All over the world, pharmaceutical companies have been involved in numerous scandals in which they have been charged with pursuing unethical business practices, thus weakening the public image of the industry. The list of allegations in the sector include charges last year that Pfizer, the U.S.-based multinational, bribed health officials in the Philippines as well as the general rumor that the pharmaceutical industry has a vested interest in raising the level of alarm concerning the spread of swine flu merely in order to increase sales of vaccine.
Such excesses on the part of global pharmaceutical companies, added to more local Spanish problems, inspired Spain’s pharmaceutical industry association, known popularly as Farmaindustria, to prepare a list of reprehensible practices as well as a series of recommendations aimed at promoting transparent behavior in the sector. The industry’s Code of Professional Ethics is supervised by a special unit headed by José Zamarriego, professor at the European University of Madrid (UEM), who is also dean of the UEM’s faculty of economics and business administration, and executive director of the UEM’s General Foundation.
Using this code, Farmaindustria, which represents 197 companies that operate in Spain (including 88 Spanish companies and 109 international firms), hopes to do away with such notorious abuses by pharmaceutical companies as providing gifts and free travel to doctors who attend their supposedly scientific conferences, and who then go on to prescribe their drugs.
The story of The Code begins in 1991, when Farmaindustria adopted the European Code of Good Practices for the Promotion of Medications, established by EFPIA, the European Federation of the Associations of the Pharmaceutical Industry). That code laid out a series of rules for good governance of the pharmaceutical industry, including rules about what kinds of practices are legal when it comes to holding industry events and about the proper relationship between such events and the doctors who prescribed pharmaceuticals discussed at the events. “The activities and the materials tied to [pharmaceutical] promotion as well as the interrelationships [between drug companies] and health professionals must contribute, in their content and very nature, to building confidence in the pharmaceutical industry,” said the 1991 Code.
A Measure That Is Applauded
These rules were promoted within the pharmaceutical industry, and they were warmly received by everyone who understood why it was important to strengthen the industry’s public image by promoting responsible practices. “I applaud Farmaindustria for having decided to set up and to audit the ethical behavior code” which aimed to eliminate the practice of gift-giving and even corporate exhibitions of pharmaceutical products that did not incorporate explanations of exactly how these prescriptions would be used, noted Simon Viñals. A former counselor in the health department of the Madrid local government, and general director of the medical institution Mained Medical, Viñals spoke at a recent colloquium of the Foundation for the Promotion of Business Tourism in Madrid.
In 2004, after the Code was fully established in Spain, and after successive revisions of both the Spanish and European norms, Farmaindustria created its Unit for Supervising Ethical Practices. This organization, known by its Spanish-language initials as the ‘USD,’ is responsible for analyzing alleged acts of non-compliance by companies in the sector. “The goal of the self-regulatory code is to control unfair competition through a system of internal self-regulation.” The idea is for these scientific seminars and conferences to provide only one sort of value-added product to the doctors who attend them: information about the pharmaceuticals themselves, as opposed to the other benefits that often accompany such conferences, said Zamarriego during the event.
Between 2004 and 2009, 75% of the accusations concerning alleged ethical violations by drug companies were resolved through mediation by the USD. In this process, the pharmaceutical company recognizes its infraction and accepts such corrective measures as publicly admitting its mistake, and apologizing to the doctors either in public or by issuing an announcement in the press.
The most important activities monitored by the USD are the events that are sponsored by pharmaceutical firms. Many excesses have been committed there, and they have been harmful to the spirit of scientific investigation that originally inspired these sorts of professional meetings. The sorts of events are widespread. In the case of Madrid, there were 1,532 such events in 2009, involving 45,000 professional participants; 51.4% took place in four-star hotels, and a bit less than 7% in even more luxurious five-star hotels.
The USD monitors such events to make sure that no corporate sponsor uses a congress, conference, symposium or meeting as an excuse to influence the doctors who attend them by providing gifts and other benefits unrelated to the scientific value provided by the conferences. “They are not allowed to provide any unnecessary incentives for doctors in an effort to get them to choose any specific medication or to choose a specific location for such conferences,” explains Zamarriego.
Until 2005, the USD code said it was improper for pharmaceutical companies to choose luxury hotels as a location for a scientific event even if they had logistical or pragmatic reasons for doing so. However, “In 2005, the 2004 code was made more flexible, permitting the use of five-star hotels for pharmaceutical meetings, yet making it clear that very luxurious and ostentatious hotels were still outside the code,” notes Zamarriego.
Restrictions governing these sorts of events are meant to do away with any perception that these conferences are actually a way to reward doctors for prescribing specific drugs, or that these events are tantamount to vacations. The goal is to make the hotel merely the location for the scientific meeting, not the very rationale for the trip. “The pharmaceutical industry wants to make it clear that the location of the meeting is not the main attraction; there are some hotels where, because of their amenities (such as golf courses and other tourist attractions), there is a very significant risk of damaging the image of the sector,” added Zamarriego. He added that although there exists “a principle of freedom, we cannot support any practice that goes against the image [of the industry] that we want to communicate.”
For example, Zamarriego believes that when an event takes place at a ski resort “at the height of the season,” and the conference at the event doesn’t even get started until the middle of the afternoon, it undermines the perception that the pharmaceutical sector is fully professional.
Classification of Events
How frequently do such infractions occur? In 2004, there were no incidents of any sort at 75% of the events that were analyzed by the USD – that is to say, a total of 945 business meetings. However those numbers changed radically last year. In 2009, in 91% of the 2,989 cases studied by the USD, there was some sort of infraction.
In an effort to make such infractions easier to identify before the actual events take place, the USD now classifies pharmaceutical industry events into five categories, each identified by a color code:
1. Green: Companies in the industry may participate in these events without any fear that they are violating the USD code of ethical practices.
2. Yellow: Companies may attend these events but only as observers, not as participants.
3. Red: Companies that participate in these events will be judged to have failed to comply with the USD code of ethical practices.
4. Purple: The only acceptable way for companies to participate in these events is send someone to make a presentation at the event.
5. Blue: The USD cannot yet provide an evaluation of these events because it does not have access to the scientific program. These events are still under review.
Beyond color categories, in those cases where the sponsor of the event fails to publicize its scientific agenda at least two months in advance of the event, the USD will categorize the event as “irrelevant” for the industry, and it will classify the event as “red,” which means that companies cannot participate.
Madrid’s local government agrees with the criteria used by Farmaindustria’s supervisory institutions. In its medical centers and hospitals, Madrid government employees distribute a list of events that are marked in red, indicating that they don’t meet requirements for scientific participation. “We want to our warnings to become fundamental for behavior and credibility,” notes Zamarriego.
Farmaindustria also hopes to prevent pharmaceutical companies from inviting “companions” (spouses and other escorts) of the participants to these sorts of scientific events. In such cases, a pharmaceutical company creates a special program for these people, which has nothing to do with the scientific or medical content of the event. “We are trying to avoid having companions appear on the agenda because this gives the impression that the recreational components and the entire social agenda are broader than the scientific program,” asserts Zamarriego.
However, this restriction does not affect every event. “When a pharmaceutical company organizes an event, it is totally forbidden for companions to attend it. But when a third party organizes the event, the pharmaceutical company must not subsidize the attendance of the companions,” he adds.
According to the USD, preventing such companions from attending events has also made it possible for more doctors to attend these events. “If, in the past, 20 doctors were going to an event, now 40 doctors are going to that event, but they aren’t bringing along companions,” Zamarriego told hotel executives during the meeting. The executives questioned him about whether the prohibition of companions would harm Spain’s hotel sector, which has already been affected so much by the crisis. The number of tourists is already down, and so is the amount they are spending. Zamarriego said, “We don’t want to harm anyone but, yes, we must communicate what we’re doing, and we must explain the interrelationship between the pharmaceutical industry and its doctors.”
Everyone in the business hotel sector has been calling to reduce room rates so it is easier for Farmaindustria to create flexible criteria for choosing event locations. “For us, it’s not particularly useful that hotel room rates have dropped because we don’t move on the basis of economic parameters,” argued Zamarriego. However, he added, when this sort of event takes place in a hotel, it can generate extra revenue for the hotel, especially if the publicity about the event is exclusively targeted at professionals skilled at making prescriptions.
Whenever a company fails to comply with the code, the USD informs the general public and the competent authorities, such as the Association for the Self-Regulation of Commercial Communication. This non-profit institution, known as ‘Autocontrol,’ manages Spain’s self-regulated advertising industry. It is Autocontrol, not the USD, that imposes any possible fines, explained Zamarriego. There were 12 cases of fines last year, and a total of 76 over the last six years.
The USD also monitors behavior to make sure that scientific conferences do not turn into mere promotional activities for the medications of the organizer. In such a case, a pharmaceutical company might take advantage of the event to advertise its products or to improperly promote its products not just to doctors but to the general public. This is punishable by existing Spanish legal regulations.
Citing that law, the USD last year lodged a complaint about the presentation of a research paper entitled “Research into Dystonia” (a medical term for certain involuntary contractions of parts of the body), made at the Fourth Catalonian Meeting on Dystonia organized by the Catalonian Association for Fighting Dystonia. Merz Pharma España, a drug company, took part in the event. A jury later concluded that Merz Pharma España’s research paper, in effect, promoted a medication called Xeomin to the general public. The jury said that the presentation of the report by Merz Pharma España violated Article One of the Spanish Code of Good Practices for the Interrelationship of Industry and Patient Organizations. The infraction was a ‘light’ one, however. The sanction imposed on Merz Pharma España was minimal; only 6,000 euros, Zamarriego said
For its part, the USD suggests that sanctioned companies might make symbolic gestures such as sending personal letters to the doctors who attended such events, pleading their forgiveness if the drug company’s behavior was interpreted in a harmful way. The USD also suggests that any pharmaceutical company sanctioned for violating the code could make a public apology in the communications media, in which it admits its own mistakes, commits to cleaning up its practices, and promises that such a violation will never occur again.