Session 1.01 US Healthcare Professionals Abroad – Issues and Practical Solutions Caroline West – Senior VP, Chief Compliance and Risk Officer Shire Pharmaceuticals Valli Baldassano – Executive VP and Chief Compliance Officer Cephalon Karen Lowney – International Compliance Director Schering-Plough

- 1 - Session Topics  Engaging US Healthcare Professionals abroad – Determining fair market value – Contracting and payment – Logistics – Capturing data and tracking spending – US Kickback analysis  Differences between US and non-US – Healthcare professionals – Programs and activities  Practical solutions for global companies – Conducting training – Achieving a common ground

- 2 - Engaging US HCPs Abroad  Globalized products and clinical research continue to grow  Pharma companies need to rely on expertise of US physicians  Regulatory environment makes it necessary to build good controls  US HCPs take the Anti-kickback Act with them in their luggage

- 3 - US vs. non-US HCPs: The Good News  IFPMA Code is global – Interactions should be focused on informing healthcare professionals about products, providing scientific and educational information and supporting medical research and education. – No financial benefit or benefit-in-kind (including grants, scholarships, subsidies, support, consulting contracts or educational or practice related items) may be provided or offered to a healthcare professional in exchange for prescribing, recommending, purchasing, supplying or administering products or for a commitment to continue to do so – Promotion should encourage the appropriate use of pharmaceutical products by presenting them objectively and without exaggerating their properties – Promotion should not be disguised  Local country pharma codes comply with IFPMA – including the US PhRMA Code

- 4 - Programs and Other Activities Abroad  Typical Engagements – Lectures or speeches – Satellite symposium – Advisory boards – Faculty for other company-sponsored meetings  International Congresses – Company-sponsored booth may contain information that is off- label in the US  Continuing Medical Education – Definition is not consistent outside of the US – Lack of guidelines for commercial supporters – Distinction between education and promotion not always clear – CME/CPD is voluntary in many countries

- 5 - Anti-Kickback Concerns – Before They Leave  Contract? – Whose law applies? Does it matter?  Fair Market Value? – Different than similar activities here?  Legitimate services? – High level of scrutiny  Accommodations/Travel?  Spend tracking? – Particular challenges with non-US organized event  Policy Development/Awareness Training – Help the business people understand the issues – Yes, this applies to R&D too!

- 6 - What to do?  Tracking/reporting – Procurement – Aggregate Spend systems/processes  Awareness – The colleagues who hire – The KOLs themselves – Vendors  Leverage existing marketing code and anti-bribery training

- 7 - Common Pitfalls with US HCPs  Local customs – Thank-you gifts – Special entertainment – Lavish meals and hospitality – Inappropriate meeting venues  Incorrect contracts  Inconsistent fees for service  Sponsorships to Congresses – Allowed for HCPs from almost every country except the US  Lack of communication by hiring country with US counterparts