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Health International Trade

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

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

Human Germline Genome Editing – Genetics bodies weigh in on debate with position paper

by Allen & Overy LLP on

In an article published in American Journal of Human Genetics on 3 August 2017, an international group of 11 organisations with genetics expertise has issued a joint position statement, setting out 3 key positions on the...more

Healthcare Industry May Not Be Prepared For Internet of Things

by Knobbe Martens on

A recent survey conducted by ZingBox, a Silicon Valley internet security startup, found that more than 90% of healthcare IT networks have Internet of Things (IoT) devices. The survey further found that more than 70% of IT...more

News from Abroad -- Briefing on Supplementary Protection Certificates for Medicinal Products

What are SPCs? A Supplementary Protection Certificate (SPC) is an intellectual property right available for active ingredients of human and veterinary medicinal products requiring marketing authorisation. Originally...more

EMA prepares plan to face Brexit

by Hogan Lovells on

European Medicines Agency (EMA) has released a business continuity plan dealing with the potential implications of Brexit. EMA, which is currently established in London, will be required to transfer the Agency’s headquarters...more

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

The exuberance of a November election victory for Republicans has given way to the difficult reality of passing legislation in a closely divided Senate. While the GOP has made significant gains in the area of regulatory...more

A Difficult Decision for EMA

by Hogan Lovells on

The bids to host the EMA are in! We have reviewed all of them and give you our personal impressions on what to expect. After the EMA has announced the development of a business continuity plan to deal with the workload...more

Investigations in the Healthcare Sector by the French Competition Authority: Drugmakers’ Potential “Excessive Pricing” At Stake

by Reed Smith on

French competition authority to start investigations into potentially “excessive prices” in the healthcare market in the next weeks, following increasing scrutiny across Europe. On 3 July 2017, the president of the French...more

Approved Biosimilar Products Around The world

Please see full chart below for approved biosimilar products around the world. ...more

Biosimilars in Europe

Europe has led the way globally with respect to biosimilar medicines since 2005. In that year, the European Medicines Agency (EMA) issued regulatory guidelines for the development and assessment of biosimilars....more

Journal of Nanobiotechnology Publishes Special Issue on Swiss National Research Program on the “Opportunities and Risks of...

by Bergeson & Campbell, P.C. on

The Journal of Nanobiotechnology published a special issue on the outcome of Switzerland’s five-year National Research Program on the “Opportunities and Risks of Nanomaterials” (NRP 64). The editorial states that the...more

Dietary Supplement & Cosmetics Legal Bulletin | July 2017

JAMA Study and Editorial Call for Improvements in Cosmetic Regulation and Surveillance - In response to a study analyzing adverse events for cosmetics and personal care products, the Journal of the American Medical...more

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

On June 30, Congress gaveled out for the July 4 recess after postponing a critical vote to begin debate on an Affordable Care Act (ACA) repeal-and-replace bill. Senate Majority Leader Mitch McConnell (R-KY) and the GOP caucus...more

Ministers Provide Insight on the UK's Position on the Regulation of Medicines post-Brexit

by Hogan Lovells on

With the negotiations for the UK’s withdrawal from the EU formally under way, the UK healthcare sector is calling on the UK Government to make patient safety and access to medicines a priority in negotiations – and it appears...more

New UK Brexit Health Alliance Formed

by Hogan Lovells on

A “Brexit Health Alliance” (BHA) has been formed to bring together a diverse range of UK stakeholders in the healthcare industry and provide a single voice for the sector on Brexit-related issues. Members of the BHA include...more

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