Medical Device Legal News with Sam Bernstein: Episode 11
The European Commission (EC) has published draft antitrust guidelines on exclusionary abuses (the Draft Guidelines) and is conducting a public consultation to gather feedback....more
The European Commission has published for public consultation its long-awaited draft Guidelines on exclusionary abuses (draft Guidelines). The draft Guidelines aim at making it faster and easier for the Commission to pursue...more
The Draft Guidelines set out the European Commission (EC)’s approach on exclusionary abuse by dominant undertakings. The EC is proposing a shift away from the effects-based approach set out in its earlier enforcement...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more
Article 5(3) of the EU ePrivacy Directive (ePD) requires consent for tracking cookies (unless exceptions apply). Although this rule is best known as the reason behind ‘cookie’ banners, it is technology neutral and applies to...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
On November 20, 2023, the UK’s Competition and Markets Authority (CMA) announced proposed reforms to its in-depth merger control review process (the phase 2 review) that seek to provide more opportunities for engagement with...more
Welcome to the October edition of the UK Tax Round Up. This month has seen the Supreme Court’s judgment on the operation of the employment-related securities deeming provision, the Court of Appeal’s decision on what...more
On 17 October 2023, the European Securities and Markets Authority (ESMA) published a statement (the Statement) clarifying the timeline for implementation of the Regulation on Markets in Cryptoassets ((EU) 2023/1114) (MiCA)...more
Antitrust enforcers remained active across the globe, with the announcement by the FTC and DOJ of proposed guidelines that have an emphasis on tech mergers in the United States, and several investigations of major tech deals...more
The global AI market was valued at $95.60 billion in 2021 and is predicted to reach $1.85 trillion by 2030, registering a compound annual growth rate of 32.9%. Alongside this growth and the proliferation of AI use cases...more
In Short - The Development: The European Commission ("EC") has published highly anticipated draft guidelines ("Draft Guidelines") detailing a new antitrust exemption for agreements in the agriculture and food supply chain...more
The updated guidelines (05/2021) from the European Data Protection Board (“EDPB”) issued on 14 February 2023 (the “New Guidelines”) look at the interplay of two fundamental, protective mechanisms contained in the EU GDPR....more
Specific compliance considerations apply to M&A transactions and public tenders. On 12 January 2023, the Foreign Subsidies Regulation (FSR) entered into force. The FSR empowers the European Commission (Commission) to...more
On February 6, 2023, the European Commission (EC) published a draft Implementing Regulation (the Implementing Regulation) setting out rules and procedures for the application of the Foreign Subsidies Regulation (FSR)....more
The Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) was signed into law alongside other reforms to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) on December 29, 2022, as part of a broader consolidated...more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
Summary and Background - On 11 May 2022, the European Commission (the “Commission”) published its draft proposal for a debt-equity bias reduction allowance (“DEBRA” or, the “Directive”), which forms part of the...more
MHRA LAUNCHES UK CLINICAL TRIAL REGULATION CONSULTATION - The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom),...more
Background - On 12 April 2022, the European Banking Authority (the “EBA”) announced the publication of its final draft Regulatory Technical Standards (“RTS”) specifying the requirements for originators, sponsors and...more
Research and development, innovation, product and service improvement, AI design and deployment...these are key commercial drivers for the successful modern business. They also underpin technological, medicinal, and other...more
On January 18, 2022, the European Data Protection Board (the "EDPB") issued the Guidelines 01/2022 on data subject rights - Right of access (the "Draft Guidelines"), laying out its interpretation of Article 15 GDPR on the...more
As part of its review of the EU antitrust rules governing vertical agreements, the European Commission (EC) has published for consultation a draft new section of its Vertical Guidelines, which contains proposed guidance on...more
The European Commission has published a new draft guidance with regard to exchange of information related to dual distribution. This draft guidance provides valuable dos and don’ts for companies concerning the information...more