Averitas applies the highest level of ethical standards by encouraging transparency, and embracing diversity and inclusivity.
I. Introduction
Averitas Pharma, Inc., is a wholly owned subsidiary of GRT US Holding, Inc., both of which are part of the Grünenthal group of companies (“Averitas” or the “Company”). The Company is committed to establishing and maintaining an effective pharmaceutical compliance program in accordance with the “Compliance Program Guidance for Pharmaceutical Manufacturers,” published in 2003 by the Office of Inspector General, US Department of Health and Human Services (the “HHS-OIG Guidance”) and other applicable government and industry guidances. Our Ethics and Compliance Program is a key component of our commitment to the highest standards of pharmaceutical corporate responsibility.
The purpose of our Ethics and Compliance Program is to prevent, detect, and remediate violations of law, regulations, or the Company policies, and to promote a culture of the highest ethics within the organization. It is the Company’s expectation that employees will comply with our Global Code of Conduct and our Global Compliance Policies (the Global Compliance Framework), as well as our tailored US Compliance Program. As the HHS-OIG Guidance recognizes, however, the implementation of such a program cannot guarantee that improper employee conduct will be entirely eliminated. If the Company becomes aware of violations of law or Company policy, we will investigate the matter and, where appropriate, take disciplinary action and implement corrective measures to prevent future violations.
The Company has described below the fundamental elements of its Ethics and Compliance Program. As HHS-OIG calls for in its Guidance, we have tailored our Ethics and Compliance Program to fit the unique environment of the Company. Moreover, our Ethics and Compliance Program is dynamic; we regularly review and enhance our Program to meet our evolving compliance needs.
II. Overview of Ethics and Compliance Program
1. Leadership and Structure.
Compliance Officer. The Grünenthal group of companies has a Global Compliance Officer, who is responsible for all Grünenthal Group companies, including Averitas. We also have a US Compliance Officer for Averitas in the United States, who reports into the Global Compliance Officer and who serves as the primary contact for Compliance activities in the United States. We will ensure that the US Compliance Officer has the ability to exercise independent judgment and effectuate change within the organization as needed. Together, the Global Compliance Officer and the US Compliance Officer have the responsibility of developing, operating, and monitoring the Ethics and Compliance Program.
Compliance Committees. The Company has established a Compliance Committee to advise the US Compliance Officer and assist in the implementation of the Global and US Compliance Program. The Compliance Committee and other working groups meet regularly to identify and manage areas of risk and areas of critical focus for the Company.
2. Written Standards.
The Company has developed a Global Code of Conduct as our statement of ethical and compliance principles guiding our daily operations. The Code of Conduct establishes our expectation that management, employees, and agents of the Company act in accordance with all laws, regulations, and Company policies. The Code of Conduct articulates our fundamental principles and values, providing a framework for action within our organization.
The HHS-OIG Guidance has identified several potential risk areas for pharmaceutical manufacturers, and has called on companies to develop compliance policies in these areas. These risk areas are: (1) data integrity pertaining to government reimbursement policies, (2) kickbacks and other illegal remuneration, and (3) compliance with laws regulating drug samples. The Company has published Compliance Policies to help address these risks and train our employees to act in accordance with these policies.
3. Education and Training.
As with any Pharmaceutical Compliance Program, the education and training of our employees on their legal and ethical obligations under applicable federal healthcare programs is critical to the program’s success. The Company will effectively communicate our standards and procedures and regularly review and update our training programs.
4. Internal Lines of Communication.
The Company actively fosters dialogue among management and employees. Our goal is that all employees should know who to turn to when seeking answers to questions or reporting possible Code of Conduct violations, and should be able to do so without fear of retribution. To that end, we have adopted open-door policies, as well as confidentiality and non-retaliation policies. We have a confidential, toll-free Ethics and Compliance Hotline (1-833-211-3671, access code 64001) through which employees and persons outside of the Company may report any concerns or suspected violations of law, regulation, or Company policy.
5. Auditing and Monitoring.
The Company Compliance Program includes efforts to monitor, audit, and evaluate adherence to the Company’s compliance policies and procedures. The nature, extent, and frequency of our Compliance monitoring and auditing may vary according to new regulatory requirements, changes in business practices, and other considerations.
6. Responding to Potential Violations.
The Company Compliance Program sets forth clear disciplinary consequences of violating a law or Company policy. While each situation will be considered on a case-by-case basis, we will utilize disciplinary action to address inappropriate conduct and deter future violations.
7. Corrective Action Procedures.
A compliance program increases the likelihood of identifying and preventing unlawful and unethical behavior. However, HHS-OIG recognizes that even an effective compliance program may not prevent all violations. As such, our Company Compliance Program requires the Company to respond promptly to potential violations of law, regulation, or policy. This allows us to assess whether the violation is due to gaps in our policies, practices, or internal controls, take appropriate disciplinary action, and work to prevent future violations.
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