Anti-Corruption for Pharma & Life Sciences

Minimizing Exposure Under Expansive Definitions of Foreign

Tuesday, May 01, 2007

About

Pharmaceutical and life sciences companies are at the greatest risk for committing violations of anti-corruption laws

While every industry must deal with FCPA and anti-corruption compliance, the pharmaceutical and life sciences industries are particularly vulnerable to being investigated for FCPA violations. The pharmaceutical/life sciences business model relies heavily on interaction with doctors, who are often considered "government officials" outside of the U.S., and payments or incentives given to these "government officials" can trigger an FCPA investigation. If a company has 25,000 sales representatives who see eight doctors per day, five days per week, that company has had a million opportunities per week to commit an FCPA violation.

Government enforcement agencies are cracking down on the pharmaceutical and life sciences industries

In October 2006, the WHO launched an anti-corruption drive to eliminate bribery in medical procurement. Since 2002, there have been multiple investigations and charges by the DOJ, SEC and foreign government enforcement agencies against pharmaceutical/life sciences companies for violations of anti-corruption laws. As a result of these investigations, pharmaceutical and life sciences companies have had to pay millions in fines and often agree to the appointment of a special monitor.

Minimize the risk of violations and prevent devastating losses

Learn from the most experienced FCPA practitioners and from pharmaceutical and life sciences compliance officers, heads of internal audit and counsel how to detect and avert potential FCPA/corruption problems. Discover how to incorporate effective controls to protect your company from damage and negative publicity.

Contents & Contributors

About

Pharmaceutical and life sciences companies are at the greatest risk for committing violations of anti-corruption laws

While every industry must deal with FCPA and anti-corruption compliance, the pharmaceutical and life sciences industries are particularly vulnerable to being investigated for FCPA violations. The pharmaceutical/life sciences business model relies heavily on interaction with doctors, who are often considered "government officials" outside of the U.S., and payments or incentives given to these "government officials" can trigger an FCPA investigation. If a company has 25,000 sales representatives who see eight doctors per day, five days per week, that company has had a million opportunities per week to commit an FCPA violation.

Government enforcement agencies are cracking down on the pharmaceutical and life sciences industries

In October 2006, the WHO launched an anti-corruption drive to eliminate bribery in medical procurement. Since 2002, there have been multiple investigations and charges by the DOJ, SEC and foreign government enforcement agencies against pharmaceutical/life sciences companies for violations of anti-corruption laws. As a result of these investigations, pharmaceutical and life sciences companies have had to pay millions in fines and often agree to the appointment of a special monitor.

Minimize the risk of violations and prevent devastating losses

Learn from the most experienced FCPA practitioners and from pharmaceutical and life sciences compliance officers, heads of internal audit and counsel how to detect and avert potential FCPA/corruption problems. Discover how to incorporate effective controls to protect your company from damage and negative publicity.

Contents & Contributors

ORGANIZING AN EFFECTIVE GLOBAL COMPLIANCE PROGRAM
Karen Lowney, Schering-Plough Corporation (Kenilworth, NJ)

SHAPING AN FCPA COMPLIANCE PROGRAM FOR A MEDICAL DEVICE, PHARMACEUTICALS AND LIFE SCIENCES COMPANY: LESSONS LEARNED FROM FORENSIC INVESTIGATIONS
Peter Maher, Deloitte & Touche LLP (London)

SHAPING AN FCPA COMPLIANCE PROGRAM FOR A MEDICAL DEVICE, PHARMA AND LIFE SCIENCES COMPANY
Lawrence T. Weiss, Tyco Healthcare Group LP (Mansfield, MA)
Routine Healthcare Activities and the FCPA
Joshua G. Berman, Sonnenschein Nath & Rosenthal LLP (Washington, DC)
Michael D. Quinlan, Merck & Co., Inc. (Whitehouse Station, NJ)

MANAGING FCPA RISKS: INTERMEDIARIES, DISTRIBUTORS & AGENTS
William T. Fitzgerald, Alcon Laboratories (Fort Worth, TX)

CLINICAL TRIALS: PREVENTING CORRUPTION AND POTENTIAL INVALIDATION OF DATA
Drew Harker, Arnold & Porter LLP (Washington, DC)

EXERTING GREATER CONTROL – AVOIDING LIABILITY FOR THE ACTIONS OF NON- U.S. SUBSIDIARIES
Daniel T. Kessler, Wyeth (Madison, NJ)
Craig Shepherd, Esq., Amgen International

FCPA ISSUES IN MERGERS AND ACQUISITIONS – RECENT DEVELOPMENTS
Jay Holtmeier, Wilmer Cutler Pickering Hale and Dorr LLP (New York, NY)
Roger M. Witten, Wilmer Cutler Pickering Hale and Dorr LLP
Kimberly A. Parker, Wilmer Cutler Pickering Hale and Dorr LLP

AVERTING THE “PURCHASE” OF AN FCPA VIOLATION IN THE NEW WAVE OF PHARMACEUTICAL/LIFE SCIENCES MERGERS AND ACQUISITIONS
Jay Holtmeier, Wilmer Cutler Pickering Hale and Dorr LLP (New York, NY)
Larry Miller, Pfizer Inc (New York, NY)
Edward A. Rial, Deloitte Financial Advisory Services LLP (New York, NY)

FOREIGN ENFORCEMENT OF LOCAL ANTI-CORRUPTION LAWS – HOW PHARMACEUTICAL AND LIFE SCIENCES COMPANIES CAN BE COMPLIANT IN MULTIPLE JURISDICTIONS
Alexandra Wrage, TRACE (Annapolis, MD)

CONDUCTING FCPA AUDITS IN PHARMACEUTICAL AND LIFE SCIENCES COMPANIES
Jeffrey L. Antoon, Johnson & Johnson (New Brunswick, NJ)

COMMUNICATING THROUGHOUT THE COMPANY
Louise Pearson, Dade Behring (Deerfield, IL)

THE OECD CONVENTION AND ITS IMPLICATIONS FOR PHARMA
Sandrine Hannedouche, Directorate for Legal Affairs OECD



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