Corporate Compliance Program

Implementing Our Commitment to Performance
With Integrity

Recognizing our long-standing commitment to compliance with the law, Boehringer Ingelheim has established a Corporate Compliance Program. The success of the program begins with our employees exercising good judgment and personal integrity, complying with our Code of Conduct and our policies and procedures, and by detecting and reporting any violations of laws or policies.

The Boehringer Ingelheim Corporate Compliance Program conforms with the principles and recommendations published in the Office of Inspector General, U.S. Department of Health and Human Services’ “Compliance Program Guidance for Pharmaceutical Manufacturers,” and the PhRMA “Code on Interactions with Healthcare Professionals.” The Program consists of the following components:

Chief Compliance Officer and Corporate Compliance Committee
Corporate Policies and Procedures
Code of Conduct Annual Certification
Confidentiality
Helpline
Compliance Training and other Resources
Audits and Investigations
Corrective Action and Discipline
No Retaliation Policy
State and Local Compliance

Chief Compliance Officer and
Corporate Compliance Committee

The Boehringer Ingelheim Corporate Compliance Program is under the direction of the Chief Compliance Officer, who is a member of the Corporate Compliance Committee. The Corporate Compliance Committee is comprised of senior executives of the Boehringer Ingelheim Corporation and its subsidiaries. The Chief Compliance Officer also provides annual updates, and substantive matter updates as required, directly to the Board of Directors of Boehringer Ingelheim Corporation.

Corporate Policies and Procedures

The company provides its employees guidance on certain legal issues as well as procedures for implementing business practices. This guidance can come in many forms. It may be in the form of corporate policies/procedures or individual subsidiary policies/procedures. It may also come from department-specific policies and procedures. Sometimes, it may come from more informal direction from management or other leaders in the company. The company continually evaluates and refines its policies and procedures to address specific and applicable legal, regulatory and business requirements. Policies and procedures are made available through employee manuals, department managers, and/or on the company’s web sites.

Sales and Marketing Compliance is one specific area in which the company has expended an enormous amount of effort and compliance resources. Under the guidance of the Sales and Marketing Compliance department, Boehringer Ingelheim has developed specific policies and procedures to address issues identified in the OIG Guidance document and the PhRMA Code. These policies and procedures are provided to the relevant employees in a variety of formats. For example, our field based employees each receive a “Field Guide to Performance with Integrity.” The Field Guide is a tool to assist field-based employees in meeting the high standards of Boehringer Ingelheim and provide them with a quick summary and description of the application of policy to key sales and marketing activities. Additionally, there is targeted training designed specifically for the field force on many of these same issues, policies and procedures.

Areas addressed through policy development, procedural implementation and training programs specifically for Sales and Marketing include some of the following:

Code of Conduct
Product Promotion
Sample Management
Grants and CME Support
Promotional Speaker Programs
Charitable Donations
Local Exhibits & Displays
Patient Assistance Programs
Requests for Medical Discussions and Limitations on Interactions with Company Field-based Medical Personnel
Business Intelligence
Adverse Event Reporting

Code of Conduct Annual Certification

All employees must carefully read and acquaint themselves with the Boehringer Ingelheim Code of Conduct. Under company policy, all employees are required to annually acknowledge and certify that they have read and understood the Code of Conduct. Failure to do so will subject the employee to disciplinary action.

Confidentiality

For our Corporate Compliance Program to be effective, it is essential that employees feel confident and secure when raising compliance concerns and issues. Therefore, it is critical for employees to know that every effort will be made to ensure the confidentiality of the compliance process. To help achieve this, the company provides anonymous reporting capabilities through the Compliance Helpline or anonymous emailing through the company’s Compliance Web site.

Helpline

The Corporate Compliance Program maintains a company Helpline that all employees can call to ask for guidance on the Code of Conduct, clarification of policies or procedures or to report compliance concerns. The Helpline is a toll free telephone number that can be accessed 24 hours a day, 7 days a week. The Helpline is administered by an independent contractor whose employees are specially trained in interviewing callers and collecting pertinent information. The Helpline provider will send reports summarizing incoming calls to the Compliance department within one business day.

Employees have the option of providing their identification or making an anonymous report. We recognize that in some cases, employees may not feel comfortable identifying themselves when reporting a compliance concern. Whether made anonymously or not, the identity of the caller and the fact that a report has been made will be kept confidential to the extent possible while still allowing a thorough investigation to proceed.

Compliance Training and other Resources

In addition to the Code of Conduct, employees may be required to take additional training designated by the Corporate Compliance Program and senior management. This training may be through an ethics and compliance on-line training program, other on-line or computer-based training programs specific to a department or organization, training on policies and procedures necessary to carry out individual job duties, and training required by the Human Resources department. This list is not exhaustive, and an employee’s training requirements will likely vary over the course of employment. Any training assigned to employees is part of the company’s overall compliance efforts to provide them with the information and guidance needed to meet Boehringer Ingelheim’s ethical and business standards and its legal obligations.

In some areas of the company, employees may have access to a library of on-line training courses. The subjects of the courses cover a variety of business and legal issues that support any required training. The Compliance Web site also hosts various tools and resources about compliance related subjects.

Audits and Investigations

Every concern, question and allegation of wrongdoing reported to the Corporate Compliance Program - whether via the Helpline, the Compliance Web site, or by directly contacting the Chief Compliance Officer, the Compliance Counsel a member of the Legal department or reported through management - shall be reviewed, evaluated and responded to promptly and professionally, in a manner that respects the rights of all parties concerned. Follow up will include remediation and corrective actions as necessary, as well as appropriate disciplinary action when warranted. Investigations shall, to the maximum extent possible, be conducted confidentially. All employees are expected to fully cooperate with any compliance investigation.

Corrective Action and Discipline

Any violations of the Code of Conduct or company policies and procedures will be taken very seriously. When a violation is identified, prompt, thorough and appropriate corrective action will be taken in response to the violation. The response may include making changes to policies, procedures and/or other compliance processes to ensure that repeat or similar violations do not occur. Failure to comply with the Code of Conduct or any company policy or procedure will subject the employee to disciplinary action, up to and including termination of employment.

Employee Responsibility to Report and
Protection from Retaliation

In addition to acting in compliance with the Code of Conduct and our policies and procedures, every employee has the responsibility to report to the company any violations of the Code of Conduct, law, policy or procedure that he or she may discover. Employees are assured that they can report such violations without fear of retribution or retaliation. Any employee who threatens, retaliates against or harasses any person who has reported in good faith a compliance concern, or is considering reporting such a concern, shall be subject to disciplinary action, up to and including termination. Employees are encouraged to report such violations directly to management. They are also counseled to talk to someone in the Human Resources department. However, if employees believe concerns cannot be raised in either of these manners, they are strongly advised to use the Compliance Helpline or submit questions or concerns via the anonymous e-mail capability hosted on the Boehringer Ingelheim Compliance Web site.

State and Local Compliance

Click here to learn more about our compliance with specific state requirements.

Corporate Compliance department contact information:

Boehringer Ingelheim Pharmaceuticals, Inc.
P.O. Box 368
Ridgefield, CT 06877-0368

Corporate Compliance
Phone: 203.798.4260
Fax: 203.798.4408

To request a hard copy of the Boehringer Ingelheim Corporate Compliance Program or the annual public declaration of compliance with our Corporate Compliance Program – please call 1.800.243.0127.