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

Ethicon Endo-Surgery California Law 2007 Compliance Declaration

I.  Introduction

Ethicon Endo-Surgery (EES) has complied with the requirements of the California Health & Safety Code § 119402, (S.B. 1765) through establishment of systems, policies, procedures and practices that meet federal and state laws. Ethicon Endo-Surgery’s adherence to these standards is evidenced through the implementation of a Comprehensive Compliance Program structured to meet the Compliance Program Guidance for Pharmaceutical Manufacturers, published by the Office of Inspector General, under the U.S. Department of Health and Human Services (the ”OIG Guide”). In addition, Ethicon Endo-Surgery has implemented and maintains a website (www.ethiconendo.com) and 800 number (1-800-933-9530) to facilitate communication and requests for information related to California state requirements. 

II.  Ethicon Endo-Surgery Compliance Program Overview

1. Written Policies and Procedures

EES has written policies to assure substantial compliance with applicable laws and regulations and standards governing the marketing and promotion of our products. Among these standards are recognized industry codes of conduct including the Code of Ethics on Interactions with Health Care Professionals, published by the Advanced Medical Technology Association ("AdvaMed"). EES 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. EES also has policies governing activities involving the advancement of scientific and educational activities supporting medical research and education. These policies include:

Policy on Educational Grants and Research Grants

EES 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 EES. All requests are subject to scientific review prior to funding approval.

Policy on Charitable Contributions and Patient Assistance

EES will consider charitable contributions and requests for patient assistance in the areas of children's health, health care education, and access to health care and community responsibility, consistent with EES’ policies.

Policy on Travel Expense Reimbursement for CME, Promotional or Product Training Meetings

EES will, with very limited exceptions that are in accordance with nationally recognized standards, not reimburse for travel and lodging expenses of attendees at promotional and educational programs. EES 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 Ethicon Endo-Surgery's medical device products is required, EES may provide training at company facilities, at independent teaching centers such as medical institutions, or in other appropriate clinical settings.

Policy on Business Meals

EES may occasionally offer a modest meal as part of an educational presentation or a business discussion. The appropriate focus of these activities is directed to an informational presentation or discussion; therefore, venues that feature entertainment or recreation, and attendance by spouses or guests, are not permitted. Modesty is to be judged by local standards, but in general cost of meals with customers should not exceed $25.00 for breakfast, $50.00 for lunch or $125.00 for dinner.

Policy on the Provision of Educational and Practice-Related Items

On occasion, EES representatives may provide patient or practice-related items to customers. These items must be of reasonable value, $100.00 or less (except medical texts and anatomical models must be less than $350.00) and infrequent. Promotional items of nominal value (less than $25.00) such as coffee cups, pens, and notepads are permitted under EES policy. These items usually feature a company or product logo.

Total Annual Dollar Limit for Meals, Educational or Practice-related Items

EES has established an annual limit of $1500.00 for meals and educational or practice-related item 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).

Policy Prohibiting Entertainment During Sales Functions

In general entertainment (e.g. sporting events, golf outings, concerts, hunting, etc.) is not permitted as part of Ethicon Endo-Surgery’s sales activities. In circumstances when customers are retained in a consulting relationship, recreational or social events in conjunction with the consulting services may occur provided they are clearly subordinate to the consulting services in terms of time and emphasis.

2. Assigned Compliance Officer

EES 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. EES has appointed a Health Care Compliance Leadership Committee (CLC). The CLC is comprised of the company's Health Care Compliance Officer and members of the company's Senior Management team. EES has also established a Board level oversight committee.

3. Training.

EES has an annual Health Care Compliance training process that includes testing and annual certification of affected employees. The training covers applicable guidelines governing our compliance program. Employees are also trained on the consequences of failure to comply with the requirements of the company's compliance program.

4. Communication.

EES encourages open and candid discussion between management and employees regarding any compliance concerns. EES employees are encouraged to report their concerns to their manager, to the Human Resources Department, to the Law Department or to the company's Health Care Compliance Officer. Associates also have the option to report potential violations using the EES Compliance Hotline at (800) 371-2029.

5. Auditing and Monitoring.

EES self-assesses and periodically audits its compliance with its policies and procedures. Audit observations are reviewed and tracked to ensure timely and effective closure of identified items. 

6. Enforcement and Disciplinary Guidelines.

EES will take disciplinary actions in response to violation of the company's compliance policies or procedures. EES 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.

7. Responses To Detected Problems and Actions To Correct Issues.

EES 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.

Ethicon Endo-Surgery Inc.'s verbiage on the 800 numbers addressing the California Health & Safety Code 119402 (S.B. 1765)

Ethicon Endo-Surgery Inc. (EES) will provide its compliance program and declaration as it relates to the California Health & Safety Code 119400-119402 via fax or hard copy upon request. To request this information please contact us at 1-800-933-9530.

Last Updated:  May 5, 2007