Approach and policies
The Group requires compliance with laws, regulations and industry practice at all times. Its comprehensive compliance programs include a focused compliance staff and policies across the full panoply of operations, including:
- An anti-bribery policy
- A data protection policy
- A commercial interactions with healthcare professionals policy
- A healthcare business ethics policy
- A share dealing policy and code
- A field medical personnel policy
- A records and information management policy
Regulatory and legal compliance is a key aspect of the Group’s patientfocused business model. The Group maintains a Corporate Compliance Department to guide compliance efforts through policies, training education and monitoring. These steps ensure adherence to industry codes, laws and regulations in all the countries in which the Group operates. The department also works to ensure that all of the Group’s operations are conducted in line with all regulatory requirements and industry codes of ethics, including those published by US PhRMA; Association of the British Pharmaceutical Industry (ABPI); and by Medicines Australia, along with the Pharmaceutical Manufacturer’s Compliance Program Guide published by the Office of Inspector General of the US Department of Health and Human Services.
The Vice President, Corporate Compliance has routine access to the Board and Executive Committee.
The compliance team’s responsibilities include oversight of pharmaceutical marketing, Medical’s scientific interactions with healthcare professionals, healthcare fraud prevention and anti-bribery guidance to all of the Group’s employees.
The Group strives to continuously enhance its corporate compliance department as part of its risk mitigation strategy.
The department’s responsibilities include:
- Ensuring that the department has access to the Board and executive team, which oversee the program.
- Establishing, maintaining and communicating standards of conduct for the business as a whole.
- Ensuring appropriate internal and external due diligence systems are in place to avoid and mitigate wrongful or potential criminal activity.
- Maintaining a confidential reporting system and ensuring that its existence and purpose is communicated effectively across the organization.
- Ensuring that effective and prompt response processes are in place following the receipt of reports submitted through the confidential system.
- Ensuring that robust monitoring and investigative processes are in place to ensure that allegations of wrongdoing are detected and corrective action is taken promptly; and
- Designing and conducting enforcement processes that include incentives and disincentives that are consistent with related levels of risk and opportunity.
As part of its continuing mission to identify and mitigate business risks, Corporate Compliance implemented the following in 2017:
- Added a compliance director in the EMEA region and two employees in the US: a manager responsible for policy development and education, and a director of compliance program operations responsible for project management initiatives.
- Revised and updated over 25 corporate compliance policies, provided comprehensive education on compliance standards of conduct to employees and contractors globally, and delivered targeted education to clinical liaisons, sales management team, field medical team and field reimbursement specialists. Global policy update trainings were delivered by April 2017 with a 100% completion rate.
- Enhanced the due diligence processes, both for employees and for third parties, and increased monitoring and oversight to assure appropriate business practices, which will continue in 2018.
- The Group also has a separate internal audit department that is responsible for designing and implementing its own work programs and reports to the Audit Committee.
Indivior significantly expanded its compliance and related monitoring activities in 2017. These procedures did not discover any material instances of non-compliance with the Group’s business conduct policies and procedures during the year.