In accordance with California Health and Safety Code §§119400-119402, W. L. Gore & Associates, Inc. (“Gore”) has established an effective Corporate Compliance Program (“CCP”). The Gore Corporate Compliance Program follows the “Compliance Program Guidance” issued in 2003 by the Office of Inspector General, U.S. Department of Health and Human Services.
The Gore CCP is specifically tailored to fit the scale, culture and environment of the medical device business of Gore. The CCP is regularly reviewed to ensure that it continues to meet applicable compliance requirements and reflects changes in the laws, regulations and industry guidance. This includes the AdvaMed Code of Ethics on Interactions with Healthcare Professionals (the “AdvaMed Code”), a code of conduct established by the medical device industry. The AdvaMed Code is substantially equivalent to the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals, but reflects the unique aspects of the medical device industry, including the interactions between healthcare professionals and medical device companies. Accordingly, the Gore CCP includes policies for compliance with the AdvaMed Code. Furthermore, Gore has established an annual dollar limit for educational gifts, promotional materials, or items or activities provided to California healthcare professionals pursuant to the requirements of the California Health & Safety Code.
The Gore CCP includes:
- Documented standards of ethical conduct, compliance policies and procedures
- Dedicated compliance officers, including officers responsible for the medical products division
- Oversight by Gore Enterprise Leadership through a Risk Management Committee
- Regular and effective compliance awareness education and training;
- Open lines of communication, including a toll-free number phone number and web portal for reporting compliance concerns
- Programs to monitor business activities to evaluate and reassess compliance with the Gore Corporate Compliance Program
- Procedures for responding to identified problems and implementing documented corrective actions
Additional information regarding the Gore Comprehensive Compliance Program and this declaration can be obtained by contacting Gore at W. L. Gore & Associates, Inc., Medical Compliance, 1505 North 4th St, Flagstaff, AZ 86004 or by calling 800-528-1866 (request the Compliance Department) or by contacting [email protected].
Updated 01 January 2018