Among planners of physician-attended
pharmaceutical meetings in the United States, the PhRMA Code and
the Office of the Inspector General’s guidance on pharmaceutical
marketing are the twin tablets of the regulatory bible. The first,
from the Washington, D.C.-based Pharmaceutical Research and
Manufacturers of America, is the voluntary code of conduct that
keeps U.S. companies aboveboard when marketing to health-care
professionals, and the second is the mandatory and somewhat vague
set of government-imposed rules which, if broken, can result in
severe financial retribution.
For U.S.-based planners of such
meetings held abroad, American rules still apply -- while a set of
European authorities applies still more regulations. Although good
practices generally are the same everywhere, planners should know
how the guidelines differ, depending on where the meeting is
held.
“If you’re already following the PhRMA
Code, you’re pretty good anyway,” says Judy Benaroche Johnson, CMP,
president and CEO of Rx Worldwide Meetings, based in Plano, Texas.
However, she adds, “Erring on the side of caution, it would be up
to me to know what the laws were, and to know what I could or
couldn’t do.”
Following is a brief rundown of the
rules to know when holding pharmaceutical meetings in Europe.
The overarching
code
The Geneva-based International
Federation of Pharmaceutical Manufacturers Associations (www.ifpma.org), to which
many national associations of pharmaceutical companies belong, put
into effect its revised global code of marketing conduct on Jan. 1
of this year. This document is meant to fill in holes in the
regulatory landscape: It will act as the voluntary code in
countries where regulations are not in place and will serve as a
baseline set of rules to follow for companies that do not belong to
a pharmaceutical manufacturers association. Though it’s very
similar to the PhRMA Code, here are some key points.
* The code states that all meetings for
health-care professionals should be meant either to provide
information to attendees (an educational meeting or speaker
training) or to get information from them (an investigator or
consultant meeting). Doctors should not be invited to meetings that
aren’t education-based.
* No company can take a health-care
professional abroad unless there is a logistical or security reason
to do so. In other words, if a company is holding a meeting for
French doctors, the meeting must be held in France. A
pharmaceutical company cannot choose a location for doctors,
whether it has hired them or not, based on where they’ll want to
go. The same logic applies to resorts: “Renowned or extravagant
venues” cannot be chosen for meetings.
* All promotional material must be
explicit as to where the medication has been approved.
* Sponsorship of doctors’ attendance
can include only the attendees’ travel, meals, accommodation and
registration fees. Meals can be provided only for educational
programs.
* Entertainment must be secondary to
the education.
* When looking over the elements of the
program, every aspect should be seen as “moderate,” “modest” and
“reasonable.” Hospitality should not exceed what the recipients
would pay on their own.
* Gifts must be modest and relevant to
the health-care profession. Other inexpensive gifts may be given
“infrequently” on holidays.
The European code
Based in Brussels, Belgium, the
European Federation of Pharmaceutical Industries and Associations
updated its voluntary code (which can be downloaded at www.efpia.org) in
November 2004. This set of guidelines affects meetings for doctors
who live in member countries. The code is similar to others, with
the following minor differences.
* Venues “renowned for their
entertainment facilities” should be avoided.
* “Inexpensive,” as it applies to the
cost of gifts, is better defined and varies from country to
country. In some countries, it means 1.5 euros (about US$2); in
others, it means 25 to 30 euros (about US$33 to $39).
Country codes
Countries with their own codes
regarding pharmaceutical marketing include Finland, France,
Germany, Greece, Ireland, Italy, the Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey
and the United Kingdom. Specific rules must be followed for
meetings held in these countries and should be considered when
attendees are from that country.
Links to the codes are available at www.efpia.org.
Here are a few examples of noteworthy differences.
France: Requests to
sponsor physicians for meetings must be made to the country’s
national association of doctors, Le Conseil National de l’Ordre des
Medecins, at least a month in advance.
Germany: Gifts can be
given to doctors for special occasions, as long as their value is
within “socially acceptable limits” and they are intended for use
in the office. Sweepstakes for doctors are not permitted, except
when entry is based on the doctor having provided a legitimate
service to the company offering the prize, and when the prize is
not outlandishly large.
Italy: Companies must
collect a consent form from health-care professionals that allows
their names to be sent to the Monitoring Committee of
Farmindustria, Italy’s pharmaceutical industry association. If a
company wants to host mainly Italian physicians, the meeting must
be held in Italy. Also, tourist destinations cannot be used for
meetings. For regional, national and international scientific
meetings, the hospitality provided must not last more than 12 hours
before or after the meeting.
The Netherlands:
Hospitality must not exceed 500 euros (about US$658) per person,
with a maximum of 1,500 euros (US$1,974) per year, per therapeutic
class, per company. A single presentation must not exceed 50 euros
(US$66) per person. If the invitee pays half of the costs, any
amount can be spent. Only gifts of “meager value” that are
significant to the practice of medicine are allowed.
Spain: Gifts cannot be
worth more than 30 euros (US$39), unless they are books or
technical equipment.
United Kingdom: Gifts
of medical and educational value can be provided but must not be
imprinted with the name of any medication. Donations to charity in
return for a medical professional attending a meeting are
permitted, but not when used to pressure doctors to prescribe
certain medications. Promotional gifts must not only be relevant to
the recipient’s practice, they must not cost more -- or be of
greater perceived value -- than 6 pounds (US$12). Only
economy-class airfare can be purchased for all physicians; those
who want to fly first class can pay the difference.