Ethics & Compliance Program

I. Introduction

Averitas Pharmaceuticals, a wholly owned subsidiary of GRT US Holding. and certain of its independent associated U.S. companies (the “Averitas OR the Company”) are 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, U.S. Department of Health and Human Services (the “HHS-OIG Guidance”). 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 Code of Conduct and Policies (the Global Framework) as well as our US Compliance Policies. As the HHS-OIG Guidance recognizes, however, the implementation of such a program cannot guarantee that improper employee conduct will be entirely eliminated. In the event that 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.

Company has described below the fundamental elements of its Ethics & Compliance Program. As HHS-OIG calls for in its Guidance, we have tailored our Ethics & Compliance Program to fit the unique environment of Company. Moreover, our Ethics & Compliance Program is dynamic; we regularly review and enhance our Program to meet our evolving compliance needs.

II. Overview of Ethics & Compliance Program

1. Leadership and Structure.

  • Compliance Officer. Dr. Cordula Meckenstock is the Global Compliance Officer for Averitas and related entities. Elise Roth is our Compliance Officer for Averitas in the United States. Ms. Roth serves as the primary contact for compliance activities in the United States. We will ensure that Ms. Roth has the ability to exercise independent judgment and effectuate change within the organization as needed. Together, Dr. Meckenstock and Ms. Roth have the responsibility of developing, operating, and monitoring the Ethics & Compliance Program.
  • Compliance Committees. Company has established a Compliance Committee to advise the Compliance Officer US and assist in the implementation of the Compliance Program. The Compliance Committees and other working groups meet regularly to identify and manage areas of risk and areas of critical focus for 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 establishes our expectation that management, employees, and agents of Company act in accordance with all laws, regulations, and Company policies. The Code 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. 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. Averitas will effectively communicate our standards and procedures and regularly review and update our training programs.

4. Internal Lines of Communication. Averitas 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 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 & Compliance Hotline (1-833-211-3671) through which employees and persons outside of Averitas 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 Company’s compliance policies and procedures. In accordance with the HHS-OIG Guidance, 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 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, Compliance Program requires the company to respond promptly to potential violations of law, regulation, or policy. Then we can 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.

Statement Regarding Compliance with California Health & Safety Code § 119402

NOTICE: This information is provided pursuant to the requirements of California Health & Safety Code, Section 119402, which requires pharmaceutical companies doing business in California to make available their Compliance Program and annual written declaration of compliance with the Compliance Program.

California Health & Safety Code, Sections 119400 – 119402, (“California Compliance Law”) requires pharmaceutical companies to adopt a compliance program in accordance with the April 2003 publication “Compliance Program Guidance for Pharmaceutical Manufacturers” (“OIG Compliance Guidance”) developed by the United States Department of Health and Human Services Office of Inspector General (“OIG”) and policies for compliance with the Pharmaceutical Research and Manufacturers of America (“PhRMA”) “Code on Interactions with Health Care Professionals” (“PhRMA Code”) within six months of any update or revision of the PhRMA Code. Revisions to the July 1, 2002 PhRMA Code were effective January 2009.

Grünenthal USA, Inc., GRT US Holding, Inc and Averitas Pharma (all three companies collectively the “Company”) have established a Compliance Program in accordance with the OIG Compliance Guidance and have policies in place to foster compliance with the PhRMA Code for their pharmaceutical businesses. This Compliance Program is part of the US Compliance Program and Global Compliance Framework. For purposes of compliance with the requirements of the California Compliance Law and as part of the Compliance Program, Company has established a specific annual aggregate dollar limit of $2000 on gifts, promotional materials, or items or activities that the Company may give or otherwise provide to an individual medical or healthcare professional licensed in California on an annual basis from January 1st to December 31st each year. Such items or activities primarily include: modest meals associated with a substantive discussion of a Company product or a disease state; medical textbooks and other items that principally entail a patient benefit or are related to the healthcare professional’s practice; and other items or activities permitted under the PhRMA Code, and/or the OIG Compliance Guidance. These items and activities are primarily directed to the dissemination or communication of medical and scientific information as a resource for healthcare professionals to assist in making clinical or other medical judgments. This limit may be revised from time to time, in which case the revised limit will be published in this section of the Company websites. This limit represents a spending cap, not a goal or average; in many cases, the amount spent per physician may be substantially less than the cap amount. The Company has established an internal monitoring system designed to help ensure compliance with the annual spending limits in California and is working to establish additional monitoring processes.

The annual limits do not include the following:

  • Drug samples given to physicians and healthcare professionals
  • Financial support for continuing medical education program
  • Financial support for educational scholarships
  • Payments for bona fide professional services made pursuant to a contract, and any meals or expenses associated with the provision of such services
  • Items of nominal value with a retail value of less than $10 (e.g., visual aids, reprints of medical journal articles)
  • Patient educational materials provided to patients by their physician with the purpose of educating the patient or enhancing the patient’s understanding or management of the condition

Annual Declaration (February, 2019)

As stated in its Compliance Program description, the Company is committed to conducting its business ethically and in compliance with all applicable laws. To the best of its knowledge and based on a good faith understanding of the statutory requirements, the Company has established a Compliance Program that meets the requirements set forth in California Health & Safety Code, Sections 119400-119402. The Company has tailored its Compliance Program to meet the specific needs of the Company and continuously assesses the effectiveness of the Compliance Program. The Company has established an internal monitoring system designed to help ensure compliance with its respective annual spending limits in California and is working to establish additional corporate tracking and monitoring processes. Thus, subject to the limitations described above, the Company declares that, based upon current tracking and monitoring systems, the Company is, in all material respects, in compliance with the Compliance Program.

As recognized by the OIG Compliance Guidance, even an effective compliance program cannot eliminate the possibility that one or more individual employees engage in conduct that would be considered improper. Accordingly, this declaration is not intended and should not be construed to imply that the Company has not identified any individual instances in which an employee has or may have violated one or more provisions of its Compliance Program. In such situations, the Company takes reasonable and appropriate remedial or corrective action in a manner consistent with its Compliance Program.

For a written copy of the Compliance Program description or this declaration, call 1-833-211-3671.