Indivior PLC

Additionally, we are investing in growing our advocacy voice on behalf of patients at all levels of government. This work supports our efforts to normalize the disease space to reduce barriers to treatment, including social stigma, challenges around access to treatment, and disease-related difficulty in adhering to treatment plans, all of which negatively impact the ability of patients to achieve long-term recovery. [...] Indivior advocates on public policy issues that relate to addiction by engaging responsibly with public officials, policymakers, and other stakeholders at all levels of government, and with healthcare professionals and community stakeholders (for example NGOs, patient support organizations, and charities that address addiction and related matters). [...] Indivior supports public policies that: Enable long-term OUD recovery for patients; Promote increased access to evidence-based OUD treatments; Reduce and help prevent the abuse, misuse, and diversion of our products; Accelerate innovation; Promote public health [...] In the US, Indivior's public policy priorities are focused on the following key areas: Expanding access to medication-assisted treatment: Indivior believes that medication-assisted treatment (MAT), or medication for opioid use disorder (MOUD), including treatment with buprenorphine (BMAT), is a critical part of the solution to the global opioid crisis. MAT brings substantial value to both patients and society, but remains, for many reasons, severely underutilized. Removing barriers to innovative treatments: Indivior believes that new, evidence-based buprenorphine long-acting injectable medications are innovations in MOUD. Indivior also believes that any ambiguity in current federal and state controlled substance distribution laws should be addressed to ensure patients and providers can realize the full value of these innovations. Increasing disease and treatment education: Indivior advocates for accelerated public, healthcare provider, and patient education on the disease of OUD and evidence-based treatment options, including all FDA-approved medication-assisted treatments. Advocating for increased medical education: Indivior advocates for education on addiction and evidence-based treatments in medical, physician assistant, and nursing schools, and as a core requirement for continuing medical education programs within the healthcare system. Advocating for access to treatment in correctional settings: Because OUD is more prevalent in the criminal justice system, Indivior advocates for expanding access to MOUD in correctional settings, and for smooth transitions to care and coverage in society upon release. Supporting the enforcement of the Mental Health Parity and Addiction Equity Act: Indivior supports robust education, enforcement, and awareness of US federal and state parity laws, and advocates to strengthen these where necessary, working together with key external stakeholders. Supporting advocacy groups: Indivior continues to support and work with advocacy groups for those affected by opioid use disorder."
"received comprehensive briefings on the Group's public policy strategies with emphasis on the federal and state landscape in the US, including legislative developments focusing on the provision of medication assisted treatment and drug pricing reforms; › revision of strategy and priorities for the Group's Global Medical Affairs team including strategic alignment and collaboration between the US Medical Affairs team and the Group's Government Affairs team; › reviewed initiatives for controlled product involvement in the US Criminal Justice System and greater participation and delivery to health ecosystems; › endorsed the Group's fresh initiative focused on advancing patient interests through innovation, advancing policies and messaging resulting in the initiative 'New Leaf for Patients'; [...] At each meeting, the Committee received an update from the Chief Integrity & Compliance Officer on the Group's Integrity & Compliance Program. The Compliance Expert to the Board also attends these parts of the Committee's meeting. For part of each meeting, the Committee meets privately with the Chief Integrity & Compliance Officer and the Compliance Expert to the Board and then also separately meets with the Compliance Expert to the Board only. Ahead of each meeting, the Committee receives the Integrity & Compliance dashboards, which show performance across all program areas, including: › progress against the Integrity & Compliance key strategic priorities for the year; › key program enhancements, including developments to policies and process enhancements supported by external advisors; › risk assessments and mitigation plans; › details of training and workforce education activities; › field monitoring activities; › transparency reporting; › reports received via the Group's confidential reporting hotline (Ethicsline) and subsequent investigations; and › staffing and resourcing of the Integrity & Compliance Department. During the year, the Group entered into a Corporate Integrity Agreement (CIA) with the Office of the Inspector General of the U.S. Department of Health and Human Services, as well as Department of Justice Compliance Measures and FTC Stipulated Order commitments. The Committee has received reports on the implementation of these commitments and the effectiveness of Indivior's Integrity & Compliance Program."
"Under the terms of a related agreement with the HHS, Solutions Inc. will be excluded from participating in government health programs. This exclusion will not apply to any other entities within the Group. The Group does not anticipate the exclusion of Solutions Inc. will have any material impact on the Group's ability to continue to participate in government health programs. Under the terms of the five-year Corporate Integrity Agreement with the HHS Office of the Inspector General (HHS-OIG), the Group will continue its commitment to promote compliance with laws and regulations and its ongoing evolution of an effective compliance program, including written standards, training, reporting, and monitoring procedures. The Group will be subject to reporting and monitoring requirements, including annual reports and compliance certifications from key management and the Board Nomination & Governance Committee submitted to HHS-OIG. In addition, the Group will be subject to monitoring by an Independent Review Organization, who will submit audit findings to HHS-OIG, and review by a Board Compliance Expert, who will prepare two compliance assessment reports in the first and third reporting periods of the Corporate Integrity Agreement. See Risk factors update section on page 37 for further discussion. [...] Under the terms of the Resolution Agreement with the Justice Department, the Group has agreed to compliance terms regarding its sales and marketing practices. Compliance with these terms is subject to annual Board and CEO certifications submitted to the U.S. Attorney's Office.

Our advocacy work, stakeholder engagement, and community relationships are a critical element of how we help make a measurable difference. Our public policy priorities focus on expanding treatment access, reducing barriers, and promoting equitable access to MOUD. In 2022, these activities focused on: • [Advocating for the reduction of treatment barriers, ] including at the federal level, in December 2022, the Mainstreaming Addiction Treatment Act was signed into law in the United States, which removes caps on the numbers of patient's healthcare professionals may treat with buprenorphine; • [Supporting expanded treatment, research, ] and education through increases in federal funding enacted for state opioid response and justice programs; • [Supporting expanded treatment funding and ] initiatives in Criminal Justice System (CJS) settings, initiatives were enacted in California, Colorado, Massachusetts, Missouri, and several other states; • [Supporting the implementation of the New York ] State CJS treatment initiative, including advocating for jails and prisons to expand treatment and support using opioid settlement resources; and • [Sponsoring the National Alliance for Recovery ] Residences convention, aligning with the lead national organization for recovery housing. [...] Indivior has an ESG Committee which comprises all members of the Executive Committee and is co-chaired by the Chief Global Impact Officer and the Chief Manufacturing and Supply Officer. It meets quarterly and has overall responsibility for the development, implementation, and monitoring of Indivior's sustainability and ESG strategy. Indivior also has a Compliance Committee which also comprises all members of the Executive Committee and meets approximately monthly and is responsible for overseeing compliance with applicable laws, rules and regulations that relate to Indivior's operations. It also has oversight of the Group's Global Integrity and Compliance Program.

We advocate on public policy issues that relate to substance use and mental health. We responsibly engage with public officials, policymakers, and other stakeholders at all levels of government, as well as healthcare professionals and community organizations. In the U.S., Indivior works to shape policy through a patient-focused advocacy and government affairs agenda with these four goals: 1. Ensure opioid crisis funds are allocated toward treatment. 2. Address and eliminate barriers to OUD treatment. 3. Expand medication for opioid use disorder (MOUD) in the criminal justice system. 4. Ensure patients have access to innovative overdose reversal medication. We work at the local county and city levels, as well as at state and federal levels, to help enact needed change to address the largest and most urgent public health crisis of our time—the opioid crisis. For example, Indivior continues to work to change state standing orders to include all FDA-approved overdose medications and to ensure patients have access to innovative new products that can save lives. [...] We are committed to doing business ethically and in compliance with governing laws and regulations. The Compliance, Ethics & Sustainability Committee (CESC), a committee of Indivior PLC's Board of Directors, has oversight of Indivior's Global Integrity & Compliance Program (I&C Program). The CESC oversees our approach to ethical, responsible, and sustainable business conduct. Our I&C Program is dedicated to encouraging a culture of learning and ongoing evolution through the three main tenets of the program: "Learn, Adjust, Prevent." This approach helps create a high integrity culture that supports employees' efforts to anticipate, promptly identify, and mitigate key risks effectively. Our I&C team maintains best practices, driving a culture of learning, and continuing to evolve the I&C program. This approach is enabled by both an annual Risk Assessment & Mitigation Plan (RAMP) process and a focus on RiskIQ (i.e., risk awareness and application). [...] Monitoring Integrity & Compliance Performance Indivior has put in place a corporate governance structure to provide strategic oversight within a framework of prudent and effective controls. Indivior's Chief Executive Officer is ultimately responsible for the day-to-day leadership of the business, including matters relating to compliance and sustainability. Indivior's Compliance Committee, composed of all members of the Executive Committee, is scheduled to meet monthly and is responsible for the management of the I&C Program, along with overseeing operational compliance with applicable laws, rules, and regulations. The committee continues to assess for areas of evolution and works to create a strong understanding of risk, which drives our culture of integrity and accountability. To inform governance, our Board receives regular reports including activities measurement, training and investigation outcomes, monitored data, and Integrity & Compliance audit results.

**_Leadership and Stakeholder Engagement – Indivior's ESG Committee will have oversight of the climate change_** action plan and implementation, with regular updates on GHG performance as initiatives progress. Indivior will continue to engage with and communicate its climate change efforts to suppliers, customers, consumers, shareholders and other stakeholders interested in climate change matters.

**_Leadership and Stakeholder Engagement – Indivior's ESG Committee will have oversight of the climate change_** action plan and implementation, with regular updates on GHG performance as initiatives progress. Indivior will continue to engage with and communicate its climate change efforts to suppliers, customers, consumers, shareholders and other stakeholders interested in climate change matters.

Indivior PLC (LON: INDV) announces the appointment of Nina DeLorenzo as Chief Global Impact Officer. DeLorenzo will serve on the Executive Committee and report to Indivior Chief Executive Officer Mark Crossley.

In this role, DeLorenzo will lead global corporate affairs, including public affairs, government affairs, communications, policy, advocacy, and stakeholder engagement. In addition, DeLorenzo's role will concentrate on sharing and shaping the company's overall global impact, including Environmental, Social and Governance (ESG) and sustainability programs.

DeLorenzo brings over two decades of public affairs, communications, policy, and government affairs experience to Indivior. Previously, DeLorenzo was senior vice president of global communications and public affairs for Emergent BioSolutions. DeLorenzo has also overseen external affairs operations and engagement at Sanofi in Paris; led global government affairs and public policy functions at AbbVie; and held senior government and public affairs roles at Pfizer Inc., Schering-Plough Corp. (now Merck), and the Pharmaceutical Research and Manufacturers of America (PhRMA).

The Committee has responsibility for reviewing the Group's corporate governance arrangements and oversees its Integrity & Compliance Program. As part of the settlement with the US Attorney's Office for the Western District of Virginia, the Group entered into a Corporate Integrity Agreement with the Office of Inspector General of the U.S. Department of Health and Human Services (the "CIA"), DOJ Compliance Measures and FTC Stipulated Order, which present ongoing reporting and annual requirements. To support it in its oversight of the Integrity & Compliance Program, the Board appointed an independent consultancy, Epsilon Life Sciences, as Compliance Expert to the Board. The Board and the Committee will continue to oversee the continuous development of our Integrity & Compliance Program in 2022. [...] At each meeting, the Committee received an update from the Chief Integrity & Compliance Officer on the Group's Integrity & Compliance Program. The Compliance Expert to the Board also attends these parts of the Committee's meeting. For part of each meeting, the Committee meets privately with the Chief Integrity & Compliance Officer and the Compliance Expert to the Board and then also separately meets with the Compliance Expert to the Board only. Ahead of each meeting, the Committee receives the Integrity & Compliance dashboards, which show performance across all program areas, including: › progress against the Integrity & Compliance key strategic priorities for the year; › key program enhancements, including developments to policies and process enhancements supported by external advisors; › risk assessments and mitigation plans; › details of training and workforce education activities; › field monitoring activities; › transparency reporting; › reports received via the Group's confidential reporting hotline (EthicsLine) and subsequent investigations; and › staffing and resourcing of the Integrity & Compliance Department. Further information regarding the Group's Integrity & Compliance program can be found on page 35.

Our advocacy work, stakeholder engagement, and community relationships are a critical element of how we help make a measurable difference. Our public policy priorities focus on expanding treatment access, reducing barriers, and promoting equitable access to MOUD. In 2022, these activities focused on: • [Advocating for the reduction of treatment barriers, ] including at the federal level, in December 2022, the Mainstreaming Addiction Treatment Act was signed into law in the United States, which removes caps on the numbers of patient's healthcare professionals may treat with buprenorphine; • [Supporting expanded treatment, research, ] and education through increases in federal funding enacted for state opioid response and justice programs; • [Supporting expanded treatment funding and ] initiatives in Criminal Justice System (CJS) settings, initiatives were enacted in California, Colorado, Massachusetts, Missouri, and several other states; • [Supporting the implementation of the New York ] State CJS treatment initiative, including advocating for jails and prisons to expand treatment and support using opioid settlement resources; and • [Sponsoring the National Alliance for Recovery ] Residences convention, aligning with the lead national organization for recovery housing. [...] Mark Crossley, Indivior's Chief Executive Officer, is responsible for the day-to-day operation of the Program, and he is supported at Board level by the Nomination and Governance Committee. The Board's oversight of the operation of the Global I&C Program is supported by an independent Compliance Expert, who also reviews the performance and operation of the Global I&C Program and related culture annually, with the results reported to the Board. The Nomination and Governance Committee and Board each sign an annual resolution certifying Indivior's compliance with the Corporate Integrity Agreement (CIA) and the DOJ Compliance Measures, respectively. Cindy Cetani, Indivior's Chief Integrity & Compliance Officer (CICO) leads the design and administration of the Program supported by a team of nineteen people. The I&C team operates with independence from the business as defined by U.S. government standards and requirements. The CICO has a direct reporting line to the Nomination and Governance Committee of the Board. [...] Indivior's operational controls also include regular reporting to and monitoring by the Indivior Compliance Committee which meets regularly and comprises all members of Indivior's Executive Committee. Indivior has three regional compliance committees. These are staffed by regional management and chaired by the regional compliance officers to monitor the regional implementation and performance of the Global I&C Program. The CICO and the regional compliance officers participate in quarterly business reviews across the three regions and relevant Global functions, e.g., Research & Development/Global Medical Affairs– alongside the Chief Executive Officer and the Chief Financial Officer – to discuss performance, strategy plans, and ensure the integration of the Global I&C Program into their day-to-day operations, and review program maturity initiatives and status.

Advocating for Change

We advocate on public policy issues that relate to substance use and mental health. We responsibly engage with public officials, policymakers, and other stakeholders at all levels of government, as well as healthcare professionals and community organizations.

In the U.S., Indivior works to shape policy through a patient-focused advocacy and government affairs agenda with these four goals:

1. Ensure opioid crisis funds are allocated toward treatment.

2. Address and eliminate barriers to OUD treatment.

3. Expand medication for opioid use disorder (MOUD) in the criminal justice system.

4. Ensure patients have access to innovative overdose reversal medication.

We work at the local county and city levels, as well as at state and federal levels, to help enact needed change to address the largest and most urgent public health crisis of our time—the opioid crisis.

For example, Indivior continues to work to change state standing orders to include all FDA-approved overdose medications and to ensure patients have access to innovative new products that can save lives.

The Committee has responsibility for reviewing the Group's corporate governance arrangements and oversees its Integrity & Compliance Program. As part of the settlement with the US Attorney's Office for the Western District of Virginia, the Group entered into a Corporate Integrity Agreement with the Office of Inspector General of the U.S. Department of Health and Human Services (the "CIA"), DOJ Compliance Measures and FTC Stipulated Order, which present ongoing reporting and annual requirements. To support it in its oversight of the Integrity & Compliance Program, the Board appointed an independent consultancy, Epsilon Life Sciences, as Compliance Expert to the Board. The Board and the Committee will continue to oversee the continuous development of our Integrity & Compliance Program in 2022. [...] At each meeting, the Committee received an update from the Chief Integrity & Compliance Officer on the Group's Integrity & Compliance Program. The Compliance Expert to the Board also attends these parts of the Committee's meeting. For part of each meeting, the Committee meets privately with the Chief Integrity & Compliance Officer and the Compliance Expert to the Board and then also separately meets with the Compliance Expert to the Board only. Ahead of each meeting, the Committee receives the Integrity & Compliance dashboards, which show performance across all program areas, including: › progress against the Integrity & Compliance key strategic priorities for the year; › key program enhancements, including developments to policies and process enhancements supported by external advisors; › risk assessments and mitigation plans; › details of training and workforce education activities; › field monitoring activities; › transparency reporting; › reports received via the Group's confidential reporting hotline (EthicsLine) and subsequent investigations; and › staffing and resourcing of the Integrity & Compliance Department. Further information regarding the Group's Integrity & Compliance program can be found on page 35.

Does your organization have a public commitment or position statement to conduct your engagement activities in line with the goals of the Paris Agreement?[…]No, and we do not plan to have one in the next two years