To achieve our objectives, we strive to apply the highest legal and ethical standards to all of our business activities. Sobi will comply with all applicable laws and expects all employees to do the same. No employee may violate the law on Sobi's behalf, or direct anyone else to do so. Overall, Sobi expects our employees to perform their jobs with honesty and integrity.
Sobi, Inc. has established a comprehensive Compliance Program as a key component to deliver on its commitment to integrity. The mission of the Sobi Compliance Program is to:
- promote compliance with applicable laws, rules and regulations as well as company policies;
- prevent, detect, investigate, and correct violations; and
- foster a corporate culture valuing integrity and ethical behavior.
While no program can guarantee that improper employee conduct will be entirely eliminated, Sobi requires all of its employees to comply with the Sobi Code of Conduct & Ethics and its supporting policies.
Below is an overview of Sobi’s Compliance Program, which is subject to change from time to time as Sobi’s Compliance Program evolves.
Our Code of Conduct & Ethics demonstrates Sobi’s commitment to integrity, and explains some of the most important laws and policies that apply to Sobi's business.
Sobi's Compliance Program addresses among other things:
- compliance leadership;
- policies and procedures;
- education and training;
- internal lines of communication;
- auditing and monitoring;
- screening and discipline;
- responding to potential violations.
Our Vice President, Head of Compliance and Legal is responsible for developing, operating and monitoring the Compliance Program.
The Vice President, Head of Compliance and Legal also Chairs the Compliance Committee, formed to advise and assist in the implementation of the Compliance Program. The Compliance Committee comprises other members of senior management, including the Vice President, Head of Marketing & Sales, Vice President, Head of Medical, Vice President, Head of Human Resources and Vice President, Head of Finance.
Policies and Procedures
As noted in the Code of Conduct & Ethics, Sobi has adopted in full the Code on Interactions with Healthcare Professionals issued by the Pharmaceutical Research and Manufacturers of America (the "PhRMA Code"). The Code of Conduct & Ethics and the PhRMA Code are supported by additional company policies, including policies that limit meals and educational items provided to healthcare professionals. One of these policies includes an explicit annual dollar limit on educational items, promotional materials, and other promotional activities that may be provided to healthcare professionals.
Explicit Limits on Expenses for Health Care Professionals
Sobi's policy on Compensation and Expenses for Healthcare Professionals and policy on Annual Limits on Compensation and Expenses for Healthcare Professionals states that the dollar value of permissible items and permissible meals accompanying informational presentations that may be given to any individual healthcare professional during a calendar year may not exceed the company's limit. The limit is renewed and applied on a calendar year basis. As this is the maximum that may be provided, the average annual expenditures for permissible items and meals given to healthcare professionals will be below the annual limit. Effective October 2014, the company's annual limit is $2,000.
Training and Education
Every year Sobi requires all employees to complete training courses addressing legal and ethical issues that may arise in our business.
Lines of Communication
Sobi has established a toll-free Compliance Helpline 1-855-717-6202 or Compliance Hotline where employees or others can seek guidance as to any compliance matter or report a suspected violation of law or company policy. Employees may also seek guidance or report a suspicious compliance violation 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.
Declaration of Compliance
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 2020, Sobi, Inc. is in compliance both with its own Compliance Program and with California Health & Safety Code §119402.
By making this declaration, Sobi, Inc. is not asserting that in all circumstances it can prevent individual employees from engaging in conduct that deviates from its policies, but it will make a good faith effort to enforce the Compliance Program, prevent violations, and address any inappropriate conduct that may occur. Sobi, Inc. reassesses, enhances, and makes changes to its Compliance Program on an ongoing basis. This declaration will be updated annually.
Copies of Sobi's Code of Conduct & Ethics and the information on this site can be obtained by calling 1-(855)-717-6202 or 1-(781)-786-7364 and asking to be transferred to the Vice President, Head of Compliance and Legal.