Sobi’s Commitment to Ethics and Compliance
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
- Lines of Communication
- Auditing and Monitoring Program
- Responding to Potential Violations and Remediating Issues
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.
Sobi has adopted the Code on Interactions with Healthcare Professionals issued by the Pharmaceutical Research and Manufacturers of America (the "PhRMA Code"). 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.
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.
Sobi has established a toll-free Compliance Hotline, 1-855-717-6202, which offers employees, business partners, customers and members of the public the ability to report concerns about any potential misconduct or unethical behavior by Sobi.
Employees may also seek guidance or report suspicious or concerning conduct through a variety of other internal mechanisms. Moreover, all employees are obligated to report all suspected violations of law or company policy under the company’s policy on Reporting, Investigating and Responding to Compliance Issues and there are several internal mechanisms to do so. Sobi’s Non-Retaliation Policy protects employees who make good faith reports about issues and concerns.
Sobi has instituted an Auditing and Monitoring Program in accordance with the OIG’s Compliance Program Guidance for Pharmaceutical Manufacturers, which includes a comprehensive Auditing and Monitoring Plan. The program promotes Sobi’s commitment to integrity by reviewing and analyzing U.S. promotional and non-promotional activities to identify potential signals of risk. The Auditing and Monitoring Plan for Sobi North America is reviewed and approved by the North America Compliance Committee and consists of both transaction audits and systems audits. Monitoring activities could be live or consist of document reviews. Employees are expected to cooperate with all auditing and monitoring activities, with results reviewed and remediated as appropriate.
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.
As described on this site, Sobi, Inc. has established a comprehensive Compliance Program. The Program has been designed in accordance with the Compliance Program Guidance for Pharmaceutical Manufacturers published by the Office of the Inspector General of the US Department of Health and Human Services. To the best of our knowledge, as of July 2021, Sobi, Inc. is in compliance both with its own Compliance Program and with California Health & Safety Code §119402.
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