Corporate Compliance Program

The E&C Program conforms with the principles and recommendations published in guides from various Federal agencies (e.g., FDA, OIG, DOJ, USDA, DEA, etc.) and industry related organizations (e.g., PhRMA, BIO, AAALAC, etc.).

The E&C Program consists of the following components:

U.S. Chief Ethics & Compliance Officer, other compliance professionals and Compliance Committees
The Boehringer Ingelheim Corporate (US) Ethics and Compliance Program is under the direction of the U.S. Chief Ethics & Compliance Officer, who is a member of the Boehringer Ingelheim U.S. Compliance Committee (The Committee). The Committee is comprised of senior executives of the Boehringer Ingelheim Corporation and its subsidiaries. The Chief Ethics & Compliance Officer also provides annual updates, and substantive matter updates as required, directly to the Board of Directors of Boehringer Ingelheim Corporation.

Company Regulations and Written Guidance
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 policies or procedures (corporate, operating units (OPU), and/or local). It may also come from more informal direction through 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, document repository systems and/or on The Company’s websites.

Pharmaceutical Sales and Marketing Compliance is one specific area in which The Company has expended an enormous amount of compliance resources effort and. Under the guidance of the U.S. Ethics & Compliance program, Boehringer Ingelheim has developed specific policies and procedures to address issues identified in the most recent guidance provided by the OIG, DOJ 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 “Performance with Integrity Guide.” The 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 for Sales & Marketing through policy development, procedural implementation and training programs specifically for Sales and Marketing include but are not limited to the following:

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

Code of Conduct Annual Certification
The Code of Conduct is the cornerstone of BI's culture and is designed to ensure that ethical compromises are never made and that all actions are honest and ethical. The Code of Conduct provides guidance for performing with integrity in the workplace, in the markets where BI competes, in the local communities, and with the public.

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

Confidentiality
For our Ethics and Compliance Program to be effective, it is essential that employees feel confident and secure when raising concerns and issues. In an effort to protect participants from retaliation, the identity of all those reporting or participating in the investigation of allegations is initially kept confidential by The Company and, like other information pertaining to an investigation, will only be shared as needed to assist with or resolve the investigation. However, there are other times when confidentiality is not required, such as when maintaining confidentiality would compromise an effective investigation or a resolution of the problem, or for other legitimate business concerns. Lastly, The Company may be required by law to reveal the identity of the complainant or facts of the investigation.  

Ethics and Compliance Helpline
The Ethics and Compliance Program maintains a company Helpline that is available to all employees to ask for guidance on the Code of Conduct, clarification of policies or procedures, report compliance concerns, or provide information to Ethics and Compliance. The Helpline can be accessed by calling a toll free telephone number (800) 958-9704 or on-line and is available 24 hours a day, 7 days a week. The Helpline is administered by an independent contractor. The toll free number is answered by vendor representatives who are specially trained in interviewing callers and collecting pertinent information. Reports summarizing the calls are sent to BI Corporate (US) Ethics and Compliance within one day. The on-line Helpline allows employees to create their own email report by answering topic related questions. These reports are automatically routed to BI Corporate (US) Ethics and Compliance.

Whichever method is chosen, 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 employee 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.

Ethics and Compliance Training and other Resources
Regular communication about the E&C Program and/or the Legal Compliance Topics shall be delivered by senior management in order to ensure that the importance of compliance is conveyed. In addition to the Code of Conduct, employees may be required to take additional training designated by the Corporate (US) Ethics and 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.

Auditing & Monitoring
As part of our E&C Program, we engage in ongoing auditing and monitoring of business activities to evaluate compliance with The Company’s written standards. Employees, third parties, and processes are addressed in response to monitoring and auditing results; and opportunities for potential improvement identified through monitoring and auditing are further incorporated into compliance training, policies, procedures and communication in support of continual improvement of compliance program elements and awareness.

Investigations
Individuals are expected to report any potential non-compliance of laws, regulations, Company policies, procedures, or the Code of Conduct. Every concern, question and allegation of wrongdoing reported to Ethics and Compliance - whether via the Helpline, the Ethics and Compliance Web site, or by directly contacting a member of the Ethics and Compliance Department, the US Chief Ethics & Compliance Officer, a member of the Legal department, a member of the Human Resources 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. The Company takes all reports of non-compliance seriously and addresses matters according to the nature of the report. Investigations shall, to the maximum extent possible, be conducted confidentially. All employees are expected to fully cooperate with any compliance investigation without fear of retaliation.

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 a compliance concern in good faith, 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, the Legal Department or the Ethics and Compliance Department. However, if employees do not feel comfortable reporting concerns in either of these manners, they are strongly advised to use the Ethics and Compliance Helpline, where reports can be made anonymously.

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. 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. Follow up will include remediation and corrective actions as necessary, as well as appropriate disciplinary action when warranted. The response may include making changes to policies, procedures, and/or other compliance processes to ensure that repeat or similar violations do not occur.

Transparency & Disclosure

• Federal and State Laws

Ethics and Compliance department contact information:
Boehringer Ingelheim Pharmaceuticals, Inc.
P.O. Box 368
Ridgefield, CT 06877-0368

Ethics and Compliance:
Phone: 800.958.9704
Fax: 203.798.4408

1. Chief Ethics and Compliance Officer:
   Phone: (203) 798-4825
2. To request a hard copy of the Boehringer Ingelheim Corporate (US) Ethics and Compliance Program or the annual public declaration of compliance with our E&C and Ethics Program – please call 1.800.243.0127.