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Direct-to-Consumer Advertising

of Pharmaceuticals as a Matterof Corporate Social Responsibility?

Pepijn K. C. van de PolFrank G. A. de Bakker

ABSTRACT. Direct-to-consumer advertising (DTCA)

of prescription drugs has been a heavily contested issue

over the past decade, touching on several issues of

responsibility facing the pharmaceutical industry. Much

research has been conducted on DTCA, but hardly any

studies have discussed this topic from a corporate social

responsibility (CSR) perspective. In this article, we use

several elements of CSR, emphasising consumer auton-

omy and safety, to analyse differences in DTCA practices

within two different policy contexts, the United States of

America and the European Union (EU). Doing so results

in an alternative analysis of the struggle between propo-

nents and opponents of DTCA from a CSR perspective,

adding an alternative view on this debate.

KEY WORDS: corporate social responsibility (CSR),

pharmaceutical industry, direct-to-consumer-advertising(DTCA), consumer safety

Introduction

As in many industries, addressing corporate respon-

sibility has become increasingly important in the

pharmaceutical industry. This industry regularly

features in the media and is confronted with a wide

variety of stakeholder demands: issues of corporateresponsibility then often are raised. After all, the

products the pharmaceutical industry develops, pro-

duces and markets are related to crucial issues such as

health, well-being and poverty, while developing

these products requires huge investments and is

heavily regulated. These diverse characteristics could

easily give rise to contradictory interests. In order to

examine some of these contradictions, we will focus

on one practice used in this industry taking a

corporate social responsibility (CSR) perspective: the

direct promotion of prescription drugs to consumers.

Over the past decades, the pharmaceutical

industry has been struggling to address differentstakeholder demands effectively since merely meet-

ing regulatory requirements did not seem to be

enough to address these demands well and to

operate in a manner perceived as responsible by the

wider public. Issues often debated include the

availability of drugs in developing countries and,

closely related, patent issues (Attaran, 2004; Resnik,

2001), as well as the growing attention for issues of

environmental management within the pharma-

ceutical industry (Berry and Rondinelli, 2000;

Blum-Kusterer and Hussain, 2001). Issues like these

are related to the broader theme of CSR, which is

often defined as comprising the economic, legal,

ethical and philanthropic responsibilities of a firm

(Carroll, 1999) and which is receiving increased

attention within the pharmaceutical industry

(Leisinger, 2005; Sones et al., 2009). CSR involves

a careful balancing act of different demands, which

can be complicated, not in the least when differ-

ent national contexts are involved, bringing in an

even wider variety of stakeholder expectations. All

these issues are at play in the continuing debate on

the acceptability of direct-to-consumer advertising(DTCA) of pharmaceuticals.

Much has already been written about DTCA and

the advantages and disadvantages associated with it,

often focusing on issues of patient autonomy and

empowerment (Fisher and Ronald, 2008; Zachry

and Ginsburg, 2001). Proponents of DTC com-

munication emphasize the need for patient

empowerment, as a patient has the right to receive

accurate and reliable information (Fabius et al.,

Journal of Business Ethics (2010) 94:211224 Springer 2009

DOI 10.1007/s10551-009-0257-z
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2004, p. 169). Other claimed advantages of DTCA

include that it would contribute to lowering pre-

scription drug prices through increased competition

within the industry, improve patient compliance to

their therapy, and educate patients on availabletreatments for causes they considered untreatable

(Desselle and Aparasu, 2000). Also, Auton (2006)

points at improved relationships between doctors

and patients. Yet, as Deselle and Aparasu (2000, p.

104) also note Opponents to DTCA cite numerous

concerns. One is that the principles of advertising are

not synonymous with patient education. Oppo-

nents for instance argue that these advertisements

are not unbiased sources of information but, instead,

tend to be one sided product appraisals which pro-

duce unrealistic expectations of the benefits ofmedicines (Gilbody et al., 2005, p. 246). DTCA

also could increase pressure on doctor visits, which

could damage the doctor/patient relationship (Au-

ton, 2006). Other potential problems these authors

signal include the creation of an unnecessary demand

for drug products, the risk of misguided self-diagnosis

by patients, and the fact that an increase in adver-

tising costs will be included in drug prices. Diverting

R&D funds might be another problem associated

with DTCA (Auton, 2006), while DTCA also is

claimed to highlight cure over prevention (Wyke,

2004). Many of these advantages and disadvantagesrelate to issues of responsible corporate behaviour.

This makes CSR a relevant angle to analyse DTCA.

Over the past decade, many studies on DTCA

and its effects have been published,1 often with

mixed results (see Auton, 2006 for a review). This

ranges from studies on responses of medical profes-

sionals (Parker and Pettijohn, 2003; Zachry et al.,

2003) and health care consumers to DTCA (Auton,

2007; Friedman and Gould, 2007), to the techniques

used in advertisements to convince consumers

(Cline and Young, 2004; Kaphingst et al., 2004),and the consumer believability and understanding of

these advertisements (Beltramini, 2006). Surprisingly

few studies, however, link DTCA to issues of CSR,

even though arguments of both proponents and

opponents rely heavily on different aspects of

responsibility. This article aims to fill this gap in the

current literature.

In different geographical spheres, different assess-

ments of DTCA and its advantages and disadvantages

have been made, leading to different responses to the

question of whether DTCA of prescription drugs

should be allowed or not? In the European Union

(EU), DTC advertising is prohibited, whereas in the

United States (US) and in New Zealand this form of

advertising has been allowed.2 Both proponents andopponents of DTCA claim that their position would

contribute to a safe choice of prescription drugs,

while pointing at the risks associated with their

adversaries perspective. A central argument of both

groups hence is based on consumer autonomy and

issues of safety; the way pharmaceutical companies

deal with this issue could be seen as part of CSR.

Assessing DTCA from a CSR perspective is a novel

contribution to this debate which can help in ana-

lysing the tensions between social and corporate

interests involved. After all, CSR speaks to both thecorporate and societal interests that are at play. In

this article, we therefore address the question: how

could the contribution of DTCA of prescription

drugs to a safe product choice in the pharmaceutical

industry be understood from a CSR perspective? In

order to address this question, we analyse the dif-

ferent positions on DTCA from a CSR perspective.

In the next section we will first discuss the concept

of DTCA, followed by a section on its link with

CSR. Then, we present the main arguments pro-

ponents and opponents raise, leading to an overview

of arguments used in two different policy contexts tofinally explain how arguments based on CSR could

contribute to an alternative analysis of this debate in

the final section.

Direct-to-consumer advertising

for prescription drugs

The pharmaceutical industry regularly attracts pub-

licity. New treatments or promising discoveries

make it to the headlines but every now and then thecollision between commercial and health interests in

this industry also generates attention. In order to

understand the background of DTCA, it is impor-

tant to realize that promoting and marketing activ-

ities in the pharmaceutical industry have strongly

increased over time (Medawar, 2002). The World

Health Organization (WHO) defines drug promo-

tion as: all informational and persuasive activities by

manufacturers and distributors, the effect of which is

to induce the prescription, supply, purchase and/or

212 Pepijn K. C. van de Pol and Frank G. A. de Bakker
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use of medicinal drugs (Norris et al., 2004, p. 3).

How could this increase in drug marketing be

explained? The structure of the pharmaceutical

industry is an important factor here as patents play an

important role in this industry. Patents allow firms aperiod of above-normal profits for a technically and

commercially successful product; this period then

should stimulate further investment and invention

(Vogel, 2002). Such a system impedes competitive

imitation of an invented product (Vogel, 2002), but

also causes a concentrated marketing effort during

the first few years a product is on the market (de Laat

et al., 2002). After all, these are the years most

money can be earned by the patent holder as patents

allow them a set of exclusive rights for a limited

period of time. This business model contributes toan increased reliance on marketing.

Since the 1980s marketing activities gradually

extended towards the general public (ACP/ASIM,

1998; Berger et al., 2001), next to a (continued)

focus on medical professionals. The traditional push

strategy, in which prescription drugs were mainly

promoted to physicians, is supplemented with a pull

strategy in which consumer demand is actively

stimulated (Buckley, 2004; Parker and Pettijohn,

2003). According to Pinto et al. (1998; in Mintzes,

2006), in the US this development can be attributed

to the growth of managed care and to the intro-duction of policies to restrict drug costs, such as

limits on manufacturer representatives access to

doctors, limited formularies and bulk buying.

DTCA allowed manufacturers to bypass these limits

by turning directly to the patient/consumer.

Medawar (2002) argues that in the EU the phar-

maceutical industry is also interested in DTCA

because it considers itself no longer able to be

innovative enough to preserve constant high growth

rates. Market growth then can only be realized by

focusing on the most profitable pharmaceuticals, theso-called blockbusters (Medawar, 2002) which

requires more emphasis on marketing and branding.

As Auton (2007, pp. 667668) notes it is likely that

as consumers become increasingly engaged in the

awareness and choice of drug treatments [], the

pharmaceutical brand will become as important as

any consumer brand. Indeed, Fisher and Ronald

(2008, p. 3) for instance reported that 48% of the

$20.8 increase in spending for prescription drugs in

the US from 1999 to 2000 was from sales of the 50

drugs most advertised to consumers; the remaining

9850 available drugs accounted for the remaining

52%. The same authors also note that DTCA

spending rose steeply from $300 million in 1995 to

$3 billion in 2003 (Fisher and Ronald, 2008).Although these figures only form part of the total

amount of the US promotional spending on phar-

maceuticals (which Gagnon and Lexchin (2008)

recently estimated at $57.5 billion) and can be

contested, they do indicate that huge commercial

interest are at stake in DTCA and that the amounts

spend on DTCA are increasing.

Toop et al. (2003, p. iii)3

define DTCA as the

practice of advertising medicines to lay populations

in order to increase sales brand awareness and

establish loyalty. Yet, there is a difference betweenDTCA for prescription-only drugs and DTCA for

non-prescription drugs. The latter are also known as

over-the-counter drugs. Over-the-counter drugs

are generally relatively safe and are for conditions

that do not require a physicians diagnosis. Other

medicines have prescription-only status because a

physicians assistance is considered necessary for safe

and appropriate use. This may be due to the com-

plex nature of the diagnosis or because of the

medicines potential toxicity (Mintzes, 2006, p. 5).

It is this category of prescription only drugs we focus

on here. Before we can identify and analyse bothproponents and opponents arguments from a CSR

perspective, in the next section we will explore the

link between CSR and DTCA.

CSR and DTCA

On CSR a wide variety of definitions and concepts

has already been coined (cf. Carroll, 1999; de Bakker

et al., 2005; Garriga and Mele, 2004; Lee, 2007), also

in relation to marketing activities (Maignan andFerrell, 2004). Given the variety of definitions and

interpretations of CSR, some authors argued that

CSR has become an umbrella construct (den Hond

et al., 2007; van Oosterhout and Heugens, 2007).

We will not discuss these definitions here4 as our aim

is not to provide yet another definition of CSR.

Rather, we will look for some key elements of CSR

to see how they could be applied to DTCA. After

all, the precise definition of a firms responsibility

strongly depends on who is defining the term; one

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stakeholder will see a firms responsibility as more

encompassing than another; one will see DTCA as

contributing to consumer safety while another one

will not. For our question of how DTCA of pre-

scription drugs could contribute to a safe productchoice, using one single definition of CSR probably

is not helpful as we are not highlighting CSR per-

formance of individual firms or industries, but focus

on CSR aspects of one particular marketing practice.

We therefore approached CSR from a slightly dif-

ferent point of view.

As proponents and opponents of DTCA both

claim that their perspective leads to a safe choice of

prescription drugs, and therefore could be seen as

responsible behaviour, it is useful to look at some

arguments often used to justify CSR. Werther andChandler (2006), for instance, distinguish between

moral, rational and economic arguments for CSR. A

moral argument rests on the relationship between a

firm and the societal expectations and principles; a

rational argument involves performance maximiza-

tion by a firm through minimizing restrictions on its

operations; and an economic argument is based on

the firms economic self-interest (Werther and

Chandler, 2006). Likewise, Garriga and Mele (2004)

suggest that most CSR theories highlight four ele-

ments: long-term profits, responsible behaviour by

firms, the integration of societal demands, and acontribution to society via ethical corporate con-

duct. Many of these classifications boil down to a

mix of economic and societal arguments, where

societal demands also incorporate ethical consider-

ations. Using these two broad categories also makes

sense if we look at the limited relevant international

guidelines available.

The DTCA debate unfolds at an international

level: different judgements are made in different

geographical spheres and proponents and opponents

alike point at the situation in other countries.Therefore, we focus on several CSR notions based

on international guidelines that pose direct or indi-

rect obligations and responsibilities to corporations.

In CSR literature an international context reference

is often made to the OECD guidelines and the ILO

convention. Although these two sets of guidelines

provide relevant recommendations, mainly aimed at

multinational enterprises (MNEs), they cover a wide

variety of issues related to CSR, including the way

MNEs deal with business, labour, governments and

society as a whole (Gordon, 2001). As we are

focusing on consumer safety and autonomy rather

than on broader chain management issues such as

workers conditions, the United Nations Guidelines

for Consumer Protection (UN, 1999) provide auseful set of criteria. They form a frame of reference

that contains an inventory of standards, agreements

and operational aspects that play a role in an inter-

national CSR context. The UN guidelines can be

seen as an internationally recognized set of minimum

objectives in terms of consumer protection (Harland,

1987) an issue central to the DTCA debate. They

cover different areas, including promotion and

protection of consumers economic interests, stan-

dards for the safety and quality of consumer goods

and services, educational programs, but also mea-sures relating to specific products, including phar-

maceuticals (Harland, 1987). In a sense, these

guidelines thus can be seen as a CSR framework

which highlights the position of consumers. In the

case of DTCA, such a framework can be interpreted

as striving to increase transparency through a safe and

reliable provision of information to consumers. The

discussion then is whether this information should

be provided via the prescriber or directly to the

patient/consumer. In order to apply these con-

sumer-oriented CSR guidelines to the DTCA de-

bate we will focus on the central objectives ofDTCA policies in the US and the EU and the

possible tensions between these objectives in the

next section, highlighting firms economic and

societal responsibilities.

Proponents and opponents on DTCA

Reading the extensive literature on DTCA learns

that opinions and findings on DTCA diverge. From

some of the debates, especially those in the editorialpages of medical journals or in newspaper articles, it

seems as if the opinions are sharply divided: either

you support DTCA or you strongly reject it.

However, in reality there often appear to be more

nuances in the debate and opinions among pre-

scribers, pharmacists and patients are more divided.

They might see some of the positive aspects of

DTCA, but also understand some of the difficulties

associated with it.5 In order to discuss the main

arguments put forward in this debate, in this section

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we will nevertheless contrast proponents and oppo-

nents views on DTCA. As DTCA is presented as a

matter of responsibility, we will organize the argu-

ments pro and con according to the two types of

arguments for CSR outlined earlier: economic andsocietal arguments.

Proponents arguments

Regarding the economic arguments, proponents of a

more tolerant DTCA policy argue that banning

DTCA would lead to restrictions on competition,

which eventually could be disadvantageous for the

consumer. Competitiveness could be in the con-

sumers interest if it would lead to lower prices,better quality, new products and greater choice

(Vickers, 2002). Wilkes et al. (2000) suggest that

advertising may increase drug costs to the consumer

under certain circumstances, but decrease costs in

other circumstances. When there is a competing

drug on the market, advertising may stimulate

competition and lower prices; when no such com-

petitor exists, advertising costs may simply be passed

onto the consumer. However, this argument does

not consider the prescription drugs effectiveness.

An inexpensive drug that is not needed or that treats

a trivial condition adds to health spending, whereas avery expensive drug that prevents a costly disease

could be a bargain (Wilkes et al., 2000, p. 122). In

relation, some other arguments also rely on eco-

nomics as DTCA is claimed to add to improved

treatment and compliance. This should avoid more

expensive medical treatments such as hospitalization

and surgeries and therefore contribute to overall

healthcare cost savings (Auton, 2007).

As for societal arguments, proponents of DTCA

suggest that promotion of medicines leads to more

conscience about diseases, both with patients anddoctors and therefore could lead to better detection,

diagnosis and treatment (Dubois, 2003). This greater

conscience then would also lead to an improved

patient compliance in taking prescribed medication

and to more patient autonomy in their own health

care (cf. Mintzes, 2006) and would tackle under-

treatment. As Auton (2007, p. 168) summarizes this

stance DTCA-informed patients are more involved

in their healthcare. He also points at the overall

trend towards greater consumer involvement in

healthcare and the role DTCA could play in that

trend and at the improved physician/patient rela-

tionship (Auton, 2007). Raising patients involve-

ment in their treatment could be regarded as

contributing to safety in consumer choice and to animproved patient autonomy. Although both eco-

nomic and societal arguments seem quite favourable

for DTCA, opponents have a different view on this.

Opponents arguments

While proponents paint a rosy picture of DTCA,

strong opponents of DTCA believe there are no

possible competitive advantages associated with

DTCA, while safety in consumer choice is threa-tened by this advertising practice. Regarding the

economic arguments, early in the DTCA debate

the American College or Physicians (ACP) and the

American Society of Internal Medicine (ASIM)

warned that, in a situation of trade liberalization,

producers in the pharmaceutical industry could focus

just on producing blockbuster medicines (ACP/

ASIM, 1998). Such an over-marketing of the most

profitable medicines could harm quality, price,

innovativeness and doctors options to choose

medicines, they argued Marketing is for profit,

not consumer education and health (Auton, 2006,p. 25). Opponents also believe DTCA may have

negative effects on competition in pharmaceutical

industry because the huge costs associated with

DTCA contribute to higher drug prices and are a

hurdle for the potential market entry of new com-

petitors (cf. Almasi et al., 2006).

Next to the impact that results from competition,

regarding societal responsibilities opponents point at

the danger that DTCA negatively influences doc-

tors prescription behaviours. Berger et al. (2001)

note that health differs from other typical consumerneeds because of its fundamental necessity and the

huge impact of a wrong diagnosis and/or treatment.

Given the possible health risks for the consumer,

DTCA differs from regular advertising expressions

(Berger et al., 2001). Mello et al. (2003) wonder

whether the information given through DTCA is

not prejudiced by nature and therefore would be

unsuitable for passing on objective and balanced

information as would be expected from medical

professionals. Where proponents argue that DTCA

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serves an educational mission, opponents argue it is

contradictory to have a category of drugs labelled

prescription made available through those with

specialized training, yet allow those same drugs to be

marketed to people who lack that specializedknowledge (Wilkes et al., 2000). Due to lack of

knowledge about benefits and risks, DTCA may

encourage patients to pressure their prescribers to

switch them from well-studied treatments to new

prescription drugs, on which benefits and risks less is

known (Wilkes et al., 2000). DTCA then could

damage the doctor/patient relationship and could

medicalise conditions, for instance those often seen

as common to human existence and ageing (Auton,

2006). Likewise, Auton (2006) continues, DTCA

could increase pressure on doctor visits and ondoctors workloads.

Opponents and proponents hence use different

arguments, both on the economic and societal side.

Following this, in different countries different

judgements have been made. Remarkably, in these

different situations, policy makers often refer to

elements of CSR to underpin their respective stance.

In the next section, we will briefly compare the US

context to that in the EU as two examples of policy

contexts that show a stark contrast on this issue.

DTCA in two different policy contexts

In order to judge the arguments advanced to claim

that DTCA leads to a safe choice of prescription

drugs and an improvement of health care, we

examined the situation in the US6 where DTCA for

prescription drugs is permitted, and in the EU where

DTCA for prescription drugs is not permitted. We

base our analysis on close reading of the literature on

DTCA over the past decade, highlighting the

arguments quoted for both situations.

7

Differences in regulatory frameworks are impor-

tant when different policy contexts are compared.

Norris et al. (2004) highlight that governments, and

other organizations that introduce policies to regu-

late promotional activities for pharmaceuticals, need

good evidence of the potential advantages and

drawbacks of different systems. Regarding DTCA

policies, in the US a relatively central regulation is

pursued through the Food and Drug Administration,

FDA (Toop et al., 2003). Meanwhile, in the EU

since January 2005 the regulation of medicines8

offers two main routes for authorizing medicinal

products: a centralised authorisation procedure

through the European Medicines Evaluation Agency

(EMEA), which results in a single marketingauthorisation that is valid across the EU; and a

national authorisation procedure in which each EU

member state has its own procedures for the

authorisation, within their own territory, of medic-

inal products that fall outside the scope of the cen-

tralised procedure (EMEA, 2009). In a way, the

EMEA has a centralized role just like the FDA in the

US to harmonize the work of existing national

medicine regulatory bodies. At the same time,

Griffiths (2003) points out that in the complex

reality theoretical concepts such as self-regulationand government regulation must not be seen as

absolute contrasts but rather as part of a continuous

interaction. Acknowledging the fact that differences

in regulation make it more difficult to compare and

generalize these policies, we will now outline the

main objectives on DTCA in both contexts in more

detail.

US context

Since marketing activities for prescription drugs havegradually been expanded from medical professionals

only to the general audience as well, an increase in

DTCA in the US can be noted. This increase in

DTCA was driven in part by manufacturers need to

be more aggressive at marketing their products and

by regulators willingness to provide consumers with

new information, hoping to provide further con-

sumer education (Wilkes et al., 2000). Following

this development, within certain limits, it became

possible in the US to advertise for prescription-only

drugs. In 1997, this policy stance was ratified in aDraft Guidance for Industry: Consumer Directed

Broadcast Advertisements issued by the US FDA. In

August 1999, this Guidance got its final form (FDA,

1999). According to Zachry and Ginsburg (2001),

by issuing this guidance the FDA acted to protect the

consumer, based in part on its own interpretation of

what the level of consumers autonomy should be.

Autonomy in this discussion implies that a con-

sumer has the capacity to inform oneself, reason,

understand, and execute a choice satisfactorily free

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from controlling influence (Zachry and Ginsburg,

2001, p. 2026). Yet, some controlling influence still

remains present. Although DTCA is permitted

according to US regulations, several directives apply

for these advertisements. These directives havemostly been based on a voluntary basis and all

contain the expectation that advertisements are sin-

cere and that the contents of these ads provide fair

and balanced information on the benefits and risks of

therapy (ACP/ASIM, 1998; Zachry and Ginsburg,

2001). The degree of consumer/patient autonomy

hence is also restricted as DTCA must offer the

consumer an option to choose by providing insight

in the available prescription drugs and the way they

work. In addition, DTCA must also provide the

arguments that give the consumer a possibility tomake a safe choice out of the available products the

guidelines for instance refer to risk information.

In the current US policy these directives generally

are still guiding. Especially prescribers, gathered in

the American College of Physicians (ACP), have

been opposing this development. They advised the

FDA to forbid DTCA, or at least to strengthen the

existing regulations. The main objection ACP has

is that DTCA puts pressure on the relationship

between prescriber and patient/consumer because

publicity is often confusing, while it is time-con-

suming to clear up the misunderstandings that arisebecause of different interpretations of this informa-

tion (ACP, 2005). The FDA nevertheless has not

changed its position on DTCA.

EU context

The EU already responded in 1992 to the shift of the

marketing activities of the pharmaceutical industry

towards the general public.9 This directive con-

cerned European legislation on paid publicity formedicines in all European member states (Sullivan,

2000), stating for instance that DTCA for prescrip-

tion-only medicines was prohibited in all member

states. The aim of this directive seemed to be to

protect health care consumers, prescribers and sup-

pliers from any form of commercial pressure while

making a choice for medicines. Within the EU

context, each individual member state is responsible

for compliance with and interpretation of this

directive.

In July 2001, the European Commission adopted

a proposal in which a relaxation of restrictions

regarding DTCA was presented. In this proposal, it

was advised to enable pharmaceutical companies in

EU member states to provide direct information topatients suffering from AIDS, asthma or diabetes. In

October 2002, however, the European Parliament

rejected the proposal to relax the policy restrictions

on DTCA (EC, 2004). Despite this rejection, the

European Commission seems to recognize a grow-

ing demand for alternative information provision for

consumers. Probably this explains why the European

Commission has been developing a report with

forward proposals setting out an information strategy

to ensure good-quality, objective, reliable and non-

promotional information on medicinal products andother treatments and shall address the question of the

information sources liability (EC, Directive 2004/

27/EC, article 88a, p. 51).

A particular concern in the EU regulation is the

use of the Internet for DTCA. The global nature of

the Internet makes it hard to regulate DTCA, and

according to Sullivan (2000) this is weakening the

European DTCA regulation. As Buckley (2004, p. 6)

notes the Internet offers pharmaceutical companies

a largely unregulated way to reach the consumer

directly. Next to the difficulties of any potential

Internet regulation there is the fact that Europeanconsumers can legitimately see DTC advertisements

on US and New Zealand Internet sites (Sullivan,

2000). Closely related is the rise in Internet phar-

macies offering all sorts prescription drugs: consumer

safety aspects are often debated (Buckley, 2004).

However, DTCA on the Internet differs from other

kinds of DTCA because it requires a more active

search for information on the end of the consumer

(Sullivan, 2000). We will therefore not include this

specific form of DTCA in our analysis.10

Now that we have portrayed the main differencesbetween the US and the EU regarding DTCA over

the past decade, we will return to the CSR literature

to analyse these different situations.

Analysing both contexts

from a CSR perspective

In the individual choice process of prescription drugs,

the consumer, the prescriber, and the interactions

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between them, play a central role. In the original

objectives of both US and EU policies, different

weights were given to the roles these different actors

played. Where the US policy clearly emphasized

autonomy in consumers choice, the EU policyhighlighted prescribers control over the prescription

process. In order to analyse both situations from a

CSR perspective, we focused on the economic and

societal arguments used. From the overview above, it

appears that many of the arguments put forward in

both contexts by proponents and opponents alike

boil down to either economic/cost-effectiveness or

consumer empowerment and safety issues.

Proponents of DTCA argue that inhabitants of

countries in which DTCA is not allowed should

have access to the same information to make theirown choices as inhabitants of countries in which

DTCA actually is allowed (cf. Sullivan, 2000). Being

able to choose can be seen as an element of CSR,

comparable to the consumers right of choice as

outlined in the UN Guidelines for Consumer Pro-

tection. If consumers want to make an autonomous

choice out of several possible alternatives, DTCA

should provide them with enough information to

enable them to make a safe choice (Mello et al.,

2003). The second precondition for autonomy,

having the right arguments therefore can be linked

to the right for consumer education (UN, 1999). Inthe end, from a CSR perspective, one cannot speak

of autonomy until the pharmaceutical industry can

guarantee both the right to choose andthe right for

consumer education.

According to DTCA opponents, the very nature

of the products concerned, together with the strong

commercial interests involved, make DTCA an

unsuitable instrument to inform pharmaceuticals

end-users of their choices (cf. ACP/ASIM, 1998;Hollon, 1999). Similar arguments are found in the

original policy objectives the EU presented (EFPIA,

1993) in which maintaining control over the pre-

scription process by the doctor is important. In order

to do so, prescription of any treatment will have to

take place based on a medical judgement, without

being pressurized via DTCA. From such a point of

view, it is mainly the prescriber, the doctor, who has

to educate the patient/consumer, rather than the

industry. Therefore, the emphasis in this policy stance

on physicians control over the prescription processcan be linked to the CSR aspect the right for con-

sumer education (UN, 1999). When the prescriber

can indeed educate/inform the patient this could lead

to mutual consensus between prescriber and patient

on the choices made (ACP/ASIM, 1998). When a

consumer, based on this information, accepts the

prescribers choice more easily, this will lower the

pressure exerted on this prescriber.

In Table I, we have summarized the different

observations on the EU and US. Confronting the

central arguments of both contexts shows there is a

tension between the objective of consumer auton-omy and of prescribers control over the prescrip-

tion process. Question then is to what extent this

potential tension between both policy contexts

influences the eventual objective of safe consumer

TABLE I

Main arguments in EU and US around 2003

EU context US context

Central argument Control over prescription process Consumer autonomy

DTCA policy standpoint DTCA pressurises consumers and

prescribers in prescription process

DTCA provides consumer with arguments

to make a (more) independent and educated

choice

Expected result of DTCA Lack of objective and balanced

medicine information

Fair and balanced medicine information

Main CSR element applied The right for consumer education The right to choose

The right for consumer education

Way to accomplish

consumer safety

Rely on mere prescriber information DTCA Information, supplemented

with prescriber information



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choice of prescription drugs. After all, both policy

contexts aim for a safe choice of prescription drugs,

relating to the CSR element right for safety (UN,

1999). Yet, the ways both approaches contribute to

that right for safety vary. Given the specific prop-erties of prescription drugs and the potential health

risks associated with them, one could argue that

safety in choice is the main criterion to be used in

evaluating the different policy contexts in terms of

CSR. In the end, it is not the option to choose in

itself, nor the right to receive enough information

but the outcome of the choice process that matters

most: is the choice made, either by the prescriber or

the patient, a safe one? Underlying issues regard the

degree in which it is appropriate to allow an

industry such as Big Pharma to self-regulate in thearea of marketing (Buckley, 2004, p. 9). Societal

arguments as discussed in the earlier sections seem to

dominate the debate in both geographical spheres,

although ample reference also is made to economic

arguments. Responsibility, being willing and able to

answer justified questions from society (Lucas, 1993)

plays out in all these issues, both in the US and in

Europe.

According to Angel (2000, p. 1903), the phar-

maceutical industry is extraordinarily privileged: an

industry so important to the public health and so

heavily subsidized and protected by the governmenthas social responsibilities that should not be over-

shadowed by its drive for profits. Dealing with its

social responsibilities is important for firms to estab-

lish and to maintain its legitimacy, to decide where

companies fit within the social fabric (Werther and

Chandler, 2006, p. xvii). The pharmaceutical indus-

try indicates to be aware of its special position and

refers to CSR in its communications, both in Europe

and in the USA. The European Federation of

Pharmaceutical Industries and Associations (EFPIA),

which represents the research-based pharmaceuticalindustry operating in Europe, for instance claims to

view CSR as an important means for those involved

in looking for a balance between economic and

health care consumer interests see for instance their

recent position paper on patient information (EFPIA,

2009). The pharmaceutical industry also states to

recognize and acknowledges the need to act

responsibly towards society and the communities in

which it operates and to see the discovery of new

medicines and vaccines as a primary role and major

social responsibility (EFPIA, 2009). EFPIA (2009)

presents the continuing and expanding industry

efforts to ensure that patients have access to the

medicines they need as one example of CSR. They

view the promotion of medicines, for instance viaDTCA, as part of these efforts. In order to guide

these efforts EFPIA revised its Industry Code of

Practice for the Promotion of Medicines in 2004 to

ensure that pharmaceutical companies would con-

duct their promotional activities in a truthful manner,

avoiding deceptive practices and potential conflicts of

interest with healthcare professionals, and acting in

compliance with applicable laws and regulations

across Europe (EFPIA, 2009).

Meanwhile, in the US CSR arguments are quoted

as well. For instance, in the New York Times, thechief executive of Pfizer and chairman of the Busi-

ness Roundtable is portrayed as recognizing the

importance of CSR in the pharmaceutical industry,

also in relation to DTCA (Holstein, 2006). He

indicates that DTCA was a factor that caused a loss

of respect for the industry and suggests that the

industry didnt do enough to strengthen and rein-

force the importance of the physicianpatient rela-

tionship. It was a consequence of our success that we

created visibility for products and many people in

the public said, That would be nice, but we cant

afford it. (Holstein, 2006, p. 13). Again, societalarguments feature prominently but economic argu-

ments are also raised.

As outlined, in the EU, DTC advertising is cur-

rently prohibited whereas in the US and in New

Zealand this form of advertising has been allowed.

Certainly, differences in policies across countries are

not uncommon. Yet, what is typical in this case is

that both proponents and opponents of DTCA claim

to contribute to advantages for healthcare and a safer

choice of prescription drugs. Proponents view

commercial and societal interests as coming nicelytogether in DTCA, whereas opponents see these

two interests as diametrically positioned. In practice

the distinction might be less clear-cut: proponents

will see some possible advantages and opponents are

aware of possible disadvantages. At present, reforms

are presented by the EU to allow DTCA in a

restricted manner. Both the economic and societal

CSR arguments do not lead to one clear answer as to

how DTCA of prescription drugs could contribute

to a safe product choice in the pharmaceutical

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10/15

industry. Yet, taking the precautionary principle into

account, it is probably better to be safe than sorry.

Using such arguments recent proposals to relax the

ban on DTCA in Europe have been contested by a

broad coalitions of NGOs and other stakeholderssuch as the Standing Committee of European

Doctors (CPME). They stressed that the prescribing

doctor is a fundamental supplier of information and

thought it was not appropriate to allow the industry

to inform patients directly by any other means

(Euractiv, 2008).

Concluding remarks

As Cheah and colleagues (2007, p. 434) recentlyargued the pharmaceutical sector presents a stimu-

lating lens through which research in CSR can be

conducted, given the potential social and environ-

mental impact posed by its products and services. In

this article, we examined a practice within the

pharmaceutical industry that led to huge differences

in interpretation of what responsible corporate

behaviour would entail. It appeared that interpreta-

tions of what should be seen as responsible corporate

behaviour on DTCA differed between countries

where DTCA was allowed and ones in which it was

not. How much autonomy, and along with that,responsibility is to be handed over to the patient?

Would a patient be able to make a safe choice,

provided he/she has enough information, even

though this information is provided by a party with a

commercial interest in this information: the phar-

maceutical company? Until a few years ago, in

Europe the answer would have been negative and in

the US it would have been positive.

However, over the last few years both contexts

appear to have moved in each others direction. In

the US, serious doubt have been cast on DTCA,especially following the catastrophe with several

highly profitable, highly advertised products such as

Vioxx following clinical trials (ORourke, 2006).

Other reports suggest that the debate on DTCA

indeed has been an ongoing struggle in the US as

well (Elliot, 2002), that the FDA has been consid-

ering a tightening of DTCA regulations (Vastag,

2005), and, very recently, that the related topic of

advertisements for medical devices has become

subject of Senate Hearings (Meier, 2008). All in all,

in the US, the ideas on DTCA seem to be changing

and to become less in favour of a widespread use of

this instrument, referring to issues of responsibility.

Meanwhile, in Europe an opposite development can

be observed as the EU is looking into ways to relaxthe strict bans that currently apply (Euractiv, 2008).

Again, the debate in both policy contexts revolts

around the issue of safety of choice. As summarized

on the European news website Euractiv (2008):

Those opposed to the new rule argue that, if the

industry were allowed to inform the public directly,

a system should be put in place to oblige pharma

groups to validate the information according to

certain quality criteria. Firms need to provide ample

information, not only because they are liable for the

products they provide, but also to allow thosemaking a choice to make it well-informed.

Throughout the debate in both policy contexts there

is a clear tension between firms responsibility and

their liability. What should firms do on moral

grounds and what on legal grounds (and can these be

combined)? Ideas in both contexts seem to go more

and more towards blending both motivations, hence

reiterating Carrolls (1999) idea of CSR being

composed of economic, legal and ethical responsi-

bilities,11 or joining the economic and societal

arguments we applied in our analysis.

How DTCA will ultimately be shaped in both theEU and the US is yet to be seen but it certainly is an

interesting development to watch closely as it

highlights an element of CSR in the pharmaceutical

industry not often discussed. This alternative analysis

of the struggle between proponents and opponents

of DTCA provides an example on how different

policy contexts can lead to different interpretations

of a similar phenomenon. Further research would be

useful and several different areas seem opportune.

First, it would be interesting to build on stake-

holder theory to highlight in detail the roles andpositions of different stakeholders over time in this

debate in both policy contexts to understand why

these opposed positions initially were taken and now

seem to be abandoned. Second, the article has been

built on anecdotal analyses of the huge literature on

DTCA. As this topic touches on many issues,

ranging from medical professionals responses to

communication strategies, an extensive literature

review would be useful to uncover all the different

findings and opinions. Third, issues of governance



11/15

would form another relevant angle to study DTCA.

After all, one of the questions is whether DTCA

should be regulated and by whom. Is self-regulation

by the industry feasible or desirable? A recent study

on the effectiveness of codes of conduct on phar-maceutical marketing notes that there is a growing

body of academic and non-academic literature from

around the world that highlights growing public

concern over the pharmaceutical industries market-

ing practices and the industrys self regulation of

these practices (Devlin et al., 2007, p. 145).

Meanwhile, in the EU there are several plans to

increase the reliance on self-regulation. Finally, a

comparative study of similar debates in different

industries would be useful as interpretations of what

responsibility entails, to whom one is responsible andwho is to oversee this responsibility are not restricted

to the pharmaceutical industry. Comparable issues of

safety, economic and societal impact can be found in

the debate on food safety (Maloni and Brown, 2006),

although other debates might qualify as well. Using

a CSR perspective could introduce an alternative

interpretation of debates within such industries al-

though it must be noted that in practice the CSR

perspective does not exist. Although there might be

agreement on terminology, practical implementation

often leads to differences (den Hond et al., 2007).

Repeating this study over time might reveal some ofthese differences.

Notes

1 A literature review conducted a few years ago al-

ready spoke of 2853 articles on DTCA (Gilbody et al.,

2005).2 Although DTCA is allowed in the US and New

Zealand other countries are keeping an eye on this phe-

nomenon as well. For instance, in Canada, the ban on

DTCA is currently being challenged (Priest, 2007)

while the debate in the US and the EU also continues

(cf. Auton, 2007; Guthrie, 2007; Magrini and Font,

2007).3 It must be noted that, like many studies and publi-

cations on DTCA, this commissioned report by Toop

et al. (2003) was not uncontested (cf. Saunders, 2003).

In this article, we will not dwell into each individual

debate on these studies. However, the fierce debates

underline once again the difficulties associated with this

issue.

4 For an extensive overview of CSR in the context

of pharmaceuticals, see for instance Parker and Pettijohn

(2003).5 Thanks to an anonymous reviewer for this obser-

vation.6 As noted, DTCA is not only allowed in the US

but also in New Zealand. As most of the literature dis-

cusses the situation in the USA, we focus on this coun-

try.7 We did not conduct a full literature review aimed

at characterizing all studies on DTCA. After all many

papers focus on DTCA as a context for a specific

research question, such as its effects on patients and

physicians behaviour, or the way DTCA messages were

understood by consumers. We focused on those parts of

the papers in which policy issues were discussed and

sampled the texts to get a complete overview of these

discussions as possible.8 These regulations are laid out in Regulation (EC)

No 726/2004.9 This response was formulated in European direc-

tive 92/28/EEC.10 See Fabius et al. (2004) for an example of research

on DTCA via the Internet.11 Carroll (1999) also includes discretionary responsi-

bilities but these go beyond our study of DTCA in

general.

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Pepijn K. C. van de Pol

School of Sport and Exercise Sciences,

University of Birmingham,Birmingham, B15-2TT, U.K.

E-mail: [email protected]

Frank G. A. de Bakker

Department of Organization Science,

Faculty of Social Science,

Vrije Universiteit Amsterdam,

De Boelelaan 1081, 1081 HV, Amsterdam,

The Netherlands

E-mail: [email protected]

http://www.chmeds.ac.nz/report.pdfhttp://www.chmeds.ac.nz/report.pdfhttp://www.chmeds.ac.nz/report.pdfhttp://www.chmeds.ac.nz/report.pdf


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