Regulating drug information in Europe: a pyrrhic victory for pharmaceutical industry critics?
Address for correspondence: Shai Mulinari, Centre for Gender Studies, Lund University, Sweden, Box 117, 221 00 Lund, Sweden
Informed by recent sociological debates on pharmaceuticalisation, this article examines the evolution of the current EU legal proposal on prescription drug information to patients, as well as the surrounding controversies. In 2008 the European Commission proposed the relaxation of the existing rules governing drug information provision to patients by the pharmaceutical industry. Critics of the industry’s influence over health policy and markets, including consumer organisations, industry-independent patient organisations and health professionals, rejected the Commission’s proposal, claiming that the industry cannot be considered a reliable source of patient information due to inherent financial conflicts of interest. Since these critics were at least partially successful in rallying opinion against the Commission proposal, they functioned as countervailing forces to promotion-driven pharmaceuticalisation. Even so, as a watered-down version of the proposal moved through the European Parliament it was further modified to ultimately resemble the Swedish system that was held up as a high-quality example of industry-based information provision. Yet this article contends that the Swedish system displays evidence of corporate bias. Significantly, basing EU policy on a drug information system not resistant to corporate bias risks creating practices that violate the legally mandated mission of EU drug regulation, which is to ‘promote and protect public health’.
The last few years have witnessed the intensification of sociological research on pharmaceuticals, largely focused on the shaping of drug markets (Abraham 2010, Busfield 2010, Williams et al. 2008). Specifically, recent debates have centred on the concept of pharmaceuticalisation (Abraham, 2011, Williams et al. 2011), which one writer defined as ‘the process by which social, behavioural or bodily conditions are treated or deemed to be in need of treatment, with medical drugs by doctors or patients’ (Abraham 2009: 100). Pharmaceutical companies, regulators, clinicians, patient organisations, the media, managed care and health insurers – all have been implicated in contributing to pharmaceuticalisation, albeit to varying degrees. However, due to an acknowledged interest in market shaping to bolster sales, the role of pharmaceutical companies has come under increasing scrutiny (Abraham 2002, 2010, Busfield 2010, Conrad 2005).
Needless to say, the literature on market-shaping practices of pharmaceutical companies contains many pertinent insights, such as the alarming corporate influence over regulatory decisions and scientific claim-making, often in collaboration with the deregulatory political proclivities of neoliberal governments and the ‘patient–industry complex’ (Abraham 2010, Davis and Abraham 2011: 810). However, I contend that there has been an unfortunate trend among some theorists to depict the industry as omnipotent controllers of drug markets, where most other stakeholders, including regulators, scientists, politicians, patients, and – especially – doctors, are either outmanoeuvred or even co-opted by the industry (for example, Busfield 2010, Moncrieff 2007). As a counterweight to such excessively pessimistic perspectives on the willingness and capacity of stakeholders to mobilise against the industry’s market-shaping powers, this article presents the development of the new EU legal proposal on prescription drug information to patients by manufacturers as a case study to explore how various stakeholders successfully engage in activities aimed at hampering pharmaceuticalisation.
For over a decade prescription drug information by manufacturers has probably been the most contentious pharmaco-regulatory topic in the EU. On one side, the European Commission, supported by the pharmaceutical industry, has advanced a liberalising agenda aimed at changing the existing legal framework to allow drug manufacturers to speak more freely and directly to the general public. However, this liberalising agenda has encountered fierce opposition from the Council of the EU and European Parliament, as well as from a coalition of stakeholder groups, including patient and consumer organisations, which collectively have lobbied against increased corporate influence over European health policy and markets (Watson 2003, 2008).
In November 2010, after years of negotiations and lobbying, the European Parliament nonetheless voted resolutely in favour of a new legal proposal allowing manufacturers to publically disseminate limited, regulator-approved prescription drug information via channels such as company websites or designated internet portals. Although this legislative draft has yet to pass the Commission and Council of the EU before entering into force, its chances of doing so without major modifications have been deemed to be fairly high (Shaw 2011). Should this happen, a new EU law on prescription drug information could be fully operational as early as 2013 (Watson 2010). While countries like Sweden and the UK have had similar systems in place for years, countries like Germany, where health officials and drug regulatory authorities were solely responsible for providing drug information, will need to adjust to the new EU standards.
Owing to the similarities between the proposed system and the Swedish system, which – as this article will show – was repeatedly cited during the EU legislative process to endorse the benefits of allowing manufacturers to speak directly to patients, it should be important to determine whether this system has actually succeeded in ensuring the provision of reliable information on medicines. To this end, this article closes with a brief analysis of drug information provided by manufacturers to the Swedish public, taking selective serotonin-reuptake inhibitor antidepressants (SSRIs) as a case in point. This choice is not random: since the early 1990s SSRIs have been among the most prescribed drugs in the world and a large body of research now points to an association between major promotional activity and the explosion of the antidepressant market (Healy 1997, Shorter 2009). For this reason, the ability of the Swedish system to ensure high-quality and unbiased information on SSRIs may predict the ability of the emerging EU framework to ensure acceptable information on future blockbuster medicines across Europe.
Theoretically and methodologically, this article builds on a realist conceptualisation of interests and bias, as proposed by Abraham (1995, 2008), to investigate the development and application of EU legislation on the dissemination of prescription drug information to patients, where bias is defined as ‘a consistent trend or pattern of technical inconsistencies or contradictions mapped on a set of social interests’ (Abraham 2008: 878). The profit-maximising interest of pharmaceutical companies is a prime example of such social interests.
According to Abraham (1995), technical inconsistencies or contradictions may exist between the technical standards that regulators are supposed to uphold and actual regulatory decisions. Importantly, he contends that such inconsistencies or contradictions can be detected through a micro-level analysis of decision-making, taking into account the validity of the knowledge claims in question – for example, that a drug works via a certain biological mechanism. Here, Swedish patient information about SSRIs was chosen as a case study to explore such micro-level technical knowledge claims and contradictions because (i) politicians and industry representatives have depicted Sweden as a high-quality example of industry-based information provision to patients that should be extended Europe-wide; and (ii) prior research has shown that manufacturers vigorously promoted SSRIs by claiming they correct a specific neurochemical deficit, despite lack of evidence to support this view (Healy 1997, Mulinari 2012, Shorter 2009).
This article also employs a framework of countervailing powers or forces (Light 1995) to explore how various stakeholders worked to balance the industry’s influence throughout the EU legislative process. Previous research on the shaping of drug markets using this framework focused on a few countervailing forces: the pharmaceutical industry, European governments, health insurers, the public, and clinicians (Busfield 2010). It was argued that only governments and insurers typically act as countervailing forces to the industry, mainly because of their interests as payers in limiting medicines expenditure. The focus here will be on a larger collection of countervailing forces. A first set operates in the formal legislative process. This includes members of the European Parliament (MEPs) and European health ministers who completely or partly rejected the industry-friendly agenda put forth by the Directorate-General Enterprise and Industry (DG ENTR) – the European Commission’s arm for trade and economic development. A second set operates in the body politic as a whole. This includes some doctor, patient and consumer organisations, as well as health insurers and regulators that sought to delimit the industry’s influence over the emerging EU patient information proposal. Importantly, for some of these stakeholders there were internal divisions between those friendly to the industry and those acting independently of the industry and that consider it their mission to counterbalance the industry’s market-shaping powers.
This article begins by focusing on the development of the EU patient information proposal from its emergence in 2007/2008 in the hands of the DG ENTR to its approval by Parliament in 2010. The analysis traces the changing content of the proposal, as well as the activities and arguments of various stakeholders that sought to influence this content. To this end, key documents relating to the development of the proposal were scrutinised, including consultation responses from stakeholders. While most of these documents are available on the European Commission (n.da.) and European Parliament (n.d.) websites, some were identified through web-based searches. For reasons stated above, the second part of the article examines Swedish patient information about SSRIs. This material is available at Fass.se, an internet portal managed by the Swedish Association of the Pharmaceutical Industry.
Early developments: harmonisation and the informed or expert patient discourse
The new EU patient information proposal approved by Parliament in 2010 has a long, contentious history, resulting from more than a decade of negotiations, lobbying and debate within and outside EU institutions. Specifically, in 2002 and 2003 respectively, the Council of the EU and the European Parliament rejected a Commission proposal to allow a five-year pilot of pharmaceutical company ‘patient-oriented and controlled information’ about prescription-only medicines to treat human immunodeficiency virus infection/acquired immunodeficiency syndrome, diabetes and asthma, because this was perceived as a first step towards legalising direct-to-consumer advertising (DTCA) (Watson 2003). However, as a compromise, the European Parliament and the Council (2004: 51) asked the Commission – who possess the formal power to draft and revise legislation and handle all questions or doubts about it, via one of its directors-general – to return to the drawing board and present a report by 2007 ‘on current practice with regard to information provision’ and, if deemed necessary by the Commission, also to ‘put forward proposals setting out an information strategy to ensure good quality, objective, reliable and non-promotional information on medicinal products’.
In response, the Commission services began to prepare (i) a draft report on current practices in member states; and (ii) an updated Community legal framework for the dissemination of prescription drug information to the public by manufacturers. It is remarkable that on the Commission level, the topic of drug information was placed under the jurisdiction of the DG ENTR, whose main role is to promote industrial growth, rather than the Directorate-General for Health and Consumers, which is concerned with public health. In the DG ENTR this task was delegated to a small team of experts with close ties to the pharmaceutical industry and who, as demonstrated by Adamini et al. (2009), consider the expansion of the pharmaceutical industry to be their chief task. By contrast, in both member states and on a Council level, health ministers’ staff managed this issue, pointing to important divisions between the Commission and member states over whether commercial or public health considerations should be given primacy.
The stance of the DG ENTR vis-à-vis the basic contents of the forthcoming EU regulation was laid down in a speech delivered by Enterprise and Industry Commissioner Günter Verheugen (2006) at the first meeting of the Pharmaceutical Forum, a high-level political platform for European discussions on pharmaco-regulatory topics. He stated:
I strongly believe that industry should have the right to produce non-promotional information for patients about their own medicines and diseases and to publish it. This information should comply with strictly defined rules (emphasis in original).
Subsequently, in April 2007 the DG ENTR published its draft report on current practices, which was sent out for public consultation (European Commission 2007a). The report made clear the DG ENTR’s ambitions to once again push for the relaxation of existing EU rules about information provision on prescription medicines. As hinted by Commissioner Verheugen’s speech, the underpinning idea was that ‘the pharmaceutical industry has the potential to be an important source of information’ as long as the information is non-promotional (European Commission 2007a: 14). The report began by pointing out that while existing EU law (Directive 2001/83/EC) bans the advertising of prescription medicines to the general public, different member states interpret the law differently. In Germany drug information is publically accessible through the Arzneimittelinformationssystem (drug information system) database, managed and updated by drug regulatory authorities. Importantly, in Germany manufacturers are only allowed to disseminate information to patients through package information leaflets (PILs) in drug packaging, since all other information provision by manufacturers is considered to be marketing and therefore in violation of Directive 2001/83/EC. In Sweden and the UK, however, provision of regulator-approved information on company websites is not generally regarded as marketing but as information and therefore in accordance with EU law.
The DG ENTR report contested that such divergent interpretations of the existing legal framework had become a substantial problem because this meant that European patients have unequal and limited access to drug information. According to the DG ENTR, unequal and limited access was particularly detrimental in the present situation where patients play an increasingly active role in seeking information in order to make informed choices, and the report therefore professed there was an urgent need to harmonise practices across the Community. The DG ENTR report was thus clearly aligned with the consumer policy discourse of the informed or expert patient which, as Abraham (2009) noted, has been repeatedly deployed in the past by the Commission and the pharmaceutical industry in their joint efforts to gain political support for legalisation of DTCA – even if the present report tried to circumvent the contentious issue of DTCA by proposing a distinction between promotional advertisement (banned) and non-promotional information (permitted).
Critique and support of the draft report: actors stake out their positions
Although the DG ENTR report contained no legal text, given its controversial content it came as no surprise that it stirred up fierce debate. Indeed, even before the report was made public, The Lancet (2007) published an editorial warning readers that the Commission was again preparing to legalise DTCA. The editorial took a strong position against DTCA, stating that the way forward was instead to fund ‘independent information sources, free of industry influence’ and that ‘if industry truly wants to inform the public, it should supply no-strings-attached funds to support such efforts’ (2007: 1). While the DG ENTR office responded to this attack by forcefully rejecting all allegations that it wanted to legalise DTCA by referring to the distinction in the draft report between marketing and non-promotional information (van Lierop 2007), pharmaceutical industry critics continued to deride the Commission for attempting to slip in DTCA through the back door even after the report was released (Medawar 2008, Moynihan 2007). Specifically, DG ENTR assurances that the ban on DTCA would remain failed to calm consumer organisations, industry-independent patient organisations and health insurers – the latter represented by the European Social Insurance Platform, an alliance of major insurers in 16 EU member states (European Commission 2007b). In general, these stakeholders reacted to the draft report by challenging neither the consumer policy discourse of the informed or expert patient nor the need to harmonise practices across the Community. Instead, their strategy was to undermine the DG ENTR position by mounting a counter-discourse against the pharmaceutical industry’s vested interests, representing a potential danger to public health and, in some cases, state finances (see Health Action International Europe et al. 2007, Picker Institute Europe 2007). For example, in a joint declaration entitled ‘Relevant health information for empowered citizens’, key consumer organisations and other groups critical of the industry called ‘for campaigning to help patients and citizens avoid confusion between health information and drug promotion by the pharmaceutical industry purporting to be “patient information”’ (HAI Europe et al. 2007: 8).
While an array of stakeholders thus rallied against the report, the pharmaceutical industry expressed wholehearted support for a pan-European system that would allow the industry to give patients more and direct information while still retaining the ban on DTCA (European Commission (2007b). Brian Ager, the Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents 31 European national pharmaceutical industry associations as well as 38 leading pharmaceutical companies, concluded:
We do not advocate U.S.-style direct-to-consumer advertising as an appropriate model for Europe. Instead, we call on the European institutions to improve access for all patients and citizens in Europe to health and medicines information in their own language. We firmly believe that better informed patients will lead to safer and more successful health outcomes, a more efficient use of health-care resources, and ultimately to healthier societies.
(Ager 2007: 822)
DG ENTR’s second consultation: doctors emerge as a countervailing force to the industry
In February 2008, after the closure of consultation on the draft report, the DG ENTR launched a second consultation round, this time on the key ideas of their forthcoming draft legal proposal (European Commission 2008a). As the draft report hinted, the DG ENTR had been preparing a proposal for a law aimed at harmonising practices on information provision to patients, while maintaining the existing advertisement ban. Thus, provided that all information is compatible with regulator-approved data, the DG ENTR now clearly stated that the industry should be allowed to disseminate (push) non-promotional information about their prescription drugs through commercial TV, radio and the print media. The industry should also be allowed to provide non-promotional information to patients who actively seek it (pull) through registered websites, presentations and seminars. Note, however, that the practice endorsed of pushing non-solicited, non-promotional information went beyond even the most permissive interpretation of the current EU law by member states such as Sweden and the UK. This suggests that the DG ENTR’s call for an urgent need to harmonise practices is best understood as a specious argument for relaxing existing regulation and, as such, should be viewed in the context of a more general liberalisation strategy, where harmonisation is merely a pretext for relaxing pharmaceutical regulations across broad areas of governance (Abraham and Lewis 2000).
As with the previous consultation round, the DG ENTR stance that the pharmaceutical industry should be allowed to speak directly to patients received a mixed response (European Commission 2008b). Thus, roughly half of the 185 respondents who officially commented on the proposal felt that the pharmaceutical industry was ‘not an appropriate source of prescription-only medicine information in general, mainly because there may be a conflict of interest relating to financial interests’ (European Commission 2008c: 8). Only 26 per cent explicitly supported the right of the industry to disseminate information (Table 1). Insurance organisations such as the European Social Insurance Platform and the French National Federation of Mutual Insurance Societies, and health professionals or organisations were the strongest critics. Indeed, in the latter group, 70 per cent, or 41 respondents, rejected a role for pharmaceutical companies as information providers, whereas only 7 per cent, or four respondents, considered the industry to be a reliable source of information. For example, in their responses to the DG ENTR consultation report, both the British and Swedish Medical Association supported measures to empower patients and harmonise practices but they believed that information should be provided by independent sources, free of commercial interests (British Medical Association 2008, Sveriges Läkarförbund 2008).
Table 1. Overview of respondents’ comments on the pharmaceutical industry as provider of information about prescription-only medicines. Adapted and modified from European Commission (2008b)
|Healthcare professionals and organisations||7||70||15||8||59|
|Pharmaceutical industry organisations and companies||96||0||0||4||26|
|Research and others||20||30||0||50||10|
|Media and patient information organisations||72||14||0||14||7|
|Social insurance organisations||0||100||0||0||6|
At this juncture, the critical stance of health professionals and organisations emerges as particularly noteworthy in light of recent sociological accounts that tend to depict doctors in the role of handmaidens of the industry, enthusiastically helping to expand the use of medicine beyond what is scientifically or ethically sound. For example, Busfield (2010) argues that, as a consequence of their professional activity and ideology, doctors ‘have little interest in mobilising against the industry and do not usually act as a countervailing power, allowing it free reign to encourage the expansion of medicine use’ (2010: 938). However, I suggest that this may be an oversimplification of the doctor–industry relationship, as evidenced by consultation responses indicating that doctors have organised to limit the ability of the industry to speak directly to patients, and thereby have the potential to act as a countervailing power to the industry. Moreover, it might be worth considering that industry interests may occasionally run counter to the professional interests of doctors. Specifically, in the present case, the industry aspires to speak directly to patients, clearly encroaching upon doctors’ professional territory. By lobbying against the relaxation of existing regulations, doctors were arguably at the same time defending their role as experts and principal providers of drug information.
The industry response: a European FASS – the Swedish Medicines Compendium for Physicians?
Most supportive, albeit not categorically so, of the DG ENTR’s position were the pharmaceutical industry, industry-funded patient organisations such as European Patients’ Forum and the International Diabetes Federation, as well as some of the media consulted (Table 1). The media and some patient organisations probably saw an opportunity to increase their revenue through industry-sponsored disease-awareness campaigns and pharmaceutical advertising. However, most respondents – including the pharmaceutical industry – who commented on the DG ENTR’s suggestion to allow the dissemination of information via commercial media rejected the DG ENTR’s position. According to Arthur Higgins, President of EFPIA, the pharmaceutical industry did not want information to be disseminated through the commercial media because it could open the door for DTCA (EFPIA 2008). Rather, EFPIA said it now supported the public–private partnership model already found in countries like Sweden and the UK, where manufacturers are allowed to disseminate approved information about drugs and diseases via designated online portals. While it is certainly possible that the industry’s rejection of ‘pushed’ information was based on genuine discomfort with such practices, this interpretation is clearly contradicted by the industry’s prior support for DTCA in Europe and by its unbroken commitment to DTCA in the USA and New Zealand. From this angle, the EFPIA’s unqualified rejection of pushed information is difficult to interpret as anything other than a tactical retreat, perhaps elicited by fears that European politicians could terminate the legal process should the proposal be perceived as too industry-friendly.
Under these pressing circumstances, the Swedish system emerged as especially valuable to the industry, offering an excellent example of how a self-regulating industry could provide supposedly reliable information to patients over an extended period of time. Thus, Sweden not only allows manufacturers to disseminate ‘pulled’ information about drugs, but also governs the dissemination of this information through a code of ethics monitored by the Swedish pharmaceutical industry’s own system of self-regulation (LIF 2008, Perman 1990). Thus, since 1966 the pharmaceutical industry has supplied Swedish doctors with a printed directory on pharmaceuticals, the Swedish Medicines Compendium for Physicians (FASS) (Swedish Association of the Pharmaceutical Industry 1966). Since 1983 nearly 1.5 million copies of Patient-FASS (Swedish Association of the Pharmaceutical Industry 1983), a kindred publication aimed at the general public, have been distributed. Since August 2001 FASS and Patient-FASS have been available free of charge at Fass.se, one of the world’s most visited medicines information sites, with some four million visitors each month, of whom 40 per cent are patients/citizens. While each company must ensure that uploaded information is based on regulator-approved information (PILs and summaries of product characteristics [SPCs]), companies risk economic sanctions by self-regulatory bodies if they upload non-approved information or information that violates the industry code. It was thus this information provision system that the European Federation of Pharmaceutical Industries and Associations (EFPIA 2008) suggested the Commission should extend Europe-wide.
The Commission’s patient information proposal: partial victory for countervailing forces to the industry
In December 2008, more than six months after closure of the public consultation on the draft legal proposal, the Commission put forth their proposal for the legislation of patient information,1 which was submitted to the European Parliament and the Council under the EU’s co-decision procedure (European Commission 2008d). As expected, the proposal aimed at allowing the industry to disseminate regulator-approved information (SPCs and PILs) about their prescription medicines to the public. However, under pressure and lobbying from various stakeholders including health insurers, organisations for doctors, consumers and patients, industry’s tactical disapproval and heavy criticism from the health ministers (Council of the EU 2008), as well as disputes within the Commission itself – especially between Health Commissioner Androulla Vassiliou and Industry Commissioner Günter Verheugen (Ranik 2008) – the Commission decided to drop the idea of allowing the industry to disseminate information through commercial TV and radio.
Thus countervailing forces lined up against the pharmaceutical industry – with an array of allies including, but not limited to, health insurers, doctors’ organisations, industry-independent consumer and patient groups on one side, and health ministers on the other – succeeded in persuading individuals in the Commission to retreat from their prior commitments. However, while the Commission proposal had been significantly watered down, it still endorsed the industry’s right to engage directly with patients despite the majority view of regulators, health professionals, insurers and independent patient/consumer organisations consulted by the Commission, all of whom held that the industry should not be regarded as a reliable source of medicine information owing to its commercial interest in the matter. Hence, the Commission’s proposal still allowed pharmaceutical companies to disseminate approved information online, through health-related publications ‘as defined by the member state of publication’, and through written answers to requests for information from members of the general public. Note also that the proposed legal text endorsed the right of the industry to freely disseminate material relating to human health or disease, provided no reference – even indirect – is made to individual products. Thus, the outcome was without prejudice to industry-sponsored disease awareness-campaigns which, as several commentators have noted, are probably the most effective vehicles available to drug manufacturers for promotion-driven pharmaceuticalisation (Abraham 2010, Busfield 2010).
Exporting Sweden’s FASS
Despite declarations from the Commission that the patient information directive was primarily concerned with patients’ rights, the proposal clearly revolved around manufacturer interests in disseminating information. As the legal text moved through various EU institutions this imbalance became the focus of controversy. For example, the Presidency’s progress report on the pharmaceutical package (see note 1), published in May 2009, made it clear that many member states did not consider the industry to be a reliable source of information on prescription medicines (Council of the EU 2009a). In fact, a majority of member state delegations did not even consider the proposal worthy of continued negotiations, mainly because of its focus on manufacturers’ rights. Similarly, in June 2009, at a Council meeting for European health ministers, many delegations expressed concern that the proposals would not ‘provide sufficient guarantees that the prohibition of advertising of prescription-only medicinal products to the general public will not be circumvented’ (Council of the EU 2009b: 17). This division between member states and the Commission may, as noted above, in part be attributed to the fact that the ministers of health rather than commerce managed the patient information proposal in both member states and on a Council level. However, perhaps a more fundamental reason for unease among some member states was the fear that a permissive legal framework would undermine healthcare budgets by increasing regulatory and medicinal costs (Council of the EU 2009a).
In the European Parliament – where national budgets are of lesser concern – the proposal fell under the responsibility of Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI). Parliamentary committees play a significant role in the EU. It is within committees that most amendments are drafted and negotiated before being sent to the plenary for a final vote. Typically, parliamentary committees appoint a rapporteur to lead work on a proposal. In February 2009, Swedish centre-right ENVI member Christopher Fjellner was appointed rapporteur to lead work on the patient information directive, which included writing a draft report to serve as a framework for any future discussions on the proposal. As rapporteur, Fjellner thus came to play a decisive role in guiding the proposal through Parliament. Early on, Fjellner clarified his position that the industry should be allowed to speak directly to patients, albeit under strict restrictions. Thus, within a few weeks of being appointed rapporteur, Fjellner specified that one of his key missions was to protect the Swedish system from those wanting to impose tighter regulations on the industry (Fjellner 2009a). As he later told Swedish state television, he considered Sweden’s FASS‘the best example that patients can receive more accurate information’ and that the compendium ‘shows that it is possible to distinguish between what is advertising and what is information’ (Fredriksson 2010). Then, in early March 2009, speaking in front of representatives from the industry and the healthcare sector, Fjellner stated that, despite opposition from many member states, Parliament should proceed as planned with the proposal (Fjellner 2009b). Indeed, using particularly strong words, he criticised the health ministers for sidestepping the co-decision procedure by trying to ‘precede the institutional procedure and settle their position on this dossier even before the Parliament has had a say’. For Fjellner, the way forward was not to reject the Commission’s proposal in its entirety, as argued by some member states, but to save it by steering in the direction of a Swedish FASS system – the position also officially championed by the industry (European Voice 2010).
Following the June 2009 European elections, Fjellner was re-appointed as rapporteur. In March the following year he published a draft report on the proposal (Fjellner 2010a), which included 27 amendments to the Commission’s proposal to be considered by ENVI before submitting the amended proposal to Parliament for a final vote. While Fjellner’s report welcomed the Commission proposal, he chided it for being overly focused on companies’ rights to disseminate information rather than patients’ rights to access quality information. To amend this, Fjellner (2010a: 9) proposed to ‘oblige [sic] the pharmaceutical industry to make certain fundamental information on prescription-only pharmaceuticals available’; essentially the SPCs and PILs. The shift in emphasis from manufacturers’ rights to disseminate information to patients’ rights to receive that same information was enthusiastically greeted by legislators and industry representatives, since it promised to break the current deadlock caused by opposition to the proposal from the Council and some member states (European Voice 2010, Shaw 2011). Besides this shift in emphasis, Fjellner also proposed to prevent the industry from disseminating information through ‘health-related publications’ and to expressly disallow the provision of this information through the print media, as well as on television and the radio. Moreover, he wanted to extend the regulation to include not only the industry but also all those who act ‘on behalf of, in the interest of, or upon instructions from the pharmaceutical companies’ (2010a: 9) Importantly, these amendments, which admittedly made the proposal less industry-friendly, were justified by making reference both to the vested interests of the pharmaceutical companies and the need to empower patients and harmonise practices, and thus arguably represented an attempt to amalgamate the various arguments that had been circulating into a unified concept that would be more acceptable to MEPs.
Two months later, in May 2010, ENVI voted on Fjellner’s draft report. This resulted in the addition of numerous new amendments, mostly aimed at placing an even stronger emphasis on patients’ rights to receive high-quality information (ENVI 2010). Thus, ENVI added the obligation that national authorities should undertake prior vetting of any information that the industry wishes to disseminate to patients unless it had already been approved during the marketing authorisation process. They also decided that health professionals should disclose any ties to the industry if they provide information on medicines to the public. Committee members critical of the industry proposed several amendments imposing even tighter regulation on the industry, including a ban on industry-driven disease-awareness campaigns and a prohibition of industry engagement with healthcare professionals aimed at promoting drug sales. These were rejected, however, indicating that as far as the ENVI majority was concerned there was a limit to how far the argument about vested interests should be pushed. Similarly, ENVI rejected a proposal to require competent authorities to be more permissive in allowing public access to regulatory information pertaining to drug applications.
After ENVI voted overwhelmingly in favour of a new amended proposal (46 for and 3 votes against), it was sent to Parliament for final consideration and Fjellner issued a press release stating that the Committee had voted not only to save the Swedish FASS model but to extend it to the rest of Europe: ‘Now, with FASS as prototype, we have enabled industry to disseminate information, within strict limits and under strict control’ (Fjellner 2010b). On 22 November 2010 Parliament voted resolutely in favour of the amended proposal (European Parliament 2010a). Before his fellow MEPs, Fjellner summarised the outcome of the legislative process: ‘the way Parliament has voted here not only means that it is possible to retain FASS, but it is also possible for other countries to introduce similar systems’ (European Parliament 2010b).
Trouble in paradise: antidepressants information in Sweden shows corporate bias
As we have seen, the proposed EU law aims to introduce information provision resembling the Swedish system for prescription medicines to all member states, allowing the industry to disseminate regulator-approved information to the general public. Potential biases in the Swedish system should therefore be investigated. Moreover, both the proposed and existing laws endorse the industry’s right to engage in disease-awareness campaigns. Either case assumes that regulators and the industry are able to clearly distinguish between advertising versus non-promotional information, and between marketing of a drug versus marketing of a disease-treatment model. However, as argued repeatedly by critics of the proposal, these are problematic assumptions and advertising may easily be disguised as information.
Table 2 provides examples of information about SSRIs and depression where, arguably, Swedish regulators and the manufacturers have indeed failed to accurately make such distinctions, resulting in low-quality information and bias favouring the pharmaceutical industry interest in drug promotion. These examples refer to the assertion found in regulator-approved patient drug information uploaded to Fass.se that depression is caused by a specific brain monoamine deficit that can be rectified by SSRIs. As scholars have noted, professing such monoamine theories of depression – that is, the idea that depression is caused by low levels of monoamines such as serotonin and noradrenaline – has been a centrepiece of the industry strategy to expand markets for SSRIs (Healy 1997, Shorter 2009). Notably, the industry has disseminated monoamine theories not only through DTCA in the USA but also, and more relevant to Europe, through disease-awareness campaigns, as well as scientific and clinical symposia and journal supplements sponsored by the industry (Abraham and Davis 2009, Conrad and Leiter 2008). Crucial to my argument is the fact that monoamine theories are inconsistent with the evolving biomedical literature (Krishnan and Nestler 2008, Mulinari 2012). An often-cited objection to monoamine theories is the overall low efficacy of monoamine-boosting antidepressants, including SSRIs. Remarkably, meta-analyses of clinical trial data submitted by manufacturers to regulatory agencies for marketing authorisation have established that SSRI efficacy approaches, or even surpasses, clinical irrelevance (for example, Kirsch et al. 2008). Thus, for both industry and regulators, the debunked status of monoamine theories should come as no surprise – indeed, presently, most major drug companies have dropped antidepressant research, partly due to the lack of viable biological hypotheses (Abbott 2011).
Table 2. Selected and translated statements about depression, serotonin and SSRIs in Swedish patient information material from manufacturers
|Serotonin is a neurotransmitter that occurs mainly in the brain but also in the gastro-intestinal tract and the bloodstream. In the brain, serotonin has an important function as it regulates our mood and a deficiency can lead to depression.|
|Most depressions are believed to be due to a lack of various neurotransmitters in the brain, including serotonin. Citalopram increases levels of serotonin. This brings about an improvement in mood and you feel less depressed (PIL Citalopram, Actavis).|
|Fevarin belongs to the group of antidepressant medicines (also known as serotonin reuptake inhibitors, SSRIs). These medicines help to correct certain chemical imbalances in the brain that are causing the symptoms of your illness (PIL Fevarin, Solvay Pharma).|
|Cipramil is a selective serotonin reuptake inhibitor (SSRI) and belongs to a group of medicines called antidepressants. These medications help to normalize serotonin levels in the brain. Disturbances in the serotonin system in the brain are considered important factors in the development of depression and related disorders (PIL Citalopram, Lundbeck).|
|Seroxat is one of a group of medicines called SSRIs (selective serotonin reuptake inhibitors). Everyone has a substance called serotonin in their brain. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how Seroxat and other SSRIs work but they may help by increasing the level of serotonin in the brain (PIL Seroxat, GlaxoSmithKline).|
Consequently, promoting monoamine theories must be regarded as incompatible with the industry’s code of ethics that mandates that drug information must be truthful and up-to-date, thereby revealing a malfunction in the Swedish system of industrial self-regulation. Moreover, allowing manufacturers to proclaim that depression is caused by a monoamine deficit – despite mounting evidence to the contrary – must be regarded as a failure by Swedish regulators to uphold their own standards of ensuring high-quality and unbiased information on medicines. This violation of regulators’ own standards offers a further example of what Abraham and Davis (2009) have called the permissive principle in pharmaco-regulatory practices. Furthermore, Abraham (2007) has shown how corporate interests have biased UK regulatory agencies and experts, thereby shaping drug markets to the advantage of pharmaceutical companies in that country. Similarly, I argue that the permissive Swedish system for the oversight of information provision on medicines to the general public is evidence for such corporate bias, resulting in skewed information about depression and antidepressants favouring drug manufacturers’ commercial interests.
Under the guise of harmonisation and the informed or expert patient discourse, European politicians and experts attuned to the interests of the industry have advanced a liberalising agenda that would allow drug manufacturers to speak more freely and directly to the general public. In response, a number of organisations, including industry-independent patient and consumer groups, have collectively mounted a counter-discourse against the vested interests of the drug industry. Moreover, many have likened the liberalising agenda to a Trojan horse that will bring DTCA to Europe. Thus far this anti-liberalisation lobby has achieved at least partial victory as a countervailing force to the industry and its aligned interests since it has contributed to preventing the most radical aspects of this agenda from entering into force. Doctors’ organisations have played an active role, mainly by pointing out in consultation responses that an inherent conflict of interests makes the industry an unreliable source of information on medicines. Contrary to what is sometimes implied in the sociological literature on drug market shaping, it is therefore entirely possible that many doctors recognise that the industry’s commercial interests may diverge from – and even conflict with – public health, and they are willing to actively support regulatory measures aimed at prioritising public health over the industry interests (see also Abraham 2009, Gabe and Bury 1996). Thus, in summary, the present analysis points to (i) the need for a more nuanced view of the willingness and capacity of various stakeholders to mobilise against the industry’s market-shaping powers; (ii) the importance of taking a larger set of countervailing forces into account in sociological analyses of pharmaceuticalisation, including, but not limited to, the pharmaceutical industry, clinicians, patient and consumer groups, health insurers, regulators and the media, as well as institutions and politicians at both the national and supranational level; and (iii) the salience of internal divisions among some actors, for example, the state (DG ENTR versus the Council of the EU) and patient groups (industry-friendly versus critics).
As the patient information proposal moved through Parliament, it became increasingly apparent that supporters of an updated EU framework would attempt to save it by steering it in the direction of the Swedish system, touted as a high-quality illustration of the benefits that the industry can bring to patient empowerment. Indeed, by modifying the Commission’s proposal in this direction, and by merging the rhetoric of proposal proponents (such as harmonisation and patient empowerment) with that of its critics (vested interests), this group succeeded in bringing most MEPs behind an amended proposal. However, as shown here, the Swedish system is far from immune to corporate bias and therefore does not deserve unequivocal support – which is not to imply that all information produced by the industry is of low quality and biased (indeed, not all FASS texts contained overtly misleading statements about depression), or that non-industry produced information is automatically of better quality and unbiased. Nonetheless, basing EU policy on a drug information system not resistant to corporate bias risks creating practices that violate the legally mandated mission of EU drug regulation, which is to ‘promote and protect public health’ (see Abraham and Lewis 2000: 118).
But if not the Swedish model, what other alternatives could be considered? The British Medical Association (2008) has, for instance, suggested creating an industry-independent European body responsible for providing information on medicines to patients. This information should be pre-approved by an advisory board comprising health professionals with no industry ties. However, if any industry-independent model is to emerge as a viable alternative, critics of industry-based information provision must first persuade the Council to reject the current proposal.
The legislative proposal was part of the pharmaceutical package European Commission (n.db). This consisted of two other proposals and one communication, designed to increase European drug industry competitiveness, tackle issues of counterfeit and illegal distribution of medicines, and improving pharmaco-vigilance in the EU.
The author thanks Dr Kerstin Sandell, the editors and two anonymous reviewers for their input. Riksbankens Jubileumsfond in Sweden supported this work.