Legal Updates

The Pharma Legal Handbook Baltics

The Pharma Legal Handbook Baltics >> https://bit.ly/324EJz2 >> a comprehensive guide to the legal framework regulating the pharmaceutical sector and related industries! The Handbook is a valuable tool for pharma companies and practitioners operating in the pharmaceutical business to stay in compliance with the various regulations applicable to the industry:

  • Answers to the most critical questions about this environment for pharmaceuticals in Estonia, Latvia and Lithuania;
  • It is a must-have for any company operating in the country or seeking to enter the market.

The TGS Baltic team Dalia Tamašauskaitė-Žiliene, Sander Kärson, Ingeri Luik-Tamme, Andra Rubene, Audronė Ežerskė, Rokas Kazakevičius and Zane Skļamina have prepared a detailed article presenting: regulation, pricing, clinical and preclinical trials, marketing, manufacturing, trademarks, patents, and more!The Pharma Legal Handbook is an essential guide to the legal and regulatory environment for pharmaceutical companies worldwide.

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NYC Job Postings Must Include Salary Ranges Effective May 15, 2022

NYC employers will soon be required to include a minimum and maximum salary on all job postings for positions performed within the City. As we previously reported, the City Council passed Int. 1208-B (Law) on December 15, 2021, and due to new NYC mayor Eric Adam’s inaction within the 30-day veto period, it became a law as of January 15, 2022. Beginning May 15, 2022, the Law requires employers with four or more employees to include a “good faith” minimum and maximum salary range on for all advertised NYC job, promotion and transfer opportunities. Additionally, the Law makes the failure to include salary range an unlawful discriminatory practice under the City’s Human Rights Law.

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Kim Kardashian and Floyd Mayweather Sued Over Cryptocurrency Promotions

Kim Kardashian and Floyd Mayweather were sued in a class action lawsuit in the United States District Court for the Central District of California on January 7, 2022 over their promotion of the cryptocurrency token EthereumMax (EMAX). The celebrities were named as co-defendants with the creators of the cryptocurrency, and are alleged to have helped bilk millions from investors.

What is EMAX?EMAX was launched in May 2021. Soon thereafter, the creators of the token announced that they were partnering with Floyd Mayweather, including by acting as the exclusive cryptocurrency of a boxing match between Mayweather and Logan Paul and providing free items like Mayweather-signed boxing gloves in exchange for purchases of EMAX. According to class allegations, the trading volume for EMAX exploded after the press release, increasing ten-fold in the course of two days. Read more…

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MODIFICATIONS TO CANADA’S SPECIAL ACCESS PROGRAM: IMPLICATIONS ON MEDICAL ACCESS TO AMPHETAMINES, PSILOCYBIN, LSD AND MORE

Overview:

On January 5, 2022 the Canadian Government amended the Food and Drug Regulations to allow healthcare practitioners to apply, on a case-by-case basis, to the Minister of Health (the “Minister“) for special access to a certain class of “restricted drugs” including amphetamines, psilocybin and lysergic acid diethylamide (LSD). Further, the January 5, 2022 amendments simplify the framework of regulation over all forms of cocaine in Canada, thereby reducing complexity for stakeholders applying to conduct activities with cocaine (e.g. research).

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Small Change in Colorado Law Could Have Large Effect: Criminalizing Restrictive Covenants

Colorado statutory law has traditionally limited enforcement of restrictive covenants.  C.R.S. § 8-2-113, entitled “Unlawful to intimidate worker – agreement not to compete,” provides that all contractual restrictions on a person’s post-employment competitive activity are “void” unless they fit into one of four categories: (1) contracts for the purchase and sale of a business or the assets of a business; (2) contracts for the protection of trade secrets; (3) contracts providing for recovery of expenses of educating and training an employee who have served an employer less than two years; and (4) agreements with executives, management personnel, and their professional staff.  This statute applies not only to non-compete agreements, but also to agreements not to solicit customers or employees.  Most companies trying to defend their restrictive covenants do so under the exception to protect trade secrets or the exception for executives/managers/professional staff.

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2022 Update: Preparing for Non-Compete Litigation

Thomson Reuters Practical Law has released the 2022 update to “Preparing for Non-Compete Litigation,” co-authored by our colleague Peter A. Steinmeyer.

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Podcast: No Surprises Act: New Rules and Guidance for Stakeholders (Part 2) – Diagnosing Health Care

In this episode of the Diagnosing Health Care Podcast:  The Biden administration has released a series of rules and guidance to implement the No Surprises Act, which went into effect on January 1. All providers and facilities must now provide a good faith estimate to uninsured and self-pay patients scheduling appointments for services or upon request.

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A Year in Review: Top 10 Privacy, Cybersecurity & Data Asset Management Issues in 2021

Throughout 2021, we closely monitored the latest privacy laws and a surge of privacy, cybersecurity, and data asset management risks that affect organizations, small and large. As these laws continue to evolve, it is important for companies to be aware and compliant. We will continue to monitor these trends for 2022.

The attorneys of the Privacy, Cybersecurity & Data Asset Management group have written on a wide range of notable developments and trends that affect employers and health care providers. In case you missed any, we have assembled a recap of our top 10 blog posts of 2021, with links to each, below:

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CMS “Splits the Baby” on Aduhelm—Medicare Coverage But Only with Evidence Development for Now

On January 11, 2022, the Centers for Medicare and Medicaid Services (“CMS”) published an anticipated proposed National Coverage Determination (“NCD”) decision memorandum that begins the process of determining whether the Medicare program will cover FDA-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s Disease. (https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=305).

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CONFLICT BETWEEN APPLE AND EUROPEAN REGULATORS ON SIDELOADING

Although it is not clear when the fundamental EU digital market legislation—Digital Services Act and Digital Markets Act (DMA)—will enter into force (it is unlikely that this will happen before 2023), the mere publication of the drafts and the official European discourse are putting an increasing strain on the big players in digital services. The DMA establishes a long list of specific ex ante obligations for the so-called gatekeepers, i.e. providers of core platforms. These ex ante obligations are mainly aimed at protecting the business models of gatekeepers’ competitors (e.g. requiring business users to use any other core platform service to access core platform services is prohibited, etc.).

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