On September 7, 2023, the Center for Drug Evaluation (the "CDE") of the National Medical Products Administration (the"NMPA") released "Annual Report on Progress of Clinical Trials for New Drug Registration in China (2022)"(the"2022 Annual Report") ...
On July 14, 2023, the Ministry of Science and Technology of the PRC ("MOST") issued the Notice on Updating the Guidelines on Administrative Approval Items and the Scope and Procedures for Filing and Prior Reporting of Human Genetic Resources, which unveiled six documents, including the administrative guidelines on collection approval, biobanking approval, exportation approval and international collaboration approval of human genetic resources ("HGRs"), as well as the scope and procedures for int
We are glad to present you a current digest of the most significant bills, regulatory changes, and measures affecting the pharmaceutical and healthcare industry for the period from June to October 2022. Follow the link to download the digest. ALRUD_Newsletter_Key_changes_in_Life_Sciences_for_the_June-October_2022_period_upd ...
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 ...
The Federal 340B Drug Discount Program (the “340B Program”) is a budget-neutral drug-pricing program that allows certain hospitals and clinics (“Covered Entities”) to buy discounted medication from drug manufacturers ...
As the delivery of health care continues to evolve and hospitals bear additional pressures to adapt to new payment models, more nonprofit hospitals are partnering with for-profit providers, through a sale, joint venture, or other arrangements. Partnerships between independent nonprofit hospitals and larger health care systems (nonprofit and for-profit) have been growing over the past two decades ...
As applications for Module 3 Core Participant (CP) status drew to a close on 5 December 2022, the Inquiry team have announced two key dates, as we continue to monitor progress of the UK Covid-19 Inquiry. No timescales have been given as to when applicants will be informed of the outcome of their CP applications, with the only information provided being that the Inquiry Chair (Baroness Heather Hallett) will be reviewing and determining in 'due course' ...
July 2022 saw the formal commencement of the UK Covid-19 Inquiry. Opened by Inquiry Chair Baroness Heather Hallett, we later witnessed preliminary hearings for Modules 1 and 2, held in October and November. As a reminder, Modules 1 and 2 cover the overarching topics of the UK’s pandemic preparedness and resilience, and core political and administrative decision-making throughout the UK (incorporating sub-modules for Scotland, Wales and Northern Ireland), respectively ...
Recent reports indicate that mental health and well-being have dropped back down the business agenda, despite levels of workplace stress remaining high in the wake of the pandemic. A recent report by the Chartered Institute of Personnel and Development (CIPD) found that many employers are failing to keep mental health and well-being at the forefront of their business agenda despite the lingering impact of the pandemic ...
Karanovic & Nikolic provided complete legal support to Affidea, a largest European medical service provider with respect to opening the first foreign hospital located in Belgrade. Our services consisted of extensive regulatory and corporate advice related to formation and start of operations of Affidea&s first hospital in Serbia. Affidea is one of the largest healthcare investors and operates over 180 Diagnostic and Cancer Treatment Centers in 15 countries across Europe ...
On the occasion of Children’s Day on January 12, 2023, Kudun and Partners launched an internal donation drive on January 12 to rally firm members to support children’s centers in Bangkok and Hat Yai. The donation drive was initiated as part of the firm’s continuous aspiration to contribute back the society ...
In its conference on Feb. 19, the U.S. Supreme Court is scheduled to consider two pending petitions for certiorari that could resolve a critical but deeply disputed issue that impacts both the False Claims Act and health care law. The cert petitions in those cases — U.S. v. Care Alternatives,[1] and Winter v ...
Following a month-long retrial, a South Carolina jury has concluded that Tuomey Healthcare System, Inc. (Tuomey) violated the Stark Law and the False Claims Act by illegally paying referring physicians. The jury found that Tuomey’s compensation arrangements with referring physicians were impermissible under the Stark Law, resulting in almost 22,000 false claims and more than $39 million in overpayments ...
A federal court jury in Illinois found that nursing home operator Momence Meadows fraudulently billed Medicare and Medicaid for “worthless services” and falsely certified compliance with health care laws and regulations, resulting in $28 million in damages to the government. United States ex rel. Absher v. Momence Meadows Nursing Ctr., Inc., No. 2:04-cv-02289 (C.D. Ill. Feb. 8, 2013) ...
The Joint Resolution No ...
The Affordable Care Act (ACA) has been one of the most sweeping, and most divisive, pieces of legislation related to healthcare in a generation. More ink has been spilled over enactment, constitutionality, and repeal than any other government healthcare program. With the election of Donald Trump, and a Republican-controlled Congress, the repeal of the ACA is all but assured ...
On March 30, the Department of Justice (DOJ) announced a major new initiative to target quality of care and fraud and abuse in elder care by forming 10 Elder Justice Task Forces throughout the United States. The DOJ intends to build these task forces on interdisciplinary teams – including Health Care Fraud Enforcement Action or HEAT Teams – already at work in several districts across the country. The teams include representatives from the U.S ...
Haynes and Boone, LLP Partner Jason Habinsky talked with Bloomberg Law about labor and employment implications for employers at companies with COVID-19 survivors.Below is an excerpt:Millions of people could be dealing with medical issues including heart, kidney and lung damage long after the pandemic subsides ...
In a recent survey conducted by Fertility Network UK, 40% of patients undergoing fertility treatment admitted to experiencing suicidal feelings, with the majority feeling that they would benefit from counselling. Sadly, this support is not readily available and reportedly only half of those in need have access. Often, the only option is to go private, but with sessions estimated to be between £10-£70 per session, that is not always feasible for everyone ...
In association with Macmillan Davies and led by Employment Partner, Emma Morgan and Associate, Lauren Bholé, this webinar focused on the menopause in the workplace. With World Menopause Day having just passed (18 October 2021) and a parliamentary debate on the menopause having entered the House of Commons in September 2021, the menopause has been a focal point for media coverage ...
It’s the final countdown, with only one year to go before EU member states must transpose the EU’s new Network and Information Security 2 Directive (“NIS 2”) into national law. Key Dates EU Member States have until 17 October 2024 to transpose NIS 2 into national law and those national laws will apply to organisations as early as 18 October 2024. Enforcement is likely to start from 17 January 2025, in line with parallel legislation affecting financial services ...
In its judgment of 19 January 2012 (case no. 08332/11), the Southern Central Administrative Court, decided that INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. (the national authority for medicines and healthcare products), is obliged to issue a certificate of subsidisation of the price of a medicine even when the person requesting the issue of the certificate was not the person who applied for the subsidy ...
On November 7, 2023, Ohio voters passed Issue 2, a measure that will legalize the purchase and use of recreational marijuana. By passing this initiative, Ohio becomes the 24th state to legalize recreational marijuana. Issue 2 creates Chapter 3780 of the Ohio Revised Code. This new law will become effective on December 7, 2023 ...
Institutional Shareholder Services, Inc. (“ISS”) and Glass, Lewis & Co. (“Glass Lewis”) recently released their 2019 proxy voting policy updates. ISS and Glass Lewis are two of the leading proxy advisory services worldwide, and each evaluates and updates their proxy voting policies annually. The key ISS and Glass Lewis updates for the 2019 proxy season are summarized below. ISS ISS published its 2019 Proxy Voting Guidelines Updates on November 19, 2018 ...
Further to the decline of the Covid-19 spread in Israel after the successful vaccination rollout, Israel has announced changes in foreign entry policy into the country, which will allow, among others, the regular entry of foreign experts and businessmen. These reliefs come after several months in which the state borders were almost completely closed to foreigners ...
