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The Pharma, Biotech and Device ColloquiumCompliance Pre-Conference WorkshopMonday, June 6, 2005 Louise Mehrotra VP WW Health Care Compliance Johnson Johnson World’s Most Comprehensive and Broadly Based Health Care Company Worldwide Net Trade Sales Sales by Segment Guidant Corporation Structure Overview Why are Compliance Programs Important? History and Basics of the U.S. Sentencing Commission Guidelines HHS OIG Compliance Program Guidelines Compliance Program Basics Written Standards of Conduct Leadership and Infrastructure Education and Training Internal Communications and Reporting Monitoring and Auditing Enforcement of Disciplinary Standards Responding to Detected Offenses Concluding Thoughts Why Are Compliance Programs Important? (Or … Who Cares?) Effective programs can prevent wrongdoing and lessen the damage when violations do occur. A credible compliance 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 U.S. Sentencing Commission Guidelines The 1984 Sentencing Reform Act created the U.S. 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 USSC Guidelines (cont’d) The original guidelines defined an “effective compli