Judgement of the European Court of Justice in case C-212/03 – Commission v. France, dated 26 May 2005 The Commission acted against France on the grounds that certain French rules on the importation of medicines are contrary to Article 28 of EC Treaty on the free movement of goods. The relevant national rules and administrative practice required a licence for the importation of medicines for personal use in France ...
After the Netherlands, Slovakia, and the UK, it is now France’s turn to impose Sunshine-like obligations on the pharmaceutical industry. Soon, similar obligations will apply to all EU countries, after EFPIA, the European trade association for the pharmaceutical industry, adopts a code of conduct on disclosure of transfers of value between pharmaceutical companies and health care professionals or institutions ...
When startup founders get together to form a new company, one of the first steps after actually incorporating the entity is to issue the founders their initial equity in the company. This is commonly referred to as “founders stock.” Most initial cap tables target the issuance to founders of around 8 million shares, so that combined with a 2 million share option pool, the initial “fully diluted” capitalization is 10 million shares ...
The term «næringsdrivende» (business activity) in the Norwegian Foundation Act shall be understood as activity with taxable profit («erverv til formål») The Ministry of Trade, Industry and Fisheries’ work on amending the Norwegian Foundation Act has been going on for several years, cf. proposals for a new Foundation Act in the NOU 2016: 21. Further law amendment proposals have now been proposed in a public hearing ...
Don't bank just yet on putting your marketing muscle behind the safe and effective off-label uses of your FDA-approved drugs, or defending your next mass consumer class action on First Amendment grounds. But you can start giving those multi-billion dollar prospects some serious thought, because constitutional winds are blowing through the Code of Federal Regulations ...
Key Points Employers that claimed a tax credit for qualified COVID-related leave paid to employees in 2021 must report the amount of leave paid in Box 14 of the employee's 2021 Form W-2 or on a separate statement. The reporting requirement is new for 2021 for governmental employers, because those employers were not eligible for a tax credit for COVID-related leave paid in 2020 ...
As Hurricane Harvey continues to cause far-reaching disruptions, it is important to understand how to effectively assert or respond to assertions of force majeure. This summary outlines the steps to take to assert force majeure, and initial considerations for those who have received several notices of force majeure from counterparties ...
Hospitals and health systems are on the frontlines fighting the COVID-19 pandemic. But, behind the scenes, they are grappling to sustain operations and finances significantly impacted by the state of the economy. In the latest version of our PointbyPoint podcast, Waller’s Ken Marlow and Eb LeMaster, managing director at Ponder, discuss the various factors impacting hospitals and health systems today ...
On Capitol Hill, U.S. lawmakers are considering legislation that would authorize the U.S. Food and Drug Administration (FDA) to approve generic versions of biological products. Representative Henry Waxman (D, CA), of “Hatch-Waxman” fame, has introduced the “Access to Life Saving Medicine Act” (H.R. 1038) to advance this change to U.S. law. In introducing the legislation, Rep ...
IN OUR JUNE 2005 “FDA WATCH” column, we provided an overview of the regulatory, political, and scientific landscape for follow-on biological products in the U.S. As reported a year ago, the biogenerics debate centers around whether generic biologics are scientifically possible (i.e ...
On 13 December 2005, the European Court of Justice ("ECJ") found Marks and Spencer plc ("M&S") could claim group tax relief from UK tax authorities in relation to the losses incurred by its former European subsidiaries that had ceased trading in Belgium, France and Germany in 2001. M&S argued that just as UK resident companies in a group may set off their profits and losses among themselves, so the same should be possible for the losses of foreign subsidiaries ...
The Florida Agency for Health Care Administration (“AHCA”) earlier this month fined Humana $3.4 million for failing to promptly report suspected cases of Medicaid fraud and abuse by others, as required by statute and Humana’s Medicaid HMO contract. Though many states have similar laws or regulations, this appears to be the first enforcement action of its kind in the nation ...
“Government efforts to manipulate markets and prices on consumer goods never work as intended, and in this case, would be counterproductive.” The waning days of summer signal the approaching midterm election season. Amid inflation, recession and voter discontent, it’s understandable that a group of congress members are anxious to put points on the board with a price-control scheme that they wrongly believe will lower prescription drug prices ...
If the generation-skipping transfer tax (“GST tax”) provisions of the proposed Tax Bill from December 9 remain unchanged, the most significant year-end tax planning opportunity is the ability to make gifts to trusts for grandchildren and great-grandchildren without imposition of the GST tax and without utilizing any of your GST tax exemption ...
Here are the most significant estate, gift, and generation-skipping tax features of the Tax Bill introduced in the Senate yesterday: The estate of an individual who died in 2010 can elect the 2011 rules ($5,000,000 exemption and top estate tax rate of 35%) or the "repeal" provisions (no estate tax but special rules for limited increase in the income tax basis of the assets of the decedent) ...
Legislators filed bills before the official start date of the 83rd Texas Legislative Session; many of the bills already filed address healthcare issues. 1. The Budget. Texas legislative leaders recently approved a self-imposed budget cap for the 2014-2015 biennium based on a conservative estimate of growth in the state’s economy, holding lawmakers to not more than a 10 ...
While the pandemic and subsequent economic downturn are creating unprecedented challenges for health systems across the country, opportunities for collaboration remain as strong as they had been pre-COVID, and large health systems are well positioned to take advantage of new opportunities. In light of this, Waller has partnered with Kaufman Hall to develop a guide for health system leaders, The Health System Growth Imperative: Charting Opportunities During the Pandemic and Beyond ...
The question of the scope of the cost-sharing VAT exemption, also referred to in the Council Directive 2006/112/EC of 28 November 2006 as amended ("EU VAT Directive") as "Independent Groups of Persons" or "IGPs", is currently being debated at the Court of Justice of the EU ("CJEU") in several cases. Last Thursday marked the first milestone regarding this specific VAT exemption since the CJEU released its judgment in the case Commission v Luxembourg (C-274/15) ...
The Health Care Arbitral Tribunal (Arbitral Tribunal) has pronounced a decision on a dispute between an independent medical specialist and a Medical Specialist Company (MSC) for the first time since the introduction of the comprehensive rates on 1 January 2015. Although neither party has terminated the existing (membership) agreement between them, the Arbitral Tribunal is of the opinion that termination of membership and deregistration of the specialist from the members' register are justified ...
On August 6, 2020, the U.S. Court of Appeals for the First Circuit affirmed the conviction of Massachusetts gynecologist Rita Luthra for criminal HIPAA violations and obstructing a health care investigation. Although such HIPAA prosecutions are uncommon, the case underscores the risks health care providers and others run when handling protected patient information and when speaking with government investigators ...
On December 18, 2015, Congress passed the “Protecting Americans from Tax Hikes Act of 2015” (the “Act”), which provides significant reforms to the Foreign Investment in Real Property Tax Act of 1980 (“FIRPTA”) and to the rules applicable to real estate investment trusts (“REITs”). To read the full alert, click here ...
Charles Arrand considers the Regulatory Reform (Fire Safety) Order 2005, with a focus on both the potential business and human costs of failing to discharge obligations under the Order. Fire safety is regulated by the Regulatory Reform (Fire Safety) Order 2005 (the Order), which applies to almost all buildings, places and structures other than individual private homes ...
The Finnish government proposes significant changes to transfer taxation. Transfer tax is levied on the acquisition of shares and other securities and real property. The proposed changes may have significant effects to the taxation of M&A and real estate transactions. Some of the proposed changes will decrease the tax burden while some will result in increased tax liability. The most significant changes include: The general rate for securities (1 ...
This is an important year on the taxation front. New rules restrict interest deductions and increase the transfer tax related to the sale of shares in housing and real estate. Additionally, two tax incentives support research and development activities, as well as innovation and growth. Restriction on interest deductionThe Finnish legislature has restricted interest deductions applied in taxation starting in the 2014 taxation year ...
While stock exchanges worldwide have experienced dramatic downturns and the economy is apparently heading for a global recession, supervisory organs are taking measures to respond to the situation by means of financial market regulation ...
