Health Care Alert
November 2008
Authors:
Mary Beth F. Johnston
+1.919.466.1181
marybeth.johnston@klgates.com
William J. Spratt, Jr. +1.305.539.3320
william.spratt@klgates.com
Darlene S. Davis
+1.919.466.1119
darlene.davis@klgates.com
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companies, leading FORTUNE 100 and
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www.klgates.com.
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PhRMA Revises Voluntary Code on Interactions
with Healthcare Professionals
The Pharmaceutical Research and Manufacturers of America (“PhRMA”) recently
released a revised, voluntary Code on Interactions with Healthcare Professionals
(“New PhRMA Code”). This new Code, which will become effective in January of
2009, replaces the previous version that has been in effect since July 1, 2002 (“2002
PhRMA Code”).
Compliance with the New PhRMA Code will require companies to review and modify,
where necessary, existing policies and procedures. Companies will be well-advised
to conduct training sessions for their executives and sales representatives. PhRMA
will publish on its web site the names of companies that publicly announce their intent
to comply and sign an annual certification confirming that they have implemented
compliance policies and procedures. As of the publication of this Alert, over 30
companies have expressed their intent to adhere to the New PhRMA Code. Healthcare
providers, and physicians in particular, should also be familiar with its new, more
restrictive provisions.
A foundational principle stated in both the previous and current versions of the
PhRMA Code is that “a healthcare professional’s care of patients should be based,
and should be perceived as being based, solely on each patient’s medical needs and
the healthcare professional’s medical knowledge and experience.” As envisioned by
the New PhRMA Code, “[i]nteractions should be focused on informing healthcare
professionals about products, providing scientific and educational information,
and supporting medical education.” In keeping with this principle, many of the
changes in the New PhRMA Code increase emphasis on the educational functions of
pharmaceutical company representatives by restricting non-educational aspects of the
their interactions with healthcare professionals. Some of the more significant changes
include the following:
• M
odest Meals In the Office. The New PhRMA Code restricts meals to those that are
modest in nature and provided in the office or hospital to healthcare professionals and
members of their staff who actually attend informational presentations or discussions
by sales representatives. Meals provided outside of the office or hospital setting by
field sales representatives or their immediate managers are prohibited. However,
other company employees may still provide a modest meal outside the office or
hospital if it is not for entertainment or recreational purposes, but is instead part of
an informational discussion with the healthcare professional. Additionally, scientific
or medical presentations made on behalf of a company by healthcare professionals
engaged as speakers may be held at an appropriate setting outside of the office or
hospital and a modest meal that is incidental to the presentation may be served.
Health Care Alert
• N
o Non-Educational or Practice-Related Items.
The New PhRMA Code prohibits representatives
from giving non-educational items or gifts,
even those of minimal value (e.g., pens, mugs,
clipboards) and those that are medical in nature
but primarily serve a treatment-related purpose
(e.g., stethoscopes). This prohibition applies to the
office or hospital setting, as well as to third-party
conferences and professional meetings. When
legally permissible, however, companies may
occasionally provide healthcare professionals with
certain educational items if the items are valued
at no more than $100. Examples of such items
include anatomical models, medical textbooks,
scientific journal subscriptions, copies of relevant
clinical treatment guidelines, and informational
brochures for patients. Additionally, companies
may continue to provide product samples for
patient use pursuant to applicable laws, particularly
the Prescription Drug Marketing Act.
• No
Entertainment or Recreational Items.
Strengthening the prohibition in the 2002 PhRMA
Code, the New Code prohibits companies from
giving any items of an entertainment and/or
recreational nature to healthcare professionals.
• D
isclosure Requirement. If a healthcare
professional has a permissible relationship with
a pharmaceutical company, for example, as a
consultant or speaker, and serves on a formulary
or clinical committee that may influence the
prescription or use of medications, the healthcare
professional must disclose the relationship they
currently have, or have had within the past two
years, with the pharmaceutical company. The
purpose is to disclose and avoid a potential conflict
of interest. Such a disclosure may then necessitate
that the healthcare professional abstain from
decision-making involving medicines that are
manufactured or distributed by the pharmaceutical
company or take other actions as indicated by
the policies and procedures of the committee
or institution.
• Use
of Prescriber Data. The New PhRMA
Code also contains a new section for companies
that use non-patient identified prescriber data.
Among other things, companies should have
policies in place and provide training to ensure the
appropriate use of this data, indicate a contact to
whom questions about data use can be addressed,
and allow healthcare professionals to opt-out of
having their data used in this manner.
• A
dditional Guidance on Financial Support
for CME and Professional or Other Meetings,
Consulting Arrangements, and Speaker Training.
The New PhRMA Code expands its guidance with
respect to the appropriate role of companies in
providing financial support for continuing medical
education (“CME”) and third-party educational
or professional meetings. It is inappropriate for
the company to fund CME and other educational
events sponsored or conducted by healthcare
practitioners. However, it is appropriate for a
company to support education with respect
to treatment options and not with respect to a
particular drug as long as the support is directed to
an independent organization presenting the CME.
Any grant from the company should follow the
standards for commercial support adopted by the
Accreditation Council for Continuing Medical
Education. The New PhRMA Code recommends
that companies separate their educational efforts
from their marketing and sales functions. It
also lays out additional guidance on healthcare
professional consulting arrangements and speaker
engagements and training sessions.
So that pharmaceutical company representatives
know their obligations under relevant laws,
regulations, and industry guidance, including the
New PhRMA Code, and are adequately informed
about the company’s products and general science
as mandated by the FDA, the Code also incorporates
training requirements. The New PhRMA Code,
which contains a series of useful frequently asked
questions and answers, is accessible on PhRMA’s
web site at http://www.phrma.org/code_on_
interactions_with_healthcare_professionals/.
November 2008 | 2
Health Care Alert
It is important to emphasize that compliance with
the PhRMA Code will not immunize a company
or healthcare practitioner from sanctions under the
federal Anti-Kickback Statute. As a component of
a comprehensive compliance program, companies
should take this opportunity to review current
operations and practices, compare them with the
New PhRMA Code as well as applicable federal
and state laws, review questionable practices with
counsel, and adopt new policies as indicated.
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maintaining offices throughout the U.S., in Berlin, in Beijing (K&L Gates LLP Beijing Representative Office), and in Shanghai (K&L Gates LLP
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This publication is for informational purposes and does not contain or convey legal advice. The information herein should not be used or
relied upon in regard to any particular facts or circumstances without first consulting a lawyer.
©1996-2008 K&L Gates LLP. All Rights Reserved.
November 2008 | 3