文档介绍：The Pharma, Biotech and Device Colloquium Compliance Pre-Conference Workshop Monday, June 6, 2005
Louise Mehrotra
VP WWance program can be influential at key stages of the investigative and enforcement processes:
Whether to continue or expand an investigation
Whether to turn investigatory results over to prosecutors
Whether to charge a company with wrongdoing
Whether to pursue criminal or civil charges
Whether to settle a case and, if so, on what terms
Whether to pursue exclusion or debarment of a company
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. Sentencing Commission Guidelines
The 1984 Sentencing Reform Act created the . Sentencing Commission and directed it to develop guidelines for sentencing of individuals and entities convicted of Federal crimes.
Sentencing guidelines for individuals were issued in 1987. The Guidelines for Organizations (including corporations convicted of Federal crimes) were issued in 1991.
Effect under the Guidelines:
An effective compliance and ethics program is one of mitigating factors that can reduce a company’s fine
Absence may be a reason to place a corporation on probation
Implementation of a program may be condition of probation
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USSC Guidelines (cont’d)
The original guidelines defined an “effective compliance program” as having seven “elements”
Standards and procedures for employees
Specific high-level individual(s) must be assigned overall responsibility for compliance program
Exercise of due care not to delegate substantial authority to individuals
Training and communication of standards to employees and agents
Reasonable steps to achieve compliance – both through auditing and monitoring programs and internal reporting systems
Consistent enforcement of disciplinary standards
Steps to respond to reported misconduct and prevent future violations
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USSC Guidelines (cont’d)
Recent amendments (effective November 1, 2004) strengthened each of the seven elements (and arguably added a new element).
Among the major changes:
Compliance programs should b