key areas to be covered l overview of advertising arrangements l the review - new advertising...

Key Areas to be Covered Key Areas to be Covered

Overview of advertising arrangements The Review - New Advertising

Arrangements The Approval Process Complaints about advertisements of

therapeutic goods



therapeutic goods

Advertising - What and to Whom?

Advertising - What and to Whom?

Consumers Unscheduled, S2, some S3 and devices

Healthcare professionals Entire spectrum

Consumers Unscheduled, S2, some S3 and devices

Healthcare professionals Entire spectrum

The LegislationThe Legislation

Trade Practices Act Broadcasting Services Act Therapeutic Goods Act and Regulations

Trade Practices Act Broadcasting Services Act Therapeutic Goods Act and Regulations

The Trade Practices Act 1974The 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

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

The Broadcasting Services Act 1992

Advertisements relating to medicines Delegation of approval function

PMAA since 1991

Advertisements relating to medicines Delegation of approval function

PMAA since 1991

The Therapeutic Goods Act 1989

The Therapeutic Goods Act 1989

Major legislative control Uniformity across States and Territories ARTG Parts of TGAC incorporated

Major legislative control Uniformity across States and Territories ARTG Parts of TGAC incorporated

How to identify therapeutic goods

How to identify therapeutic goods

Therapeutic claims Product Categories

Listable AUST L Registrable AUST R Exempt

Therapeutic claims Product Categories

Listable AUST L Registrable AUST R Exempt

Definition of AdvertisementDefinition 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

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 40018 December 1997Amendment 400

18 December 1997 Defining the TGACC

Complaints Resolution Panel

Defining the TGACC

Complaints Resolution Panel

Amendment 400 - AdvertisingAmendment 400 - Advertising

Definining mainstream media Formal approval - approval number Responsibility of sponsor/advertiser Responsibility of publishers (42D)

Definining mainstream media Formal approval - approval number Responsibility of sponsor/advertiser Responsibility of publishers (42D)

The Therapeutic Goods Advertising Code Council

today

The Therapeutic Goods Advertising Code Council

today Manufacturing and supply Industry Advertisers Healthcare professionals Consumers Government Observers

Manufacturing and supply Industry Advertisers Healthcare professionals Consumers Government Observers

Formal Approval of Advertisements

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

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

Members Consumers Healthcare professionals Government Industry

Complaints about print advertisements No similar mechanism for broadcast ads

Self-regulatory ArrangementsSelf-regulatory Arrangements

Non-mainstream advertising Industry bridges the gap

CRC of CHC Complaints Panel of PMAA

Non-mainstream advertising Industry bridges the gap

CRC of CHC Complaints Panel of PMAA

SummarySummary

3 Main pieces of legislation Therapeutic Goods Act and Regs TGACC and CRP Formal approval legislated Approval delegated to Industry

3 Main pieces of legislation Therapeutic Goods Act and Regs TGACC and CRP Formal approval legislated Approval delegated to Industry

Key Areas Key Areas



therapeutic goods



therapeutic goods

NEW ADVERTISING ARRANGEMENTS

NEW ADVERTISING ARRANGEMENTS

Areas to Be CoveredAreas to Be Covered Overview of reform process The new Therapeutic Goods Advertising

Code “The Guidelines” Overview of regulatory reforms

Overview of reform process The new Therapeutic Goods Advertising


The ReviewReforms Since 1998

The ReviewReforms 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

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 CodeAgreement 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

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

The Broader Context of the Review

Office of Complementary Medicines Elevating the status of CMEC Major reform of ELF

Office of Complementary Medicines Elevating the status of CMEC Major reform of ELF

Objectives of the ReviewObjectives 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

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)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

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 ProcessThe Review Process

TGACC to oversee the Review Task Force:

CHC, CMEC, CHF, PMAA, TGA, APMA ASM’s

TGACC to oversee the Review Task Force:

CHC, CMEC, CHF, PMAA, TGA, APMA ASM’s

Guidelines for Levels of Evidence

Guidelines for Levels of Evidence

Sponsors required to hold evidence - April 99 amendment

Need for guidance indentified CMEC and Working Party developed

guidelines

Sponsors required to hold evidence - April 99 amendment

Need for guidance indentified CMEC and Working Party developed

guidelines

SummarySummary 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

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 ProgressTracking Progress Overview of reform process The new Therapeutic Goods

Advertising Code “The Guidelines” Overview of regulatory reforms

Overview of reform process The new Therapeutic Goods

Advertising Code “The Guidelines” Overview of regulatory reforms

Rationale - OutcomesRationale - Outcomes

Clean sheet Principle based Open to interpretation - flexible Evergreen Consistency across all media Reflect current social values

Clean sheet Principle based Open to interpretation - flexible Evergreen Consistency across all media Reflect current social values

Clause 1- Object of the CodeClause 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

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 - DefinitionsClause 2 - Definitions

Advertisement Label Mainstream media Healthcare professional (Appendix 2) Sponsor Therapeutic goods and therapeutic use

Advertisement Label Mainstream media Healthcare professional (Appendix 2) Sponsor Therapeutic goods and therapeutic use

Clause 3 - Compliance and Application

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

Compliance with TPA, Therapeutic Goods Act and other legislation

Consumer ads - entire Code applies Healthcare professional ads (Appendix

2) - industry codes

Clause 3 (contd)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)

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 - PrinciplesClause 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- 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 (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 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)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

(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 5Appendix 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

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

Clause 4.2 - Scientific Information

Accurate, balanced, not misleading Appropriate terminology, readily

understood Research results to identify researcher

or sponsor

Accurate, balanced, not misleading Appropriate terminology, readily

understood Research results to identify researcher

or sponsor

Clause 4.3Comparative Advertising

Clause 4.3Comparative Advertising

Balanced, not misleading Factual, reflect body of scientific

evidence Competitor product harmful or

ineffectual

Balanced, not misleading Factual, reflect body of scientific

evidence Competitor product harmful or

ineffectual

Clause 4.4 - Professional Recommendation

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 4.4.1- endorsement not permissible by: government agency or healthcare

professional except for availability - place and price

Clause 4.4.2 - Endorsement Permitted

Clause 4.4.2 - Endorsement Permitted

Bodies or associations, under certain conditions: body or association named authenticated nature disclosed valuable consideration disclosed

Bodies or associations, under certain conditions: body or association named authenticated nature disclosed valuable consideration disclosed

Clause 4.5 - TestimonialsClause 4.5 - Testimonials

Must not breach Code Documented, genuine, not misleading Exceptional cases not depicted as

typical

Must not breach Code Documented, genuine, not misleading Exceptional cases not depicted as

typical

Clause 4.6 - SamplesClause 4.6 - Samples

Advertisements may not contain offer of sample

Advertisements may not contain offer of sample

Clause 5 - ProhibitionsClause 5 - Prohibitions

Clause 5.1 No references allowed: Appendix 6 Part 1:

Abortifacient action Neoplastic disease STD’s HIV/AIDS Mental illness

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 & Appendix 6

Clause 5.2 Restricted representations References allowed on prior approval

from TGA Appendix 6 Part 2:

Table 1: Serious manifestations of diseases

Clause 5.2 Restricted representations References allowed on prior approval

from TGA Appendix 6 Part 2:

Table 1: Serious manifestations of diseases

“Serious” Defined“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

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

Permissible Representations - The Glossary

Examples of currently permissible representations

New representations added in future

Examples of currently permissible representations

New representations added in future

Clause 6 - Minimum Requirements

Clause 6 - Minimum Requirements

Clause 6.1 Ads of unbranded therapeutic goods

Only 6.2 (b) applies (plus rest of Code)

Clause 6.1 Ads of unbranded therapeutic goods

Only 6.2 (b) applies (plus rest of Code)

Clause 6 - branded adsClause 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’

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 CategoriesClause 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 7.1 - 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 - VitaminsClause 7.2 - Vitamins

Not permissible: vitamins a substitute for good nutrition or

balance diet, or superior to or more beneficial than dietary

nutrients

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

Appendix 4 - Appeals and Complaints

Non-approval - mechanism for appeal Complaints about advertisements

Non-approval - mechanism for appeal Complaints about advertisements

Tracking ProgressTracking Progress Overview of reform process The new Therapeutic Goods Advertising


Overview of reform process The new Therapeutic Goods Advertising


Tracking ProgressTracking Progress Overview of reform process The new TGAC “The Guidelines” Overview of regulatory reforms

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

Guidelines for the Levels and Kinds of Evidence to

Support Claims for Therapeutic Goods

Principles: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

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 TypesClaim 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.

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

Kinds of evidence which may support claims

Scientific evidence

Evidence based on traditional use

Scientific evidence

Evidence based on traditional use

Claims based on Scientific Evidence

Claims based on Scientific Evidence

Scientific evidenceScientific evidence

Categorised as:

Primary- High

- Medium

- General

Non-primary ( supporting evidence)

Categorised as:

Primary- High

- Medium

- General

Non-primary ( supporting evidence)

Claims based on Scientific EvidenceClaims based on Scientific Evidence

High

Medium

General

High

Medium

General

High level claims - scientificHigh level claims - scientific

Treats/cures/manages

Prevents

Vitamin and mineral deficiency diseases

All claims referring to serious diseases/disorders

Treats/cures/manages

Prevents

Vitamin and mineral deficiency diseases

All claims referring to serious diseases/disorders

Medium level claims - scientificMedium level claims - scientific

Health enhancement

Risk Reduction

Symptomatic relief of named (non-serious) diseases/disorders

Health enhancement

Risk Reduction

Symptomatic relief of named (non-serious) diseases/disorders

General level claims - scientificGeneral level claims - scientific

Health maintenance

Nutritional support

Vitamin or mineral supplementation

Relief of symptoms

Health maintenance

Nutritional support

Vitamin or mineral supplementation

Relief of symptoms

Claims based on Evidence of Traditional Use

Claims based on Evidence of Traditional Use

Evidence of Traditional UseEvidence of Traditional Use

Medium level - need medium level evidence

General level - need general level evidence

Medium level - need medium level evidence

General level - need general level evidence

General level scientific evidence

General level scientific evidence

Descriptive studies or reports of relevant expert committees

Texts such as approved Pharmacopoeias/ monographs or other evidence based texts

Descriptive studies or reports of relevant expert committees

Texts such as approved Pharmacopoeias/ monographs or other evidence based texts

Medium level scientific evidenceMedium 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.

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 evidenceHigh 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.

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

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

One of TGA approved Pharmacopoeia/Monograph 3 independent written histories of use in



Medium level traditional evidenceMedium level traditional evidence

Two of TGA approved Pharmacopoeia TGA approved Monograph 3 independent written histories of use in



Two of TGA approved Pharmacopoeia TGA approved Monograph 3 independent written histories of use in



Tracking ProgressTracking Progress



Overview of Regulatory ReformsOverview of Regulatory Reforms

Current situation:• Non-mainstream advertisements -

comply with specified parts of the Code• Mainstream print and Broadcast

advertisements - comply with the entire CodeNew 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


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 memberssecretariat 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 AreasRemaining Areas


Arrangements Complaints about advertisements of

therapeutic goods The Approval Process


Arrangements Complaints about advertisements of

therapeutic goods The Approval Process

COMPLAINTS ABOUT ADVERTISEMENTS

COMPLAINTS ABOUT ADVERTISEMENTS

•Mainstream print and specified media

•Broadcast•Non-mainstream print

Advertisements:

Response ???

Non-mainstream print advertisement

Non-prescription and complementary medicines

PMAA Complaints Panel CHC Complaints Resolution Committee (CRC)

Chemicals and Non-prescription Medicines Branch

CNPM Co-ordination Unit

Recalls UnitAdvertising Unit Drug Listing Unit

Surveillance Unit

Response ???

Non-prescription/ complementary medicine

Broadcast advertisement

Non-prescription/ complementary medicine

- Approval -


PMAA PMAA and CHC

Response ???

Mainstream print and specified media advertisement

Secretary/Secretary’s delegate

Chemicals and Non-prescription Medicines Branch

CNPM Co-ordination Unit

Recalls UnitAdvertising Unit Drug Listing Unit

Surveillance Unit

Response ???

THE FORMAL APPROVAL OF ADVERTISEMENTS

THE FORMAL APPROVAL OF ADVERTISEMENTS

CHC- print - complementary PMAA print - OTC & all broadcast Submit

Script for ad Listing certificate Coded/approved indications Label

CHC- print - complementary PMAA print - OTC & all broadcast Submit

Script for ad Listing certificate Coded/approved indications Label

WebsiteWebsite

May 2000 Code & Glossary Levels of Evidence FAQ’s & How to’s Links

May 2000 Code & Glossary Levels of Evidence FAQ’s & How to’s Links

key areas to be covered l overview of advertising arrangements l the review - new advertising...

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