 Incorporate a User Acceptance Statement on your social media page that
highlights possible areas of non-compliance
 Moderate all comments and delete comments in breach of the Code
 Check the identity of those providing testimonials and verify the use of the
goods. Disclose any incentives/payments/connections to the company in
relation to those making testimonials
 If you make clinical/scientific claims, provide supporting study details
 If in doubt, leave it out! 111

Summary & finding
more information
112

Find out more about advertising
• Advertising hub – www.tga.gov.au/advertising-hub
• Regulatory affairs consultant / legal advice
• TGA Online advertising inquiry form -
https://compliance.tga.gov.au/advertising-enquiry/
• Email: advertising.education@tga.gov.au
113

Find out more about the TGA
TGA website www.tga.gov.au
TGA Advertising Hub https://www.tga.gov.au/advertising-hub
Facebook https://www.facebook.com/TGAgovau/
Twitter https://twitter.com/TGAgovau
Youtube -
https://www.youtube.com/channel/UCem9INJbMSOeW1Ry9cNbucw
114

TGA Presentation: Therapeutic Goods Advertising Code (No. 2) 2018

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TGA Presentation: Therapeutic Goods Advertising Code (No. 2) 2018