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:
promote compliance with applicable laws, rules and regulations as well as company policies;
prevent, detect, investigate, and correct violations; and
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 Conduct
Our 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:
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.
Policies and Procedures
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.
Explicit Limits on Expenses for Health Care Professionals
EMD Serono's policy on Expenses for Healthcare Professionals 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 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 July 1, 2012, the company's annual limit is $2,000.
Training and Education
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.
Lines of Communication
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.
Prescriber Data Privacy
EMD Serono strives to uphold the individual privacy of all Personal Information it receives from the European Economic Area Countries and Switzerland. To this end, EMD Serono self certifies to the European Union and Swiss Safe Harbor Privacy Frameworks for Personal Information obtained by or on behalf of EMD Serono in European Economic Area countries and Switzerland. In connection with this self-certification, EMD Serono has adopted the below Safe Harbor Policy for Information Transferred from the European Economic Area Countries and Switzerland.
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 US Department of Health and Human Services. To the best of our knowledge, as of July 1, 2012, 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.