The decision of the Indian Supreme Court to deny Novartis’s application for patent protection for an improved version of its patented Glivec drug – the culmination of a seven-year battle - has certainly made the headlines. There are a number of reasons for this. First, Glivec is a well-known drug – described by some as a ‘wonder drug’ – that’s used to combat cancer, including leukaemia and gastro-intestinal cancer ...
With the continued risk of the spread of COVID-19 in assisted care facilities, more and more facilities are implementing a virtual admissions process. This process includes providing all of the admissions documents, including an arbitration agreement, to potential residents and/or their legal representatives electronically. While it is preferable from a legal standpoint that the arbitration agreement be presented and executed in person, in today's world that is not always possible ...
One way to change the law fast is to amend or repeal statutes in budget legislation. That is what the federal government of Canadadid in 2009, 2010 and 2011. Federal programs, staff positions and budgets for environmental science, conservation and protection have been eliminated. That leaves a lot of responsibility with the provinces and territories, and many open questions for industry. This article describes what has happened and identifies what to look out for ...
Environmental Protection Agency (EPA) has issued a new rule that will impact the operations of a wide-range of health care facilities and the manner in which those facilities manage hazardous waste pharmaceuticals ...
Key Points Employers may mandate employee COVID-19 vaccination programs, subject to certain exemptions. When requiring employee vaccinations, employers should consider the fact that these COVID-19 vaccines are currently approved under the FDA's Emergency Use Authorization (EUA). Mandatory employer COVID-19 vaccination programs must include religious and disability-related employee exemptions. INTRODUCTION On Dec ...
The Patient Protection and Affordable Care Act ("ACA") has significantly changed the healthcare industry in the United States. Among the many changes is the new requirement that healthcare providers must provide all "Food and Drug Administration approved contraceptive methods, sterilization procedures, and patient education counseling for all women with reproductive capacity."77 Fed. Reg. 8725 (Feb. 15, 2012); see 42 U.S.C. 300gg-13(a)(4), 45 C.F.R. § 147.130(a)(1)(iv) ...
As seen in Law Journal Newsletters The False Claims Act (FCA or Act) can be a real punch in the gut for businesses on the wrong side of an FCA claim. The Act, codified at 31 U.S.C. §§ 3729-3733, is designed to prevent private companies contracting with the government from knowingly submitting false or fraudulent claims for their services ...
On Dec. 22, 2021, Ohio Governor Mike DeWine signed “Esther’s Law,” allowing long-term care residents to install and use video cameras and recording devices in their rooms. The law is named for Esther “Mitzi” Piskor, who was a victim of elder abuse at a nursing home in Cleveland. Esther’s Law is intended to combat elder abuse and neglect and will likely lead to increased enforcement actions against Ohio nursing homes and long-term care facilities ...
Horizon 2020 is the new EU Framework Programme offering more than €70bn funding for Research and Innovation initiatives over the period 2014 to 2020 and covering every stage of the innovation process from research to market uptake. Ivan Waide and Kate Keith, IP & Technology lawyers at A&L Goodbody, take a closer look at the programme, including opportunities available to Northern Ireland businesses and research organisations ...
Hemp seeds have been eaten in the EU for a long time. The seeds may contain trace amounts of tetrahydrocannabinol (THC) because this cannabinoid is a natural constituent of the cannabis plant from which the seeds originate. The EU regulator has decided to harmonize the maximum levels for THC in hemp seeds throughout the Union within the food contaminants framework. Commission Regulation 2022/1393 of 11 August 2022 amends the annex to Regulation No1881/2006 on food contaminants to this effect ...
The EU regulator has harmonized the maximum levels for tetrahydrocannabinol (THC) in hemp seeds throughout the Union within the food contaminants framework. This EU harmonization puts pressure on conservative national food laws such as the Belgian Royal Decree of 31 August 2021, which treats hemp seeds as a prohibited food.The situation in Belgium, however, is changing to better align it with EU law ...
The sector inquiries "into a particular sector of the economy or into a particular type of agreements cross various sectors", set in Article 17 of EC Regulation 1/2003, are one of the tools available to the European Commission to enforce Competition Policy ...
The European Commission has presented its Proposal for a Regulation on the European Health Data Space (the “Proposal”). While it aims to strengthen the rights of individuals and unlock data’s potential for research purposes, it also adds complexity to an already extensive legal framework. Here is what you need to know: In its 2020 Data Strategy, the European Commission outlined a plan to unlock the untapped potential of the EU data economy ...
Judgments of the European Court of Justice in Merk, Sharp & Dohme BV v. Etat Belge (C-245/03) and Glaxosmithkline SA v. Etat Belge (C-296/03) of 20 January 2005 Directive 89/105, on the transparency of medicines pricing and reimbursement rules (hereinafter the “Directive”) was first interpreted in 2001 and 2002, when the European Court of Justice (hereinafter the “ECJ”) rendered two decisions regarding the implementation of the Directive in Austria and in Finland ...
Introduction An EU Regulation on the making available on the Union market as well as export from the Union of certain commodities and products associated with deforestation and forest degradation (“Deforestation Regulation”) was agreed upon by the EU legislators in December 2022. The European Parliament has now green-lighted the Provisional Agreement at this month’s plenary session ...
Regulation (EC) 2017/746 of 5 April came into force on 26 May 2022 and it establishes the regulatory framework for in vitro diagnostic medical devices (IVDs). In doing so, it replaces the previous regulations in Directive 98/79/EC of 27 October 1998 ...
Introduction The rapid spread of COVID-19 pandemic has led to a significant increase in demand for medical devices (MDs) and personal protective equipment (PPE), masks for social use (textile articles) and other products destined to prevent the spread of the disease. As a result, it became clear that there was insufficient supply to meet existing needs during the state of emergency and the subsequent period ...
As of March 19, 2020, the requirement to receive a certificate of need (CON) prior to increasing bed capacity has been temporarily suspended byTennessee Executive Order No. 15(the “Order”) ...
The Ohio Department of Commerce (Department) recently announced licensed medical marijuana cultivators who are maxing out their grow area capacity will be permitted to apply for an expansion. Presently, there are 20 Level I cultivators capable of growing up to 25,000 square feet of medicinal marijuana, and 15 Level II cultivator licensees that are smaller in scale and permitted up to 3,000 square feet of grow capacity ...
The Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”)[1] was enacted on October 24, 2018. Among other things, the SUPPORT Act amended the Physician Payments Sunshine Act (“Sunshine Act”)[2] to expand the definition of “covered recipients”[3] for payment tracking and reporting purposes ...
