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Focus on Regulation

WRC-19 Revamps ITU Radio Regulations to Accommodate Emerging Communications Technologies

Communications technologies often evolve more quickly than the regulatory frameworks governing them. To keep pace, the International Telecommunication Union (ITU) World Radiocommunication Conference (WRC) revisits the ITU’s Radio Regulations governing radiofrequency spectrum use approximately every four years to accommodate new technologies and uses. Between WRCs, national administrations and ITU sector members (interested companies and trade associations, for example) meet in working parties to study how proposed rule revisions would impact existing and planned services.

Following four years of careful deliberations at the ITU working party level, more than 3,400 participants from 165 countries and ITU staff recently gathered at WRC-19 in Sharm El-Sheikh, Egypt. During the four-week conference, participants crafted regulatory pathways for emerging communication technologies, including a few listed below. Continue Reading

Updates on the newest regulatory legislation (Royal Decree 717/2019) in Spain

On 5 December 2019, the Official State Gazette of Spain published a new regulation passed by the Spanish government which has introduced many significant developments in the Spanish legal framework on medicinal products for human use, such as new obligations on marketing authorisation holders, further requirements on safety features for medicinal products, or the deletion of the Spanish category of “medicinal product under special medical monitoring”, among other important developments. This new piece of legislation is Royal Decree 717/2019, of 5 December 2019, amending Royal Decree 1345/2007, of 11 October 2007, on the authorisation procedure, registration and dispensing conditions for industrially manufactured medicinal products for human use.

Below we highlight five of the main developments introduced by RD 717/2019: Continue Reading

Germany opens online sports betting market for private operators on 1 January 2020

The third amendment to the German State Treaty on Gaming (GlüStV) will come into force on 1 January 2020. Private operators of online sports betting platforms will now be given the opportunity to apply for a licence for the operating of online sports betting in Germany. Unlike in the past, the number of licence holders is no longer limited. The application procedure will be carried out by the Regional Council Darmstadt from 2 January 2020. The Regional Council Darmstadt expects interested operators of online sports betting to submit their licence applications by 2 January 2020. Only in this case could the applications be decided on promptly. It is still unclear how long the licences issued by the Darmstadt Regional Council will be valid. This depends on the outcome of the current negotiations between the federal states regarding a further amendment to the GlüStV, which is to deal in particular with the regulation of online casino games.

Gaming law expert Prof. Dr. Thomas Dünchheim, Office Managing Partner in Düsseldorf, Head of Global Regulatory Continental Europe and Head of the Hogan Lovells Gaming & Gambling Law Initiative comments on the up-coming third amendment as follows: Continue Reading

European Commission publishes new documents regarding the Clinical Trials Regulation

1.            Introduction

Shortly after updating the related draft Questions and Answers document (see our blog), the European Commission has published two new documents concerning the Clinical Trials Regulation (EU) 536/2014. The first document is an informed consent and patient recruitment procedure template. The second document is an updated clinical trial Application Form. Continue Reading

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FCC Issues Public Notice on Spectrum Allocations for UAS Operations

The FCC recently issued a Public Notice that sought comment on whether to make the 960-1164 MHz and 5030-5091 MHz bands available to support unmanned aerial system operations (UAS).

The FAA Reauthorization Act of 2018 required the Federal Aviation Administration (FAA), the National Telecommunications and Information Administration (NTIA), and the FCC to submit a report to Congress on whether to allow UAS communications in these frequencies. The joint agency report must discuss: (1) whether the FCC should permit, but not require, UAS operations in these bands on an unlicensed, shared, or exclusive-use basis; (2) any technological, statutory, regulatory or operational barriers to the use of the spectrum for UAS purposes; and (3) recommendations of other spectrum bands if the agencies conclude that the 900 MHz and 5 GHz bands are not suitable to support UAS operations.

As part of the public notice soliciting public comment for the joint agency report, the FCC has also asked for public input on several related issues, including: (1) actions the FCC might take to promote the use of licensed commercial spectrum for UAS operations; (2) information on UAS applications and deployment scenarios wireless service providers and equipment manufacturers are considering; and (3) potential interference concerns and other technical issues associated with UAS operations that might inform the FCC’s decision making.

Comments are due Thursday, December 26, 2019, and reply comments are due Monday, January 27, 2020.

Use of ethanol in medicinal products: European Medicines Agency publishes guidance concerning safety information for the package leaflet

1.               Introduction

On 22 November 2019, the European Medicines Agency (“EMA”) published an updated Annex to the European Commission’s Guidelines concerning excipients in the labelling and package leaflet of medicinal products for human use. This updated Annex provides a list of the excipients for which specific information should appear in the package leaflet. The list includes Ethanol. In this context, the EMA adopted a guidance document concerning the package leaflet of medicinal products in which ethanol is used as an excipient.   Continue Reading

Highlights from the DigiHealth Leaders Conference: interoperability, reimbursement, patient centricity, and forging effective partnerships

DigiHealth Leaders ConferenceDigital health offers huge potential for improving care and alleviating the increasing burden on our over-stretched healthcare systems. However, its uptake remains slow and varies significantly across the EU.

The two daylong DigiHealth Leaders conference featured presentations, panel discussions and roundtable conversations on topics viewed as hurdles to the realisation of digital health’s potential. Hein van den Bos, a Partner in our Amsterdam office, delivered a presentation on how to navigate the EU and Member States’ regulatory approaches to digital health, and Jane Summerfield, Counsel in our London office, moderated a panel discussion on gaining traction and navigating regulatory pathways when scaling across borders.

Here we discuss a selection of the prevailing themes that were present throughout the conference. Continue Reading

FCC Announces Members of Precision Agriculture Task Force

The Federal Communications Commission (FCC), in consultation with the Department of Agriculture, announced the members of the Task Force for Reviewing the Connectivity and Technology Needs of Precision Agriculture in the United States (Task Force). The Task Force, an advisory body to the FCC, will investigate the current state of broadband access in agricultural lands and recommend policies and regulatory solutions to the FCC to promote broadband deployment and precision agriculture, standardize data collections, and target funding towards unserved areas.  The Task Force is also slated to identify ways for the Department of Agriculture and the FCC to collaborate to achieve these shared goals.

Teddy Bekele, Land O’Lakes Senior Vice President and Chief Technology Officer, will serve as Chair of the Task Force, and Catherine Moyer, Pioneer Communications Chief Executive Officer and General Manager, will serve as Vice Chair. A full list of members is included in this Public Notice. The first meeting of the Task Force is scheduled for Monday, December 9, 2019, at 9:30 am, and is open to the public.

In addition to announcing the members of the Task Force, the FCC released another Public Notice soliciting nominations for four working groups charged with assisting the Task Force. Those working groups are: (1) Mapping and Analyzing Connectivity on Agricultural Lands, (2) Examining Current and Future Connectivity Demand for Precision Agriculture, (3) Encouraging Adoption of Precision Agriculture and Availability of High-Quality Jobs on Connected Farms, and (4) Accelerating Broadband Deployment on Unserved Agricultural Lands.  The Public Notice provides instructions on eligibility for the working groups and how to submit nominations. Nominations to the working groups are due by Tuesday, December 3, 2019.