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1、The Pharma, Biotech and Device Colloquium Compliance Pre-Conference Workshop Monday, June 6, 2005,Louise Mehrotra VP WW Health Care Compliance Johnson & Johnson,A Primer on Compliance Programs for Pharmaceutical and Medical Device Companies,Kathy Lundberg SVP/Chief Compliance Officer Guidant Corpora
2、tion,2004 Sales of $47.3 Billion Over 200 operating companies in 57 countries around the world Leadership positions in ethical and OTC pharmaceuticals, medical/surgical supplies, diagnostics and a variety of consumer products Broad based, diverse portfolio of products,Worlds Most Comprehensive and B
3、roadly Based Health Care Company,By Geographic Area,Worldwide Net Trade Sales,2004,U.S.,Europe,W. Hem (ex. US),Asia Pacific & Africa,12%,5%,24%,59%,$47.3 Billion,2004,Sales by Segment,46.7%,17.6%,35.7%,MD&D $16.9 Billion,Pharmaceutical $22.1 Billion,Consumer $8.3 Billion,Indiana-based company sellin
4、g products in 100 countries around the world Leader in design and manufacture of cardiac and vascular devices and therapies Business units with up to 30 years experience in key markets Over 12,000 employees worldwide GDT traded on the NYSE and PCX,Guidant Corporate Profile,Guidant Corporation Struct
5、ure,CRM,VI,ES,CS,CARDIAC RHYTHM MANAGEMENT,ENDOVASCULAR SOLUTIONS,CARDIAC SURGERY,VASCULAR INTERVENTION,COMPASS,Headquarters,Geographic Operations,Overview,Why are Compliance Programs Important? History and Basics of the U.S. Sentencing Commission Guidelines HHS OIG Compliance Program Guidelines Com
6、pliance 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
7、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 ov
8、er 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. Sen
9、tencing 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. Effec
10、t under the Guidelines: An effective compliance and ethics program is one of mitigating factors that can reduce a companys fine Absence may be a reason to place a corporation on probation Implementation of a program may be condition of probation,USSC Guidelines (contd),The original guidelines define
11、d 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
12、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,USSC Guidelines (contd),Rece
13、nt amendments (effective November 1, 2004) strengthened each of the seven elements (and arguably added a new element). Among the major changes: Compliance programs should be designed to reasonably prevent and detect all violations of law (not just crimes) Significantly expands responsibility of “gov
14、erning authority,” including a requirement to “otherwise promote an organizational culture that encourages ethical conduct and a commitment to compliance ” Requires “high-level personnel” to have ultimate responsibility for program Requires adequate resources to implement the program Extends trainin
15、g requirement to all levels of the organization Requires periodic evaluation of program effectiveness Adds duty to promote program conduct through incentive to existing requirement to ensure enforcement of discipline for wrongdoing,USSC Guidelines (contd),Arguably adds new “element” a requirement to
16、 implement an on-going process to assess the risk of violations and to take steps to address such risks Bolsters provisions relating to “small organizations” (defined as those with less than 200 employees) States that waiver of attorney-client privilege and work-product protections “is not a prerequisite to a reduction in culpability score unless such waiver is necessary in order to prove timely and thorough disclosure of all pertinent information known to the o
