Compliance program for Sanofi US and Genzyme
Sanofi is a global pharmaceutical company engaged in the research, development, manufacture, and marketing of healthcare products. Sanofi is committed to conducting its business ethically and in compliance with all applicable laws, regulations, guidelines, and policies. In keeping with that commitment, its United States affiliates Sanofi US Services Inc., sanofi-aventis U.S. LLC (collectively “Sanofi US”) and Genzyme Corporation (“Genzyme”) (all three companies collectively the “Company”) have implemented a comprehensive compliance program for their US operations (“Compliance Program”); this document describes that Compliance Program. The Compliance Program is part of the North America Compliance Program.
CSanofi, formed in 2004 following the acquisition of Aventis SA by Sanofi-Synthelabo SA, conducts certain business in the US through Sanofi US. The integration, development, and refinement of the Compliance Program for Sanofi US started in late 2004; the Compliance Program continues to improve. Sanofi acquired Genzyme in 2011. The integration of the Genzyme Compliance Program with the Sanofi US Compliance Program began after the acquisition and has continued.
Mission of the compliance program
The purpose of the Compliance Program is to: (a) prevent, detect, and correct violations of law and Company policy and procedures; (b) assure the establishment of compliance-related policies and procedures for business operations; (c) assure development of training and other programs designed to educate employees regarding applicable policies, procedures and standards; (d) implement a mechanism to evaluate the effectiveness of essential elements of the Compliance Program; (e) implement a mechanism for internal reporting of questionable or inappropriate activities to enable timely investigation and resolution; and (f) assure appropriate corrective action is taken to prevent recurrence of misconduct.
Elements of the compliance program
A. U.S. Compliance Officer
The U.S. Compliance Officer is responsible for overseeing the administration and implementation of the Compliance Program and will report at least quarterly on Compliance Program operations to, among others, the Company Compliance Committees and periodically to the Global Executive Compliance Committee. The U.S. Compliance Officer is vested with the authority to direct and implement compliance-related change in the organization as necessary and has the authority to exercise independent judgment in assessing compliance-related matters. The U.S. Compliance Officer has authority to seek advice from independent legal counsel or other outside experts when appropriate. The U.S. Compliance Officer is authorized to report issues of any kind directly to the Company officers and directors.
B. Compliance Committee
The Company has established one or more Compliance Committees, which meet at least quarterly. The mission of the Compliance Committees includes ensuring the implementation and effectiveness of all components of the Compliance Program, which shall include, among other things:
- Development and implementation of compliance-related policies, standards, and procedures in all areas of the U.S. business;
- Development and implementation of training and other programs designed to educate Company employees regarding applicable laws, rules, regulations, policies, procedures, and standards (collectively, “Requirements”);
- Development and implementation of auditing, monitoring, and other controls and processes designed to prevent, detect, and correct violations of applicable Requirements;
- Development and implementation of mechanisms for internal reporting of questionable or inappropriate activities and timely investigation and resolution of such instances; and
- Development and implementation of corrective and disciplinary action to address and prevent recurrence of misconduct or non-compliance.
The Compliance Committees also shall provide advice, counsel, and support to the U.S. Compliance Officer, who shall have day-to-day oversight responsibilities for the North America Compliance Program.
C. Compliance related policies
As part of its commitment to the highest ethical standards of business conduct, the Company has implemented corporate standards and requirements that are consistent with that obligation and are specific to the Company’s operations and the evolving business and regulatory environment.
The Company expects employees at all levels of the organization to comply with the Compliance Program, the standards set forth in the Code of Ethics and US Supplement (“Code”), the Company’s policies and procedures, and all applicable laws. All U.S. employees must annually acknowledge their responsibility and commitment to conduct the Company’s business consistent with these standards and to report to management, Human Resources, Legal, or the U.S. Compliance Officer or Compliance Department knowledge of any violation of these standards. An employee who violates these standards will be subject to appropriate disciplinary action, up to and including termination. The Code expressly prohibits retaliation or retribution against any employee for making any good faith report of suspected misconduct or improper behavior.
A number of policies and procedures are designed to ensure that interactions with healthcare professionals are appropriate, ethical, and consistent with applicable laws and standards, including (but not limited to) the April 2003 “Compliance Program Guidance for Pharmaceutical Manufacturers” issued by the U.S. Department of Health and Human Services Office of Inspector General (“OIG Guidance”), the Pharmaceutical Research and Manufacturers of America (PhRMA) “Code on Interactions with Healthcare Professionals,” revised effective January 2009 (“PhRMA Code”), and the AdvaMed Code of Ethics on Interactions with Health Care Professionals revised effective July 1, 2009 (“AdvaMed Code”). The Company has policies and procedures in place to foster compliance with the PhRMA Code and AdvaMed Code. For a statement regarding compliance with California Health & Safety Code § 119402, click here.
D. Training and educational programs
A critical component of the Compliance Program is the training and education of employees concerning their general ethical obligations and their specific obligations to comply with Company policies and procedures and with all applicable laws and regulations. The Company has implemented training programs to educate employees on the Code, on new and existing compliance policies, and on the standards and procedures applicable to their job functions. New employees receive or will receive compliance training as part of their initial training; employees receive on-going compliance training on a routine and periodic basis. The Company implements additional training for the entire Company or particular departments and/or business units on an as-needed basis.
E. Communicating compliance issues and concerns
The Company is committed to fostering an environment in which the open communication regarding questions about the Code or Company policies and procedures or concerns about suspected improper business practices is encouraged. Any employee who has concerns about a particular activity that the employee feels may violate policies or the law is required to report such concerns.
Employees are encouraged to ask questions about compliance issues or make reports of potentially problematic conduct to their managers. As an alternative, employees may contact the U.S. Compliance Officer or use the North America Compliance Helpline (1-800-648-1297). The Helpline, a toll free number available 24 hours a day and 7 days a week, allows confidential, anonymous reporting. The Helpline is administered by an independent outside contractor whose employees are trained to handle such calls. Employees may also e-mail the North America Compliance Department at NACompliance@sanofi.com.
The Code expressly prohibits retaliation or retribution against any employee for making any good faith report of suspected misconduct or improper behavior.
F. Monitoring, auditing, and investigations
The Compliance Program includes activities designed to monitor and audit compliance with the Company’s policies and procedures. The U.S. Compliance Officer oversees and/or coordinates systems for periodic monitoring and auditing. On a periodic basis, but not less than annually, the U.S. Compliance Officer develops an audit plan, recognizing that the nature and frequency of reviews depends upon a variety of factors. A variety of internal and external auditing resources may be used to conduct periodic monitoring and auditing. The U.S. Compliance Officer works with relevant internal experts and management to evaluate audit findings and ensure the implementation of any corrective action deemed necessary as the result of audits or routine monitoring activities.
The U.S. Compliance Officer (or designee) reviews and evaluates concerns communicated to the North America Compliance Department to determine whether further investigation is required of activities that may be inconsistent with the Code, policies or procedures, or any provision of the Compliance Program or applicable law. The U.S. Compliance Officer may, as required, request assistance from the members of the Compliance Committees or outside experts to conduct an investigation, depending on the nature of the alleged misconduct. Investigations shall be conducted confidentially to the greatest extent possible and with every effort to respect the rights of all concerned.
G. Corrective action and discipline
If it is determined, after investigation, that noncompliant conduct occurred, the matter is forwarded to the appropriate parties for corrective and/or disciplinary action. Such response and disciplinary action may include (but is not limited to): terminating or otherwise disciplining the employee(s) involved; disciplining supervisors in accordance with the facts for failure to supervise adequately and control the behavior of the employee(s); revising guidelines, policies, and procedures or any function of the Compliance Program to prevent the reoccurrence of misconduct in the area; or increasing auditing and monitoring procedures.
H. Updating the compliance program
From time to time, the Company may amend its Compliance Program. The Compliance Committees shall review all changes suggested by the U.S. Compliance Officer, members of the Compliance Committees, or other Company personnel. The U.S. Compliance Officer shall be responsible for communicating changes in the Compliance Program to Company employees in a timely manner.
For a written copy of this North America Compliance Program description, call 1-800-648-1297.