Corporate Compliance
EMD Serono, Inc. is dedicated to delivering innovative products for unmet medical needs that improve the lives of patients. Our commitment to integrity in everything we do is fundamental to achieving this vision.
To achieve our objectives, we strive to apply the highest legal and ethical standards to all of our business activities. EMD Serono, Inc. will comply with all applicable laws and expects all employees to do the same. No employee may violate the law on EMD Serono, Inc.'s behalf, or direct anyone else to do so. Overall, EMD Serono, Inc. expects our employees to perform their jobs with honesty and integrity.
EMD Serono, Inc. has established a Compliance Program as a key component to deliver on its commitment to integrity. The mission of EMD Serono, Inc.'s Compliance Program is to:
- promote compliance with applicable laws and company policies;
- prevent, detect, investigate, and correct violations; and
- foster a corporate culture valuing integrity and ethical behavior.
Of course, no program can guarantee that improper employee conduct will be entirely eliminated. Nonetheless, EMD Serono, Inc. expects all of our 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 Conduct
Our Code of Conduct demonstrates EMD Serono, Inc.'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.
Our Code of Conduct demonstrates EMD Serono, Inc.'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, Inc.'s compliance program addresses:
- compliance leadership
- policies and procedures
- education and training
- internal lines of communication
- auditing and monitoring
- screening and discipline
- responding to potential violations
Additional detail supplementing the Code of Conduct as to certain of these items is provided below.
- Code of Conduct (PDF 438kB)
Compliance Leadership
Our Chief Compliance Officer is responsible for developing, operating and monitoring the Compliance Program.
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, comprised of other members of senior management.
U.S. Compliance can be contacted at compliance.us@emdserono.com
Policies and Procedures
As noted in the Code of Conduct, EMD Serono, Inc. has adopted 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 gifts and incentives provided to healthcare professionals. One of these policies includes an explicit annual dollar limit on gifts, promotional materials, and other promotional items or activities that may be provided to healthcare professionals.
As noted in the Code of Conduct, EMD Serono, Inc. has adopted 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 gifts and incentives provided to healthcare professionals. One of these policies includes an explicit annual dollar limit on gifts, promotional materials, and other promotional items or activities that may be provided to healthcare professionals.
Explicit Annual Dollar Amounts
EMD Serono's policy on Compensation and 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 applied on a calendar year basis. 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's policy on Compensation and 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 applied on a calendar year basis. 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.
Training and Education
EMD Serono, Inc. prides itself on being a learning organization, and all employees participate in a variety of training programs. Every year EMD Serono, Inc. requires all employees to complete training courses addressing legal and ethical issues that may arise in our business.
EMD Serono, Inc. prides itself on being a learning organization, and all employees participate in a variety of training programs. Every year EMD Serono, Inc. requires all employees to complete training courses addressing legal and ethical issues that may arise in our business.
Lines of Communication
EMD Serono, Inc. 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.
EMD Serono, Inc. 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.
Prescriber Data Privacy
EMD Serono, Inc. abides by the wishes of physicians who choose to have the use of their prescriber data restricted and register those wishes are under the American Medical Association's Physician Data Restriction Program.
EMD Serono, Inc. abides by the wishes of physicians who choose to have the use of their prescriber data restricted and register those wishes are under the American Medical Association's Physician Data Restriction Program.
Declaration of Compliance
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 U.S. Department of Health and Human Services. To the best of our knowledge, as of July 1, 2009, EMD Serono, Inc. is in compliance both with its own program and with California Health & Safety Code § 119402.
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 U.S. Department of Health and Human Services. To the best of our knowledge, as of July 1, 2009, 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 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.
Additional Information
Copies of EMD Serono, Inc.'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.
Copies of EMD Serono, Inc.'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 in Interactions with Healthcare Professionals (PDF 195 kB)
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