Therapeutic
Goods Act 1989
Therapeutic Goods
Advertising Code 2006
I,
Christopher Pyne, Parliamentary Secretary to the Minister for Health and Ageing
for the purposes of the exercise of the Minister’s powers under subsection 3(1)
of the Therapeutic Goods Act 1989 and acting under that subsection,
hereby:
1) REVOKE the Therapeutic
Goods Advertising Code 2005; (the superseded Code) and;
2) REPLACE the
superseded Code with the Therapeutic Goods Advertising Code 2006.
The
Therapeutic Goods Advertising Code 2006 commences on the day after it is
registered in the Federal Register of Legislative Instruments.
Dated
this 9th day of July 2006
Christopher
Pyne
Parliamentary
Secretary to the Minister for Health and Ageing
Therapeutic Goods Act 1989
Therapeutic Goods Advertising Code 2006
______________________________________________________________________
1
Object
of the Code
(1) The Object of
the Therapeutic Goods Advertising Code 2006 (the Code) is to ensure that the
marketing and advertising of therapeutic goods to consumers is conducted in a
manner that promotes the quality use of therapeutic goods, is socially
responsible and does not mislead or deceive the consumer.
(2) The Code is
generally consistent with the World Health Organisation (WHO): Ethical
Criteria For Medicinal Drug Promotion 1988 (refer Appendix 1). In
the event of any inconsistency between the Code and the WHO criteria, the Code
prevails.
(3) In
interpreting the Code, emphasis will be placed on the Object and the Principles
of the Code and the total presentation and context of the advertisement.
2
Definitions
Advertisement in relation
to therapeutic goods as defined in the Therapeutic
Goods Act
1989 includes
any statement, pictorial representation or design, however made, that is
intended, whether directly or indirectly, to promote the use or supply of the
goods”.
Broadcast media in relation to an
advertisement or generic information, means any means (other than a means
declared in the Therapeutic Goods Regulations to be an exempted means) by which
the information is disseminated electronically in a visible or audible form or
a combination of such forms.
Healthcare Professional includes a person that
meets the description of a healthcare professional in subsection 42AA(1), (2),
(3) of the Therapeutic Goods Act 1989 (see Appendix 2) and any other
person represented directly or indirectly to be a healthcare professional.
Label in relation to
therapeutic goods, means a display of printed information:
(a)
on
or attached to the goods; or
(b)
on
or attached to a container or primary pack in which the goods are
supplied;
or
(c)
supplied
with such a container or pack.
Mainstream media means any magazine or
newspaper for consumers containing a range of news, public interest items,
advertorials, advertisements or competitions.
Specified media in relation to an
advertisement or generic information, means:
(a)
mainstream
media, within the meaning of s.42B of the Act; or
(b)
broadcast
media, within the meaning of s.42B of the Act; or
(c)
cinematograph
films; or
(d)
displays
about goods, including posters:
(i) in shopping malls
(except inside individual shops);
(ii)
in or on public transport; and
(iii)
on billboards.
Sponsor in relation to
therapeutic goods, means:
(a)
a
person who exports, or arranges the exportation of, the goods from
Australia; or
(b)
a
person who imports, or arranges the importation of, the goods into
Australia; or
(c)
a
person who, in Australia, manufactures the
goods, or arranges for
another
person to manufacture the goods, for supply (whether in
Australia or elsewhere);
but does not include a
person who:
(d)
exports,
imports or manufactures the goods; or
(e)
arranges
the exportation, importation or manufacture of the
goods;
on behalf of another person who, at the time of the exportation, importation,
manufacture or arrangements, is a resident of, or is carrying on business in, Australia.
Therapeutic
goods are defined in the Therapeutic Goods Act 1989
as goods:
(a)
that
are represented in any way to be, or that are, whether because of the way in
which the goods are presented or for any other reason, likely to be taken to
be:
(i)
for
therapeutic use; or
(ii)
for
use as an ingredient or component in the manufacture of therapeutic goods; or
(iii)
for
use as a container or part of a container for goods of the kind referred to in
subparagraph (i) or (ii); or
(b)
included
in a class of goods the sole or principal use of which is, or ordinarily is, a
therapeutic use or a use of a kind referred to in subparagraph (a) (ii) or
(iii);
and includes medical
devices and goods declared to be therapeutic goods under an order in force
under section 7, but does not include:
(c)
goods
declared not to be therapeutic goods under an order of force under section 7;
or
(d)
goods
in respect of which an order is in force, being an order that declares the
goods not to be therapeutic goods when used, advertised or presented for supply
in the way specified in the order where the goods are used, advertised or
presented for supply in that way; or
(e)
goods
(other than goods declared to be therapeutic goods under an order in force under
section 7) for which there is a prescribed standard in the Australia New
Zealand Food Standards Code as defined in subsection 3(1) of the Australia
New Zealand Food Authority Act 1991; or
(f)
goods
which, in Australia or New
Zealand,
have a tradition of use as foods for humans in the form in which they are
presented.
Therapeutic Goods
Advertising Code Council - means the broadly representative body of peak
stakeholder groups, established in the Regulations to the Therapeutic Goods
Act 1989 to:
Therapeutic use is defined in the Therapeutic
Goods Act 1989 as meaning use in or in connection with:
(a)
preventing, diagnosing, curing or alleviating a disease, ailment,
defect or injury in persons or animals; or
(b)
influencing, inhibiting or modifying a physiological process in
persons or animals; or
(c)
testing the susceptibility of persons or animals to a disease or
ailment; or
(d)
influencing, controlling or preventing conception in persons; or
(e)
testing for pregnancy in persons; or
(f)
the replacement or modification of parts of the anatomy in persons
or animals.
Typical means that
which reflects the characteristic of a group ie. a result obtained from
the use of a product which would be likely to be attained by most people using
the product within the audience to which the advertisement is directed.
3
Compliance
with, and application of, the Code
(1) All
advertisements for therapeutic goods are subject to the Therapeutic Goods
Act 1989 and Therapeutic Goods Regulations, the Trade Practices Act 1974
and other relevant laws. Compliance with this Code does not exempt
advertisements from the application of those laws.
(a) Advertisements
for therapeutic goods directed to consumers must comply with the Code.
(b) Advertisements
for therapeutic goods directed exclusively to healthcare professionals are
governed by industry codes of practice and are not subject to this Code. (Appendix
2 refers).
(c) This Code
does not apply to bona fide news, public interest or entertainment programs.
(2) The
conformity of an advertisement with this Code should be assessed in terms of
its probable impact upon the reasonable person to whom the advertisement is
directed.
(3) Advertisements
for therapeutic goods appearing in specified and broadcast media must be
approved by the appropriate Advertising Services Manager for compliance with
the Code (Appendix 3 refers) prior to publication or broadcast, other
than:
(a) therapeutic devices,
and
(b) advertisements
for those therapeutic goods that may be advertised and which display only name,
picture and/or price and /or point of sale, without therapeutic claims.
(4) Appeals and
complaints shall be dealt with as set out in Appendix 4.
4
General
Principles
(1) An
advertisement for therapeutic goods must:
(a) comply with
the statute and common law of the Commonwealth, States and Territories; and
(b) contain
correct and balanced statements only and claims which the sponsor has already
verified.
(2) An
advertisement for therapeutic goods must not:
(a) be likely to
arouse unwarranted and unrealistic expectations of product effectiveness;
(b) be likely to
lead to consumers self-diagnosing or inappropriately treating potentially
serious diseases;
(c) mislead, or
be likely to mislead, directly or by implication or through emphasis,
comparisons, contrasts or omissions;
(d) abuse the
trust or exploit the lack of knowledge of consumers or contain language which
could bring about fear or distress;
(e) contain any
matter which is likely to lead persons to believe:
(i)
that
they are suffering from a serious ailment; or
(ii) that harmful
consequences may result from the therapeutic good not being used.
Sunscreen preparations
are exempted from (ii) if the claims made in the advertisement are consistent
with current public health messages.
(f) encourage, or
be likely to encourage, inappropriate or excessive use;
(g) contain any
claim, statement or implication that it is infallible, unfailing, magical,
miraculous, or that it is a certain, guaranteed or sure cure;
(h) contain any
claim, statement or implication that it is effective in all cases of a
condition;
(i)
contain
any claim, statement or implication that the goods are safe or that their use
cannot cause harm or that they have no side-effects; or
(j) be directed
to minors, except the therapeutic goods listed in Appendix 5.
(3) Incentives to pharmacy
assistants and other non-healthcare professional sales persons
(4) Scientific
Information
Any scientific
information in an advertisement should be presented in a manner that is
accurate, balanced and not misleading. Scientific terminology must be
appropriate, clearly communicated and able to be readily understood by the
audience to whom it is directed. Publication of research results must identify
the researcher and financial sponsor of the research.
(5) Comparative
Advertising
Comparative advertisements must be balanced and
must not be misleading or likely to be misleading, either about the therapeutic
goods advertised or the therapeutic goods, or classes of therapeutic goods,
with which it is compared. Points of comparison should be factual and reflect
the body of scientific evidence. Comparisons should not imply that the
therapeutic goods, or classes of therapeutic goods, with which comparison is
made, are harmful or ineffectual.
(6) Professional
Recommendation
(a) Advertisements
may include reference to sponsorship of any government agency, hospital or
other facility providing healthcare services, provided that sponsorship is
explicitly acknowledged and is not presented as an endorsement of a therapeutic
good.
(b) Advertisements
may contain or imply an endorsement by individual, or individual groups of,
healthcare professionals in their professional capacity, bodies or associations
representing the interests of the health of consumers, conducting or funding
medical research or representing healthcare professionals, provided that the
endorsement does not imply endorsement by any government agency, hospital or
other facility providing healthcare services.
Such endorsements must
have prior consent from the endorser, be authenticated and the advertisement must
contain, prominently displayed, the name of the endorser and acknowledgement of
any valuable consideration.
(7) Testimonials
Testimonials
must not breach the Code. They must be documented, genuine, not misleading and
illustrate typical cases only.
(8) Samples
An
advertisement for therapeutic goods (other than therapeutic devices and sun
screening preparations) must not contain an offer of a sample.
5
Prohibitions
(1)
An advertisement for therapeutic goods must not contain,
expressly or by implication, a representation specified in Part 1 of Appendix 6.
(2)
An advertisement for therapeutic goods must not refer,
expressly or by implication, to serious forms of diseases, conditions,
ailments or defects specified in Part 2 of Appendix 6, unless prior approval is
given under the Therapeutic Goods Act 1989.
6
Minimum
Requirements
(1) This section,
other than paragraph (3)(b), does not apply to:
(a) advertisements
for unbranded therapeutic goods; or
(b) labels.
(2) This section
does not apply to retail advertisements displaying only the name/picture of the
goods and/or price and/or the point of sale, provided the advertisement does
not contain a claim for therapeutic use.
(3) An
advertisement for therapeutic goods shall contain:
(a) the trade
name of the goods;
(b) a reference
to the approved/permitted indication(s) for the use of the goods; and
(c) where
applicable, a list of ingredients or the following statement prominently
displayed or communicated, i.e. standing out so as to be easily read from a
normal viewing distance, and/or heard and understood:
ALWAYS READ THE LABEL
except:
(i) in
the case of direct marketing and Internet marketing, which must contain:
·
a full list of the active ingredients. (Where the product name is
also the single active ingredient, the pack shot displaying the product name
will be sufficient to meet this requirement); and
·
the mandatory warning statements prominently displayed on each
page of the catalogue or internet that features therapeutic goods; and
·
any mandatory advisory statements required to be included on
the product label, prominently displayed on each page that features the
relevant medicine/s; and
·
if the medicine, when used according to the directions:
-
has known serious adverse effects (in terms of severity and
clinical importance); or
-
is contraindicated for a known group of people because it
could cause serious adverse effects which are reflected in the regulatory
requirements on the label or in the Consumer Medicine Information (CMI);
an appropriate warning
of those effects must be given, prominently displayed on each page that features
the relevant medicine/s”; and
(ii) radio
commercials which are 15 seconds or less.
(d) words to the
following effect, prominently displayed or communicated, i.e. standing out so
as to be easily read from a normal viewing distance, and/or heard and
understood:
USE ONLY AS DIRECTED
and, in all
advertisements other than radio commercials that are 15 seconds or less, for
claims relating to symptoms of diseases or conditions,
IF SYMPTOMS PERSIST SEE
YOUR DOCTOR/HEALTHCARE PROFESSIONAL
(e) or, in the
case of Schedule 3 therapeutic goods listed in Appendix H of the Standard
for the Uniform Scheduling of Drugs and Poisons, words to the effect of -
YOUR PHARMACIST’S ADVICE IS REQUIRED; and
(f) in the case
of therapeutic goods that are able to be lawfully advertised and are available
only directly from, or on the recommendation of, a health professional (except
in the case of S2 and S3), the following statements should be prominently
displayed or communicated, i.e. standing out so as to be easily read from a
normal viewing distance, and/or heard and understood:
YOUR [APPROPRIATE
HEALTHCARE PROFESSIONAL] WILL ADVISE YOU WHETHER THIS PREPARATION [PRODUCT
NAME] IS SUITABLE FOR YOU/YOUR CONDITION.
(4) Print media
advertisements for therapeutic goods must include the approval number which is
to stand alone, be prominently displayed and located in the bottom right hand
corner of the advertisements.
7
Specific
Categories
(1) Analgesics
(a)
Analgesics
are those preparations for internal use containing one or more of the following
substances intended for the relief of minor aches and pains:
(i) salicylic acid, its
salts, its derivatives (including aspirin) and their salts;
(ii) codeine;
(iii) other
non-steroidal anti-inflammatory drugs; or
(iv) paracetamol.
(b)
This
excludes preparations for internal use in self-limiting conditions and which
contain an analgesic in combination with one or more other active ingredients
such as cough mixtures and cold tablets.
(c)
An
advertisement for analgesics (other than product labels and radio
advertisements which are 15 seconds or less) must contain the following warning
statement, prominently displayed or communicated i.e. standing out so as to be
easily read from a normal viewing distance, and/or heard and understood:
“Use only as
directed. Incorrect use could be harmful. Consult your healthcare
professional if symptoms persist”
(d)
Radio
advertisements which are 15 seconds or less must include the following:
“Always read the label.
Use only as directed by a healthcare professional”
(e)
An
advertisement for analgesics must not imply that:
(i) analgesic
consumption is safe; or
(ii) analgesics will
relax, relieve tension, sedate or stimulate.
(2) Vitamins
An advertisement for
vitamins shall not imply that vitamin supplements:
(a) are a
substitute for good nutrition or a balanced diet; or
(b) are in any
way superior to or more beneficial than dietary nutrients or that normal health
may be affected by not taking vitamin supplements.
(3) Weight
management
Appendix 1
(Subsection 1(2) refers)
World Health Organisation (WHO): Ethical
Criteria For Medicinal Drug Promotion 1988
WHO's
Ethical Criteria for Medicinal Drug Promotion 1988 are underpinned by
the following main principles, cited verbatim:
(a) Promotion refers to
all informational activities by manufacturers and distributors, the effect of
which is to induce the prescription, supply, purchase and/or use of medicinal
products.
(b) All
promotion-making claims concerning medicinal drugs should be reliable,
accurate, truthful, informative, balanced, up-to-date, capable of
substantiation and in good taste. They should not contain misleading or
unverifiable statements or omissions likely to induce medically unjustifiable
drug use or give rise to undue risks.
(c) Comparison of
products should be factual, fair and capable of substantiation.
(d) Advertisements
to the general public should help people to make rational decisions on the use
of drugs determined to be legally available without prescription. While they
should take into account people's legitimate desire for information regarding
their health, they should not take undue advantage of people's concern for
their health, nor mislead the consumer into unwisely relying on medicines to
solve physical, emotional or mood problems.
(e) The provision
of free samples to the general public for promotional purposes is difficult to
justify from a health perspective.
(f) Advertisements
may claim that a drug can cure, prevent or relieve an ailment only if this can
be substantiated.
(g) Language
which brings fear or distress should not be used.
(h) Advertisements
should not be allowed for certain serious conditions that can be treated only
by qualified health practitioners.
Appendix 2
(Section 2 – Definitions – Healthcare Professional and
Subsection 3(1)(b) refer)
Section 42AA of the Therapeutic Goods Act 1989
42AA This Part not to apply to advertisements directed at
health professionals etc.
(1) This Part does not apply to advertisements
directed exclusively to:
(a) medical
practitioners, psychologists, dentists, veterinary surgeons,
pharmacists,
physiotherapists, dietitians, scientists working in medical laboratories or
nurses; or
(b) persons who are:
(i) engaged in the business of
wholesaling therapeutic goods; or
(ii) purchasing officers in
hospitals; or
(c) herbalists,
homoeopathic practitioners, chiropractors, naturopaths,
nutritionists,
practitioners of traditional Chinese medicine, podiatrists or osteopaths
registered under a law of a State or Territory.
(2) This
Part does not apply to advertisements directed exclusively to persons who are
members of an Australian branch (however described) of one of the bodies prescribed
for the purposes of this subsection.
(3) For
the purposes of subsection (2), a person is taken to be a member
of an Australian
branch of one of those bodies if, and only if, the person has the
qualifications and training that are necessary or appropriate for membership of
the relevant body.
(4) This Part
does not apply to advice or information given directly to a patient by a person
referred to in paragraph (1)(a) or (c) or paragraph (2) above in the course of
treatment of that patient.
Refer to Schedule 1 of
the Regulations for a full list of bodies currently covered by subsection 42AA(2).
Appendix 3
(Subsection 3(3) refers)
Approval
of mainstream advertisements
Advertisements
for complementary healthcare products (other than devices) in specified media,
other than broadcast media and cinematograph films are required under the
Therapeutic Goods Act and Regulations to be submitted to:
Advertising
Services
Complementary
Healthcare Council
PO Box 104
DEAKIN
WEST ACT 2600
Ph:
(02) 9542 5860
Fax:
(02) 6260 4122
Email:
advertising@chc.org.au
Advertisements
for complementary healthcare products advertised in broadcast media or
cinematograph films, and all other therapeutic goods (other than devices) advertised
in specified media, are required under the Therapeutic Goods Act 1989
and Regulations to be submitted to:
Advertising
Services
PO Box 764
NORTH SYDNEY NSW 2059
(Suite 2202
Level
22, 141
Walker Street
NORTH SYDNEY NSW
2060)
Ph:
(02) 9955 7205
Fax:
(02) 9957 6204
All specified media advertisements, other than broadcast
media advertisements, for therapeutic goods must display the current approval
number allocated to that advertisement as required under s.42C(4)(b) of the Therapeutic
Goods Act 1989.
Minimum
Requirements for the Submission of Advertisements
1. Typed copy
(no smaller than 10 point), black copy on white background.
2. Draft layout
or clear description of layout
3. For TVC’s,
copy of script with storyboard
4. For radio,
copy of script to include sound-effect descriptions
5. Copy of
appropriate documentation
A –
Certificate of Listing/Registration
B – Label (enlarged for
legibility)
C – Approved indications
of use (where applicable)
D – Copy of any
research/surveys/data referenced in advertisement (note –
further evidence to be
provided if requested).
E – Copy of
documentation supporting professional recommendations and testimonials [note:
further evidence to be provided if requested]
Note:
1. Substantiation
of therapeutic claims to be provided upon request
2. Substantiation,
in line with levels of evidence required to be held by the sponsor at the time
of listing or registration, may be required by the advertising services manager
3. Notwithstanding
the above, further substantiation may also be requested
4. Listing or
registration of a claim does not automatically mean that the claim may
be advertised
Appendix 4
(Subsection 3(4) refers)
Appeals and Complaints Mechanisms
Review of a decision not to approve an
advertisement
In
the event of an advertisement not gaining approval, a request to review the
decision must be submitted to the Minister for
Health & Ageing (refer Regulation 5M).
The
request must be made within 30 days after notice of the decision.
For a decision not to
approve a print media advertisement, the applicant must, at the same time, send
a copy of the request to the Therapeutic Goods Advertising Code Council.
Complaints about advertisements (refer Part 6, Division 3 of
the Therapeutic Goods Regulations)
A
person may complain in writing to the Complaints Resolution Panel about an
advertisement for a designated therapeutic good or therapeutic device that is
published or inserted in specified media that the person believes to be in
breach of the Therapeutic Goods Advertising Code (TGAC) or the Therapeutic
Goods Act 1989 or Regulations (refer Regulation 42ZCAB).
Complaints
about other advertisements must be directed to the appropriate industry
association, i.e. CHC for complementary medicines and ASMI for
non-complementary OTC medicines.
Appendix 5
(Paragraph 4(2)(j) refers)
Goods that may be advertised to minors
In considering whether or
not to make a recommendation to the Secretary to amend Appendix 5 so as to
permit therapeutic goods to be advertised to persons under the age of 18, the
TGACC will satisfy itself on the following factors (which are not exhaustive):
1. That the likely
audience could be expected to have the knowledge and maturity to self-diagnose
and self-manage the condition(s) for which the goods are to be advertised;
2. That the advertising
of the goods to the likely audience could reasonably be expected to deliver to
them significant health benefits or significant improvements to their quality
of life;
3. That the risk of
over-use, misuse or inappropriate use in the likely audience is insignificant;
4. That over-use, misuse
or inappropriate use of the goods is unlikely to cause significant harm;
5. That the advertising
of the goods can be confined to the intended audience.
The
following are not subject to paragraph 4(2)(j) -
·
Tampons
·
Acne
preparations
·
Sunscreens
SPF 15 +
·
Condoms
and personal lubricants
·
Bandages
and dressings
·
Devices
for management of chronic conditions under medical supervision
·
Cold
sore preparations
·
Lip
balm
·
Unscheduled
anti-dandruff preparations
Appendix 6
(Section 5 refers)
Prohibited, Restricted and Permissible
Representations
Part 1 – Prohibited Representations
A
prohibited representation is defined as:
(i) Any
representation regarding abortifacient action
(ii)
Any representation regarding the treatment, cure or prevention of the following
diseases:
·
Neoplastic
·
Sexually
Transmitted Diseases (STD)
·
HIV
AIDS and/or HCV
Except for the following representations which are to become restricted
representations:
(i) prevention of skin
cancer through the use of sunscreens
(ii) devices used in
contraception or in the prevention of transmission of disease between persons
Part 2 – Restricted Representations
An advertisement for therapeutic goods
may refer, expressly or by implication, to a disease, condition, ailment or
defect specified in Table 1, provided that prior approval is obtained for such a reference. Approval may be
obtained from the TGA, upon recommendation from the TGACC and appropriate
expert committee or committees.
Table 1. Diseases, conditions, ailments
and defects for which the advertising of serious forms is restricted
·
Diseases of the
liver, biliary system or pancreas
·
Endocrine diseases
and conditions including diabetes and prostatic disease
·
Gastrointestinal
diseases or disorders
·
Metabolic disorders
·
Musculo-skeletal
diseases
Serious in the context of this table will mean
forms of those diseases, conditions, ailments or defects which are:
·
Generally
accepted not to be appropriate to be diagnosed and/or treated without
consulting a suitably qualified healthcare professional, and/or
·
Generally
accepted to be beyond the ability of the average consumer to evaluate
accurately and to treat safely without regular supervision by a qualified
healthcare professional.
Public interest criteria
to be applied by TGACC
In
considering an application for approval to include in an advertisement a
reference to a disease, condition, ailment or defect specified in Part 2 of Appendix 6, the Secretary must consult the TGACC. In making a recommendation to
the Secretary, the TGACC must take into account:
1.
Consumers’, or certain groups of consumers’, vulnerability
when faced with the disease, condition, ailment or defect;
2. Whether the
reference would be likely to result in consumers not seeking timely
professional advice where appropriate (such as where timely professional advice
is important to prevent negative health consequences or irrevocable
deterioration or progression of disease);
3. Whether the
reference would be likely (alone or through repetition or together with other
references) to have a negative impact on public health (or to have an effect on
persons other than those to whom the advertisement is directed); and
4. Such other
aspects of the public interest as may appear to be appropriate.
5. The World
Health Organization notes that responsible self-medication can:
·
Help
prevent and treat symptoms and ailments that do not require medical
consultation;
·
Reduce
the increasing pressure on medical services for the relief of minor ailments,
especially when financial and human resources are limited;
·
Increase
the availability of health care to populations living in rural or remote areas
where access to medical advice may be difficult; and
·
Enable
patients to control their own chronic conditions.
Additional Note: If this were
to apply to products that require prescribing following initial diagnosis, the
Code would apply to the advertising of such products.