Statement regarding compliance with California Health & Safety Code § 119402
NOTICE: This information is provided pursuant to the requirements of California Health & Safety Code, Section 119402, which requires pharmaceutical companies doing business in California to make available their Compliance Program and annual written declaration of compliance with the Compliance Program.
California Health & Safety Code, Sections 119400 – 119402, (“California Compliance Law”) requires pharmaceutical companies to adopt a compliance program in accordance with the April 2003 publication “Compliance Program Guidance for Pharmaceutical Manufacturers” (“OIG Compliance Guidance”) developed by the United States Department of Health and Human Services Office of Inspector General (“OIG”) and policies for compliance with the Pharmaceutical Research and Manufacturers of America (“PhRMA”) “Code on Interactions with Health Care Professionals” (“PhRMA Code”) within six months of any update or revision of the PhRMA Code. Revisions to the July 1, 2002 PhRMA Code were effective January 2009.
Sanofi US Services Inc. and sanofi-aventis U.S. LLC (collectively “Sanofi US”) and Genzyme Corporation (“Genzyme”) (all three companies collectively the “Company”) have established a Compliance Program in accordance with the OIG Compliance Guidance and have policies in place to foster compliance with the PhRMA Code for their pharmaceutical businesses. This Compliance Program is part of the North America Compliance Program. For purposes of compliance with the requirements of the California Compliance Law and as part of the Compliance Program, Sanofi US and Genzyme have each established a specific annual aggregate dollar limit of $2000 on gifts, promotional materials, or items or activities that Sanofi US or Genzyme 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 PhRMA Code, AdvaMed Code and OIG Compliance Guidance. 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 Company websites. 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:
- Drug samples given to physicians and healthcare professionals
- Financial support for continuing medical education forums
- Financial support for health educational scholarships
- Payments for legitimate professionals 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
As stated in its Compliance Program description, the Company is committed to conducting its business ethically and in compliance with all applicable laws. To the best of its knowledge and based on a good faith understanding of the statutory requirements, the Company has established a Compliance Program that meets the requirements set forth in California Health & Safety Code, Sections 119400-119402. The Company has tailored its Compliance Program to meet the specific needs of the Company and continuously assesses the effectiveness of the Compliance Program. The Company has established an internal monitoring system designed to help ensure compliance with its respective annual spending limits in California and is working to establish additional corporate tracking and monitoring processes. Thus, subject to the limitations described above, the Company declares that, based upon current tracking and monitoring systems, the Company is, in all material respects, in compliance with the Compliance Program and with the respective established annual spending limits for reporting period of July 1, 2015 through June 30, 2016.
As recognized by the OIG Compliance Guidance, even an effective compliance program cannot eliminate the possibility that one or more individual employees engage in conduct that would be considered improper. Accordingly, this declaration is not intended and should not be construed to imply that the Company has not identified any individual instances in which an employee has or may have violated one or more provisions of its Compliance Program. In such situations, the Company takes reasonable and appropriate remedial or corrective action in a manner consistent with its Compliance Program.
For a written copy of the Compliance Program description or this declaration, call 1-800-648-1297.