California Declaration of Compliance
This California Compliance Disclosure (“Compliance Disclosure”) is provided pursuant to the requirements of Cal. Health & Safety Code §§ 119400 – 119402, which requires that certain pharmaceutical and medical device companies adopt and make public Comprehensive Compliance Programs (“Compliance Programs”) that govern such companies’ marketing and promotional activities.
Indivior Inc. (the “Company”) is committed to complying with all applicable laws, regulations and industry standards. Indivior has developed a Corporate Compliance Program in accordance with the Compliance Program Guidance for Pharmaceutical Manufacturers published by the U.S. Department of Health and Human Services Office of Inspector General in April 2003 (OIG Guidance) and which includes policies consistent with the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Health Care Professionals (PhRMA Code). The Indivior Compliance Program includes numerous policies and procedures and is continually assessed and evaluated to ensure consistency with additional laws and guidance. It is designed to prevent, detect and remediate violations of law, regulations and company policies, as well as to promote an ethical culture that will, among other things, guide our interactions with healthcare professionals and healthcare entities. In the event that Indivior becomes aware of any potential or actual violations of policy or law, an investigation will be triggered and, if necessary, followed by appropriate remedial or corrective actions in accordance with the Indivior Compliance Program.
For purposes of compliance with the requirements of the California Compliance Law and as part of the Compliance Program, the Company has established a specific annual aggregate dollar limit of $3,500 on gifts, promotional materials, or items or activities that the Company and its subsidiaries may give or otherwise provide to an individual medical or healthcare professional in California. Such items or activities primarily include: medical textbooks and other items that principally entail a patient benefit or are related to the healthcare professional’s practice; modest meals associated with a substantive discussion of a Company product or a disease state; and other items or activities permitted under the OIG Compliance Guidance and PhRMA Code. These items and activities are primarily directed to the dissemination or communication of medical and scientific information as a resource for healthcare professionals to assist in making clinical or other medical judgments. This limit may be revised from time to time, in which case the revised limit will be published in this section of the website. This limit represents a spending cap, not a goal or average; in many cases, the amount spent per physician may be substantially less than the cap amount. The Company has established an internal monitoring system designed to help ensure compliance with the annual spending limits in California and is working to establish additional monitoring processes.
The annual limits do not include the following:
- Financial support for continuing medical education forums
- Financial support for health educational scholarships
- Payments for legitimate healthcare professional services, and any meals or expenses associated with the provision of such services
- Items of nominal value with a retail value of less than $10 (e.g., visual aids, reprints of medical journal articles)
- Patient educational materials provided to patients by their physician with the purpose of educating the patient or enhancing the patient’s understanding or management of the condition
California law requires pharmaceutical companies interacting with medical or healthcare professionals in California to make an annual written declaration of their adherence to their compliance program.
The Company’s Compliance Program is tailored to its size, organizational structure and resources and reasonably intended to meet the specific needs of the Company. Internal monitoring mechanisms have been implemented which are designed to measure compliance with the spending limits as set by the company for California medical and healthcare professionals.
Based on a good faith understanding of the requirements of Section 119402 of the California Health & Safety Code, Indivior hereby declares that, its Corporate Compliance Program addresses the California statutory requirements for inclusion of policies addressing the OIG Guidance and PhRMA Code and limits on gifts and incentives to health professionals. Subject to the above, Indivior also hereby declares that it is, in all material respects, in compliance with its Comprehensive Compliance Program as of January 1, 2016.
Questions regarding Indivior’s Code of Business Conduct or this Compliance Disclosure may be addressed to Indivior’s Corporate Compliance Department at: Corporate.Compliance@indivior.com
Last update: June 30, 2016