Anti-Corruption Compliance in the Pharmaceutical and Medical Devices Industry
Under the Foreign Corrupt Practices Act of 1977, the United States Department of Justice and the Securities and Exchange Commission are investigating and prosecuting alleged bribery and corruption overseas by US pharmaceutical and medical device companies.
These law suits have generated global interest in stronger enforcement of anti-corruption and bribery laws and the addition of new regulations in several countries.
Many countries now require greater transparency and more ethical business practices. However, many multi-national companies remain unsure of or misinterpret the regulations of countries, fail to develop robust compliance programs, or fail to train employees, exposing them into significant legal risks nationally and globally.
- Recent Developments (US) (Lead: Frank) -
- Recent FCPA enforcement trends- Phillips, Stryker, other cases; focus on foreign health or licensing officials as public officials
- Increased use of DPA agreements, common clauses
- Increase in individual prosecutions
- Self-reporting and possible impact, e.g., Ralph Lauren
- Challenges with foreign subsidiaries covered by US statutes, aggressive assertion of US jurisdiction based on wires from US accounts, e-mails through US servers
- Recent Developments (International) (Lead: Cori) -
- Recent UK Anti-Bribery and other foreign country (China, Argentina, UAE) corruption law trends
- GSK as a model for a potentially compounding problem (China, Iraq, Poland)
- Risks with vendors, distributors, meeting planners and other third parties
- Trends in Chinese enforcement, including scrutiny of pharmaceutical and medical device manufacturers
- Audit Issues (Lead: Jeremy) -
- Developing a structured control environment:
- Gap and readiness assessments
- Defined audit schedule built around FCPA / UK Anti-bribery / local laws
- Capturing third parties (e.g., vendors, distributors), etc. in audits and during the due diligence process
- Common internal controls unique to the international pharma, medical device context
- Employee/Contractor T&E and cash compensation issues
- Using data analytics and surveys to assess risk environment, detect and proactively monitor
- Developing a structured control environment:
- Best Practices (Lead: Joe) -
- How to proactively identifying risks and compliance/healthcare fraud/corruption exposure
- Education and training
- Process Improvements – continuous monitoring and testing to evaluate effectiveness
- Implications from disclosure of payment information from Sunshine Act
- Going Forward/Lessons Learned – closing remarks Frank, Cori, Jeremy and Joe
Who Should Attend:
- Medical Device Regulatory Officers
- Pharmaceutical Regulatory Officers
- Multi-national Company Lawyers
- Multi-national Company Human Resources Personnel
- Multi-national Sales and Marketing Staff
Frank Burke, a partner in Foley & Lardner’s San Francisco office, works in a wide variety of areas, including white collar defense and counseling in the life sciences and health care industries. He defends companies and individuals against alleged criminal and civil antitrust, securities, FCPA, health care and pharmaceutical violations, export controls and government contracts violations and False Claims Act matters. He represents clients in trials, grand jury, agency and internal investigations, including parallel civil and criminal proceedings and in developing compliance programs. He is a former Assistant U.S. Attorney. He is a member of the firm’s Government Enforcement, Compliance & White Collar Defense Practice and the firm’s Health Care, Life Sciences and Technology Industry Teams. He is a graduate of Cornell University where he graduated Magna Cum Laude in Economics, and Harvard Law School.
Frank Burke, a partner in Foley & Lardner’s San Francisco office, works in a wide variety of areas, including white …
Cori Lable is currently a senior associate in the Boston office of Ropes & Gray. In July 2014, she will assume the position of Counsel and become resident full-time in Ropes’ Hong Kong office. Cori concentrates her practice in defending multinational organizations in a variety of government investigations, enforcement actions, and related complex civil litigation, and has extensive experience advising on potential violations of the Foreign Corrupt Practices Act, False Claims Act, Food, Drug, & Cosmetic Act, Anti-Kickback Statute, and Stark Law. Cori has represented multiple major pharmaceutical and medical device manufacturers in federal criminal investigations into the companies’ marketing practices and relationships with physicians. She has also led over a dozen FCPA internal investigations in China, Malaysia, and Taiwan relating to commercial sales, marketing, and distribution issues in the pharmaceutical industry. In 2012, Cori was a senior member of the trial team defending a major medical device company against a 13-count felony indictment in federal court in Massachusetts; after one day of testimony, the government dismissed all felony charges against her client in exchange for a plea to a single-count, no-intent misdemeanor.
Cori received her JD from Yale Law School in 2004.
Cori Lable is currently a senior associate in the Boston office of Ropes & Gray. In July 2014, she will …
Jeremy Perisho is a partner and leader of the Life Sciences & Health Care industry practice at Deloitte Financial Advisory Services LLP (“Deloitte FAS”).
Jeremy has more than 25 years of experience with Deloitte and has served as client service and engagement partner on Financial Advisory Services projects for some of the leading global companies in the life sciences industry. In particular, she has wide-ranging experience in handling both internal and government investigations of corruption and health care fraud, as well as SEC accounting investigations. Jeremy assists clients navigating risks associated with the Foreign Corrupt Practices Act (“FCPA”) and anti-corruption laws, including identifying exposure resulting from interactions with distributors, healthcare professionals and other government officials or third parties. She also advises clients on enforcement matters related to off-label promotion, aggregate spend regulations and implications of health care reform. Prior to joining Deloitte FAS, she served as a financial statement audit partner with Deloitte & Touche LLP focusing on global life sciences engagements.
Jeremy is an active leader in several professional industry organizations and is a frequent speaker on health sciences and women's leadership topics in the United States and abroad. She is also a member of the American Institute for Certified Public Accountants. She holds a BS in accounting from the University of Connecticut and is a graduate of the Simmons College Leading Edge program.
Jeremy Perisho is a partner and leader of the Life Sciences & Health Care industry practice at Deloitte Financial Advisory …
Joseph Moreno is a special counsel in Cadwalader's Business Fraud and Complex Litigation Group, where he represents corporate and individual defendants under grand jury investigation and at trial. Joseph is a former federal prosecutor with the Department of Justice in the National Security Division, where he focused on investigating and prosecuting money laundering and terrorist financing investigations. He has extensive experience counseling clients on internal investigations and compliance programs with respect to the Foreign Corrupt Practices Act, the Bank Secrecy Act, and the Commodity Exchange Act. Joseph has a JD/MBA from St. John’s University, a BA from Stony Brook University, and is a Certified Public Accountant. He is admitted to practice as an attorney in New York and the District of Columbia, and as a solicitor in England and Wales.
Joseph Moreno is a special counsel in Cadwalader's Business Fraud and Complex Litigation Group, where he represents corporate and individual …
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About Foley & Lardner LLP
Foley & Lardner LLP is a full-service law firm providing comprehensive legal services to an international clientele. With 20 offices worldwide, we serve clients in business and government, including Fortune 500 companies. In the recent BTI Consulting Group survey of Fortune 1000 corporate counsel, Foley received a Top 10 ranking out of more than 500 firms for its strong client focus, breadth of service, innovation, and value for the dollar. In addition, Foley was a Top 10 firm on the U.S. News – Best Lawyers® 2010 “Best Law Firms” list, based on the total number of first-tier metropolitan rankings. The firm continues to be a perennial selection for the prestigious CIO-100 List, CIO Magazine’s survey recognizing technological innovation that enhances business value. Learn more at Foley.com.
About Ropes & Gray LLP
Ropes & Gray, a global law firm with more than 1,100 lawyers and professionals, has a rich history of achieving success for the world’s leading businesses, educational institutions and technology innovators from offices in the world’s major centers of business, finance, technology and government – Hong Kong, Shanghai, Tokyo, Seoul, London, New York, Washington, D.C., Boston, Chicago, San Francisco and Silicon Valley. The firm has consistently globally ranked practices in private equity, M&A, finance, investment management, hedge funds, life sciences, health care, intellectual property, litigation, securities litigation and government enforcement.
About Deloitte Financial Advisory Services LLP
At Deloitte, we focus on helping clients transform their strategic vision into innovative, practical health care solutions that support their business goals today and tomorrow. The mission of Deloitte’s Life Sciences & Health Care practice is to work with our clients to help shape the new health economy and the roles they play within it. Drawing on more than 70 years of Life Sciences & Health Care experience, we offer wide-ranging, customized services and solutions designed to help our clients in their efforts to capitalize on opportunities and tackle their most pressing and complex challenges.
About Cadwalader, Wickersham & Taft LLP
Established in New York in 1792, Cadwalader, Wickersham & Taft LLP is a leading advisor to corporations and financial institutions, providing innovative solutions to complex legal issues. With offices in strategically located financial and governmental centers, the firm is well positioned to offer top-flight services to clients conducting business across the globe.