News & Analysis as of

Compliance Department of Justice (DOJ) Novartis

Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations. ... more +
Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations.  In response to many corporate scandals evidencing rampant unethical business practices, many nations, including the United States, began passing strict regulatory frameworks aimed at curbing these abuses. Notable pieces of legislation in this area include the U.S. Foreign Corrupt Practices Act (FCPA), Sarbanes-Oxley (SOX), and the U.K. Bribery Act, to name a few. The foregoing statutes and the severe penalties often associated with them form the basis of many modern institutional compliance programs. less -
The Volkov Law Group

Incentives and Disincentives as the New Engine of Effective Compliance (Part I of III)

The Volkov Law Group on

Some were surprised by the recent move by the Department of Justice in focusing on the importance of incentives and disincentives as an important factor in an effective ethics and compliance program. Others, however, had been...more

Skadden, Arps, Slate, Meagher & Flom LLP

DOJ Introduces Novel Theories of Liability and Requires Unprecedented Controls in Speaker Program Settlement

Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - About the Enforcement in Life Sciences Series - Recent settlements between the U.S....more

The Volkov Law Group

2020 Year in Review: Interesting Enforcement Actions (Part III of IV)

The Volkov Law Group on

DOJ and the SEC each had a great year in FCPA enforcement.  But it is important to acknowledge that the blockbuster case, Goldman Sachs, was the driver of this successful year. ...more

The Volkov Law Group

2020 FCPA Review: Another Record Year for Enforcement (Part I of IV)

The Volkov Law Group on

The Justice Department and the Securities and Exchange Commission had another record year of enforcement.  In fact, the last four years of FCPA enforcement included two years of record enforcement – 2019 and 2020.  After...more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 6 – Final Thoughts

We are nearing the end of this exploration of two major corruption enforcement actions involving the pharmaceutical giant Novartis. One in the US and one for the rest of the world....more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 4 – CIA Structural Requirements

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more

Arnall Golden Gregory LLP

CIA Imposes Requirements for Pharmaceutical Speaker Programs and Events

On July 1, 2020, the United States Department of Justice (DOJ) announced two settlements with Novartis Pharmaceuticals Corporation (“Novartis”), resolving allegations that the company had paid illegal kickbacks to physicians...more

The Volkov Law Group

Novartis Settles False Claims Act Cases and Pays $729 Million for Domestic Bribery Schemes

The Volkov Law Group on

We have a new poster-child for a defective corporate culture of wrongdoing.  Novartis has joined the exclusive club, along with Siemens, General Motors, Wells Fargo, and others in the misconduct Hall of Fame. ...more

A&O Shearman

Global Healthcare Company To Enter DPA, Pay $345 Million To DOJ And SEC, To Resolve FCPA Claims

A&O Shearman on

On June 25, 2020, Novartis AG, a global healthcare company headquartered in Switzerland, and two of its subsidiaries (one current and one former) agreed to pay a total of $345 million in disgorgement and fines to the U.S....more

The Volkov Law Group

Novartis and Alcon FCPA Enforcement Action: Lessons Learned (Part III of III)

The Volkov Law Group on

At the outset, Novartis is “lucky” – the settlement is relatively positive, despite its 2016 SEC enforcement action in China.  Given Novartis weak culture of compliance (if anything, a better description may be a culture of...more

The Volkov Law Group

Novartis and Alcon Settle FCPA Violations for $345 Million (Part I of III)

The Volkov Law Group on

Even during this difficult time of the pandemic, economic uncertainty and social unrest, the Justice Department and the SEC have concluded a major FCPA enforcement action....more

The Volkov Law Group

Episode 148 -- A Review of the Novartis and Alcon FCPA Enforcement Action

The Volkov Law Group on

Even during this difficult time of the pandemic, economic uncertainty and social unrest, the Justice Department and the SEC have concluded a major FCPA enforcement action. Novartis and Alcon (which was a Novartis subsidiary...more

Baker Donelson

Update on Regulatory Compliance in the Global Health Care Industry

Baker Donelson on

A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more

A&O Shearman

Shearman & Sterling’s Recent Trends and Patterns in the Enforcement of the Foreign Corrupt Practices Act (FCPA)/FCPA Digest -...

A&O Shearman on

Shearman & Sterling’s bi-annual Trends & Patterns in FCPA Enforcement report provides insightful analysis of recent enforcement trends and patterns in the US, the UK and elsewhere, as well as helpful guidance on emerging best...more

The Volkov Law Group

Headlines from Mid-Year FCPA Enforcement Review

The Volkov Law Group on

Just to add my voice to the cottage industry surrounding FCPA enforcement and compliance, I wanted to take a deep breath and offer some observations on FCPA enforcement in 2016. There are a few significant headlines...more

Dorsey & Whitney LLP

Dorsey Anti-Corruption Digest - April 2016

Dorsey & Whitney LLP on

Welcome to Dorsey & Whitney’s monthly Anti-Corruption Digest. In this digest, we draw together news of enforcement activity throughout the world and aim to reduce your information overload. Our London, Minneapolis, New York...more

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