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Long-Running Corruption Scheme Exposed in Brazil: Operation "Exposed Invoice" Provides Continuous Improvement Opportunity for...

by Pepper Hamilton LLP on

A massive scheme involving medical products sales to Brazilian public entities has led to recent high-profile arrests. The events highlight the importance to a well-functioning compliance program of keeping up with new...more

EU-U.S. Agreement for Mutual Recognition of GMP Inspections Entered Into Force

by Jones Day on

On March 4, 2017, the "Decision No 1/2017 of March 1, 2017, of the Joint Committee established under Article 14 of the Agreement on Mutual Recognition between the European Community and the United States of America, amending...more

Sally Yates’ was Already Famous for Changing the Focus of Compliance Investigations - The Yates Memorandum

by Ruder Ware on

By now the whole world knows about Sally Yates. We are likely to see a lot more of her as a central figure in Congressional investigations. For some of us who deal with compliance investigations, Sally Yates was famous long...more

Pro Te: Solutio - Vol.9 No.3 – Fall 2016

by Butler Snow LLP on

The Fall 2016 issue of Pro Te is about all things regulatory, including a peek at the newly developing issue of crowdfunding for medical devices. In EMA Guidance on Clinical Data Publication, we discuss recent guidance...more

Outsourcing of Services in the Medical Device Industry

As the medical device market continues to grow, the medical device industry has strived to reduce costs through outsourcing. An industry report has found that the global medical device outsourcing market was valued at $33.2...more

Tokyo Dispute Resolution & Crisis Management Newsletter – February 2017

by King & Spalding on

Product Pricing and Antitrust Law in the United States - A recent US court action by a Japanese company in respect of a competitor’s volume discounts - Introduction - The current position in the US on the rules...more

Restrictions on Advertising with Nutrition and Health Claims Apply to Both Communications Addressed to Consumers and to...

by King & Spalding on

The Court of Justice of the European Union (ECJ) held that the restrictions on promoting foodstuffs with nutrition and health claims not only apply to communications addressed to the general public but also to communications...more

The GDPR – Possible Impact on the Life Sciences and Healthcare Sectors

by Ropes & Gray LLP on

Regulation (EU) 2016/679 of the European Parliament and the Council of 27 April 2016, (the “GDPR”) came into force in May 2016 and introduced a number of changes to European data protection law. Such changes will impact upon...more

"OFAC Eases Restrictions on the Export of Medical Devices to Iran"

On December 22, 2016, the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) announced amendments to the general license (GL) that authorizes the export or re-export of certain medical devices to Iran....more

Happy New Year: OFAC Expands Exports of Medical Devices to Iran

by Bass, Berry & Sims PLC on

Effective December 23, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) amended the Iranian Transactions and Sanctions Regulations (ITSR) to expand the scope of medical devices that can be exported to...more

One Step Up: U.S. Export Controls for Pharma/Device Companies

by Arnall Golden Gregory LLP on

2016 was an active year for U.S. export control developments impacting U.S. pharma/device companies. We expect 2017 also to be busy, especially with the upcoming change in Administrations. This article briefly will review for...more

International News: Focus on International Dispute Resolution

by McDermott Will & Emery on

Overview of the Proposed Reforms of the EU Merger Control Regime - In October 2016, the European Commission launched a public consultation to continue the process of identifying possible areas of the EU Merger Regulation...more

Highlights from McDermott’s 2016 Pharmaceutical/Medtech Dealmaking Symposium

by McDermott Will & Emery on

On October 25, 2016, McDermott Will & Emery held its fifth annual Pharmaceutical/Medtech Dealmaking Symposium in Cambridge, Massachusetts. The day consisted of a series of thought-provoking panels with leading dealmakers in...more

Antitrust M&A Snapshot - October 2016

by McDermott Will & Emery on

UNITED STATES: Continuing an active first half of 2016, the Federal Trade Commission (FTC) and US Department of Justice (DOJ) have challenged several large mergers and acquisitions. In fact, trials for the two...more

"OFAC and BIS Implement Additional Amendments in Support of Cuba Policy Shift"

On October 14, 2016, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) and the Department of Commerce’s Bureau of Industry and Security (BIS) announced further amendments to ease U.S. sanctions and...more

Top Ten International Anti-Corruption Developments for September 2016

by Morrison & Foerster LLP on

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

Member States cannot impose uniform retail prices for prescription-only medicinal products, highest EU Court says

by White & Case LLP on

EU law precludes national legislation setting fixed retail prices for prescription medicinal products, as it unreasonably restricts imports - On 19 October 2016, the European Court of Justice issued a ruling concluding...more

U.S. Authorities Amend Cuba Sanctions Regulations

by Reed Smith on

On October 17, 2016, the U.S. Treasury Department’s Office of Foreign Assets Control (OFAC) and the Commerce Department’s Bureau of Industry and Security (BIS) issued new amendments to the Cuban Assets Control Regulations (31...more

GSK Settles SEC FCPA Case for $20 Million

by Michael Volkov 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

The Oscar Meyer Wiener Theme and Revisiting GSK in China

by Thomas Fox on

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

The Oman Update - 1162

by Dentons on

Amending MD 174/2014 Issuing the regulations on the work of establishments and companies that operate in contracting. Issued on 31 August 2016. Effective from the day after the date of publication....more

Put the Candle Back: the AstraZeneca FCPA Enforcement Action

by Thomas Fox on

I am back from a two-week summer study program at Oxford, run by Michigan State University through its Odyssey to Oxford program. It was a great experience. My class was on The Tudors in film and print so not only did I...more

Lessons Learned from AstraZeneca’s $5.5 Million SEC FCPA Settlement

by Michael Volkov on

Last week, the SEC added another pharmaceutical company to its list of FCPA violators when AstraZeneca agreed to a $5.5 million settlement with the SEC. AZ is now the 25th drug or medical device company to pay an FCPA penalty...more

Corporate Investigations and White Collar Defense - August 2016

Spotlight on the False Claims Act - Why it matters: This month, we review a recent Ninth Circuit case that allowed a qui tam relator’s action against various Medicare Advantage organizations to proceed, holding that the...more

Changes in Cuba May Impact the Insurance Industry

by Carlton Fields on

While much remains to be determined, the recent easing of U.S. restrictions on travel to and trade with Cuba may bring opportunities for U.S. and global insurance companies. However, many questions and obstacles remain. This...more

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