It hasn't been easy to let go of the old days when docs would flock to junket-like meetings for the wining, dining, golfing, and gift-giving. Not for the pharmaceutical industry, which lost an easy way to get on the doctors' good sides. Not for the continuing medical education providers, whose meetings at luxury resorts were doc magnets. And not for the physicians themselves, who loved those perks. But now that rules such as the U.S. Pharmaceutical Manufacturers of America's Code on Interactions with Healthcare Professionals and the Office of Inspector General's pharma marketing guidance have been around for a while, the industry seems to have moved through the stages of grief from denial, anger, and bargaining, to depression, and into acceptance. And not just in the United States.
Witness the new International Federation of Pharmaceutical Manufacturers Association's Code of Conduct, which goes into effect worldwide on January 1, 2007. The most widely applicable pharmaceutical marketing code yet — most of the world's countries and pharma companies are IFPMA members — the IFPMA's code once would have been greeted with denial and anger. In 2006, though, acceptance seems to be the main reaction, mainly because most countries already have adopted a similar code. And the codes aren't onerous, because experts say they just formalize what's already been happening.
What's Old Is New Again
Much of what the new global code requires is already familiar to most U.S.-based CME providers and medical meeting planners. For example, the new international code specifies the following: “The purpose and focus of all symposia, congresses, and other promotional, scientific, or professional meetings for healthcare professionals organized or sponsored by a company should be to inform healthcare professionals about products and/or to provide scientific or educational information.” Although the IFPMA code appears to apply to both informational presentations put on by pharmaceutical companies and certified CME, it does not distinguish between those two types of meetings, unlike the PhRMA code. Similar to the PhRMA code, the new code does prohibit pharma companies from paying costs associated with guests.
There are other similarities between the IFPMA code and existing U.S. codes and regulations:
Speaker fees must be “reasonable,” and travel and accommodation can be provided.
Venues should be “conducive to the scientific or educational objectives and the purpose of the event or meeting,” and should not be “extravagant.”
Refreshments and meals should be incidental to the main purpose of the event, and should be “moderate and reasonable as judged by local standards.” The interesting addendum to this last provision is that, unlike current U.S. codes, IFPMA encourages its member associations to spell out what “moderate,” “reasonable,” and “extravagant” mean in their local area. The default is: “the hospitality provided should not exceed what healthcare professionals recipients would normally be prepared to pay for themselves.”
IFPMA member companies are not allowed to pay for stand-alone entertainment or “other leisure or social activities,” though it does allow “entertainment of a modest nature which is secondary to refreshments and/or meals.”
Whose Rules Rule?
While the international code blankets much of the planet, most countries either have their own pharma marketing laws or are covered under a national or regional pharmaceutical manufacturer association that has already drawn up its own code of conduct. Whose rules rule? The international code says, “In all cases, all relevant laws, local regulations, and industry codes must be observed and companies have a responsibility to check local requirements in advance of preparing promotional materials or events in any specific country.”
Padraic Gilligan, marketing director and partner, Ovation Group, a conference, destination, and event management group in Dublin, Ireland, says, “The IFPMA code is supposed to provide parameters within which all other codes reside. IFPMA clearly states its expectation that all national codes of member countries should be at least as strict as that of IFPMA.” According to Lewis A. Miller, MS, principal, WentzMiller Associates, a global CME consulting firm based in Darien, Conn., this means that planners taking U.S. medicaloutside the U.S. most likely won't need to make changes, since the U.S. PhRMA Code “will undoubtedly supersede the international” code.
This likely also will be the case for European Union planners says Miller, since “most countries in Europe have their own fairly stringent codes.” The European Federation of Pharmaceutical Industries and Associations also has its own Code of Practice on the Promotion of Medicines, adopted two years ago. When it comes to events and hospitality, the EFPIA code also is very similar to the IFPMA and PhRMA codes in terms of not allowing companies to pay for guests, limiting meals to “reasonable” levels, and prohibiting companies from paying for outside entertainment.
Country Codes Toughen Up
Moreover, some of the local codes are becoming stronger. In the U.K., the Association of the British Pharmaceutical Industry recently publicly reprimanded three companies and suspended a fourth for six months for violating its code of conduct by providing over-the-top hospitality and other infractions. It also put in place more stringent punishments for violators. The Canadian Pharmaceutical Industry Association just strengthened its code after a company took some docs to a conference on the French Riviera and on an educational junket to a resort in Jamaica. Its code is now stricter even than PhRMA's in some areas: It limits service-oriented gifts to the point where a pen embossed with a logo wouldn't pass muster.
Medicines Australia recently set a code of conduct to rein in unethical marketing practices, and this one has some serious teeth, fines of up to $200,000 for companies whose promotional activities are found in breach. In the Netherlands, the government enforces the rules with sometimes hefty fines.
If a company has a subsidiary in the country in which the meeting is to be held and is a member of either the local, regional, or international associations for pharma manufacturers, the safest practice is to follow that country's guidelines as well as that of the headquarters company and IFPMA, and EFPIA, if the country is European, experts agree.
Though, like the PhRMA code, many of these codes are guidelines rather than legal requirements, most companies appear to be following suit, and the same is expected of the IFPMA code. Gilligan says, “I believe there is an appetite to eliminate any activity that might be regarded as professionally compromising, and I believe that all stakeholders are conscious of this and buy into it.”
Carol Krugman, CMP, CMM, director, client services, The George P. Johnson Co., North Easton, Mass., and a long-time third-party international pharmaceutical meeting planner, notes, “Medical meeting planners now have an added responsibility to know the local rules. It's like in the U.S., where you have to know what the regs are in each state. Ignorance is no defense.”
In other areas of the world where pharma marketing guidelines have been more lax, some pharma marketing execs are bracing for a push for stricter local regulations as well. According to one pharma company's national sales manager in Saudi Arabia, who asked to remain anonymous, the current “very limited and weak regulatory environment” in the Middle East is likely to change, with tougher regulations imposed. In some IFPMA member countries, such as Malaysia — where, according to Miller, it's acceptable to devote 25 percent of a CME event to drug promotion — the IFPMA code itself may cause some upheavals. “If this international code has any effect, it might be in countries that aren't as regulated as the U.S.” He adds that Mexican pharma firms have been informed of the IFPMA code, and it may influence the amount of pharma industry participation in medical events starting in 2007, since Mexico currently has no code governing interaction with physicians. “Some American companies have already asked their Mexican affiliates to inform them about how they now manage relationships with doctors,” he says.
Gifts and Travel
While companies long have been barred from paying U.S. healthcare providers' travel, accommodations, and registrations directly, that has not been the case in other countries. The IFPMA code still allows companies to pay the way for individual docs to attend educational congresses, but it does impose some limits. It states: “No company may organize or sponsor an event for healthcare professionals (including sponsoring individuals to attend such an event…) that takes place outside of their home country unless it is appropriate and justified to do so from the logistical or security point of view. International scientific congresses and symposia that derive participation from many countries are therefore justified and permitted.” This means an end, for IFPMA member countries and companies, of taking a group of, say, German physicians to France for an educational activity. They are still permitted to pay for those German docs to attend a meeting in Germany, or to attend a symposia in another country that will be attended by healthcare professionals from other countries. Unlike the PhRMA code's ban on paying for individual physicians' attendance costs, the IFPMA code “shouldn't impact significantly on international attendance at U.S. events as it allows the pharma industry to pay travel, accommodation, and subsistence to physicians attending bona fide international conferences,” says Gilligan. He has noted “increasingly fewer U.S. physicians at international conferences” due to PhRMA's restrictions.
Exhibitors, however, may feel a pinch from the new international code, which prohibits cash payments to healthcare professionals and personal gifts, and limits giveaways to items “of modest value” that “are beneficial to the provision of medical services and for patient care.” Gilligan adds, “Pens and small medical equipment items are allowed and that's about it. The IFPMA recommends, in fact, that each individual country specify in monetary terms what the maximum value for all gifts and entertainment would be.”
Adds Krugman: “We're in a program of mass behavior modification, and now it's global. It's no longer a constant game of one-upmanship when it comes to gaining the loyalty of physicians. Now that the playing field has been leveled out, it's all about who's going to provide the best education for the money, not who's going to throw the most lavish party.”
Editor's note: Thanks to Lewis A. Miller, MS, principal, WentzMiller Associates, Darien, Conn.; and Debra L. Gist, MPH, consultant, Carlsbad, Calif., for their contributions to this article.
Who's Watching the Hen House
The influence of the new International Federation of Pharmaceutical Manufacturers Association's Code of Conduct will depend largely on how strictly it is followed, monitored, and enforced. According to Guy Willis, director of communications with the IFPMA in Geneva, Switzerland, the code is actionable as soon as it goes into effect on January 1, 2007. “The full text of the new code has been published well in advance (at ifpma.org) to allow all IFPMA members to familiarize themselves with the contents, translate them, and integrate them into their own national/company codes.”
Enforcement and consequences for violating the IFPMA code, however, are somewhat of a gray area. The association itself will accept complaints and send a letter to the offending company with a request to validate the claim and, if it's found valid, to remedy the situation. Violators' names will be published on the IFPMA Web site. In addition, IFPMA wants individual countries and companies to police themselves. “Even with the European code, they don't expect to enforce it on a Europe-wide basis,” says Lewis A. Miller, MS, principal, WentzMiller Associates, Darien, Conn. “If there are any sanctions, they need to be done within the member association, which is the national association. Any crackdown is always going to be within the country. I'd say the same is true for the international code. It sets an example for each country to follow, and that's about all it can do.”
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