COMPLIANCE MONITORING AND REMEDIATION IN THE PHARMACEUTICAL SECTOR
Few other industries have been under the spotlight more of late than the pharmaceutical sector. For many years, society’s trust in the pharmaceutical industry has been low. Building trust with patients, physicians and other stakeholders is thus critical to delivering a pharma company’s purpose, as well as securing its long-term financial performance.
Having a clear and solid risk and compliance framework is non-negotiable, and a company’s expectations need to be summarised in a clear code of ethics or similar document. Successful implementation requires a curious mindset to continuously learn through the generation of insights on how well guidelines and procedures support associates to do what is right. A company-wide monitoring and remediation process will help to generate such insights, to continuously improve risk awareness across organisations, control systems, policy frameworks and training.
In this context, a strong central monitoring and remediation second line assurance function provides support, monitoring and constructive challenge on risk-related matters to local businesses, and will help them to assess how effectively compliance frameworks are implemented, and to remediate any gaps related to compliance with laws, regulations, acceptable ethical behaviour and internal controls.
Challenges for effective compliance monitoring and remediation
An internal audit function, which makes in-depth reviews to provide objective and independent assurance to senior management, is an essential element of any compliance programme. However, there are certain limitations given the nature of the function. First, given the in-depth nature of reviews (typically over two to three weeks and conducted by two to four auditors) a limited number of audits can be conducted each year. Second, given its full independence, the internal audit function cannot be involved in-depth operationally in the remediation of activities. Third, given the perception that a negative internal audit outcome may impact the career or reputation of associates, they may not welcome an internal audit with a curious learning mindset.
Jul-Sep 2021 Issue
Novartis International AG