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Focus on Regulation

Congress Eliminates Obama-Era Regulations on Teacher Preparation Programs

President Trump signed into law on March 27 a joint resolution to nullify U.S. Department of Education (ED) regulations relating to teacher preparation programs pursuant to the Congressional Review Act (CRA).  As noted in its Statement of Administration Policy, the White House “strongly supports the actions taken . . . to begin to nullify unnecessary regulations” and highlighted the rule on teacher preparation programs as one that “impose[d] new burdensome and costly data reporting requirements on States and institutions of higher education.”

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General Election 2017: Comply with the Campaigning Rules

The 2017 General Election campaign is up and running.  There are strict rules on campaign spending by non-political parties during the 365 days leading up to a General Election, which apply retrospectively back to 9 June 2016 until 8 June 2017.  With businesses engaging with the British public about important political issues like never before, they will need to ensure that past and future publications, events and other activities during the regulated period do not inadvertently breach the widely-drafted regulations on controlled expenditure.  Read the full blog here.

New E.O. Reinforces President Trump’s “Buy American” Agenda

On April 18, 2017, President Donald Trump signed the executive order “Buy American and Hire American” aimed at maximizing the federal government’s use of goods, products, and materials produced in the United States.  The E.O. does not attempt to change existing law, but requires agencies to increase monitoring, enforcement, and compliance with Buy American Laws while minimizing the use of waivers.  The order also focuses on President Trump’s policy to protect the interests of United States workers and “Hire American.”  With an emphasis on the Trump Administration’s “Buy American” agenda, it will be more critical than ever for federal contractors and grantees to focus on their own compliance with domestic preference requirements. Continue Reading

Finger on the polls – May calls for snap General Election

UK Prime Minister Theresa May has today announced that she intends to trigger a General Election to take place on 8 June 2017. The announcement is the latest unexpected twist in an unpredictable 12 months in British politics.  What does this surprise development mean for the Brexit process?  Read the full blog here.

EMA seeks to support the use of patient registries and to improve dialogue between various stakeholders

 

In September 2015, the European Medicines Agency (EMA) launched the initiative for patient registries. The purpose of the initiative is to improve the benefit-risk evaluation of medicinal products for human use. The EMA’s initiative for patient registries focuses mainly on the ways in which existing patient registries could be improved. This could be systematically considered by regulators and pharmaceutical companies when collecting regulatory data.

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European Commission publishes recommendations concerning the summary of product characteristics and patient information leaflet for medicinal products

 

The European Commission (EC) has published a report (Report) recommending improvements in the summary of product characteristics (SmPC) and the Patient Information Leaflet (PIL) of medicinal products for human use. The report identifies shortcomings concerning the SmPC and the PIL, and provides recommendations on the way in which SmPC and PIL could be improved.

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Regional Accrediting Agency Proposes Ban on Paying Recruiters of International Students

On March 27, the Middle States Commission on Higher Education (“Middle States”) released for public comment a draft policy on its expectations for honesty and truthfulness in published information and in student recruitment practices. Among other things, the policy would prohibit Middle States-accredited institutions from paying commissions to agents to recruit international students. Middle States is accepting public comment on the policy through April 17, 2017. Continue Reading

Sky full of drones – Germany opens up for new drone opportunities as it introduces its new UAS Regulation

Germany has introduced a new “Regulation for the Operation of Unmanned Aircraft Systems” (“Drone-Regulation“). On 7 April 2017, the new Drone-Regulation entered into force adapting national legislation to the risk-based approach of the European Union and setting the way for innovative technologies. However, the new rules also contain identification and qualification obligations as well as strict authorisation requirements for specific operations of Unmanned Aircraft Systems (“UAS”).

Some aspects of Germany’s new UAS regulations parallel the Federal Aviation Administration’s (“FAA”) Small UAS Rule (Part 107) that went into effect in the United States last August. Similar to the rules adopted by the FAA, Germany’s new UAS regulations place general restrictions on operating UAS beyond visual line of sight (“BVLOS”) and limit operations over people. Notably, however, Germany’s new regulations also provide a pathway for authorizing more advanced commercial UAS operations that go beyond the scope of the regulations in circumstances where it is safe to do so. This is similar to the waiver process adopted by the FAA in Part 107 for authorizing operations beyond the scope of the rule. Continue Reading

Court Upholds DOJ Antitrust Lawsuit Challenging Carolinas HealthCare System’s Anti-Steering Provisions

Despite a recent decision by the Second Circuit suggesting that anti-steering contractual provisions in other industries may not be anticompetitive, DOJ’s lawsuit (United States v. Carolinas HealthCare System) against Carolinas HealthCare System’s (CHS’s) contracting practices continues forward after surviving a motion for judgment on the pleadings. On March 30, a North Carolina federal judge found that DOJ’s lawsuit targeting CHS’s direct and indirect anti-steering provisions preventing insurers from steering patients to lower-cost providers alleged plausible antitrust violations and should continue to discovery.

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