CORPORATE COMPLIANCE PROGRAM OVERVIEW
As a company engaged in the challenging pursuit of finding solutions for progressive liver diseases with high unmet medical need, Intercept Pharmaceuticals, Inc. and its affiliated companies (Intercept) is committed to bringing positive impact on patients’ lives. As a good corporate citizen, in addition to focusing on WHAT our mission is, Intercept is committed to ensuring ethics, integrity and compliance in HOW we achieve our mission. As such, it is Intercept’s policy to conduct all aspects of our business in accordance with the highest standards.
As part of this commitment, Intercept has established a comprehensive Compliance Program in accordance with the principles set forth by the United States Department of Health and Human Services Office of Inspector General (OIG).
Intercept has designated a Chief Compliance Officer (CCO), who is responsible for developing, overseeing, and monitoring the operation of our Compliance Program. Our CCO reports to the Head of Legal Affairs. The CCO has effective lines of communication with other departments of the company and has access to the Chief Executive Officer or, if required, the Board of Directors on compliance related matters. Intercept also established a Compliance Committee comprised of senior-level representatives from various functions across the company. The Compliance Committee is charged with oversight of Intercept’s Compliance Program and meets quarterly to review and develop action plans to address compliance related matters.
Policies and Procedures
Intercept has a publicly available Global Code of Business Conduct setting forth the company’s commitment to compliance by its management, employees and agents. Intercept also has internal policies in place requiring all relevant associates to comply with appropriate standards and legal requirements, such as laws, regulations, codes or other guidelines, as may be applicable in the jurisdictions in which we conduct business.
Where required, Intercept has implemented a $3,000 per healthcare professionals (HCP) per year limit on gifts, meals, promotional materials or other items they might receive from Intercept. These limits do not include the value of grants for medical education, medical scholarships, professional services, or other permitted items under the applicable rules and regulations.
Responding and Reporting
Intercept has a toll-free hotline any employee can use to make a report of suspicious activity, anonymously if desired. Employees must promptly report any violation of the Compliance Program or any policies of the company using any of the available company resources. Employees making good faith reports are protected from retaliation. Employees are permitted to cooperate with law enforcement and are required to refrain from taking any action to interfere with any ongoing investigation.
Intercept employees are trained on issues contained on the Compliance Program, including compliance with the Global Code of Business Conduct, and how to report concerns. Refresher and update training is routinely given to employees covering issues relevant to the industry and interactions with HCPs.
Auditing, Monitoring and Discipline
Each operating function / department within Intercept has the authority to monitor and audit the activities of its employees and third parties for compliance with this Compliance Program. Should wrongdoing on the part of an employee be found, disciplinary action up to, and including, termination of employment may be taken.
This Compliance Program may be amended, altered or revised from time-to-time as needed and without prior notice.
PROCEDURES POLICIES ON INTERACTIONS WITH HEALTHCARE PROFESSIONALS IN CALIFORNIA
Consistent with the requirements of California Health & Safety Code §§ 119400-119402, Intercept Pharmaceutical, Inc. (hereinafter “Intercept”) has established an aggregate limit on certain promotional expenditures that may be provided to individual medical and healthcare professionals (HCPs). Intercept has annual aggregate limit on covered promotional expenditures at $3,000 per covered HCPs for annual periods. This limit may be revised by Intercept from time to time. The foregoing limit does not represent any usual, customary, average, or typical amount for HCPs. Intercept exempts certain expenditures from this limit based upon a good faith understanding of California Health & Safety Code §§ 119400-119402 and the PhRMA Code.
Such exemptions include:
- Financial support for continuing medical education forums;
- Financial support for health educational scholarships;
- Payments made for legitimate professional services provided by a HCPs that are provided at the fair market value for the services rendered;
- Items of de minimis value and primarily associated with an HCP or patient’s education; and
- Documents, informational or educational brochures, and other items that inform HCPs about Intercept’s products, provide scientific and educational data, support medical research and education, or enhance a patient’s understanding or management of a disease state or disorder.