Journal of Business Ethics (2010) 94:211224 DOI 10.

1007/s10551-009-0257-z

Springer 2009

Direct-to-Consumer Advertising of Pharmaceuticals as a Matter of Corporate Social Responsibility?

Pepijn K. C. van de Pol Frank 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 autonomy 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 proponents 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 responsibility 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 corporate responsibility then often are raised. After all, the products the pharmaceutical industry develops, produces 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 different stakeholder demands effectively since merely meeting 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 pharmaceutical industry (Berry and Rondinelli, 2000; Blum-Kusterer and Hussain, 2001). Issues like these are related to the broader theme of CSR, which is often dened as comprising the economic, legal, ethical and philanthropic responsibilities of a rm (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 different 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 communication emphasize the need for patient empowerment, as a patient has the right to receive accurate and reliable information (Fabius et al.,

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Pepijn K. C. van de Pol and Frank G. A. de Bakker 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 and opponents 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 analysing the tensions between social and corporate interests involved. After all, CSR speaks to both the corporate 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 different positions on DTCA from a CSR perspective. In the next section we will rst discuss the concept of DTCA, followed by a section on its link with CSR. Then, we present the main arguments proponents and opponents raise, leading to an overview of arguments used in two different policy contexts to nally explain how arguments based on CSR could contribute to an alternative analysis of this debate in the nal section.

2004, p. 169). Other claimed advantages of DTCA include that it would contribute to lowering prescription drug prices through increased competition within the industry, improve patient compliance to their therapy, and educate patients on available treatments 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. Opponents for instance argue that these advertisements are not unbiased sources of information but, instead, tend to be one sided product appraisals which produce unrealistic expectations of the benets of medicines (Gilbody et al., 2005, p. 246). DTCA also could increase pressure on doctor visits, which could damage the doctor/patient relationship (Auton, 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 advertising 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 disadvantages relate 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 professionals (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 ll this gap in the current literature. In different geographical spheres, different assessments of DTCA and its advantages and disadvantages have been made, leading to different responses to the

Direct-to-consumer advertising for prescription drugs The pharmaceutical industry regularly attracts publicity. New treatments or promising discoveries make it to the headlines but every now and then the collision between commercial and health interests in this industry also generates attention. In order to understand the background of DTCA, it is important to realize that promoting and marketing activities in the pharmaceutical industry have strongly increased over time (Medawar, 2002). The World Health Organization (WHO) denes drug promotion as: all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or

Direct-to-Consumer Advertising of Pharmaceuticals 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 rms a period of above-normal prots 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 rst 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 to an 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 introduction 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 pharmaceutical 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 protable pharmaceuticals, the so-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

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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 gures only form part of the total amount of the US promotional spending on pharmaceuticals (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 dene 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 between DTCA 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 complex 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 both proponents 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 denitions and concepts has already been coined (cf. Carroll, 1999; de Bakker , 2004; Lee, 2007), also et al., 2005; Garriga and Mele in relation to marketing activities (Maignan and Ferrell, 2004). Given the variety of denitions 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 denitions here4 as our aim is not to provide yet another denition 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 denition of a rms responsibility strongly depends on who is dening the term; one

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Pepijn K. C. van de Pol and Frank G. A. de Bakker 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 a useful 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 international 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, standards for the safety and quality of consumer goods and services, educational programs, but also measures relating to specic products, including pharmaceuticals (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 consumer-oriented CSR guidelines to the DTCA debate we will focus on the central objectives of DTCA policies in the US and the EU and the possible tensions between these objectives in the next section, highlighting rms economic and societal responsibilities.

stakeholder will see a rms 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 prescription drugs could contribute to a safe product choice, using one single denition of CSR probably is not helpful as we are not highlighting CSR performance of individual rms or industries, but focus on CSR aspects of one particular marketing practice. We therefore approached CSR from a slightly different 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 and Chandler (2006), for instance, distinguish between moral, rational and economic arguments for CSR. A moral argument rests on the relationship between a rm and the societal expectations and principles; a rational argument involves performance maximization by a rm through minimizing restrictions on its operations; and an economic argument is based on the rms economic self-interest (Werther and (2004) Chandler, 2006). Likewise, Garriga and Mele suggest that most CSR theories highlight four elements: long-term prots, responsible behaviour by rms, the integration of societal demands, and a contribution to society via ethical corporate conduct. Many of these classications boil down to a mix of economic and societal arguments, where societal demands also incorporate ethical considerations. 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 indirect 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

Proponents and opponents on DTCA Reading the extensive literature on DTCA learns that opinions and ndings on DTCA diverge. From some of the debates, especially those in the editorial pages 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 prescribers, pharmacists and patients are more divided. They might see some of the positive aspects of DTCA, but also understand some of the difculties associated with it.5 In order to discuss the main arguments put forward in this debate, in this section

Direct-to-Consumer Advertising of Pharmaceuticals we will nevertheless contrast proponents and opponents views on DTCA. As DTCA is presented as a matter of responsibility, we will organize the arguments pro and con according to the two types of arguments for CSR outlined earlier: economic and societal arguments.

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healthcare and the role DTCA could play in that trend and at the improved physician/patient relationship (Auton, 2007). Raising patients involvement in their treatment could be regarded as contributing to safety in consumer choice and to an improved patient autonomy. Although both economic and societal arguments seem quite favourable for DTCA, opponents have a different view on this.

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 consumers 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 competitor 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 a very 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 economics 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 and doctors 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 undertreatment. 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 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 threatened 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 protable medicines could harm quality, price, innovativeness and doctors options to choose medicines, they argued Marketing is for prot, 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 competitors (cf. Almasi et al., 2006). Next to the impact that results from competition, regarding societal responsibilities opponents point at the danger that DTCA negatively inuences doctors prescription behaviours. Berger et al. (2001) note that health differs from other typical consumer needs 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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Pepijn K. C. van de Pol and Frank G. A. de Bakker 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 marketing authorisation 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 medicinal products that fall outside the scope of the centralised 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, Grifths (2003) points out that in the complex reality theoretical concepts such as self-regulation and 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 difcult to compare and generalize these policies, we will now outline the main objectives on DTCA in both contexts in more detail.

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 specialized knowledge (Wilkes et al., 2000). Due to lack of knowledge about benets and risks, DTCA may encourage patients to pressure their prescribers to switch them from well-studied treatments to new prescription drugs, on which benets 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 on doctors 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 briey compare the US context to that in the EU as two examples of policy contexts that show a stark contrast on this issue.

US context Since marketing activities for prescription drugs have gradually 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 consumer 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 ratied in a Draft Guidance for Industry: Consumer Directed Broadcast Advertisements issued by the US FDA. In August 1999, this Guidance got its nal 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 consumer has the capacity to inform oneself, reason, understand, and execute a choice satisfactorily free

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 important when different policy contexts are compared. Norris et al. (2004) highlight that governments, and other organizations that introduce policies to regulate 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

Direct-to-Consumer Advertising of Pharmaceuticals from controlling inuence (Zachry and Ginsburg, 2001, p. 2026). Yet, some controlling inuence still remains present. Although DTCA is permitted according to US regulations, several directives apply for these advertisements. These directives have mostly been based on a voluntary basis and all contain the expectation that advertisements are sincere and that the contents of these ads provide fair and balanced information on the benets 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 to make 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-consuming to clear up the misunderstandings that arise because of different interpretations of this information (ACP, 2005). The FDA nevertheless has not changed its position on DTCA.

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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 concerned European legislation on paid publicity for medicines in all European member states (Sullivan, 2000), stating for instance that DTCA for prescription-only medicines was prohibited in all member states. The aim of this directive seemed to be to protect health care consumers, prescribers and suppliers 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 to patients 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 growing 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 nonpromotional information on medicinal products and other 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 difculties of any potential Internet regulation there is the fact that European consumers can legitimately see DTC advertisements on US and New Zealand Internet sites (Sullivan, 2000). Closely related is the rise in Internet pharmacies 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 specic form of DTCA in our analysis.10 Now that we have portrayed the main differences between 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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Pepijn K. C. van de Pol and Frank G. A. de Bakker 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 prescription 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 process can be linked to the CSR aspect the right for consumer 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 autonomy and of prescribers control over the prescription process. Question then is to what extent this potential tension between both policy contexts inuences the eventual objective of safe consumer

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 policy highlighted 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 their own 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 Protection. 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). In the end, from a CSR perspective, one cannot speak of autonomy until the pharmaceutical industry can guarantee both the right to choose and the right for consumer education.

TABLE I Main arguments in EU and US around 2003 EU context Central argument DTCA policy standpoint Control over prescription process DTCA pressurises consumers and prescribers in prescription process Lack of objective and balanced medicine information The right for consumer education Rely on mere prescriber information US context Consumer autonomy DTCA provides consumer with arguments to make a (more) independent and educated choice Fair and balanced medicine information The right to choose The right for consumer education DTCA Information, supplemented with prescriber information

Expected result of DTCA Main CSR element applied Way to accomplish consumer safety

Direct-to-Consumer Advertising of Pharmaceuticals 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 specic properties 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 the area 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 justied 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 pharmaceutical industry is extraordinarily privileged: an industry so important to the public health and so heavily subsidized and protected by the government has social responsibilities that should not be overshadowed by its drive for prots. Dealing with its social responsibilities is important for rms to establish and to maintain its legitimacy, to decide where companies t within the social fabric (Werther and Chandler, 2006, p. xvii). The pharmaceutical industry 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 pharmaceutical industry 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

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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 via DTCA, 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 conduct their promotional activities in a truthful manner, avoiding deceptive practices and potential conicts 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, the chief executive of Pzer and chairman of the Business 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 reinforce the importance of the physicianpatient relationship. 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, societal arguments feature prominently but economic arguments are also raised. As outlined, in the EU, DTC advertising is currently 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 nicely together 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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Pepijn K. C. van de Pol and Frank G. A. de Bakker 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 relax the 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 those making a choice to make it well-informed. Throughout the debate in both policy contexts there is a clear tension between rms responsibility and their liability. What should rms 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 responsibilities,11 or joining the economic and societal arguments we applied in our analysis. How DTCA will ultimately be shaped in both the EU 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 stakeholder theory to highlight in detail the roles and positions 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 ndings and opinions. Third, issues of governance

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 stakeholders such 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) recently argued the pharmaceutical sector presents a stimulating lens through which research in CSR can be conducted, given the potential social and environmental 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 interpretations 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 pharmaceutical 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 protable, 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 considering 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,

Direct-to-Consumer Advertising of Pharmaceuticals 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 pharmaceutical 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 marketing 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 and who 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 although 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 of these differences.
4

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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 observation. 6 As noted, DTCA is not only allowed in the US but also in New Zealand. As most of the literature discusses the situation in the USA, we focus on this country. 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 specic 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 directive 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 responsibilities but these go beyond our study of DTCA in general.

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Notes
A literature review conducted a few years ago already 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 phenomenon 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 publications 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 erce debates underline once again the difculties associated with this issue.
1

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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: pkv776@bham.ac.uk 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: fga.de.bakker@fsw.vu.nl

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