For purposes of compliance with the requirements of California Health and Safety Code, §§ 119400-119402, Roche Diagnostic Corporation (“RDC”) has established, as part of its Comprehensive Compliance Program, an annual dollar limit concerning appropriate items covered by California law (“Covered Items”) that are provided to individual California medical and healthcare professionals (“HCPs”) as part of RDC’s interactions with these professionals. “Medical or health professional” means any of the following:
● A person licensed by state law to prescribe drugs for human patients.
● A medical student.
● A member of a drug formulary committee.
Roche Diagnostics Corporation has established an annual dollar limit of $2,000 for promotional materials, or other transfers of value, including items or activities that RDC employees may give or otherwise provide to an individual HCP.
This limit represents an annual spending cap and not an average or target. In most instances, the amount spent per HCP will be substantially less than this annual limit.
● Evaluation, replacement, or demonstration devices or equipment
● Financial support of continuing medical education forums
● Financial support for health education scholarships
● Educational items that physicians give to their patients to enhance understanding or management of a disease state or disorder
● Fair market value compensation for bona fide professional services, and any meals or other expenses related to the provision of such services
● Training or educational programs and expenses (e.g., meals, flights, lodging) incurred deemed necessary for the safe and effective use and understanding of RDC products
● Receptions at third party educational or professional meetings
● Items used to provide charity care
● De minimis items of nominal value with a retail value of less than $10 (e.g. reprints of medical journal articles).
Annually, for the period beginning July 1 and concluding June 30, RDC set an annual aggregate limit on promotional expenditures provided at $2,000 per California HCP. Based upon our current internal monitoring process, to the best of our knowledge and belief, and based on a good faith understanding of California Health & Safety Code §§ 119400-402, RDC is in compliance with all material respects with the requirements described in California SB1765. RDC will continually evaluate and update its Compliance Program as necessary and appropriate given the changing environment and needs.
RDC makes this declaration available on this website and a copy of this document and/or RDC Comprehensive Compliance Program may be obtained by calling 1-800-428-5074.
The following is an overview of RDC’s comprehensive ethics and compliance program which is reviewed and updated periodically to meet changing legal and compliance requirements.
Roche’s Global Code of Conduct (“Code of Conduct”) reflects our commitment to conducting business with high standards of ethical behavior. The Code of Conduct is applicable to all employees of RDC. All directors, officers and employees are expected to act with integrity and to make ethical decisions consistent with the Code of Conduct.
RDC is committed to establishing and maintaining an effective ethics and compliance program that promotes conducting business with integrity and complying with the laws applicable to RDC and its operations. Our ethics and compliance program is based on the elements described in the "Compliance Program Guidance for Pharmaceutical Manufacturers" issued by the Office of Inspector General of the U.S. Department of Health and Human Services (the "OIG Guidance") and the "Code of Ethics on Interactions with Healthcare Professionals" issued by the Advanced Medical Technology Association (“AdvaMed Code”)
RDC’s ethics and compliance program is designed, implemented and operated with the goal of preventing, detecting and responding to potential or actual instances of non-compliance. All RDC employees are required to comply with the Code of Conduct, company policies, and applicable laws. However, as acknowledged by the OIG Guidance, the implementation of a comprehensive compliance program does not guarantee that there will be no misconduct. If RDC becomes aware of potential violations of law, the Code of Conduct or company policy, the matters are investigated. As appropriate, disciplinary and corrective actions are implemented to address any wrongdoing and prevent future violations. Additionally, RDC continuously assesses the effectiveness of its compliance program to enable it to implement necessary adjustments or refinements to the program.
RDC has a Chief Compliance Officer who is responsible for leading, developing, operating, and monitoring the ethics and compliance program. The Compliance Officer reports directly to the General Counsel.
RDC has established a Compliance Committee designed to provide leadership and support for the company’s ethics and compliance program, assist RDC’s leadership team in managing the ethics and compliance program, and to provide assistance and guidance in assessing and verifying the effectiveness of the ethics and compliance program to promote our ethical business culture and compliant operating environment. The members of the Compliance Committee are senior leaders from multiple business functions. The Compliance Committee meets on a regular basis to monitor RDC’s comprehensive ethics and compliance program.
In addition to the Code of Conduct, RDC has developed and implemented compliance policies and procedures to help ensure compliance with applicable laws and to support ethical decision-making. These policies and procedures have been developed under the direction and supervision of the Chief Compliance Officer and Compliance Committee. RDC’s written standards address the key areas of potential risk for medical device manufacturers identified in the OIG Guidance. All RDC employees are required to adhere to the company’s policies and procedures.
RDC’s relationships with healthcare professionals are intended to benefit patients and to enhance the practice of medicine. Informational presentations and discussions by company representatives and others speaking on behalf of RDC provide valuable scientific and educational benefits. In connection with such presentations or discussions, RDC may offer occasional meals and educational items designed primarily for the education of patients and healthcare professionals.
All RDC employees in the U.S. receive appropriate compliance training which includes education on the OIG Guidance, the AdvaMed Code, anti-kickback and anti-corruption laws, the federal False Claims Act, and requirements related to product promotion, privacy, conflicts of interest, and other applicable federal, state, and industry rules and guidelines. RDC regularly reviews and revises its compliance training and seeks to identify new areas of training that may be needed to educate employees on compliance matters and the laws and requirements applicable to RDC.
RDC encourages open communication and maintains an open reporting environment. The company has adopted and reinforces its policy against retaliation. RDC’s Code of Conduct and policies require employees to report any actual or suspected violations of the Code of Conduct, company policies or applicable law. Each reported matter is appropriately investigated and addressed. Employees can raise concerns or report potential misconduct in a number of ways, including to managers and business leaders; the Ethics & Compliance, Legal or Human Resources teams; the third-party operated helpline. Employees may raise concerns anonymously without fear of retaliation. In addition, RDC’s Ethics & Compliance team maintains an internal website on which compliance-related policies, guidance and information can be found.
RDC’s comprehensive ethics and compliance program includes an auditing and monitoring plan to assess whether policies and procedures which address compliance risk areas have been implemented and communicated and are followed. The areas for monitoring and auditing are reviewed and updated to reflect evolving compliance concerns, new regulatory requirements, changes in business practices, and other considerations. The results of auditing and monitoring activities are considered in adapting and improving existing compliance policies, procedures and training.
Employees are required to adhere to the Code of Conduct and company policies. Any violations can subject an employee to serious disciplinary measures, including possible termination of employment. Although the disciplinary and corrective actions for each situation are determined on a case-by-case basis, RDC seeks to ensure consistent and appropriate disciplinary and corrective actions are taken in response to violations.
RDC conducts investigations of potential violations of the Code of Conduct and company policies in accordance with its written investigations and corrective action protocol to ensure timely, complete, and objective investigations. In accordance with the OIG Guidance, the exact nature and level or thoroughness of the internal investigation will vary according to the circumstances. Once an internal investigation is completed, corrective action and preventive measures are determined and implemented as appropriate.
This description is effective as of July 1, 2022. RDC will assess its compliance program at least annually, for the purpose of declaring compliance with California Health and Safety Code §§ 119400-119402.