In whose interest? Relationships between health consumer groups and the pharmaceutical industry in the UK
Address for correspondence: Kathryn Jones, Department of Public Policy, De Montfort University, Bosworth House, Leicester LE1 9BH
This paper explores how health consumer groups in the UK disclose and manage links with pharmaceutical companies in the context of their growing involvement in the policy process. In particular, it examines claims that industry engages with groups in an attempt to capture the groups’ policy agenda, thereby increasing industry's political influence. Drawing on theories of disclosure, analysis of group and industry websites revealed a varying level of detail on the nature and extent of relationships. Only 26 per cent of consumer groups known to be in receipt of industry financial or in-kind support openly acknowledged this. Interviews undertaken with representatives from consumer groups, industry and other health-care stakeholders, highlighted a coincidence of aims between the two sectors, an acknowledgement that collaboration was inevitable, and tacit support for policy guidelines to manage conflicts of interest. The paper concludes by arguing that while claims of organisational capture are over-stated, the shallow approach to transparency adopted by the majority of companies and groups strengthens critiques of undue influence. This may ultimately reduce policy makers’ willingness to see consumer groups as the legitimate voice of patients, users and carers in the policy process.
If ensuring the delivery of effective health care in modern welfare states requires a ‘political settlement between important interests’ (Moran 1999: 14), then it follows that, in balancing interests, policy makers must make trade-offs. For example political settlements to ensure the availability of safe and effective medicines must contend with the state's need to ensure access while containing costs, the medical profession's desire to maintain control over prescribing and the pharmaceutical industry's desire for profitability and a supportive research and development and regulatory environment. In other words, competing power relations play a formative part in the resulting health-care system. It also follows that any political settlement may need to be revisited as and when new pressures or agendas arise. Moran (1999) describes how in capitalist democracies, technological innovation may ‘disrupt any equilibrium between [health-care] interests: it enriches some and impoverishes others’ (1999: 14). He contends that the resulting competition may reshape political agendas, with both winning and losing interests resorting to the policy process to minimise damage and maximise benefits. Other pressures can also test agreements, for example changes in population demographics may increase strain on resources; or the arrival of new actors in the policy arena may challenge the long-held assumptions of existing interests (Baggott et al. 2005).
Indeed, policy making in health care, once the preserve of powerful interests, is now confronted by a hitherto inchoate voice, that of the health-care consumer (Baggott 2007, Salter 2004). Since the 1960s, health consumers have increasingly mobilised around particular medical conditions or in response to broader issues such as patients’ rights. They have formed organisations to provide self-help, advice and advocacy. Health consumer groups – voluntary sector organisations that promote and/or represent the interests of patients, users and carers – (hereafter consumer groups1) reflect features of new social movements (Allsop et al. 2004). For example they are involved in confronting scientific knowledge with ‘real world’ experience; protesting against adverse events, and claim a representative role in policy making. Indeed, their perspectives on policy problems have been welcomed by established interests who have increasingly drawn on their expertise (Baggott et al. 2005). However, they lack the political and financial resources of other policy actors, and Lofgren (2004) cautions that their critical edge may be compromised through participation in governance structures and alliances with health professionals and industry.
These more powerful interests may simply be attempting to subvert the activities of consumer groups, reshaping or redefining their concerns to match their own, creating a situation which implicitly or explicitly mutes groups’ critique of their actions. In other words, the agenda of the consumer group is ‘captured’, raising questions of independence, power and legitimacy. In the light of these concerns, the focus here is on understanding how UK consumer groups manage their relationships with one key interest in health care – the pharmaceutical industry. In addition, this paper explores how these links affect broader policy debates around access to medicine, regulation of industry's promotional activities and the inclusion of consumer groups in policy deliberations.
Available evidence suggests that links between industry and consumer groups have grown recently (Baggott and Forster 2008, Ball et al. 2006). This, however, has given rise to fears that groups are being used by industry to indirectly lobby health-care decision makers, particularly in light of wider debates about the influence of the pharmaceutical industry over health-care delivery (Busfield 2006, Health Committee 2005, Health Action International 2002). A key concern is that groups may become too focused on securing pharmacological interventions for conditions which may be better served by alternative means (O'Donovan 2007). Indeed, in a recent survey, only 16 per cent of bmj.com readers agreed it was acceptable for groups to take industry funding (British Medical Journal 2007).
Yet, while their motives may differ, it is clear that industry and groups will share an agenda around the availability of, and access to, medicine. With globalised information networks, consumers can learn about treatments available in one health-care system and advocate their availability in another (Fox and Ward 2005). In the UK, the National Institute for Health and Clinical Excellence (NICE) has a key role in appraising the cost-effectiveness of medical technologies and in developing clinical guidelines on appropriate treatments. Its refusal to fund treatments, and delays in the implementation of NICE guidance, have done much to galvanise the activities of both industry and groups (Duckenfield and Rangnekar 2004). These actors may therefore simply be highlighting issues that other policy actors would rather remain hidden – cost constraints in the delivery of health care.
One difficulty in exploring the implications of collaboration is that groups are not required to disclose information on links with industry (Which? 2003). However, following revisions to the Code of Practice (ABPI 2005) which regulates the promotional activities of industry in the UK, the Association of the British Pharmaceutical Industry (ABPI) now requires companies to release this information on their websites or annual reports. This provides a useful baseline from which to determine acknowledgement of industry support and to make some judgements about the nature of the relationship. Drawing on broader ethical debates, however, it is recognised that disclosure of information is not a neutral phenomenon (Gray et al. 1996, Moon and Bonny 2001). Disclosure may reflect a desire for reputation management rather than a commitment to freedom of information (Gray et al. 1996). Nonetheless, a requirement for transparency provides access to information that would otherwise remain hidden, and it can reinforce openness by facilitating further demands for information (Gray et al. 1996). In the context of industry-professional relationships, Hurst and Mauron (2008) identify two key problems with disclosure: first, it may make any conflict of interest seem acceptable by appearing to legitimise activities, and second, acknowledgement of links may not be sufficient to assess the likelihood of bias. In this way disclosure may reflect and support existing power structures in society (Gray et al. 1996). Yet without public disclosure of the extent of contact, and the decision rules which underpin links, informed decisions about collaboration and influence are impossible (Ball et al. 2006, Jack 2006).
In exploring industry-group co-operation, this paper addresses a number of key questions. How is collaboration and potential conflict of interest currently acknowledged? How are existing power relationships in the policy process affected by industry-group collaboration? Does collaboration with industry strengthen or undermine groups’ legitimacy among policy makers? How should disclosure be regulated? The paper is divided into three sections. The first provides an overview of positions taken by consumer groups on disclosing industry support, together with an assessment of the information provided on company and group websites. The second addresses both sectors’ response to criticisms of organisational capture and the use of policies which outline how groups seek to manage links to industry. The final section addresses how other health-care stakeholders view these links and the wider policy response to issues of disclosure.
The paper draws on a series of interviews with representatives of UK consumer groups, the pharmaceutical industry and other health-policy actors. They were undertaken in relation to two studies. The first, funded by the ESRC, on consumer groups in the UK health-policy process, was undertaken in three phases between 1999 and 2001 (Baggott et al. 2005). The initial phase entailed a semi-structured postal questionnaire sent to 187 groups (66% response rate (n = 123)). The second phase consisted of semi-structured interviews with leaders (chief executives and policy officers) from a sample of consumer groups (n = 39). The final phase involved semi-structured interviews with representatives (n = 31) from the health professions, government, Parliament, charities and ABPI (the UK drug industry's trade association). The second study, undertaken in 2005/6, was a pilot study of the pharmaceutical industry in the UK health-policy process (Jones 2007). Ten semi-structured interviews were undertaken with representatives (senior officers) from pharmaceutical companies and ABPI (n = 4), government (n = 3) and industry observers, including a consumer group (n = 3). In both studies, interviews were taped and transcribed. Using principles of qualitative data analysis, a coding framework based on multiple readings of interviews was devised and data were sorted into categories relating to internal and external relationships and sub-themes within these were identified. To maintain the anonymity of interviewees, respondents from the consumer group sector are referred to as ‘CG’, the pharmaceutical industry as ‘PI’ and government/stakeholders as ‘GSH’.
The paper also draws on an assessment in May 2007 of the Association of British Pharmaceutical Industry's full-members’ websites detailing support given to consumer groups. Data were downloaded and recorded onto a matrix which logged group name, condition area, group type, and grant information. In some instances, companies also listed links with other health-care stakeholders,2 such as professional associations and NHS trusts. These donations were however excluded from further analysis as the focus was on support for consumer groups. As a cross-check, the websites of consumer groups identified by industry were searched. Again, data were transposed onto a matrix which logged whether and how links were acknowledged. Websites were considered to be more up to date than annual reports, because of time-delays between submission to auditors and publication. In addition, websites of the 39 groups interviewed for the ESRC study were searched for up-to-date information on relationships with industry (following mergers and closures, 34 groups remained). This was undertaken as a check against change in circumstances to ensure that data from interviews were still valid.
Links between consumer groups and industry in the UK
This section explores disclosure by industry and consumer groups of links between the two sectors, it suggests three possible positions taken by groups on disclosure, and then compares and contrasts the level of detail provided by companies and groups. Not all groups seek to develop relationships with industry, some serve areas that may not require pharmacological intervention (e.g. natural childbirth). Other groups may represent those who have had adverse reactions to medication and have sought legal redress; again they are unlikely to accept links. The majority of groups, however, need to consider whether and how to collaborate with industry (Baggott et al. 2005). For their part, industry may seek links to gain access to groups’ expertise, aid mutual understanding, raise public awareness of conditions and/or for altruistic reasons (Baggott et al. 2005). There have been a number of attempts to classify relationships that form between companies and other health-care stakeholders (e.g. Doran and colleagues (2006) on the medical profession; O'Donovan (2007) on consumer groups). In particular, distinctions are made between those who refuse links and the attitudes of those who accept them. Of interest here, however, is how consumer groups choose to disclose links with industry; evidence from the ESRC study indicates there are three possible positions:3
- • Refusers: groups refusing contact with industry on principle, arguing it compromises independence, providing a definitive statement to this effect. It is likely that this position is adopted by a minority of groups; two of the 34 interview groups did so. For example, the National Heart Forum (2006) website states:‘The NHF is an independent organisation and does not take money from commercial organisations or from the food, alcohol, tobacco, pharmaceutical or marketing industries. The NHF has limited resources in comparison to these industries and there is a need to constantly monitor industry practices. It is important to do this in an independent way that does not compromise the public interest.’
- • Accepters: those accepting funding and/or links with industry; they however argue that any relationship should be transparent. These organisations have policies which guide their activities and make them publicly available. It is likely that this reflects a small but growing number of groups; nine of the 34 interview groups had policy guidelines. For example, one group interviewee said:We have an ethical policy round working with drugs companies . . . we will accept funding from drugs companies but as long as it doesn't have strings attached to it (CG38).
- • Non-disclosers: groups that do not reveal details of acceptance or refusal of industry support. Twenty-three of 34 interview groups were in this category. However, it is likely that a significant number accept funding – eight interview groups were identified by a company as receiving support but did not acknowledge this themselves.
Industry support for consumer groups
Around 40 per cent of the Association of British Pharmaceutical Industry's 74 full-members listed financial and in-kind support for consumer groups on their websites. In total, industry provided 488 grants to 246 groups. Most companies (n = 15) listed between one and ten groups on their websites. However, as Table 1 below shows, nine companies, some of the largest in the sector, funded twenty or more groups with six disclosing additional information beyond group name.
Table 1. Pharmaceutical companies funding 20 or more consumer groups
It appears that industry is selective in the groups it supports, for example, the majority of groups (57%) were named by only one company, just over a quarter were named by two or three companies, and the remainder by four or more. Table 2 lists those groups named by six or more companies.
Table 2. Consumer groups named by six or more pharmaceutical companies
|Diabetes UK|| 8|
|Blood Pressure Association|| 7|
|Men's Health Forum|| 6|
|National AIDS Map|| 6|
|National Rheumatoid Arthritis Society|| 6|
|Patients Association|| 6|
|Stroke Association|| 6|
The company websites provided a varying amount of detail on links with groups. Less than half listed any information other than group name. Only 12 of the 29 websites noted the time-frame the agreements covered. While the majority of websites indicated that links related to the provision of financial support, not all were explicit about the extent or purpose of funding. Only four companies (Bayer, GSK, Lilly and Co, and Pfizer) listed the amount provided to individual groups. Eight companies either made a general statement of why links were valuable or explained the purpose of specific grants. Three companies (GSK, Lilly and Co, and Pfizer) gave more comprehensive information and outlined principles governing their joint work, the amount and purpose of funding and the percentage of total income these grants accounted for. In addition, Astra Zeneca provided links to the formal agreements between it and named groups. Types of projects supported by industry ranged across sponsorship of conferences, publications, disease awareness campaigns, provision of core grants to cover groups’ running costs, funding specialist nurses and/or research projects.
Of the four companies revealing the exact funding provided to groups, two-fifths of grants were for £9,999 or less, a quarter between £10,000 and £19,999 and 13 per cent between £20,000–£29,999. Only six per cent of grants were for £100,000 or more. The figures on percentage of funding provided by three companies showed that the majority of grants accounted for less than 10 per cent of total group income (31% of grants accounted for <1 per cent of income, 33% for 1–4.9 per cent of income, and 17% for 5–9.9 per cent of income). Significant contributions, where funding was over 20 per cent of total group income, were provided in only nine per cent of cases. These figures suggest that concerns that industry ‘bank-rolls’ the consumer group sector are largely unfounded, although this assessment is based on data provided by those few companies providing sufficient detail to determine funding levels. Indeed, if more companies released this information, a more accurate assessment could be made. It appears, however, that the majority of groups are not reliant on the pharmaceutical sector for support.
Industry sponsored groups across a range of condition areas, summarised in Table 3. The majority of groups (23%) were concerned with cancers, either specific diseases or all cancers. Around 10 per cent of links were with groups dealing with mental health issues, neurological conditions or HIV/AIDs. Heart/circulatory disease and arthritis-related charities also attracted funding. This is unsurprising since these are major areas of drug research and therapy. A fifth of groups had a broader agenda rather than specific conditions, indicating that industry sees a role in supporting general issues such as patients’ rights. The data also showed that around five per cent of groups were alliance organisations to which other consumer groups were affiliated.
Table 3. Conditions/areas receiving support from pharmaceutical companies
|General Health|| 49||20|
|Mental Health|| 24||10|
|Neurological conditions|| 23||9|
|Heart / Circulatory disease|| 17||7|
|Arthritis / related conditions|| 13||5|
Disclosure by consumer groups
A cross-check of consumer groups’ websites revealed they were less likely than industry to acknowledge relationships. Only 26 per cent of groups known to receive industry support revealed this on their websites. While 10 per cent of groups did not have a website, nearly two-thirds gave no online financial information, although some provided access to annual reports which may acknowledge links (see Ball et al. 2006). The level of transparency and openness from those who acknowledged support also varied significantly. Four groups simply put the company's logo on their site, and three indicated that they accepted industry funding but did not identify where from. Twenty-two groups named individual companies and 18 gave details of the type of grant provided (mainly educational or unrestricted) and their purpose (for example, sponsoring websites, funding publications). Only 14 groups gave details of the financial arrangements, with four stating the percentage of income obtained. A similar number indicated they had policies for working with industry. In addition, a minority of groups gave no indication of links to industry, but provided details on their funding policy.
It is interesting to note that groups named most frequently by industry gave more details. Even so, a third gave no information. Of the 22 groups receiving grants from five or more companies, eight gave details of the policy governing these relationships and five listed the amount of funding received. Cancerbackup, which as noted earlier was listed by 12 companies, revealed the purpose and amount of funding, its policy on working with industry and the percentage of total income from industry. Overall, however, only a minority of groups disclosed links with industry, or set out a policy governing these relationships. Non-disclosure leaves the sector open to accusations of naivety at best and at worst, unprofessional or unethical conduct.
Managing the relationship
Rationale for links with industry
This section, from the perspective of groups and industry, explores why relationships between the sectors form and develop. It also examines how they view claims of conflict of interest that might arise from these links and the importance placed on ethical guidelines in structuring the relationship. Interviewees argued that, given their common agenda, communication between the two sectors was inevitable and relationships likely to occur. In part, it is a relationship between producer and consumer. For example, in its policy on working with industry, Cancerbackup argues:
We believe it is important to maintain cooperative relationships with companies that manufacture and market cancer drugs . . . in order to foster communication between the patients Cancerbackup represents and the companies whose decisions will affect their treatment (Cancerbackup 2006: 1).
Groups were also pragmatic, arguing that without industry support some services they provided for the public would not exist (see also Baggott et al. 2005). For example, while acknowledging public concerns, the Stroke Association's respondent said:
We recognise that, we know that and we work within those constraints, i.e. there are advantages to them but there are advantages to us because if a company is sponsoring a leaflet that costs, you know, £20,000 . . . that £20,000 can go somewhere else, either directly helping an individual that's had a stroke or perhaps funding new research.
Another interviewee whose organisation accepted sponsorship for a help-line argued that it remained independent and that accepting funding did not amount to support for industry products:
Yes we do get criticised because it could be seen that there's a conflict of interest there. But they provide a resource for patients that wouldn't otherwise have that information. But we’re not going to go out and flog their drugs for them (CG33).
Groups also argued that no funding source is dilemma-free, for example, the UK government's current emphasis on providing groups with project funding was linked to support for particular policies. Indeed, one group's website declared that it refused government funding because it would conflict with their policy-related activity.
The majority of groups were aware that industry had its own agenda, specifically the need to maximise profits, but argued that, despite this, it was possible to develop mechanisms to manage relationships. One interviewee said:
Nobody should pretend that [company name] isn't driven by profit, but once you understand that then you can work out how you deal with it (CG40).
Mechanisms suggested by those endorsing links between industry and groups included policy guidelines which specify terms of reference for co-operation (Health Coalition Initiative 2005). Within the consumer group sector, calls for public disclosure have risen in recent years. In the late 1990s, the alliance organisation, Long-term Medical Conditions Alliance (LTCA) published Working with the Pharmaceutical Industry: Guidelines for Voluntary Health Organisations on Developing a Policy (Wilson 1998). A few years later, the UK consumers organisation, Which? published a critique of links between the two sectors (Which? 2003). This was a catalyst for some groups to produce their own policies or adopt others. For example, a small number of groups are signatories to Health on the Net Foundation's‘HonCode’, which accredits good practice in the provision of online health information. Among its principles is disclosure of industry funding (HONF 2007). Policies serve both an internal and external role. The policies published by groups noted that their purpose was not just to inform companies of the ground rules for collaboration, but also to inform others about the nature of this relationship. For example, the Alzheimer's Society's (2006) policy states:
The Society has prepared this note to help clarify what assistance it can and cannot give to pharmaceutical companies and those working for them and to define for interested parties its independence from the pharmaceutical industry.
The policies also noted internal decision rules for collaboration, often a statement that the Chief Executive must be persuaded the relationship would not bring adverse publicity or damage the charity's reputation. They also noted when the Board of Trustees – those responsible for ensuring compliance with charity law – would be involved in funding decisions. Yet, few stipulated the requirement for a written contract as advocated by the Long-term Medical Conditions Alliance guidelines (Wilson 1998). In addition to establishing decision rules, many policies outlined the principles underpinning relationships. For example, Arthritis Care (2005) listed: transparency– to ensure the relationship was not seen as an endorsement of the company or its products; equal partnership– working together to meet the needs of people with arthritis; mutual benefit– the relationship should benefit both parties; independence– ensuring the charity remained independent.
As would be expected, the policies discussed the management of financial arrangements. The majority suggested that groups would prefer any project to be funded by consortia of companies and that good practice required multi_source funding for projects. A number of policies noted members had the right of access to a range of interventions, not simply pharmacological. Policies were split between those that automatically disclosed funding and those that stated this was a matter of negotiation. One organisation stated the amount of funding would not be revealed unless the sponsoring company agreed, and two noted that only funding over £1,000 would be disclosed. Only one group noted the maximum funding it would accept in a given financial year.
Most policies stated the group would not endorse or promote industry's products (see also below). Groups also claimed full editorial independence: any publicity using their name or logo had to be pre-approved. Interviewees argued the value of these policies was to ensure an appropriate framework for co-operation and to guarantee transparency:
The group had a pragmatic view of if you can get money out of people with no strings attached and you watch yourself very carefully and it's all very clear and written down in abundance then it doesn't really matter (CG11).
This point was acknowledged by industry interviewees. They suggested written policies and agreements were a useful tool for reputation management. In addition, they described how, given increasing public scrutiny, their own organisations had adopted more formal strategies for dealing with groups:
At one stage work with patients’ groups was viewed as a ‘nice thing to do’, and it wouldn't be looked at as part of pharmaceutical business interest. Now there is more scrutiny and scepticism of the industry, and corporate affairs work is an integral part of business (PC1).
A respondent from another company said:
I think my view of why there has been an increased corporate focus is reputation management . . . [company name] got caught completely bank-rolling organisations and I think it's more to make sure that we are behaving appropriately, that there is more corporate control (PC2).
Ethical issues: A political alliance?
Consumer groups argued that while collaboration may accrue differential benefits, theirs was an equal partnership. In addition, there were areas where both sectors had similar concerns, for example, in publicising conditions and ensuring access to treatment, as one group interviewee said:
We both share a number of objectives and one is to get arthritis higher up the political agenda and another is to get the general public more aware of arthritis and another is to try to empower patients because all three of those things are in our mutual interest. What we try and do is find ways of working that achieve those benefits for most of us (CG17).
A few group representatives suggested their influence and involvement in the policy process meant industry had an interest in ensuring their success. Offering support for member-based activities could free-up resources for lobbying, it was argued, to the benefit of both parties. A representative of an alliance group said:
I would say the influence of patients’ groups in most views is far higher than that of the pharmaceutical industry. And that might be why the pharmaceutical industry wants a relationship with patients’ groups because it sees them succeeding in achieving their objectives as being useful to the pharmaceutical industry (CG40).
However, groups were wary of working too closely with industry on policy issues, believing it would damage their credibility; concerns about perceived impropriety were paramount. For example, a mental-health group, which had audited access to new generations of anti-psychotic drugs, said that had the audit been sponsored by a company, policy makers would assume bias: ‘you could argue until you are blue in your face that it had been independent . . . (but) it wouldn't matter’ (CG23). Some group websites stressed that industry funding was not used for lobbying purposes. For example, the Alzheimer's Society which sought a judicial review on NICE's rejection of three drugs to treat early-stage dementia, publicly stated that industry funding was not used for campaign activity (Alzheimer's Society 2006).
Respondents from industry agreed that they shared a common agenda with groups, and that groups were increasingly influential policy actors. One company respondent explained why links were important: ‘they do want access to medicines, so if they have a voice that helps us . . . It's in our interests for patients’ groups to have a reasonable voice’ (PC2). Given that groups lobby for access to optimum care, companies undoubtedly benefit from another voice making similar demands. Yet in response to criticisms that funding of member-based activities amounts to undue influence, industry representatives argued that groups place a premium on their independence, taking a lead role in any relationship:
They are professional organisations who are independent and capable of advocating on their own terms, the corollary of that is they do not want to be seen as anyone's poodle . . . It's no longer a question of industry being able to advise how or what particular issues to proceed with, it's very much done on NGOs’ terms (PC3).
Ethical issues: promoting industry products?
Given the reliance on pharmacological intervention in medical care, it is inevitable that groups develop views on specific drugs, particularly newer treatments which may have more potential for improving quality of life. A core concern for groups was how to approach this, while concurrently managing links with industry. In interview, the majority of groups were aware of accusations of promoting company products, although one interviewee suggested claims about endorsement are over-stated:
Patients, you have to remember, aren't necessarily always aware which company produces the drug if they just take them, so the drug companies who put their name on our literature, our patient doesn't know which drugs they produce . . . so I can't see how on earth can there be any ethical problems (CG39).
With the growing focus on evidence-based health care and in particular the advent of NICE guidance, groups face new dilemmas about endorsing products. For example a breast cancer alliance representative stated: ‘if we’re campaigning for equality of access to the best then there's going to be times when we’re campaigning for equality of access to a specific drug’ (CG36). Indeed, the public's right to access best-practice treatment was noted in various policies, for example, Cancerbackup's (2006: 1) policy states:
Cancerbackup does not endorse individual treatments of whatever kind . . . however, if there is widespread consensus that a particular type of treatment might be beneficial for cancer patients, if for example it has been recommended by the NICE, then the charity has no hesitation in calling for funders to make resources available to implement NICE guidance.
Dilemmas over industry funding also arise when concerns about drug safety and efficacy are raised. In 2005, various arthritis charities, including Arthritis Care, were criticised for accepting funding from the manufacturer of rofecoxib, withdrawn from the market due to safety concerns (Frith 2005). In response, Arthritis Care (2006) pointed to its ethical guidelines, noted that the company had provided less than one per cent of its total income in 2003/4, and highlighted how it publicised concerns about the drug to its members. Clearly, it is difficult to balance the tension between maintaining co-operative relationships and criticising industry. The mere accusation of impropriety may damage a charity's reputation irrespective of any policy to which it is committed.
The views of stakeholders and policy developments
So far, the paper has explored the extent of contact between industry and consumer groups. It has argued that although policy guidelines are recommended, the majority of groups have not publicly adopted them. This section examines how other policy actors view industry-group collaboration, particularly around issues of influence and transparency. It then explores how criticisms relating to disclosure have brought a regulatory response from within and outside industry. Stakeholders have accepted there would be links between the two sectors, noting their shared interests. However, they have also suggested that there were pragmatic reasons why industry would seek collaboration. For example, one interviewee said:
The difficulty for the industry is that a cynic might just say ‘you are just in it for the money aren't you?’, so it's in their interest to get third-party endorsement from something like a charity or a patient group or a body with medical expertise or kudos to give it a bit more credibility, and you can sort of understand why that would be the case (GSH6).
Others argued as long as there was public disclosure about links, then policy makers should not be too concerned. A Department of Health civil servant noted:
Each group has a responsibility to their shareholders/stakeholders to do the best for their organisation and in some cases that is to lobby government, get your point across; so long as that is done in an open and transparent way and everyone understands the relationships that's all right, I'm not clear that's always been the case . . . (GSH5).
Indeed, the transparency of industry's relationships with other policy actors was one focus of the recent UK Parliamentary Health Committee's investigation into the influence of the pharmaceutical industry (Health Committee 2005). At the time, industry was concerned with the committee's agenda as a number of its advisors were known critics of industry practices (Jones 2007). As part of its remit, the committee addressed links between industry and consumer groups, and while it recognised that there were reasons for co-operation, it was critical of non-disclosure, recommending that:
Patient groups be required to declare all substantial sources of funding including support given in-kind and make such declarations accessible to the public (Health Committee 2005: 119).
Around the same time the Association of British Pharmaceutical Industry reviewed its Code of Practice for industry's promotional activities (ABPI 2005). Previously, it had not explicitly addressed relationships with consumer groups. The revised version, however, gives clear guidance, requiring companies to declare publicly which groups they support, and have a written agreement outlining terms of reference. Interviewees from both groups and industry suggested that increased scrutiny from policy makers prompted stronger guidance, the ABPI preferring to maintain self-regulation rather than risk a statutory response. Government has also chosen to promote self-regulation to improve disclosure by consumer groups, rather than pursue amendments to charity law (Department of Health 2005). An interviewee noted:
Post (health committee) report there is a very big sensitivity about the issue . . . I do think the industry is going to be a lot more careful. Probably patient organisations are as well . . . I think groups will get a lot better at declaring their relationships and so on (CG40).
This paper has examined how and why consumer groups and pharmaceutical companies disclose information on their financial relationships. It has shown that while concerns have consistently been raised about the nature and effects of these links within the context of a regulatory process which now requires disclosure from one party (industry) and recommends disclosure by another (consumer groups), a lack of transparency still persists. This lack of disclosure makes it difficult to fully assess the consequences of such links for the policy process; however, some tentative conclusions may be drawn.
Consumer groups share policy concerns with industry specifically around the profile of particular conditions and access to medication. It is no surprise therefore that they explore avenues where they have mutual interests. Indeed, across both studies, interviewees accepted the likelihood of this, although they also argued groups and industry should recognise potential conflicts of interest. These links have evolved at a time when the state has developed new regulatory processes for the approval of drugs and the development of treatment guidelines. This has had the potential to disrupt what Moran (1999) terms the ‘political settlement’ between state and industry around markets for industry products. Evidence from this study shows that consumer groups claim an interest in these policy debates and have at times increased pressure on the state to overturn NICE rulings.
So has industry captured the policy agenda of UK consumer groups in these debates? The findings presented here suggest not. It is unsurprising that groups insist on the availability of drugs which in their view prolong or improve quality of life. Consequently, they may question, critique and challenge government decisions to restrict or refuse funding for treatments they believe would benefit their members. From the perspective of groups, that this mirrors industry's agenda is a secondary consideration, and while industry representatives recognised they benefited from consumer groups holding other health-care stakeholders to account, they were adamant that they remained independent. Gauging whether groups are more concerned with the availability of drugs at the expense of other interventions is more problematic. Only a small number of funding policies commented on the rights of patients to pursue a range of treatment options. This said, consumer groups pursue a broad agenda in the policy process beyond the availability of drugs, adopting a holistic view of the needs of patients, users and carers (Baggott et al. 2005). In addition, it should be noted that groups, including those accepting funding, also use the policy process to hold industry to account, for example around adverse pharmacological reactions.
It is also unlikely that the interests of groups have been captured due to dependence on industry resources. While industry clearly supports a range of groups across a number of conditions, the evidence from websites (albeit limited) suggests it is not systematically bank-rolling the UK consumer group sector; in most cases funding from industry is only a small proportion of a group's total income. Where industry has supported the formation of a small number of groups, this has not necessarily been done in a clandestine way (Baggott et al. 2005), although that it has identified a gap in provision is noteworthy. Funding from industry for member-based activity, may free up resources for groups to pursue their policy goals; however, as already stated these may or may not reflect those of industry. If industry funding was withdrawn, it is highly unlikely that groups would be forced to cease participation in the policy process.
Finally, does disclosure reduce or reinforce concerns about power imbalances? Currently, the lack of systematic disclosure by both sectors suggests that unease about the nature of links will endure. Their shallow approach to transparency simply strengthens critiques of undue influence because the necessary detail to facilitate informed decisions is withheld. This lends weight to those who suggest that a move to regulate disclosure is an attempt to capture the agenda of those who believe such relationships are inherently problematic (Gray et al. 1996, Hurst and Mauron 2008). Properly executed disclosure, however, can challenge these critiques. If the good practice adopted by some was replicated across both sectors, informed decisions about the implications of collaboration could be made (Gray et al. 1996). Given the role claimed by consumer groups as representatives of the public interest, it is important they acknowledge sources of funding. While there are pockets of good practice, and some relationships are becoming increasingly structured through codes of conduct and explicit statements of intent, the lack of disclosure about funding sources from the majority of groups suggests this may ultimately reduce the willingness of policy makers and other health-care stakeholders to see them as the legitimate voice of patients, users and carers in the policy process.
ESRC Grant Number R000237888. The author would like to thank Professor Rob Baggott, De Monfort University and Professor Judith Allsop, University of Lincoln and the two anonymous referees for their comments on early drafts of the paper.
It is recognised that the term ‘health consumer’ is contested. However, ‘health consumer group’ accommodates the broad nature of citizens’ interactions with the health-care state (for further discussion see Baggott et al. 2005).
Industry websites listed 57 grants to 54 health-care stakeholder organisations.
Figures add up to 34. Five groups had merged or closed since 2001, one did not have a website.