Abstract
The European Commission Pharmaceuticals Unit is currently developing a legal proposal to increase the public provision of information about prescription medicines. Their preliminary proposal would achieve this by permitting pharmaceutical companies to provide unsolicited information about their prescription-only products directly to the public via the mass-media. 1 The permitted channels of dissemination would include television, radio and print media, as well as standalone products distributed directly or via healthcare professionals. The stated intention of this controversial proposal is to meet a public need for high quality, reliable information about medications.
Legislative debate in this area is not new. In 2002, the European Parliament debated a proposed five-year pilot scheme of mass-media advertising limited to drugs for diabetes, asthma and AIDS. The proposal was rejected by 494 votes to 42. 2 Currently, the USA and New Zealand are the only developed countries that permit direct-to-consumer advertising (DTCA) of prescription-only medications; it is a contentious issue in both. 3, 4
The preliminary proposal insists that our ban on advertising should be maintained, instead forwarding a suggestion that the pharmaceutical industry be able to disseminate ‘non-promotional information’. Herein lies the conundrum, as the distinction between ‘advertising’ and mass-provision of unsolicited information by industry is not immediately obvious. Indeed, despite widespread agreement that such a distinction is absolutely crucial to the current proposal, neither the proposer nor any stakeholder has yet offered a clear means to achieve this. 5 Opponents therefore fear that permitting such legislation would be tantamount to allowing advertising in all but name. 6
The importance of this debate cannot be underestimated: widespread information dissemination has the potential to significantly impact the public's understanding of health, disease and medications, and to alter the nature of the doctor-patient relationship. Whilst this debate may be relatively new to Europeans, it is both long-standing and familiar in North America and Australasia. We are therefore fortunate to have the benefit of others' experiences. Indeed, we are urged to learn from these experiences by physicians in New Zealand. They fear that Europe's current trajectory represents a ‘slippery slope’ to their own situation in which drug advertising is omnipresent, though unpopular with doctors and with patient groups. 7
Within this article we draw on international experience to contextualize and consider the potential European policy. We summarize the discourse that surrounds DTCA in the USA and New Zealand and present a taxonomic framework. Starting from a discussion of Canada's experience, we discuss the distinction between information and advertising. We consider how Europe could draw all of this together to carve its own path towards world-class provision of patient-centred information.
Direct-to-consumer advertising
The DTCA debate is well-rehearsed. Proponents of DTCA believe that it can reduce morbidity and mortality by prompting patients to present with previously undiagnosed illness, and by encouraging concordance with prescribed medications. They argue that the public wants to be empowered with reliable healthcare information, that DTCA can provide this, and that to deny such access is paternalistic and a breach of citizens' human rights. 8
Opponents of DTCA argue that it generates excessive and inappropriate demand for medications. Though advertisements may reach a few individuals who stand to benefit, they will reach many more ‘worried well’ and the consequent unnecessary consultations waste healthcare resources, whether or not they result in an unnecessary and potentially dangerous 9 prescription. DTCA spending is allocated between drugs based on projected financial return rather than public health benefit. As a result, important but out-of-patent medications receive no attention whilst the newest (and hence most expensive and least proven) medications are vastly over-represented. 10 The promotion of many individual drugs serves to promote drugs in general, producing a medicalized society reliant upon the quick fix of medication where many ills may be more appropriately, fully and cost-effectively addressed through lifestyle or social measures.
However well rehearsed the suppositions inherent in the DTCA debate may be, they are based more on assertion than evidence. The arguments for and against DTCA are multifaceted and complex; they do not readily lend themselves to any unified outcome measure with which the effect of DTCA can be quantified. Unsophisticated opinion surveys and uncontrolled studies that examine only a part of the picture predominate. Attempts to review the evidence relating DTCA to health and wider economic outcomes have demonstrated a paucity of quality research examining its effects; it is clear that DTCA influences prescribing, but beyond this the health and economic consequences are largely unknown. 11, 12
Whilst the evidence from the public's perspective is unclear, the pharmaceutical industry's actions have made its perspective entirely apparent. In 2006, pharmaceutical companies spent $4.8 billion on such advertising in the USA. This represented 40% of its total promotional spend, $16 per capita, and a 12-fold increase since 1997. 13 The average American television viewer sees as much as 16 hours of DCTA per year. 14 The great surge in DTCA over the last decade represents the fact that advertising of medications brings great financial reward, with industry marketing consultants describing its return on investment as ‘nearly unprecedented’ compared to advertising in other industries. 15
Defining DTCA
Taxonomy is vital to this debate. Three forms of mass-media communication have been clearly defined; in the USA, all three are regarded as advertising and all three are permitted. 13
Help-seeking advertisements inform consumers that a treatment
(usually new) is available for a named medical condition or symptom but do not
name the treatment, prompting the consumer to ‘ask your doctor’
Reminder advertisements do the reverse – they provide the name
of a product and sometimes information on its strength, dosage, form and price,
but make no mention of its indications, benefits or risks
Product-claim advertisements are analogous to advertisements
for any other commercially available product, naming a product and making
statements about its use and effectiveness.
In a sense, product-claim advertisements are a combination of the other two advertisement types. They are, unsurprisingly, the most widespread in the USA and New Zealand. Frosch et al. analysed the content of 38 US advertisements. 16 The typical product claim advertisement conveys the ‘story’ of a character who is able to able to gain control over a social, emotional or physical aspect of their life thanks to the medication. Often the medication is portrayed as engendering social approval. Whilst a majority of advertisements make claims about a product's effectiveness, a minority give any information regarding condition cause, risk factors, prevalence or alternatives to medication.
Whilst the USA recognizes and allows these three forms of advertisements, the situation in Canada is more complex. Canada's Food and Drugs Act prohibits DTCA, but subsequent government policy has re-interpreted the definition of DTCA such that help-seeking and reminder advertisements are excluded; hence only product-claim advertisements are banned. 17 It is notable that there is nothing to prevent advertisers from running reminder advertisement campaigns and help-seeking advertisement campaigns concurrently, using visual and auditory branding to implicitly link the two – providing that no single advertisement explicitly links the named drug with its indications.
Distinguishing ‘advertising’ from ‘information’
Central to the current EC proposal is the need to firmly distinguish between ‘advertising’ and ‘non-promotional information’, such that the latter can be allowed to the exclusion of the former. The wish to exclude advertising and to ensure that information is ‘non-promotional’ seems to assume that this increases the value of the communication for the recipient. This assumption is key but, whilst it may be true in some cases, it would not appear that ‘informativeness’ can be defined, and hence ensured, by lack of promotion. An information leaflet produced by a patient group, with no promotional intent, may give an unintelligible explanation of a disease, whereas an advertisement for a drug may clearly and accurately convey information about the drug and the disease. ‘Information’ and ‘promotion’ are not mutually exclusive, nor are they inversely related; indeed, there is no inherent relationship between the two at all. ‘Non-promotional’ information is not necessarily good information; the corollary also holds. The value of a communication for its provider does not determine, inversely or otherwise, its value for the recipient. Therefore legislating in terms of the former in an attempt to control the latter is both ineffective and inefficient. In the extreme, it should be apparent that providing funding for communications with absolutely no positive effect for the pharmaceutical industry whatsoever (as one may read ‘non-promotional information’) would be unjustifiable for corporations answerable to their shareholders. Limiting promotional effectiveness may limit the potential for harm if the message is undesirable, but it also limits the potential for benefit where the message is worthwhile.
Canada's situation further illustrates this point: Canada permits reminder advertisements and help-seeking advertisements, which are less overtly promotional than product-claim advertisements. But product-claim advertisements openly link drug and disease for the viewer, and in doing so arguably providing more useful information than the two permitted advertisement forms, which each provide only half of the story.
An interpretation for Europe
Though the effects of DTCA are far from proven, popular discourse (and indeed logic) suggests a number of benefits and a number of harms. A government seeking to establish its own policy on information provision de novo would do well to learn from the DTCA experience – not by adopting DTCA and its accompanying flaws wholesale, but by developing a novel communications strategy that harnesses the benefits of DTCA whilst minimizing its harms. The preliminary proposal from the European Commission effectively aims to do so by introducing the mass-media provision of medication information whilst preventing the harms associated with ‘advertising’. As has been demonstrated, however, legislating to achieve quality information by excluding promotion is neither effective nor efficient.
Aligning differing interests
In what manner, then, could the European Union legislate to adapt DTCA for the better? If the needs of the information provider were perfectly aligned with the needs of the information recipients, the requirement for legislation would not arise. The provider would reliably create communications that effectively and efficiently serve the needs of both provider and recipient. It is apparent that where the needs of provider and recipient differ, attempting to apply legislation to control for this is fraught with difficulty.
In 1996, a Canadian health policy statement recognized the difficulties of applying blanket legislation in this way, and suggested that each communication from the pharmaceutical industry should instead by judged individually by its ‘primary purpose’. 18 This is clearly resource-intensive.
The ideal scenario would be one in which the motive of the provider was well-aligned with the needs of the recipient. The motive of the pharmaceutical industry is intrinsic; it can be tempered by legislation but not truly altered, and applying legislation reduces efficiency. This naturally suggests an alternative: change the provider. A separate body, whose interests align closely with those of the public, would need legislation to ensure its effective composition but, providing this were done well, its communications would need to be subject to little ongoing legislation. Governments have difficulty ignoring the needs of the pharmaceutical industry, and so it could be represented within this body.
The debate should now turn away from how ongoing legislation can be used to control adifference of interest, and towards how a legislative effort can be used to create a body that, hampered by little ongoing legislation, acknowledges and reflects the true interests of the public and industry in an appropriate balance. The creation of this body should incentivize the pharmaceutical industry to invest in its scientists rather than its marketers; provide patients with comparative information that empowers them to make healthcare decisions; and harness the positive aspects and technologies of DTCA whilst avoiding its pitfalls. The debate in Europe is currently focused on flawed means to introduce and control a flawed system. Instead, Europe should embrace this opportunity to embark upon a different path and to develop a truly world-class approach to the provision of medication information.
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