The Danish Regions have proposed a new model for establishing a so-called Treatment Council which is to assess whether the price of treatments and health technology measure up to the effect for the patients. The model will now go out for consultation. The purpose and scope In their proposal, the Danish Regions want to establish a Treatment Council which is to make recommendations regarding the use of medical devices and health technology ...
The Danish Government's Growth Team has just Presented its Recommendations for how to Strengthen Denmark's International Position within Life Science. This happened at a Press Conference with the Participation of the Chair of the Growth Team, Kåre Schultz and the Minister for Industry, Business and Financial Affairs, Brian Mikkelsen ...
On 21st July 2022, the COVID-19 Inquiry was opened. Module 1 will consider the extent to which the risk of a Coronavirus pandemic was properly identified and planned for and whether the UK was ready for that eventuality. In broad terms, the module will look at the UK’s preparedness for whole-system civil emergencies, including resourcing, the system of risk management and pandemic readiness ...
The recent COVID-19 Inquiry's public consultation on its draft terms of reference has captured a substantial amount of public engagement; balancing the representation of all affected groups and avoiding lengthy delays looks like a real challenge. Baroness Hallett’s draft terms of reference (draft terms), published on 11 March, requested the views of individuals and organisations by 7 April on the scope of the COVID-19 Inquiry ...
Shoosmiths’ Public Inquiries team is delighted to present a series of podcasts in respect of reflections and experiences of the COVID-19 pandemic. Hosted by Hayley Saunders and Alex Friston, we are delighted to be joined by a variety of speakers, each bringing something different to the table in relation to impacts, views and then thoughts towards the Public Inquiry, which is set to commence its first public hearings on 13 June ...
On 21 July 2022, Baroness Heather Hallett issued an opening statement in respect of the COVID-19 Inquiry ('the Inquiry'). As Chair, Baroness Hallett expressed her determination to “run the Inquiry as thoroughly and as efficiently as possible” and “to undertake and conclude the work of this Inquiry as speedily as possible so that lessons are learned before another pandemic strikes ...
SVW has, across its offices, been giving guidance to clients both under English and Norwegian law as to the Coronavirus impact on shipping contracts, including on force majeure and similar exceptions clauses, and contract frustration. Read our recent publication, touching upon these issues. The Covid19 Virus Only two months have passed since the novel coronavirus was detected in Wuhan, China ...
Scotland is currently home to one of the largest life science clusters in Europe, with more than 700 organisations based here employing some 37,000 people. With 15 universities producing highly skilled graduates; the NHS as a massive single source of patient data; and world leading research centres in life sciences, Scotland attracts some of the brightest international scientists and life science businesses ...
The Centers for Disease Control and Prevention has expanded the definition of close contact to now evaluate exposure cumulatively over a 24-hour period such that “15 cumulative minutes of exposure at a distance of 6 feet or less can be used as an operational definition for contact investigation,”[1] Because the newly expanded definition is not limited, it impacts many different industries (inclu
On October 21, 2020, the Center for Disease Control (CDC) published a new guidance for use by contact tracers that clarifies what had been a somewhat fuzzy definition of “close contact.” The new definition increases the number of individuals presumed to have an exposure to COVID-19, and will significantly affect schools and workplaces since those presumptively exposed individuals will be asked to isolate for a period of 14 days ...
On Wednesday, April 26, 2017, the Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. et al., a landmark case that many hope will provide clarity and guidance for consumers and the pharmaceutical industry on the regulatory approval pathway for biosimilar drugs under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA” or “Biosimilars Act”) ...
In its priorities note for 2023, the Belgian Competition Authority (“BCA”) listed the pharmaceutical and health care sector as one of it major interests. It noted that “in the coming months, the BCA will also devote additional attention and resources to the continued consolidation in the hospital sector ...
On March 25, 2020, Governor Jim Justice signed into law House Bill 4497, which shall be known as The Alex Miller Law. The Alex Miller Law will take effect June 5, 2020, but the mandated requirements do not take effect until the 2021-2022 school year. Alex Miller, was a Roane County football player who collapsed and died during a high school football game. The Alex Miller Law (W. Va. Code 18-5-25c) requires defibrillators (AED devices) at certain events by the 2021-2022 school year ...
Both the Belgian legislator and government have played an active role in 2023 when it comes to pharma legislation, which has led to a number of changes in the legal framework. In this article, we look back and discuss five noteworthy developments in Belgian pharma law. 1 ...
The 2020 Investment Priorities Plan (2020 IPP) has been promulgated by the Philippine President under Memorandum Order No. 50 dated November 18, 2020 (https://www.officialgazette.gov.ph/downloads/2020/11nov/20201118-MO-50-RRD.pdf), and it became effective on December 6, 2020. The IPP is issued pursuant to the Omnibus Investments Code of 1987 (Executive Order No. 226), as amended (Omnibus Investments Code) ...
The ongoing COVID-19 pandemic crisis—infecting more than 2.7 million people worldwide, with almost 870,000 cases in the United States alone as of the writing of this article—has thrown nearly every industry into chaos as the world struggles to adjust to the new reality of social distancing and self-quarantining ...
The ongoing COVID-19 pandemic crisis—infecting more than 2.7 million people worldwide, with almost 870,000 cases in the United States alone as of the writing of this article—has thrown nearly every industry into chaos as the world struggles to adjust to the new reality of social distancing and self-quarantining ...
Historically, telehealth services were limited both in reimbursement and location. Most encounters took place for purposes of rural health treatment and in underserved areas as a way to get specialized treatment to patients in geographic locations where they would not otherwise have treatment options. The use of telehealth services has increased in recent years ...
Kudun and Partners represented Thammasat University with the preparation of the licensing agreement with Antitoxin GmbH, a German company founded in 1966 and specializes in the development of certified blood typing reagents for automated and manual applications ...
The third wave of COVID-19 is now spreading all over Thailand. The rise in confirmed numbers of cases and deaths has been reported by the Centre for the COVID-19 Situation Administration (“CCSA”). In response to the outbreak, the Ministry of Public Health announced a vaccination plan which ultimately aims to reduce the spread of COVID-19 infections by having around 50 million people (roughly 70% of the population) in Thailand vaccinated by the end of the year ...
Thailand’s government is on the process of launching a groundbreaking multiple-entry Medical Treatment visa (“non-MT visa“) with a generous one-year validity period, aiming to solidify its position as a premier international medical hub. The Subcommittee on Developing Thailand into a Medical Service Hub, authorized by the Ministry of Public Health, recently convened to craft the framework for this visionary visa program ...
On July 1, the Texas Supreme Court handed down an opinion that has the potential to impact any case where medical or health expenses are at issue. In the wake of the Court’s ruling, a plaintiff may not recover medical expenses for amounts that the plaintiff’s health providers bill but have no right to be paid. In addition, the Court held that such bills are inadmissible - including to show pain and suffering. Case Background and Issues Presented Haygood v ...
On September 25, 2015, the Texas Board of Pharmacy (“TBP”) issued proposed rules that will allow pharmacists to substitute interchangeable biological products for brand name drugs. Currently, Texas regulations only allow for the substitution of lower-priced, generically equivalent drugs instead of certain brand name drugs. In contrast, the proposed rules allow pharmacists to dispense interchangeable biological products ...
Governor Perry recently signed four bills into law designed to combat Medicaid fraud, waste, and abuse. The bills are a mixed bag of enhanced enforcement capabilities for the state and a few new protections for healthcare providers. Most notably, the legislature made several changes to the Texas Medicaid Fraud Prevention Act (TMFPA), bringing the statute more in line with the federal False Claims Act. Changes to the Medicaid Fraud Laws On the enforcement side, S.B ...
Texas is increasingly a purple political state. The motto of the state's capital city implores its citizens to keep it weird.[1] Recent polling shows that Texans overwhelmingly support medical cannabis.[2] Every one of Texas' neighboring states has a real medical cannabis program ...
