Effective Auditing and Monitoring Across MultiCountry Operations Paris

Effective Auditing and Monitoring Across Multi-Country Operations Paris, France - 27 May 2008 Ted Acosta +1 212 773 3022 Ted. acosta@ey. com

The Concept of Monitoring ► On-going (routine) pursuit of information about the business based upon which one can: ► ► Detect possible aberrancies or trends Decide that more information is needed or in-depth inquiry is warranted Aimed at determining whether controls operate effectively: design and operation Can serve as a control simultaneously Page 2 Observations on Trends & Practices

The Concept of Monitoring (continued) ► ► Based on the risk assessment that led to the controls Depends upon: ► ► ► Proper tone at the top regarding its importance An organizational structure that tasks people with appropriate skills and authority in the monitoring role Adequate resources Integrated, to the extent possible, into operations Not audit (retrospective, periodic) Page 3 Observations on Trends & Practices

Who performs monitoring? ► Relevant operations (e. g. , sales, marketing, medical affairs) – locally and regionally ► Finance – locally and regionally ► Compliance ► Legal ► Information technology ► Human resources ► Outside experts (akin to the internal audit model) Page 4 Observations on Trends & Practices

Areas typically monitored § Free value provided to customer/influencer individuals and entities § § § § Gifts Funding: Direct and Indirect Fee-for-Service Arrangements § Clinicians and influencers § Entities Tender process Third-party relationships: distributors and agents Vendors Employee time and expense (“T&E”) reporting Page 5 Observations on Trends & Practices

Areas typically monitored (continued) § § § § Congresses and other events (especially non-local) Government “status” of entities and individuals Discretionary marketing expenditures Strategic plans and sales targets Value-added services Totality of spend or number of relationships and transactions Cross-border activities Page 6 Observations on Trends & Practices

Sample Compliance Measures Diagram IMPROVE Compliance Risk Assessment Monitor Policies Procedures Separate Evaluation On Going Education Compliance Performance Assessment (Current State) Page 7 Observations on Trends & Practices Training Audit

Continuous Control Monitoring - Potential Indicators TYPES TRANSACTIONAL § § § WHERE THEY MAY BE FOUND Disbursements Contracting Sales and receivables Segregation of duties Approvals and authorizations BUSINESS MODEL/ ENVIRONMENT/ PERFORMANCE BEHAVIORAL § § § Sales call notes Time and expenses reports Performance evaluations Emails Management communications System access § § § SAMPLE MONITORING TASKS § § SAMPLE AUDITING TASKS Page 8 Confidential § § § Foreign government official identification Regulatory requirements Historical performance Legislative/enforcement climate Product portfolio/market share/pipeline Forecast, budgeting, planning Market profile and business history Product regulatory and reimbursement profile and lifecycle Customs and import activities Local business model Track completion of training modules/lessons and comprehension scores Track number of contracts with HCPs per hospital of affiliation and by type and compensation Track totality of payments (honoraria, gifts, meals) to HCPs Track totality of disbursements to hospitals and foundations Test comprehension of policies and procedures Test contracts on government status, written document; timeline of key events; proof of service; approvals Test donations on government status, timeline of key events, originator/requestor, approval Test disbursements: nature, supporting documentation, approvals Observations on Trends & Practices

Databases & Other Monitoring “Tools” ► ► ► General ledger classifications: consistent; descriptive Time and expense: even if decentralized Discretionary expenditures with physicians (e. g. , gifts, FFS arrangements, grants) – web-based; available to relevant people Contracts Funding: grants (research, congresses, other education) Funding: philanthropic and political contributions Promotional review process (including approved materials, version dates, expiration) Sales agents and distributors: name, contact, principals, debarment status HCP: name, alias, practice group, hospital affiliations/employer, government status, debarment status, license number Vendor master list (all vendors) Budgetary and brand planning process Tender schedules Page 9 Observations on Trends & Practices

Questions Ted Acosta Ernst & Young +1 212 773 3022 ted. acosta@ey. com Page 10 Observations on Trends & Practices