Background
Methods
Stakeholder interviews
1. | In your opinion, how should the relationship between physicians and PCs be managed, and to what extent does the legislation in this issue follow the right direction? |
2. | In the last few years, where there changes in the conduct of PCs and their beneficiaries; what type of changes? |
3. | A question to representatives of PCs: In the last few years what actions did you take regarding the relationship between the company and physicians? What does the company intend to do in the future? |
4. | In the last two years, has the relationship between physicians and PCs decrease/expand/did not change? Please specify. |
5. | In the last two to three years did the characteristics of medical research and conferences you have visited change? |
6. | To what extend are the members of the health basket committee involved with technology manufacturers (funding of travel to conferences, lectures, counselors, etc.)? |
7. | Are any writers of guidelines related in any way to manufacturers of technologies that are included in these guidelines? How many? |
8. | To what extent are decision makers in HMOs (including pharmaceutical services and medical directors, purchase managers) involved with commercial companies or bodies? |
9. | Are lecturers at professional conferences given guidance to disclose their relationship with pharmaceutical companies at the beginning of a lecture? |
10. | In activities organized by patient organizations in the last year, how much of the activities were funded by the patient organization itself and who was involved in funding the difference between the actual cost of the activities and the sum of money given by the patient organization? |
11. | Was there a change in the practice of giving physicians products with PCs’ logos? To what extent was the observed change? Is there employer supervision on this practice? |
12. | Was there a change in the characteristics of visit of PCs’ representatives to HMO physicians? Is there supervision in this issue? |
13. | Who should supervise the relationship between PCs, physicians and their organizations? |
14. | How should the behavior in this relationship be regulated (legislation, self-regulation)? |
15. | To what extent should the legislator be involved in the relationship between PCs and physicians? |
Descriptive analysis of payment reports
Results
Interviews with stakeholders
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.”
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“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.”
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Views on regulating the relationship between PCs and physicians
Views on transparency of the relationship between PCs and physicians
None of the interviewees opposed the requirement of the law to disclose payments."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."
Issues relating to implementation of the law
Lack of awareness of the law
Loopholes in the law
Another form of remuneration to physicians that does not require disclosure under the law is payment for lectures. Many physicians, mostly key opinion leaders, are sought-after speakers by PCs organizing conferences and lectures. These key opinion leaders bestow an aura of respectability to PCs’ sponsored events, and therefore PCs are willing to pay large sums of money to have them lecture about their products. But as the CEO of a PC explained, these payments may serve other purposes as well:"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 “buy” senior physicians without disclosure to the Ministry of Health is to sponsor or even to create patients’ organizations and to appoint physicians to their boards. These physicians are paid for their service, but they receive the money from the patients’ organization and not directly from the PC, thus bypassing the law’s disclosure requirements. A still other form of remuneration is payment for funding of post-marketing or phase IV trials. Some interviewees attested that these studies have no real scientific interest and are mostly meant to shift patients to the drug made by the company funding the study. A PC’s CEO quoted above describes this method:"PCs invite physicians to speak at conferences and pay them large sums of money in order to become 'friends'. For example, a company offers ten thousand shekels to a physician for one lecture. This same physician would have agreed to lecture for one thousand and five hundred shekels and the company knows it, but nevertheless the company offers him a bigger sum in order to become his 'friend'".
Finally, several interviewees mentioned that the law might be bypassed by business and accounting procedures, such as paying directly for the hotel and the conference fee when inviting a physician to attend conference abroad. Moreover, in the PCs’ view, these are business expenses, not payments, and thus do not require disclosure. This leads us to another shortcoming of the law, which is the lack of a clear-cut definition of a payment."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'."
Ambiguous definition of payments
On the other hand, Ministry of Health officials dismissed this criticism and argued that the definition of payment is very clear. They also invited those who have questions to turn to the Ministry for clarifications and pointed to the fact that as to this moment there were no inquiries from any party requiring disclosure about this issue."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
Lack of enforcement or even of minimal checking of fulfillment of disclosure obligations by all the relevant parties was noted, as a senior executive at an international PC remarked:"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."
On the other hand, Ministry of Health officials explained that the lack of enforcement during the first years of the law is a deliberate policy whose goal is to learn from the data obtained and only then to start enforcing. Notably, the Ministry of Health has changed the disclosure framework and for the last several years so that the sum and general purpose of the payments have to be disclosed; however, many purposes are noted as “other” because they do not fall under any of the specified categories in the disclosure form."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 disclosed. […] A further problem is that the report includes only sums of money and names. They do not ask what the money was for. They don't check if the sums are correct either."
Lack of deterrence
Attitudes to self-regulation
"the ethical code is a nice booklet, but it is not implemented in practice. […] There are no enforcement mechanisms. Everything depends on people's goodwill".
Observed changes in the relationship between PCs and physicians due to regulation
In the same vein, another executive explained their new policy on gifts to physicians:"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."
The most significant change in the physician-PCs relationship appeared to be the enactment of contractual relations between PCs and physicians accepting favors. In contrast to past custom, in recent years all financial support from PCs to physicians and medical organizations is based on formal contracts. According to our interviewees, the contracts are strict and include minute detail of the activities being funded and the expenses for each activity. The chairperson of a medical society describes (and complains about) this shift in companies’ policy:"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."
Another change is the funding of individual physicians’ travel to medical conferences through their employer or medical association and not directly like in the past. A senior hospital physician illustrates this change with a personal story:"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."
The goal of this regulation was to cut off this channel of influence on physicians by taking the decision of who to send to the conference from the hands of PCs. However, many interviewees explained that PCs often find ways to circumvent this and choose which doctors will be benefitted. Still, they stated that the shift towards stricter standards in the relationship between physicians and PCs had a significant impact in Israel. At the company level, some interviewees indicated that company headquarters abroad are very strict towards their local branches in Israel on this issue, enforcing the company’s ethical standards and closely supervising their activities. Thus, the local branches of multinational PCs have strong incentives to comply with company standards, even if it reduces profitability. An HMO senior executive with close professional ties to the industry explains how this works:"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."
Additionally, because most patient organizations receive a large part of their budget from pharmaceutical companies they felt that the law affected their fundraising opportunities."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."
Participation of stakeholders in the legislation process
"The problem with the temporary order was that they didn't check its influence and they proceeded directly to legislation, without examining the situation in the field and without letting the relevant parties to express their views."