Is Banning Direct to Consumer Advertising of

Prescription Medicine Justified Paternalism?

Yvonne Lau
Genera/Surgeon, PhD Candidate in Bioethics

Abstract
New Zealand is one of two OECD countries in the world where direct-to-consumer advertising of prescription medicine
(DTCA-PM) is permitted. Increase in such activity in recent years has resulted in a disproportionate increase in dispensary
volume of heavily advertised medicines. Concern for the potential harm to healthcare consumers and the public healthcare
system has prompted the medical profession to call for a ban on DTCA-PM as the best way of protecting the public
interest. Such blanket prohibition however also inte~eres with the public's right of access to information. This paper will
examine if banning DTCA-PM would constitute a justified form of paternalism in the context of today's New Zealand.

Keywords public to receive information. Liberal societies do sometimes

Drug industry; advertising; public policy; ethics
Introduction
Direct-to-consumer advertising (DTCA) of medicines is
permitted in New Zealand. The Medicines Act 1981 makes
no distinction between prescription-only medicines (PM)
and non-prescription medicines (NPM). The only other
OECD country which permits DTCA-PM is the United States
of America where there has been a signficant increase in
this activity over the past decade.(1) In New Zealand, the
state agency which purchases pharmaceutical products
(PHARMAC) has reported a disproportionate increase in
expenditure on newer, more expensive medicines. This trend
has been attributed to DTCA-PM.(2) The New Zealand
Ministry of Health has recommended that regulation of
DTCA-PM be tightened.(3) However, it has not resulted in
any substantial actions with much effect. In 2003, a group
led by professors of general practice from all four New
Zealand Schools of Medicine submitted to the Ministry of
Health a report (hereafter referred to as the Toop Report)
which called for DTCA-PM to be banned.(4)
Banning DTCA-PM interferes with the freedom of the
limit the freedoms and rights of citizens in order to protect
their interests. This is referred to as paternalism. This paper
asks whether a ban on DTCA-PM constitutes justified
paternalism. In the first section of the paper, the regulation
of DTCA-PM in New Zealand is reviewed. Part 2 of the
paper explores the status of rights and freedoms that are
protected in New Zealand. In Part 3, the alleged harms of
DTCA-PM are discussed, and it is argued that banning
DTCA-PM in New Z e a l a n d w o u l d not be j u s t i f i e d
paternalism.
Part 1 : Regulation of DTCA-PM in New Zealand
Direct-to-consumer advertising for prescription medicine
(DTCA-PM) refers to 'promotional material transmitted via
television, radio, magazines and the Internet, as well as to
a range of'patient education promotional activities' (such
as disease-oriented advertisements, toll-free telephone
numbers, information materials distributed by company-
funded organisations, media reports generated by company-
s p o n s o r e d press conferences, and public meetings)
generated for the purpose of marketing prescription
drugs.(3) It has been said that DTCA-PM is permitted in

journal of bioethical inquiry volume two number two page 69

Lau
New Zealand 'by default'(4) since the law regulating DTCA
makes no distinction between prescription-only and non-
prescription medicines. The latter distinction is made in
most other 0ECD countries but no case has been made
that it should be the standard for all regulation of DTCA.
Sections 56 to 62 of the Medicines Act 1981 describe
s t a t u t o r y r e g u l a t i o n s for m e d i c a l a d v e r t i s e m e n t s .
Essentially, the law prohibits false and misleading claims,
including unrealistic claims of efficacy. Additional rules
dictate that certain types of information should be included
and presented in a certain manner. Section 58 of the act
also seeks to protect patients with specific conditions,
including cancer, heart disease, diabetes, arthritis, obesity,
sexual impotence and baldness. The Fair Trading Act 1986,
the Consumer Guarantees Act 1994 and the Misuse of Drugs
Act 1975 also restrict DTCA-PM.
Monitoring DTCA-PM for compliance with the law is a
matter of self-regulation. This is to a large extent the
responsibility of the Advertising Standards Authority (ASA).
Since the ASA's funding comes from advertisers, it has a
glaring conflict of interest. In addition, its operating arm,
the Advertising Standards Complaint Board (ASCB), has
been accused of being insufficiently specialised to handle
complaints about medical advertisements. On another front,
the Association of New Zealand Advertisers (ANZA)
introduced the Therapeutic Advertising Pre-Vetting System
(TAPS) in 1999. The system is now mandatory for all
medical advertisements destined for mainstream media, and
it aims to remove problematic advertisements before they
are broadcast.(5) The fact that pre-vetting is done by agents
directly linked to pharmaceutical companies again raises
the issue o f c o n f l i c t of i n t e r e s t and r e d u c e s the
trustworthiness of TAPS, especially in the eyes of medical
professionals.
Implementing and enforcing law concerning DTCA has
proved to be difficult, even in the United States where the
FDA supervises DTCA-PM from a powerful and centralised
position.(1) In New Zealand, a three-month survey of DTCA-
PM was conducted using adjudicators from the division of
the New Zealand Ministry of Health which is responsible
for overseeing the approval of medicines for general use
(MEDSAFE). The survey found that up to 31 percent of
DTCA-PM breached the law.(6) We can only guess how
this result might have compared to adjudication by the
ASCB. Furthermore, since the ASCB deals only with
complaints, it is an open question as to how many of the
page 70 j o u r n a l of bioethical inquiry volume two number two
advertisements identified as problematic by MEDSAFE
would actually have reached the stage of adjudication.
Because the activity of TAPS does not depend on complaints
being lodged, it would theoretically be an improvement
over ASCB adjudication process. But the issue of its conflict
of interest remains.
Part 2: Freedoms and Rights in New Zealand
- when might limitations be placed?
Every society has a unique history, culture and law. The
extent to which human rights are respected and protected,
and the manner in which they are respected and protected,
varies from country to country.
A. The New Zealand Bill of Rights Act 1990
The New Zealand Bill of Rights Act 1990 lays down the
fundamental rights and freedoms protected under New
Zealand s t a t u t o r y law. To say that s o m e o n e has a
fundamental right to do something in a given society
implies that it would be wrong for the government to
interfere with this right, or at least that there must be special
reasons to justify the interference.(?: 188)
Freedom of expression is protected under section 14 of
the Act which states that '(E)veryone has the right to
freedom of expression, including the freedom to seek,
receive and impart information and opinions of any kind
in any form'. While the presumption is in favour of
protecting rights, the New Zealand g o v e r n m e n t m a y
sometimes find reasonable justifications to restrict them.
Under the law, freedom to receive information is
protected as much as the freedom to impart or to seek
information. In other words, a ban on DTCA-PM would be
considered interference with the freedom of expression
under New Zealand law.
B. The Code of Rights
The Code of Health and Disability Services Consumers'
Rights, d e v e l o p e d u n d e r the Health and Disability
Commissioner Act 1994, affirms the respect and rights due
to every healthcare consumer. All healthcare services
providers are obliged to c o m p l y with it. The Code
presupposes that every healthcare consumer is sufficiently
competent to make their own healthcare decisions, which
should be respected as far as possible even if they might
not be in full accord with preferences of the healthcare
provider.

C. Protecting rights and protecting the public
interest: striking a balance
The case of Moonen v Film and Literature Board of
Review(9) illustrates the circumstances under which it would
be reasonable, under New Zealand law, to place limitations
on the rights and freedoms protected under the New Zealand
Bill of Rights Act 1990. The case concerns the classification
of two publications as 'objectionable' on the ground that
they tended to promote or exploit sexual activity with
y o u n g boys under the Films, Videos, and Publications
Classification Act 1993. The Court of Appeal declared that
to classify M o o n e n ' s publications as 'objectionable',
stringent criteria compatible with the Bill of Rights Act
1990 must be complied with, and the Board of Review had
failed to do so. Tipping J recommended in his ruling that,
where competing interests are present, the objective of a
legislature must be to pose 'as little interference as possible
with the right or freedom affected' and that 'the way in
which the objective is statutorily achieved must be in
reasonable proportion to the importance of the objective'
with 'the limitation (imposed being) justifiable in the light
of the objective:(8)
Part 3: Is banning DTCA-PM Unjustified Paternalism?
While there is always a moral reason to interfere with a
party who causes harm to others, the law will only have a
place to intervene when the harms are wrongful. Volenti
non f i t injuria ('To one who has consented no wrong is
done') is fundamental to the understanding of wrongful
harms. A person cannot be held responsible for harm
brought on another if the latter has voluntarily assumed
the risk of harm himself through his free and informed
consent.(9: 116)
Risks are not uncommonly taken by individuals in their
pursuit of interests, and harms might befall them with their
full k n o w l e d g e . These are not w r o n g f u l harms. A
government that intervenes to protect its citizens from every
harm will result in an over-restrictive society where its
citizens' every move will be controlled and regulated. This
clearly exceeds the function expected of and the power
permitted for any system of government based on liberal
principles. However, occasions do arise when the state might
find it necessary to interfere with their citizens' freedoms
for their own good, be it to promote benefits or simply to
prevent harms. Such government interventions will be
regarded as paternalistic.(lO)
journal of bioethical inquiry volume two number two
Justified Paternalism?
Although paternalism arises from a sense of altruism, it
is morally undesirable. The opportunity to rightfully decide
for oneself, to exercise one's autonomy is fundamental to
the recognition of this person as a full and competent member
of society. Removal of this opportunity robs the person of
the rightful respect he or she deserves. In a society whose
government follows such liberal principles, any paternalistic
policies will require serious justifications.
Feinberg's ' w e a k p a t e r n a l i s m ' allows the state to
interfere in order to protect individuals from their
nonvoluntary choices. A person's consent is considered
voluntary 'when he is a competent and unimpaired adult
who has not been threatened, misled, or lied to about
relevant facts, nor m a n i p u l a t e d by subtle forms of
conditioning:D: 116) Where the decision is non-voluntary,
it could provide a justification for external interference. In
this manner, state interference will only be permissible if
it is the sort to which the agent would consent to as if he
were making a fully voluntary choice.(ll) Voluntariness
will be assessed with direct relevance to the individual's
circumstances and the seriousness of the decisions that he
faces. The 'Principle of hypothetical individualised consent'
aims to 'nudge (the agent) back onto a path compatible
with his own goals and values'.(10: 87) This type of
autonomy respecting paternalism would probably
a p p r o x i m a t e most to the paternalististic b e h a v i o u r
compatible with New Zealand society.
As we have seen, the freedom to receive information is
a fundamental right and freedom ensured for every New
Zealand citizen. To justify a ban on DTCA-PM, the state
must show that the voluntariness of action based upon
information from DTCA-PM is sufficiently compromised
to warrant a paternalistic policy. The nature and the
seriousness of the harms caused by DTCA-PM will be crucial
to the verdict.
A. How substantial are the alleged harms of
DTCA-PM?
The Toop Report(4) offers a comprehensive documentation
of the harms of DTCA-PM. Much of the evidence comes
from the USA which is battling steeply rising costs in the
health care sector. New Zealand's health care system is
different to that in the USA. Hence it is problematic to
generalise the US experience of DTCA-PM to New Zealand.
Any decision to ban DTCA-PM in New Zealand will need
to consider such a ban within the local context.
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Lau
1) DTCA is harmful because the information it provides
is biased, incomplete, misleading or deceptive
The fact that advertisements are inherently biased or
inadequate as sources of information is not sufficient reason
to ban them. Advertisements are common in capitalist
economies. Consumers generally understand their nature
and do not trust all the claims that advertisements make.(12,
13) According to both the Colmar Brunton telephone survey
quoted in the Toop Report (14) and the survey conducted
by the UK Consumers' Association,(15) consumers are in
general sufficiently aware that the information provided
by drug advertisements may not be trustworthy.
Given that sick people might be more vulnerable to
e x p l o i t a t i o n , and given that i n a p p r o p r i a t e use of
prescription medicines can lead to serious harm, New
Zealand regulators have insisted that certain information
be included in DTCA-PM so that sound choices can be
made. Where there are serious omissions (e.g. failure to
mention side effects or specific indications for use, or where
benefits are exaggerated), it would be simple enough to
require that advertisements be more specifically and tightly
regulated under the existing provisions of the Medicines
Act 1991. Health warnings similar to those that appear on
tobacco advertisements could be mandated to advise
consumers that a drug may have a higher risk of side effects.
Closer monitoring of advertisements and heavier penalty
for non-compliance are more direct ways of dealing with
the problem of bias and incompleteness.
It is concerning that up to 30O/oof all DTCA-PM in New
Zealand may have breached the law.(6) The introduction
of TAPS in 1999 shows that advertisers are not completely
resistant to regulations, although concerns about conflict
of interest make the system controversial. Representation
of medical and health professionals in the adjudication
process may bolster the efficacy of this system of regulation
as well as public confidence in it.
While the system is not completely effective yet, it is not
convincing that a satisfactory level of protection might not
be achievable using different means other than a ban. Indeed,
a survey conducted in New Zealand showed that almost
700/0 of over 600 adult respondents opposed such a ban.(16)
2) DTCA is harmful because it leads to over-prescription
of expensive new drugs and distorts expenditure on health
In 2002, PHARMAC reported a 42% increase in dispensing
volumes for the four most heavily advertised prescription
page 72 journal of b i o e t h i c a l inquiry v o l u m e t w o n u m b e r t w o
medicines: Flixotide (Fluticasone), Losec (Omeprazole),
Lamisil (Terbinafine), and Oxis (Oxiconazole).(2) This may
appear alarming, but it should be considered in context.
The increase in dispensing volumes could reflect an increase
in the need for the drugs rather than unreasonably raised
expectations.
In New Zealand, PHARMAC determines when and how
government subsidies will be made available, and for which
medicines. Its influence in the use of prescribed medicines
is substantial. For prescription medicines that are not
covered by PHARMAC, the entire cost is borne by the
c o n s u m e r with no effect on the healthcare budget.
PHARMAC effectively controls public expenditure on
medicines. Its budget has increased at a consistent rate of
1.5O/o per annum over the past ten years in spite of the rise
in DTCA-PM activity in the past six years.(17) Furthermore,
information disclosed by PHARMAC in 2003 showed that
the actual e x p e n d i t u r e on asthma inhalers, w h i c h
represented one of the medicines heavily advertised and
subsidised, had remained relatively stable over a three year
period from 2000 to 2003.(18) Thus, it appears that more
people might be benefiting without a concomitant increase
in overall cost. So far, there is no data to support a distortion
of the distribution of the healthcare budget.
3) DTCA is harmful because it puts pressure on doctors to
prescribe new drugs whose side effects are not fully known
Like other medicines available to the consumers, DTCA-
PM drugs have gone through Phase III clinical trials and
relevant approval processes. The fact that they are relatively
new might mean that not all possible side effects are known.
New Zealand law recognises the potential harm that could
result from indiscriminate use of these medicines. Medical
knowledge and experience together with proper monitoring
are required for their administration. They are classified as
prescription-only medicines in order that they can only be
legally sold, supplied and administered with a prescription
from a medical practitioner or other designated personnel.
Prescribers are the 'gate-keepers'. An ordinary consumer
does not have direct access to these medicines. The only
option for a consumer persuaded by the information
received from DTCA-PM is to approach his or her doctor
for f u r t h e r advice. A p a r t f r o m cost and m i n o r
inconveniences, no substantial harm would result from such
a visit. On the contrary, it is often a source of valuable
medical information.

The Toop Report suggested that doctors perceive pressure
from healthcare consumers exposed to DTCA.(4: 6, 19)
Studies conducted on family practitioners in New Zealand
have not shown this to be a serious concern. For example, a
majority of the general practitioners interviewed in one study
reported that most patients accepted recommendations that
were different from what they had asked about without
serious disappointment. Only under a quarter of GPs
perceived, in less than a quarter of their patients, serious
disappointment to the extent that patients would consider
changing doctors.(20: 23) Today's healthcare environment
nurtures a partnership relationship between doctors and
patients. As patients become more generally informed, they
also become more forthcoming and assertive with their needs.
Feeling some pressure in the clinical encounter is therefore
not unusual. Prescribing a medicine requires not only
knowledge and experience, but also good communication
skills. With or without DTCA, patients frequently have
preconceived ideas about a medical condition. Doctors need
not perceive these as unreasonable demands from patients
and therefore a source of pressure. The clinical encounter
provides a precious opportunity for communication.
Handling pressure does require skill. Training doctors
in communication and pressure management will be useful.
By establishing guidelines and recommendations in the
use and monitoring of medicines, as well as by continually
educating the public on good medical practices, the medical
profession promotes positive exchange of information.
Recent data revealed serious harmful effects of certain
new drugs such as Vioxx (Rofecoxib), which have to be
recalled by their manufacturers.(21) The magnitude of the
harm was alarming. Given that these drugs were very
heavily advertised directly to consumers, it was tempting
to conclude that pressure induced by DTCA-PM was the
primary reason for the problem. But instead, at a United
States Senate Hearing on Finance, serious flaws were
discovered on how the FDA, through its Center for Drug
Evaluation, approved and monitored new drugs.(22) It
would have been easy to blame DTCA for the harm of
Vioxx (Rofecoxib). Paradoxically, this might have caused
more harm as the real reason for the problem might have
remained hidden.
B. The negative implications of banning
Advertisements reach audiences that span different social
classes and education levels. They may be an important
journal of b i o e t h i c a l inquiry volume two number two
Justified Paternalism?
source of information for underprivileged groups who enjoy
limited access to other sources of information. If it were
not for information obtained from DTCA, consumers may
not become aware of new treatments (e.g. for male sexual
impotence) and discuss treatment options with their doctors.
In a recent survey about the role of media in women's
healthcare decisions, half of the respondents indicated that
DTCA had helped them better understand and better
c o m m u n i c a t e with their doctors about p r e s c r i p t i o n
medicines.(23) A n o t h e r s u r v e y found that African-
American doctors supported DTCA because it prompted
their African-American patients to ask questions about their
medical conditions thus increasing their awareness and
participation in treatment.(24)
Providing information that is vetted by qualified medical
professionals is desirable. Limiting its provision to medical
sources is however not a good idea. The medical profession
has not always placed the interests of patients first, as the
history of medical experimentation shows. A diversity of
information sources could protect the public against the
possibility of unethical medicine. Ensuring minimal
interference with information exchange enables such
diversity to exist. Granted that it does not guarantee the
accuracy or the comprehensiveness of information, even
partially true or incomplete information can have benefits.
Diversity of information trains the mind to be inquisitive,
sceptical and aware. In the context of the 'information
revolution', the practicability of limiting sources of
information is doubtful in any case. Banning DTCA-PM is
unlikely to achieve the result of 'sanitising' health-related
information that the public is exposed to.
Conclusion
There are presently insufficient justifications for imposing
a ban on DTCA-PM in New Zealand. A ban directly
contravenes the public's right to freedom of expression.
Blanket prohibition of advertisements on prescription
medicines removes not only the problematic information
but also useful and informative health messages. While
there may still be many inadequacies in its regulation, there
is insufficient data to support that the claim that DTCA-
PM is causing serious harms to New Zealanclers. Restrictive
g o v e r n m e n t policies require clear and c o n v i n c i n g
justifications that are lacking in this case. Admitting
h o w e v e r that DTCA-PM can cause serious potential
problems, the government has undeniable responsibility
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Lau
to explore alternative solutions. Policies should be
specifically directed towards preventing the anticipated
h a r m . T h e m e d i c a l p r o f e s s i o n also h a s a c r u c i a l role to
play. P r a g m a t i c p r o g r a m m e s to e n h a n c e d o c t o r - p a t i e n t
communication a n d to e d u c a t e t h e p u b l i c are u s e f u l .
L i m i t i n g i n f o r m a t i o n d i s s e m i n a t i o n to s p e c i f i c s o u r c e s is
unnecessary and impractical. Any intervention for the
purpose of preventing harm must be balanced against
restricting fundamental rights and freedoms. Paternalism
is j u s t i f i e d w h e n t h e i n t e r e s t s to b e p r o t e c t e d r e p r e s e n t t h e
likely projected interests of the particular individual, when
t h e m e a n s o f d o i n g so w o u l d p o s e t h e l e a s t i n t e r f e r e n c e
with his rightful freedoms, and when non-interference was
n o t a n o p t i o n . T h e p r o p o s i t i o n to b a n D T C A - P M h a s n o t
b e e n s h o w n to m e e t t h e s e criteria. B a n n i n g D T C A - P M is
therefore not justified paternalism.
Bibliography
1. GAO. Prescription drugs: FDA oversight of direct-to-consumer
advertising has limitations. In: Report to Congressional Requestors.
United States General Accounting Office; 2002.
2. PHARMAC. Analysis of the increase in dispensing volumes in 2001/
2002. In. Wellington: PHARMAC; 2002.
3. Ministry of Health. Direct-to-consumer advertising of prescription
medicines in New Zealand. A discussion paper. In. Wellington:
Ministry of Health, New Zealand; 2000.
4. Toop L, Richards D, Dowell T, Tilyard M, Fraser T, Arroll B. Direct to
consumer advertising of prescription drugs in New Zealand: For health
or for profit? In: New Zealand Departments of General Practice,
Christchurch, Dunedin, Wellington and Auckland Schools of Medicine;
2003.
5. Health Care Program. Direct-to-Consumer Advertising (DTCA) and
Marketing of Pharmaceuticals (http://www.ncsl.org/programs/health/
rxads.htm), accessed 10 May 2005.
6. Pratt P. The results of a regulatory compliance survey of direct-to-
consumer advertisements for medicines. In. Wellington: Medsafe;
2000.
7. Dworkin R. Taking Rights Seriously, 7th edn. Cambridge,
Massachusetts: Harvard University Press; 1980.
8. Moonen v Film and Literature Board of Review. In: 2 NZLR. vol. 2:
page 74 j o u r n a l of b i o e t h i c a l i n q u i r y v o l u m e t w o n u m b e r t w o
CA; 2000: 16.
9. Feinberg J. Harm to Others, vol. 1. New York: Oxford University
Press; 1984.
10. VanDeVeer D. Paternalistic Intervention the moral bounds on
benevolence. New Jersey: Princeton University Press; 1986.
11. Feinberg J. Harm to Self, vol. 3. New York: Oxford University Press;
1986.
12. Hodnett J. Targeting consumers. Medical Marketing ~t Media 1995;
30(11):91-95.
13. Calfee J E. Public policy issues in direct-to-consumer advertising of
prescription drugs. Journal of public policy and marketing 2002;
21(2):174.
14. Colmar Brunton. Consumer opinion: Prescription medicines
information. Prepared for Department of General Practice Christchurch
School of Medicine and Health Sciences. In: Colmar Brunton Social
Research Agency; 2003.
15. Consumers' Association (UK). DTCA survey results. In. London:
Consumers' Association (UK); 2002.
16. Massey News. Massey Researchers Question Otago DTCA Survey
Conclusions. In: Massey News, Massey University, 2003.
17. Association of New Zealand Advertisers. Direct to consumer
advertising of prescription medicine (DTCA) part of a well
functioning democracy and economy. In: New Zealand Direct
Marketing Association Inc., 2004.
18. Saunders B. DTCA and the cost of asthma inhalers. The New Zealand
Medical Journal 2003; 116(1185):672.
19. Aiken K J. Direct-to-consumer advertising of prescription drugs:
physician survey preliminary results. In. Rockville, Maryland: Division
of Drug Marketing, Advertising and Communications, FDA; 2003.
20. Eagle L, Chamberlain K: DTC. Dogma, doubts, diversity and
divergence: Perspectives from the medical professions regarding the
impact of the promotion of medications direct to consumers- Technical
report 03.01. In. Auckland: Massey University; 2003; 1-64.
21. The Vioxx Recall (http://www.abe.net.au/4eorners/eontent/2005/
s1341036.htm), accessed 10 May 2005
22. United States Senate Committee on Finance Hearings 'FDA,Merck
and Vioxx. Putting patient safety first?' (http://finanee.senate.gov/
sitepages/hearing lll804.htm), accessed 10 May 2005.
23. Kahn C. How the media influences women's perceptions of health
care. Marketing Health Services 2001(Spring):13-17.
24. Allision-Ottey S D, Ruffin K, Allision K B. To do no harm. In: Survey
of the physicians of the National Medical Association regarding
perceptions on DTC advertisements. Survey of the physicians of the
National Medical Association regarding perceptions on DTC
advertisements; 2002.