Corporate Compliance
To achieve our objectives, we strive to apply the highest legal and ethical standards to all of our business activities. EMD
Serono will comply with all applicable laws and expects all employees to do the same. No employee may violate the law on EMD
Serono's behalf, or direct anyone else to do so. Overall, EMD Serono expects our employees to perform their jobs with honesty
and integrity.
EMD Serono, Inc. has established a comprehensive Compliance Program as a key component to deliver on its commitment to integrity.
The mission of the EMD Serono Compliance Program is to:
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promote compliance with applicable laws, rules and regulations as well as company policies;
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prevent, detect, investigate, and correct violations; and
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foster a corporate culture valuing integrity and ethical behavior.
While no program can guarantee that improper employee conduct will be entirely eliminated, EMD Serono requires all of its
employees to comply with the Code of Conduct and its supporting policies.
Fundamental elements of our Compliance Program are described below. Please note that the Program is dynamic, and we regularly
review and enhance the Program to meet our evolving compliance needs.
Code of ConductOur Code of Conduct demonstrates EMD Serono’s commitment to integrity, explains some of the most important laws and policies
that apply to EMD Serono's business, and describes EMD Serono's Compliance Program.
As described in the Code of Conduct, EMD Serono's Compliance Program addresses among other things:
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compliance leadership
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policies and procedures
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education and training
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internal lines of communication
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auditing and monitoring
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screening and discipline
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responding to potential violations
Additional detail supplementing the Code of Conduct as to certain of these items is provided below.
Our Chief Compliance Officer is responsible for developing, operating and monitoring the Compliance Program.
Our Chief Compliance Officer also chairs a Compliance Committee, formed to advise the Compliance Officer and assist in the
implementation of the Compliance Program. The Compliance Committee is comprised of other members of senior management, including
the Chief Commercial Officer, Chief Medical Officer, Chief Financial Officer, General Counsel and Vice President of Human
Resources.
US Compliance can be contacted at compliance.us@emdserono.com
As noted in the Code of Conduct, EMD Serono has adopted in full the Code on Interactions with Healthcare Professionals issued
by the Pharmaceutical Research and Manufacturers of America (the "PhRMA Code"). The Code of Conduct and the PhRMA Code are
supported by additional company policies, including policies that limit meals and educational items provided to healthcare
professionals. One of these policies includes an explicit annual dollar limit on educational items, promotional materials,
and other promotional activities that may be provided to healthcare professionals.
EMD Serono's policy on Expenses for Healthcare Professionals states that the dollar value of permissible items and permissible
meals accompanying informational presentations that may be given to any individual healthcare professional during a calendar
year may not exceed the company's limit. The limit is renewed and applied on a calendar year basis. As this is the maximum
that may be provided, the average annual expenditures for permissible items and meals given to healthcare professionals will
be below the annual limit. Effective January 1, 2010, the company's annual limit is $750.
EMD Serono prides itself on being a learning organization, and all employees participate in a variety of training programs.
Every year EMD Serono requires all employees to complete training courses addressing legal and ethical issues that may arise
in our business.
EMD Serono has established a toll-free Compliance Helpline—877-846-8839—where employees or others can seek guidance as to
any compliance matter or report a suspected violation of law or company policy. Employees may also seek guidance or report
a suspicious compliance violation through a variety of other internal mechanisms. Moreover, all employees are obligated to
report all suspected violations of law or company policy.
EMD Serono abides by state laws that regulate the use of prescriber data as well as the wishes of physicians who choose to
have the use of their prescriber data restricted and register those wishes under the American Medical Association's Physician Data Restriction Program.
As described on this site, EMD Serono, Inc. has established a comprehensive Compliance Program. The Program has been designed
in accordance with the Compliance Program Guidance for Pharmaceutical Manufacturers published by the Office of the Inspector
General of the US Department of Health and Human Services. To the best of our knowledge, as of July 1, 2010, EMD Serono, Inc.
is in compliance both with its own Program and with California Health & Safety Code §119402.
By making this declaration, EMD Serono, Inc. is not asserting that in all circumstances it can prevent individual employees
from engaging in conduct that deviates from its policies, but it will make a good faith effort to enforce the Program, prevent
violations, and address any inappropriate conduct that may occur.
EMD Serono, Inc. reassesses, enhances, and makes changes to its Compliance Program on an ongoing basis. This declaration will
be updated annually.
Copies of EMD Serono's Code of Conduct and the information on this site can be obtained by sending an email to compliance.us@emdserono.com or by calling toll-free 1-800-283-8088 and asking to be transferred to the Compliance Office.
> Code on Interactions with Healthcare Professionals
> Code on Interactions with Healthcare Professionals
