On 24 March 2021, the EU Member States agreed to begin negotiations with the European Parliament concerning a legislative proposal on health technology assessment. Health technology includes medicinal products, medical devices or medical and surgical procedures, as well as measures for disease prevention, diagnosis or treatment used in healthcare ...
Research and development ("R&D") of medicinal products is fundamentally important in peoples’ daily lives. This is true both from an individual perspective – when considering the objective of identifying and treating pathologies (with a consequent increase in the quality of life of patients) – and from a collective perspective, when considering the role of R&D in controlling the spread of diseases and in eradicating them altogether ...
Two of the most prominent arbitral institutions globally, the London Court of International Arbitration and the International Chamber of Commerce, have recently updated their rules to modernise and streamline the way in which arbitrations are administered. The changes are designed to increase efficiency, flexibility and transparency and to embrace the growing use of technology in business today ...
Food producers can breathe a sigh of relief, at least temporarily, thanks to efforts by the California Chamber of Commerce resulting in a preliminary injunction barring the State of California and all private plaintiffs from filing any new Proposition 65 lawsuits targeting acrylamide in food and beverage products. On March 31, 2021, Chief United States District Judge for the Eastern District of California, Kimberly J ...
In Facebook v. Duguid, (Case No. 19-511) on April 1, 2021, the United States Supreme Court unanimously confirmed that equipment without the capacity to randomly or sequentially store or produce numbers is not an autodialer for TCPA purposes. The Facebook ruling focuses on text messages, which many institutions are using as a primary method of customer contact, but it is also a victory for those using predictive dialers and preview dialers without random and sequential source codes ...
The grounds for appealing an arbitration award are limited. Even when the tribunal admits that it has made a mistake that is not always enough. So, when is an admitted error serious enough to permit an appeal? This was the question before the court in Doglemor Trade Ltd and others v Caledor Consulting Ltd and another [2020] EWHC 3342 (Comm). The Facts Mr Khabarov (majority owner of Caledor) was granted an option to purchase 30% of the share capital of Doglemor ...
Wellbeing, selfcare is key in order to give the world the best of you, not what’s left of you…. Shoosmiths’ Learning & development Manager, Yvonne Oakenfull gives us an insight into HeartMath – how different patterns of the heart activity have different effects on your thoughts and behaviours ...
In our last issue of the newsletter, we told you of a decision of the United States Circuit Court for the Sixth Circuit, in which the Sixth Circuit considered the issue of whether a party waived its arbitration right through its pre-litigation conduct. In Borror Property Management, LLC v ...
Phasing is one of the key factors to consider and get right in planning for large scale, strategic development. A well-phased scheme divides the site into distinct parcels of land allowing reserved matters to be submitted and conditions discharged in relation to each parcel, individually, as it comes to be developed. It also allows planning obligations in section 106 Agreements to be apportioned between parcels and (in some cases) to be attached and limited to particular parcels ...
ENSafrica recently released Africa Regulatory Insight: Coronavirus (COVID-19) Regulatory Measures. This comprehensive report outlines the COVID-19 regulatory measures for each country across Sub-Sahara Africa, providing the sector, measure, effective date/status and key points and impact for each region. The information provided herein is intended to provide a general overview, and is not an exhaustive list of all legislatice developments across Sub-Sahara ...
The DIFC Court of First Instance has, for the first time in its history, issued a judgement allowing the examination of witnesses resident in the UAE pursuant to two requests for judicial assistance (Letters Rogatory) from the District Court of the State of Minnesota, USA (the US Court). The judgement, issued by Justice Robert French, clarifies the scope of Rules 30.65, 30.66 and 30.67 of the Rules of the DIFC Courts (the RDC) ...
Understanding the Employer's Entitlement to Liquidated Damages When there is Sectional Completion - ǼLEX Legal .avada-select-parent .select-arrow{background-color:#ffffff}.select-arrow{background-color:#ffffff} It is common for parties in commercial construction projects to include sectional completion provisions in their contracts where they have agreed to complete works in sections or phases ...
(Antelope Valley Groundwater Cases, JCCP No. 4408 (3/16/21))[1] After twenty-two years, the protracted proceedings in the Antelope Valley groundwater adjudication resulted in a settlement and court-approved "physical solution." A physical solution equitably allocates available water under California's laws governing water rights. The physical solution in Antelope Valley limited pumping to balance the overdrafted aquifer with the available native safe yield ...
On March 22, 2021, through a televised address, the President of the Republic announced the strengthening and extension of the Social Protection Network, destined to mitigate the adverse effects caused by the restrictions due to the COVID-19. These measures are based on 5 pillars: • Greater protection to the families’ incomes. • Strengthening of the middle-class support. • Greater job protection ...
Beginning of Stage 2 of the National Vaccination Plan The Colombian Ministry of Health and Social Protection (Minsiterio de Salud y Protección Social) declared the initiation of stage 2 of the National Vaccination Plan against COVID-19 for the population between 60 and 79 years of age. This does not mean that vaccination for those over 80 years of age will be stopped; these people will continue to be vaccinated without any interruption ...
President Biden signed the American Rescue Plan Act of 2021 (the Act) on March 11, 2021. The Act provides COBRA premium subsidies, increases the tax-exclusion amount for employer-sponsored dependent care assistance programs and expands who may be eligible to receive premium tax credits for marketplace coverage. This alert explains how these provisions may impact your welfare benefit plans. Please contact your Dykema benefits attorney to explore the new provisions in greater depth ...
It has been said that, sooner or later, everything old is new again. In the wake of the novel coronavirus pandemic (COVID-19) sweeping the globe in 2020, a heretofore largely overlooked and even less understood nineteenth century legal term has come to the forefront of American jurisprudence: force majeure ...
Now that we have persevered through one year of the COVID-19 pandemic, much has been written about pandemic fatigue and associated social isolation, mental stress, and anxiety. Employers may be seeing an increase in the incidence of mental illness claims in their workplaces ...
As a reminder to our life sciences clients including drug manufacturers, medical device manufacturers, and group purchasing organizations, all Open Payments data from the 2020 program year must be reported to CMS by no later than March 31, 2021. Organizations that participate in the Open Payments program are also reminded that they must submit a final attestation that their data is timely, complete and accurate in addition to reporting data from fiscal year 2020 ...
Competition & Antitrust Resolution No. 237/2021 of the Secretariat of Commerce: New prices information regime for companies (SIPRE) By Agustín Waisman and Mercedes Pando Through Resolution No ...
On 14 March 2021, the law of 5 March 2021 on certain rules for the implementation of Regulation (EU) No 2019/1150 of the European Parliament and of the Council of 20 June 2019 on promoting fairness and transparency for business users of online intermediation services (the “P2B Regulation”) (hereinafter the “Law”) entered into force ...
The EB-5 Immigrant Investor Program is one that attracts its fair share of attention, not all of it good, and too much of it from organizations named with that part of the alphabet — SEC and DOJ — that can strike fear in the heart of a business person. And Texas is often the center of the investigators’ focus ...
Courts nationwide have struggled for years with the question of when a subjective opinion is false under the False Claims Act. The Supreme Court’s decision to deny review of two cases involving health-care providers that had allegedly submitted false claims for payment based on subjective clinical judgment still leaves us without a uniform, national answer, says Nicholas A. Danella. The U.S ...
In one of the latest and most high-profile decisions from across the country relating to commercial tenants’ rent obligations during the COVID-19 pandemic, the United States District Court for the Southern District of New York rejected an attempt by The Gap, Inc. (“Gap”) to excuse payment of such obligations due to the pandemic and related government restrictions ...
