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International Trade Health

Read need-to-know updates, commentary, and analysis on International Trade issues written by leading professionals.

Compulsory Licensing of Biopharmaceutical Inventions

Very few topics in international intellectual property have been as controversial as compulsory licenses. While the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) sets minimum standards for...more

Alert: China Issues New Policy for Drug and Medical Device Approvals

by Cooley LLP on

On October 8, 2017, the General Office of the CPC Central Committee and the General Office of China's State Council jointly issued Opinions of the State Council on Promulgating the Reform of Review and Approval System for...more

Gig Economy Ripples From Across The Pond: An App For Healthcare Workers On Demand?

by Fisher Phillips on

Roughly 3,500 miles on the other side of the Atlantic Ocean, the British government is contemplating an idea which will marry the national healthcare industry with the gig economy. Such an idea could send a ripple toward the...more

IP and healthcare in South East Asia: “Bigger than BRIC”. So why aren’t you filing your patent applications there?

by FPA Patent Attorneys on

The South East Asian healthcare market is emerging as one of great importance, expected to experience faster rates of healthcare spending growth over the next 5 years than the BRIC (Brazil, Russia, India, China) countries...more

What’s New in Washington: 10 Things You Need to Know

Congress returned after Labor Day for a busy September and acted quickly to avoid a government shutdown by passing stop gap funding for Fiscal Year (FY) 2018 and raising the debt ceiling. The already crowded congressional...more

EMA publishes external guidance for clinical data publication

by Hogan Lovells on

On 22 September 2017, the European Medicines Agency (“EMA”) published an external guidance document concerning the implementation of Policy 0070 on the publication of clinical data for medicinal products for human use....more

Canada Institutes Certificates of Supplementary Protection for Approved Drug Products

On September 21, 2017, the Comprehensive Economic and Trade Agreement (CETA) signed between the European Union (EU) and Canada provisionally entered into force in Canada.  Among other things, this agreement seeks to harmonize...more

Unintended Consequences: Ex-U.S. Activities Impacting U.S. Federal Health Care Business

by Ropes & Gray LLP on

Given the uptick in global awareness and enforcement of anti-bribery and corruption laws, most health care companies are attuned to the risks associated with legal infractions caused by ex-U.S. activities. However, ex-U.S....more

ArthroCare CEO Reconvicted for Fraud

by Michael Volkov on

The healthcare industry continues to be a frequent target for criminal prosecutions. More importantly, federal prosecutors are ready, willing and able to bring criminal cases against C-Suite actors involved in healthcare...more

Rx IP Update - September 2017

by Smart & Biggar on

Federal Court of Appeal Applies Supreme Court’s Utility Test to SPRYCEL Patent - In its first decision to consider the Supreme Court of Canada’s landmark decision in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36...more

Window on Washington - This Week in the Nation's Capital - Vol. 1, Issue 28

by Clark Hill PLC on

White House to Request Emergency Supplemental Funding for Puerto Rico: The White House will submit an additional request to Congress in the next two to four weeks which is not expected to include any deficit restructuring...more

Window on Washington - This Week in the Nation's Capital - Vol. 1, Issue 27

by Clark Hill PLC on

Senate Again Delays Action on Remaining Appropriations Bill: The Senate has yet to schedule any mark-ups for next week for its remaining four appropriations bills (Clark Hill Insight). Senate Reaches Deal on Budget...more

Pfizer and Flynn Pharma fined €101 million for charging the UK health service excessive prices for Phenytoin sodium capsules, an...

by Dechert LLP on

The UK Competition and Markets Authority (“CMA”) recently published its infringement decision of 7 December 2016 that imposed a fine on Pfizer and Flynn Pharma (“Flynn”) for abusing their respective dominant positions by...more

Netherlands Adopts US FDA-based UDI System for Medical Devices

by Knobbe Martens on

A voluntary agreement (link in Dutch) was consummated by the Dutch Ministry of Health, industry, and hospitals. According to an Emergo blog post, under the terms of the agreement, the Netherlands will adopt the US Food and...more

EMA Updates Guidance Concerning Medicinal Products Intended Exclusively For Non-EU Countries

by Hogan Lovells on

The European Medicines Agency (“EMA”) has updated its guidance (Guidance) regarding procedural advice for medicinal products intended exclusively for markets outside the European Union (“EU”). The Guidance addresses several...more

International News: Focus on Health Care - Fall 2017

by McDermott Will & Emery on

Nationalism and Cross-Border M&A: Navigating Populist Politics in Deal Making - More than half of the G20 countries voted-in campaigns that focused on harming foreign, outside interests as a means to strengthen domestic...more

Drones Delivering Medical Supplies in East Africa but not in U.S.

Residents in remote areas of Tanzania and Rwanda in East Africa are receiving medical supplies through the use of drones, far surpassing similar efforts in the U.S., according to Robert Graboyes, a senior research fellow at...more

Japan Legal Update - Volume 28 | July 2017

by Jones Day on

Labor - Japanese Supreme Court Decision on Overtime Payments to Doctors - In a court case in which a doctor employed by a health care corporation sought extra pay for overtime and late-night work (collectively, "overtime"),...more

General Data Protection Regulation: What It Means For US Healthcare/Life Science Companies (Part Three)

Even though the GDPR is a general regulation, some provisions are expressly addressing the specificities of the processing of personal data in the healthcare/life science sectors....more

Window on Washington - This Week in the Nation's Capital - Vol. 1, Issue 23

by Clark Hill PLC on

CBO Confirms Size of Breach of Defense Cap for FY18 Bills: The House FY18 Omnibus Appropriations Bill scheduled to be taken up in September would bust the Defense cap by $72 billion. This would cause the Office of Management...more

General Data Protection Regulation: What It Means For US Healthcare/Life Science Companies (Part One)

The clock is ticking: on May 25, 2018, in less than a year from now, the General Data Protection Regulation (“the GDPR”) will apply in all Member States of the European Union (“EU”) and will replace the Directive 95/46/CE...more

General Data Protection Regulation: What It Means For US Healthcare/Life Science Companies (Part Two)

New General Features of the GDPR - Some of the GDPR general features may be of particular interest for companies in the healthcare/life science sectors....more

DOJ Announces Enhanced Enforcement of Healthcare FCPA Compliance

by Holland & Knight LLP on

The Department of Justice’s (DOJ) Criminal Fraud Section announced a new partnership between DOJ’s Healthcare Fraud Unit’s Corporate Strike Force and Foreign Corrupt Practices Act (FCPA) prosecutors. The partnership is meant...more

FDA Announces Import Staffing Change at International Mail Facilities

Earlier this month, The Washington Post reported that Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that he was reallocating three dozen employees to international mail facilities (IMF), as well as...more

Building a sound strategy against false advertising claims in Europe

by Hogan Lovells on

Advertising is a major expenditure for pharmaceutical companies launching new products, but in the cutthroat European market, companies often try to gain competitive advantage by accusing competitors of engaging in false...more

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