Healthy Skepticism International News

January 2003

Pharmaceutical firms’ generosity and physicians: Legal aspects in Belgium.

Abstract

In this article we will examine the relationships between physicians and (representatives of) the pharmaceutical industry.  In particular we will discuss the appropriateness of some of the gifts that are given to physicians by companies in the pharmaceutical (and medical equipment) industry, since there has been growing concern about the potential negative consequences of these so-called ‘gift-giving practices’. Although the relation between physicians and industry can result in impressive medical advances, they also create opportunities for bias and can result in unfavourable public perceptions, over-consumption and misuse of public money.

First of all, a concise factual summary of the different types of gift-giving will be given, since not every gift can automatically be considered as inappropriate. Depending on the extent to which the gift serves a function beneficial to patient care and on whether the same benefits could be realised through less costly promotional activities, gifts could be appropriate. In connection with that remark, we will next outline the positive and negative impact pharmaceutical promotion has on patient welfare, according to advocates as well as opponents of ‘gift-giving’.

We will not take a position in the discussion whether ‘gift-giving’ is appropriate or not. This paper focuses on the position taken in this controversy by Belgian legislature following a European Directive of 1992. For the answer to that question the following documents are of crucial importance: the Belgian Law on Medicinal Products of 25 March 1964, the European Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use and the Belgian Crown Order of 7 April 1995 on the advertising of medicinal products for human use. To round up, we will examine how the principles laid down in these documents are being interpreted in Belgian case-law.
Keywords

Gift-giving practices – Pharmaceutical Industry – Drug Promotion – Conflict of Interest – Financial relationships - Undue influence – Prescribe behaviour – Seeding Trial

§ 1. Introduction: formulation of the problem.

Gifts to physicians from pharmaceutical companies are common and controversial. Although relationships between the industry and the medical community have resulted in important benefits for patient care, in recent years, however, many troubling practices have occurred[1]. As a consequence, the appropriateness of some of the gifts that are given to physicians by companies in the pharmaceutical and medical equipment industries, has been questioned[2].

In Belgium the medical as well as the legal literature has given little or no attention to the issue of gift-giving practices until now[3], in great contrast to the differing opinions that exist abroad amongst physicians, ethicists and lawyers about their appropriateness.

This paper will discuss the legal aspects of gift-giving practices according to Belgian pharmaceutical legislation (§4), after giving a summary of the arguments both in favour and against gift-giving practices (§3). But first we will distinguish between the different types of gifts that are generally provided because not all types of gifts will always cause inappropriate effects and that is what is important from a legal point of view.

§ 2. Classification of Gift-Giving Practices.

In the medical-pharmaceutical sector there’s a strong competition between equivalent or similar drugs. Pharmaceutical companies therefore try to persuade physicians about their products and try to establish a ‘tie of confidence’ between them and the physicians by means of a system of incentives via the so-called principle of reciprocity, ‘do ut des’.

Generally, gift-giving practices can be subdivided in three main categories.

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    The first group consists of a whole range of small gifts, pecuniary advantages or benefits in kind. Some of them are small and inexpensive gifts such as ballpoint pens, penlights, note pads, coffee mugs, diaries, calendars, puzzles, etc. … upon which is often printed the name of the company or one of its products[4]. Sometimes more valuable gifts are offered, such as subscriptions to (medical) journals, champagne, CD-players, cellular phones, stethoscopes, fax-machines, radios, camera’s, tickets for cultural, gastronomic or sports events, flights, vouchers or even cash.
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    Companies also (co-)organise or sponsor medical conferences, or invite physicians to dinners at which presentations are held. They often subsidise the participation, travel and lodging expenses, sometimes even for the participant’s partners. These meetings are typically held at attractive locations, often for a weekend of presentations, meals, recreation and entertainment, all or largely at company expense.  It’s also a public secret that some of the speakers at some of these conferences are listed on the pay-roll of the sponsoring drug firm. (Often a so-called “MOL”, Medical Opinion Leader. When the speakers are selected by the company, one may seriously doubt the objectiveness of the presentation, certainly when that speaker is on the pay-roll of that company). Sometimes physicians-attendees receive a fee to compensate for their time. (In doing so, the companies indirectly defray the costs of the conference or meeting: the physician will initially have to pay for the meeting, conference or dinner, but afterwards he gets a ‘honorarium for the time spent’, which is nothing more nor less than a disguised compensation for participation, travel and accommodation expenses.)
  *

    Finally there is the practice of gifts or cash to compensate for the performance of clinical studies. Gift-giving here comes attached with strings: the physician has to set up a study, spend time and energy to the study, has to analyse the results, might have expenses, etc. … Rather than a being profit, the gift here serves the purpose of remuneration.

§ 3. Appropriateness of pharmaceutical generosity : arguments in favour and against gift-Giving Practices in medicine.

Gift-giving practices towards physicians provoke heavy discussions between advocates and opponents. For the sake of convenience the arguments in favour of gift-giving practices can be reduced to three major points.

First of all, according to a liberal vision, gift-giving practices are nothing more nor less than a promotional instrument, and promotion is omnipresent in our modern society. The advocates find it inexplicable that such a common attempt to influence consumers is generally accepted, but towards physicians it is deemed to be unethical and even legally prohibited[5].

Secondly, the advocates claim that acceptance of gift-giving practices towards physicians would not be as a harmful (for health care, for patient care, for society,…) as is often contended by opponents. The advocates claim that there is no high quality scientific evidence that the prescription behaviour of physicians is in fact influenced by the gifts from the pharmaceutical industry. They say that physicians are intelligent enough and experienced enough to ensure that patient welfare prevails[6]. The physician has no interest in prescribing an inferior drug to a patient, only because of a pharmaceutical firm’s generosity, since patients will only return if they were carefully treated. There is no evidence that physicians knowingly or intentionally compromise their patients’ care as a result of gifts from industry.

Finally, the advocates believe that we should not lose sight of the fact that many gifts from the industry to physicians result in significant benefits to patients and health care, by serving educational purposes. For example, books and medical conferences contribute to the education of physicians, and meals at medical meetings or conferences provide a forum for colleagues to exchange information[7].

Opponents on the other hand point out to the specific nature of the profession, of which the key element is the tie of confidence between physician and patient. The profession needs to be distinguished from pure merchandising, since physicians not only enjoy the patient’s confidence, but the confidence of the entire society[8]. Patients should be confident that they are receiving their physicians’ best care, uninfluenced by personal or financial benefits or by the interests of third parties.

But, according to the opponents, it is not only because of the honourable character of the profession, with which commercial principles are hard to combine, that gift-giving practices should be condemned. This strict vision states that even when gifts from the industry have no actual effect on a physician’s prescription behaviour, there might be a public impression of impropriety, especially if the gifts are of substantial value, which might undermine the trust of the public that physicians are above all dedicated to the welfare of their patients[9]. Because of their social role physicians must not only act in an objective manner and be independent of direct or indirect financial incentives, they also must be seen to be independent.

Also, according to the opponents, although there are no published randomised trials to show that gifts have an adverse impact on prescribing there is good observational evidence to show that gifts can influence prescribing.[10] The opponents also claim that gifts may mobilise subtle influences that create social relationships with real obligations. No company gives away its shareholders’ money in an act of disinterested generosity: The industry invests in promotional activities because promotions increase sales. The industry does not intend to offer free lunches that are really free of any obligation.[11]. Pharmaceutical companies expect that by giving presents physicians will be ready to return a favour: the ‘do ut des’-principle, or ‘norm of reciprocity’. The most obvious way to fulfil this ‘social obligation’ is by being more responsive in granting interviews with sales representatives, or by changing prescribing behaviour[12]. (The opponents enforce this “social obligation argument” by pointing out at two conclusions of common sense. One is that if pharmaceutical companies investments in gift-giving practices were not efficient, they would be wasting company resources, in which case they would cease these forms of marketing and promotion. The other is the conclusion that physicians remain sceptical towards the so-called ‘generic drugs’: although generics are identical to the brand drugs and are accompanied by guarantees as to their quality, so that there is no ‘reasonable’ argument not to discuss this alternative with the patients, according to recent statistics only 1% of all prescriptions of physicians are for generics. That poor co-operation of physicians is food for thought as to what is the main reason why they stick to brand name drugs.)

Since from the point of view of the opponents there is influence on the prescription behaviour of physicians, albeit as a vague social obligation to return a favour, they also draw the attention to the fact that, although physicians are unlikely to knowingly compromise their patients’ care by using inferior drugs, it has indirect negative consequences for the patient as well as for society. The expenses pharmaceutical firms make for their promotional gifts or sponsorships are passed on to the public throughout the price of the drugs. In effect, then, patients may be paying for a benefit that in some cases is captured primarily by their physicians. Combined with the possibility of over-consumption because of altered prescription behaviour of physicians, this may lead to a serious drain on the resources for health care, because of the system of reimbursement. The opponents see this as misuse of public money.

As to the argument that gift-giving also serves educational purposes, either by sponsoring conferences or by giving medical books or journals, opponents rarely deny the need for physicians to receive the broadest possible exposure to new and different health care products nor the need to stay abreast of advances in medicine. They do however have questions about the educational value of some of the organised conferences and of the information published in medical journals[13]. (A company that donates funds for a conference may want a role in shaping the program, for instance by selecting speakers from its own panel of experts, selected for their knowledge and experience in the use of the company’s products. When companies schedule speakers that are on their pay-roll, these experts may show bias with regard to use of company’s products, thereby undermining the objectivity and impartiality of the educational event. Also when a meeting is not primarily, in both time and effort, dedicated to scientific presentations, it is difficult to view the meeting as serving a legitimate educational purpose. The same goes for the information (comments, studies, etc. …) concerning medicinal products in medical journals: for a journal to be of value, it must publish authoritative, up-to-date information that is free of commercial influence. Therefore financial associations of authors (often MOLs) should be disclosed so that readers will be cued to the possibility that the published articles were influenced by those financial associations.)

§ 4. Admissibility of gift-giving practices according to the Belgian Law on Medicinal Products and jurisprudence.

1.    Gifts and benefits in general

Art. 10 of the Belgian Law on Medicinal Products of 25 March 1964[14] states that it is forbidden to offer, either directly or indirectly, gifts or benefits to persons qualified to prescribe or supply medicinal products. Neither shall those persons accept nor solicit such gifts or benefits.

At first sight, it seems that the law makes no exception, so that all gifts or advantages are improper. But in the parliamentary proceedings of the Law on Medicinal Products, we find evidence that the legislature did not intend to prohibit all kinds of gifts[15]. It was formally stated that although, in principle it is forbidden to offer any kind of gift, objects with no or little value are allowed[16]. For the main concern of the legislature was the pursuit of practices in excess. (When the influence created by the meal, the entertainment or material advantages, such as money, valuable objects, discounts off the price of objects or services, works of art, valuable commodities, etc. … in and of itself has the potential to alter the physician’s prescribing patterns, rather than the efficacy of the particular product being touted, it should be considered illegal.)

This point of view was later on confirmed by the Crown Order of 7 April 1995, which implemented the E.C.-Directive 92/28 into Belgian law[17]. In its definitions[18], it is stated that promotion consists – amongst other things – in the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except when their intrinsic value is minimal. The prohibition to accept or demand gifts or benefits in art. 12, §1, second sentence, therefore needs to be refined, by reading together with the exception made in the preliminary definitions of the Crown Order.

At this point however, it’s interesting to look at the formulation of art. 94 of the E.C.-Directive 2001/83:

Art. 94 – “Where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons, unless they are inexpensive and relevant to the practice of medicine or pharmacy.”

The wording of the Directive is tighter because not only must the gift be inexpensive, it also must be relevant to “the practice of medicine” (or more in general, “patient care”). The acceptation of such gifts or benefits by persons qualified to prescribe drugs is also prohibited, according to subsection 3 of art. 94 of the E.C.-Directive.

To sum up, it may be stated that gifts and advantages may be considered appropriate by the legislature, depending on the extent to which the gift serves a function beneficial to patient care and on whether the same benefits can be realised through less costly promotional activities[19].

2.    Conferences

Physicians often participate in (foreign) conferences, symposia, lectures (over dinner), presentations, etc. … that are organised or sponsored by pharmaceutical companies, typically for a week-end at attractive locations. Participation, travel and accommodation expenses are frequently paid for by the companies. Sometimes the physicians have to pay a small contribution, which can be refunded afterwards through a so-called ‘participator’s fee’. 

In some cases also the partners of the physicians can participate, for a small payment or even for free. It has been reported that sometimes the educational component of conferences takes up only a small part of the program, with the greater part consisting of gastronomic or tourist activities. It has also been reported that some “conferences” have no educational component at all.

The legislature believed that they should allow physicians to receive the broadest possible exposure to new and different health care products and their clinical application.  This is because they believed that patient care benefits can benefit from such exposure. Conferences, presentations, lectures, … were therefore regarded to be always of genuine educational value, in that they are the means through which physicians stay abreast of rapidly occurring advances in medicine and can interact with colleagues discussing developments in their field.

On the other hand, when companies schedule their conferences at attractive resorts and pay for physicians (and their spouses) to attend for a weekend that includes only a few hours of lectures and many hours of recreation, lavish meals and expensive entertainment, is the legislature found it difficult to view the conference as serving a legitimate educational purpose. This dilemma is reflected in the provisions of the Crown Order of 7 April 1995.

According to art. 12 of the Crown Order, the hospitality of pharmaceutical firms at events for purely professional and scientific purposes must always be reasonable in level and remain subordinate to the main scientific objective of the meeting. It may not be extended to persons other than health professionals.

In case of dinner-invitations for instance, this means that the dinner must be a modest meal and that there is in fact a speaker who discusses a scientific issue. However, in my opinion, if a dinner speaker is selected from the sponsoring pharmaceutical company’s own panel of experts, difficulties may still arise as to the scientific objectivity of the educational event. It is also problematic that companies might influence physician’s educational choices by making one presentation or lecture more attractive than another, by offering dinners in well-established restaurants or by subsidising the costs of attending, either directly or indirectly through a fee as compensation for the time spent.

How is the admissibility of such conferences, presentations, lectures, etc. … being judged according to Belgian jurisprudence? In 1994 a judgement was passed in the so-called Colmar case[20]. The pharmaceutical firm Glaxo Belgium had put on a weekend, both for physicians and their spouses in Colmar (France), for the promotion of a drug for stomach ulcers. According to Glaxo Belgium only the breakfast-conference on Saturday morning was paid for by the company; all the other (gastronomic, cultural and tourist) activities during the weekend were organised by those interested, and this without any financial intervention of Glaxo Belgium. But the tribunal found it very difficult to believe that Belgian physicians would spend several hours on a bus-trip to Colmar, and in addition pay € 100 per person for travelling expenses and accommodation, only to attend a conference of barely 3 hours.

The tribunal came to the conclusion that the gastronomic and cultural activities were not subordinate to the scientific objective of the weekend. The hospitality of the company was therefore held to be disproportionate to the scientific program, so that the weekend in fact was nothing more than a disguised commercial promotion rather than a scientific conference. In addition, that hospitality was extended to other persons than the physicians. The tribunal concluded that art. 10 of the Law on Medicinal Products[21] was violated.

3.    Fees for clinical studies.

Companies sometimes give gifts or cash payments to physicians for every patient who is started on a particular drug, for instance in a phase IV clinical study. The promoted purpose of such studies, also called post marketing surveillance studies, is to discover possible side effects of new drugs, or to confirm the effectiveness or tolerance data.

The concern about undue influence from a gift seems particularly justified, when gift-giving comes with strings attached. However, I agree with VANSWEEVELT and MOENS’ position[22] that we should not lose sight of the fact that physicians who perform such clinical studies spend a lot of time and energy in setting up the study, analysing and registering the results, and might also have expenses. It therefore seems reasonable that physicians are being compensated for their work, since rather than a being profit, the gift here serves the purpose of remuneration.

Leaving aside the question of whether this compensation in practice exceeds the normal payment of expenses or not, the problem is that the Law on Medicinal Products of 1964 as well as the Crown Order of 1995 until recently opposed even against this type of “gift”. Moreover, in the Schering Plough case[23] the Belgian courts rejected the argument that rather than being a profit, such gifts or cash payments would have a reimbursing character.

The Schering Plough case concerned a pharmaceutical firm that had approached 1000 physicians to assist in evaluating the health status of patients suffering from angina pectoris, who were treated with a nitrate patch. During an evaluation period of six months, every physician had to prescribe the patch to seven patients suffering from angina pectoris. As a reward for their co-operation to the phase IV clinical study, the physicians received a cash payment of € 175 or a voucher of € 250. The Court of Appeal as well as the Court of Cassation judged this to be a violation of art. 10 of the Law on Medicinal Products and of art. 12 of the Crown Order of 1995, since these previsions do not distinguish whether the benefits serve a remunerating purpose or not.

In my opinion this judgement is rather surprising because, as we already mentioned above, the legislature only wanted to prohibit gifts when they are of substantial value, and as a consequence, might influence the physician’s prescribe behaviour.[24] Compensations for the co-operation to clinical studies must be regarded from that point of view: if the compensation is reasonable in level with the expenses of the physician and forms a return for a legitimate performance, the compensation should be regarded as acceptable. Pharmaceutical company should be allowed to cover the expenses of participation in a clinical study , unless the compensation is out of proportion or adversely influences physician’s prescribing behaviour.

On 2 August 2002 a law was passed to modify article 10 of the Law On Medicinal Products[25]. A second paragraph was inserted, stating that “without prejudice to the first paragraph, persons qualified to prescribe medicinal products can be compensated for their co-operation in the performance of a clinical trial or other scientific studies”. In doing so, the legislature distances itself from the above-mentioned case law, but only to some extent. It is clear that the second paragraph – being an explicit exception to the first paragraph – needs to be interpreted in a restrictive manner: it’s only allowed to compensate the physicians, not to reward them[26]. Moreover, following a strict interpretation, only non-commercial clinical trials qualify for such compensation, since otherwise also collaboration in promotional “seeding trials” could be compensated, whereas such trials have no direct benefit for patients, but are especially intended to change physician’s prescribing behaviour. Thus a payment for every patient started on a specific drug during a phase IV-study remains illegal. (Having regard of the definition of clinical trial in the Directive 2001/20/EC[27], it’s difficult to see to which particular hypothesis the wording “or other scientific studies” in the law refers, since a phase IV clinical trial already seems to be included within in the definition of the wording “clinical trial”. However, these “other scientific studies” also must be “scientific”, and can under no condition be seen as a legal backdoor for seeding trials, so that there is no contradiction with the expressed view that commercial trials do not qualify for compensation.)

§ 5. Conclusion

When we look at the sanctions that apply to the violation of the relevant stipulations in the Belgian Law on Medicinal Products (imprisonment of one month till one year and/or a fine of € 500 till € 15000[28]), it seems that the Belgian legislature wanted to take firm action against these gift-giving practices. These punishments concern the donor (pharmaceutical firm, laboratory) as well as the receiver of the gift or benefit (the physician). But in practice these sanctions are unlikely to have much impact because neither the donor nor the receiver will report gift-giving practices.

The two cases we already mentioned above were the result of complaints from rival pharmaceutical companies and only concerned the commercial aspects (fair merchandising), not the penal aspects. However, according to Belgian law, the public prosecutor does not have to wait until there’s a complaint, so that theoretically action could be taken against these practices as soon as they are known. In practice, again, we see that no action is taken against these violations of the Law on Medicinal Products, neither by the Public Prosecutor, nor by the pharmaceutical inspectorate-agents. The main reason for this seems to be understaffing as well as the lack of complaints.

We agree with Vansweevelt[29] that the most effective way to enforce the principles of the Law on Medicinal Products would be by using tax law. Pharmaceutical firms spend millions on the promotion of their products and these expenses are tax-deductible for them. Vansweevelt is right in arguing that the costs of promotion and marketing contrary to the intention of the Law on Medicinal Products should no longer be considered as tax-deductible professional expenses. Tax law could function as a method of coercion for pharmaceutical firms, forcing them to modify their policies[30].

For abuses concerning gift-giving practices to come to an end, it’s not only the law that needs to be enforced more strictly. The fact that gift-giving practices more often go out off the rails, is a consequence simply of inattention to the issue, from the government, but also from the physicians and from the society as a whole. Most people have not been challenged to consider that the relationships between pharmaceutical firms and physicians might compromise the judgement of the latter, nor have they always been made aware that some of these practices are illegal, not to mention the fact that the promotional expenses are in the end passed on to the tax-payer and to the health insurance system: in practice the attention is mostly drawn onto the educational and scientific benefits of the gift-giving practices, and on the fact that promotion is omnipresent in our modern societies. A change of mentality, the willingness to comply with the law, is then needed to re-establish the balance between the advantages and disadvantages of these gift-giving practices. And finally it’s up to society to decide what we want, because notwithstanding the fact that the ethics of medicine and the ethics of business sometimes diverse, both are legitimate and a thoughtful collaboration of physicians and industry can result in the best of patient care[31].

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