California Annual Declaration of Compliance
Nestlé HealthCare Nutrition, Inc. is committed to conducting its business ethically and in accordance with all applicable laws and regulations. Effective January 2, 2017, to the best of its knowledge and based upon a good faith understanding of the applicable statutory requirements, Nestlé HealthCare Nutrition is in compliance, in all materials respects, with a comprehensive compliance program that satisfies the requirements of the California Health and Safety Code §§ 119400-119402 as they may apply to a medical device manufacturer.
Nestlé HealthCare Nutrition has adopted a comprehensive compliance program to implement internal controls and procedures that promote adherence to applicable statutes, regulations and requirements of the federal healthcare programs and to provide specific guidance to employees. Our compliance program is based on the requirements of applicable federal and state laws and the recommendations set forth in the “Compliance Program Guidance for Pharmaceutical Manufacturers” which was developed by the United States Department of Health and Human Services Office of Inspector General. As a manufacturer of medical devices, our Compliance Program was developed taking into consideration applicable compliance guidance as well as relevant requirements and best practices set forth in the “Advanced Medical Technology Association (AdvMed) Code of Ethics for Interactions with Healthcare Professionals” and various codes and guidance issued by other healthcare professional associations, industry organizations, and Nestlé HealthCare Nutrition’s customers. While California Health and Safety Code §§ 119400-119402 makes reference to compliance with the Pharmaceutical Research and Manufacturers of America’s Code on Interactions with Healthcare Professionals (“PhRMA Code”), Nestlé HealthCare Nutrition manufactures medical devices rather than pharmaceutical products. Therefore, Nestlé HealthCare Nutrition determined that it was more appropriate for the company instead to adopt policies and procedures consistent with The AdvaMed Code of Ethics on Interactions with Healthcare Professionals (“AdvaMed Code”) which, although substantially similar to the PhRMA Code, recognizes significant differences applicable to the medical device industry.
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 has made a good faith effort to enforce its provisions, prevent violations, and address inappropriate conduct that may occur.