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 ...
As sustainable development and social responsibility are increasingly stressed in the business community, major institutional investors have come to focus on environmental, social, and governance (ESG) investing, an approach that directs socially responsible investment decisions ...
European Securities and Markets Authority (ESMA) published its final report on “guidelines of MiFID II product governance requirements” yesterday ...
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 ...
In order to tackle the effects of the Corona crisis, it is planned at EU level to temporarily facilitate the raising of equity capital for companies. This will enable certain issuers to publish a shortened prospectus with only 30 pages instead of a full prospectus to issue shares. Through this, issuers will have the option to issue shares at short notice, without bureaucracy and inexpensively, thereby improving the debt-to-equity ratio in their balance sheets ...
These days more and more use is being made of the Treaty rules on State aid. The European Commission is using the State aid rules in an innovative way to take over competence from the Member States in tax regulation by challenging the selectivity of national measures or rulings, which give preferable treatment to certain taxpayers ...
Beneficiaries of UK, USA or other non-EU state subsidies will have to notify the European Commission under a new regime when engaged in certain mergers & acquisition (M&A) transactions or tendering for certain EU public contracts.This notification obligation commences on 12 October 2023. The transaction cannot be completed or the procurement contract entered into, until consent has been received from the European Commission following notification ...
BVI government welcomes announcement. Blacklist expands to include 12 jurisdictions.On 18 February 2020, EU Finance Ministers updated the EU list of non-cooperative tax jurisdictions, upgrading the British Virgin Islands to whitelist status, which designates the country as a fully co-operative tax jurisdiction in line with all of the tax good-governance standards ...
The European Commission recently issued guidelines on mobile applications supporting the fight against COVID-19 in relation to data protection. Mobile applications commonly installed on smartphones can act as a support mechanism for health authorities at the national and EU level in monitoring and managing the ongoing COVID-19 pandemic and are particularly important in easing measures to reduce the spread of the disease ...
The European Commission has presented an Action Plan setting out ways to reboot the current EU VAT system to make it simpler, more fraud-proof and business-friendly. The current VAT rules urgently need to be updated so they can better support the Single Market, facilitate cross-border trade and keep pace with today's digital and mobile economy ...
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 ...
This publication includes the latest developments in Trade for the European Union. This issue contains information on takeover bids under company law, abridged registration of pharmaceuticals, fine for cartel of steel producers, free movement of biocides, labeling of foodstuffs, compensation to crime victims and restriction on alcohol advertising for sports events ...
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 ...
The European Parliament recently passed the Alternative Investment Funds Directive («AIFMD»). The AIFMD is focused on managers rather than investment funds and will implement broad regulatory measures on both fund managers located within the European Union («EU») and those established outside of the EU that provide asset management services to European alternative investment funds. The Swiss fund industry will have to closely examine the details of the AIFMD ...
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 ...
Within the European Union the issue of taking evidence in another member state has been regulated uniformly by the Council regulation (EC) No 1206/2001 of 28 May 2001 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters. However some general rules relating to the procedure of taking evidence abroad were developed and established long before the adoption of the regulation ...
