California Annual Declaration of Compliance
COMPREHENSIVE COMPLIANCE PROGRAM
Nestlé HealthCare Nutrition, Inc. (“Nestlé” or “Company”) is committed to ensuring that its business practices are conducted in an ethical and transparent manner and in compliance with all applicable laws, including the California Health and Safety Code §119400-119402 (the “California Code”). The California Code requires pharmaceutical companies to adopt a Comprehensive Compliance Program that is 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).
Nestlé has developed a Comprehensive Compliance Program in accordance with the OIG Guidance. As part of this Comprehensive Compliance Program, Company employees dedicated to our pharmaceutical business are governed by policies consistent with the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Health Care Professionals (PhRMA Code). Nestlé is committed to developing and providing effective compliance training for all of its employees on these policies as well as pertinent federal and state standards. Nestlé periodically conducts internal auditing and monitoring to evaluate compliance with Company policies and procedures.
Nestlé’s Comprehensive Compliance Program includes a corporate Code of Conduct that all employees must read, acknowledge understanding of, and certify to. Nestlé has also established internal lines of communication and requires all employees to report instances of noncompliance with the Code of Conduct or Company policies. Nestlé provides a Compliance Hotline that allows for anonymous reporting of compliance violations (1-866-894-3424).
Annual Spending Limit
The California Code also requires pharmaceutical and medical device companies to adopt a specific annual dollar limit on gifts, promotional materials, or items or activities that the company may give or otherwise provide to an individual medical or healthcare professional (HCP) in accordance with the OIG Guidance and PhRMA Code. As part of Nestlé’s Comprehensive Compliance Program, the Company prohibits the giving of gifts to HCPs, including items for the personal benefit of HCPs or their family members, cash gifts or cash equivalents, and non-educational items. Nestlé has established an annual aggregate dollar limit of $2,000.00 for promotional materials or items or activities that the Company may give or otherwise provide to an individual HCP in accordance with the PhRMA Code and OIG Guidance. This limit may be revised from time to time. This dollar limit is a maximum only and does not necessarily represent a typical, average, usual, or customary amount. This dollar limit does not include the following types of expenditures:
- Drug, medical foods and nutritional supplement samples given to physicians and HCPs intended for free distribution to patients;
- Financial support for continuing medical education forums;
- Financial support for health educational scholarships; and
- Payments made for legitimate professional services provided by an HCP or medical professional, including, but not limited to, consulting.
As of January 1, 2022, to the best of its knowledge and based on a good faith understanding of the requirements of the California Code, Nestlé declares that it is in compliance with its Comprehensive Compliance Program and the California Code.
The Office of Inspector General has recognized in its Compliance Program Guidance for Pharmaceutical Manufacturers that the implementation of an effective compliance program cannot ensure the elimination of improper conduct from a pharmaceutical manufacturer. By making this declaration, Nestlé HealthCare Nutrition is not declaring that in all circumstances it can prevent individual employees from conduct that deviates from its policies. To the extent that any deviations are identified, we are committed to taking necessary and appropriate corrective actions. Nestlé HealthCare Nutrition expects employees to comply with the Nestlé Code of Business Conduct and its comprehensive compliance program, and makes good faith efforts to enforce its provisions, prevent violations, and address inappropriate conduct that may occur.