In recent years, the regulatory framework for human genetic resources ("HGR") in China has become increasingly mature ...
Recently, modifications announced by the Department of Health and Human Services (“HHS”) to 42 C.F.R. Part 2 (“Part 2”) rules governing Confidentiality of Substance Use Disorder (“SUD”) Patient Records went into effect. This is a major rule change for Part 2 providers and the enhanced penalties and enforcement measures make compliance with the new rules essential for any Part 2 provider ...
The United States is on the verge of one of the biggest, if not the biggest, transformations to marijuana policy in the last 50 years. According to an Associated Press report, the Drug Enforcement Administration (DEA) is expected to reschedule marijuana from a Schedule I drug to a Schedule III drug under the Controlled Substances Act (CSA) ...
Between September 2021 and May 2022, the words 'stress', 'mental health' and 'depression' appeared in more than 12,000 early conciliation or employment tribunal cases , demonstrating the prevalence of this subject matter in employment-related disputes. Today, more than ever, employers are expected to afford greater consideration to workplace conditions that do or could impact upon employees’ mental health ...
China's National Medical Products Administration (NMPA) released the 2023 Drug Review Annual Report on its official website on February 4, 2024, closely followed by the 2023 Medical Device Registration Annual Report on February 5. According to the public information, more than 60 innovative drugs have been approved by NMPA from 2022 to 2023, and a total of 61 innovative medical devices have been approved in 2023 ...
On 21 September 2023,the EU Court of Justice (‘CJEU’) handed down its ruling in the Apotheke B. case (C-47/22), and it is a good example of the high threshold set by the EU Court of Justice to uphold the Community Code’s main aim of protecting public health ...
On April 23, 2024, the Federal Trade Commission (“FTC”) voted to issue a final rule banning non-compete provisions in most industries in the United States (“Final Rule”). Dinsmore attorneys were quick to publish the details and impact of the Final Rule, which is available here. This supplement focuses on the impact of the Final Rule on the healthcare industry ...
In the latest update to Kentucky’s Medical Cannabis Program (the “Program”), Governor Andy Beshear signed House Bill 829 which moved up the timeline to apply for cannabis business licenses by six months. Additionally, two emergency regulations were issued by the Program that explain how to apply for a cannabis business license ...
For the past five years there has been an ongoing battle between the Belgian Competition Authority (“BCA”) and the legislator about the BCA’s competence to review mergers between hospitals. This wrangling has lead to a whole collection of legislative reforms, opinions, merger decisions with strong press releases, and communications going back and forth ...
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 ...
Norwich Pharmacal applications against BVI registered agents: BVI Commercial Court provides new guidance In its recent judgment, the BVI Commercial Court has provided clarification and guidance on Norwich Pharmacal applications against BVI registered agents ...
Violence in the workplace is something all employers prohibit and try to prevent. Healthcare employers have a tougher time, because the violence often comes from patients. How do you best protect workers while still providing needed patient care? There are no federal laws addressing this issue, so some states have stepped in. Recently, Texas joined states like California in enacting statutory protections against workplace violence directed at healthcare workers.[1] Texas S.B ...
At any hour, your company is vulnerable to cybercriminals aiming to cripple your operations. The repercussions are vast, from productivity loss to compromising sensitive information, which erodes trust with customers and employees alike. The financial toll and reputational harm can be severe and lasting. Whether facing a widespread assault or a precise strike, these attacks are escalating in frequency, sophistication and financial impact ...
Quebec is a fertile ground for class actions, with over 550 active cases and between 50 to 100 applications for authorization filed each year. While 2023 marked the fifth anniversary of the ?new? class action division: what is there to watch in 2024? Read on to find out. Opioids and the State: Sanis Health v ...
In recent years, license-in/out transactions have become the most common way for innovative drugs and medical devices (including medical aesthetics) companies to collaboratively develop and commercialize medical products and related technologies. According to public information, in China, the total amount and number of investment and financing in life sciences sector have witnessed a significant decline from 2021 to 2023, with the investment amount being only a quarter of that in 2021 ...
Obtaining a medical report on an employee can be a sensitive and complex process. We set out our top tips for employers, including the key matters to include in the letter of instruction and the legal considerations they need to navigate. When to seek a medical report There are several situations where an employer might seek a medical report on an employee or prospective employee ...
From Dominic Cummings to Nicola Sturgeon, 2023 was a noisy, headline-grabbing year for the UK’s public inquiry into the Covid-19 pandemic. What’s coming in 2024? And what does it mean for businesses? In terms of media exposure, the first full year in the life of the UK’s official Covid-19 Inquiry was a resounding success ...
The case concerns the interpretation of Article 269 of the AHL, which provides that additional or more stringent measures by Member States may be adopted concerning responsibilities for animal health in certain limited areas. (As provided for Articles 10 to 17 AHL ...
The transformational power of AI is set to redefine the modus operandi across various sectors, including healthcare. The life sciences sector in particular are already realising the benefits of AI. Their shared experiences offer other health organisations the opportunity to pre-empt some of the challenges associated with AI. The rapid and profound impacts emerging from AI advancements are truly staggering, leaving no room for delay ...
Belgium is welcoming a significant development in the field of veterinary medicine law. The Act of 11 July 2023 containing various provisions on health, which entered into force on 8 September 2023, introduces changes across a wide spectrum of healthcare domains, which are encompassed in approximately 20 chapters. In this blog post, we provide an overview of the key changes related to the marketing of veterinary medicines set out in Chapters 4 and 14 of the new Law ...
State efforts to address the 340B Drug Program[1] continue to ramp up in 2024. Early this January, Kentucky Senator Stephen Meredith introduced Senate Bill 27 ("SB-27"), which intends to address a number of purchasing restrictions drug manufacturers unilaterally imposed on health care providers participating in the 340B Program ...
Can a patent be infringed even if the patented product is not manufactured, assembled, or even used? Indeed, such infringement is possible. In fact, this is known as the theory of inducement of infringement. Naturally, acts of ?inducement? must meet certain conditions before inducement of infringement can be found. The Federal Court of Appeal recently clarified these conditions ...
In recent years, the job market has changed considerably, especially further to the pandemic and the impacts it has had. Employers and employees in Quebec faced unprecedented situations, and these appear to have led to a significant increase in claims for recognition of psychological occupational injuries, such as adjustment disorders and depression ...
