FCPA & Anti-Corruption for the Life Sciences Industry

Opening Remarks from the Conference Co-Chairs

Mariana Kurlat
Senior Director, Anti-Corruption Program Office Lead
Pfizer

Jennifer H. Saperstein
Partner
Covington & Burling LLP

FCPA Enforcement in the Life Sciences Arena:

Emerging Liability Risks and New Enforcement Priorities Amid Covid-19

David Last
Assistant Chief, FCPA Unit, Fraud Section, Criminal Division
U.S. Department of Justice

Robert I. Dodge
Assistant Director, FCPA Unit
U.S. Securities and Exchange Commission

Bernard J. Cooney
Assistant United States Attorney
U.S. Attorney's Office, District of New Jersey

Hear from an esteemed panel of DOJ and SEC representatives on key topics, including:

• The agencies’ views on subsidiary liability in light of the Novartis settlement
• Deficiencies that led to the first FCPA recidivist in the pharma industry
• Deterring improper influence over foreign healthcare providers through sponsorship and hospitality
• Fostering a culture of compliance and adapting your anti-bribery/corruption program to the pandemic context

INTERACTIVE DISCUSSION – AUDIENCE POLLING

The Newest, Unwritten Rules for Third Party Due Diligence: How to Resolve the Most Industry-Specific Dilemmas

Kathleen M. Hamann
Partner
Pierce Atwood LLP

Jill Dailey
Vice President and Chief Compliance Officer
Incyte Inc.

Nancy S. Travis
Acting Chief of Staff
Vice President, Global Compliance & Governance
Advanced Medical Technology Association (AdvaMed)

With over 90% of FCPA enforcement actions involving third parties, ensuring adequate oversight of distributors and foreign subsidiaries continues to be a critical concern for life sciences companies.

Test your knowledge on the most vexing grey areas of third party due diligence. You will engage in 2 hypothetical exercises – participate in anonymous polling or turn on your audio and video to share your perspective with fellow participants.

PART I: SUB-DISTRIBUTORS

• How companies are tackling ongoing internal supply chain and vendor management challenges that preceded the pandemic
• Particular risks facing drug and medical device companies distributing products in key high-risk jurisdictions: Russia, China, and Brazil
• Mitigating bribery risks associated with the distribution of valuable Covid testing products and vaccines
• Due Diligence: How far to go and how much is enough

PART II: FOREIGN SUBSIDIARIES

• What constitutes adequate FCPA diligence in mergers and acquisitions?
• To what extent are companies responsible for the conduct of foreign subsidiaries and ongoing oversight of these entities?
• Upgrading your compliance program to better police your subsidiaries post-Novartis

Break

SPECIAL INTERVIEW WITH NOVARTIS

Reflecting on the 2020 Settlement and a Reimagined Approach to Ethics & Compliance

Robert N. Sikellis
Global Head Legal Investigations and US Head of Litigation
Novartis

Marc Hennes
Executive Director & Senior Litigation Counsel
Novartis

James M. Koukios
Partner
Morrison & Foerster LLP

• Navigating a multijurisdictional investigation
• Effectively communicating compliance enhancements to enforcement authorities
• Organizing a global investigations function

Digital Transformation for Anti-Corruption: Leveraging Data Analytics, Automation and Machine Learning to Prevent and Detect FCPA Violations

Ash Aggarwal
Senior Director, Compliance Excellence & Transformation
Astellas Europe

Parth Chanda
Founder & CEO
Lextegrity

Kate Kiesel
Global Health Care Compliance Officer
LifeScan

• Implementing end-to-end anti-corruption spend controls, from third party due diligence and HCP/HCO engagements to continuous spend monitoring
• How digital tools can drive greater effectiveness and efficiency in your FCPA compliance program
• How companies are working to satisfy the DOJ’s data analytics expectations using technology
• How technology can break down perennial data silos across multiple systems, functions and geographies

1:1 Peer-to-Peer Networking

Break

JOIN THE CONVERSATION

How to Measure the Effectiveness of Your Compliance Program: Industry-Specific Considerations

Joseph Mack
Senior Assistant General Counsel, Compliance and Investigations
Bayer U.S.

Mona Peterson Rosow
Sr. Director, Global Auditing & Monitoring
Medtronic

William Simmons
Head of Global Investigations; Associate Director, Ethics & Compliance
Lonza

Moderator:

David H. Resnicoff
Partner
Riley Safer Holmes & Cancila LLP

• What the DOJ’s June 2020 guidance changes and how life sciences companies are complying with it
• Perspectives on designing and operationalizing a compliance program that can resist prosecutorial scrutiny
• Assessing your compliance controls in an era of remote work
• How to evaluate your training and controls by means other than audits
• Ensuring that your program is aligned on paper and in practice

Turn on your audio and video during the latter part of the session to chat, compare notes, and share “war stories” with the speakers and fellow participants!

PUBLIC PROCUREMENT

Engaging with Foreign Governments and Providers Amid Covid-19: Special Considerations for the Sale of Medical Supplies and Vaccine Procurement

Derek A. Cohen
Partner
Goodwin Procter

Megan Gordon
Partner
Clifford Chance

The global pandemic has triggered unprecedented levels of negotiation with foreign governments. From Covid testing products to personal protective equipment, therapeutics, and vaccines, lack of access and critical need for these products creates fertile ground for bribery and corruption around the world. This session will address:

• Anticipated scrutiny of emergency spending that did not follow regular public bidding procedures
• The implications of the bribery schemes that occurred in relation to the Covid response
• Challenges facing vaccine manufacturers, suppliers, and their procurement intermediaries as they balance the need for speedy distribution with compliance considerations
• Additional bribery risks facing vaccine companies as they compete for market share
• Operational challenges in countries with national healthcare systems, where there is heightened contact with government officials in sales and licensing
• Considerations for retaining sub-distributors and tender agents for assistance in winning tenders
• Overseeing interactions with customs officials seeking bribes in light of pandemic-induced financial pressures on government

Break

SPOTLIGHT ON CLINICAL TRIALS

Determining When (and When Not) to Proceed with Clinical Trials Abroad: Managing Unique, Evolving Bribery Risk Factors

Jessica S. Pill
VP, Chief Compliance Officer
Boston Scientific

William B.F. Steinman
Senior Partner
Steinman & Rodgers LLP

• What the Novartis settlement teaches us about FCPA liability resulting from clinical trials
• Developing processes to determine the legitimacy of and need for clinical trials
• How to go about bridging the legal/technical divide
• Mitigating bribery risks when engaging local doctors in your clinical trials

TEST YOUR KNOWLEDGE: AUDIENCE POLLING

The Nuances of Sponsorship, Hospitality, and Advisory Board Membership of Foreign Healthcare Providers: What Companies are Now Doing to Strengthen Compliance

Peter G. Jensen
Global Chief Compliance Officer
Arthrex

Patrick F. Stokes
Partner
Gibson, Dunn & Crutcher LLP

Respond to panel questions confidentially in a user-friendly digital polling system. An effective way to compare your compliance and investigations practices to your peers across the globe!

• The impact of Covid-19 on the life sciences industry and practices for interacting with healthcare professionals and patient associations
• Responding to scrutiny over improper influence of healthcare providers through travel, gifts, entertainment – particularly in sponsorship of educational meetings and conferences
• Discerning when it is appropriate to retain a foreign healthcare provider for advisory services and compensate for their time
• Best practices for mitigating FCPA risk while staying on top of local legal requirements
• What level of due diligence is now required before outreach to an HCP?
• How companies are operationalizing controls around HCP conflicts of interest

Conference Concludes