Key Areas to be Covered

Overview of advertising arrangements

The Review - New Advertising
Arrangements

The Approval Process

Complaints about advertisements of
therapeutic goods
Advertising - What and to
Whom?

Consumers


Unscheduled, S2, some S3 and devices
Healthcare professionals

Entire spectrum
The Legislation

Trade Practices Act

Broadcasting Services Act

Therapeutic Goods Act and Regulations
The Trade Practices Act 1974


Commercial conduct in general

prevents misleading marketing practices

prevents restrictive trade practices
Consumer safety and protection

standards for product safety and
information
The Broadcasting Services
Act 1992

Advertisements relating to medicines

Delegation of approval function

PMAA since 1991
The Therapeutic Goods Act
1989

Major legislative control

Uniformity across States and Territories

ARTG

Parts of TGAC incorporated
How to identify therapeutic
goods

Therapeutic claims

Product Categories

Listable AUST L

Registrable AUST R

Exempt
Definition of Advertisement

Any statement, pictorial representation
or design

Intended to, whether directly or
indirectly to

Promote the use or supply of goods

Product labels - a form of advertising
Amendment 400
18 December 1997

Defining the TGACC

Complaints Resolution Panel
Amendment 400 - Advertising

Definining mainstream media

Formal approval - approval number

Responsibility of sponsor/advertiser

Responsibility of publishers (42D)
The Therapeutic Goods
Advertising Code Council
today

Manufacturing and supply Industry

Advertisers

Healthcare professionals

Consumers

Government

Observers
Formal Approval of
Advertisements


Delegation of approval function to
industry

CHC: print ads for complementary
healthcare products

PMAA: non-prescription medicines
Appeals mechanism for non-approved
ads
The Complaints Resolution
Panel

Members

Consumers

Healthcare professionals

Government

Industry

Complaints about print advertisements

No similar mechanism for broadcast ads
Self-regulatory Arrangements

Non-mainstream advertising

Industry bridges the gap

CRC of CHC

Complaints Panel of PMAA
Summary

3 Main pieces of legislation

Therapeutic Goods Act and Regs

TGACC and CRP

Formal approval legislated

Approval delegated to Industry
Key Areas

Overview of advertising arrangements

The Review - New Advertising
Arrangements

The Approval Process

Complaints about advertisements of
therapeutic goods
NEW ADVERTISING
ARRANGEMENTS
Areas to Be Covered

Overview of reform process

The new Therapeutic Goods Advertising
Code

“The Guidelines”

Overview of regulatory reforms
The Review
Reforms Since 1998

The Govt/Industry Working Party

Regulation of complementary
healthcare products

Deficiencies of the old TGAC

Restricted-product indications/information

Emphasis on illness and disease

Not reflecting current values
Agreement for New Code

Greater orientation towards health and well-being

Greater range of permissible representations in
advertising

Ensuring a level playing field

Deregulation without compromising public health
and safety
The Broader Context of the
Review

Office of Complementary Medicines

Elevating the status of CMEC

Major reform of ELF
Objectives of the Review

Start new Code with clean sheet

Principle based Code

New Code to reflect current values

User-friendly, practical, all in one
document

Evergreen - requiring minimum
legislative amendments
Objectives (continued)

Clarify issues relating to claim
substantiation

Starting point- all existing permissible
representations

Strengthening the TGA’s ability to act:
timeliness and teeth

Deregulatory approach without
compromising public health and safety
The Review Process

TGACC to oversee the Review

Task Force:

CHC, CMEC, CHF, PMAA, TGA, APMA

ASM’s
Guidelines for Levels of
Evidence

Sponsors required to hold evidence April 99 amendment

Need for guidance indentified

CMEC and Working Party developed
guidelines
Summary

Contemporary and flexible Code

Legislative underpinning for the Code

Extended range of claims

Guidelines for substantiating evidence

Safeguards for consumers

Regulatory amendments to underpin
changes
Tracking Progress

Overview of reform process

The new Therapeutic Goods
Advertising Code

“The Guidelines”

Overview of regulatory reforms
Rationale - Outcomes

Clean sheet

Principle based

Open to interpretation - flexible

Evergreen

Consistency across all media

Reflect current social values
Clause 1- Object of the Code

The key elements:

Socially responsible marketing and
promotion

Desired outcome-Quality use of medicines

WHO Ethical Criteria (Appendix 1)

Context and total presentation of ads interpretation and application
Clause 2 - Definitions

Advertisement

Label

Mainstream media

Healthcare professional (Appendix 2)

Sponsor

Therapeutic goods and therapeutic use
Clause 3 - Compliance and
Application
Compliance with TPA, Therapeutic
Goods Act and other legislation
 Consumer ads - entire Code applies
 Healthcare professional ads (Appendix
2) - industry codes

Clause 3 (contd)
Information - generic or branded
 Advertisement - generic or branded
 Bona fide news, public interest - Code
does not apply
 Mainstream ads - formal approval
(Appendix 3)

Clause 4 - Principles

Clause 4.1- General

4.1.1Ads for therapeutic goods must:
(a) Comply with the statute and
common law
(b) Contain correct and balanced
statements and claims already
verified.
Clause 4.1 (continued)

Clause 4.1.2 Ads must not:
(a) arouse unwarranted expectations
(b) lead to inappropriate self-diagnosing and
treatment
(c) mislead directly or indirectly
(d) abuse trust, exploit, bring about fear or
distress
(e) lead to belief that consumer is suffering
from serious ailment or harm coming to
consumer
Clause 4.1.2 (continued)
(f) inappropriate or excessive consumption
(g) infallible, unfailing, magical, a certain,
guaranteed or sure cure
(h) effective in all cases of a condition
(i) safe, no harm, no side-effects
(j) directed to minors, except for those goods
in Appendix 5
Appendix 5

Therapeutic goods not subject to
Clause 4.1.2 (j)

tampons

topical preparations for acne

sunscreens SPF 15+

condoms and personal lubricants

bandages and dressings

devices for management for chronic
conditions under medical supervision
Clause 4.2 - Scientific
Information

Accurate, balanced, not misleading

Appropriate terminology, readily
understood

Research results to identify researcher
or sponsor
Clause 4.3
Comparative Advertising

Balanced, not misleading

Factual, reflect body of scientific
evidence

Competitor product harmful or
ineffectual
Clause 4.4 - Professional
Recommendation

Clause 4.4.1- endorsement not
permissible by:

government agency or healthcare
professional

except for availability - place and price
Clause 4.4.2 - Endorsement
Permitted

Bodies or associations, under certain
conditions:

body or association named

authenticated

nature disclosed

valuable consideration disclosed
Clause 4.5 - Testimonials

Must not breach Code

Documented, genuine, not misleading

Exceptional cases not depicted as
typical
Clause 4.6 - Samples

Advertisements may not contain offer of
sample
Clause 5 - Prohibitions

Clause 5.1 No references allowed:

Appendix 6 Part 1:

Abortifacient action

Neoplastic disease

STD’s

HIV/AIDS

Mental illness
Clause 5 & Appendix 6

Clause 5.2 Restricted representations

References allowed on prior approval
from TGA

Appendix 6 Part 2:

Table 1: Serious manifestations of
diseases
“Serious” Defined

Inappropriate to be diagnosed and/or
treated without consulting a healthcare
professional

Beyond the ability of the average
consumer to evaluate and treat
accurately without supervision by a
healthcare professional
Permissible Representations The Glossary

Examples of currently permissible
representations

New representations added in future
Clause 6 - Minimum
Requirements

Clause 6.1 Ads of unbranded
therapeutic goods

Only 6.2 (b) applies (plus rest of Code)
Clause 6 - branded ads

Trade name

Approved indications

Ingredients OR ‘mandatory’(not direct
marketing & Internet)

“Use only as directed”

For symptom relief: ‘mandatory’

Advertisable S3’s - ‘mandatory’
Clause 7 - Specific Categories

Clause 7.1 - Analgesics

Applies to ‘primary’ internal analgesics

One of 2 mandatory statements in all
media

Not permissible:
• safe
• relax, relieve tension, sedate or stimulate
Clause 7.2 - Vitamins

Not permissible:

vitamins a substitute for good nutrition or
balance diet, or

superior to or more beneficial than dietary
nutrients
Appendix 4 - Appeals and
Complaints

Non-approval - mechanism for appeal

Complaints about advertisements
Tracking Progress

Overview of reform process

The new Therapeutic Goods Advertising
Code

“The Guidelines”

Overview of regulatory reforms
Tracking Progress

Overview of reform process

The new TGAC

“The Guidelines”

Overview of regulatory reforms
Guidelines for the Levels
and Kinds of Evidence to
Support Claims for
Therapeutic Goods
Principles:
Sponsors
must hold adequate evidence to
support all claims
Claims
must be true, valid and not
misleading, and consistent with recorded
use on ARTG
Claims
should not lead to unsafe or
inappropriate use of a product
Claim Types

Registrable claims


Require high level evidence. Must be
evaluated by expert committee
Listable claims

Require evidence appropriate to the nature
of the claim. Sponsor must have access to
the evidence.
Kinds of evidence which may
support claims

Scientific evidence

Evidence based on traditional use
Claims based on Scientific
Evidence
Scientific evidence
Categorised as:
Primary
- High
- Medium
- General
Non-primary ( supporting evidence)
Claims based on Scientific Evidence
High
Medium
General
High level claims - scientific

Treats/cures/manages

Prevents

Vitamin and mineral deficiency diseases

All claims referring to serious
diseases/disorders
Medium level claims - scientific

Health enhancement

Risk Reduction

Symptomatic relief of named (non-serious)
diseases/disorders
General level claims - scientific

Health maintenance

Nutritional support

Vitamin or mineral supplementation

Relief of symptoms
Claims based on Evidence of
Traditional Use
Evidence of Traditional Use
Medium level - need medium level
evidence
General level - need general level
evidence
General level scientific
evidence

Descriptive studies or reports of
relevant expert committees

Texts such as approved
Pharmacopoeias/ monographs or other
evidence based texts
Medium level scientific evidence

Evidence obtained from well designed controlled
trials without randomisation. In the case of a
homeopathic preparation, evidence from well
designed, controlled homeopathic proving OR

Evidence obtained from well designed analytical
studies, preferably from more than one centre or
research group, including epidemiological cohort or
case-control studies OR

Evidence from multiple time series with or without
intervention, including population and ecological
studies.
Sources of most medium level evidence will be peer reviewed published
papers and evidence based reference texts. Web sites evaluating peer
reviewed research may be a source of suitable evidence.
High level scientific evidence

Evidence obtained from a systematic review
of all relevant control trials eg Cochrane
review OR

Evidence obtained from at least one
properly designed (preferably multi-centre)
randomised double blind trial. It is
preferable to have data from at least two
independent trials, but in some cases one
large well conducted trial may suffice.
There is a Complementary medicine field of study within
Cochrane
General level traditional
evidence

One of

TGA approved Pharmacopoeia/Monograph

3 independent written histories of use in
the classical or traditional medical literature

Availability through any country’s
government public dispensaries for the
indication claimed
Medium level traditional evidence
 Two
of

TGA approved Pharmacopoeia

TGA approved Monograph

3 independent written histories of use in
the classical or traditional medical literature

Availability through any country’s
government public dispensaries for the
indication claimed
Tracking Progress

Overview of reform process

The new TGAC

“The Guidelines”

Overview of regulatory reforms
Overview of Regulatory Reforms
Current situation:
• Non-mainstream advertisements comply with specified parts of the Code
• Mainstream print and Broadcast
advertisements - comply with the entire
Code
New situation:
• All advertisements will be required to
comply with the entire Code
Current situation:
• Therapeutic devices - not subject to
Complaints Resolution Panel (CRP)
New situation:
• Therapeutic devices - subject to
Complaints Resolution Panel (CRP)
Current situation:
• Difficulties separating ‘generic’ information
from advertising
New situation:
• ‘Generic’ information defined as a
separate category and subject to parts
of the Code
Current situation:
• Clause 4 indicates many prohibited
conditions
New situation:
• Clause 5 prohibits 5 conditions
• Short list of other restricted
representations
New situation:
• CMEC or MEC can recommend a
Regulation 9 exemption for a restricted
condition (ie: for labelling purposes)
•TGACC can recommend a Regulation 7A(2)
exemption for a restricted condition (ie: for
advertising purposes)
New situation:
• Role of the Complaints Resolution Panel
(CRP) enhanced :
 consider a broader range of
advertisements
 handle anonymous complaints
 consider issues not raised in a
complaint or in a withdrawn complaint
 call for substantiating evidence and
seeking expert advice on it
New situation (cont.):
 withdraw an advertisement’s approval
and require:
- the discontinuance of an
advertisement
- the publication of a retraction or
correction
- the recovery and destruction of
offending advertisements
 two alternate members
 secretariat to make initial enquiries
 report to the TGACC
Current situation:
• Schedule 4 (Regulations) references
clause 4 of the old Advertising Code
New situation:
• All references to clause 4 will be
replaced by clause 5 of the new Code
(ie: includes prohibited and restricted
representations)
Remaining Areas

Overview of advertising arrangements

The Review - New Advertising
Arrangements

Complaints about advertisements of
therapeutic goods

The Approval Process
COMPLAINTS ABOUT
ADVERTISEMENTS
The Complaints Resolution
Panel
Advertisements:
• Mainstream print and
specified media
• Broadcast
• Non-mainstream print
Non-mainstream print
advertisement
Non-prescription and
complementary medicines
PMAA Complaints Panel
CHC Complaints Resolution
Committee (CRC)
Response ???
Chemicals and Non-prescription Medicines Branch
CNPM Co-ordination Unit
Advertising Unit
Recalls Unit
Response ???
Surveillance Unit
Drug Listing Unit
Mainstream print and specified media advertisement
Broadcast advertisement
Non-prescription/ complementary medicine
PMAA
Non-prescription/ complementary medicine
- Approval -
PMAA and CHC
Complaints Resolution Panel (CRP)
Response ???
Secretary/Secretary’s delegate
Chemicals and Non-prescription Medicines Branch
CNPM Co-ordination Unit
Advertising Unit
Recalls Unit
Response ???
Surveillance Unit
Drug Listing Unit
THE FORMAL APPROVAL OF
ADVERTISEMENTS

CHC- print - complementary

PMAA print - OTC & all broadcast

Submit

Script for ad

Listing certificate

Coded/approved indications

Label
Website

May 2000

Code & Glossary

Levels of Evidence

FAQ’s & How to’s

Links