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Focus on Regulation

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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We have moved all content related to Pharmaceutical, Biotechnology, and Medical Device and Technology regulations to the new Hogan Lovells knowledge platform Engagewhich will give you the legal and regulatory insight and analysis you need, from across our global network, when you need it.

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We are gradually moving all other blog content to Engage as well, but while we are making this transition, you will continue to be able to find all other content (that is not related to pharmaceutical, biotechnology, or medical device and technology regulations) on this website.

We value your loyal readership and look forward to seeing you on Engage!

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.

Engage is coming: A new home for Medical Devices, Pharmaceutical & Biotechnology News!

Dear reader,

On December 2, we will begin publishing all content related to Medical Devices, Pharmaceutical, and Biotechnology regulations on our new knowledge platform: Hogan Lovells Engage.  We are gradually moving all other blog content to Engage as well, but while we are making this transition, you will continue to be able to find all other content (that is not related to pharmaceuticals, biotechnology, or medical devices) on this website.

Engage gives you the latest legal and regulatory news and provides our clients with insights and analysis for their business, from across our global network, when you need it.

We value your loyal readership and look forward to seeing you on Engage – Be on the lookout for our launch email!

Algorithms in the spotlight of antitrust authorities

Joint study by the Bundeskartellamt (German Cartel Office) and the Autorité de la concurrence (French Competition Authority) indicates need for higher compliance standards

Digital ubiquity, and the resulting rules, do not only concern tech giants. To the contrary, digital regulation is relevant for companies in all market sectors (see our recently published global study on regulation in digital markets – A Turning Point for Tech). The ever-growing amount of data and its use inevitably involves the use of artificial intelligence and in particular algorithms. On the one hand, algorithms have increasingly become key in making (digital) business models more successful, efficient and innovative by creating significant competitive advantages.

On the other hand, algorithms can also have a negative competitive impact as they might be used by companies to facilitate collusion. Consequently, it is not a surprise that antitrust authorities, especially in Europe, have their radars set, even though there are still very few precedents. Continue Reading

European Commission provides clarification regarding the implementation of the Clinical Trials Regulation

1.               Introduction

The European Commission has published an updated Questions and Answers document concerning the Clinical Trials Regulation (EU) 536/2014. The document provides clarification regarding the implementation of the rules governing clinical trials within the Regulation. The draft document has been submitted for discussion to the Expert Group on Clinical Trials. Continue Reading