Endo International plc., is committed to establishing and maintaining an effective Corporate Compliance Program that reflects our role as a health solutions provider. Our Compliance Program derives from the “Compliance Program Guidance for Pharmaceutical Manufacturers,” published by the Office of Inspector General, U.S. Department of Health and Human Services (the “HHS-OIG Guidance”). Our Corporate Compliance Program takes into consideration the nature of our business, whether it be pharmaceuticals, devices, or diagnostics, and is one of the key components of our commitment to the highest standards of corporate conduct.
The purpose of our Corporate Compliance Program is to prevent and detect violations of law or company policy. As HHS-OIG calls for in its Guidance, we have tailored our Corporate Compliance Program to fit the unique environment of our company. Moreover, our Corporate Compliance Program is dynamic; we regularly review and enhance our Corporate Compliance Program to meet our evolving compliance needs.
To the best of our knowledge, we are in compliance with our Corporate Compliance Program as described, meaning that we have established the elements outlined. Furthermore, based on our good faith understanding of the statutory requirements, our Corporate Compliance Program is compliant with the requirements of California Health & Safety Code §§ 119400-119402.
Overview of Our Corporate Compliance Program
1. Leadership and Structure
We have designated the Executive Vice President, Corporate Compliance & Business Practices, as Endo's, Chief Compliance Officer and we are committed to ensuring that this individual has the ability to effectuate change within the organization as necessary and to exercise independent judgment. Our Executive Vice President, Corporate Compliance & Business Practices is charged with the responsibility for developing, operating, and monitoring the Corporate Compliance Program. Our Executive Vice President, Corporate Compliance & Business Practices reports directly to the Chief Executive Officer and is empowered to report compliance matters directly to our Board of Directors.
2. Written Standards
As we integrate several distinct companies into a single health solutions provider, we are developing standardized written policies, including our Code of Conduct. Our Code of Conduct is our statement of ethical and compliance principles that guide our daily operations. The Code of Conduct establishes that we expect management, employees, and agents of the company to act in accordance with law and applicable company policy. The Code of Conduct articulates our fundamental principles, values, and framework for action within our organization. In addition to our Code of Conduct, we have policies and procedures that address various legal and regulatory requirements that apply to our company. We have specific policies and procedures that address the risk areas identified in the HHS-OIG Guidance and the requirements of the PhRMA and AdvaMed Codes on Interactions with Healthcare Professionals.
3. Education and Training
A critical element of our Corporate Compliance Program is the education and training of our employees on their legal and ethical obligations under applicable federal health care program requirements. Accordingly, we conduct regular education and training sessions with our employees.
4. Internal Lines of Communication
Endo is committed to fostering dialogue between management and employees. Our goal is that all employees, when seeking answers to questions or reporting potential instances of fraud and abuse, should know who to turn to for a meaningful response and should be able to do so without fear of retaliation or retribution. To that end, employees are encouraged to seek advice from their supervisors or the Corporate Compliance & Business Practices Department. Employees may also report such matters anonymously by calling the Compliance Hotlines. The substance of every report will be taken seriously and promptly investigated, and where necessary, Endo will put corrective measures in place.
5. Auditing and Monitoring
Our Corporate Compliance Program includes efforts to monitor, audit, and evaluate compliance with the company's compliance policies and procedures. We note that in accordance with the HHS-OIG Guidance, the nature of our reviews as well as the extent and frequency of our compliance monitoring and auditing varies according to a variety of factors, including new regulatory requirements, changes in business practices, and other considerations.
6. Responding to Potential Violations
Our Corporate Compliance Program includes disciplinary policies that set out the consequences of violating the law or company policy. Although each situation is considered on a case-by-case basis, we will consistently undertake appropriate disciplinary action to address inappropriate conduct and deter future violations.
7. Corrective Action Procedures
A Compliance Program increases the likelihood of preventing, or at least identifying unlawful and unethical behavior. However, HHS-OIG recognizes that even an effective Corporate Compliance Program may not prevent all violations. As such, our Corporate Compliance program requires the company to respond promptly to potential violations of law or company policy, take appropriate disciplinary action, assess whether the violation is in part due to gaps in our policies, practices, or internal controls, and take action to prevent future violations.
To request a copy of the Endo Corporate Compliance Program Description, please call: 1-800-462-ENDO (3636)
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1 In accordance with California Health and Safety Code §§ 119400-119402, we have established an annual dollar limit of $2,500 on food, gifts, and promotional materials that we may provide to individual medical or health care professionals in California, as defined in the statute.