Sobi’s Commitment to Ethics and Compliance
Sobi, Inc (“Sobi”) strives to apply the highest legal and ethical standards to all our business activities. Sobi personnel conducts activities consistent with all applicable laws and regulations. Sobi has established a comprehensive Ethics and Compliance Program to deliver on its commitment to integrity and ethics. All Sobi employees are expected to know, understand and support the organization’s Ethics and Compliance Program and perform their jobs with honesty and integrity in line with our Core Values.
The objective of the Sobi Ethics and Compliance Program is to:
- Promote compliance with applicable laws, rules, and regulations as well as company policies
- Prevent, detect, investigate, and correct violations
- Foster a corporate culture valuing integrity and ethical behavior
Sobi’s Ethics and Compliance Program is in alignment with the “Compliance Program Guidance for Pharmaceutical Manufacturers” developed by the United States Department of Health and Human Services, Office of Inspector General (OIG).
The Elements include:
- Compliance Leadership
- Policies and Procedures
- Training and Education
- Responding to Potential Violations and Remediating Issues
Compliance Leadership
The Head of Ethics and Compliance, North America (NA) is responsible for the development and ongoing implementation of the Sobi NA Compliance Program with support and oversight from the Sobi NA Compliance Committee.
The Compliance Committee is comprised of senior management, including the President, Sobi North America who co-chairs with the Head of Ethics and Compliance, North America.
Policies and Procedures
Sobi has adopted the Code of Ethical Practices by Innovative Medicines Canada (IMC). The Sobi overarching guidance for business conduct is the Sobi Code of Conduct.
The Code is supported by additional company policies, including policies that limit meals and educational items provided to healthcare professionals. One of these policies (Policy on Business Meals, Courtesies, and Educational Items for HCPs) includes an explicit annual dollar limit on educational items, promotional materials and other promotional activities.
Training and Education
Every year Sobi requires all colleagues to complete training relevant to the Code of Conduct and the Ethics and Compliance Program. The goal for the Sobi Ethics and Compliance training program is the development of a best in class solution that will support colleagues’ execution of activities related to their responsibilities and to ensure compliance with Sobi’s written standards, policies, and procedures. Training is assigned based on roles and delivered in person and through the learning management system.
Responding to Violations and Remediating Issues
Sobi has in place policies that outline the processes and steps for following up on potential violations or misconduct related to Sobi policies and procedures and/or laws and regulations. Sobi responds to potential violations in a prompt and effective manner. The investigations process includes intake, triage, analysis, remediation and follow-up. Remediation activities could range from process changes, re-training or discipline up to and including termination of employment.