Integrity And Compliance

Indivior PLC (the “Group”) has in place various resources for raising ethics questions and compliance concerns. You can raise questions or concerns directly with the Chief Integrity and Compliance Officer at Compliance@Indivior.com.

Written Policies and Procedures

The Group has written policies to assure substantial compliance with the applicable laws and regulations and standards governing the marketing and promotion of our products. The Group has established written policies that govern activities involving interactions with our customers regarding the appropriate use of our products including appropriate instruction, education, training, and technical support required for the safe and effective use of our products. The Group also has policies governing activities involving the advancement of scientific and educational activities supporting medical research and education.

 

Assigned Compliance Officer

The Group has appointed a Chief Integrity & Compliance Officer who has been empowered with authority to exercise independent judgment and has free and unencumbered access to the Board.

In addition, the Indivior Compliance Committee  (ICC) has been formed. The ICC consists of the CEO of the Group and all of his/her direct reports who are also members of the Indivior Executive Committee.  The CEO has appointed the Chief Integrity & Compliance Officer (“CICO”) to serve as the chairperson of the ICC.

 

Training

The Group has an annual Integrity & Compliance Code Of Conduct Training process that is mandated for all employees. New employees receive training at the time of hire and annually thereafter. The training covers applicable guidelines governing our compliance program.

 

Communication

The Group encourages open and candid discussion between management and employees regarding any compliance concerns. Employees are encouraged to report their concerns to their manager or to their Human Resources, Legal or Integrity & Compliance partners. Employees also have the option to report potential policy or integrity violations by calling EthicsLine at 1-855-881-7196 or online at secure.Ethicspoint.com.

 

Auditing and Monitoring

The Group self-assesses and audits its compliance programs and reviews policies and procedures periodically. Audit observations are tracked to ensure timely closure of any identified items.

 

Enforcement and Disciplinary Guidelines

The Group will take disciplinary actions in response to violation of the Group’s policies or procedures. An investigation of any matter that is brought to the Group’s attention will be conducted and will be brought to closure in a timely manner.

 

Responses to Detected Problems and Actions to Correct Issues

The Group responds promptly to any potential violations of the Group​​’s Integrity & Compliance program. Responses may include additional training, enhanced communications, refinement of policies, or possible disciplinary actions.

 

Raising Compliance Concerns

Indivior PLC (the “Group”) has in place various resources for raising ethics questions and compliance concerns.  You can raise questions or concerns directly with the Chief Integrity & Compliance Officer at Compliance@Indivior.com.

Another resource is the Indivior EthicsLine, a telephone and web-based reporting resource available 24 hours a day, seven (7) days a week. It is hosted by a third-party vendor Navex.  Any matter reported to the Chief Integrity & Compliance Officer or through the EthicsLine is treated as confidentially as possible and is shared only with personnel that need to know about these matters for the purposes of an investigation and, if appropriate, corrective action.

Reports concerning our operations may be made anonymously to the EthicsLine. In certain European countries, anonymous reporting is prohibited and the Group may be required to reveal a caller’s identity.

The EthicsLine can be accessed by either phone or online. You can report a concern online by visiting this link or to determine  which hotline number is most appropriate for you.

The Group will not retaliate against any individual who reports a concern in good faith or participates in the Group’s investigation of such a concern. Any employee found to have retaliated against anyone for reporting or participating in an investigation will be disciplined according to Group policy.

 

California Declaration of Compliance

This California Compliance Disclosure (“Compliance Disclosure”) is provided pursuant to the requirements of Cal. Health & Safety Code §§ 119400 – 119402, which requires that certain pharmaceutical and medical device companies adopt and make public Comprehensive Compliance Programs (“Compliance Programs”) that govern such companies’ marketing and promotional activities.

Indivior Inc. (the “Company”) is committed to complying with all applicable laws, regulations and industry standards. Indivior has developed an Integrity & Compliance Program in accordance with the Compliance Program Guidance for Pharmaceutical Manufacturers published by the U.S. Department of Health and Human Services Office of Inspector General in April 2003 (OIG Guidance) and which includes policies consistent with the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Health Care Professionals (PhRMA Code). The Indivior Integrity & Compliance Program includes numerous policies and procedures and is continually assessed and evaluated to ensure consistency with additional laws and guidance. It is designed to prevent, detect and remediate violations of law, regulations and company policies, as well as to promote an ethical culture that will, the  Company among other things, guide our interactions with healthcare professionals and healthcare entities. In the event that Indivior becomes aware of any potential or actual violations of policy or law, an investigation will be triggered and, if necessary, followed by appropriate remedial or corrective actions in accordance with the Company’s Integrity & Compliance Program.

For purposes of compliance with the requirements of the California Compliance Law and as part of the Integrity & Compliance Program, the Company has established a specific annual aggregate dollar limit of $3,500 on gifts, promotional materials, or items or activities that the Company and its subsidiaries may give or otherwise provide to an individual medical or healthcare professional in California. Such items or activities primarily include: medical textbooks and other items that principally entail a patient benefit or are related to the healthcare professional’s practice; modest meals associated with a substantive discussion of a Company product or a disease state; and other items or activities permitted under the OIG Compliance Guidance and PhRMA Code. 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 website. 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:

California law requires pharmaceutical companies interacting with medical or healthcare professionals in California to make an annual written declaration of their adherence to their compliance program.

The Company’s Integrity & Compliance Program is tailored to its size, organizational structure and resources and reasonably intended to meet the specific needs of the Company. Internal monitoring mechanisms have been implemented which are designed to measure compliance with the spending limits as set by the company for California medical and healthcare professionals.

Based on a good faith understanding of the requirements of Section 119402 of the California Health & Safety Code, Indivior hereby declares that, its Integrity & Compliance Program addresses the California statutory requirements for inclusion of policies addressing the OIG Guidance and PhRMA Code and limits on gifts and incentives to health professionals. Subject to the above, Indivior also hereby declares that it is, in all material respects, in compliance with its Comprehensive Compliance Program as of January 1, 2019.

Questions regarding Indivior’s Code of Conduct or this Compliance Disclosure may be addressed to Indivior’s Integrity & Compliance Department at: Compliance@indivior.com

 

Corporate Integrity Agreement

On July 24, 2020, Indivior Inc. reached a global resolution with the United States Attorney’s Office for the Western District of Virginia regarding the previously disclosed investigation into civil and criminal allegations in connection with Indivior’s sales and promotion of SUBOXONE® Film. Under the agreement, Indivior will pay a total of USD 600 million in criminal and civil claims.

As part of the settlement, Indivior entered into a Corporate Integrity Agreement (CIA) with the Office of the Inspector General of the US Department of Health and Human Services. Under the terms of this agreement, Indivior was required to implement additional compliance-related measures, which include additional monitoring, auditing, training, education, reporting and disclosures for a period of five years.

Indivior is committed to high standards of ethical business conduct and has a comprehensive compliance program in place to help ensure we consistently act in a responsible manner.

View the full Corporate Integrity Agreement
View the Dear Healthcare Professional Letter
 

Indivior Global Conduct Policies

Indivior maintains a global policy framework and a Global Code of Conduct which applies to all employees and contractors. These are regularly reviewed by the Integrity and Compliance team. The Code of Conduct was recently reviewed and a substantially updated version was published in the summer of 2019.

Downloadable versions of the Code of Conduct, Anti-Bribery and Corruption Policy and Diversity and Inclusion Policy are provided below.