Direct-to-Consumer
Advertising of Prescription
Medicines in New ZealandConsultation document

Citation: Ministry of Health. 2006. Direct-to-Consumer Advertising of Prescription
Medicines in New Zealand: Consultation document. Wellington: Ministry of Health.
Published in March 2006 by the
Ministry of Health
PO Box 5013, Wellington, New ZealandISBN 0-478-29909-5
ISBN 0-478-29910-9
HP 4212This document is available on the Ministry of Health’s website:
http://www.moh.govt.nz

Foreword
New Zealand and the United States are the only industrialised countries that allow
direct-to-consumer advertising of prescription medicines (DTCA).1 New Zealand andUnited States citizens view DTCA via the mainstream media, as well as through a rangeof ‘patient education’ promotional activities. Like all other forms of advertising, the aimof DTCA is to increase sales, although some would argue that the purpose of this kindof advertising is to educate consumers about diseases, allowing patients to participate
in decisions concerning their health care.2
The policy debate on DTCA has raised questions about the impact of DTCA on
individual and public health outcomes in terms of:• provision of pharmaceutical information to consumers• overall health care costs• the appropriate use of pharmaceuticals• the patient–doctor relationship.
DTCA policy in New Zealand is a contentious issue, and the adequacy of the current
legislative and self-regulatory controls governing DTCA in New Zealand is a matter ofpublic debate. DTCA in New Zealand is currently regulated under the Medicines Act
1981 and Medicines Regulations 1984 (outlined on pages 4-5). The Therapeutic
Products Bill is set to repeal this legislation with the establishment of the Australia New
Zealand Therapeutic Products Authority (‘the Therapeutic Products Authority’) (seepages 12-14).
Regardless of the decision on the future regulation of DTCA in New Zealand, it is
proposed that the Australia New Zealand Therapeutic Products Advertising Code(outlined on pages 13-14) come into force under the Therapeutic Products Authority.
Currently, the Therapeutic Products Advertising Code allows DTCA to continue in New
Zealand, albeit with more stringent regulation than under the Medicines Act currently.
For the purpose of clarity, the regulation of DTCA under the Therapeutic Products
Advertising Code should be considered as the status quo, to provide the benchmark
against which the other options for DTCA regulation may be measured.
The purpose of this document is to review the policy debate on DTCA as it relates to
New Zealand. The policy debate provided is not exhaustive but brings together themain issues and findings. The document outlines the current policy for DTCA, alongwith the Therapeutic Products Advertising Code, and provides three options for the
regulation of DTCA, which form a basis for comment by interested individuals andagencies on the future of DTCA in New Zealand.

1

2

For the purposes of this document, ‘DTCA’ will refer to direct-to-consumer advertising of prescription
medicines.
Pharmaceutical Research and Manufacturers Association, ‘Direct-to-consumer advertisingstrengthens our health care system’. URL: http://www.phrma.org/publications/quickfacts//2002-1004.581.pdf.

Direct-to-Consumer Advertising of Prescription Medicines in New Zealandiii

Following consultation on this document, the Ministry of Health will be providing advice
to the Government on policy options for the regulation of DTCA in New Zealand in the
future.

iv

Direct-to-Consumer Advertising of Prescription Medicines in New ZealandDirect-to-Consumer Advertising of Prescription Medicines in New Zealandv

How to Have Your Say
Make a submission
The Ministry of Health encourages you to make a submission, outlining your views on
DTCA and how it should be regulated in New Zealand. A number of questions are
posed throughout the document to help focus your responses.
Please forward only one copy of your submission to:
DTCA consultation
Sector Policy Directorate
Ministry of Health
PO Box 5013
WELLINGTON
Email: DTCA_consultation@moh.govt.nz
Fax: (04) 496 2340
All submissions are due by 5 pm, Friday 28 April 2006.
If you require additional copies of this document, you can print them out from thepublications section of the Ministry of Health website: www.moh.govt.nz
The Ministry of Health will consider the arguments and views outlined in submissions
when developing advice to the Government on policy options for the regulation of DTCA
in New Zealand in the future.
The Ministry of Health is interested in any comment you may have on any aspect of the
DTCA consultation document but is particularly interested in your views on theregulation of DTCA in New Zealand. It would help the analysis of submissions if yourcomments were referenced to either the specific questions raised throughout thisdocument or to the relevant section of this document. To assist you in making asubmission, the questions raised throughout the document are summarised below:
1.

Are you concerned about DTCA in New Zealand?
OR
Are you supportive of DTCA in New Zealand?

2.

Does your concern about or support for DTCA relate to:• the quality use of prescription medicines• the provision of consumer information to maximise public health and safety• practicable and cost-effective regulation• appropriate and proper standards for prescription medicine advertising• other issues? If so, what?

3.

Which of the arguments outlined in Section 5, ‘The Cases For and Against DTCA’,
do you find most persuasive: those for or against DTCA? Why?

vi

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand4.

Do you have any further information or arguments that you consider should be
added to this review of the evidence that supports or opposes DTCA? If so,please forward this information to the Ministry of Health.

5.

Which of the options outlined in Section 6, ‘DTCA Regulatory Options’, do you
support? Why?

6.

What further options, if any, relating to the regulation of DTCA in New Zealand do
you support? Why?

7.

Do you have any other views on how to achieve the purported benefits of DTCA
(eg, consumer access to pharmaceutical information, enhanced doctor-patient
relationship, increased diagnosis of previously untreated conditions), without
experiencing the purported costs of DTCA? If so, please forward these views to
the Ministry of Health.

If you are making a submission on behalf of an organisation, please describe theorganisation and its interest in relation to the regulation of DTCA, identify your position
within the organisation, and indicate the extent of any consultation or discussion you
have undertaken with your organisation. If you are making a submission individually,please indicate the reason for your interest in the regulation of DTCA (eg, as aconsumer, researcher or health practitioner).
Please note that your submission and all correspondence you have with the Ministry
may be the subject of requests under the Official Information Act 1982. If there is any
part of your submission or correspondence that you consider could properly be withheld
under the Act, please include comment to this effect along with reasons why you want
the information withheld. If you are an individual as opposed to an organisation, theMinistry will omit your personal details from the submission if you include the following
statement at the front of your submission and sign it:‘I do not give my permission for my personal details to be released to persons
requesting my submission under the Official Information Act 1982.’

Direct-to-Consumer Advertising of Prescription Medicines in New Zealandvii

Contents
Forewordiii

How to Have Your Say

vi

Make a submissionvi

Introduction

1

Purpose
Policy objectives

1
1

1

2

3

4

5

Prescription Medicine Advertising2

Direct-to-consumer advertising
Disease-state advertising

2
2

DTCA: The New Zealand and Australian Situations and the Roleof Regulation

4

Introduction
New ZealandAustralia
Regulation of advertising under the Australia New Zealand Therapeutic Products Authority(Therapeutic Products Bill)

4
4
10
12

The Cases For and Against DTCA

15

Reported concerns and benefits of DTCA
Provision of information
Fiscal pressures
Medicalisation
Impact on patient–doctor relationships
Section 14 of the New Zealand Bill of Rights Act 1990
Conclusions

15
17
19
21
23
25
26

DTCA Regulatory Options

27

Introduction
Option 1 – Allow DTCA to continue with more stringent regulation
Option 2 – Allow DTCA but with stricter requirements than specified by the Therapeutic
Products Advertising Code
Option 3 – Ban DTCA and regulate disease-state advertising
Considering the options for DTCA

27
30
32
34
36

Appendices
Appendix 1: DTCA – International Situations and the Role of Regulation
Appendix 2: Other Forms of Medicine Advertising

References

viii

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand

37
43
44

List of Tables
Table 1:

Instruments of control over DTCA in the Joint Regulatory Scheme

14

List of Figures
Figure 1:
Figure 2:
Figure 3:

Advertisements by product, 2004
Expenditure on DTCA (Analgesics, Remedies, Medicines), 1999 and 2002–2004
Main decisions in arriving at DTCA policy conclusion

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand

7
8
28

ix

1

Introduction

PurposeThe purpose of this document is to provide a basis for discussion and to encourage
feedback on DTCA policy in New Zealand.
This document:•

provides an explanation of DTCA and other forms of prescription medicine
advertising•

reviews the current advertising policies in New Zealand and Australia (international
positions on DTCA are attached in Appendix 1)•

outlines the proposed advertising arrangements under the Therapeutic Products
Authority•

outlines the main arguments for and against DTCA•

develops and analyses three policy options for the regulation of DTCA in the future.

Policy objectives
The public policy objectives for the regulation of DTCA are to:•ensure the quality use of prescription medicines is maximised•

contribute to the provision of consumer information that is balanced and easily
understood by New Zealanders, to maximise public health and safety•

ensure regulation is as practicable and as cost-effective as possible•

ensure appropriate and proper standards for prescription medicine advertising.

This document is confined to an examination of DTCA of prescription medicines. The
advertising of prescription medicines directly to the public has been the main focus ofconcern and debate about the impact of advertising of health products on healthoutcomes.

Q1. Are you concerned about DTCA in New Zealand?
OR
Are you supportive of DTCA in New Zealand?
Q2. Does your concern about or support for DTCA relate to:• the quality use of prescription medicines• the provision of consumer information to maximise public health and safety• practicable and cost-effective regulation• appropriate and proper standards for prescription medicine advertising• other issues? If so, what?

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand1

2

Prescription Medicine AdvertisingThis section outlines what DTCA and disease-state advertising are. Descriptions ofother forms of medicine advertising are attached in Appendix 2.

Direct-to-consumer advertising
DTCA is the advertising of prescription-only medicines or treatments to consumers.3
DTCA specifically advertises individual branded medicines for a specific condition,
which is what differentiates DTCA from disease-state advertising (described below).
DTCA refers to:• promotional material transmitted via television, radio, magazines and the Internet• a range of ‘patient education promotional activities’ (such as disease-oriented
advertisements, toll-free numbers, information materials distributed by companyfunded organisations, media reports generated by company-sponsored press
conferences, and public meetings).
DTCA differs from all other advertising in two respects. First, consumers must visit aprescriber, usually a general practitioner (GP), to obtain a prescription before obtaining
the product. This requirement provides a ‘gate-keeper’ function as prescribers are
required to assess whether and what prescription medicine is appropriate for a patient,and it also impacts on the cost to the consumer (Calfee 2002). Secondly, DTCA iscontrolled via regulation, as is advertising of other products that have the potential toharm human health (eg, alcohol, tobacco).

Disease-state advertising
Disease-state advertising comprises information that aims to raise awareness regarding
specific diseases and treatments available, without identifying a specific therapeutic
product. Information presented in this form of advertising focuses on encouraging
consumers to seek health care practitioner advice about the diagnosis, treatment or
prevention of a disease or condition. Disease-state advertisements often tellconsumers that there is a therapeutic product available to treat the condition andinclude material that directs consumers to a source for further information. The
information sources recommended by disease-state advertisements often contain
information about individual branded products or specific programmes.

3

2

The Medicines Act 1981 defines ‘advertisement’ broadly to mean ‘any words, whether written, printed,
or spoken, and any pictorial representation or design, used or appearing to be used to promote thesale of medicines or medical devices or the use of any method of treatment; and includes any tradecircular, any label, and any advertisement in a trade journal’.

Direct-to-Consumer Advertising of Prescription Medicines in New ZealandThere are three main kinds of disease-state advertising (Association of New ZealandAdvertisers 2004):•

Unbranded advertising promotes the use or supply of product by inviting theconsumer to seek further information about symptoms or conditions and/or theirtreatment or management while not referring overtly to any particular branded
product. For example: ‘Did you know that there is a new product available forcontrolling {medical condition}? If you are suffering from {symptoms/conditions} ask
your medical practitioner about appropriate treatment options.’•

Generic advertising promotes the benefits of a particular category of therapeutic
products, substance, ingredient or medical device component and is not related toany particular branded product. For example: ‘Have you considered the benefits of{substance}? Recent research has shown that {substance} in combination with
exercise reduces oxidative stress in older adults. Call {phone number} for more
information on products that contain this substance.’•

Disease awareness campaigns comprise information that aims to raise awarenessregarding specific diseases, including public health campaigns. For example: ‘Do
you suffer from {symptoms/conditions}? If so, you could be experiencing {medical
condition} or be at risk of developing {medical condition}. See your medical
practitioner for more information about the diagnosis, treatment or prevention of{medical condition}.’Direct-to-Consumer Advertising of Prescription Medicines in New Zealand3

3

DTCA: The New Zealand and Australian Situations
and the Role of Regulation

Introduction
This section outlines the current systems that operate in New Zealand and Australia
with regard to the regulation of DTCA. It should be noted that the Therapeutic ProductsBill (outlined on pages 12-14) is set to repeal the existing legislation relating toadvertising (outlined below) in both countries.
The explanation of the current arrangements for the regulation of advertising in New
Zealand (provided below) and the arrangements for advertising proposed under the
Therapeutic Products Authority (outlined on pages 12-14) provide the background andcontext for considering DTCA regulation in New Zealand.

New Zealand
The introduction and rapid growth of DTCA in New Zealand was not anticipated; thequick uptake of DTCA in the United States, where it first appeared in the 1980s, may
explain its subsequent appearance in New Zealand. Legislation relating to medical
advertising was drafted before DTCA became commonplace in New Zealand, and theintroduction of the New Zealand Bill of Rights Act in 1990 that explicitly protected
freedom of speech (including commercial speech) also fostered a regulatoryenvironment in which DTCA could develop (Hoek and Gendall 2004). New Zealand has
never explicitly prohibited DTCA.
Medicines Act 1981 and Medicines Regulations 1984
All medical advertising (including DTCA) in New Zealand is currently regulated under
the Medicines Act 1981 and Medicines Regulations 1984.4 This legislation prohibits
false or misleading claims or branding, and endorsements by health practitioners.
The Medicines Act imposes a range of controls on activities relating to the supply of
medicines in New Zealand in order to protect the public. The Medicines Act sets out thesort of information that must and must not be included in an advertisement for a
medicine. Information that must be disclosed in any advertisements includes:• the name of the advertiser• the ingredients and authorised uses of the product• most importantly, information detailing all the contraindications to use andappropriate precautions for using the medicine.

44Medicines Regulation 1984 and Medicines Act 1981 are available on the New Zealand Legislation
website at http://www.legislation.govt.nz

Direct-to-Consumer Advertising of Prescription Medicines in New ZealandCurrently, the penalty provisions in the Medicines Act offer only limited disincentives
against unbalanced or inappropriate DTCA. A successful prosecution will result in afine of up to $500 plus up to $50 per day that a non-conforming advertisement
continues to be disseminated. There are no suitable alternative statutory mechanisms
under which to regulate DTCA. Although the Fair Trading Act 1986 includes
prohibitions against false or misleading representations, it is not designed to regulate
advertising of potentially dangerous substances, such as medicines, which require
specific controls.
The current legislation relating to medical advertising in New Zealand is inconsistent
with the World Health Organization’s (WHO) Ethical Criteria for Medicinal Drug
Promotion 1988 (see Appendix 1), which states that DTCA ‘should not generally bepermitted for prescription medicines or to promote medicines for certain serious
conditions that can be treated only by qualified health practitioners’. However, the WHO
ethical criteria are not legally binding; they are standards that can be used to develop
regulation. It is important to note that in New Zealand, a full prohibition on DTCA may
constitute a limitation on the right to freedom of expression as outlined in section 14 of
the New Zealand Bill of Rights Act. This issue is detailed on page 25.
Regulation of advertising
DTCA is co-regulated in New Zealand. The system relies on legislation and, primarily,
on industry codes of practice. Currently, there is far greater reliance on industry selfregulation, with a major role played by the media and advertising industries in ensuringthat the advertising of therapeutic products is socially responsible. The industry in thiscontext includes pharmaceutical companies and associations, advertisers andpublishers. They have developed a self-regulatory system for ensuring thatadvertisements making therapeutic claims meet standards of social responsibility, as
well as complying with legislative requirements. No formal framework for monitoringand evaluation on the effectiveness of the current advertising model is in place.
The Advertising Standards Authority (ASA) and the Researched Medicines Industry(RMI) administer the self-regulatory component of the co-regulatory model for DTCA.
The ASA has developed a Code for Therapeutic Advertising that covers all
advertisements making therapeutic claims and applies across all media. While New
Zealand Medicines and Medical Devices Safety Authority (Medsafe) is consulted on any
proposed changes to the Code, the Code is not linked to the Medicines Act 1981.
However, the requirements of the Code are broadly consistent with the requirements of
the Act. The principles and requirements of this Code are modelled on the proposed
Australia New Zealand Therapeutic Products Advertising Code, which is intended toreplace the ASA Code when the Therapeutic Products Bill is introduced.5 The ASA is
responsible for:• setting and maintaining appropriate and proper standards for advertising• establishing and promoting an effective self-regulatory system for advertising
standards.

5

Advertising Standards Authority, URL: http://www.asa.co.nz/codes/codes.htm.

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand

5The ASA requires advertisers and publishers who recognise its authority to also abideby the RMI Code of Practice when they are advertising pharmaceuticals. The RMI
Code of Practice contains additional requirements for advertising to those set out in the
ASA Code for Therapeutic Advertising. Membership of the RMI is voluntary and not allpharmaceutical companies are members. However, all pharmaceutical companies canbe required to correct or withdraw an advertisement that does not meet the RMI or ASA
codes of practice, regardless of membership of the RMI.
Pre-publication approval
The Association of New Zealand Advertisers has developed and manages a system of
pre-vetting of advertisements to ensure that they comply with the requirements ofrelevant legislation and the codes of practice administered by the RMI and ASA. Thissystem is known as the Therapeutic Advertising Pre-vetting System (TAPS). Under thissystem, approval of advertisements is undertaken voluntarily by industry, withmainstream media agreeing not to accept an advertisement for publication unless thereis evidence that the advertisement has been pre-approved by TAPS.
The ASA scheme also allows a TAPS approval number to be issued by a DelegatedAuthority within either a media company or a manufacturing company. To obtain a
Delegated Authority the person in the company must be assessed and approved byseveral members within the ASA scheme. The Delegated Authority can then assess
and approve advertisements for publication.
Complaints made to the ASA
The ASA maintains a complaints and appeals system and has the ability to require an
advertisement to be withdrawn if a complaint is upheld. The complaints and appealsboards include independent members of the medical profession and consumer
representatives. The members are selected by the ASA. The scheme is entirely
funded by industry and is essentially voluntary in nature, as the self-regulatory system is
not formally linked to the regulator’s powers (the Medicines Act and Regulations).
TAPS approved 1596 advertisements for therapeutic products during 2004 (seeFigure 1 below). There were 34 complaints under the ASA Code for Therapeutic
Advertising in 2004; three concerned prescription medicines advertised to consumers.
One was a complaint against Pfizer concerning a Celebrex advertisement and wasupheld. The other two complaints were against separate Ministry of Healthadvertisements concerning the meningococcal vaccine. One was upheld and the otherwas not accepted (Advertising Standards Authority 2004).

6

Direct-to-Consumer Advertising of Prescription Medicines in New ZealandExtent of DTCA in New ZealandFigure 1: Advertisements by product, 2004

Other products
14%
Prescription
medicines
36%
Complementary
products
26%

Over-the-counter
medicines
24%
Source: Association of New Zealand Advertisers

For the purposes of this document, only the ‘prescription medicines’ section of Figure 1
should be considered.
In 2004, pharmaceutical companies spent approximately $38 million on DTCA.6 The
figures presented in Figure 2 are for the category ‘Analgesics, Remedies, Medicines’
only, which represents most products involved in DTCA. Note that this category does
not include advertising for products such as Xenical, as it is recorded in the category‘Diet/Slimming, Health Clinics’.

6

Email correspondence with the Association of New Zealand Advertisers, 1 August 2005.

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand7

Figure 2: Expenditure on DTCA (Analgesics, Remedies, Medicines), 1999 and 2002–2004
40

Expenditure ($ millions)

35
30
25
20
15
10
5
0
1999

2002

2003

2004

Source: Association of New Zealand Advertisers

Previous reviews of DTCA policy in New Zealand1998 inquiry
As a result of the growth in DTCA activity, specifically a high-profile advertising
campaign for the anti-obesity drug Xenical, in 1998 the then Minister of Health called for
an inquiry into DTCA. The New Zealand Medical Association and individual healthprofessionals had claimed that these advertisements put pressure on doctors toprescribe inappropriately. An Intercontinental Medical Statistics Health poll of
400 GPs,7 with a 30 percent response rate, found that:•75 percent of respondents either wanted DTCA to stop altogether or to be decreased•

20 percent of respondents wanted the levels of DTCA to remain the same or to be
increased•

61 percent felt DTCA created disharmony in the doctor–patient relationship•62 percent believed it was of no benefit to patients.

As a result of that inquiry, the then Government decided to keep a watching brief on
DTCA in New Zealand and to give the industry an opportunity to demonstrate acommitment to self-regulation (under the Medicines Act 1981).

7

8

As cited in: Mansfield P. Report on DTC pharmaceutical promotion for PHARMAC. URL:
http://healthyskepticism.org/other/dtca/Report%20on%20DTCA%20for%20PHARMAC.doc.

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand2001 public consultation
Public consultation on DTCA was last undertaken in 2001 through a discussion
document issued by the Ministry of Health. The discussion document reviewed theinternational positions on DTCA and provided a range of policy options for the future of
DTCA in New Zealand. Forty-three submissions were received, with an almost evensplit between those in favour of DTCA (18) and those opposed to it (20). All of thepharmaceutical companies (5) and advertising companies (7) who responded to thediscussion document were in favour of DTCA. However, the majority of submissions(77%) received from members of the public, health professionals, educational/researchand other organisations and Pharmac were opposed to DTCA.8 The outcome of thisconsultation was to continue to permit DTCA in New Zealand.

Current consultation
Due to the considerable public and industry interest in DTCA policy and the impending
Therapeutic Products Bill, the Minister of Health has asked the Ministry of Health toundertake further public consultation on the regulation of DTCA in New Zealand. The
Ministry of Health will consider the arguments and views outlined in submissions whenproviding advice to the Government on policy options for the regulation of DTCA in New
Zealand. The timing of this consultation will allow for public debate on the issue of
DTCA and, if required, for any recommended changes to be reflected in the Therapeutic
Products Bill prior to its introduction.

8

A summary of submissions can be found online on the Ministry of Health website, URL:
www.moh.govt.nz.

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand9Australia
In Australia DTCA is prohibited, but disease-state advertising about a particularcondition and general treatments is permitted. As noted above, the Therapeutic
Products Bill is set to repeal existing advertising legislation in Australia. The
Therapeutic Products Advertising Code will not change Australia’s policy towards
DTCA; however, it will tighten restrictions around disease-state advertising.
Current regulation
Medical advertising in Australia is currently regulated under the Therapeutic Goods Act
1989, which prohibits DTCA, but allows disease-state advertising and advertising
directed to health professionals. Therapeutic Advertising is a co-regulatory system inAustralia, with advertisements regulated by the Government and the advertisingindustry. Advertisements for therapeutic goods in Australia are subject to therequirements of the Therapeutic Goods Act 1989, the Trade Practices Act 1974 andother relevant laws. Additionally, advertisements for therapeutic goods directed toconsumers must comply with the Therapeutic Goods Advertising Code, which is
generally consistent with the World Health Organization’s Ethical Criteria for Medicinal
Drug Promotion 1988. The Medicines Australia (previously the Australian
Manufacturers Association) Code of Conduct complements the legislative requirements
laid out in the Therapeutic Goods Act, and requires the promotion of all prescription
products to comply with the requirements of the Code. The object of the Code is toensure that the marketing and advertising of therapeutic products to consumers is
conducted in a manner that promotes the quality use of therapeutic products, is socially
responsible and does not mislead or deceive the consumer.
Australia–United States Free Trade Agreement
The Australia–United States Free Trade Agreement (AUSFTA) came into force on
1 January 2005. The Agreement did not change the Australian prohibition on DTCA.
AUSFTA requires websites advertising pharmaceutical products to comply with the lawof the respective country (eg, Australian websites need to comply with Australian law).
This means Australian websites cannot contain DTCA; however, the Agreement does
allow Australian websites to include links to US sites that contain DTCA provided thereis clear notification of the move from an Australian to a US website.
Previous review of DTCA policy in Australia
In 2001 the Therapeutic Goods Administration (TGA) reviewed Australian legislation on
drugs, poisons and controlled substances, which included reviewing the controls on
DTCA (‘the review’). The review examined a possible liberalisation of Australia’s ban on
DTCA, conducting a cost-benefit analysis of the current Australian restrictions andcomparing this with a cost-benefit analysis of alternatives such as no regulation and coregulation. The review concluded:
The Review could not support a relaxation of the current prohibition that would
result in a situation such as those occurring in the US and New Zealand, whichcannot be assessed as providing a net public benefit, despite some individuals
also being helped (Galbally 2001).

10

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand

The review made the following points in response to the possibility of a relaxation of theadvertising regime in Australia.
•

Should DTCA be permitted, the bulk of the advertising would be for a few new andgenerally high-priced products and for those used to treat some of the more common
serious conditions (as is the case in the US).

•It would be unlikely that Australian manufacturers would advertise older (possibly
cheaper) but still effective alternatives as it would be difficult to build theseadvertising costs into selling prices.

•

The public might place too much credence in the advertisements just because
government had allowed them to be made, with the consequence of a greater
expectation that the health professional will prescribe on request.

•

DTCA of prescription products for Australia is not supported by organisations
representing doctors, pharmacists or veterinarians.

On balance, the review considered that the current prohibition on DTCA of prescription
drugs in Australia should be maintained, except where it could contribute to a net publicbenefit through information rather than promotion. This is a precautionary approach. It
is important to note that the Galbally Review was considering DTCA regulation from theAustralian status quo position of a ban on DTCA. Jurisdictions where DTCA is not
currently permitted commonly require evidence that allowing DTCA would confer a clear
benefit or at least have a neutral impact before change is endorsed.

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand11Regulation of advertising under the Australia New Zealand
Therapeutic Products Authority (Therapeutic Products Bill)
This section provides an overview of the advertising arrangements that will come into
effect under the Therapeutic Products Authority that New Zealand is establishing with
Australia. For the purposes of this document, the arrangements for the regulation ofadvertising outlined below should be viewed as the status quo.
BackgroundOn 10 December 2003, the Agreement between the Government of Australia and theGovernment of New Zealand for the Establishment of a Joint Scheme for the Regulationof Therapeutic Products was signed. The Therapeutic Products Authority will replace
Australia’s Therapeutic Goods Administration (TGA) and the New Zealand Medicines
and Medical Devices Safety Authority (Medsafe).
The role of the new Therapeutic Products Authority will be to safeguard public healththrough regulation of the quality, safety and efficacy or performance of therapeutic
products in both Australia and New Zealand. This includes prescription and over-thecounter medicines, complementary medicines, medical devices, tissue-based therapies
and blood. The new Therapeutic Products Authority will be equally accountable to boththe New Zealand and Australian Governments. It will be recognised in law in bothcountries and will assume responsibility for the regulatory functions undertaken by the
TGA and Medsafe.
Advertising controls
The Therapeutic Products Bill is to repeal the Medicines Act 1981, at which point
advertising controls will be continued and strengthened under the Therapeutic Products
Authority. A proposed trans-Tasman model for regulating the advertising of therapeutic
products has been considered by the Therapeutic Products Interim Ministerial Council.9
The proposed model aims to balance the benefits of consumer access to accurate andbalanced information and the right to freedom of speech, on the one hand, with theneed to ensure public health and safety, on the other.
In keeping with the overall approach to the Joint Regulatory Scheme, the model foradvertising is risk-based. The model provides for a joint approach to regulation thatdraws on and strengthens the co-regulatory model in Australia (medical advertisements
are regulated by the Government and the advertising industry), and preserves theexisting functions of the Advertising Standards Authority in New Zealand.

9

The Therapeutic Products Interim Ministerial Council comprises the New Zealand Minister of Healthand the Australian Parliamentary Secretary of Health and Ageing. The Interim Ministerial Council
oversees the development of the Joint Regulatory Scheme. A Ministerial Council will be establishedonce the Therapeutic Products Bills are passed and the Treaty is ratified.

12

Direct-to-Consumer Advertising of Prescription Medicines in New ZealandConsultation
There was extensive industry consultation in both Australia and New Zealand as part ofthe development of a proposed advertising regulatory model by the Interim Advertising
Council. Three formal rounds of stakeholder consultation were held between July 2003
and October 2004 in Australia and New Zealand to inform the work of the Interim
Advertising Council. TGA, Medsafe and Therapeutic Products Authority websites were
kept up-to-date with Interim Advertising Council activities and proposals, and written
submissions were welcomed throughout the process. Additionally, there were many
informal briefings provided to different stakeholder groups by the TGA and Medsafe ona ‘by invitation’ basis. The Interim Advertising Council considered all issues that were
put forward through the consultation process.
Australia New Zealand Therapeutic Products Advertising CodeThe Australia New Zealand Therapeutic Products Advertising Code is to be applied as
the standard for all advertisements of therapeutic products (directed at consumers andhealth care practitioners), which will be legally underpinned in legislation. The Key
Advertising Principles and the Advertising Requirements are to be set out in the Rules.
Any changes to these principles or requirements will require approval by the Ministerial
Council. The draft Code that has been developed accommodates the status quo ineach country with respect to DTCA. That is, the draft Code recognises that in New
Zealand DTCA is permitted, and in Australia it is not. These different approaches could
continue once the Therapeutic Products Authority is established.
An Advertising Council is proposed to be established as an expert advisory committeethat will provide advice to the Therapeutic Products Authority on the operation of theAdvertising Code for both Australia and New Zealand. The Council will have New
Zealand and Australian representatives. The Council will monitor the effectiveness ofthe processes associated with the controls on therapeutics advertising in Australia and
New Zealand and provide feedback to the Therapeutic Products Authority.
All advertising of therapeutic products (including advertising on the Internet) in Australia
and New Zealand would be required legally to comply with the Therapeutic Products
Advertising Code. Criteria will be established to distinguish between those medicinesthat require pre-approval of advertisements and those that do not. The authority torequire pre-approval of advertisements published in mainstream media will beestablished in the Rules and in the Advertising Code. Currently pre-approval isundertaken voluntarily in New Zealand by industry with advertising media agreeing not
to publish advertisements that are not pre-approved. In New Zealand TAPS willcontinue to pre-approve advertisements. However, delegation will come from the
Therapeutic Products Authority.
Compliance with the Code will be enforced through a range of administrative sanctions,civil penalties and criminal penalties or other regulatory action (eg, suspension orcancellation of licences). The levels of penalties and sanctions for breaches to the Codeare yet to be decided; however, they will be commensurate with the risk posed and likely
to be higher than the current penalties in New Zealand and Australia. Consistentoutcomes for similar offences will be maintained between New Zealand and Australia.

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand13More information on the Therapeutic Products Advertising Code can be found online at:www.jtaproject.com.
Table 1:

Instruments of control over DTCA under the Therapeutic Products Authority

Instrument

PurposeTreaty•Establishes the Ministerial Council.

•

Provides the ability for the Ministerial Council to make rules about advertising
controls.

•

Provides for the establishment of the Therapeutic Products Authority.

•

Establishes the Therapeutic Products Authority Board.

Therapeutic
Products Bill•

Gives effect to the Treaty.

•

Sets out offences, penalties and sanctions across the range of issues in thetherapeutic products area, including DTCA.

Rules

Rules will build on the principles in legislation and provide broadly for thecircumstances in which products are not to be promoted, requirements for thepromotion of products, and representations that are not to be made about
products. Rules will refer to the Therapeutic Products Advertising Code.

Australia New
Zealand
Therapeutic
Products
Advertising CodeSets out the advertising principles and requirements (drawing from theimplementing legislation and the Ministerial Council Rules) and is to be approved
and amended by order of the Managing Director of the Therapeutic Products
Authority on the advice of the Advertising Council. The Therapeutic Products
Advertising Code is detailed and the current draft reflects different policy settings
in New Zealand and Australia with respect to DTCA.

14

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand4

The Cases For and Against DTCA

This section outlines the main arguments used to support and oppose DTCA:• provision of health care information to consumers• increased and unnecessary fiscal pressures on the pharmaceutical budget• medicalisation of normal bodily processes• impact on patient–doctor relationships.
Most of the DTCA debate takes the form of claim and counter-claim rather than being
evidence-based. Consequently, the cases for and against DTCA are inconclusive.

Reported concerns and benefits of DTCA
The Australian Galbally Review (Galbally 2001) provides a useful summary ofcommonly raised concerns and benefits of DTCA.
Concerns identified in regard to DTCA were that it:•leads to inappropriate use of medicines where doctors succumb to patient pressure
to prescribe a particular medicine•

undermines the doctor–patient relationship where patients aggressively demand thata particular product be prescribed or leave the surgery dissatisfied because theproduct was not prescribed•

results in confused or misinformed consumers because they have too little
knowledge about a medical condition or treatment, and the information available toinform them is unbalanced•

generates consumer anxiety through exaggerated promotion of the risk of disease,which may adversely impact on vulnerable populations, such as the uneducated or
those with chronic or severe illness•

leads to wide use of medicines in the community before a population risk profile has
been developed•

leads to acceptance of medicines as ‘life solutions’, to the detriment of better
alternatives, such as diet and exercise (ie, increased medicalisation of society, withan associated increase in risk of medical misadventure)•

results in escalating costs to subsidise medicines and patient visits to doctors,
particularly where consumers are ‘doctor shopping’ in an attempt to find a doctor
prepared to prescribe a particular medicine.

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand15

An alternative perspective on these concerns is that, as a consequence of DTCA:•

some prescribers will react constructively to consumer pressure by ensuring that they
have all of the relevant information about a DTC-advertised medicine and related
condition to inform their prescribing decisions•

the doctor–patient relationship will be improved as a result of increased contact anddiscussion regarding patient health care•earlier knowledge of treatment possibilities will, in some cases, ease anxiety about
disease risk – those with limited education and severe illness may receive simple
accessible information about potential therapy•

medicines will be used to treat conditions earlier and result in better patient outcomes•in some cases, where professional advice would not otherwise be sought, preliminaryawareness and diagnosis by patients will improve therapy by enhancing patientunderstanding and increasing the likelihood that they will present to professionals•

innovation for new medicines will, in some cases, be brought forward.

The above summary demonstrates the range of views held about DTCA. Clearly suchpropositions and counter-propositions have varying degrees of merit. The literature
available does not clearly demonstrate unequivocal evidence of harm or benefit inrelation to DTCA.

16

Direct-to-Consumer Advertising of Prescription Medicines in New ZealandProvision of information
Arguments for and against
The main argument against DTCA is that the fundamental nature and goals ofadvertising make it an inappropriate mechanism for the dissemination of high-quality
information to the general public about high-risk products. All advertising aims to sell a
product, and will always present the product in a positive light as much as possible.
Advertisements will not advise potential consumers that they do not need to take theadvertised product, that a competitor’s products are superior, or that changes in lifestyle
may be more appropriate.
Several trends have emerged in advertisements for prescription medicines including:•lack of balance between benefit and risk
– overstatement of the benefits offered by the product– minimisation of the risk associated with the product•poor presentation of risk data
– printing risk data in very small fonts– oversimplification of risk data
– use of technical language•

absence of cost information.

Critics argue that DTCA does not fully inform patients, which may lead them to form
mistaken perceptions of an advertised medicine’s effects or potential appropriateness.
There is little information provided about potentially unpleasant or serious side effects ofadvertised drugs.
The arguments used to support DTCA centre on the benefits of the provision of
information to consumers that may not otherwise be accessed and its potential to avert
underuse of effective treatments. Increasing numbers of consumers want to play anactive role in the management of their health. Proponents of DTCA argue that itprovides information that prompts consumers to discuss medication issues with theirdoctor and to raise questions about otherwise underdiagnosed or undertreatedconditions.
Comment
There are multiple agencies, including government agencies (eg, Medsafe and thePharmaceutical Management Agency of New Zealand), non-government organisations(eg, the New Zealand Guidelines Group), private companies (eg, pharmaceuticalcompanies), consumer groups and health practitioners, that provide consumers withmedicine and health information. Other avenues by which consumers receive
information include the media, Internet, family and friends. The relationships among
these organisations, institutions and individuals and the way information is provided tohealth practitioners and consumers will influence the information consumers receive.

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand17

There is little doubt that the format and method of dissemination used for DTCA make itvery difficult for an advertiser to provide all of the risk and benefit data necessary for
consumers to make informed decisions about which medicines might be appropriate forthem. It is unclear whether there was ever an expectation that DTCA would or could
fulfil the purpose of fully informing the public. It should be noted that the final decision
about the appropriateness of a prescription medicine lies with the prescriber, not thepatient, and prescribers are professionally accountable for their prescribing decisions.
Research indicates that most consumers view their GP as their primary source of
reliable medicines information. Pharmacists are identified as a second preferred sourceof information, partly because the advice is free, and also because the information
provided is considered to be reliable. In a recent study, information from medical andhealth professionals was preferred over that from advertisements, friends and family as
it was associated with reliability and accuracy. Concerns expressed about othersources of information such as advertisements, friends and family were based on
uncertainty about the accuracy of the information and the motives of those providing it(Health Services Research Centre 2004).
Despite being sceptical about the commercial nature of the advertising of medicines,
some consumers may find DTCA useful. Hoek et al (2004) report that 23% of a sample
of New Zealand consumers ‘had asked their doctor about a medicine after seeing it
advertised and 15% had discussed a health issue they had not previously discussed
following exposure to DTCA’.
Mauback and Hoek’s (2005) study of New Zealand GPs found favourable views of
DTCA’s ability to increase awareness of some health conditions. However, some GPs
expressed serious concerns about the adequacy of the risk and contraindication
information provided and the lack of cost information.

18

Direct-to-Consumer Advertising of Prescription Medicines in New ZealandFiscal pressures
Arguments for and against
Advertising is a key marketing strategy employed by the pharmaceutical industry toincrease brand recognition and sales revenue. Critics argue that DTCA increases
pressure on PHARMAC, from the public and others, to subsidise the new, higher-priced
pharmaceuticals. Some opponents argue that in the majority of cases the productadvertised offers little advantage over existing products. Concern has also been raisedthat DTCA increases demand for unsubsidised ‘lifestyle medications’ (eg, treatments forunwanted weight gain, erectile dysfunction and hair loss). However, this argument isbased on the premise that lifestyle medications offer no health benefits to consumers
and makes the value judgement that lifestyle medications are unnecessary in medical
practice.
There is also a claim that the cost of subsidies for medicines and patient visits to GPs isescalated as a result of DTCA, particularly if consumers visit a number of physicians in
an attempt to find one willing to prescribe the advertised medicine. This cost is borneby both the consumer and the government (taxpayers).
Where the medicine is not subsidised, high prices become an issue for individuals. It
has been suggested that public confidence in the state-funded health care system canbe undermined when individuals find it difficult to access advertised medicines that do
not attract a government subsidy.
Advocates of DTCA argue that many of the medicines advertised are not subsidised
and GPs do not generally issue prescriptions that are not necessary. As a result, any
increase in prescriptions due to DTCA is seen as positive as it means more New
Zealanders are receiving appropriate treatment.
Comment
PHARMAC’s previous analysis of the impact of DTCA on the pharmaceutical budget for
Flixotide and Lamisil has shown a relationship between advertising expenditure andgovernment expenditure. For example, after the product Flixotide began to be
advertised directly to consumers in 1998, there was 62 percent growth in Flixotide
dispensings from 1998/1999 to 1999/2000. Another example is Lamisil (a treatment forfungal infections) – $539,000 was spent in advertising Lamisil and dispensingsincreased by 39%, which resulted in increased pharmaceutical expenditure of $0.770
million or 41% on Lamisil.
It should be noted that the Flixotide advertising campaign may have achieved a large
movement from existing asthma inhaler products and to the newer product, Flixotide, inpart because it led many asthmatics to believe that their current preventer inhaler was
being withdrawn and that they had no choice but to swap to Flixotide. In reality, analternative brand of their existing treatment was available. Use of Flixotide has
increased significantly, not only in New Zealand but also in countries that do not permit
DTCA.

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand19

It is also important to note that Lamisil has fewer side effects and a shorter course oftreatment than other treatments for chronic fungal infections. Once funding for Lamisil
became available, GPs may have felt more compelled to prescribe Lamisil, given theopportunity to treat a previously undertreated condition more safely and effectively.
Reports such as the General Accounting Office’s FDA Oversight of Direct-to-Consumer
Advertising Has Limitations (United States General Accounting Office 2002) identify anumber of factors that may increase the use of pharmaceuticals and, if they are
occurring at the same time as DTCA, will confound the assessment of the effects ofDTCA on sales. These factors include:•

an ageing population that is increasingly dependent on multiple medications•

increased diagnosis of chronic conditions such as arthritis•

the emergence of safer, more effective treatments•

the uptake by prescribers of published international and local guidelines advocating
use of particular medicines•

direct-to-practitioner advertising.

Hoek et al (2004) reviewed patient surveys of DTCA in the United States and New
Zealand in 2003. They found that the data indicated:that the great majority of patients neither asked for, nor received, a prescription asa result of DTCA: [the data] also show that doctors often responded to explicit
requests with alternative treatments or lifestyle advice.
The literature suggests that there are a number of confounding variables surrounding
the data that indicate there is increased prescribing in response to DTCA.

20

Direct-to-Consumer Advertising of Prescription Medicines in New ZealandMedicalisation
Arguments for and against
Medicalisation refers to the increasing tendency for people to seek pharmacologicaltreatment for a growing number of conditions: this is also known as ‘pill for any ill’behaviour. So-called ‘lifestyle medicines’, such as treatments for unwanted weight gain,
erectile dysfunction and hair loss, have been the subject of a significant proportion of
DTCA in New Zealand. As mentioned earlier, the argument against DTCA on the
grounds that it further medicalises normal body processes is based on the premise thatlifestyle medications offer no health benefits to consumers. Lifestyle medicines areusually not government subsidised and fall between medical and social definitions ofhealth.
The effects of DTCA on individual health habits, in particular DTCA for certain lifestyle
medications, should also be taken into account, as it could be argued that someconsumers may care less about maintaining healthy lifestyles because they know drug
treatments are available should they become sick. On the other hand, DTCA may alert
people to adopt healthy habits by reminding them that there are potential diseases theymight suffer that may require medical treatment.
Toop et al (2003) argue that DTCA commonly redefines normal processes or social
problems as medical problems:
Pharmaceutical solutions are offered for normal physiological or ageing processes
and encourage the belief that there is a quick fix drug for every condition. This
results directly in the medicalisation of normal health and ageing and discourages
sustainable behaviour change to address health problems, such as physicalexercise and dietary change to reduce weight.
The contrary view is that the accepted definition of health has always been about morethan just the absence of disease and has now expanded to include the management ofprocesses associated with ageing. In addition, some of the conditions identified as‘lifestyle conditions’ can be associated with significant morbidity or mortality.
Erectile dysfunction is an example of a condition that is classed as a lifestyle condition,
which is potentially caused by a number of diseases such as diabetes. It can be argued
that this label undervalues the personal and relationship problems caused by erectile
dysfunction. It also discounts the potential positive effects that may be forthcomingfrom screening a patient who presents complaining of erectile dysfunction.
Comment
Maubach and Hoek’s (2005) qualitative analysis of interviews with 20 New Zealand GPs
found divergent views on the effect of DTCA on the medicalisation of normal bodily
processes. Some respondents reported concerns about medicalisation on the basisthat it diverts attention from more appropriate treatments such as changes in diet andexercise. Others, however, thought that DTCA could promote discussions between
patients and GPs about lifestyle conditions, such as obesity and the prevention ofchronic disease.

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand21

Hoek et al (2004) found that consumer evidence suggests DTCA may prompt earlier
diagnosis of conditions that require management. New Zealand consumers reported
that they typically asked about an advertised medicine during an already scheduled
consultation made to discuss another matter.
Iizuka and Zhe Jin (2005) studied the effects of DTCA on two health habits: smoking
and exercise. The study found that DTCA of tobacco cessation products did notdecrease the tendency of smoking in the adult population, and more disturbingly,
appeared to increase the proportion of smokers within educated and insured adults. In
terms of exercise, the study focused on DTCA that targeted four chronic conditions:diabetes, hypertension, heart diseases and overweight. The study found that DTCA
related to the four conditions decreased the likelihood of moderate exercise (but had
zero impact on vigorous exercise). One explanation offered for this phenomenon isthat, by learning the existence of a drug treatment, people substitute medical treatment
for moderate exercise.
While it is appropriate for both doctors and consumers to be concerned about the
impact of DTCA on medicalisation of normal bodily processes, other drivers for
medicalisation – such as the media news, editorials, medical advertisements, research
journals and other publications – should also be acknowledged. The effects of DTCA
on individual health habits should also be taken into consideration; however there islittle evidence available to suggest that all DTCA results in negative health outcomes(only one study has found evidence of a negative effect of DTCA on individual healthoutcomes in the cases of smoking cessation and exercise).

22

Direct-to-Consumer Advertising of Prescription Medicines in New ZealandImpact on patient–doctor relationships
Arguments for and against
Critics of DTCA argue that advertising can create conflict in the doctor–patient
relationship, particularly when physicians decide that the advertised drugs requested
should not be prescribed. Toop et al (2003) argue that there is evidence thatprescribers often feel pressured to write prescriptions for DTCA medicines that theywould not otherwise have used for particular patients.
Advocates of DTCA argue that advertising helps patients learn about new medicinesand encourages patients to talk to their doctors about possible treatments for aparticular condition. It may also create greater opportunities for a partnership between
patients and doctors to work together to find appropriate treatments for medical
conditions.
Comment
Prescription medicines can only be accessed through a consultation with a prescriber
recognised by the Medicines Act 1981 – a medical practitioner, dentist, midwife or
nurse. During a prescriber–patient consultation, the Code of Health and Disability
Services Consumers’ Rights expects that the prescriber will:• assess the medical condition of the patient• determine whether a prescription is necessary• determine the appropriateness of a medicine for that particular patient• discuss any relevant issues in relation to the medical diagnosis and the prescribed
medicine with the patient.
There is often a failure, particularly in broadcast DTCA, to provide consumers with all
the information necessary to determine the best treatment outcome. Queries initiatedby DTCA can therefore require significant additional explanation by doctors to explain
why a particular drug or treatment may not suit a patient’s situation, and this can takeconsiderable time.
The Auckland University Centre for Health Research conducted research on prescribing
information resources used by GPs. GPs reported that DTCA did not have a significant
impact on their decision-making when prescribing medications. DTCA was
acknowledged, however, as a factor that influenced patients’ expectations of prescribing(Auckland University Centre for Health Research 2005).
Maubach and Hoek’s (2005) qualitative analysis of interviews with 20 New Zealand GPs
found a low incidence of DTCA-related queries. In addition, respondents did not reportfeeling under undue pressure to prescribe requested medications.

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand23

Maubach and Hoek (2005) also found that while some GPs resented having to deal with
DTCA-generated questions, few considered that this form of advertising undermined therelationship they had with their patients. Many of the 20 GPs interviewed appreciatedthe influence DTCA had on patients, in terms of encouraging them to take a more activerole in managing their health care. However, GPs also reported spending timedispelling misunderstandings created by DTCA, which caused frustration for some GPs
due to the impacts on already tight schedules. The study found strong disquiet amongst
GPs with regard to particular aspects of DTCA. The researchers concluded that:
While some doctors’ responses suggest DTCA has the potential to provide
information that fosters better dialogue between doctors and their patients, it isclear that this potential is far from being realised.
Hoek and Gendall’s 2003 survey of New Zealand consumers (Hoek et al 2004) foundthat just over half of the respondents (51 percent) thought DTCA promoted more
informed discussions with their doctors. The same survey found that:
11% of respondents considered that DTCA would harm patients’ relationships with
their doctor, and a slightly higher proportion (16%) felt it could actually improve therelationship. But the majority considered DTCA would have no effect on theirrelationship with their doctor.
The doctor–patient relationship is an evolving one that has already gained momentum
towards a more mutual partnership, with patients more willing to question doctors’
advice and seek alternative forms of treatment. The effects of DTCA on the doctor–
patient relationship remain largely unquantified.

24

Direct-to-Consumer Advertising of Prescription Medicines in New ZealandSection 14 of the New Zealand Bill of Rights Act 1990
Section 14 of the New Zealand Bill of Rights Act 1990 (NZBORA) provides for the right tofreedom of expression. This right extends to all forms of communication that attempt to
express an idea or meaning, and extends to commercial speech, such as advertising.
Overseas case law suggests that not all forms of expression are equally deserving of
the protection of freedom of expression and that commercial expression is considered
to be at the edge of being part of that right to freedom of expression. The courts haveheld the view that commercial expression is of less importance than political or artistic
expression and consequently limitations on the right in this context are easier to justify.
An argument may be advanced that the advertising of prescription medicines isprotected by section 14 of the NZBORA. However, a restriction on DTCA could bejustified under section 5 of that Act if the restriction serves an important and significant
objective, and the restriction achieves that objective in a logical and proportional way.

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand25

Conclusions
From the research to date, it is apparent that patient and physician behaviours do alterin response to DTCA. Prompted by DTCA, people are going to doctors; discussing andrequesting advertised medicines; and receiving prescriptions. While not quantifiable,
these behaviours can influence increasing prescription medicine costs.
To date, the debate over the positive versus negative impact of DTCA on healthoutcomes has been supported primarily by indirect evidence, however one recent study
has found evidence of a negative effect of DTCA on individual health outcomes in thecases of smoking cessation and exercise (Iizuka and Zhe Jin 2005). The majority of
research has focused on the effects of DTCA on consumer awareness, attitudes,
perceptions and self-reported behaviour, and physician attitudes and self-reported
behaviour. The Ministry is not aware of any published analysis establishing whether
DTCA creates additional use of pharmaceuticals that is primarily appropriate or costeffective or the opposite. As stated by Meredith Rosenthal, ‘it is not the case that thehealth services community has missed the point, but that the methodological challenges
of conducting such a study are substantial’ (Rosenthal 2004).
Until evidential studies are able to establish the direct impact of DTCA on healthoutcomes and public health in New Zealand and elsewhere, the evidence pointing toeither a predominantly positive impact or a predominantly negative impact is likely toremain inconclusive.
In the meantime, the critics of DTCA argue that in the absence of evidence that DTCA
has a positive or at least neutral impact, the precautionary principle should apply and
DTCA should be restricted or banned. Proponents of DTCA, in contrast, argue that in
the absence of evidence that DTCA has a negative impact, the status quo or littlechange to it should apply.

Q3. Which of the arguments outlined in Section 5, ‘The Cases For and Against DTCA’,
do you find most persuasive: those for or against DTCA? Why?
Q4. Do you have any further information or arguments that you consider should be
added to this review of the evidence that supports or opposes DTCA? If so, pleaseforward this information to the Ministry of Health.

26

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand5

DTCA Regulatory Options

Introduction
This section outlines the costs and benefits of three options for the regulation of DTCA.
Clearly, there are other possible responses such as a moratorium, but these are notdiscussed further here.
The current regulatory requirements for DTCA under the Medicines Act 1981 andMedicines Regulations 1984 are outlined on pages 4-5. However, regardless of thedecision on the future regulation of DTCA in New Zealand, these arrangements are to
be superseded by the Therapeutic Products Advertising Code applied under the
Therapeutic Products Authority (outlined on pages 12-14). As currently proposed, theTherapeutic Products Advertising Code allows DTCA to continue in New Zealand, albeit
with more stringent regulation than under the Medicines Act currently. For the purposesof this document, therefore, option 1 should be considered as the status quo, providing
the benchmark against which the other two options may be measured.
The regulatory options for DTCA are:•Option 1 – Allow DTCA to continue with more stringent regulation (Therapeutic
Products Advertising Code + different approach taken to DTCA in New Zealand tothat taken in Australia).

•

Option 2 – Allow DTCA but with stricter requirements than specified by the
Therapeutic Products Advertising Code (Therapeutic Products Advertising Code +New Zealand-only restrictions on DTCA).

•

Option 3 – Ban DTCA and regulate disease-state advertising (Therapeutic Products
Advertising Code + harmonisation with Australia’s policy on DTCA and disease-state
advertising).

It is important to note that under the Therapeutic Products Authority, New Zealand has
the ability to consider adopting proposed future changes to the Therapeutic Products
Advertising Code or DTCA policy, as does Australia.

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand27

Figure 3: Main decisions in arriving at DTCA policy conclusion
Allow DTCA?
Yes

Retain DTCA

Option 1:
Allow DTCA to continue
with more stringent
regulation (Therapeutic
Products Advertising Code+ different approach taken
to DTCA in New Zealandto that taken in Australia)

More regulation thanproposed under the
Therapeutic Products
Advertising CodeNo

Option 3:
Ban DTCA and regulate disease-state
advertising (Therapeutic Products
Advertising Code + harmonisation with
Australia’s policy on DTCA anddisease-state advertising)

Option 2:
Allow DTCA but with stricter
requirements than specified by the
Therapeutic Products Advertising
Code (Therapeutic Products
Advertising Code + New Zealandonly restrictions on DTCA)

Problem statement
As outlined above, the evidence is not definitive regarding the impact of DTCA on healthoutcomes.
The Toop report (Toop et al 2003) highlights that the medical and pharmacy professions
remain very concerned about DTCA, and report finding themselves under significant
pressure from partially informed consumers. While the evidence from the local research
conducted by Maubach and Hoek (2005) indicates this may not be a major problem forthe majority of practitioners, the Toop report indicates that DTCA is a current focus of
dissatisfaction amongst many health care practitioners.
Some consumer groups in New Zealand have opposed DTCA. Other consumer
groups, however, have challenged both sides of the debate by questioning critics’assertions about DTCA and challenging the pharmaceutical industry to do more todeliver on the purported benefits of DTCA.
Public policy objectives
As stated in Section 2, the public policy objectives for the regulation of DTCA are to:•ensure the quality use of prescription medicines is maximised•

contribute to the provision of consumer information that is balanced and easily
understood by New Zealanders, to maximise public health and safety•

ensure regulation is as practicable and as cost-effective as possible•

ensure appropriate and proper standards for prescription medicine advertising.

28

Direct-to-Consumer Advertising of Prescription Medicines in New ZealandDTCA and the internet
The internet has seen a proliferation of sites advertising prescription and over-thecounter medicines, as well as more general health information. The quality of suchsites varies considerably. There can be direct or hidden bias depending on the source
and/or sponsor of the website, which is not always obvious to consumers.
The global nature of the Internet makes it hard to regulate. DTCA is permitted in the
United States, which means pharmaceutical companies are effectively able to promote
DTCA worldwide. It is questionable whether New Zealand’s DTCA regulatory
requirements could be implemented beyond New Zealand domain websites.
It could be argued that the ability of New Zealanders to access DTCA information from
United States websites undermines New Zealand’s regulation of DTCA and is a reason
against tightening the current regulatory requirements. However, this argument could
lead to the lowest common denominator approach, where New Zealand allows any
DTCA if another country allows it, despite any New Zealand-based concerns about
negative impacts of DTCA.

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand29

Option 1 – Allow DTCA to continue with more stringent regulation(Therapeutic Products Advertising Code + different approach taken to DTCA in New
Zealand to that taken in Australia)
This option would allow both Australia and New Zealand to retain different policies
regarding DTCA (ie, DTCA would continue in New Zealand but be prohibited inAustralia). As outlined on pages 12-14, the trans-Tasman model would apply a single
Therapeutic Products Advertising Code that specifies the requirements for all
advertisements of therapeutic products (directed to consumers and health carepractitioners). There was extensive industry consultation in both Australia and New
Zealand as part of the development of the proposed advertising regulatory model.
Regardless of the decision on the future regulation of DTCA in New Zealand, it is
proposed that the Therapeutic Products Advertising Code come into effect under the
Therapeutic Products Authority. This option should thus be considered as the statusquo, against which the other options may be measured.
Description
This option involves the following:•

DTCA would continue in New Zealand.

•

Medical advertising controls would continue to be co-regulatory (medical
advertisements would be regulated by the Therapeutic Products Authority and theadvertising industry), however less reliance would be placed on industry selfregulation (as is currently the case).

•

There would be mandatory pre-approval of DTCA. TAPS would continue to preapprove advertisements in New Zealand; however, delegation would come from the
Therapeutic Products Authority.

•

The Therapeutic Products Advertising Code would cover the advertising of all
therapeutic products, including prescription medicines, over-the-counter medicines,
complementary medicines and medical devices in Australia and New Zealand.

•

Stronger penalties for non-compliant advertisements would be implemented.

Expected costs and benefits

Costs
•

Information provided to consumers may not adequately identify the risks,
contraindications and costs of advertised prescription medicines.

•

Possible fiscal risks may arise from pressure on the pharmaceutical budget due tooverprescribing or prescribing of newer, more expensive medicines when generic
medicines may be as or more effective.

•

There may be potential for prescribing pressure and stress on the doctor-patient
relationship.

30

Direct-to-Consumer Advertising of Prescription Medicines in New ZealandBenefits•Some may consider that there would be more appropriate deterrent penalties forindividuals and corporations, which could be expected to enhance consumer safety
through encouraging the provision of more balanced information.

•

Information would continue to be provided to consumers from a source that some
may find useful.

•

The industry would continue to self-fund the regime.

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand

31

Option 2 – Allow DTCA but with stricter requirements than specified
by the Therapeutic Products Advertising Code
(Therapeutic Products Advertising Code + New Zealand-only restrictions on DTCA)
Under this option DTCA would continue to be permitted in New Zealand, but with stricter
requirements than specified under the Therapeutic Products Advertising Code. Criteria
for stricter regulatory requirements on DTCA would be developed in consultation withthe sector.
Description
This option involves the following.
• The Therapeutic Products Advertising Code (outlined on pages 13-14) would beapplied.
• Additional New Zealand-specific DTCA requirements would be developed.
• Criteria for approval of DTCA before advertisements could be shown would be
developed.
Examples of possible additional requirements under this option•More explicit generic warning statements in all DTCA could be required (eg, warningstatements must be provided at the beginning of the advertisement, or be of a certainsize).

•

Advertising a product could be prohibited until it had been on the market for a set
period (eg, two or five years).

•

Require mandatory pre-approval of all DTCA by the Therapeutic Products Authority(in addition to industry self-regulation of advertisements).

Expected costs and benefits

Costs
•

Advertising revenue through DTCA may fall (although this may be redirected into
other forms of advertising).

•

The pharmaceutical and advertising industry may react negatively.

•

Consumer access to information about prescription medicines from DTCA may
decrease.

32

Direct-to-Consumer Advertising of Prescription Medicines in New ZealandBenefits•

The risk of a negative influence on the doctor–patient relationship is lower than with
Option 1.

•

The risk of medicalisation of normal bodily processes is lower than with Option 1.

•

Approved DTCA would continue to provide a source of information to consumers thatsome may find useful.

•

It may provide assurance of reasonable ongoing co-operation from pharmaceuticalcompanies involved in the DTCA industry who view this option as a compromise
between Option 1 and banning DTCA.

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand33

Option 3 – Ban DTCA and regulate disease-state advertising(Therapeutic Products Advertising Code + harmonisation with Australia’s policy on
DTCA and disease-state advertising)
Under this option DTCA would be prohibited and disease-state advertising would be
regulated. This approach would align New Zealand’s regulatory position with that ofAustralia and other Organisation for Economic Co-operation and Development countries
with the exception of the United States.
Under this option consumers’ information about specific prescription products would be
limited to that provided by health care professionals and the instructions that
accompany their medication or Medsafe’s information leaflets. In addition, providing
Consumer Medicine Information (instructions and contraindications of use of a particular
medicine) for prescription medicines is proposed to be compulsory under the
Therapeutic Products Authority (currently pharmaceutical companies are not legallyrequired to produce this information). As almost all DTCA is for pharmaceuticals forwhich there are already equally effective treatments, consumers are not likely to be
deprived of information about innovative medicines.
It is important to note that under this option there would be an ability to advertise where
there is a clear public health benefit, such as for Ministry of Health vaccination
campaigns (eg, meningococcal vaccine).
Disease-state advertising
There is international concern that where DTCA is banned or restricted, inappropriate
disease-state advertising has been used to create a demand for prescription medicines.
As outlined on pages 2-3, disease-state advertisements are designed to raiseawareness about particular medical conditions without mentioning specific medicines.
They are also used to inform the public that new medications are available and that
consumers should contact their GP for further information.

Costs of disease-state advertisements•

Consumers may make unnecessary doctor visits due to the inadequacy of
information supplied to them.

•

Disease-state advertisements often fail to raise awareness of potential risks
associated with the use of a particular category of medicines.

Benefits of disease-state advertisements•

They encourage consumers to seek medical advice for conditions that mightotherwise have gone untreated, or where initiation of treatment would otherwise havebeen delayed.

•

They promote awareness of specific conditions and available treatments.

•

Consumers can participate in decisions concerning their health care without being‘sold’ on a particular product prior to consulting with a doctor.

34

Direct-to-Consumer Advertising of Prescription Medicines in New ZealandMany of the costs and benefits associated with DTCA could also apply to disease-state
advertising, although to a lesser extent.
Description
This option involves the following:•

The Therapeutic Products Advertising Code (outlined on pages 13-14) would beapplied.

•New Zealand policy would be harmonised with Australia’s current policy on DTCA
and disease-state advertisements, and the Therapeutic Products Authority would
take the same approach to regulation of advertising in both countries.

•

The Therapeutic Products Bill would include a prohibition on DTCA.

Expected costs and benefits

Costs
•

The ability of consumers to access information may be reduced.

•

There may be a risk of undertreating undiagnosed health conditions.

•

The decision to ban DTCA could be interpreted by the pharmaceutical industry as a
discouraging signal for their further investment in New Zealand. There could be aflow-on impact on the development of the biotechnology sector, where New Zealandcompanies look to investment from the pharmaceutical industry.

•

There could be a reduction in economic activity and employment in the broadcast
industry. However, it is possible that DTCA revenue may be reverted to other formsof advertising, such as advertising over-the-counter medicines or advertising directto-prescribers.

Benefits•

It may satisfy a significant proportion of the medical profession who are unhappy with
DTCA.

•

A higher level of protection may be provided for the vulnerable, easily exploited target
groups.

•

The risk of a negative influence on the doctor–patient relationship would be lower
than with Option 1 or Option 2.

•

The risks of medicalisation of normal bodily processes may be lowered.

•

The fiscal risk arising from pressure on the pharmaceuticals budget could belowered.

New Zealand Bill of Rights Act 1990 issue
As outlined on page 25, putting stricter controls on DTCA would need to be justified
under the New Zealand Bill of Rights Act 1990.

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand35

Considering the options for DTCA
If you consider that the evidence fails to demonstrate the costs of banning DTCA
outweigh the benefits of DTCA, you may support Option 1 – allow DTCA to continue
with more stringent regulation (Therapeutic Products Advertising Code + different
approach taken to DTCA in New Zealand to that taken in Australia) or Option 2 –allow
DTCA with stricter requirements than specified by the Therapeutic Products Advertising
Code (Therapeutic Products Advertising Code + New Zealand-only restrictions onDTCA).
Alternatively, a decision to ban or restrict DTCA can be drawn from the application of aprecautionary approach, if the lack of evidence of benefit to the community is
considered more important. If you consider that the costs of DTCA outweigh thebenefits, or consider a precautionary approach10 is merited, you may support either
Option 2 – allow DTCA with stricter requirements than specified by the Therapeutic
Products Advertising Code (Therapeutic Products Advertising Code + New Zealandonly restrictions on DTCA) or Option 3 – ban DTCA and regulate disease-state
advertising (Therapeutic Products Advertising Code + harmonisation with Australia’s
policy on DTCA and disease-state advertising).
Now that you have considered the arguments for and against DTCA, this paper asks
you to consider whether you support the level of controls proposed under the
Therapeutic Products Advertising Code (Option 1), DTCA with stricter requirements
than specified under the Code (Option 2) or a complete ban on DTCA and regulation of
disease-state advertising (Option 3).

Q5. Which of the options outlined in Section 6, ‘DTCA Regulatory Options’, do you
support? Why?
Q6. What further options, if any, relating to the regulation of DTCA in New Zealand do
you support? Why?
Q7. Do you have any other views on how to achieve the purported benefits of DTCA (eg,consumer access to pharmaceutical information, enhanced doctor-patient
relationship, increased diagnosis of previously untreated conditions), without
experiencing the purported costs of DTCA? If so, please forward these views to the
Ministry of Health.

10

For the purposes of this document, a ‘precautionary approach’ refers to banning or restricting DTCA in
the absence of evidence that shows DTCA to have a positive or at least neutral impact.

36

Direct-to-Consumer Advertising of Prescription Medicines in New ZealandAppendix 1: DTCA – International Situations and theRole of Regulation
United States
The United States is the only other country in the OECD that allows DTCA, although it
has adopted a regulatory model and processes that are strikingly different to New
Zealand. DTCA critics in the US acknowledge that DTCA is unlikely ever to be banned,
as the First Amendment in the US Constitution would make this impossible (Meek
2001).11
Regulation
The United States has never had any legislation specifically prohibiting advertising ofprescription drugs to the public. The US Food and Drug Administration (FDA) directly
regulates pharmaceutical advertising through the 1962 Kefauver-Harris Amendments to
the Federal Food, Drug, and Cosmetic Act, which require advertisements to meet thefollowing conditions:
1.

They must not be false or misleading in any respect.

2.

They must present a fair balance of information about the risks and benefits ofusing the drug.

3.

They must include a ‘major statement’ of the drug’s major risks.

4.

They must make ‘adequate provision’ for dissemination of further details provided
in package labelling.

5.

They must provide information in ‘consumer friendly’ language (Hoek and Gendall2004).

The FDA oversees the advertising of prescription drug products through acomprehensive surveillance, enforcement and education programme, and by fostering
better communication of labelling and promotional information to both healthprofessionals and consumers. The FDA has the authority to require an offending
company to undertake corrective actions and (ultimately) to remove a product’s
marketing licence.

11

The US First Amendment – Freedom of religion, press, expression states: ‘Congress shall make nolaw respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging thefreedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition
the government for a redress of grievances’.

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand37

Previous review of DTCA in the United States
After the first DTCA campaigns began to appear in the US in the early 1980s,
researchers began to question whether pharmaceutical advertisements could meet thepromotional interests of the pharmaceutical industry and the health needs of the public.
In response to the concerns of the public and manufacturers, the FDA asked theindustry to suspend its prescription medicine advertising while the FDA researched
DTCA to assess its impact on consumers and, if necessary, put appropriate reforms inplace.
The American Medical Association and most of the consumer organisations andmembers of the public attending FDA public consultations during the moratorium were
opposed to product-specific prescription drug advertising. DTCA was also controversial
within the pharmaceutical industry. At a conference organised by the pharmaceuticalindustry in 1984, nearly 80 percent of the industry executives were opposed to DTCA,
citing fear of increased product liability, increased marketing costs and lower
profitability. However, in September 1985 the FDA ended the moratorium on DTCA
satisfied that most of its concerns had been met, and announced that DTCA would be
regulated in a similar manner to advertisements targeting health professionals.
The FDA held a second set of public consultations on DTCA in 1995. Little newresearch evidence on the impacts of DTCA was produced. One significant change,
however, was in the increased proportion of major companies supportive of DTCA andalready engaging in this form of promotion. Another was the push for changes to theregulation of television and other broadcast advertising.
In 1997 the FDA relaxed its rules governing broadcast advertising, allowing omission ofthe ‘brief summary’. Instead, it required manufacturers to state a product’s major risks
and provide additional sources of information: a toll-free phone number; a website
address; and simultaneous DTC print advertisements that included the brief summary or
brochures in doctors’ offices, libraries and stores.
This regulatory change led to considerably more television advertising of prescription
drugs, with over 30 drugs advertised in the following year and the majority of new DTCA
spending focusing on television. Spending on DTCA in the US has continued toaccelerate, reaching US $1.3 billion in 1998, $1.9 billion in 1999, $2.5 billion in 2000
and $2.7 billion in 2001 (Calfee 2002), and rising to an estimated $3.2 billion in 2003
(Kaiser Family Foundation 2004).
An FDA announcement on broadcast advertising issued in August 1999 emphasised
the need for balance in DTCA, with equal time to be given to both benefits and side
effects of prescription drugs advertised by brand name.

38

Direct-to-Consumer Advertising of Prescription Medicines in New ZealandIn response to comments that its final guidance was inappropriate because of possible
negative effects associated with DTCA, the FDA advised:
FDA is unaware of any data supporting the assertion that the public health oranimal health is being harmed, or is likely to be harmed, by the Agency’s actions infacilitating consumer-directed broadcast advertising. FDA has repeatedly
requested empirical data that would document the hypothesised effects – negativeand positive – of DTC promotion on several factors related to public health.
Despite years of print DTC advertising, no rigorous evidence has been presented
to demonstrate that DTC advertising has had any of the hypothesised ill effects. In
the absence of such data, FDA believed that the advantages of having abroadcast environment that would encourage communication of both the benefits
and the risks of advertised products outweighed the postulated, but neverdemonstrated, disadvantages. In issuing the draft guidance, FDA again asked
that research be conducted to document the effects of DTC promotion on the
public health and animal health and specified that it would conduct an evaluationof such effects within two years of finalising the guidance (FDA 1999).
In June 2005 the American Medical Association voted to further study the issue of
DTCA because of concerns about the effects of these advertisements on the patient–doctor relationship and on health care costs. The American Medical Association will
study the effect of DTCA on patient care and consider strategies that could minimise its
potential negative impact.
In August 2005 the Pharmaceutical Research and Manufacturers of America (PhRMA)
issued voluntary ‘Guiding Principles’ on DTCA for its member companies. These
guidelines are to address concerns expressed by American Psychiatric Association, theAmerican Medical Association, and public policy officials, among others, about DTCA.
The PhRMA guidelines were also issued in response to a proposal by Senate Majority
Leader Bill Frist for a voluntary moratorium on DTCA, in an effort to cap spiralling healthcare costs and promote patient safety.
Among the PhRMA Guiding Principles are provisions that would encourage drugmakers to:1.

refrain from running misleading advertisements

2.

educate doctors about a new drug for an ‘appropriate’ amount of time before
starting DTCA on that drug (giving the drug maker the sole discretion to decide themeaning of ‘appropriate’)3.

avoid targeting audiences who are not age-appropriate.

The guidelines also establish a PhRMA ‘Office of Accountability’ responsible forreceiving comments from the general public and health care professionals regarding
DTCA.
Although the PhRMA Guiding Principles are not mandatory, the Wall Street Journal
reports that 23 companies have already promised to comply (Wasserstrum 2005). The
PhRMA Guiding Principles are available online at: www.phrma.org.

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand39CanadaDTCA is prohibited in Canada. However, concerns have been expressed in medical
publications about the interpretation of the policy governing this marketing strategy, as aresult of the partial introduction of DTCA showcased in reminder advertisements andhelp-seeking advertisements. Canada also has the difficulty of dealing with the crossborder drift of advertisements from the United States, where DTCA is legal.
Regulation
Regulation of pharmaceutical advertising in Canada is covered by the Food and Drugs
Act, which explicitly prohibits DTCA. The Act prohibits the advertising of any drug to thegeneral public as a treatment, preventive or cure for serious diseases and prohibits theadvertising of prescription-only drugs.
Although the pharmaceutical industry cannot directly advertise prescription-only
products to the public – with the exception of advertisements mentioning only productname, price and quantity – it can provide ‘educational’ information tied to specificproducts in the form of reminder or help-seeking advertisements. Reminder
advertisements provide the name of a product without stating its use, and help-seeking
advertisements inform consumers of new but unspecified treatment options for diseases
or conditions (Gardner et al 2003).
Published advertisements of prescription medicines, in all forms, are subject to a
voluntary pre-clearance review by independent agencies endorsed by Health Canada.
These agencies are Advertising Standards Canada and the Pharmaceutical Advertising
Advisory Board, who provide advisory opinions on messages directed to consumers forprescription drugs to ensure that they meet the regulatory requirements. In addition,
Advertising Standards Canada reviews advertising material for non-prescription drugs
directed to consumers, while the Pharmaceutical Advertising Advisory Board reviews
advertisements for all drugs directed to health professionals. Advertising Standards
Canada and the Pharmaceutical Advertising Advisory Board review and pre-clear
advertising material in order to determine compliance with the regulatory provisions of
the Food & Drugs Act and Regulations and the various codes of advertising. These
regulations are intended to protect the health of Canadians.
Health Canada is the national regulatory authority for drug advertisements. Health
Canada provides policies to effectively regulate marketed health products and oversees
regulated advertising activities. Although it is not mandatory, Health Canada andvarious manufacturer associations such as the Non-prescription Drug Manufacturers’
Association of Canada and Canada’s Research-Based Pharmaceutical Companies
encourage all sponsors to comply with the voluntary pre-clearance review byAdvertising Standards Canada and the Pharmaceutical Advertising Advisory Board.

40

Direct-to-Consumer Advertising of Prescription Medicines in New ZealandPrevious review of DTCA in Canada
The Canadian federal health agency, Health Canada, initiated a regulatory review in1996 and sponsored a consultative workshop to discuss DTCA in June 1996. The
provincial governments, which are responsible for administration of health services,were opposed to the introduction of DTCA on the grounds that it might be a potential
cost driver and that the effects of DTCA had not been sufficiently researched. Health
Canada initiated a further round of consultations on DTCA in late 1998 as part of abroader discussion of renewal of Canada’s health protection legislation, and a separate
multi-stakeholder consultation on DTCA in April 1999. One of the goals of the HealthProtection Legislative Renewal initiative was to address the situation around advertisingof prescription drugs.
In June 2003 Health Canada launched national consultations on a detailed legislative
proposal for a new framework for health protection legislation. The proposal outlined anumber of possible tools that could be used to better control DTCA. As part of theconsultative process, Health Canada held focused sessions on issues related to healthproduct promotion, including DTCA. While there was no agreement on whether or not
to allow DTCA, stakeholders did indicate that whichever tool is used to control DTCA it
should ensure access to balanced information based on valid data for healthpractitioners and consumers.
The health and safety of Canadians is the primary consideration in the Government of
Canada’s approach to Health Protection Legislative Renewal. Health Canada isfinalising its analysis of what Canadians have said on this issue with a view to moving
forward with new legislation as soon as possible. Ensuring a system that provides
balanced and objective information to consumers so that they may make informed
decisions about their health is key to decisions around the regulation of DTCA.

European Union
Regulation
Currently, advertising of prescription drugs to the public is prohibited in all countries of
the European Union (EU), despite pressure from drug companies and the European
Commission. The relevant European legislation on advertising is contained in Title VIII
of European Directive 2001/83/EC (‘the Codified Directive’), which states: ‘Member
States shall prohibit the advertising to the general public of medicinal products which
are available on medicinal prescription only’.12 Title VIII contains rules on the contentsof advertising and promotions, and requirements for national monitoring of advertising.
Individual legislation in Member States of the European Union implement Title VIII of the
Codified Directive.

12

Council Directive 92/28/EEC, 31 March 1992.

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand41

Previous review of DTCA in the European Union
In 2002 the European Parliament rejected the European Commission’s proposals topermit advertising of prescription medicines for certain conditions (HIV/AIDS, asthma
and diabetes) to the public for a five-year trial period. This proposal was part of thebroad review of EU medicines legislation. The European Parliament committee withlead responsibility for the review of EU medicines legislation also rejected theCommission’s proposals (Royal Pharmaceutical Society of Great Britain 2003). As analternative to the European Commission’s proposals on DTCA, the committee
suggested that the European Commission should draft a comprehensive patient
information strategy to ensure that good-quality, objective and reliable information ismade available. The Commission has been asked to prepare ‘a report on current
practice with regard to information provision – particularly on the internet – and its risks
and benefits to the public’ (Directive 2004/27/EC, article 88a) (Anon 2004).

International guidelines
In 1988 the World Health Organization (WHO) developed a set of criteria to guide theregulation of pharmaceutical promotion, the Ethical Criteria for Medicinal Drug
Promotion. The WHO ethical criteria recommended that while advertisements to thegeneral public ‘should take account of people’s legitimate desire for information
regarding their health, they should not take undue advantage of people’s concern for
their health’. The WHO ethical criteria recommended against DTCA, stating that:
Advertisements to the general public should not generally be permitted forprescription drugs or to promote drugs for certain serious conditions that can betreated only by qualified health practitioners.
The WHO ethical criteria are not legally binding; but they are standards that can beused to develop regulation.

42

Direct-to-Consumer Advertising of Prescription Medicines in New ZealandAppendix 2: Other Forms of Medicine Advertising
Direct-to-prescriber advertising
Direct-to-prescriber advertising is the promotion of prescription drugs directly toprescribers by pharmaceutical companies. While the ostensible purpose of thesemeetings between pharmaceutical company sales representatives and prescribers is
educational, direct-to-prescriber advertising is a contentious issue as it has proven to be
extremely effective in facilitating the sales of drugs and influencing prescribers’prescribing (Vaithianathan 2004).
The concerns over direct-to-prescriber advertising originate from the notion of consumer
informed consent, as consumers are not aware of pharmaceutical advertising that is
directed at their GP. The reasoning behind this link is that while patients can choose toignore DTCA, they cannot choose to ignore a GP who is biased by direct-to-prescriber
advertising (Vaithianathan in press). The alternative view is that because health carepractitioners have expert and professional knowledge in their relevant field, they areable to discriminate between information of value and advertising hyperbole.
The Therapeutic Products Advertising Code is to be applied as the standard for all
advertisements of therapeutic products, including those aimed at health carepractitioners. More information on the requirements for direct-to-prescriber advertisingunder the Therapeutic Products Advertising Code can be found online at:www.jtaproject.com.

Advertising of over-the-counter medicines
Advertising of over-the-counter medicines is the promotion of medicines that do not
require a prescription for use, such as some cold and flu remedies. Advertising forover-the-counter medicines must comply with the Medicines Act 1981 and the
Medicines Regulations 1984 to ensure consumers are provided with a balanced
presentation of the benefits and risks associated with all medicines. These Guidelines
incorporate provisions for ‘Generic Risk/Benefit’ and ‘Generic Limitation’ statements aswell as ‘Major Risk’ information. This is considered to fulfil those requirements under
Regulation 8 covering Appropriate Precautions, Contra-indications and Adverse Effects
for over-the-counter medicines consistent with their various classifications underPharmacist Only, Pharmacy or General Sale medicines.
Regulations for advertising of over-the-counter medicines will be continued under the
Therapeutic Products Advertising Code. More information on the requirements foradvertising of over-the-counter medicines under the Therapeutic Products Advertising
Code can be found online at: www.jtaproject.com.

Direct-to-Consumer Advertising of Prescription Medicines in New Zealand43

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