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Your daily dose of financial news - The Brief – 7.22.16

EU financial watchdog ESMA has fined rating agency Fitch Ratings Ltd. $1.5 million for reportedly violating the EU’s rules for rating agencies relating to the 12-hour requirement, internal controls, and unauthorized...more

Corporate Investigations and White Collar Defense - July 2016

“Official Acts”—What They Are… and Are Not - Why it matters: On June 27, 2016, the Supreme Court decided McDonnell v. U.S., holding that, for purposes of the federal public corruption statutes, an “official act”...more

FDA Deep Dive: Real Life Implications of FDA NEST Program Explored

In our Israel Connect Summer 2016 edition we summarized the FDA’s post-market surveillance data programs, including the NEST program designed to consolidate and analyze real-world device data once a device is legally...more

European Life Sciences Review: Issue 3

Welcome to the third issue of our European Life Sciences Review that covers some of the most critical developments in the pharmaceutical and medical technology sectors in the last month and is produced by our life sciences...more

New EU Rules for Medical Devices

After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies...more

China Issues Guidance Clarifying Core Tasks and Deadlines for Application of the Country’s Telemedicine System

The Chinese government has been in the process of modernizing its telemedicine law and policy and associated infrastructure for nearly 2 years now, to support broad, domestic application of telemedicine. We outline one of the...more

Three Questions with Former Senate Majority Leader Tom Daschle (D-SD), Founder and CEO of The Daschle Group, a Public Policy...

1. As we head into a new Administration and the new Congress, what do you see as the opportunities and challenges for the Affordable Care Act? The Affordable Care Act (ACA) is much greater than a single legislative action....more

Privacy & Cybersecurity Newsletter: July 2016

General Data Protection Regulation Update - As reported in the April Locke Lord Privacy & Cybersecurity Newsletter, the European Parliament gave the final approval to the General Data Protection Regulation (GDPR) on...more

28 Organizations Seek Clarification from President Obama Regarding Colombian Compulsory License -- U.S. Chamber of Commerce...

On July 5, 2016, we reported on two letters sent by two Senators and fifteen Representatives to Michael Froman, the U.S. Trade Representative ("USTR"), seeking clarification regarding the Administration's position on...more

Will the USPTO’s “Patents 4 Patients” Program Even Make It Off the "Cancer Moonshot" Launch Pad?

The White House recently announced the Cancer Moonshot Task Force, an effort to “focus on making the most of Federal investments, targeted incentives, private sector efforts from industry and philanthropy, patient engagement...more

EMA’s New Draft Guideline On Good Pharmacogenomic Practice - Implications For Personalized Medicine

Embracing personalized medicine, the European Medicines Agency (EMA) released a draft guidance document titled Draft Guideline on Good Pharmacogenomic Practice (“Guidance”) on good pharmacogenomic practice with the stated...more

Cuba an Untapped Market for Medical Device Exports

The United States is the world’s largest medical device exporter, according to reports accounting for $45 billion of over $140 billion in global exports in 2014. This is not surprising since it also produced the largest...more

The Supreme Court - June 2016 #4

The Supreme Court of the United States issued decisions in three cases on June 16, 2016: Universal Health Services, Inc. v. United States ex rel. Escobar, No. 15-7: Yarushka Rivera, a teenage beneficiary of...more

2016 Top Export Markets for U.S. Goods

Last week the Commerce Department’s International Trade Administration (ITA) released the second installment of its Top Markets Reports. The reports–nineteen different industries are highlighted in total–do an excellent job...more

Implications of Brexit for the mining and minerals sectors

The debate surrounding Britain’s proposed exit from the EU (Brexit) has primarily focused upon its potential impact on the British economy, Britain’s international standing and its capacity for self-governance. This article...more

IREG Update - Global pandemic emergencies: the insurance industry tackles a seemingly unmanageable risk

Global pandemic emergencies: the insurance industry tackles a seemingly unmanageable risk - On May 21, 2016, the World Bank Group announced the Pandemic Emergency Financing Facility (PEF), a new global financing...more

Colombian Organizations Send Letter to CEWG Regarding Imatinib Compulsory License

In letter from three Colombian organizations to the Chairman of the World Health Organization (WHO) 2016 Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) (posted on the...more

European General Data Protection Regulation to Apply from May 2018

In Depth - On 4 May 2016, the General Data Protection Regulation (GDPR), was published in the Official Journal of the European Union (L 119/1). It will apply from 25 May 2018, at which point it replaces the current legal...more

RECAP: Highlights from the Sixty-Ninth World Health Assembly in Geneva, May 23rd to 28th

Every year in May, the health ministers from all 194 World Health Organization (WHO) Member States meet at the WHO headquarters in Geneva to attend the World Health Assembly (WHA). As the decision-making body of WHO, the WHA...more

EU Reaches Deal on New Medical Device Regulations

The European Parliament and European Council recently jointly announced an agreement regarding new rules on medical devices and in vitro diagnostic medical devices. The process that lead to the agreement began in 2012. ...more

China Competition Authority Initiates Drug Pricing Investigation

On May 22, 2015, the National Development and Reform Commission (the NDRC) of China promulgated a notice (the Pricing Investigation Notice) announcing that it would carry out a nationwide drug pricing investigation on...more

Ukraine further simplifies the registration of medicinal products marketed in the US, the EU, Switzerland, Japan, Australia or...

As we reported in our previous alert, the Cabinet of Ministers of Ukraine has recently adopted Resolution No. 312 simplifying the registration of medicinal products marketed in the US, the EU, Switzerland, Japan, Australia or...more

EU Law Making Bodies Entered into an Agreement on the New EU Medical Devices Regulations on May 25, 2016

On May 25, 2016, the European Parliament, European Council and the European Commission agreed on new rules regarding the approval and surveillance of medical devices and in vitro diagnostics for the European market. The...more

USA vs. Europe: Patients Hang in Balance as Big Pharma Reports Drug Side Effects Differently to FDA, EMA

A newly published study shows that drugmakers are doing a disservice to patients by inconsistently reporting side effects of medications depending on whether the information is being filed with the U.S. Food and Drug...more

Ukraine simplifies the registration of medicinal products marketed in the US, the EU, Switzerland, Japan, Australia or Canada

On 20 April 2016 the Cabinet of Ministers of Ukraine adopted Resolution No. 312 amending the Procedure for State Registration (Registration Renewal) of Medicinal Products (the Procedure.) The changes took effect on May 13....more

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