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 ...
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 ...
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' ...
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 ...
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 ...
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 ...
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 ...
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
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 September 8, 2023, the China National Center for Biotechnology Development (the "CNCBD"), a public institution under direct charge of the China's Ministry of Science and Technology (the "MOST"), released the"Notice on Issuing Answers for Frequently Asked Questions on Human Genetic Resource Administration"(the "Updated FAQs"), which summarized and responded to questions that are constantly raised among the relevant industry (the "Industry") ...
The Department of Agriculture (USDA) announced in late February that it's delaying enforcement of certain requirements set forth in its Interim Final Rule (IFR) on the Domestic Hemp Production Program (84 FR 58522) under certain circumstances until October 31, 2021, or until publication of the final rule on such hemp production program, whichever occurs first ...
The Finance Minister Smt. Nirmala Sitharaman envisages a holistic vision of healthcare that translates into wellness of the citizen ...
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 ...
In a statement issued by the National Regulatory Agency, Control and Surveillance (ARCSA), drugs that are sold in Ecuador must have labels stating the words 'generic', otherwise it can not be marketed as of January 24, 2014 ...
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 ...
LabMD, Inc. renewed its argument that the FTC lacks authority to regulate the data security practices of HIPAA covered entities by appealing the dismissal of its case for lack of jurisdiction (see our coverage here) to the Eleventh Circuit. LabMD also filed an emergency motion seeking expedited briefing and requesting an order enjoining the administrative proceedings until the appellate court rules on the merits of its argument ...
On Oct. 19, 2021, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would establish a new category of over-the-counter (OTC) hearing aids. The rule came in response to President Joe Biden’s July 9 executive order, which among other things, calls for wide availability of low-cost hearing aids in order to promote economic competition ...
“Why don’t I own this?” The words of oil prospector Daniel Plainview to his property advisor, querying the land rights for his oil pipeline to the California coast in the Oscar winning film ‘There Will Be Blood, and a blunt, single sentence reminder of the need for early due diligence on large scale developments ...
Key Points The Supreme Court's upcoming decision regarding the Affordable Care Act could render its tax provisions retroactively unconstitutional. Depending on the outcome, there is a potential opportunity for refunds on open tax years for taxpayers who paid the net investment income tax and additional Medicare tax. For most taxpayers, the deadline for a protective claim of refund on a 2016 tax return, filed without extensions, is July 15, 2020 ...
Novartis Pharmaceuticals Corporation v. Accord Healthcare, Inc., Appeal No. 2021-1070 (Fed. Cir. Jan. 3, 2022) In this week’s Case of the Week, the Federal Circuit affirmed a district court’s bench trial finding that claims of a pharmaceutical patent were supported by adequate written description under 35 U.S.C. § 112(a) ...
University of Strathclyde v. Clear-Vu Lighting LLC, Appeal No. 2021-2243 (Fed. Cir. Nov. 4, 2021) In this week’s Case of the Week, the Federal Circuit reversed an inter partes review decision finding claims directed to light-based disinfecting methods to be obvious over the prior art. This case provides a helpful example of how negative claim limitations can affect an obviousness determination ...
AstraZeneca AB v. Mylan Pharmaceuticals Inc., Appeal No. 2021-1729 (Fed. Cir. Dec. 8, 2021) Our Case of the Week again focuses on numerical values in claims. Last week we addressed a case involving whether there was written description support for a number in a claim, and we addressed a similar issue the week before. This week, our case focuses on the meaning and scope of a number in a claim ...
Biogen International GMBH v. Mylan Pharmaceuticals Inc., Appeal No. 2020-1933 (Fed. Cir. Nov. 30, 2021) For the second time in two weeks, our Case of the Week focuses on the written description requirement, in particular where the patent claims a range. In fact, all three precedential decisions issued this week concern issues relating to patents that claim numerical ranges. Below, we discuss two of those cases in our “Also This Week” section ...
On September 28th, Law 21,614 of the Ministry of Labor and Social Security was published in the Official Gazette (hereinafter the “Law”), which establishes amendments to Law No.21,063, which Creates an Insurance for the Accompaniment of Children Suffering from Diseases as Indicated and Modifies the Labor Code for these purposes (hereinafter “SANNA Law”) ...
