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Health International Trade

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

Compliance into the Weeds-Episode 60, Cardinal Health and Joint GC-CCO Role

by Thomas Fox on

In this episode, Matt Kelly and I take a deep dive into the Cardinal Health corporate governance imbroglio. In it, a disgruntled shareholder, the Teamsters Pension fund brought a motion to have the CEO stripped of his title...more

Italian Regions cannot recommend against use of costly medicines – says highest administrative court

by Allen & Overy LLP on

A recent decision by the Italian Council of State (CS) comes as welcome news for the innovative pharmaceutical industry as it sets important boundaries to the initiatives that regional authorities can take in the attempt to...more

Australia aligns with the European medical device regulatory framework

by Dentons on

In July 2017, the TGA sought comments from interested parties to further align Australian and European medical device regulatory requirements to - - up-classify surgical mesh from Class IIb (medium to high risk) to...more

Big Pharma BI, CBI, and Service Interruption Claims Percolating in Puerto Rico

by Zelle LLP on

As recovery and rebuilding efforts drag on in Puerto Rico, Hurricane Maria’s impact on Big Pharma is radiating across the U.S., and around the globe as the dozens of drugs manufactured in Puerto Rico become scarce. Maria...more

CFDA Issues New Classification Catalogue for Medical Devices In China

by Morgan Lewis on

The new catalogue, which becomes effective on August 1, 2018, is likely to have a significant impact on the registration, manufacturing, operation, and distribution of medical devices in China. ...more

The UK Care Sector | Problem or Opportunity for Investors?

by McDermott Will & Emery on

For investors considering the UK care sector, the Care Quality Commission (CQC) State of Care report released 10 October 2017 again raises alarm bells. Beds in nursing homes declined meaningfully, and funding pressures are...more

EMA senior officer: pharmaceutical companies encouraged to prepare for Brexit

by Hogan Lovells on

Agnès Saint-Raymond, MD, Head of International Affairs at the European Medicines Agency (“EMA”), recently urged pharmaceutical companies to be “proactive” in preparing for Brexit, as there is still uncertainty around a...more

Window On Washington - This Week in the Nation's Capital - Vol. 1, Issue 31

by Clark Hill PLC on

Senate Adopts Budget Resolution Making Way for Tax Reform: The Senate on a party-line vote of 51-49 adopted its FY18 budget resolution that includes $5.1 trillion in spending reductions and instruction for reconciliation for...more

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

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