Corporate Compliance Overview
Eyevance Pharmaceuticals, Inc. (“Eyevance” or the “Company”), maintains a Comprehensive Compliance Program (CCP), in accordance with all applicable federal and state requirements. This program, which is described in further detail below, contains all of the elements of an effective compliance program identified in the “Compliance Program Guidance for Pharmaceutical Manufacturers” published by the Office of the Inspector General, U.S. Department of Health and Human Services (“HHS-OIG Guidance”). In addition, Eyevance voluntarily subscribes to the “Code on Interactions with Healthcare Professionals” published by the Pharmaceutical Research and Manufacturers of America (the “PhRMA Code”) and has adopted policies, procedures and processes to ensure compliance with the PhRMA Code.
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COMPREHENSIVE COMPLIANCE PROGRAM DESCRIPTION
The Eyevance Comprehensive Compliance Program was established by the Company’s senior management to ensure that our commitment to the highest standards of corporate ethics and conduct is clearly defined and comprehensive. This document will serve to outline the measures that Eyevance has undertaken to prevent and detect violations of law or Company policy with respect to the interactions of our employees with the healthcare community, as well as with other defined and applicable regulatory standards.
An effective Comprehensive Compliance Program must be dynamic and responsive to new developments. Eyevance will make conforming changes to its CCP within six months of any update or revision to the OIG Compliance Program Guidance for Pharmaceutical Manufacturers or the PhRMA Code on Interactions with Healthcare Professionals. We expect to review our CCP yearly and to enhance it over time to meet our evolving compliance needs.
II. Overview of Compliance Program
A. Written Policies and Procedures
Eyevance has established written standards of conduct, including a Corporate Compliance Policy and Marketing Code of Conduct, that are designed to ensure compliance with the requirements associated with federal, state and local laws and regulations. The Corporate Compliance Policy and Marketing Code of Conduct shall be reviewed annually and updated as necessary. Eyevance employees, contractors, consultants and agents are required to comply with these written standards.
B. Head of Compliance and Compliance Committee
Eyevance has designated a Head of Compliance who is charged with the responsibility of developing, implementing, monitoring and updating the Eyevance CCP. The Head of Compliance has the authority to effectuate change and exercise independent judgment within the company. Additionally, the Head of Compliance has direct access to Eyevance’s Chief Executive Officer, leadership team, Board of Directors and its committees, and legal counsel.
Eyevance also has a Compliance Committee comprised of senior management personnel from a variety of business units. The Compliance Committee’s responsibility is to advise, and provide feedback to the Head of Compliance in the development, operation and monitoring of the CCP.
C. Effective Training and Education
All employees are required to receive compliance training applicable to their job function and responsibilities, which includes training on the CCP and relevant Eyevance policies. In addition, further specialized training may be provided where a need for additional training has been identified. Annual compliance training is required of all employees, contractors and agents who engage in, or support, commercial activities. Eyevance regularly reviews and updates its training programs to help ensure it continues to meet the educational needs of its employees.
D. Open Lines of Communication
Eyevance has an “open-door” policy and employees can freely approach the Head of Compliance with questions or concerns they may have or report non-compliance issues. In order to encourage communication between employees and the Head of Compliance, Eyevance has confidentiality and non-retaliation policies in place; therefore, employees can report matters of concern confidentially and without fear of retribution.
The Company has established a confidential and anonymous Compliance Hotline number that is available 24 hours a day, seven days a week for making good faith reports of known or suspected violations. Any such report relating to the CCP may be directed to the Head of Compliance or designated Compliance staff through any of the following means:
- Compliance Telephone Hotline: 1.833.290.0001 (anonymous)
- Compliance Web: www.lighthouse-services.com/eyevance (anonymous)
- Compliance Email: firstname.lastname@example.org (non-anonymous)
E. Internal Monitoring and Auditing
Eyevance will conduct periodic audits and monitoring of certain facets of Eyevance operations, including its sales and marketing practices. The nature of these reviews as well as the extent and frequency of our monitoring and auditing activities will vary depending upon perceived regulatory risk, new regulatory requirements, changes in business practices, and other considerations. We expect our routine evaluation of enforcement developments coupled with our periodic assessments of our operations to result in the identification of new and emerging risk areas that will be subsequently addressed through enhancements to our CCP. As appropriate, auditing and monitoring results will be reported to senior management in order to help guide the Eyevance risk-assessment process.
F. Responding to Potential Violations
A key purpose of the Eyevance CCP is to prevent and detect violations of law or Company policy. As the HHS-OIG Guidance recognizes, however, the implementation of such a program cannot guarantee that improper employee conduct will be entirely eliminated. Nonetheless, it is Eyevance’s expectation that all employees will comply with the CCP, and the policies established in support of such program. All Eyevance employees have a duty to promptly report any violation of the CCP or any Company policies using any of the available Company resources. In the event that Eyevance becomes aware of violations of law or Company policy, it will promptly investigate the matter and take appropriate corrective action to ensure the integrity of the CCP and prevent future violations. Personnel who violate Eyevance’s policies and procedures and applicable state and federal laws may be subject to disciplinary action, up to and including termination.
III. Annual Aggregate Dollar Limit in California
In accordance with California law, which requires each pharmaceutical company to establish limits on gifts, promotional materials or items or activities that the company may provide to individual healthcare practitioners, Eyevance has established an aggregate annual spend limit for individual healthcare practitioners of $2,500.00.
IV. Declaration of Compliance
Eyevance declares that, to the best of its knowledge and based on a good faith understanding of the statutory requirements, for the period commencing January 1, 2019 to July 1, 2019, it is in compliance with its CCP, including its established annual aggregate spend limit of $2,500.00 and the requirements of California Health and Safety Code sections 119400-119402 (SB 1765).
Eyevance is committed to the maintenance and ongoing assessment necessary to ensure an effective CCP. This Corporate Compliance Program may be amended, altered or revised from time to time as needed and without prior notice.