A. U.S. Corporate Compliance Officer
The U.S. Corporate 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 US Compliance Committee and at least annually to the sanofi-aventis Global Ethical Committee. The U.S. Corporate 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. Corporate Compliance Officer has authority to seek advice from independent legal counsel or other outside experts when appropriate. The U.S. Corporate Compliance Officer is authorized to report issues of any kind directly to the sanofi-aventis US President/CEO.
B. U.S. Compliance Committee
Sanofi-aventis U.S. has established a U.S. Compliance Committee, which meets at least quarterly. As of Fall 2010, the U.S. Compliance Committee is comprised of the following:
Gregory Irace, President and Chief Executive Officer, sanofi-aventis U.S.
Philippe Grillet, VP, Finance and Chief Financial Officer, U.S and Canada region
Paul Chew, Sr VP and U.S. Chief Science Officer/Chief Medical Officer
Ed Greissing, VP, U.S. Corporate Affairs
Judy O'Hagan, VP, U.S Human Resources
Osric Reavis, Site Manager Kansas City, U.S. Industrial Affairs
John Spinnato, VP and General Counsel, U.S. Legal
Gabriela Aguado, VP, U.S. Quality and Compliance
Nanci Bergamo, VP, U.S. R&D Quality & Compliance
Christer Odqvist, VP, Business Strategy & Support
Robert DeLuca, VP, U.S. Managed Markets
Jerome Durso, Sr VP and Chief Commercial Officer, Pharmaceuticals U.S.
Brent Ragans, VP, U.S. Consumer Healthcare and U.S. Dermatology
Tom Forrester, VP and U.S. Corporate Compliance Officer, Chair
It is the mission of the U.S. Compliance Committee to ensure the implementation and effectiveness of all components of the sanofi-aventis U.S. 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 sanofi-aventis U.S. 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 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 U.S. Compliance Committee also shall provide advice, counsel, and support to the U.S. Corporate Compliance Officer, who shall have day-to-day oversight responsibilities for the Compliance Program.
C. Compliance-Related Policies
As part of its commitment to the highest ethical standards of business conduct, sanofi-aventis U.S. 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 U.S. Code of Business Conduct (“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 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. Sanofi-aventis U.S. policy 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) both 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”) and the Pharmaceutical Research and Manufacturers of America (PhRMA) “Code on Interactions with Health Care Professionals” (“PhRMA Code”), revised effective January 2009. Sanofi-aventis U.S. has policies and procedures in place to foster compliance with the modified PhRMA 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. Sanofi-aventis U.S. has implemented training programs to educate employees on the Code, on new and existing U.S. Corporate Policies, and on the standards and procedures applicable to their job functions. New employees receive compliance training as part of their initial training; employees receive on-going compliance training on a routine and periodic basis. Sanofi-aventis U.S. 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
Sanofi-aventis U.S. 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. Corporate Compliance Officer or use the sanofi-aventis U.S. 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 U.S. Compliance Department at USCorporate.Compliance@sanofi-aventis.com.
Sanofi-aventis policy 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. Corporate Compliance Officer oversees and/or coordinates systems for periodic monitoring and auditing. On a periodic basis, but not less than annually, the U.S. Corporate 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. Corporate 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. Corporate Compliance Officer (or designee) reviews and evaluates concerns communicated to U.S. Corporate Compliance 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. Corporate Compliance Officer may, as required, request assistance from the members of the Compliance Committee 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, sanofi-aventis U.S. may amend its Compliance Program. The U.S. Compliance Committee shall review all changes suggested by the US Corporate Compliance Officer, members of the US Compliance Committee, or other company personnel. The US Corporate Compliance Officer shall be responsible for communicating changes in the Compliance Program to sanofi-aventis employees in a timely manner.
For a written copy of this sanofi-aventis Compliance Program description,
call 1-800-648-1297.
