FCPA and International Anti-Corruption for Pharma & Life Sciences

Tuesday, April 29, 2008

About

Since 2007, there have been multiple investigations and charges by the DOJ, SEC and non-U.S. government enforcement agencies against pharmaceutical/life sciences companies for violations of anti-corruption laws. These recent investigations emphasize the difficult compliance challenges and enormous liability exposure faced by life sciences companies operating outside the U.S. In addition, high-profile investigations of multi national corporations headquartered outside the U.S., illustrate that the DOJ and the SEC are pursuing non-U.S. companies as well.

Recent enforcement actions show that the government has turned its focus towards the pharma and the life sciences industries, and these industries are particularly vulnerable to investigations because of their numerous contacts with “government officials” outside the U.S. While most pharmaceutical and life sciences companies have robust compliance programs in place and understand what their obligations are under the FCPA and local anti-corruption laws, they still struggle with creating and implementing policies and procedures that truly control corruption problems.

ACI’s publication from FCPA and International Anti-Corruption for Pharma & Life Sciences has been designed to focus on solutions for problematic FCPA and anti-corruption challenges. ACI has brought together the most experienced FCPA practitioners, pharmaceutical and life sciences counsel, compliance officers, and heads of internal audit to create a forum for industry practitioners who share their experiences and best practices for dealing with anti-corruption challenges. Learn how pharma and life sciences industries are uniquely affected by the FCPA and get industry specific solutions.

Contents & Contributors

About

Since 2007, there have been multiple investigations and charges by the DOJ, SEC and non-U.S. government enforcement agencies against pharmaceutical/life sciences companies for violations of anti-corruption laws. These recent investigations emphasize the difficult compliance challenges and enormous liability exposure faced by life sciences companies operating outside the U.S. In addition, high-profile investigations of multi national corporations headquartered outside the U.S., illustrate that the DOJ and the SEC are pursuing non-U.S. companies as well.

Recent enforcement actions show that the government has turned its focus towards the pharma and the life sciences industries, and these industries are particularly vulnerable to investigations because of their numerous contacts with “government officials” outside the U.S. While most pharmaceutical and life sciences companies have robust compliance programs in place and understand what their obligations are under the FCPA and local anti-corruption laws, they still struggle with creating and implementing policies and procedures that truly control corruption problems.

ACI’s publication from FCPA and International Anti-Corruption for Pharma & Life Sciences has been designed to focus on solutions for problematic FCPA and anti-corruption challenges. ACI has brought together the most experienced FCPA practitioners, pharmaceutical and life sciences counsel, compliance officers, and heads of internal audit to create a forum for industry practitioners who share their experiences and best practices for dealing with anti-corruption challenges. Learn how pharma and life sciences industries are uniquely affected by the FCPA and get industry specific solutions.

Contents & Contributors

EFFICIENTLY AND EFFECTIVELY CONDUCTING DUE DILIGENCE OF THIRD PARTIES
Daniel T. Kessler, International Trade Controls Wyeth (Madison, NJ)
Karen Lowney, Cephalon (Frazer, PA)
Kay Georgi, Arent Fox PLLC (Washington, DC)
Carolyn Lindsey, TRACE International, Inc. (Annapolis, MD)

ASSESSING THIRD PARTIES RISK IN THE PHARMACEUTICAL INDUSTRY
Daniel T. Kessler, International Trade Controls Wyeth (Madison, NJ)

FCPA COMPLIANCE PROGRAMS FOR THE COMPLIANCE MATURE PHARMA/LIFE SCIENCES INDUSTRIES
Linda R. Horton, Hogan & Hartson LLP (Washington, DC and Brussels, Belgium)

ESTABLISHING CRITICAL FCPA CONTROLS FOR ROUTINE INTERACTIONS RELATED TO HEALTH CARE PROFESSIONALS, CHARITIES, HOSPITALITY, AND EDUCATION – A ROADMAP
Harold Glasser, Merck & Co., Inc. (Whitehouse, NJ)
Jay Holtmeier, Wilmer Cutler Pickering Hale and Dorr LLP (New York, NY)

DEVELOPING A TRAINING PROGRAM THAT DEMONSTRATES THE COMPANY’S COMMITMENT TO COMPLIANCE
Mark N. Bonaguro, Covidien (Mansfield, MA)
Lawrence T. Weiss, Covidien (Mansfield, MA)
Gregory Husisian, Thompson Hine LLP (Washington, DC)

DEVELOPING A TRAINING PROGRAM THAT DEMONSTRATES THE COMPANY’S COMMITMENT TO COMPLIANCE
Gregory Husisian, Thompson Hine LLP (Washington, DC)

CLINICAL TRIALS: ASSESSING POTENTIAL RISKS
Natasha Leskovsek, Heller Ehrman LLP (Washington, DC)

THE HIGH COST OF SMALL BRIBES
Alexandra Wrage, TRACE International, Inc. (Annapolis, MD)

EXERTING GREATER CONTROL OVER NON-U.S. SUBSIDIARIES
Ela Bochenek, C.R. Bard, Inc. (Murray Hill, NJ)
Peter Maher, Deloitte & Touche LLP (London, UK)
Mark A. Srere, Morgan, Lewis & Bockius LLP (Washington, DC)

FCPA DUE DILIGENCE CHECKLIST FOR MERGERS, ACQUISITIONS AND JOINT VENTURES
Paul V. Gerlach, Sidley Austin LLP (Washington, DC)

VOLUNTARY DISCLOSURES UNDER THE US FOREIGN CORRUPT PRACTICES ACT
Gary F. Giampetruzzi, Pfizer Inc (New York, NY)
Bret A. Campbell, Cadwalader, Wickersham & Taft LLP (Washington, DC)

STATEMENT FOR THE RECORD
James Robinson, Cadwalader, Wickersham & Taft LLP (Washington, DC)

IDENTIFYING AND CORRECTING BOOKS AND RECORDS VIOLATIONS
Richard Grime, O'Melveny & Myers LLP (Washington, DC)

USING INTERNAL AUDITS TO UNCOVER ANTI-CORRUPTION VIOLATIONS
Matthew Birk, Deloitte Financial Advisory Services LLP (St. Louis, MO)

THE OECD ANTI BRIBERY CONVENTION AND THE PHARMACEUTICAL AND LIFE SCIENCE INDUSTRIES
Sandrine Hannedouche-Leric, Organization for Economic Co-operation and Development (Paris, France)



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