Santen Inc. (“Santen”) maintains a Comprehensive Compliance Program, in accordance with all applicable federal and state requirements. Santen’s Compliance 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, Santen voluntarily subscribes to the “Code on Interactions with Healthcare Professionals” published by the Pharmaceutical Research and Manufacturers of America (the “PhRMA Code”), as well as the “AdvaMed Code of Ethics on Interactions with U.S. Healthcare Professionals” published by the Advanced Medical Technology Association (the “AdvaMed Code”). Santen has adopted policies, procedures and processes to ensure compliance with the PhRMA Code and the AdvaMed Code, where applicable.
SANTEN COMPLIANCE PROGRAM DESCRIPTION
I. Introduction
The Santen Compliance Program was established by Santen’s senior management to ensure that our commitment to the highest standards of corporate ethics and conduct is clearly defined. This section of our website serves to outline the measures that Santen 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 detect employee violations of other defined and applicable regulatory standards.
Effective Compliance policies must be dynamic and adaptable to new developments. Santen will make revisions to its Compliance policies, as necessary, upon regular review and in accordance with changes of applicable law, regulations, and state and federal requirements. Santen’s Compliance Team expects to review Santen’s Compliance policies regularly to enhance them over time to meet the ever-evolving Compliance landscape in the pharmaceutical industry.
II. Overview of Santen’s Compliance Program
A. Head of Compliance and Compliance Committee
Santen has designated a Head of Compliance who is responsible for developing, implementing, monitoring and updating the Santen Compliance Program. The Head of Compliance has the authority to effectuate change and exercise independent judgment within Santen. Additionally, the Head of Compliance has direct access to Santen’s Chief Executive Officer, Leadership Team, Board of Directors and its committees, and internal and external legal counsel.
Santen’s Compliance Department instituted a Compliance Review Committee comprised of senior management personnel from a variety of business units. The Compliance Review Committee’s responsibility is to provide Compliance policy and regulation updates to the senior management team, report on findings and observations from regular auditing and monitoring, and discuss Compliance support of business activities, among other responsibilities.
B. Written Policies and Procedures
Santen has established written standards of conduct, including Compliance policies and a Code of Conduct, which are designed to ensure compliance with the requirements associated with federal, state and local laws and regulations. Santen’s Compliance policies shall be reviewed and updated regularly, and as necessary. Santen’s employees, contractors, consultants and agents are required to comply with these written standards.
C. Effective Training and Education
All employees are required to receive regular Compliance training applicable to their job functions and responsibilities, which includes training on required Santen Compliance policies. In addition, tailored training is provided to specific business units when there is a need determined (e.g., new hire training, pre-conference trainings, department specific annual refreshers, etc.). Annual Compliance training is required of all employees, contractors and agents who engage in, or support, commercial activities. Santen regularly reviews and updates its training programs to help ensure it continues to meet the educational needs of its employees. The Compliance Team also collaborates with the Sales Training Team during sales training initiatives and new hire trainings.
D. Compliance Support and Hotline
Santen has an “open-door” policy and employees can freely approach the Compliance Department with questions or concerns they may have, or report suspected non-compliance. To encourage communication between employees and the Compliance Department, Santen has a confidentiality policy and a strict non-retaliation policy in place; therefore, employees can report matters of concern confidentially and without fear of retribution.
Santen has implemented EthicsPoint to provide a platform for employees to report allegations of non-compliance. This system allows them to report both confidentially and anonymously should they choose. The reporting system has a hotline that is available 24 hours a day, seven days a week for making good faith reports of known or suspected compliance violations.
E. Auditing and Monitoring
Santen conducts periodic monitoring and auditing of certain business operations, including its sales and marketing practices, Medical Affairs activities, and many others. The nature of these reviews as well as the extent and frequency of our monitoring and auditing activities will vary depending upon perceived compliance risk, regulation changes, changes in business practices, and other considerations. As appropriate, monitoring and auditing results will be reported to senior management during the Compliance Review Committee meetings.
F. Disciplinary Consequences of Non-Compliance
Santen’s Compliance policies and Code of Conduct includes clear descriptions of disciplinary consequences, including the potential for termination as a result of non-compliance.
G. Responding to Potential Violations
A key purpose of Santen’s Compliance Program 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 Santen’s expectation that all employees will comply with all Santen Compliance policies.
All Santen employees have a duty to promptly report any suspected violation of the Santen’s compliance policies using any of the available company resources. In the event that Santen becomes aware of violations of law or company policy, the Compliance Department will promptly investigate the matter and take appropriate corrective action to ensure the integrity of the overall Santen Compliance Program and prevent future violations. Personnel who violate Santen’s policies and procedures or 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, Santen has established an aggregate annual spend limit for individual healthcare practitioners of $2,500.00.
IV. Declaration of Compliance
Santen declares that, to the best of its knowledge and based on a good faith understanding of the statutory requirements, for the period commencing July 1, 2023 to June 30th, 2024, it is in compliance with its own comprehensive Compliance Program, including its established annual aggregate spend limit of $2,500.00 and the requirements of California law (SB 1765).
Santen is committed to the maintenance and ongoing assessment necessary to ensure an effective comprehensive Compliance Program. Santen’s Compliance Program may be amended, altered or revised from time to time as needed and without prior notice.
California Compliance Declaration: Section 119402 of the California Health & Safety Code requires a pharmaceutical company to adopt a Comprehensive Compliance Program that is in accordance with the U.S. Department of Health and Human Services, Office of the Inspector General’s ("OIG") "Compliance Program Guidance for Pharmaceutical Manufacturers" ("OIG Compliance Guidance"), and include policies for complying with the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals ("PhRMA Code"). Further, the law requires that the Comprehensive Compliance Program include an annual limit for certain items and activities given to healthcare professionals licensed in California.
Santen Holdings U.S. Inc. and its affiliates ("Santen") declare that as of July 1, 2023, it has adopted a Comprehensive Compliance Program designed to comply with all applicable federal and state laws and regulations related to the marketing and promotion of our products. As of the date of this declaration, based on our good faith knowledge of the statutory requirements and to the best of our knowledge, Santen is, in all material respects, in compliance with both the California Health & Safety Code, 119400-402, and our Comprehensive Compliance Program. Any changes Santen makes to its Comprehensive Compliance Program in the future shall remain compliant with state and federal laws and regulations, the OIG Compliance Guidance, the PhRMA Code, and industry best practices.
Copies of this Declaration and our Comprehensive Compliance Policy may be obtained by contacting Santen’s Compliance Officer at the following toll-free phone number: 1-800-611-2011.