BIOTEST PHARMACEUTICALS CORPORATION
Healthcare Compliance Program
Biotest Pharmaceuticals Corporation (“BPC”) seeks to conduct itself in accordance with high ethical principles and in compliance with applicable governing laws. BPC’s Compliance Program (the “Program”) has been developed in accordance with applicable law, incorporating guidance from state and federal authorities when available, including the Office of the Inspector General of the U.S. Department of Health and Human Services (“OIG”), and relevant industry guidance from leading professional associations such as the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and the Accreditation Council on Continuing Medical Education (“ACCME”). The Program is consistent with current state law requirements to adopt a “Code of Conduct” for interactions with health care professionals and is intended to satisfy those requirements.
The Program focuses on the prevention and detection of violations of law or company policy. The Program will be updated periodically to keep BPC’s employees informed of the most current information available pertaining to compliance requirements in the healthcare industry. “BPC Employees” referenced in this Program are those employees whose primary responsibilities are commercialization of BPC’ products, e.g., sales and marketing personnel.
There are numerous federal and state laws and regulations that define and establish obligations for the healthcare industry that are applicable to BPC’s business. Any BPC Employee who violates these laws and/or regulations not only risks individual criminal prosecution and penalties, civil actions for damages and penalties and administrative exclusion, but also subjects BPC to the same risks and penalties. Any BPC Employee who violates any of these laws and regulations may be subject to termination of his or her employment.
BPC keeps current with applicable laws and guidance and uses its best efforts to ensure that its employees are made aware of new requirements on a timely basis.
BPC has adopted policies and practices consistent with the OIG’s Final Compliance Program Guidance for Pharmaceutical Manufacturers, the PhRMA Code on Interactions with Healthcare Professionals, and the ACCME Standards for Commercial Support. In particular, these policies, and practices are consistent with the Code’s guidance regarding meals, third-party educational meetings, consulting arrangements, and gifts. BPC has a system for tracking all payments to health care professionals, and other records relating to its sales and marketing activities to comply with applicable state and federal disclosure obligations.
This Program is implemented under the guidance of the Deputy General Counsel who will function as the Program Compliance Officer. In coordinating compliance efforts, she will consult with several departments, including, but not limited to, Medical Affairs, Regulatory Affairs, Finance, Human Resources and Sales and Marketing. Questions and concerns regarding compliance with this Program should be directed to the Deputy General Counsel.
EMPLOYEE TRAINING AND EDUCATION PROGRAMS
BPC Employees will receive a copy of this Program, supporting policies and procedures, and other information necessary to ensure compliance with this Program. Any BPC Employee who has questions regarding this Program or his/her obligations should contact the Deputy General Counsel. BPC Employees will receive copies of any changes to this Program or relevant policies.
As necessary, and at least annually, BPC will provide Employee training sessions on this Program, product-specific information, and relevant areas of general science which will take into account the skills, experience and knowledge of the trainees. BPC will retain records of the training of Employees. Training will be updated periodically to include new developments in law, industry guidance, and BPC’s policies.
The full cooperation of BPC Employees is expected. Some BPC Employees may receive specialized training as a result of the services they provide. This specialized training may focus on complex areas or on areas that pose a high risk of misconduct.
MONITORING, AUDITING, COMMUNICATION AND CORRECTIVE ACTION
On an ongoing basis, the Deputy General Counsel will monitor updated laws and guidance, including OIG publications, to comply with any revised or additional applicable requirements. BPC will conduct an annual audit, consistent with the OIG’s guidelines to monitor BPC’s compliance with this Program and applicable laws.
BPC has an “open door policy” that permits any employee to discuss any concern, problem or complaint directly with senior personnel of the company. BPC Employees may report any suspected misconduct to their supervisor, the Senior Director (of) Human Resources or the Deputy General Counsel for review and resolution, as applicable. Additionally, BPC maintains a confidential employee hotline available seven days a week, twenty-four hours a day, for the anonymous reporting by employees of suspected misconduct. BPC management will promptly investigate alleged violations of this Program. Responses may include appropriate corrective measures and reports to relevant governmental authorities. BPC Employees will be required to cooperate fully with any investigations.
No BPC Employee who reports suspected misconduct will be retaliated against or otherwise disciplined by BPC for making such report. A BPC Employee’s failure to comply with this Program may result in discipline up to and including termination. Enforcement and discipline will be at the sole discretion of BPC.
CALIFORNIA COMPREHENSIVE COMPLIANCE PROGRAM
To the best of its knowledge, BPC conducts its business in compliance with the requirements of California Health & Safety Code sections 119400 and 119402. BPC has set an annual dollar limit of $1500 on promotional materials, or items or activities that it may give or provide to a California medical or healthcare professional in a given year. The dollar limit does not apply to financial support for CME and health education scholarships, or payments for professional services.
A copy of this document may be obtained by calling toll free 1-800-327-7106.