Day One – Monday, May 16, 2011
7:30 Registration & Continental Breakfast
8:30 Co-Chairs’ Opening Remarks
Gary Giampetruzzi
Vice President & Assistant General Counsel
Head of Government Enforcement
Pfizer Inc (New York, NY)
Alexandra Peters
Director,
Global Anti-Corruption Program Medtronic, Inc. (Minneapolis, MN)
8:45 Discovering Hidden “Government Officials” and Navigating the Blurry Line of FCPA Compliance within Foreign Socialized and National Health Programs
Rosland Fisher McLeod
Vice President & Chief Compliance Officer
Biogen Idec (Weston, MA)
Alice S. Fisher
Deputy Managing Partner, Washington, D.C. Office
Latham & Watkins LLP (Washington, DC)
- Defining who is a “government official” under the FCPA
- Obtaining and interpreting corporate records – how to detect conflicts of interest, personal interest of a government official
- Knowing how much government ownership is enough to interest regulators
- How to evaluate the unique relationships between distributors, manufacturers, investigators and other third parties often found within the distribution or supply chain
- Comparing the definition of a government official in the FCPA with applicable local laws
- How to comply with parallel or competing centers of authority when overseeing global operations
9:30 Maintaining Research Integrity While Minimizing Bribery Risks in Foreign Clinical Trials: Effective Due Diligence & Oversight Strategies for Your Doctors, CROs, and HCPs
Sherri Morissette
Vice-President and Division General Counsel
Biomet International, Ltd. (Warsaw, IN)
Peter S. Spivack
Co-Leader, Investigations, White Collar & Fraud Practice
Hogan Lovells LLP (Washington, DC)
- How to conduct a comprehensive due diligence screening of CROs and other third parties involved in the clinical research process abroad
- selecting doctors – how this process should differ when conducting company-sponsored vs. investigator-sponsored trials
- evaluating industry reputation and professional record
- warning letters, standing with his/her/their registry
- ensuring a bona fide need for the clinical research exists
- utilizing risk rankings to evaluate distributors
- Knowing how much due diligence is enough? What to look for?
- Deciding whether or not a CROs screening of its employees and third parties is sufficient
- Discussing the pros and cons of utilizing an outside contractor to conduct compliance screenings
- Minimizing your exposure to FCPA risk by including terms in your agreements to address corrupt behavior
- How to address funding and payments in the context of your clinical trials agreement
- Understanding to what extent activities of foreign affiliates impact the U.S.-based parent company
- Anticipating what activities may come under government investigation in the clinical trials arena
- Monitoring actions undertaken by CROs, consultants and agents when seeking health ministry approval of clinical trial activity
- working with the FDA and the EMA when monitoring foreign clinical trials to ensure that all required procedures are followed to protect data integrity
- requiring CROs and other third parties to certify knowledge and compliance with FCPA and applicable anti-corruption laws, including UK anti-bribery statute
- Minimizing conflicts in investigator payments
10:30 Morning Coffee Break
10:45 Focus on CHINA: Assessing Your FCPA Risk Exposure in R&D and Manufacturing Operations, and Bracing for a New Era of Local Enforcement
Yuet Ming Tham
Head, Regulatory Compliance, Investigations and Life Sciences Groups – Asia
DLA Piper (Hong Kong)
Hui Chen
Senior Corporate Counsel, Asia-Pacific Regional Lead
International Compliance Investigations
Pfizer Inc (New York, NY)
Richard
Gane
Senior
Counsel, Strategic Planning and Business Development
AstraZeneca
(UK)
Brett A. Campbell – Panel Moderator
Partner
Cadwalader, Wickersham & Taft LLP (Washington, DC)
- Update on current FCPA enforcement initiatives in China and their impact on local life sciences business operations
- Understanding Chinese anti-corruption laws and how they apply to the life sciences industries
- Setting up subsidiary operations, conducting clinical trials and establishing local manufacturing and research and development centers in China while remaining FCPA compliant
- closely aligning compliance programs with local cultures, languages, business practices and regulations
- dealing with non-compliant third parties, distributors, subsidiary employees, CROs and HCPs in the local region
- strategies for effectively screening third parties, intermediaries, HCPs and CROs in China, particularly when new business operations are being established
12:00 Evaluating the Impact of Current DOJ & SEC Enforcement Priorities on Global Life Sciences Operations: How to Update Your Compliance Program in Response to the Industry Sweep
Guy Singer
Head, Government Investigations/White Collar Practice Group, New York Office
Fulbright & Jaworski LLP (New York, NY)
Former Trial Attorney, U.S. Department of Justice, Criminal Division, Fraud Section
Gregory S. Bruch
Partner
Willkie Farr & Gallagher LLP (Washington, DC)
Former Assistant Director, Securities and Exchange Commission, Division of Enforcement
Benefit from a private, closed-door discussion regarding high risk areas currently being targeted for enforcement by the DOJ and SEC. Gain an insider's perspective on what current and future cases will mean for the industry and what your company should do now to prepare and respond.
- Overview of business operations that are being more closely evaluated for potential FCPA violations within the life sciences industry
- overseas clinical research
- product sales and approvals
- funds paid to “boost” or “speed” drug approvals
- payments made to government-employed doctors, HCPs and hospital committees in order to facilitate drug and device purchases
- company sales commissions that are passed onto government-employed doctors and HCPs
- other high risk exposure areas that have been flagged for enforcement
- Discussing examples of illegal conduct and lessons learned from recent high profi le cases
- Highlighting differences in approaches taken by the SEC and DOJ when investigating FCPA violations – how does the process work collaboratively vs. independently?
- Update concerning whistleblower enforcement under the Dodd-Frank Act
1:00 Networking Luncheon
2:15 When Government Comes Knocking: Immediate Steps to Take When You Receive Notice That Your Company is Being Investigated
Gary Giampetruzzi
Vice President & Assistant General Counsel
Head of Government Enforcement
Pfizer Inc (New York, NY)
Chris Georgiou
Partner
Deloitte Financial Advisory Services LLP (New York, NY)
Karen A. Popp
Global Co-Chair,
White Collar Practice Group Sidley Austin LLP (Washington, DC)
- How to preliminarily assess the potential FCPA issue: measuring the severity of the allegation to plan the response strategy
- Using in-house resources as a quick response
- Deciding when to retain outside counsel, forensic accountants and how many
- Immediate steps to take to stop potential ongoing conduct and liability
- How and when to issue a document hold and take other appropriate steps to quickly preserve evidence
- Establishing and maintaining privilege during the investigation
- Cost-effective ways to deal with foreign language issues in documents, interviews, forensic accountant work and other investigation tasks
- Considerations as to whether and when to disclose to other (US and foreign) government agencies who may have jurisdiction over the issues
- Lessons learned process to implement Compliance Program enhancements to prevent repeat of problem
3:30 Preventing FCPA Pitfalls When Securing Drug and Device Approvals and Responding to Requests for Tender in Emerging Markets
Ela Bochenek
Associate General Counsel - International
C.R. Bard, Inc. (Murray Hill, NJ)
Eric D. Brown
Assistant General Counsel - Global Trade Regulations
Eli Lilly and Company (Washington, DC)
- Controlling the numerous points of interaction life science companies and their subsidiaries have with foreign government officials, particularly within the drug and device approval & pricing process
- pricing and reimbursement with national public payors
- Addressing unique FCPA compliance challenges that arise in the context of the foreign tender process
- how to avoid engaging in corrupt behavior when responding to a public tender
- monitoring actions undertaken by third parties, agents, consultants, distributors and resellers when responding to a tender
- risks associated with responding to requests for particular specifications in the tender
- Overcoming cultural attitude and local customs that facilitate violations
4:15 Afternoon Refreshment Break
4:30 Establishing Controls to Minimize FCPA Exposure When Engaging in Sales, Marketing and CME Activity
L. Stephan Vincze
Director, Forensic & Dispute Services
Deloitte LLP (Boston, MA)
Ashok Marin
Senior Counsel, Global Compliance
GE Healthcare (Princeton, NJ)
- Best practices for organizing medical conferences, travel arrangements, physician sponsorships, advisory boards, and entertainment
- Grants – creating a mechanism to monitor how grants funds are spent
- Speaker programs, KOLs and thought leaders and their use in a promotions strategy
- Crafting permissible guidelines for the use and compensation of consultants and advisory boards
- Utilizing an objective process to bestow physician benefits
- Navigating the blurry line between providing free equipment for trials and tests in a way that will not be viewed as a payment
- determining who the recipient of the free equipment really is
- Government official or person with approval authority over the sale of the drug or device
5:30 Conference Adjourns to Day Two
DAY TWO – TUESDAY, MAY 17, 2011
8:30 Co-Chairs’ Remarks
8:35 Designing a Risk-Based Anti-Bribery Compliance Program to Support Global Parent and Subsidiary Operations
Erik Eglite
Vice President, Chief Compliance Officer and Corporate Counsel
Lundbeck Inc. (Deerfield, IL)
John Goodacre
EVP, General Counsel & Corporate Secretary
Quintiles (Durham, NC)
David H. Resnicoff
Associate General Counsel & Vice President, Ethics & Compliance
Baxter International, Inc. (Deerfi eld, IL)
- Balancing risks with costs when deciding the scope of the program
- determining whether or not to customize the compliance program to every locality
- tailoring the program for the size and growth of the company
- integrating sales and marketing compliance with FCPA compliance measures
- how to coordinate an FCPA program in line with local laws and customs of foreign jurisdictions
- identifying common interactions with government officials that can result in liability
- Overcoming key language and cultural barrier challenges for global training
- Training distributors and business partners
- Evaluating the effectiveness of online training versus in-person training
- Identifying what types of controls U.S. and foreign governments expect life sciences companies to have in place
- How to translate day-to-day Board oversight into the FCPA compliance program
9:45 Focus on European Enforcement: A Behind the Scenes Examination of How Bribery Cases are Prosecuted and Coordinated Between the SFO and European Prosecutor’s Offices
Vivian Robinson, QC
General Counsel
Serious Fraud Offi ce (UK)
Jean-Bernard Schmid
State Prosecutor
Palais de Justice (Switzerland)
Michael Loer
Senior Prosecutor
Public Prosecutor’s Office (Germany)
Matthew Cowie
Counsel, Corporate Investigations Practice
Skadden, Arps, Slate, Meagher & Flom (UK)
Former Senior Prosecutor, Serious Fraud Office
Federico Busatta - Panel Moderator
Partner
Gianni, Origoni, Grippo & Partners (Italy)
- Understanding how prosecution of non-U.S. employees (agents, subsidiaries, third parties, distributors, etc.) is carried out by foreign enforcement authorities
- Discussing standards used by various European enforcement agencies to evaluate liability of individual employees, corporations and subsidiaries
- Overview of non-FCPA violations currently being pursued by the U.S. and foreign governments in association with an FCPA investigation
- commercial bribery
- wire fraud
- What foreign governments perceive as adequate for international anti-corruption compliance programs
- Identifying common triggers for investigation and enforcement within Europe
11:00 Morning Coffee Break
11:15 Contrasting the UK Bribery Act with the FCPA: Adjusting Your International Compliance Program to Prepare for New Expectations under the Act
Amy J. Conway-Hatcher
Partner
Morgan, Lewis & Bockius LLP (Washington, DC)
Charles
Mayo
Partner, Crime, Fraud & Investigations Group
Simmons & Simmons (UK)
- Addressing the lack of an “exception” for facilitation payments and the impact on how life sciences companies transact business internationally
- Defining “anything of value, ” “satisfactory compliance program,” “corporate offence,” and “failure to prevent bribery”
- Delineating the scope of the Act – how far will the Act’s extraterritorial reach go with respect to actions undertaken by parent companies vs. subsidiaries?
- How to update your compliance program to address areas of risk exposure in the context of third party, CRO, and HCP relationships with life sciences companies
- Outlining what duties and responsibilities a U.S.-based parent company has to foreign distributors and affi liates under the Act
12:15 Networking Luncheon
1:30 Focus on INDIA: Executing a Work Plan and Confronting Local Challenges Presented by the Investigation of an Alleged FCPA Violation in India
Michael Kendall
Head, White-Collar Defense Group
McDermott Will & Emery LLP (Boston, MA)
- Creating an action plan for conducting an internal investigation into a potential FCPA violation – identifying what initial steps should be taken
- Selecting and screening foreign local counsel
- Ensuring attorney client privilege is protected, both in the U.S and in the local jurisdiction
- Complying with the formalities and limitations contained in local laws, particularly local Ethics laws and accounting rules (GAP)
- Best practices for staffing and operating an investigation remotely
- Questioning reluctant witnesses and using a translator
- Determining what to do with the results of the investigation
- Overview of high risk areas often targeted for enforcement and investigation in India
- facilitating payments
- securing licenses and approvals from the government
- navigating the local tender process
2:15 Putting Your Compliance Program to the Test: How to Test the Effectiveness of Your Compliance Program in High Risk Markets
Jeffrey L. Antoon
Director – Financial Internal Audit
Johnson & Johnson (New Brunswick, NJ)
Joan Humes
Vice President, Government and Internal Investigations
Medtronic, Inc. (Minneapolis, MN)
- Deciding whether to build an internal auditing program that incorporates specifi c FCPA monitoring into recurring fi nancial audits or to create a separate FCPA audit program
- Identifying how FCPA program reviews differ from financial audits
- essential components of effective FCPA audits
- when and how often to perform audits
- delineating which areas will be audited for compliance
- understanding how auditors identify red flags
- Maintaining compliance controls without putting the company at a competitive disadvantage
- Money-saving methods – mini-audits, technology shortcuts and other tools to stretch resources
- Monitoring CRO, HCP and third party intermediary activity and interaction with foreign government officials and agents – how much auditing is enough/too much?
- How to train your distributors, third party agents, CROs and HCPs on compliance monitoring
- Practical strategies for monitoring and auditing compliance with the terms of your agreement with various parties
- Highlighting exposure areas where transactions are tested
3:00 Afternoon Refreshment Break
3:15 Navigating the Complexities of Data Privacy Protections When Conducting Internal FCPA Investigations in Europe
Dean Forbes, JD CIPP
Senior Director, Global Privacy Policy & Compliance
Johnson & Johnson (New Brunswick, NJ)
Pierre E. Dupourqué
Senior Corporate Counsel – EMEA Lead
Pfizer Inc (Germany)
Heiner Hugger
Partner
Clifford Chance (Germany)
Each country in the European Economic Area (EEA) and Switzerland has their own privacy law in place to regulate the collection, use, and disclosure of personal data. Sometimes creating confl ict, it is often a very delicate task to collect or transfer certain personal data from foreign jurisdictions to the US. During this session, the panel will lead you in a practical discussion of how to comply with international privacy requirements governing the collection, storage and cross-border transfer of personal data, particularly when conducting an internal investigation to audit FCPA compliance in Europe
- Understanding the privacy laws of Europe and balancing the risks with requests for information
- Complying with specific limitations under the recently changed German data protection provisions in the context of internal investigations
- Successfully utilizing cross-border data transfer mechanisms to appropriately obtain personal data, including the U.S., EU and U.S-Swiss Safe Harbors
- Obtaining approvals from and complying with required notifi cations to local Data Protection Authorities (DPAs)
4:15 Detecting Facilitating Payments in your Global Supply Chain and Distribution Operations: Strategies for Embedding Risk Assessment and Monitoring Activities
Sean Hecker
Partner
Debevoise & Plimpton LLP (New York, NY)
- Knowing where to draw the line regarding what does/does not qualify as a facilitation payment
- Detecting wrongdoing – how to setup effective red and green flags throughout the customs clearance process
- Satisfying U.S. recordation requirements without increasing your foreign exposure
- Installing and maintaining effective policies and procedures for monitoring activities of foreign subsidiaries, agents, distributors, resellers and suppliers
4:45 Conference Concludes
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