TAPS Prevetting System

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1. Background

The Therapeutic Advertising Pre-vetting System (TAPS) was established by the Association of New Zealand Advertisers (ANZA) in 1999 to assist advertisers, advertising agencies and the media to comply with the Advertising Standards Authority (ASA) Advertising Codes of Practice for therapeutic products and services.

The ASA Codes require that advertising of therapeutic products and services be conducted in a manner that demonstrates a high standard of social responsibility and does not mislead or deceive the consumer.

By ensuring honest, ethical and responsible therapeutic advertising, the ASA seeks:

· To ensure the consumer is fully informed and protected;

· To improve the overall standard of therapeutic advertising;

· To engender maximum support from Government and related organisations and thereby;

· To retain the legal right to promote therapeutic products directly to end-consumers.

ANZA administers TAPS on behalf of the industry to provide a robust mechanism for all therapeutic advertising to be pre-vetted for compliance with the relevant codes and regulations prior to being accepted for placement by the media. In so doing, ANZA seeks:

· To ensure a consistent standard of compliance with the relevant codes and regulations by all advertisers and across all media.

· To provide advertisers with an efficient, fair and high quality means of pre-vetting advertisements at minimum cost.

· To support the principles of responsible industry self-regulation of advertisers

2. Scope of TAPS

2.1 Therapeutic Products

Therapeutic goods and services or any goods or services which claim a therapeutic purpose as defined by section 4 of the Medicines Act 1981 and in particular are medicines, medical devices, medical treatments, herbal remedies, antiseptics, traditional remedies, and will include dietary supplements, vitamins and mineral supplements, sun-screens and any other product for which a therapeutic purpose is claimed.

2.2 Therapeutic Advertising

Any advertisement that makes a therapeutic claim, such as the product:

· Treats or prevents disease

· Diagnoses or determines the extent or existence of a disease

· Improves health or improves or strengthens function

· Reduces symptoms

· Interferes with the normal operation of a physiological function

· Effects contraception

· Induces anesthesia

· Alters the shape, structure size or weight of the human body

· Cleaning, soaking or lubricating contact lenses

· Or promotes any medical product, service or provider

2.3 Relevant Codes and Regulations


Includes the Advertising Standards Authority Codes of Practice and the Codes for Therapeutic Products Advertising and Therapeutics Services Advertising in particular, Medicines Act 1981 (and amendments) and its accompanying regulations, all other relevant industry Code of Ethics, Acts of Parliament and/or Regulations, and agreements with the Ministry of Health as to required information and methods of presentation.

Therapeutic Products Advertising Code: www.asa.co.nz/code_therapeutic_products.php

Therapeutic Services Advertising Code: www.asa.co.nz/code_therapeutic_services.php

3 TAPS Administration

3.1 Role of ANZA


TAPS is administered by ANZA as the representative of the major therapeutic advertisers in New Zealand. In this role, ANZA is responsible for:

Approval Authorities

· Appointment contract with the TAPS Adjudicator

· Appointment contract with the Alternate Adjudicator

· Maintaining a register of Delegated Authorities (See 3.2 below)

Finances

· Approving applications from organisations wishing to use the TAPS service

· Invoicing and collecting payments from organisations using the TAPS service

· Paying the Adjudicator (or Alternate) for jobs completed and invoiced. Non-recoverable expenses (training, travel, meetings) are also paid by ANZA.

Effectiveness

· Briefing and consulting the Adjudicator on all industry matters

· Organising training and reviews of Delegated Authorities

· Organising and chairing the annual Therapeutic Advertising Pre-vetting System Code Consultative Committee (TAPS CCC) meetings. This Committee is comprised of representatives of major public and private sector organisations. It reviews advertisements recently placed in the media during the months prior, as well as discussing any issues arising and further developments of the Code.

Note: ANZA does not ask for nor receive copies of any advice given to any user of the TAPS service, thereby maintaining the integrity of both TAPS and ANZA.

3.2 TAPS Approval Authorities

The Adjudicator
An appropriately qualified individual serves as Adjudicator for a defined term. The Adjudicator has responsibility for the pre-vetting of all therapeutic advertisements before they are placed with the media. This requires an independent and impartial assessment of compliance with the relevant codes and regulations. The Adjudicator generally has experience in pharmaceutical marketing and has the ability to provide high quality advice and direction.

Alternate Adjudicator
An appropriately qualified person serves as an Alternate when the Adjudicator is unable to provide the pre-vetting service for any significant period of time. Regular users are notified of these occasions. If there is any concern over availability of the Adjudicator, users of the service should contact ANZA to confirm arrangements.

Delegated Authorities
A TAPS Delegated Authority (DA) is someone within either an advertiser or media organisation who is authorised to assess compliance of a limited range of advertisements with the relevant codes and regulations and give formal approval accordingly. Note: To minimise conflicts of interest, employees of, or consultants to, advertising agencies are not accepted as DAs.

4 TAPS Approval Process

4.1 Accessing the Adjudicator Service

First-time Users:
Companies wishing to place therapeutic advertisements in the media must open an account with ANZA prior to seeking TAPS approvals from the Adjudicator. This is done by completing and returning the TAPS Registration Form. Click here to download the TAPS Registration Form.

Registered Users:
ANZA members or past users of TAPS are automatically registered and may contact the Adjudicator direct.

When an advertisement is submitted for approval, it must be accompanied by a TAPS Pre-vetting Form ( click here to download the form), and be dispatched to the Adjudicator as follows:

Finished Commercials: DVD, mpegs or hyperlinks and accurate script.

Scripts and Concepts: Copy of scripts or layouts at any stage, reduced if necessary.

Print and Outdoor: Copy of proof of finished artwork, reduced if necessary.

Point-of-Sale: Copy or proof of finished artwork, reduced if necessary.

4.2 New Concepts
The Adjudicator assesses all new concept advertisements, whether they are for print, outdoor, radio, cinema, internet or television. (In addition, the Adjudicator assesses any other advertisement which cannot be approved by a registered DA).

4.3 Pre-Production Approvals
For all TV, radio and cinema campaigns, advertisers are recommended to obtain the Adjudicator's advice at concept, script and production stages. A concept Approval is given before production. This preempts any possible contraventions of the relevant codes and regulations and avoids the substantial costs of having a completed campaign rejected.

4.4 Point-of-Sale
Only major point-of-sale displays need to be sent to the Adjudicator. These are ones which are linked to media campaigns. All other point-of-sale and promotional items can be pre-vetted by DAs.

4.5 Timeframes for Approvals
Three working days are to be allowed for normal approvals. Lengthy infomercials may require additional time. It is essential to give 24 hours' notice by phone when urgent approvals are required.

TAPS Adjudicator office hours are 9am to 5pm Monday to Friday. For urgent approvals outside these hours, prior arrangements must be made with the Adjudicator.

Urgent advertisement approvals necessitated by an unforeseen event or external announcement must be submitted to the Adjudicator after first making contact by telephone. If the Adjudicator is not immediately available, advertisements may be directed to ANZA in the first instance.

4.6 Notification of Adjudicator Approvals
When an advertisement complies, the Adjudicator grants approval for it to be placed with the media. Approval is formally advised by email and is evidenced by a TAPS approval form containing the unique approval code for the advertisement. The approval details the following:

· TAPS job reference number

· Advertisement title

· Client

· Product

· Adjudicator's signature and unique TAPS approval code

Note: All advertisements appearing in print media and approved by a TAPS Adjudicator (or Delegated Authority) should carry the prefix TAPS before every key number.

4.7 Disclaimer
ANZA and the Adjudicator do not accept liability for any loss of any nature howsoever arising out of or consequent upon the pre-vetting of any advertisement under the TAPS system. It remains at all times the sole responsibility of the advertiser and its advertising agency to ensure that the advertisement complies in all respects with all relevant codes and regulations.

5. Delegated Authorities

With advertisements that are uncontentious, a registered Delegated Authority (DA) can authorize approvals in-house. The primary advantages of this are speed of decision-making and reduced compliance costs. Having DAs within a number of organisations also serves to build knowledge and familiarity with the relevant codes and regulations, and compliance procedures.

5.1 DA Authority Limits

Organisations can choose to gain approvals from a DA for 'uncontentious' advertisements. These are defined as:

· An already approved advertisement having a straightforward modification made to it (e.g. change of price; change of pack; adaptation of creative if the resulting change is insignificant; sales promotion where permissible).

· A new campaign that is very much 'in the mould' of already-approved advertising.

· Small classified advertisements for professional services within the health arena.

· Minor point-of-sale displays and promotional items (i.e. ones which are NOT linked to a media campaign).

· Advertisements in the medical media (i.e. they're targeting a qualified audience)

· Advertisements for low-risk products e.g. anti-dandruff shampoos.

· Advertisements for products or categories which have been specifically authorised by the Adjudicator for approval by a DA.

If there is any doubt that an advertisement fits the above criteria, it should always be referred to the Adjudicator.

5.2 Qualifications for DA Nomination
Only advertisers and media organisations may apply to have an appropriately qualified executive appointed as a DA. The nominated individual should have:

· Experience in pharmaceutical or natural health/dietary supplement advertising;

· A good understanding of the relevant codes and regulations;

· A good understanding of the need for consistent compliance;

· An independent role within the organization (such as Medical Director, Compliance Officer etc)

· The ability to provide high quality judgments, advice and direction.

5.3 Nomination Procedure

· Organisations wishing to register a DA must complete and return the Delegated Authority Registration Form (obtainable from ANZA)

· The proposed DA is considered by representatives from ANZA and TAPS.

· Upon payment of the DA registration fee, ANZA issues the DA with a unique TAPS approval number which the media will recognise as belonging to that individual.

5.4 Changing DAs
An organisation can apply to change their in-house DA at any time by:

· Advising ANZA that the current DA is to be deregistered.

· Completing and returning a new Delegated Authority Registration Application (obtainable from ANZA).

· The new DA should undergo the DA training required by TAPS.

. 5.5 Training and Support
Once approved, the DA receives initial briefing and training from the TAPS DA committee. Every DA receives at least one additional refresher course per annum. These are conducted by the ASA and TAPS Adjudicator.

The DA is also able and encouraged to obtain advice from the TAPS Adjudicator, at any time, free of charge for a short telephone conversation. A charge may apply to advice that is complex and lengthy.

5.6 Day-to-Day Responsibilities
The DA is responsible for:

· Assessing whether 'uncontentious advertisements' comply with the relevant codes and regulations.

· When an advertisement complies, granting approval for it to be placed with the media. This is evidenced by an Advertisement Approval Form Note: No one other than the approved/registered DA is entitled to use that number in approving an advertisement.

· Establishing a register of decisions made with sequential numbers and dates.

· Maintaining an annual file of advertisements approved, with the register number attached. This needs to be available for spot checks if required.

· Being familiar with key decisions of the Advertising Standards Complaints Board (ASCB). These are available on the ASA website www.asa.co.nz and are updated regularly.

6. The Media's Role

6.1 Media Clearance
TAPS procedures do not alter the pre-clearance requirements of media bodies. Therapeutic advertisements must be submitted for pre-publication or pre-broadcast approval as required.

For all TV, radio and cinema campaigns, advertisers are also recommended to obtain advice from these pre-clearance authorities at concept, script and production stages.

6.2 Media Concerns
Occasionally a TAPS-approved advertisement might cause some concern to the media. If so, the following course of action should be taken:

· If the advertisement has been approved by the TAPS Adjudicator, the media should discuss the concern with the Adjudicator (at no charge for a brief consultation).

· If the advertisement has been approved by a DA, the media should first discuss the concern with the DA and if still not resolved, ask the Adjudicator to rule (at no charge for a brief consultation).

Note: When the Media requires a longer consultation (i.e. more than 5 minutes) or a written opinion from the Adjudicator, standard charges for these services do apply.

6.3 Limits of Authority
If a Media DA is asked to approve an advertisement which does not entirely fit within the 'uncontentious' category, or in some other way is beyond the DA's expertise, the DA should:

· Discuss marginal calls with the Adjudicator (no charge for a brief consultation), or

· Formally refer the advertisement to the Adjudicator (a charge will apply).

6.4 Ultimate Responsibility
Ultimately, the media running the advertisement has to take responsibility. If concerns aren't resolved, then placement of the advertisement should possibly be reconsidered.

7. Complaints Against Therapeutic Advertising

Any member of the public who considers there's been a breach of the Advertising Codes of Practice may complain to the Advertising Standards Complaints Board (ASCB) .

Established by the ASA, the ASCB is an independent body that will seek comments from all interested parties and then adjudicate on the complaint.

If the complaint is upheld, then the advertiser, advertising agency and media are, in accordance with self-regulatory principles, requested to voluntarily withdraw the advertisement. This request is invariably followed.

The ASCB's decisions set precedents for the Adjudicator and DAs to observe in granting subsequent approvals.

Executive summaries of the most recently published decisions are found on the ASA's website www.asa.co.nz

1. 8. TAPS User Costs

8.1 TAPS Approvals

TAPS is a user-pays service. ANZA invoices each Advertiser for using the Adjudicator at the following rates effective 1 May 2013:

· ANZA Members: $75.00 + GST per quarter hour

· Non-ANZA Members: $115.00 + GST per quarter hour

Note:

1. For first time users a minimum 30 minute charge applies for the initial adjudication.

2. Approvals by Delegated Authorities are not charged by ANZA.

8.2 Terms

· If a purchase order number is required prior to approval work commencing, media and Advertising Agencies, acting on behalf of their clients, must ensure that their clients issue a purchase order number for the TAPS service or alternatively, issue their own purchase order number.

· Invoices are issued by ANZA during the first week of the month following completion of the pre-vetting job. Payment is due by 20th the month following the date of invoice.

· ANZA reserves the right to require organisations to settle overdue accounts prior to commencing any new approval work.

8.3 DA Registration Costs

Organisations registering a DA pay an annual registration fee to ANZA:

· ANZA member companies with 1 DA $ 500.00 + GST. Additional DAs $150.00 + GST per DA

· Non ANZA Member companies with 1 DA $ 650.00 + GST. Additional DAs $150.00 + GST per DA

This fee funds administration, training and evaluation expenses

For further information on TAPS, please contact:

ANZA

Email: anza@anza.co.nz

Phone: +64 9 488 7455


Attached Files