3.1 Informal persuasion

An opaque reimbursement process provides multiple opportunities for informal persuasion as a lobbying method. “That the firm comes with scientific evidence is far from enough. It is the ease of access to particular people that really counts.” (7). What enables informal lobbying are close personal relationships with decision makers at the MoH, the NHF and the AHTA. “A lot depends on his [an official's] willingness to meet with one or another person. This is all based on relationships.” (7). Therefore, “[P]harmaceuticals are an extremely relational, ‘wining and dining industry’. … There are always attempts to establish personal contact [with decision makers].” (1).

The crucial form of informal lobbying is “the path of mutual favours”. “Suppose your mum is very ill and someone helps you ‘arrange’ a good hospital. You will surely react positively, if this person asks you to read some paperwork. … The exchange of favours is a debt everyone runs into but eagerly pays off.” (8). In particular, a lucrative position in the pharmaceutical sector is a means of reciprocating past favours granted by a public official. “X [a former high-ranking MoH official] used to keep some firms’ reimbursement applications in a drawer [i.e., delay them]. Having left the MoH, he started working for the firms whose applications he hadn't kept there.” (9).

Insiders describe informal persuasion as a highly effective lobbying method. For example, in 2007, a cardiology drug was accepted for reimbursement even though the scientific evidence behind it was doubtful and the decision-making process evidently breached formal regulations. The press uncovered that the positive reimbursement decision had been preceded by the help that a high-ranking ministerial official received from the drug company in ‘arranging a flat’ for his relative. ‘These totally informal relationships very often influence the policy process.’ (10).

Ironically, the widespread conviction about the effectiveness of informal lobbying stands in stark contrast with the apparently stringent ‘procedure of receiving external clients’ (procedura przyjmowania klientów zewnętrznych) established at the MoH (Procedura, 2009). “We are very cautious against contacts with the industry which might be perceived as attempts of exerting influence.” (11). However, the formal consultations are universally criticised by representatives of drug companies for the long waiting periods, infrequent meetings and limited topics discussed. Importantly, the ‘procedure of receiving external clients’ is viewed as an instrument limiting access by ‘unfriendly’ drug companies to the MoH. “The Polish law is like web: a horsefly will squeeze through yet a bee will bog down” (3; a quotation from a 16th century poet). In fact, formal regulations are “Much ado about nothing, really. What they practically mean is that the Rabbit's ‘relatives’ and ‘acquaintances’ will met outside [state organisations], while others are muzzled and can't communicate.” (3).

Our interviews indicate that drug firms lacking close personal connections with decision-makers rely on endorsements expressed by KOLs, patient organisations and the media rather than on informal lobbying. “If the door to the MoH is closed, the industry searches around and tries to find a place to enter.” (12).

3.2 The voice of experts

The most important type of KOLs relevant to Polish drug reimbursement policy are ‘national consultants’ (konsultanci krajowi) representing 84 fields of medical and pharmacological specialisation. These prominent experts – professors of medicine or pharmacology and directors of important clinics – advise the MoH, the NHF and the AHTA, drawing on their on-the spot clinical experience. “The MoH obviously asks the AHTA to assess quantitative data, but this is all in theory. The MoH very often relies on consultants and asks them if the drug is really worth reimbursement.” (6). National consultants can be remarkably effective in convincing the Minister about the merits of even controversial medicines. For instance, in 2008–2009 the national consultant in neonatology led a successful campaign aimed at the acceptance of a vaccine for Human Respiratory syncytial virus (RSV) for reimbursement (Jakubiak, Reference Jakubiak2009a), even though the drug had received two negative AHTA recommendations stressing the lack of compelling evidence of its effectiveness.

That said, “Because of their formal location, national consultants are always an indispensable element of actions aimed at drug reimbursement.” (13). Not surprisingly, the interviewed national consultants point out their personal independence from pharmaceutical companies. Notably, they are less emphatic, however, about the integrity of their colleagues: “I sometimes observe those presentations [at medical congresses], not only in Poland but also abroad. They are very emotional, saying how wonderful a drug is. I always wonder to what degree this is … induced by gratification or [results from] deep internal conviction. … Sometimes, when I listen to acknowledged professors singing praises of a medicine during a meeting organised by the firm, I keep saying to myself: ‘Gosh, I would never sell myself like this for any money.’ ” (14).

It is also worthwhile to consider the perspective of an organisation utilising national consultants’ expertise. “I have never ever heard X [a national consultant] expressing a negative opinion about a drug. He is always the greatest enthusiast. I do not know why that is, but do not think he is such a devotee, so to speak, by nature. And the more enthusiastic the expert, the greater our scepticism and uncertainty. But [we] lack good arguments to challenge him.” (15). Paradoxically, attempts to introduce more stringent regulations on national consultants’ conflicts of interests turned out to be counter-effective. “We have a big problem with external experts as many of them don't want to fill in the declaration of conflicts of interest. And even if they agree to say who they have worked for, they don't want to disclose how much they have been paid.” (16).

Consequently, for pharmaceutical companies, “Achieving KOLs’ support is vital. We do need to have permanent relationships with them. … This is the essence of pharmaceutical lobbying.” (1). Given the limited number and the important role of national consultants, “Firms obviously compete for KOLs’ attention.” (13). In doing so, innovative drug companies use a wide array of instruments key to building the professional status of national consultants. In particular, invitations to organise clinical trials give them broad access to cutting-edge exclusive medical knowledge through “regular collaboration with other KOLs and getting practical knowledge about a drug.” (6). Also, because of their high profitability, “Clinical trials are the main form of rewarding and building long-term relationships with national consultants.” (11). Finally, “A clinical trial, especially a multicenter one, is a real treat for professor X. By taking part in it he can meet big names from France, the US and the UK. This is extremely valuable, since his peers in Poland look up to him when his name appears next to those foreign names in The Lancet or BMJ.” (17).

What facilitates establishing close relationships with national consultants is, first, the fact that the MoH does not adequately reward their professional activity. “[They] should be attending congresses and visiting clinics in the country but the state does not provide [them] with funding. So they sometimes take money from drug companies. It is obviously very hypocritical of politicians to eagerly criticise relations between national consultants and the industry, whereas they give them no money.” (8). Second, it is the ability of consultants to secure reimbursement of innovative therapies that largely determines the balance of power between different medical specialities. “Doctors’ lobbies are centred on consultants. There are the very powerful oncological and cardiorogical lobbies. … They win vast sums of money to finance new, very expensive drugs.” (15).

3.3 Pressure from patients

“In Poland – as opposed to the West – there are considerable problems with access to drugs. As a result, although Polish patients also organise to provide themselves with group support, their main goal is lobbying to exercise their rights to health protection.” (6).

The shared interest with drug companies in introducing innovative drugs to reimbursement is strengthened by the weak financial and organisational resources available to patients’ organisations. “[P]ublic grants for patients’ associations … are, putting it mildly, very limited. Consequently, they rely on various other forms of external financial aid. And … this help comes predominantly from drug companies.” (18).

As the imbalance of organisational resources between the two sides is more evident in Poland than in the UK, pharmaceutical firms find it easier to control patients’ organisations in the former (Jones, Reference Jones2008; Solska, Reference Solska2009). Some drug companies create patient organisations tailored to specific lobbying campaigns. “The reimbursement application [concerning a drug for kidney cancer] was immediately followed by the appearance of the patients’ association. … It could not have been a coincidence.” (3).

Alternatively, drug companies support existing organisations, primarily through money transfers. “If the firm pays the association, then it can also draft its statute.” (19). Moreover, drug companies control organisations through manipulating medical information provided to patients. “Those people are indoctrinated and they will pass on what they were led to believe.” (20). Moreover, drug companies orchestrate patient organisations’ lobbying activities. “They [drug companies] think this way: ‘Since we want to lobby effectively for our product, we will prepare a letter which will be distributed among the association's members to save them the trouble of writing it. We will also develop an appeal list which you will just sign.’ ” (21).

The superior power of pharmaceutical companies is also acknowledged by representatives of patient organisations. “Firms support us because we don't have another source of income. We try to maintain good relationships with them to get by.” (22). One of a few strategies of restoring independence from drug companies is diversifying cooperation. “It is my aim to cooperate with all firms working for people suffering from diabetes. And I'm very principled about this.” (22).

When drug companies have no personal connections to exploit, using patient organisations as a third party “is the most effective solution.” (8). Specifically, it enables drug companies to conceal their commercial interests “under the cover of defending patients’ rights.” (23). Elected politicians find it very difficult to resist pressure involving potential voters. “It is said that officials do not react [to the patients’ pressure]. But ultimately they have to react.” (8).

A highly effective lobbying method used by patients’ organisations is “accessing the Minister of Health mediated by the medical milieu cooperating with the association.” (21). On the other hand, KOLs also rely on patients’ political support. “I protested against them [pharmacotherapy changes proposed by the MoH] and also asked the patients’ association to express their opinion on this issue. We had this type of cooperation.” (14).

3.4 Engineering media support

“Pharmaceutical lobbying primarily comprises actions in the media and informational sphere.” (11). First, “Media reports serve as a propaganda machine which builds the social awareness of the need of a certain drug. This in turn creates pressure on decision makers aimed at reimbursing this drug.” (11).

Second, pharmaceutical firms use the media to generate negative publicity against decision makers. “It's great for a [drug] company when the material is broadcast during prime-time news releases. It shows a pretty girl who suffers a lot and loves painting. The only missing thing is the drug. … It can be purchased. So why don't do it?” (8).

The extreme variant of negative publicity is the uniquely postcommunist ‘kompromat’ campaigns designed to destroy a politician's reputation (Ledeneva, Reference Ledeneva2006). For instance, in 2002, a group of innovative drug companies in conflict with Maciej Łapiński, the then Minister of Health, was linked to a series of publications accusing his closest collaborator of corruption. This eventually led to the Minister's dismissal by the Prime Minister. However, a subsequent Supreme Court ruling stated that the allegations had been unsubstantiated (Money.pl, 2007). In his book, Łapiński recounts: “I have recently met the boss of the most effective company in ‘black public relations.’ From what I have heard, three firms chipped in $3,000,000 to do away with me. It all came down to buying articles” (Łapiński, Reference Łapiński2005: 108).

Our interviewees indeed mentioned attempts of transferring money to individual journalists. “A lady from a pharmaceutical company called me [once] and said she would like to order an article with me. … I explained that I didn't do such things. I also told her they could provide us with this article and we would print it as an advertisement.” (4). Publications favourable for drug companies may also result from the fact that “For the majority of journalists, medicine is just one of many topics.” (8). Therefore, cooperation with journalists sometimes takes the form of ghost-writing: “Briefing journalists typically comes down to providing them with already prepared texts. Firms prefer to give them materials on a pen drive or a CD, so that the journalist can just do the ‘copy-paste.’ ” (8).

“The media and the public sphere … are decisive” (23) in exerting pressure on the MoH. Generating media support compensates for the lack of close personal relationships with decision-makers. “[F]irms are simply not able to access everyone. But … media pressure is strong. The press and television can broadcast what they want.” (11). In addition, using the media enables stealth lobbying. “Firms handle this with velvet gloves. … Someone passes some materials to a friend who approaches another friend who eventually goes to a journalist with them. The chances to establish who initiated the process are minimal given that the subsequent links come into play.” (13). Using the media is also highly efficient because “Sometimes there is a case of one patient which focuses a whole range of issues [and] can lead to achieving money for the whole therapeutic group.” (8).

Moreover, using the media makes it possible to combine the efforts of ‘third parties’: national consultants and patients’ organisations. “During my stay at the office, there was a problem with drug X: some national consultants were expressing themselves unreasonably. They did it publically, during press conferences. They were cited by serious media.” [23] Similarly, “Using media appearances of patients’ organisations is … a very strong lobbying method.” (24).

We summarise the relationships between the main pharmaceutical lobbying methods used in Polish reimbursement policy in Figure 1.

Figure 1

Key pharmaceutical lobbying methods in Poland

Our interviews also point to two supplementary lobbying methods, which involve support from two types of ‘influencers’, namely, domestic and foreign political organisations, which we now discuss.

3.5 Getting around the reimbursement process

Pharmaceutical firms exert indirect pressure on the Minister of Health through other ministries and members of parliament. For instance, a company may attempt to convince the Ministry of Economy that reimbursing a particular drug will positively affect its investment in the Polish pharmaceutical sector. Although a firm does not manufacture innovative medicines in Poland, “We are still an employer who pays taxes and an important partner for the scientific milieu. … Consequently, the Ministry of Economy understands that it should care for innovative drug companies.” (13). Furthermore, the opinion of the Ministry of Finance may prove crucial in persuading the Minister of Health that the reimbursement of a drug is acceptable financially. “The element of cooperation with people responsible for finances and convincing them to support our idea to reimburse the drug may greatly contribute to the eventual success.” (7).

Drug companies “expect that lobbying of members of parliament will make them understand that our problem is crucial and that they will later support our position before the MoH. We often look for an ‘ambassador’ of a particular problem among members of parliament.” (13). To this end, “firms take every opportunity to build relationships with members of parliament.” (13). A powerful variant of this method is disguised money transfers directed to well-connected politicians. “Someone from a drug company suggested that I should set up a foundation which could focus on any health-related issue … This conversation clearly suggested that money wouldn't be a problem at all, they will obviously provide it. … Their goal was to access someone with extensive political contacts. … It's important for them to influence decision making circles using such soft methods.” (10).

Drug companies also use patient organisations as intermediaries in exerting pressure on members of parliament. “Firms are cautious. They don't lobby blatantly. It's not a problem to send the president of an [patients’] association instead of going themselves.” (11). Thus, “Sometimes it is difficult to distinguish between their [members’ of parliament] contacts with firms and those with patients.” (11).

Members of parliament use a range of formal powers to facilitate the inclusion of new drugs in reimbursement. “I can write to the Minister of Health and ask if the AHTA is processing this particular application and when the recommendation can be expected. I'm the intermediary for the [patients’] association. And sometimes the ‘accelerator’ of decisions.” (25). The support that members of parliament give to new therapies is intense: “Between December 2008 and September 2009 we received 41 [parliamentary] questions concerning long-lasting insulin analogues.” (11).

3.6 Playing diplomacy

Lobbying campaigns by multinational pharmaceutical companies’ are often supported by the governments of their countries of origin. In particular, “The US is most active in supporting its firms.” (26). This is because “Drug companies have great influence on the American government and it can do a lot for them on the international stage.” (27). In doing so, they exploit the fact that the Polish government strives to attract investment from and maintain positive political relationships with its key international partner.

First, American drug companies persuade congressmen and high-ranking officials from the executive branch to offer endorsements to Polish decision-makers in the MoH. For instance, “Two congressmen sent us once a letter saying that we had made a gigantic mistake in not reimbursing a particular drug. … At present, in the MoH shows less servility to Americans. … But some time ago when they were coming, one could only hear big ‘Wow!’ ” (28).

Second, the American Embassy in Warsaw and the American–Polish Chamber of Commerce facilitate access to Polish decision-makers. “It is often the US Ambassador who brings the firm along for a meeting with the Minister of Health.” (29). The Embassy applies a range of flexible forms of pressure: “We can send a letter, the problem gets mentioned in various ways, and governments talk to each other. Everything depends on the case and the alignment of players. Everything depends on the issue.” (30). “A personal endorsement by the Embassy does help, since everyone knows each other in this milieu [people dealing with drug reimbursement]. The Embassy can organise pressure effectively.” (27).