1. ©2004 Deloitte Development LLC. All rights reserved. 2004 Pharmaceutical Regulatory and Compliance Congress Compliance Auditing & Monitoring 3.02 Auditing and Monitoring for Compliance Karen R. Lines, Esq. Associate General Counsel Genentech, Inc. South San Francisco, CA November 16, 2004 Sheryl Vacca, CHC West Coast Practice Leader, Life Sciences & Health Care Regulatory Deloitte & Touche LLP

2. Copyright © 2004 Deloitte Development LLC. All rights reserved. 1 Confidential and Proprietary Material of Deloitte Consulting. Copyright © 2002 Deloitte Consulting (US) LLC. All Rights Reserved 1 2004 Pharmaceutical Regulatory and Compliance Congress Building the Emerging Model Departmental Procedures Standard Operating Procedures Compliance Standards Code of Conduct Corporate Policies Day-to-Day Operations Corporate Compliance Program Financial Risk Regulatory Risk Systems/IT Risks Operational Risks Board & Executive Committee

3. Copyright © 2004 Deloitte Development LLC. All rights reserved. 2 Confidential and Proprietary Material of Deloitte Consulting. Copyright © 2002 Deloitte Consulting (US) LLC. All Rights Reserved 2 2004 Pharmaceutical Regulatory and Compliance Congress The Compliance Program Design Dilemma Designing an integrated compliance program that operates as one unit rather than many silos is challenging The business’s processes and operations often function in silos The compliance-related risks touch every aspect of the organization’s business & are difficult to “compartmentalize” The design should be based upon the organization’s business strategies The design should result in an organization-wide compliance monitoring plan Business Strategy Business Processes Monitoring Risk Mitigation

4. Copyright © 2004 Deloitte Development LLC. All rights reserved. 3 Confidential and Proprietary Material of Deloitte Consulting. Copyright © 2002 Deloitte Consulting (US) LLC. All Rights Reserved 3 2004 Pharmaceutical Regulatory and Compliance Congress Monitoring plan should be designed with the Compliance Program dilemma in mind. Monitoring creates the crosswalk between the Business Strategies and the Risk Areas. Create a Compliance “Crosswalk” Business Strategy Will be impacted by many risk areas Risk Area Apply to more than one business strategy Monitoring Vaccines will be available for the public Monitoring Quality Control and Drug Safety

5. Copyright © 2004 Deloitte Development LLC. All rights reserved. 4 Confidential and Proprietary Material of Deloitte Consulting. Copyright © 2002 Deloitte Consulting (US) LLC. All Rights Reserved 4 2004 Pharmaceutical Regulatory and Compliance Congress Sarbanes –Calls for evaluation of internal controls COSO Standards –Compliance with laws and regulations Federal Sentencing Guidelines –Calls for evaluation of internal controls HHS Office of Inspector General –Regulatory-specific standards –Employee Training –Compliance Audits Focus on Regulatory Risks and Controls The vast majority of health care/life science regulatory & compliance program requirements align with Sarbanes & Internal Audit standards.

6. Copyright © 2004 Deloitte Development LLC. All rights reserved. 5 Confidential and Proprietary Material of Deloitte Consulting. Copyright © 2002 Deloitte Consulting (US) LLC. All Rights Reserved 5 2004 Pharmaceutical Regulatory and Compliance Congress How Sarbanes 404 Integrates into your Auditing and Monitoring Objectives –Operations –Financial reporting –Compliance Components of a 404 Readiness –Monitoring –Information & Communication –Control Activities –Risk Assessment –Control Environment

7. Copyright © 2004 Deloitte Development LLC. All rights reserved. 6 Confidential and Proprietary Material of Deloitte Consulting. Copyright © 2002 Deloitte Consulting (US) LLC. All Rights Reserved 6 2004 Pharmaceutical Regulatory and Compliance Congress Finalize Report & Corrective Action Plan Education, Remedial Action Auditing and Monitoring Cycle Review Process for Each Risk Area Conduct Review Develop Review Criteria Define Review Sample Obtain Management Response Define Review Scope & Assumptions Test Inter-rater Reliability with Multiple Reviewers Document Observations & Findings Reaudit Define Methodology Validate Findings

8. Copyright © 2004 Deloitte Development LLC. All rights reserved. 7 Confidential and Proprietary Material of Deloitte Consulting. Copyright © 2002 Deloitte Consulting (US) LLC. All Rights Reserved 7 2004 Pharmaceutical Regulatory and Compliance Congress Continuous Monitoring Cycle Monitoring never ends… each review leads to the next, and the monitoring plan and unplanned issues drive additional monitoring activities. It is a continuous process… Define Review Scope & Assumptions Develop Review Criteria Define Review Sample Test Interrator Reliability Conduct Review Document Observations & Findings Obtain Management Response Finalize Report & Corrective Action Plan Define Review Scope & Assumptions Develop Review Criteria Define Review Sample Conduct Review Document Observations & Findings Obtain Management Response Finalize Report & Corrective Action Plan Define Review Scope & Assumptions Develop Review Criteria Define Review Sample Test Interrator Reliability Conduct Review Document Observations & Findings Finalize Report & Corrective Action Plan Re-audit and add new audits to the cycle

9. Copyright © 2004 Deloitte Development LLC. All rights reserved. 8 Confidential and Proprietary Material of Deloitte Consulting. Copyright © 2002 Deloitte Consulting (US) LLC. All Rights Reserved 8 2004 Pharmaceutical Regulatory and Compliance Congress Practical Considerations Related to Auditing and Monitoring Strategy Developing your Auditing and Monitoring Plan –Deciding what to monitor Prioritize Risk Areas –Internal Factors, i.e.: any system changes, people changes, new practice, etc. –External Factors, i.e.: new regulation, national and local enforcement activity Compliance Program evaluation Identify controls that make the process work : PROCESS AUDIT Determine overall purpose effective: OUTCOMES AUDIT –Resources available to execute plan –Consider integration with Internal Audit Plan –Identify timeframes for audits –Communication and Commitment to Plan

10. Copyright © 2004 Deloitte Development LLC. All rights reserved. 9 Confidential and Proprietary Material of Deloitte Consulting. Copyright © 2002 Deloitte Consulting (US) LLC. All Rights Reserved 9 2004 Pharmaceutical Regulatory and Compliance Congress Developing Your Audit Approach Deciding the scope –Narrow down the purpose of the audit –Avoid scope creep before you start Resources available to execute the audit Methodology Sample size determination Communication/Reporting Results

11. Copyright © 2004 Deloitte Development LLC. All rights reserved. 10 Confidential and Proprietary Material of Deloitte Consulting. Copyright © 2002 Deloitte Consulting (US) LLC. All Rights Reserved 10 2004 Pharmaceutical Regulatory and Compliance Congress Things to Consider: –The purpose of the sample or the review objective –The universe/population/sources of data –The size of the sample –What you are going to do with the results Sampling Methodologies

12. Copyright © 2004 Deloitte Development LLC. All rights reserved. 11 Confidential and Proprietary Material of Deloitte Consulting. Copyright © 2002 Deloitte Consulting (US) LLC. All Rights Reserved 11 2004 Pharmaceutical Regulatory and Compliance Congress Sampling Methodology What should you consider before you decide what your sample size will be? –Who do you expect to share the information with and what is their frame of reference? –Are you trying to figure out whether there is really a problem? –What is the organization’s perspective on “fixing” problems? –What resources are available to audit this area? –Does Senior Management agree this risk area is important? –What is the worst case scenario if this audit reflects unfavorable outcomes? Attorney/Client Privilege?

13. Copyright © 2004 Deloitte Development LLC. All rights reserved. 12 Confidential and Proprietary Material of Deloitte Consulting. Copyright © 2002 Deloitte Consulting (US) LLC. All Rights Reserved 12 2004 Pharmaceutical Regulatory and Compliance Congress Purpose of the Sample Is the review for: –Self - disclosure? –Education? –Part of an on-going monitoring plan? –Response to the federal government, subpoena, carrier or FI? –Known risk area?

14. Copyright © 2004 Deloitte Development LLC. All rights reserved. 13 Confidential and Proprietary Material of Deloitte Consulting. Copyright © 2002 Deloitte Consulting (US) LLC. All Rights Reserved 13 2004 Pharmaceutical Regulatory and Compliance Congress Other Considerations Priority –Internal –External Timeframe of data collection – concurrent – retrospective Availability of data –Manual –Leverage Technology

15. Copyright © 2004 Deloitte Development LLC. All rights reserved. 14 Confidential and Proprietary Material of Deloitte Consulting. Copyright © 2002 Deloitte Consulting (US) LLC. All Rights Reserved 14 2004 Pharmaceutical Regulatory and Compliance Congress ToolsProsCons Manual ChecklistsLow cost No training required Easy to customize Administration effort (collation of results) Reporting effort Excel based Spreadsheets (signoff process administered via email or on central server) Low cost Simple, adaptable Limited user training Limited IT involvement Ongoing maintenance Limited scalability Limited reporting Many efforts remain manual Access based Databases Low cost Simple, adaptable Limited user training Limited IT involvement Enhanced reporting options Accessibility (not web enabled) Limited scalability Training may be required No transparent dashboard reporting Web based Assessment Systems Increased functionality Usable for sophisticated, complex cos. Improved reporting (dashboard) Scalable Technology implementation effort & cost Significant IT involvement Ongoing maintenance – security, reporting Sophistication of solution Leveraging Technology

16. Copyright © 2004 Deloitte Development LLC. All rights reserved. 15 Confidential and Proprietary Material of Deloitte Consulting. Copyright © 2002 Deloitte Consulting (US) LLC. All Rights Reserved 15 2004 Pharmaceutical Regulatory and Compliance Congress Practical Application : Case Study Define Review Scope & Assumptions Develop Review Criteria Conduct Review Document Findings and Observations Obtain Management Response Finalize Report & Corrective Action Plan Compliance Training Risk Area Review Process Managed Care Contracting

17. Copyright © 2004 Deloitte Development LLC. All rights reserved. 16 Confidential and Proprietary Material of Deloitte Consulting. Copyright © 2002 Deloitte Consulting (US) LLC. All Rights Reserved 16 2004 Pharmaceutical Regulatory and Compliance Congress Case Study Define Review Scope & Assumptions –Conduct interviews with Business Process Owners –Review Policies & Procedures –Review Education and Training materials –Document scope & assumptions Develop Review Criteria –Test Review Criteria –Enter criteria into database Conduct Review –Review documentation –Enter findings into database Document Findings and Observations Query database for exception findings –Summarize observations –Develop recommendations Obtain Management Response –Share findings with Business Process Owners –Obtain reactions to recommendations –Draft a Corrective Action Plan Finalize Report & Corrective Action Plan Compliance Training Risk Area Review Process Managed Care Contracting

18. Copyright © 2004 Deloitte Development LLC. All rights reserved. 17 Confidential and Proprietary Material of Deloitte Consulting. Copyright © 2002 Deloitte Consulting (US) LLC. All Rights Reserved 17 2004 Pharmaceutical Regulatory and Compliance Congress Corrective Action Plan Area of FocusFindingRecommendationManagement Action Plan Acct/Timeframes 1. Contract load1.20% data errors in contract load 2.Etc. Periodically review data entry Etc. Develop a periodic review system Accountable Party: John Smith, VP Timeframe: 2 nd Quarter

19. Copyright © 2004 Deloitte Development LLC. All rights reserved. 18 Confidential and Proprietary Material of Deloitte Consulting. Copyright © 2002 Deloitte Consulting (US) LLC. All Rights Reserved 18 2004 Pharmaceutical Regulatory and Compliance Congress Admissions Customer Service Marketing Medical Records Privacy Inducements Privacy Notice Employee Training Complaints Employee Discipline Authorizations Minimum Necessary Access to Records Amendment of Records Confidential Communications Facility Directory Business Associate Agreements Risk Area Department Or Develop the Report Card Sample Report Card

20. Copyright © 2004 Deloitte Development LLC. All rights reserved. 19 Confidential and Proprietary Material of Deloitte Consulting. Copyright © 2002 Deloitte Consulting (US) LLC. All Rights Reserved 19 2004 Pharmaceutical Regulatory and Compliance Congress Integration into Business Strategy Use monitoring findings to develop and document ROI Assist the business process owners to identify root cause of findings Use corrective action to enhance efficiency and mitigate risk Organization-wide (vs. silo) allow program leverage

21. Copyright © 2004 Deloitte Development LLC. All rights reserved. 20 Confidential and Proprietary Material of Deloitte Consulting. Copyright © 2002 Deloitte Consulting (US) LLC. All Rights Reserved 20 2004 Pharmaceutical Regulatory and Compliance Congress Summary An effective Auditing and Monitoring approach provides a method to: –Assist in identifying risk to the business that may have been otherwise undetected internally –Assist by identifying if the controls developed to remediate a risk are working and have actually helped to mitigate the risk –Assist with preventing a real and/or potential risk from escalating by early detection through auditing which may help avoid additional harm to the company’s business –Provides a “good faith” organization the ability to approach their real and/or potential risk weaknesses with a reasonable, scaleable method Auditing and Monitoring is a critical element for an effective compliance program which helps to drive compliance and behavior.

22. Copyright © 2004 Deloitte Development LLC. All rights reserved. 21 Confidential and Proprietary Material of Deloitte Consulting. Copyright © 2002 Deloitte Consulting (US) LLC. All Rights Reserved 21 2004 Pharmaceutical Regulatory and Compliance Congress Karen R. Lines, Esq. Associate General Counsel Genentech, Inc. South San Francisco, California krl@gene.com (650) 225-8673 Ms. Lines is Associate General Counsel with Genentech, Inc. in South San Francisco, California. Genentech, Inc. is a biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. She manages a team of lawyers responsible for providing legal advice and guidance to Genentech’s commercial organization. In the past few years, much of her focus has been on leading ongoing efforts to enhance Genentech’s Commercial Compliance Program. She began her legal career in private practice in Wilmington, Delaware. Ms. Lines is admitted to the practice of law in California, Delaware and Pennsylvania. Sheryl Vacca, CHC West Coast Practice Leader Life Sciences and Health Care Regulatory Deloitte & Touche LLP (714) 436-7710 svacca@deloitte.com Ms. Vacca is the West coast Leader for Deloitte & Touche’s National Life Sciences and Health Care Regulatory practice. She has assisted several life science companies develop their compliance programs, investigations, perform risk assessments and develop auditing and monitoring plans for the compliance department. She has significant experience consulting with life sciences and health care organizations on compliance issues including self disclosure, writing plans of correction, implementing systems in response to plans of correction, implementing QA systems and general regulatory compliance.