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International Regulatory Enforcement

Key Takeaways from the Novartis $345 Million FCPA Settlement
On Thursday, June 25, 2020, the United States Department of Justice (“DOJ”) announced a pair of deferred prosecution agreements with one current and one former subsidiary of Swiss pharmaceutical giant Novartis AG to resolve criminal Foreign Corrupt Practices Act (“FCPA”) allegations to the tune of a combined $233 million. In a parallel resolution, Novartis AG agreed to pay the Securities and Exchange Commission (“SEC”) $112 million to settle charges that it violated the FCPA in connection with misconduct by its subsidiaries. Novartis’s combined $345 million resolution represents the largest FCPA resolution of this calendar year since the monumental Airbus resolution in January, as well as the third largest FCPA resolution of all time in the life sciences industry. Additionally, this resolution is the second time within the last four years that Novartis AG has fallen under regulatory scrutiny for alleged FCPA misconduct; it reached a $25 million resolution with the SEC in March 2016 related to two of its Chinese subsidiaries. With Thursday’s resolution, Novartis is the first FCPA recidivist manufacturer in the pharmaceutical sector.
Enhancing Workforce Confidence in Internal Investigations
While each company will have different approaches to reviewing potential policy and regulatory breaches, we offer five steps that companies can take right now to enhance workforce confidence in internal investigations.
CFTC Paying for a Company's Dirty Laundry: New Whistleblower Initiatives and Rewards Suggest Increased Enforcement in the Virtual Currency, Foreign Corrupt Practices, Insider Trading, and BSA Spaces
The Commodity Futures Trading Commission (“CFTC”) recently issued a series of four whistleblower alerts aimed at seeking information from would-be whistleblowers in the areas of virtual currency fraud, foreign corrupt practices, insider trading, and violations of the Bank Secrecy Act (“BSA”). These alerts suggest that the CFTC seeks to further incentivize whistleblower cooperation—particularly in areas typically policed by the Financial Crimes Enforcement Network (“FinCEN”) and the U.S. Department of Justice (“DOJ”)—consistent with the CFTC’s previously stated intent to focus its investigative resources on foreign corruption and increasingly active enforcement activity in the virtual currency space.
U.K. Serious Fraud Office Issues New Cooperation Guidance
The U.K. Serious Fraud Office issued new "Corporate Cooperation Guidance" on 6 August 2019, setting out a range of different considerations the agency will use to assess a company's cooperation when making charging decisions or supporting a company's application for a Deferred Prosecution Agreement. The Guidance represents a shift in approach and an attempt to provide more clarity and specificity as to the factors that the SFO will take into account when assessing whether a company's management has adopted a "genuinely proactive approach" after learning about the offending. This more pragmatic position under new SFO Director Lisa Osofsky moves closer to the policies and practices of the U.S. Department of Justice. However, differences remain and companies ought to carefully consider their position before seeking to make a voluntary disclosure to the SFO or embarking on an internal investigation if an SFO investigation is already underway.
"Respectful Consideration": Supreme Court Clarifies Deference Due to Foreign Governments Interpretation of Its Law
Animal Science Products, Inc. v. Hebei Welcome Pharmaceutical Co., the Supreme Court held that federal courts should not accept as binding a foreign government's representation regarding the meaning of its laws. In the aftermath of this ruling, parties engaged in international litigation before U.S. courts that raise questions of foreign law should not rely exclusively on a foreign government’s characterization of its laws. Instead, those parties should be ready to retain foreign-law experts and to present other evidence supporting their construction and application of those foreign laws.
The Privilege to Conduct an Internal Investigation
After almost a year and a half of uncertainty caused by the judgment of Justice Andrews in SFO v. ENRC, the Court of Appeal, led by Sir Brian Leveson, yesterday steadied the ship, restoring the eminently sensible position that, subject to the particular facts, documents created in the course of an internal investigation, including notes of interviews conducted by lawyers, are capable of being covered by litigation privilege, in circumstances where a criminal investigation or prosecution is a real likelihood.
DOJ May Rely on FCPA Policy in Resolving Securities and Financial Fraud Cases
On March 1, 2018, senior DOJ representatives stated that the DOJ will use the Foreign Corrupt Practices Act Corporate Enforcement Policy as nonbinding guidance in non-FCPA criminal cases. This potential shift in approach could impact a corporation's determination as to whether, and how, to cooperate with the DOJ in criminal fraud investigations.
A New Enforcement Agency Joins the World of International Corruption Enforcement
Historically, enforcement of violations of the FCPA has been the exclusive domain of the DOJ and the SEC. In the past few years, that paradigm has shifted, with numerous countries beginning to enforce their own anti-corruption laws and increasing the risks for companies operating globally. Companies now have another enforcement agency for which to prepare: on March 6, 2019, the CFTC announced its foray into the world of enforcement of foreign bribery violations and adopted a standard well familiar to FCPA practitioners in determining under what circumstances the CFTC may decline to impose civil penalties for foreign corrupt practices: self-report, cooperate, and remediate.