Therapeutic Products Advertising Code

1 Feburary 2005

PREFACE

This Code came into force on 1 February 2005. The Principles and Requirements are modelled on the proposed Australia New Zealand Therapeutic Products Advertising Code (proposed code) which has not yet come into force.

The guidelines and other information in the proposed code will apply to this code where permitted by law. Until the proposed code is introduced the Medicines Act 1981 and Medicines Regulations 1984 will apply. In particular the current restrictions on complementary medicines making therapeutic claims will apply.

The following information has been drawn from the code formulated by the Trans Tasman Harmonisation of Therapeutic Products and services interim council. As a result the numbering is not necessarily consecutive.

Principle 1 - Advertisements must comply with the laws of New Zealand.

Principle 2 - Advertisements must be truthful, balanced and not misleading.
Claims must be valid and have been substantiated.

Principle 3 - Advertisements must observe a high standard of social responsibility.

A6. DEFINITIONS

Therapeutic product

(a)

means:

(i)	a product that is represented in any way to be, or that is, whether because of the way in which the product is presented or for any other reason, likely to be taken to be for therapeutic use;
(ii)	an ingredient or component in the manufacture of a product referred to in subsubparagraph (i) above;
(iii)	a container or part of a container for a product, ingredient or component referred to in subsubparagraphs (i) or (ii) above; or
(iv)	a product falling within a class of products the sole or principal use of which is, or ordinarily is, a therapeutic use; and

(b)

means:

(i)	a product which the law provides shall be treated as a therapeutic product for the purposes of the code; and
(ii)	a product which is declared to be a therapeutic product by statutory authorities

(c)

does not include:

(i)	a product which the law provides shall not be treated as a therapeutic product for the purposes of this code; or
(ii)	a product which is declared not to be a therapeutic product statutory authorities.

Therapeutic use

(a)

means use in or in connection with:

(i)	preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in humans;
(ii)	influencing, inhibiting or modifying a physiological process in humans;
(iii)	testing the susceptibility of humans to a disease or ailment
(iv)	influencing, controlling or preventing conception in humans;
(v)	testing for pregnancy in humans; or
(vi)	the replacement or modification of parts of the anatomy in humans; and

(b)

includes any other use which the law provides shall be treated as a therapeutic use for the purposes of the code; but

(c)

does not include any use which the laws provides shall not be treated as a therapeutic use for the purposes of this code.

PART B1

ADVERTISING MEDICINES TO CONSUMERS

The advertising of all medicines, other than controlled drugs as defined in the Misuse of Drugs Act 1975, directly to consumers is legal in New Zealand. The Researched Medicines Industry Association of New Zealand (RMI) Code of Practice contains additional requirements, which must be taken into account for such advertising.

Requirement 1

Advertisements must not encourage, or be likely to encourage, inappropriate or excessive use.

Requirement 2

Advertisements must contain the mandatory information to encourage responsible use.

Any advertisement for therapeutic products must include all of the required statements in paragraphs (a) to (e), other than where:

•	the advertisement does not contain a therapeutic claim and displays only the:
•	brand/name/picture of the therapeutic products or
•	the name of the sponsor and/or the price and/or point of sale; or
•	the advertisement is an unbranded, or a reminder, or a sponsorship advertisement.

All required statements in paragraphs (a) to (e) must be prominently displayed or communicated, i.e. standing out so as to be easily read from a normal viewing distance, and/or be heard and understood.

For all required statements, other than 'Always read the label', words conveying the same meaning may be used.

(a)

(i)

Advertisements to consumers for medicines must contain:

•

the trade name; and indications consistent with those included in the database of

therapeutic products maintained by the Agency; and

•

where the advertising of prescription medicines is permitted in New Zealand, a list of the active ingredients; and

•

for all medicines, (except for prescription medicines where they may be advertised in New Zealand) the following mandatory statement:

ALWAYS READ THE LABEL

–	and the following statement or words with the same meaning:

USE ONLY AS DIRECTED

–	and the following statement, or words with the same meaning, where relevant to the product i.e. if the indication is for symptomatic relief, or a similar indication.

IF SYMPTOMS PERSIST SEE YOUR HEALTHCARE PROFESSIONAL

(ii)

If the product, 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

(Where a warning reflects the regulatory requirements for the label of the Consumer Medicine Information (CMI), an approval for use of a restricted representation is not required).

Most prescription medicines would be likely to meet the above criteria. Categories of non-prescription medicines which would be likely to meet the above criteria include sedating anti-histamines, pseudoephedrine and non-steroidal anti-inflammatory drugs.

(iii)

Additional mandatory statements based on the scheduling classification of the therapeutic product, as follows:

•	If it is a restricted/pharmacist only medicine (New Zealand) or Schedule 3 and listed in Appendix H, SUSDP (Australia), the words:
YOUR PHARMACIST'S ADVICE IS REQUIRED; or AVAILABLE ONLY FROM YOUR PHARMACIST
•	If it is a Schedule 4 (prescription medicine) able to be advertised in New Zealand:
PRESCRIPTION MEDICINE, CONSULT YOUR DOCTOR [OR OTHER REGISTERED HEALTHCARE PRACTITIONER] TO SEE IF THIS MEDICINE IS RIGHT FOR YOU
•	For New Zealand, if there is a charge for a prescription medicine in excess of the standard prescription fee, this should be indicated, e.g.
A CHARGE APPLIES, CONSULT YOUR DOCTOR OR PHARMACIST

(iv)

Where an advertisement is for the sale or supply of therapeutic products by mail order, direct mail, or the internet, the advertisement must contain, in addition to the above:

•

any mandatory advisory statements required to be included on the product label, prominently displayed on each page that features the relevant therapeutic product/s;

•

if the product, when used according to the directions:

–	has known serious adverse effects (in terms of severity and clinical importance);

–	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

(Where a warning reflects the regulatory requirements for the label of the Consumer Medicine Information (CMI), an approval for use of a restricted representation is not required);

•

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).

(b)

Where the advertising of prescription medicines is permitted (New Zealand), consumers must be notified that additional product information can be obtained, and the methods for doing so. Such information shall include the name and quantities of the active ingredients, authorised uses, appropriate precautions, contra-indications, and adverse reactions. Various acceptable methods include, but are not limited to, instructions for consumers to contact their doctor, pharmacist or health practitioner; referring consumers to the labelling of the product or the Consumer Medicine Information; provision of a toll-free telephone number; the advertiser's internet website address; the advertiser's postal address; reference to the Consumer Medicines Information, where applicable, and referring consumers to advertisements with full information appearing concurrently in other media.

(c)

In addition to the requirements specified above, analgesics require the following statement:

INCORRECT USE COULD BE HARMFUL

An advertisement for analgesics must not represent that:

(a) analgesic consumption is safe; and/or

(b) analgesics will relax, relieve tension, sedate or stimulate.

(d)

An advertisement for vitamins must not represent that vitamin supplements:

•

are a substitute for good nutrition or a balanced diet; and/or

•

are superior to, or more beneficial than, dietary nutrients or that normal health may be affected by not taking vitamin supplements.

(e)

Advertisements for therapeutic products containing claims for weight management, meaning weight loss, measurement reduction, clothing size loss and weight control/maintenance, must have an appropriate balance between those claims and references to healthy energy-controlled diet and physical activity.

Requirement 3

To assist consumers to make informed decisions, advertisements must contain truthful and balanced representations and claims that are valid and have been substantiated and:

a)

for medicines - must be consistent with the indications included on the database of therapeutic products maintained by the Trans Tasman Therapeutic Products Agency; and

b)

for exempt therapeutic products - must be compliant with the Code.

Requirement 4

Advertisements must not directly nor by implication, omission, ambiguity, exaggerated claim or comparison:

(a)

mislead or deceive, or be likely to mislead or deceive; or

(b)

abuse trust, or exploit lack of knowledge; or

(c)

exploit the superstitious or, without justifiable reason, play on fear or cause distress.

R4.1 An advertisement must not:

i)

contain any claim, statement or implication that the products are safe or that their use cannot cause harm or that they have no side effects or risks associated with use;

ii)

contain any claim, statement or implication that the product is effective in all cases of a condition;

iii)

contain any claim, statement or implication that it is infallible, unfailing, magical, miraculous, or that it is a certain, guaranteed or sure cure;

iv)

contain any matter which is likely to lead persons to believe that;

–

they are suffering from a serious ailment, or

–

harmful consequences may result from the therapeutic product not being used.

R4.2 Comparative advertising

Comparative advertising must be balanced and must not be misleading, or likely to be misleading, either about the product advertised or any therapeutic products, or classes of therapeutic products, with which comparison is made.

Comparative advertisements must not be disparaging but must be factual, fair and already substantiated, referenced to the source and reflective of the body of available evidence.

In comparing products, advertisements must not discourage consumers from taking therapeutic products prescribed by a healthcare practitioner.

R4.3 Scientific information

Scientific information within an advertisement must be presented in an accurate manner. 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 in an advertisement must identify the researcher and the financial sponsor of the research.

Requirement 5

Advertisements must not unduly glamorise products or services, or prey on the vulnerability of particular audiences.

Requirement 6

Advertisements may include reference to sponsorship of any government agency, hospital or other facility providing healthcare services, provided that sponsorship is explicitly acknowledged and cannot be misconstrued as an endorsement of a product.

Advertisements may contain or imply an endorsement by individual, or individual groups of, healthcare practitioners in their professional capacity, bodies or associations representing the interests of the health of consumers, conducting or funding medical research or representing health practitioners, provided that the endorsement does not in any way imply endorsement by any government agency, hospital or other facility providing healthcare services. However, 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.

Requirement 7

Testimonials in advertisements, where not prohibited by law, must comply with the Code, be authenticated, genuine, current, typical and acknowledge any valuable consideration.

Requirement 8

Advertisements directed to consumers must not refer directly or by implication to serious diseases, conditions, ailments or defects without approval from the Trans Tasman Therapeutic Products Agency.

PROHIBITIONS

In New Zealand, advertisements for Class A, Class B and Class C controlled drugs other than Exempted Controlled Drugs, as defined in the Misuse of Drugs Act 1975, may only be directed to healthcare practitioners and in appropriate media.

PART B2

ADVERTISING MEDICAL DEVICES TO CONSUMERS

Requirement 1
Advertisements must not encourage, or be likely to encourage, inappropriate or excessive use.

Requirement 2
Advertisements must contain the mandatory information to encourage responsible use.

Any advertisement for therapeutic products must include all of the required statements in paragraphs (a) to (e), other than where:

•

the advertisement does not contain a therapeutic claim or intended purpose for use and displays only the brand/name/picture of the therapeutic products and/or the price and/or point of sale; or

•

the advertisement is an unbranded, or a reminder, or a sponsorship advertisement.

•

All required statements in paragraph (a) must 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.

(a)

Advertisements to consumers for medical devices must contain the following statements:

•

the trade name;

•

the intended purpose consistent with that included in the database of therapeutic products maintained by the Agency. [Until 2007, where there is no intended purpose on the database, the purpose must be consistent with the manufacturer's intended purpose for use]; and

•

the following mandatory statement (except where the advertisement is for a health service or treatment program that includes a reference to the use or administration of a particular device as part of that service or treatment):

ALWAYS READ THE LABEL

and/or, where appropriate,

FOLLOW THE INSTRUCTIONS (or words to that effect)

If the medical device has contraindications or specific warnings that may affect the safe use of the device, which are reflected in the regulatory requirements for the product label or in the patient information, an appropriate warning must be given.

Requirement 3

To assist consumers to make informed decisions, advertisements must contain truthful and balanced representations and claims that are valid and have been substantiated and:

a)

for medical devices - must be consistent with the manufacturer's intended purposes included on the database for therapeutic products maintained by the Trans Tasman Therapeutic Products Agency; and

b)

for exempt therapeutic products - must be compliant with the Code.

Requirement 4

Advertisements must not directly nor by implication, omission, ambiguity, exaggerated claim or comparison:

(a)

mislead or deceive, or be likely to mislead or deceive; or

(b)

abuse trust, or exploit lack of knowledge; or

(c)

exploit the superstitious or, without justifiable reason, play on fear or cause distress.

R4.1 An advertisement must not:

i)

contain any claim, statement or implication that the products are safe or that their use cannot cause harm or that they have no side effects or risks associated with use;

ii)

contain any claim, statement or implication that the product is effective in all cases of a condition;

iii)

contain any claim, statement or implication that it is infallible, unfailing, magical, miraculous, or that it is a certain, guaranteed or sure cure;

iv)

contain any matter which is likely to lead persons to believe that;

–

they are suffering from a serious ailment, or

–

harmful consequences may result from the therapeutic product not being used.

R4.2 Comparative advertising

Comparative advertisements must not be disparaging but must be factual, fair and already substantiated, referenced to the source and reflective of the body of available evidence.

In comparing products, advertisements for medical devices must only make comparisons between products with a similar intended purpose of use.

R4.3 Scientific information

Publication of research results in an advertisement must identify the researcher and the financial sponsor of the research.

Requirement 5

Advertisements must not unduly glamorise products or services, or prey on the vulnerability of particular audiences.

Requirement 6

Requirement 7

Testimonials in advertisements, where not prohibited by law, must comply with the Code, be authenticated, genuine, current, typical and acknowledge any valuable consideration.

Requirement 8

Advertisements directed to consumers must not refer directly or by implication to medical devices, or procedures involving medical devices, that are intended to be used and/or administered solely by healthcare practitioners, without approval from the Trans Tasman Therapeutic Products Agency.

PART B3

ADVERTISING DIRECTED TO HEALTHCARE PRACTITIONERS

Preface
The Advertising Principles and relevant Advertising Requirements included in this part of the Code apply specifically to advertisements for therapeutic products that are directed to healthcare practitioners.

PART A of the Code applies to the advertising of therapeutic products directed both to consumers and to healthcare practitioners.

All advertising directed to healthcare practitioners must encourage the responsible and quality use of therapeutic products. Because healthcare practitioners have expert and professional knowledge in their relevant fields, and are able to discriminate between information of value and advertising hyperbole, not all of the Advertising Requirements in Sections B1 and B2 (i.e. advertising directed to consumers) apply.

The following requirements for advertising to healthcare practitioners have been developed jointly by the relevant industry associations in Australia and New Zealand with reference to their existing codes of practice. These requirements will continue to be reflected in the industry association codes. Where applicable, the requirements are the same as those for advertising to consumers.

While the Australia New Zealand Therapeutic Products Advertising Code sets the minimum standard for advertising requirements, additional requirements may be applied to particular industry sectors through the industry association codes. These additional requirements can be found in the individual industry association codes, which also provide additional guidance on the application of these requirements.

Requirement 1
Advertisements must not encourage, or be likely to encourage, inappropriate or excessive use.

Requirement 2
Advertisements must contain the mandatory information to ensure responsible use.

Requirement 3
Advertisements must contain truthful and balanced representations and claims that are valid and have been substantiated, and:

(a)

for medicines:

must be consistent with the approved Product Information, or other substantiation of efficacy provided by the sponsor to the Trans Tasman Therapeutic Products Agency;

(b)

for medical devices:

must be consistent with the manufacturer's intended purposes, included on the database for therapeutic products maintained by the Trans Tasman Therapeutic Products Agency; and

(c)

for exempt therapeutic products:

must be compliant with the Australia New Zealand Therapeutic Products Advertising Code.

Requirement 4

Advertisements must not directly nor by implication, omission, ambiguity or comparison mislead or deceive, or be likely to mislead or deceive.

Claims and representations made in advertisements must be truthful and have been substantiated.

R4.1 An advertisement must not:

i)

contain any claim, statement or implication that the products are safe or that their use cannot cause harm or that they have no side effects or risks associated with use;

ii)

contain any claim, statement or implication that it is effective in all cases of a condition;

iii)

contain any claim, statement or implication that it is infallible, unfailing, magical, miraculous, or that it is a certain, guaranteed or sure cure;

R4.2 Comparative advertising

Comparative advertisements must not be disparaging but must be factual, fair and already substantiated, referenced to the source and reflective of the body of available evidence.

R4.3 Substantiating Data

Any information used to support a claim must include sufficient detail, and be of adequate quality, to allow evaluation of the validity of results and hence of the claim.

Requirement 5

Advertisements must not unduly glamorize products or services.

Requirement 6

Requirement 7

Testimonials in advertisements, where not prohibited by law, must comply with the Code, be authenticated, genuine, current, typical and acknowledge any valuable consideration. The use of testimonials in advertisements to promote therapeutic products is acceptable, provided the testimonial:

•

is genuine;

•

complies with the Code;

•

is current;

•

has been authenticated; and

•

presents the typical case, not the exceptional.

"Current" means that the content of a testimonial must be up to date and hold true at the time of the publication of the advertisement.

"Typical" means that which reflects the characteristics of a group. i.e. 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.

The following Advertising Requirement is applicable only to advertising directed to healthcare practitioners

Requirement 9 (medicines)

All communications made by company representatives must comply with the Code. Where the product being advertised is a finished product, therapeutic claims for unlicensed products and unapproved indications must not be made, unless the product is exempt from product licensing.

Whenever a therapeutic claim is made for a product for which the sponsor is required to hold a product licence, a company representative must offer the approved PI, or other data used by the sponsor as the basis for obtaining the product licence for the product.

Whenever a therapeutic claim is made for:

•

an active ingredient that may be used in the manufacture of therapeutic products; or

•

a product which is exempt from product licensing;

the data used by the supplier to verify the claim must be offered by the company representative. Advertisements directed to healthcare practitioners for extemporaneously compounded therapeutic products (as finished goods which are exempt from product licensing) are required to comply with the Code.

Requirement 9 (medical devices)

The representation of medical devices/diagnostics included on the database for therapeutic products maintained by the Trans Tasman Therapeutic Products Agency must be consistent with the manufacturer's intended purposes and be consistent with the essential principles for the product.

When requested, the representative must be able to supply a copy of the sponsor's product information consistent with the manufacturer's intended purpose and essential principles.

Claims outside the manufacturer's intended purpose and essential principles must not be made.

For non-therapeutic claims the sponsor must hold substantiating data to support the claims.

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