To our knowledge as of the date of this declaration, DePuy Spine, Inc. is in compliance with our Comprehensive Compliance Program, as described here, and with California Health & Safety Code sections 119400-119402.
Dated: July 1, 2011
NOTICE: this information is provided pursuant to the requirements of Cal. Health & Safety Code § 119402 (S.B. 1765), which requires certain pharmaceutical and medical device companies doing business in California to make available their program for compliance with applicable federal and state laws and industry standards regulating the marketing and promotion of their products.
DePuy Spine, Inc. has established a program designed to materially comply with applicable federal and state laws and industry standards relating to the marketing and promotion of its products. Additionally, DePuy Spine, Inc. recognizes that adherence to these standards can be furthered through a compliance program that is informed by the Compliance Program Guidance for Pharmaceutical Manufacturers, published by the Office of Inspector General of the U.S. Department of Health and Human Services (the “OIG Guide”). The OIG Guide advises that effective compliance programs are comprised of seven elements. As described below, these elements form the basis of DePuy Spine, Inc.’s program for compliance with the standards regulating the marketing and promotion of its products.
DePuy Spine, Inc. has written policies to promote compliance with the applicable laws and regulations and standards governing the marketing and promotion of our products. DePuy Spine, Inc. also requires compliance with recognized industry codes of conduct including the Code of Ethics on Interactions with Health Care Professionals, published by the Advanced Medical Technology Association (“AdvaMed”). DePuy Spine, Inc. has established written policies that govern activities involving communicating with customers about the appropriate use of our products including appropriate instruction, education, training, service and technical support required for the safe and effective use of our products. DePuy Spine, Inc. also has policies governing activities involving the advancement of scientific and educational activities supporting medical research and education. These policies include:
DePuy Spine, Inc. may provide grants for specific educational purposes that benefit patients and customers. These may include, but are not limited to, continuing medical and paraprofessional education programs, fellowships provided to teaching institutions and similar organizations with a demonstrated commitment to scientific and technical education, and programs operated by organizations that provide high-quality, nationally recognized patient education. Funding of educational programs will generally be provided only to organizations and institutions and not to individual practitioners.
Research grants to support customer-initiated research may be provided for programs involving research in areas of legitimate interest to the company. All requests are subject to scientific review prior to funding approval.
DePuy Spine, Inc. will consider charitable contributions and requests for patient assistance in the areas of children’s health, health care education, access to health care and community responsibility, consistent with DePuy Spine, Inc. policies.
DePuy Spine, Inc. will, with very limited exceptions for health care professionals in training, which complies with the AdvaMed Code, not reimburse for travel and lodging expenses of attendees at promotional and educational programs. DePuy Spine, Inc. may reimburse attendees for their reasonable travel and lodging expenses associated with attendance at product training meetings. Product training meetings will be conducted in locations conducive to the exchange of information such as educational or conference settings. Where face-to-face or hands-on customer training is reasonably necessary for the safe and effective use of DePuy Spine, Inc.’s medical device products is required, DePuy Spine, Inc. may provide training at company facilities, at independent teaching centers such as medical institutions, or in other appropriate clinical settings.
DePuy Spine, Inc. may occasionally provide a modest meal, consistent with the standards of the AdvaMed Code as part of an educational presentation or a business discussion. Venues that feature entertainment or recreation, and attendance by spouses or guests, are not permitted. The cost of meals with customers should not exceed $35 for breakfast, $50 for lunch or $125 for dinner.
On occasion, DePuy Spine, Inc. representatives may provide items that benefit patients or serve a genuine educational function for Health Care Professionals, consistent with the standards of the AdvaMed Code. DePuy Spine, Inc. has established an annual limit of $1500 for meals and educational items as the aggregate value of the items or activities that may be provided to California health care professionals pursuant to the requirements of Cal. Health & Safety Code § 119402 (S.B. 1765).
It is the policy of DePuy Spine, Inc. not to provide Entertainment (e.g. sporting events, golf outings, concerts, hunting, etc.) to customers.
DePuy Spine, Inc. has appointed a Health Care Compliance Officer. Our Health Care Compliance Officer has been empowered with appropriate authority to exercise independent judgment and has free and unencumbered access to senior management.
DePuy Spine, Inc. has appointed a Health Care Compliance Committee. The committee is comprised of the company’s Health Care Compliance Officer and members of the company’s management team. The Health Care Compliance Committee is the Health Care Compliance leadership team.
DePuy Spine, Inc. has an annual Health Care Compliance training process that includes an assessment and annual certification of appropriate employees and sales associates. The training covers applicable guidelines governing our compliance program. Employees and sales associates are also trained on the consequences of failure to comply with the requirements of the company’s compliance program.
DePuy Spine, Inc. encourages open and candid discussion between management and employees regarding any compliance concerns. DePuy Spine employees are encouraged to report their concerns to their manager, to the Human Resources Department, to the Law Department, to the company’s Health Care Compliance Officer or to the Ethics Hotline, where anonymous reports can be made.
DePuy Spine, Inc. self-assesses and periodically audits its compliance with its policies and procedures.
DePuy Spine, Inc. will take disciplinary actions in response to violation of the company’s compliance policies or procedures. DePuy Spine, Inc. will conduct a fair and diligent investigation of matters that are brought to the company’s attention in order to ensure the consistent application of the company’s standards.
DePuy Spine, Inc. requires a prompt and diligent response to potential violations of the company’s compliance program, including its standards regulating the marketing and promotion of our products. Actions in response to detected problems may include improving policies, procedures, training, communication and monitoring or may require disciplinary action to prevent future violations.
For a copy of the above DePuy Spine, Inc. California Compliance Program, please call our toll free number, (800) 852-4382. Leave a voicemail clearly stating your name, mailing address, and a copy of the program will be sent as you requested.
As leaders in surgical innovation, we are committed to helping people get back to doing the things they love.
Whatever your career path, you can make it happen at DePuy.
find career opportunities
We pride ourselves on being good global citizens.
DePuy social responsibility