Declaration for California Compliance Law
As part of its ongoing efforts in the area of compliance, Medline Industries, Inc. has developed a Comprehensive Compliance Program that is designed to comply with applicable federal and state laws and industry standards relating to the marketing and promotion of its products. To Medline Industries, Inc.’s knowledge as of the date of this declaration, Medline Industries, Inc. is in compliance with its Comprehensive Compliance Program, as described here, and with California Health & Safety Code sections 119400-119402.
Dated: June 2021
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.
Medline Industries, Inc. (“Medline”) has established an Ethics and Compliance Program designed to materially comply with applicable federal and state laws and industry standards relating to the marketing and promotion of its products. Medline Industries, Inc. recognizes that Good Ethics Means Good Business and that with the support of senior management, Medline Industries, Inc. employees at all levels should play an active role in the company’s compliance activities. Medline Industries, Inc. has a strong commitment to establishing and maintaining an effective compliance program that promotes ethical business conduct. To help put this commitment into action, the company has established a comprehensive compliance program structure around the seven elements outlined in 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”). As described below, these seven elements form the basis of Medline Industries, Inc.’s program for compliance with the standards regulating the marketing and promotion of its products. Medline Industries, Inc.’s Ethics and Compliance Program is designed to prevent and detect violations of law or company policy. It is Medline Industries, Inc.’s policy that all employees must comply with applicable laws and regulations as well as with company policies. However, as acknowledged by the OIG Guidance, implementing a comprehensive compliance program cannot guarantee that improper employee conduct will be eliminated in its entirety. If Medline Industries, Inc. becomes aware of violations of law or company policy, the matter will be investigated and, if appropriate, disciplinary action will be taken and corrective measures will be implemented to prevent future violations.
II. OVERVIEW OF COMPLIANCE PROGRAM
1. Written Policies and Procedures.
Medline Industries, Inc. has written policies to assure substantial compliance with the applicable laws and regulations and standards governing the marketing and promotion of our products. The Medline Comprehensive Compliance Program includes a system of written policies and procedures that set forth the company’s highest level principles, to ensure compliance with applicable laws and regulations and support good business practices. Medline’s key corporate policies are referenced in the Code of Conduct. The Code of Conduct requires Medline employees to obey all laws, act in an ethical manner and make business decisions that are consistent with Medline policies.
Medline has established written policies that govern activities involving communicating with customers about the appropriate use of its products, advancing scientific and educational activities, and supporting research and education. These policies include:
Policy on Charitable Donations
Medline will consider donations to charities that are healthcare related, and to causes that generally promote the health and welfare of sick or historically disadvantaged groups and that are consistent with Medline Industries, Inc. policies.
Policy on Travel Expense Reimbursement
Medline reimburses for travel and lodging expenses of attendees at promotional and educational training programs in very limited circumstances that are consistent with accepted industry guidelines.
Policy on Business Meals
Medline may occasionally offer a modest meal, consistent with the standards of the AdvaMed Code. 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 $35 for breakfast, $65 for lunch or $150 for dinner.
Total Annual Dollar Limit for Meals and Educational or Practice-related Items
Medline has established an annual limit of $1,500 for meals and educational items as the aggregate value of the items or activities that may be provided to California healthcare professionals pursuant to the requirements of Cal. Health & Safety Code § 119402 (S.B. 1765).
Policy Prohibiting Entertainment
It is the policy of Medline not to provide entertainment (e.g. sporting events, golf outings, concerts, hunting, etc.) to healthcare providers or healthcare professionals.
2. Assigned Compliance Officer/Compliance Committee.
Medline has appointed a Chief Compliance and Corporate Integrity Officer who has been empowered with appropriate authority to exercise independent judgment and has free and unencumbered access to senior management.
Medline has appointed an Ethics and Compliance Committee. The committee is comprised of the company’s Chief Compliance and Corporate Integrity Officer and members of the company’s management team.
Medline has an annual Ethics and Compliance training process that includes testing and annual certification of appropriate employees. The training covers applicable guidelines governing Medline’s Ethics and Compliance program. Employees are also trained on the consequences of failure to comply with the requirements of the company’s Ethics and Compliance program.
Medline encourages open and candid discussion between management and employees regarding any ethics or compliance concerns. Employees are encouraged to report their concerns to their manager, to the Human Resources Department, to the General Counsel or to the Chief Compliance and Corporate Integrity Officer. In addition, Medline maintains an Ethics and Compliance Helpline through which its employees may report anonymously potential compliance incidents or seek guidance on compliance questions that include, but are not limited to: violations of laws, regulations, or company policy; fraud; unethical behavior; and employment-related issues.
5. Auditing and Monitoring.
Medline self-assesses and periodically audits its compliance with its policies and procedures.
6. Enforcement and Disciplinary Guidelines.
Medline will take disciplinary actions in response to violation of the company’s compliance policies or procedures. Medline 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.
Medline requires a prompt and diligent response to potential violations of the company’s Ethics and Compliance program, including its standards regulating the marketing and promotion of 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.