BRECKENRIDGE PHARMACEUTICAL, INC. COMPREHENSIVE COMPLIANCE PROGRAM
General
This Comprehensive Compliance Program (“CCP”) is a summary of the compliance program of Breckenridge Pharmaceutical, Inc. (“BPI”) and does not summarize all laws and regulations applicable to BPI and its employees, officers, directors and vendors. The standards enumerated below are embodied in BPI’s Code of Ethics.
Interactions with Healthcare Professionals
BPI’s CCP was established in accordance with the Office of Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers (“OIG CPG”) and the Pharmaceutical Research Manufacturers of America’s Code on Interactions with Healthcare Professionals (“PhRMA Code”) dated January 2022. BPI personnel, officers, directors and vendors are expected to interact with healthcare providers in compliance with this CCP (including the OIG CPG and PhRMA Code), BPI’s Code of Ethics and compliance policies and procedures, and other applicable laws, regulations and guidelines.
BPI’s CCP provides BPI representatives with guidance regarding interactions with healthcare providers and healthcare entities on matters including, but not limited to, advisory boards, speaker programs, gifts, educational items, grants, informational lunches, physician consulting and advisory arrangements, and promotional materials, as applicable. Members of BPI’s sales and commercial operations departments each receive BPI’s Code of Ethics and applicable policies, which include additional compliance guidance.
Compliance Officer
BPI’s Senior Associate General Counsel has primary responsibility for compliance matters, with oversight by BPI’s VP, General Counsel and Head of Litigation. The main compliance responsibilities include, but are not limited to: (i) preparing and updating the CCP as may be necessary; (ii) developing and implementing policies, procedures and practices to implement and administer the CCP; (iii) assessing, developing and implementing BPI’s compliance training activities, including dissemination of guidelines and policies; (iv) monitoring BPI’s compliance hotline and addressing reports submitted to the hotline; (v) investigating compliance matters, including recommendations and oversight of any required disciplinary or other corrective actions; and (vi) establishing and executing adequate auditing and monitoring processes to assure adherence with the CCP and other policies.
Training and Education
BPI’s Code of Ethics and relevant job-specific materials are distributed to all employees who must agree to comply with BPI’s Code of Ethics. Employees are formally trained on BPI policies as appropriate to their function. Follow-up training is provided at least annually to employees with responsibilities for the sales and marketing of BPI products.
Lines of Communication
BPI employees are encouraged to openly and promptly communicate compliance issues and concerns. Employees are instructed that any actual or perceived issue should be reported to their supervisors, the HR Department or the Legal Department as appropriate and as they feel comfortable. No retaliation will be taken against any employee for raising compliance concerns, nor will any retaliation be tolerated. Any such retaliation is grounds for disciplinary action.
BPI operates an anonymous compliance hotline accessible by phone or online, which is administered by a third-party vendor to help ensure compliance violations are properly reported and thoroughly investigated. The hotline promotes a culture of adherence to ethical business practices related to all BPI activities, including the sales and marketing of BPI products. Submissions to the compliance hotline may be made on an anonymous and confidential basis, and are monitored and answered by trained personnel. Information from each submission will be forwarded to the appropriate BPI office for follow-up. All submissions are otherwise kept confidential to the extent permitted by law. All reports of improper conduct will be reviewed and investigated, and corrective action will be taken as appropriate.
Reports can be made by:
- Emailing [email protected]
- Calling the compliance hotline on (844) 920-1212
- Accessing the compliance hotline online at towainternational.ethicspoint.com
Auditing and Monitoring
BPI works with its parent company, Towa Pharma International Holdings, S.L.U. to periodically monitor and audit BPI’s activities to ensure CCP compliance. Actions include periodic reviews of financial and other records related to interactions with healthcare professionals and reporting and monitoring employee training participation. Audit results and corrective actions are periodically reported to executive management.
Disciplinary Guidelines; Investigation; Corrective Action
BPI’s Legal Department, in conjunction with BPI’s HR Department as applicable, oversees investigations of compliance-related issues. BPI is committed to responding promptly to non- compliance with CCP or BPI policy and taking appropriate corrective action. Disciplinary actions, ranging from verbal reprimand, written warning, suspension and termination are determined on a case-by-case basis and are set forth in the BPI Code of Ethics and employee handbook.
Annual Spending Limit
California law requires pharmaceutical companies to voluntarily adopt a specific annual dollar limit on gifts, promotional materials, or items or activities that the pharmaceutical company and its employees and representatives may give or otherwise provide to an individual medical or health care professional in California. The limit does not include amounts attributable to drug samples, financial support for continuing medical education, or payment for legitimate professional services.
BPI has adopted an annual spending limit of $1,200. The annual limit may be revised from time to time.
Availability of Program: Annual Declaration of Compliance
A copy of this CCP can be downloaded from BPI’s website, www.breckenridgepharma.com, and is made available to any interested person. In accordance with Section 119402(e) of the California Health & Safety Code, BPI will post an Annual Declaration of Compliance on its website each calendar year. Requests for copies of this CCP and the Annual Declaration of Compliance (upon posting) may be made by calling BPI toll-free at (800) 466-2700 or by email to [email protected].
