California Declaration Of Compliance
Statement regarding compliance with California Health & Safety Code § 119402 California Health and Safety Code §§ 119400-119402 (“California Compliance Law”) requires pharmaceutical companies adopt a Comprehensive Compliance Program in accordance with the PhRMA Code on Interactions with Healthcare Professionals (the “PhRMA Code”) and the Compliance Program Guidance for Pharmaceutical Manufacturers developed by the U.S. Department of Health and Human Services Office of the Inspector General (the “OIG Compliance Guidance”) and to set an annual aggregate limit on certain promotional expenditures provide to a healthcare professional as defined under the California Compliance Law. IBSA shall make conforming changes to its Comprehensive Compliance Program within six (6) months of any update or revision of the PhRMA Code.
IBSA Pharma Inc. (“IBSA”) agrees to comply with all applicable laws and regulations and industry standards, including the PhRMA Code and the Compliance Program Guidance for Pharmaceutical Manufacturers developed by the OIG Compliance Guidance. As a result, IBSA has established a Comprehensive Compliance Program in accordance with the OIG Compliance Guidance and has policies in place to foster compliance with the PhRMA Code for its pharmaceutical businesses.
For purposes of compliance with the requirements of the California Compliance Law and as part of the Compliance Program, IBSA established a specific annual aggregate dollar limit of $500.00 per covered healthcare professional for gifts, promotional materials, or items or activities that the IBSA may give or otherwise provide to an individual 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 an IBSA product or a disease state; and other items or activities permitted under the PhRMA 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. t. This limit may be revised by IBSA from time to time. It is important to note that this annual dollar limit is an upper limit. It is not an accurate representation of the average value of gifts, promotional materials, items or activities that IBSA may provide generally to a healthcare professional. The average could be a lower amount. IBSA 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. In accordance with the California Compliance Law, certain items and payments are excluded in determining whether the annual limit has been met. The annual limit does not include the value of:
- Drug samples provided to physicians and healthcare professionals intended for free distribution to patients;
- Financial support for continuing medical education forums;
- Financial support for health educational scholarships; and
- Payments for legitimate professional services provided by health care or medical professionals, including but not limited to consulting fees, that are based on the fair market value of the services provided.;
Declaration of Compliance
As stated in its Compliance Program description, IBSA 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, IBSA has established a Compliance Program that meets the requirements set forth in California Health & Safety Code, Sections 119400-119402. IBSA has tailored its Compliance Program to meet the specific needs of IBSA and continuously assesses the effectiveness of the Compliance Program. IBSA 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, IBSA declares that, as of the date of this declaration, IBSA is, in all material respects, in compliance with the Compliance Program and the California Health & Safety Code, Sections 119400-119402. Our declaration is based upon information available during the twelve-month period from January 1, 2018 through December 31, 2018. The next declaration will be based upon information captured beginning January 1, 2019.
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 IBSA 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 IBSA takes reasonable and appropriate remedial or corrective action in a manner consistent with its Compliance Program.
As appropriate and consistent with applicable law, IBSA will amend and make conforming changes to its Comprehensive Compliance Program. IBSA is committed to assessing ongoing compliance with its Comprehensive Compliance Program. A copy of the Comprehensive Compliance Program and this written declaration can be requested by calling IBSA.
For a written copy of the Compliance Program description or this declaration, call 1-800-587-3513