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Compliance Pharmaceutical Industry Corruption

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 -
Hogan Lovells

China’s first compliance guidelines to prevent corruption risks in the life sciences industry

Hogan Lovells on

On January 14, 2025, China issued the final version of its compliance guidelines for health care companies to prevent commercial bribery risks (“Guidelines”), which took effect immediately. The Guidelines are applicable to...more

Morrison & Foerster LLP

China Issues First Compliance Guidelines to Combat Commercial Bribery Risks - UPDATED February 2025

On January 10, 2025, China’s State Administration for Market Regulation (“SAMR”) put into effect its Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (“Compliance Guidelines”)....more

Faegre Drinker Biddle & Reath LLP

China Issues Final Compliance Guidelines in Regulating the Medical Industry

On January 10, 2025, China’s State Administration for Market Regulation (SAMR) officially released the Compliance Guidelines on Preventing Commercial Bribery Risks for Pharmaceutical Enterprises (the Guidelines). This...more

Paul Hastings LLP

Compliance as the Catalyst: ESG in Life Sciences

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Like many companies in other sectors, Life Sciences companies recognize that corporate social responsibility (CSR)–evaluated and measured by independent rating organizations and based on their compliance with any applicable...more

The Volkov Law Group

Justice Department Declines FCPA Prosecution Against Lifecore Biomedical Under Corporate Enforcement Policy

The Volkov Law Group on

The Justice Department has brought three corporate FCPA enforcement actions in 2023 (if you include the Ericsson DPA breach settlement).  With its recent announcement of a declination under the Corporate Enforcement Policy,...more

The Volkov Law Group

Too Big to be Accountable: The Big Case Dilemma

The Volkov Law Group on

Over the last twenty year (yes, 20 years), the Justice Department’s civil and criminal enforcement record has come under greater scrutiny.  Whether you call it “Too Big To Jail” or “Too Big to Fail,” questions continue to...more

The Volkov Law Group

Merit Medical Systems Settles False Claims Act Case for $18 Million (Part I of II)

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Medical device maker Merit Medical Systems (“MMS”) agreed to pay $18 million to resolve allegations that the company submitted false claims to Medicare, Medicaid and TRICARE by paying kickbacks to physicians and hospitals to...more

Morrison & Foerster LLP

Top 10 International Anti-Corruption Developments For July 2020

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 5 – The Whistleblower

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

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

Akerman LLP - Health Law Rx

Novartis’ Simultaneous Settlements Break Records

Novartis Pharmaceuticals Corporation (Novartis) has started July with significant settlements, putting two different fraud and abuse matters behind them. In what has been identified as the largest settlement of an...more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 3 – Compliance Failures

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

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 2 – The Corruption Schemes

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

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 1 – Introduction

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

Thomas Fox - Compliance Evangelist

Novartis FCPA Enforcement Action: Data Analytics and Lessons Learned

This blog post will close my review of the Foreign Corrupt Practices Act (FCPA) enforcement action involving the Swiss pharmaceutical company Novartis AG, its Greek subsidiary Novartis Hellas S.A.C.I. (Novartis Greece) and...more

Thomas Fox - Compliance Evangelist

Novartis FCPA Enforcement Action: Fines, Penalties and the Cost of Recidivism

This week I am reviewing the Foreign Corrupt Practices Act (FCPA) enforcement action involving the Swiss pharmaceutical company Novartis AG, its Greek subsidiary Novartis Hellas S.A.C.I. (Novartis Greece) and Alcon Pte Ltd.,...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

Thomas Fox - Compliance Evangelist

Novartis FCPA Enforcement Action: Internal Controls

This week I am reviewing the Foreign Corrupt Practices Act (FCPA) enforcement action involving the Swiss pharmaceutical company Novartis AG, its Greek subsidiary Novartis Hellas S.A.C.I. (Novartis Greece) and Alcon Pte Ltd.,...more

The Volkov Law Group

Novartis and Alcon: A Review of Bribery and Accounting Violations (Part II of III)

The Volkov Law Group on

Novartis and Alcon engaged in separate but significant bribery schemes.  Considering the fact that Novartis had a similar violation in 2016 in China involving much of the same conduct, Novartis’ conduct reflects a weak...more

Thomas Fox - Compliance Evangelist

Novartis FCPA Enforcement Action: The Bribery Schemes

This week I am reviewing the Foreign Corrupt Practices Act (FCPA) enforcement action involving the Swiss pharmaceutical company Novartis AG, its Greek subsidiary Novartis Hellas S.A.C.I. (Novartis Greece) and Alcon Pte Ltd.,...more

Thomas Fox - Compliance Evangelist

Novartis FCPA Enforcement Action: Introduction

Proving that the era of large Foreign Corrupt Practices Act (FCPA) enforcement action is not over, the Swiss pharmaceutical company Novartis AG, its Greek subsidiary Novartis Hellas S.A.C.I. (Novartis Greece) and Alcon Pte...more

The Volkov Law Group

2019 FCPA Enforcement Highlights (Part II of III)

The Volkov Law Group on

In a record year, there are bound to be numerous interesting enforcement actions and principles.  I picked out a few to highlight....more

Thomas Fox - Compliance Evangelist

Bribery Schemes from 2019 FCPA Enforcement Actions

In today’s blog post, I want to look at some of the more unusual bribery schemes from Foreign Corrupt Practices Act (FCPA) enforcement actions in 2019. Some of these schemes were not unusual but they were accomplished with...more

The Volkov Law Group

FCPA 2019: A Record Year in Enforcement and Compliance (Part I of III)

The Volkov Law Group on

Happy New Year!! In the FCPA arena, 2019 was a record year – in enforcement and compliance. Many continuing trends are becoming more than trends – meaning they are turning into established practices....more

Thomas Fox - Compliance Evangelist

Top Five Department of Justice FCPA Enforcement Actions in 2019

Welcome to the 2020’s. The past decade helped shape both Foreign Corrupt Practices Act (FCPA) enforcement and corporate compliance programs. 2019 FCPA enforcements bore out many of the developments from the preceding years of...more

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