Regeneron has always placed the highest value on compliance with law, honesty and integrity.
Beth F. Levine serves as the Company’s Chief Compliance Officer
We are part of an important effort to discover, develop, manufacture and commercialize pharmaceutical products that enhance people's lives.
We pride ourselves on striving to do the right thing, whether or not it's required by law. We choose the higher ground when faced with difficult decisions and we take responsibility for ensuring that our colleagues, vendors and business partners are acting with the same standards of integrity.
Regeneron maintains a comprehensive Compliance Program that comports with the seven elements of an effective corporate compliance program, as defined by the Office of the Inspector General of the Department of Health and Human Services:
Written policies and procedures
Regeneron maintains written policies governing a wide variety of legal, regulatory and policy matters. All such policies are made available to employees on the corporate intranet and are updated frequently.
Designated compliance officer and compliance committee
Beth F. Levine serves as the Company’s Chief Compliance Officer and chairs the Compliance Committee. The Compliance Committee is made up of senior leaders of all the major functions in the company and meets at least quarterly to oversee the Compliance Program.
In addition, the Corporate Governance and Compliance Committee of the Board of Directors has oversight responsibility for all non-financial compliance matters. The Chief Compliance Officer provides a report to the Corporate Governance and Compliance Committee on the status of the corporate compliance program at each Board of Directors meeting.
Effective training and education
Training resources include live training and online compliance education, as well as online access to policies. There is also a new-hire and annual online training program that supports compliance education.
Effective lines of communication
Critical to the success of any compliance program is maintaining and fostering an environment where employees and others feel comfortable asking questions, raising concerns, or offering ideas. Regeneron has an open door policy that encourages employees to offer up ideas and solutions and allows employees to raise concerns to any supervisor, manager, Human Resources, or the Compliance department, without fear of retaliation. Regeneron maintains an anonymous and confidential 24-hour helpline at 1-877-RGN-ETHX (1-877-746-3849) that provides individuals, whether employed by Regeneron or not, the means to raise concerns over any Regeneron activity that may be inconsistent with any law, regulation, company policy, or our Code of Business Conduct and Ethics.
In addition to the confidential helpline, individuals may also make an anonymous report to our compliance website www.ethicspoint.com. After entering the website, select File a New Report to submit a question or concern.
These tools help promote an environment of compliance, integrity, and trust amongst employees and our stakeholders.
Internal monitoring and auditing
Internal monitoring and auditing are integral parts of the Regeneron comprehensive Compliance Program. Effective monitoring and auditing can detect and prevent compliance concerns. Regeneron conducts a variety of monitoring activities in an effort to detect and respond to potential non-compliance.
Enforcement of standards through well-publicized disciplinary guidelines
Regeneron's Code of Business Conduct and Ethics includes a clear description of disciplinary standards, including the potential for termination as a result of non-compliance. Regeneron publishes its policies on progressive discipline and other disciplinary matters on its corporate intranet site.
Prompt response to detected problems through corrective actions
Any reports of suspected non-compliance that are raised to the attention of the Compliance department are promptly investigated. Any corrective action will take place in a timely fashion and where necessary, offenses shall be reported to relevant governmental authorities.
Annual Declaration of Compliance
Regeneron Pharmaceuticals, Inc. is a biopharmaceutical company that is dedicated to discovering, developing, and commercializing pharmaceutical products for the treatment of serious medical conditions. Regeneron conducts its activities in accordance with all applicable laws and regulations and is committed to establishing a corporate culture of compliance, honesty, integrity, and fair dealing. Regeneron has established and maintains a comprehensive Compliance Program that is consistent with the requirements of California Health; Safety Code sections 119400 and 119402. This program has been developed in accordance with the laws applicable to the biopharmaceutical industry, the Compliance Program Guidance for Pharmaceutical Manufacturers published by the Office of the Inspector General of the United States Department of Health and Human Services in April 2003, and the PhRMA Code on Interactions with Healthcare Professionals (PhRMA Code) as revised in July 2008. Regeneron certifies annually to PhRMA that it has policies, procedures or guidelines in place to foster compliance with the PhRMA Code.
As required by California Health & Safety Code section 119402, with specific reference to the provision of gifts, promotional material, or items or activities that a pharmaceutical company may provide to an individual medical or healthcare professional, Regeneron has established an aggregate, annual dollar limit of $2,500 on promotional items and/or meals directed to an individual medical or healthcare professional who resides or practices in California. The dollar limit is a maximum only.
Regeneron declares that, to the best of our knowledge, and based on our good faith understanding of the statutory requirements of the California Health & Safety Code sections 119400 and 119402, we are in compliance with our comprehensive Compliance Program. We also declare that the structure of our comprehensive Compliance Program incorporates the principles articulated in the Compliance Program Guidance for Pharmaceutical Manufacturers published by the Office of the Inspector General of the United States Department of Health and Human Services in April 2003, and the Code on Interactions with Healthcare Professionals as revised in July 2008 adopted by the Pharmaceutical Research and Manufacturers of America.
Dated: July 1, 2012
A written copy of the Comprehensive Compliance Program and written declaration of compliance may be obtained by calling 877-REGN-7777.