Navigating Global Pharma Regs

Highlights
When organizing medical meetings overseas, planners face a welter of codes and regulations. Here are a few survival tips.
Judy Johnson

Planning a meeting in the United States for U.S. physicians is complicated enough, what with the updated and more restrictive PhRMA Code on Interactions with Healthcare Professionals, which bans giveaways, entertainment, and resort locations. In addition, many states have passed their own pharmaceutical marketing regulations, while legislation is pending in others.

No Single Standard

Take a look around the world and you will see a confusion of guidelines. Imagine you're planning a meeting in Frankfurt for physicians from the U.S., European Union, and maybe even non-E.U. countries. Whose rules apply? Ah, you might say, E.U. rules apply. But you'd be wrong. In Euroland, that great expanse dedicated to regulatory harmonization, there is no single standard when it comes to pharmaceutical meetings.

Europe does have a code concerning interactions with healthcare professionals, issued by the European Federation of Pharmaceutical Industries and Associations in 2007, but the Association of the British Pharmaceutical Industry and the Hellenic Association of Pharmaceutical Companies in Greece also have codes. France, Australia, New Zealand, Japan, and Canada have their own guidelines.

Then there's the latest revision of the International Federation of Pharmaceutical Manufacturers & Associations Code. It went into effect in January 2007 and includes more restrictive provisions regarding travel, gifts, and scientific events. It also established a code-compliance procedure and a Code Compliance Network, bringing together code experts from all over the world.

And while codes from industry groups in these and other countries may be voluntary, their punishments can be harsh, including being booted out of the trade group, at least temporarily.

The guidelines, in many instances, are vague and broad, and therefore inhibiting, leaving pharmaceutical companies to fret over potential trouble from finger-pointing civic gadflies, journalists, or disgruntled employees. For instance, under Article 26 of Poland's “Pharmaceutical Code of Good Marketing Practices, Interactions With Healthcare Professionals and Patient Organisations,” you will find the injunction (and here we summarize a 24-page treatise) that meetings must be held at a venue appropriate for their purpose. Also, meetings shall not be held at venues thought “extravagant.” The European Federation of Pharmaceutical Industries and Associations and PhRMA would do their members a service by publishing a concise and clear set of consolidated guidelines with interpretations.

Follow the Strictest Rule

Larger pharmaceutical companies have representatives in many countries, and they can help you stay current about changing regulations. For European meetings, one can turn for guidance to the European Federation of Pharmaceutical Industries and Associations. The group's Web site (www.efpia.org) has codes of practice from Belgium, Poland, Finland, Ireland, Latvia, Switzerland, and many other countries.

In planning international pharmaceutical meetings, it's best to apply the rule that the strictest country's guidelines apply. Even if that means not serving wine at lunch, you will have a meeting above reproach. In the case of cross-border partnerships and activities, another approach would be to use the industry code from the country in which the sponsoring organization has its main European location.

In this environment, when conducting an international meeting, it will pay to document the rules and regulations you are using for guidance.

Judy Benaroche Johnson, CMP is president and CEO of Rx Worldwide Meetings Inc., headquartered in Plano, Texas, which focuses exclusively on pharmaceutical and medical meetings. Reach Johnson at jjohnson@rx-worldwide.net.

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To submit a guest opinion or advice piece, please contact Editor Sue Pelletier at (978) 448-0377 or e-mail her at spelletier@meetingsnet.com.

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