ENZYVANT Declaration of Compliance
Enzyvant declares that, to the best of its knowledge, and based on a good faith understanding of the statutory requirements of California Health and Safety Code §§ 119400 and 119402, as of July 2021, Enzyvant believes that it is maintaining a comprehensive Compliance Program in compliance with the statutory requirements above.
Enzyvant Sciences Healthcare Compliance Program (October 8, 2021)
Enzyvant and its affiliated companies (“Enzyvant”) is committed to establishing and maintaining a comprehensive and effective compliance program (“Compliance Program”) in accordance with the “Compliance Program Guidelines for Pharmaceutical Manufacturers” published by the Office of Inspector General, U.S. Department of Health and Human Services (“OIG Guidance”) and California SB 1765 (California Health and Safety Code §§ 119400 and 119402). Enzyvant’s Compliance Program reflects its unwavering commitment to the highest standards of corporate conduct and integrity.
The Enzyvant Compliance Program, as described in further detail blow, addresses risk areas identified by the OIG Guidance and the Pharmaceutical Research and Manufacturers of America “Code on Interactions with Healthcare Professionals” (the “PhRMA Code”). Enzyvant’s Compliance Program is scalable to address the size, organizational structure and operations of our company. As recommended by the OIG Guidance, the Enzyvant Compliance Program is regularly reviewed and evaluated to ensure that it continues to meet changing legal requirements and the evolving needs of our company.
Compliance Program Overview
Compliance Officer: The Chief Compliance Officer is responsible for developing, operating and monitoring this Compliance Program. The Chief Compliance Officer has direct access to the Enzyvant Board of Directors and senior management and provides regular reports on the status of the Compliance Program.
Compliance Committee: Enzyvant has established an internal Compliance Committee to advise the Chief Compliance Officer and assist in the implementation of this Compliance Program. This function is currently being served by the Enzyvant Executive Committee and Legal Department.
2. Written Standards
Enzyvant has established written policies and procedures to ensure compliance with the OIG Guidance and PhRMA Code, including the Code of Business Conduct and Ethics and Healthcare Compliance Policy Manual and other policies that detail the company’s commitment to compliance and corporate responsibility. Enzyvant regularly evaluates its policies to ensure continued compliance with these rules. The standards set forth in the policies and procedures apply to all Enzyvant personnel and adherence to them is a condition of employment.
Enzyvant does not permit gifts, promotional materials, items, or activities prohibited by the PhRMA Code, OIG Guidance, or FDA regulations. For items and activities that are not prohibited, Enzyvant has set a cumulative annual spending limit of $1,500 per healthcare professional. We track and monitor compliance with this promotional spending limit to the best of our ability and will modify our internal processes as necessary. This limit does not include payments for legitimate professional services by healthcare professionals as allowed by applicable rules such as consulting services.
3. Education and Training
All employees are required to receive compliance training applicable to their job function and responsibilities, which includes training on the Compliance Program and Enzyvant policies. In addition, further specialized training may be provided where a need for additional training has been identified. Annual healthcare compliance training is required of all employees, consultants and contractors who engage in, or support, commercial activities. Enzyvant regularly reviews and updates its training programs to help ensure it continues to meet the educational needs of its employees.
4. Internal Lines of Communication
Ensuring dialogue between management and employees is a key component of our Compliance Program. Our goal is to foster a “speak up” culture where employees may ask questions or report potential instances of inappropriate activity without fear of retribution. Such reports may be communicated anonymously and confidentially from the Enzyvant Compliance Reporting Website (https://irdirect.net/ENZVNT/whistleblower_iframe?template=enzyvant)
5. Auditing and Monitoring
Enzyvant recognizes that auditing and monitoring are critical to maintaining the effectiveness of a Compliance Program. The subject of our auditing and monitoring assessments, as well as the extent and frequency of our reviews, may vary according to a variety of factors, including new regulatory requirements, changes in business practices, and other considerations, and are scaled to address the size, organizational structure and operations of our company. As appropriate, auditing and monitoring results will be reported to the Legal Department and senior management to help guide the Enzyvant risk-assessment process.
6. Responding to Potential Violations
The purpose of our Compliance Program is to prevent and detect violations of law or company policy. As the OIG Guidance recognizes, however, the implementation of such a program cannot guarantee that improper employee conduct will be eliminated. Nonetheless, it is Enzyvant’s expectation that Enzyvant personnel will comply with the Compliance Program, and the policies established in support of such program. If Enzyvant becomes aware of violations of law or company policy, we will promptly investigate the matter and, where appropriate, take disciplinary action and implement corrective measures to address potential gaps and prevent future violations.
7. Corrective Action Procedures
A key element of the Compliance Program is to provide clear disciplinary policies that set out the consequences of violating the law or company policy. After investigation of a reported or detected issue, the company will assess whether disciplinary action is appropriate, and whether a violation is in part due to gaps in our policies, practices, training or internal controls, and act to prevent future violations.