In June 2022, at one of the annual meetings of the Employment, Social Policy, Health and Consumer Affairs (“EPSCO”) Council, health ministers expressed their concerns regarding the legislative transition to Regulation (EU) No 2017/745 of the European Parliament and of the European Council of 5 April 2017 on medical devices (“MDR”) and to Regulation 2017/746 of the European Parliament and of the European Council of 5 April 2017 on in vitro diagnostic medical devi
The insurer incorrectly notified the insured of the general conditions of insurance. Could this result in the insurer being required to pay compensation, even though the general conditions of insurance state that there is an exception excluding the insurer’s liability? In our practice, we encountered an issue surrounding the need to notify the insured of the general conditions of the insurance contract ...
During the COVID-19 pandemic, questions about employee health-privacy-related symptoms, testing, and vaccination became prevalent in discussions about the workplace at all levels—from “the water cooler” to national news ...
Key Points AB 890 gave Nurse Practitioners who meet certain requirements authority to practice more independently. The bill created two categories of Nurse Practitioner—one that may perform delineated functions without the use of standardized procedures in certain clinical settings where physicians and surgeons practice and another that may perform these functions and more outside of such clinical settings ...
On September 23, Kudun and Partners were invited by TrustLaw, the charitable arm of Thomson Reuters, to be the legal experts in their Legal Health Check Workshop. The core objective of the event was to raise awareness of how law firms, like Kudun and Partners, can work with TrustLaw to provide pro bono legal services to NGOs, Civil Society Organizations (CSOs) and social enterprises (SEs). Chai Lertvittayachaikul and Emi Rowse (Igusa), partners of Kudun and Partners, presented at the event ...
Any dog owner whose hound has ever become stuck down a rabbit hole will appreciate the aphorism, “Never get into anything you don’t know how to get out of”. Like a rabbit hole, getting out of the insurance business tends to be less straightforward than getting in. For that reason, specialist “run-off” carriers offer exit solutions to insurers who have ceased writing new business ...
Acquisition of intended exclusively for the production of parenteral bags INFARMED - the Portuguese National Authority for Medicines and Healthcare Products (“Infarmed”) has recently adopted Decision 089/CD/2022, concerning the regulatory framework for the acquisition of medicines without a national Marketing Authorisation (“AIM”), intended exclusively for the production of parenteral bags ...
Regulation (EU) 536/2014 of the Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use introduced additional requirements for the labelling of investigational and auxiliary medicinal products, in particular, for unauthorised medicinal products, in order to eliminate divergences in approach among Member States ...
“Government efforts to manipulate markets and prices on consumer goods never work as intended, and in this case, would be counterproductive.” The waning days of summer signal the approaching midterm election season. Amid inflation, recession and voter discontent, it’s understandable that a group of congress members are anxious to put points on the board with a price-control scheme that they wrongly believe will lower prescription drug prices ...
While their advent was initially hailed as a revolution for the creative industries, non-fungible tokens (“NFTs”) appear to have lost significant steam over the past months with the Wall Street Journal reporting that NFT sales have dropped by 92% over September 2021 figures ...
On 31 August 2022, the UK COVID-19 Inquiry (“the Inquiry”) opened its second Module. Module 2 will examine the political and administrative decision making of the UK and devolved governments, with a particular focus on early 2020 ...
At the time, most captive owners (and their advisers) were attracted by Bermuda's perceived economic, social and political stability, its strong infrastructure, its close proximity to New York and a legal system that tended to follow the English common law and provided for an ultimate right of appeal to the Privy Council in the U.K ...
One of the main rationales for using a cash box structure is that equity securities issued by PLC are issued for a non-cash consideration so that the statutory pre-emption provisions set out in the UK Companies Act 2006 do not apply. The issue can therefore take place without the timing implications of seeking shareholder approval to disapply the pre-emption rights or conducting a pre-emptive issue ...
pOver the last several years, traditional insurance has become increasingly expensive as insurers use risks and claims associated with the COVID-19 pandemic, geopolitical risk, supply-chain disruption, inflation and intensifying severe weather events to justify premium raises and coverage reductions ...
With regulations imposing mandatory vaccination for certain workers in the care sector being implemented to those same regulations being revoked some four months later, employers in this sector may well be confused as to what options are available to them ...
On the 5th August 2022, the Malta Financial Services Authority (hereinafter referred to as “the MFSA”) issued a Circular on the amendments to: the Glossary of Terms, Chapter 5 of the Insurance Rules and the Insurance Business (Exemptions) Regulations ...
As all court cases do, the Supreme Court's landmark decision in West Virginia v. EPA last month addressed a specific question: whether the Environmental Protection Agency had the statutory authority to shut down power plants and reshape significant parts of the energy sector in its effort to reduce emissions. The answer was a plain and simple no. Equally clear was the court's argument, which has implications for administrative actions well beyond this case ...
Proposal for a regulation of the European Parliament and of the Council on standards of quality and safety Current regulatory framework and scope of application The EU regulatory framework on substances of human origin (“SoHO”) is reflected in Directives 2002/98/EC for blood and 2004/23/EC for tissues and cells ...
