From DTCA-PD to patient information to health information:the complex politics and semantics of EU health policyEleanor Brooks BA MA1 and Robert Geyer PhD2

1Researcher, Department of Politics, Philosophy and Religion, County South, Lancaster University, Lancaster, UK2Professor of Politics, Complexity and Policy, Department of Politics, Philosophy and Religion, County South, Lancaster University, Lancaster, UK

Keywords

complexity, DTCA-PD, EU, health policy,patient information, pharmaceuticals

Correspondence

Ms Eleanor BrooksDepartment of PoliticsPhilosophy and ReligionCounty SouthLancaster UniversityLancaster LA4 4YDUKE-mail e.brooks@lancaster.ac.uk

Accepted for publication: 31 May 2012

doi:10.1111/j.1365-2753.2012.01883.x

AbstractRationale, aims and objectives Between 2001 and 2011 the pharmaceutical industry,supported by DG Enterprise, was engaged in an ongoing campaign to repeal/amend theEuropean Union (EU) ban on direct-to-consumer advertising of prescription drugs (DTCA-PD). As it became increasingly clear that the ban would not be repealed, DTCA-PDsupporters tried to shift the debate away from advertising and towards the provision of‘patient information’ and the rights of patients to access such information. Meanwhile, avariety of national and European health organizations, supported by DG SANCO, soughtto maintain the ban and oppose the industry-supported ‘patient information’ campaign.Instead, they promoted a concept of ‘health information’ that included all aspects ofcitizens’ health, not just pharmaceuticals. This article aims to analyse the transition fromDTCA-PD to patient information to health information and examine its implications for EUhealth policy as a complex policy space.Methods The article examines the emergence and development of EU health policy andthe evolution of the DTCA-PD debate through the lens of complexity theory. It analyses thenature of the semantic, political and policy transition and asks why it occurred, what it tellsus about EU health policy and future EU health legislation and how it may be understoodfrom a complexity perspective.Results and conclusions The article concludes that the complexity framework is ideallysuited for the field of public health and, in particular, the DTCA-PD debate. Havingsuccessfully shifted the policy-focus of the debate to patients’ rights and health informa-tion, opponents of the legislation are likely to face their next battle in the realm ofcyberspace, where regulatory issues change the nature of advertising.

IntroductionBetween 2001 and 2011, the pharmaceutical industry was engagedin an ongoing campaign to repeal/amend the European Union (EU)ban on direct-to-consumer advertising of prescription drugs(DTCA-PD). The latest version of this industry-leaning proposalwas rejected by the European Parliament (EP) in late 2010 in favourof a more public health-orientated text, effectively putting an end tocurrent industry hopes of directly repealing the advertising ban. Thedebates surrounding this policy area have been marked by a transi-tion – from the initial anti-DTCA-PD strategy to a campaign basedon the provision of ‘patient information’ and the right of patientaccess, it is now characterized by ‘health information’.

At one level, the debate is primarily semantic. ‘Patient informa-tion’ is simply a more accessible way of presenting what is knownin the industry as DTCA-PD, while ‘health information’ is merelya term that characterizes the extension of this concept to cover a

wider policy area. The struggle over the definitions of these con-cepts relates to the regulatory nature of the issue, with actors ateach level fighting to define them in a way that retains themaximum possible competency and autonomy for their position.To settle on this explanation, however, would be to ignore theunderlying correspondence of the semantic changes to complexalterations in the strategy of DTCA-PD supporters and opponents.The transition to ‘patient information’ was accompanied by a farmore subtle and politically acceptable approach to circumventingthe advertising ban by DTCA-PD proponents, while the term‘health information’ has emerged simultaneously alongside anexpansion of the debate to include all aspects of citizens’ health,not just pharmaceuticals.

Broadly speaking, health information (sometimes termed‘health awareness’) differs as a policy goal from DTCA-PD andpatient information in that the latter two sought to disseminateinformation about specific prescription medicines, whereas the

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Journal of Evaluation in Clinical Practice ISSN 1365-2753

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former aims to provide guidance on health more generally. For theEU, health information constitutes a new approach to healthpolicy, moving away from legitimacy based on single-market com-petencies and towards justification rooted in public health treatyprovisions and the legal rights of the patient.

This article will look at the nature of this semantic, political andpolicy transition and ask why it occurred, what it tells us about EUhealth policy and future EU health legislation and how it may beunderstood through the lens of complexity.

Explaining EU health policyHistorically, EU health policy has been restricted to areas whereinternal market principles are clearly applicable or where theefficiency gains of an EU response can be clearly demonstrated –health information does not exhibit either of these characteristics.As such, it represents a fragile new expansion of the EU’s mandateand is emblematic of the wider development of European healthpolicy.

Unsurprisingly, a wide range of factors emerge from the litera-ture exploring this development of EU health policy. They includea mix of traditional integration processes and actors, institutionaland political dynamics and larger exogenous events, and can beexamined to reveal the impact of wider EU health policy develop-ment upon the transition of the DTCA-PD debate [1].

Neo-functional dynamics and the impact of theEuropean Court of Justice (ECJ)

Scott Greer [2] argued that ‘spillover’ is the fundamental driver ofEU health policy. In particular, mirroring the work by Hervery andVanhercke [3], Lamping [4] and Wismar [5], he asserts that thedecisions of the ECJ were very significant in the expansion of EUhealth policy. However, in the DTC-PD case, contrary to the pre-dictions of Greer [6] and others, the ECJ has not played a majorrole in the DTCA-PD debate. Hence, where certain spilloverdynamics do play a role, these aspects are distinct from the legalaspects that appear to be prevalent in other types of EU healthpolicy.

Liberal intergovernmentalism and theambiguous role of the member states

A liberal intergovernmental perspective stresses the importance ofthe member states in EU health policy. Leigh Hancher argues that‘national governments are reluctant to surrender sovereignty onpricing and profit controls and by implication, an important part oftheir health budgets to the European institutions’ [7]. In theDTCA-PD case, member states did play a role in the attempts toundermine the EU ban, as demonstrated by the support given bykey governments (United Kingdom, France and Germany in par-ticular). Beyond this, however, member states played a generallypassive role – the key battles were fought within the Commissionand the EP.

Administrative and policy competition withinthe commission

As detailed in Guigner [8], Mckee et al. [9], Mossialos et al. [10],and Permanand and Mossialos [11], EU health issues are spread

across a number of DGs within the Commission and competitionbetween these actors has a major influence of the nature of EUhealth policy. The creation of DG SANCO (Health and ConsumerPolicy) has only been a recent development and although moststaff remains concentrated in the area of food safety and consumerprotection, DG SANCO has been pushing into a variety of newhealth-related policy areas. Consequently, administrative andpolitical struggles within the Commission, particularly betweenDG Enterprise and DG SANCO, were of central importance to theoutcome of the DTCA-PD policy. Each organized and promotedopposing positions and clearly demonstrated that the Commissionis often divided over the internal market or public health aspects ofpolicy issues.

Growing role of the European Parliament,interest groups and political dynamics

The EP as an arena of political conflict and the increasingly ratio-nal pluralist activities of the health-oriented interest groups thatinhabit this arena [4,6,12] has a significant impact on EU healthpolicy. In the DTCA-PD case, the debates and voting outcomeswithin the committee responsible and the EP as a whole were ofcentral importance in maintaining the advertising ban. Likewise,the activities of the pharmaceutical lobby were crucial to theattempts to break the ban, while the actions of the health lobby(both Commission-supported EU groups like European PublicHealth Alliance (EPHA) and national health organizations) wereimportant in maintaining it.

The impact of crisis events

Finally, for a number of authors [8,10,13,14], unpredictable criseshave played a crucial role in the development of EU public healthpolicy. Mossialos et al. point to the example of the Bovine Spongi-form Encephalopathy crisis in 1996, which played a major role inconvincing the member states to expand the remit of Article 152 onhealth in the Treaty of Amsterdam. In the DTCA-PD case, exog-enous changes such as the transformation of the global/Europeanpharmaceutical sector, and the acceptance of DTCA-PD in theUnited States were clearly underlying factors [15]. However,unlike other EU health policy developments, health crises did notplay a role in the final outcome of the policy. The issue emergedprimarily from the evolving interests of the pharmaceutical sectorand the activities of DG Enterprise.

Historical development of EUhealth policyEU health competence originated with occupational andworkplace-related health policies. Initial moves to expand thismandate were only made in the late 1980s, but actions remainedmeasured and failed to move beyond the more technical and non-political areas of public health policy [16]. The turning point camewith the Maastricht Treaty in 1992, which expanded the remit ofpublic health policy and gave related proposals Qualified MajorityVoting status within the Council of Ministers. Subsequently, theCommission launched the first Public Health Action Programme in1993. The 1997 Treaty of Amsterdam codified a ‘mainstreaming’provision, which served to ensure that health be taken into con-

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sideration in all fields of EU policy [16]. Most recently, the Article168 of the Treaty on the Functioning Unit of EU of the LisbonTreaty reiterates the EU’s role in protecting human health butretains the ‘complementary’ nature that has traditionally confinedthe EU to supporting member states’ actions [6].

Direct-to-consumer advertisingin EuropeIn 2005, major global pharmaceutical companies spent between24% and 33% of total sales revenue on marketing, advertising andpromotional activities – around double the amount spent onresearch and development [17]. While supporters claim that thisincreases consumer awareness and improves the doctor–patientrelationship [18–21], opponents argue that DTCA-PD is designedpurely to sell drugs by ‘medicalizing’ non-essential heath issues,thereby increasing the demand for drugs and resulting in the mis-allocation of individual and public health expenditure [15,22–24].

The emergence of the DTCA-PD debatein Europe

The cycles of lobbying and legislation can be broadly grouped intotwo ‘waves’ [1].

The first wave: 1997 to 2002

When the Food and Drugs Administration announced it was relax-ing US DTCA-PD regulation in 1997, the pharmaceutical sectorbegan to put all its weight behind efforts to lift the ban in the EU.A 1998 report by the Transatlantic Business Alliance claimed thatthe ban ‘. . . deprives EU citizens of the right-to-know’ [25] and ayear later, under pressure from industry, the Blair governmentestablished the Pharmaceutical Industry Competitiveness TaskForce to examine the issues surrounding DTCA-PD. When the EUpassed the 2001 directive confirming the ban, the EU Commis-sioner for Enterprise, Erkki Liikanen, proposed an amendmentallowing for the dissemination of information [26] on three specificdisease groups: diabetes, AIDS and asthma. The amendment wasrejected in a landslide vote by the EP and the debate on DTCA-PDsubsided until the creation of a new Pharmaceutical Forum.

The second wave: 2006 to 2009

In 2006, this new high-level platform began, once again, to pres-sure EU officials and member states to review the legislationregulating DTCA-PD. Driven by DG Enterprise (DG ENTR), theForum’s membership and mandate were never publicly disclosed,contradicting the Commission’s Transparency Initiative andleading many to question the group’s democratic credentials [27].After a largely industry-sponsored public consultation, with pre-dictable results, the Commission adopted the ‘pharmaceuticalpackage’ comprised three legislative texts targeting falsified medi-cines, pharmacovigilance and patient information.

The first two, less controversial, elements of the package werecompleted with relative ease in December 2010, but the patientinformation directive made considerably slower progress. Thecommittee responsible, Environment, Public Health and FoodSafety, has struggled to reach a consensus, forcing RapporteurChristofer Fjellner (Sweden, EPP) to seek a postponement of the

vote on his draft report. Though a majority was finally gained inSeptember 2010 [28], the proposal has been significantly modifiedby the Parliament.

From ‘patient information’ to ‘healthinformation’September’s vote effectively spelt the end for patient informationas it is currently known but this shift was not sudden. Throughoutthe debate, a gradual transition occurred, as the limits of the patientinformation approach became clear and proponents of DTCA-PDbegan to reframe their position in a more politically palatablemanner.

The patient information strategy emerged as it became clear thatattacking the ban on advertising was politically infeasible. Movingaway from the language of free markets and competitiveness,those in the industry turned direct-to-consumer advertising intodirect-to-consumer information, thereby arguing a politically safeviewpoint while bringing the issue firmly onto the Europeanagenda. One of the core tactics was the direct support of ‘patientgroups’, whose importance as a stakeholder in the debate wasemphasized while simultaneously having their funding and activi-ties increasingly directed by industry. Meanwhile, established andindependent health and patient groups, who supported the ban,were ignored or refused access to key meetings [15,29].

At this point, Commissioner Liikanen’s proposals still called forthe ‘dissemination’ of information, a turn of phrase, which waslater to be used as a symbol of the industry-leaning nature of theCommission text and omitted from the Parliament report, yet itrepresented a step in the direction of a broader definition of patientinformation beyond the range of advertising. Slowly but steadily,the context of the DTCA-PD debate was being altered.

In 2004, the Parliament adopted Directive 2004/27/EC, main-taining the ban on advertising but requesting another analysis ofcurrent practice. The resulting report emphasized the need for a‘. . . clear distinction between advertising and non-promotionalinformation’ [30], marking the transition to a debate on the dis-tinction between advertising and information. In characterizingadvertising as a dangerous practice designed to further industryinterests, proponents of DTCA-PD were able to frame informationabout medicines as the de facto alternative.

In 2009, following intense pressure from independent healthand patient groups, as well as several Commissioners and EUofficials [31], competency for pharmaceuticals was transferredfrom DG ENTR to the DG for Health and Consumer Affairs (DGSANCO). This move followed the failure of a bid to classify healthcare as a service sector in the controversial Bolkenstien Directive[32], despite the increasing role of market forces in national healthcare systems. The decision not to classify health as a ‘normal’consumer good [33] and to assign responsibility to a health-oriented DG served to institutionalize the transition fromDTCA-PD to patient information.

Current positions – the vote of no confidence

The draft report approved in September 2010 dramatically alteredthe Commission text to emphasize the right of the patient toreceive health information, rather than the right of the industry toprovide it. Throughout the legislative process, concerns had been

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raised about the prominence of industry interests and market prin-ciples in the DTCA-PD debate. By asserting once and for all thatDTCA-PD is a health-related issue and should not pay undueconsideration to market concerns, the Parliament reaffirmed themore public health-oriented nature of EU policy in this area.

Why did it happen?

As discussed, a complex range of factors played a role in thetransition from DTCA-PD to patient information, and eventuallyhealth information. At a general level, significant pressure forchange came from the ratification and entry into force of theLisbon Treaty in January 2010. The Treaty emphasizes the impor-tance of transparency and openness in the functioning of the Unionand highlights the need to address the so-called ‘democraticdeficit’ [34]. In doing so, it has enhanced the powers of the Par-liament and, arguably more significantly, institutionalized the cen-trality of citizens’ rights by enshrining the Charter of FundamentalRights into EU primary law [35]. The influence of these principlescan be seen in the couching of arguments in terms of citizens’rights and the inclusion of a wider range of stakeholders.

Perhaps most important, however, is the Treaty’s aim to combinecompetitiveness with a new emphasis on social policy [36]. Themodern-day EU was born out of a functional economic union, butthe Lisbon Treaty firmly and explicitly acknowledges the socialaspects of EU [37], making it very difficult to present debates inpurely economic or trade terms. In the case of DTCA-PD, thischange in perceptions made the initial industry position politicallyinfeasible and forced proponents to redefine and repackage theirarguments in terms of citizens’ health and social policy concerns.

Recent developmentsFollowing the adoption of the draft report, the Commissionacknowledged the concerns of the Parliament and public healthinterest groups and agreed to revise the proposal. This move post-pones the Council of Ministers’ deliberation, but allows for a shiftin focus while avoiding a formal withdrawal and redrafting, whichwould likely delay the file by another 2 years. Though this decisionpostpones the Council of Ministers deliberation on the file, boththe Hungarian Presidency, which took the rotating presidency ofthe EU in January 2011 and the Polish Presidency, which began inJuly 2011, announced that the patient information dossier as one ofits presidential priorities. However, as of August 2011, a new drafthas yet to appear from the Commission.

DTCA-PD through the lens ofcomplexityAs several authors have noted [38,39], the EU can be easily con-ceived of as a large emergent complex system. It has generallystable structures and boundaries (the treaties, acquis communau-taire, etc.), demonstrates substantial unpredictable emergent prop-erties (the future of the euro, new member states?) and a healthyrange of conflicting, cooperating and co-evolving interests andactors at multiple levels that combine to make its messy but overall‘satisficing’ politics. In the case of EU health policy and the issueof DTCA-PD, one can clearly see the complex ‘dance’ of interestgroups and institutional actors and the broad range of factors,

dynamics and even chance events (crises) that continually shapethis area. Clearly, as a complexity perspective implies, trying topick the single actor, dominant dynamic and/or causal linchpin inthe development of this policy area is impossible.

Further, as recognized by various complexity and health authors[40–42], though complexity runs throughout the field of health, itis particularly prevalent in the area of public health. This is due tothe fact that public health involves and implies a much broaderrange of social actors and meaning, adding an additional level of‘conscious complexity’ [39] onto an already complex biological/medical process. Hence, though the EU has only recently movedinto the public health field, its messy politics are in some waysideally suited for the complex nature of public health. This doesnot make life easy for European public health actors. For them, EUpublic health policy development is like ‘walking through a mazewhose walls rearrange themselves with every step you take’ [43].How they act purposefully in these circumstances is that they havea particular moral/financial/policy/etc. compass that tells them thegeneral direction they want to go. They try to move the policysystem in this direction, all the while continually trying tostrengthen walls that suit their general direction and weaken thosethat move the policy away from that direction. It is also importantto note that the actors themselves are complex and have emergentand co-evolving interests [44].

More specifically, analyzing the political and semantic develop-ment of the DTCA-PD proposal and the strategic approach of itsproponents reveals a clear evolution of policy focused on industryand trade to one more oriented to aspects of health and well-being.While health information is not without its flaws (from a publichealth perspective) – the role of industry in the provision of ‘healthcare’ information has yet to be made clear – it represents a signifi-cant step in the direction of a more citizen focused health policy.

Overall, these tensions are not surprising from a complexityperspective. European integration has consistently been character-ized by a co-evolving competition between the competing aims ofthe EU itself [45] and the recent debate on DTCA-PD is emblematicof this social-economic tension. When the proposal was initiallytabled, the Commission made no attempt to portray it as a publichealth measure – its purpose was to increase the competitiveness ofEurope’s pharmaceuticals [24]. Yet, as the dossier progressed, theconcerns of social and health policy actors become more pro-nounced and, prompted by the changing external context of EUhealth policy, they acted to shift the policy to one of patients’ rightsto medicines information and health information more generally.

Clearly, this is a victory for more socially oriented public healthactors. However, again, as a complexity perspective would empha-size, this certainly does not eliminate the underlying tension nordoes it firmly resolve the issue. Regarding the complex ‘dance’of itskey actors, the very success of EU public health actors in defendingthe DTCA-PD ban helps to keep the issue off the agenda at thenational level and therefore makes it easier for powerful economicgroups to lobby ‘out of the light’ at the EU level. More fundamen-tally, with the growing ubiquity of the internet and new informationtechnologies, the nature of advertising is changing rapidly. Hence,it is likely that the next phase of this tension will involve balancingthe needs of industry against patients in the much more deregulatedrealm of cyberspace. The complex and evolving maze of DTCA-PDpolicy is clearly set for another major turn and the ‘dance’ of itsco-evolving actors will certainly continue.

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