News & Analysis as of

Bribery Medical Devices Pharmaceutical Industry

Hogan Lovells

China’s healthcare compliance guidelines: insights and actionable steps for life sciences companies

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In January 2025, China’s State Administration for Market Regulation (“SAMR”) introduced the Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (“Guidelines”), marking the first...more

DLA Piper

China Releases First-of-its-kind Compliance Case Handbook for Life Sciences Companies

DLA Piper on

The Shanghai Administration for Market Regulation (AMR) has released a set of illustrative sample cases under the Compliance Guidelines for Pharmaceutical Companies to Prevent Commercial Bribery Risks (《医药企业防范商业贿赂风险合规指引》)...more

Hogan Lovells

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

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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

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

Jones Day

China Finalizes Its First Anti-Corruption Guidelines for the Health Care and Life Sciences Industry

Jones Day on

On January 14, 2025, China's State Administration for Market Regulation ("SAMR"), the primary regulatory agency in China for overseeing market supervision, issued its Compliance Guidelines for Health Care Companies to Prevent...more

DLA Piper

Navigating China's Healthcare Compliance Landscape: New Guidelines to Mitigate Commercial Bribery Risks

DLA Piper on

China's State Administration for Market Regulation (SAMR) has released the draft Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (Draft Guidelines) for public comment. The Draft Guidelines,...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

ArentFox Schiff

Investigations Newsletter: DOJ Files Complaint in AWP False Claims Act Suit Against Pharmaceutical Ingredient Seller 

ArentFox Schiff on

DOJ Files Complaint in AWP False Claims Act Suit Against Pharmaceutical Ingredient Seller - On November 8, 2021, the Department of Justice (DOJ) announced that it intervened in a qui tam suit and filed a False Claims Act...more

Hogan Lovells

CRO Engagement: A compliance checklist to identify red flags and prevent bribery compliance risks

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The engagement of Clinical Research Organizations (CROs) by pharmaceutical and medical device companies to manage some or all of their clinical trial-related duties and functions is becoming more and more relevant as the...more

Patrick Malone & Associates P.C. | DC Injury...

Questions aplenty about medical device-makers paying doctors $3.6 billion

Although Big Pharma has taken deserved heat for selling its drugs by slathering doctors with cheesy tchotchkes, lavish or even cheap meals, and pricey trips, as well as lucrative consulting and speaking opportunities, medical...more

Stinson LLP

Is Your Prior Authorization Program Demonstrably Compliant?

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A recent settlement announced by DOJ serves as a good reminder of the need for device and pharmaceutical manufacturers to periodically revisit their prior authorization assistance programs, to assure that the programs are...more

Thomas Fox - Compliance Evangelist

Corruption in China: Part 2 – The Bribery Schemes

After a sidetrack into the ethical train wreck detailed by the SEC Cease and Desist Order re: KPMG yesterday, I am returning to the blog post series I am running based upon the New York Times (NYT) reporting by Alexandra...more

Hogan Lovells

U.S. and Brazilian Authorities Reportedly Cooperating in Investigation of Alleged Bribery and Price Fixing Related to Medical...

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In a May 17, 2019 press report that has been widely distributed in Brazil and the United States, Brazilian Federal Prosecutor Marisa Ferrari confirmed that the U.S. Federal Bureau of Investigation (FBI), the U.S. Department...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Thomas Fox - Compliance Evangelist

Stryker FCPA Enforcement Action: Compliance Lessons For Distributors and Dealers – Part II

Over this two-part blog post series, I have been considering the Stryker Corporation 2018 Foreign Corrupt Practices Act (FCPA) enforcement action brought by the Securities and Exchange Commission (SEC)....more

The Volkov Law Group

Anti-Corruption Risks and Drug and Device Companies

The Volkov Law Group on

For years, the Justice Department and the Securities and Exchange Commission touted the FCPA “sweep” of the pharmaceutical and medical device industries. With good reason, DOJ and the SEC turned the drug and medical device...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

The Volkov Law Group

The FCPA Enforcement Run Continues into 2017

The Volkov Law Group on

Just when we thought 2016 was over and we could all breathe a sigh of relief, DOJ and the SEC have continued to run with a string of new enforcement actions. To all of those prognosticators, paparazzi, commentators, chicken...more

The Volkov Law Group

GSK Settles SEC FCPA Case for $20 Million

The Volkov Law Group on

The SEC finished with the last nail in GSK China’s coffin by announcing a $20 FCPA million settlement for GSK’s violations in China. The Justice Department declined to prosecute this case. In 2014, a Chinese court...more

Thomas Fox - Compliance Evangelist

The Oscar Meyer Wiener Theme and Revisiting GSK in China

Last week a true American original died when Richard Trentlage passed away. If you do not know his name you certainly know signature contribution to American culture, the Oscar Meyer Weiner Song. Rather amazingly Trentlage...more

Morrison & Foerster LLP

Top Ten International Anti-Corruption Developments for June 2016

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

King & Spalding

New Anti-Corruption Laws on the Health Care Sector in Germany: Is There Any Impact on the Food Industry?

King & Spalding on

Germany recently adopted new anti-corruption laws that now criminalize “taking bribes in the health care sector” and “giving bribes in the health care sector.” These new laws have implications for certain segments of the food...more

The Volkov Law Group

Drug and Medical Device Corruption Risks in China

The Volkov Law Group on

Medical device and pharmaceutical companies know the risks of conducting business in China. Company after company has had to settle FCPA enforcement actions in China. Many of these enforcement actions include fact patterns...more

The Volkov Law Group

Four Clear Messages from Bristol Meyers Squibb FCPA Enforcement Action

The Volkov Law Group on

The SEC’s FCPA enforcement action for $14.6 million against Bristol Meyers Squibb (“BMS”) in China provides a textbook example of how things can go wrong in China. For the compliance practitioner (as well as CEO and...more

Mintz - Health Care Viewpoints

Avoid the Anti-Corruption “Blacklist:” Chinese Agency Guidance

On March 1, 2014, Circular No. 50, which the Chinese National Health and Family Planning Commission (NHFPC) recently promulgated to regulate the conduct of pharmaceutical and medical device companies that do business in...more

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