Table 2 Examples of quotes supporting the major categories and subcategories
The need for a state law to regulate the relationship between PCs and physicians | |
Subcategory | Examples of Quotes |
Transparency | “From the beginning the legislation was drafted around transparency in order to let the public judge. The goal was to change the norm, to get physicians to understand that receiving gifts has negative effects on them and to create a different culture based on disclosure. […] Publicity is the real deterrence.” |
The law has little to no influence on the relationship between PCs and physicians | |
Subcategory | Examples of Quotes |
Lack of awareness of the law | ““… nobody has ever read that law””. |
Loopholes in the law | “The law is not transparent enough since you don’t need to disclose consulting for PCs. Everything can be called consulting. This is the place to hide things.” |
“Another way to remunerate a physician without disclosure is to fund a post-marketing study. These ‘studies’ are conducted after the drug is in the market and they interest no one. They are conducted only for marketing purposes. The company offers money to the physician in order to shift fifty patients to its drug and write a research report about it. Both the physician and the company benefit from the deal. The physician earns a lot of money for writing some brief report and gains experience with the drug, while the company shifts patients to its drug and also forges a relationship with the physician, which from now on becomes its ‘friend’.” | |
An ambiguous definition of “payment” | “There are many issues not addressed by the legislation. For example, if a patients’ organization organizes a conference and the company buys a stand, does this count as a payment or is it a business expense? And what about a situation when the company buys a stand or funds a conference like this but pays directly to the conference company in charge, instead of giving the money to the patients or physicians’ organization? The fact is that our accounting department will write it down as a business expense for all intents and purposes. […] The same applies if I send a physician to a conference but I pay the hotel or the conference fee myself, or if the headquarters abroad pays for it. In that case, the local branch of the company doesn’t spend a penny. […] We didn’t get answers to these type of questions and we also decided not to issue directives, so that each company acts the way it looks right to it and according to the directives it receives from its headquarters”. |
Lack of enforcement | “As long as there is no enforcement, the law’s influence is reduced. I don’t see willingness to enforce the law at the Ministry of Health. In order to do that you need organizational prioritization of this issue, like assigning workers, budget. The law was not meant to deal with extreme cases, but with the everyday aspects of the relationship between physicians and PCs. If there is a complaint, the Ministry of Health with deal with it, but first you need someone to complain.” |
“The disclosure as it is today is a joke. The Ministry of Health doesn’t check if everybody that has to disclose indeed discloses. When we look at the report we discover a gap between the number of registered parties and the number of parties that reported. […] A further problem is that the report includes only sums of money and names. They don’t ask what the money was for. They don’t check if the sums are correct either.” | |
Self-regulation versus state regulation | |
Subcategory | Examples of Quotes |
Self-regulation imposed by pharmaceutical company | “I issued a directive in our company forbidding giving support to conferences spanning over weekends, unless physicians pay for the weekend from their own pocket. In the past, they would organize a conference from Thursday to Saturday: half a day of scientific content on Thursday, another two-hour meeting on Friday and then the whole weekend empty.” |
“Reps can give gifts under the following conditions: first, a cost limit of 10 dollars, and second, the gift must be related to the physician’s job. For example, we will not give a movie ticket, even though it costs less than 10 dollars.” | |
“The multinational companies have very strict ethical rules. The local CEOs of these companies are salaried employees, so if a CEO breaches the company’s internal regulations, or even if there is a slight suspicion of infringement of these rules, he goes home. The CEOs of these companies are very minded to this issue and fear the headquarters. They would prefer to sell less and forgo revenues rather than take a risk and mess with the company’s ethical rules.” | |
Self-regulation is stricter than state regulation | “We have been publishing our payments in a European site for five years now, so for us the law didn’t have any influence. […] I can surpass the local regulation in any aspect.” |
Observed changes in the relationship between PCs and physicians | |
Enactment of contractual relations between PCs and physicians | “When I ask for support for the association from company X I have to sign a complex contract, which might get me and the association into trouble. This includes a commitment to return the money that we will not use for the conference. In the past, the association retained the change and this money served to fund the association’s activities. Different companies have different requirements. Our life is more difficult.” |
“A few years ago a rep came to my office and handled me an envelope containing a flying ticket to Rome for the launching of a new drug. This practice of giving flying tickets directly to physicians was common…. Today they [PCs] do not give tickets like that and if they want to fly a physician abroad, they have to turn to the hospital.” | |