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Common Sense Statements From The Second Edition Of The FCPA Guidance (With Commentary)

commonsense

Prior posts here, here, here, and here concerned the recent release of a Second Edition of the FCPA Guidance.

This post highlights various common sense statements from the Second Edition (nearly all of them appeared in the original Guidance as well – see here) and provides certain commentary.

“[T]he FCPA does not cover every type of bribe paid around the world for every purpose …” (Pg. 13). Even the DOJ and SEC acknowledge that the FCPA is a limited statute. Moreover, the word “bribe” does not even appear in the FCPA. Rather, specific elements must be satisfied for there to be a violation of the FCPA’s anti-bribery provisions.

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This Week On FCPA Professor

ThisWeekPost

FCPA Professor has been described as “the Wall Street Journal concerning all things FCPA-related,” and “the most authoritative source for those seeking to understand and apply the FCPA.”

Set forth below are the topics discussed this week on FCPA Professor.

As highlighted here, the Second Edition of the FCPA Guidance contains several false statements and is full of selective information and half-truths.

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FCPA Professor Turns 11

Eleven

In 2009, FCPA Professor was launched with this simple mission statement.

Eleven years and 3,200+ posts later, FCPA Professor is still here and the mission remains the same.

What started out in 2009 as a “blog” has turned into a comprehensive website that has been described as “the Wall Street Journal concerning all things FCPA-related,” and “the most authoritative source for those seeking to understand and apply the FCPA.” Along the way, FCPA Professor has been named a Top Law Blog for in-house counsel by Corporate Counsel, a Top 25 Business Law Blog by LexisNexis, and a top 100 Legal Blog by the American Bar Association.

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Clinical Trials

clinicaltrial

The recent enforcement action against Novartis (the second time the company has resolved an Foreign Corrupt Practices Act matter) concerned, in part, a clinical trial.

According to the DOJ’s information, the “clinical trial scheme” involved Novartis Greece making “improper payments to HCPs [healthcare professionals] related to an epidemiological study intended to increase sales of certain Novartis-branded prescription drugs.” According to the information, Novartis Greece “falsely recorded these payments … as advertising and promotion expenses in Novartis Greece’s internal accounting records.”

The SEC’s administrative order further found: “Novartis Korea employees in the neuroscience business unit devised a local non-interventional clinical study with 17 pre-selected HCPs to improve relationships with those HCPs. The study was organized in May 2013 through a local medical journal with Novartis Korea providing the list of HCPs to participate and the $100,000 funding necessary to complete the study. Novartis Korea recorded the funding to complete the study as advertising expenses and failed to have the study reviewed and approved by medical affairs as required by internal procedures.”

As highlighted below, prior to the Novartis enforcement action several other FCPA enforcement actions also referenced clinical trials.

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