Compliance & Transparency

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:

• 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 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 Medical Officer, Commercial Senior Vice Presidents, General Counsel, Vice President of Human Resources, and Regional Controller.

US Compliance can be contacted at USCompliance@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 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 may be below the annual limit.

Effective January 1, 2018, the company's annual limit is $2,000 except where otherwise limited by state and federal law.

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 Compliance Helpline—1 (240) 204-9108—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 January 1, 2022, 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 USCompliance@emdserono.com or by calling 1 (240) 204-9108.