California compliance law
Effective Date: July 2022
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 PhRMA Code were implemented in January 2009 and October 2019.
Octapharma USA (“the Company”) has adopted a Compliance Program in accordance with these standards available here.
For purpose of the California Compliance Law and as part of the Compliance Program, the Company has established a specific annual aggregate dollar limit of $2000 on gifts, promotional materials, or items or activities that the Company may give or otherwise provide to an individual medical or healthcare professional in California on an annual basis from January 1st to December 31st. 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 and/or the 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 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.
The annual limit does not include the following: financial support for continuing medical education; financial support for health educational scholarships; payments for legitimate professional services, and any meals or expenses associated with the provision of such services; items of a 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.
Annual Declaration 2022
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. 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 January 1, 2020 through December 31, 2020.
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 Company’s Compliance Program or this declaration, please call [1-201 604 1130]