On June 28, 2005, amendments to Articles 420 and 421 as well as the addition of a new Article 414bis of the Health Law were published in the Federal Official Gazette, entering into force the following day. Article 414bis provides that herbal products, food supplements, perfumes and beauty products may be seized, as a precautionary measure, when they have been improperly advertised by being held out as medicines or as having characteristics or therapeutic qualities which they do not have ...
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 ...
Directive of the European Parliament No. 2004/27EC of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ EU [2004], L 136, p. 34) Scientific progress and the development of new types of products explain the rise in issues regarding the legal qualification of so-called “borderline” products ...
Commission Guidelines for the Notification of Dangerous Consumer Products to the Competent Authorities of the Member States by Producers and Distributors in accordance with Article 5(3) of Directive 2001/95/EC (Commission document No ...
Introduction: On June 9, 2005 the Supreme Court of Canada released its landmark decision in Chaoulli v. Quebec (Attorney General) in which a majority of the Court struck down provisions of Quebec’s Health Insurance Act and Hospital Insurance Act which prohibit private insurance for health care services that are available in the public health care system ...
In this edition: - New Corporate Manslaughter Rules - ’64 Act Stamped Out - Lock Up Your Ladders! - News Round Up - Planning: Out of Town - Out of Mind? - Use Classes Change
On May 20, 2005, the Supreme Court issued its judgment in the Smith & Nephew Inc. v. Louise Glegg and Christopher Carter and Gilles Dextradeur v. Louise Glegg cases1 ...
The EU Directives on Waste Electrical and Electronic Equipment (WEEE) and the Restriction of certain Hazardous Substances in Electronic and Electrical Equipment (ROHS) are due to take effect from 13 August 2005. The Department of the Environment recently produced draft regulations to implement these directives and make the necessary amendments to existing waste legislation ...
Introduction Advocate General Jacobs, in delivering his Opinion in Syfait and others v Glaxosmithkline (Case C-53/03, 28 October 2004), has found in favour of Glaxosmithkline (GSK) by stating that the refusal by a dominant pharmaceutical company to fulfil all orders from wholesalers does not automatically constitute an abuse of a dominant position, despite such refusal clearly limiting parallel trade of the products in question ...
In November the UK government bowed to pressure from unions and bereaved relatives and announced its intention to produce a draft bill on corporate killing for England and Wales. This bill, if successful, would have enabled companies to be prosecuted for management failures that resulted in a person's death. No such government bill has however, been forthcoming. Nor is it likely that any such government bill will appear before the 2005 general election ...
A trademark is any sign which, in the course of trade, can distinguish the goods or services from those of other undertakings. Trademarks are often also used as indications of a certain quality or life style (such as Lancome® trademark represents the luxury cosmetics) or as a marketing tool (such as the IKEA® and VOLVO® marks, which are featured not only on furniture but also on their services) ...
In late October, the IRS released a revised version of its 1023 Form. The new Form requires extensive new disclosures by organizations that seek recognition of tax-exempt status as charities under Section 501(c)(3) of the Internal Revenue Code. Many of the questions added to the exemption application are likely to be included in revised Form 990 information returns scheduled to be released later this year ...
Introduction: On March 4, 2003, the United States Supreme Court issued its unanimous decision, written by Justice John Paul Stevens, regarding the Federal Trademark Dilution Act (“FTDA”) ...
The Impact of Business Associate Rules Under the Final Privacy and Security Standards Presented at: Negotiating Technology Outsourcing Agreements Law Seminars International Seattle, Washington Introduction The Health Insurance Portability and Accountability Act of 1996, more commonly known as HIPAA, has brought many changes to the health care field, as well as our day-to-day lives ...
Authors Karen Williams Altaras Mary Jean Geroulo E. Earl Harcrow Jeffrey P. King Lewis A. Lefko Thomas William Mayo Lisa Schafroth Sooter Related Practice Groups Health Care Prompt payment by managed care organizations is once again a hot topic of debate as revisions of current law and regulations deals with claim submission deadlines, recoupment practices, prompt pay penalties, eligibility verification and underpayments ...
Healthcare Legislative Update - 78th Regular Session July 2003 © 2003 – Haynes and Boone, LLP Haynes and Boone, LLP 901 Main St., Suite 3100 Dallas, TX 75202 You have accessed the Healthcare Legislative Update for the 78th Regular Session of the Texas Legislature. This update has been compiled by the Health Care Section of Haynes and Boone LLP for use as a quick reference tool on topics that we believe that will be of interest to our clients and the healthcare industry ...
Prompt payment by managed care organizations is once again a hot topic of debate as revisions of current law and regulations deals with claim submission deadlines, recoupment practices, prompt pay penalties, eligibility verification and underpayments. Out-of-network providers scored a legislative victory as Medicaid managed care organizations will have to pay them regular Medicaid rates if use of their services exceeds new benchmarks ...
Authors Karen Williams Altaras Mary Jean Geroulo E. Earl Harcrow Jeffrey P. King Lewis A. Lefko Thomas William Mayo Lisa Schafroth Sooter Related Practice Groups Health Care Prompt payment by managed care organizations is once again a hot topic of debate as revisions of current law and regulations deals with claim submission deadlines, recoupment practices, prompt pay penalties, eligibility verification and underpayments ...
On October 16, 2003, the Health Insurance Portability and Accountability Act (“HIPAA”) requires employer-sponsored group health plans and others to be in compliance with the Transaction and Code Sets (“TCS”) standards for electronic transactions adopted by the Department of Health and Human Services (“HHS”). The federal government has been warned of potential disruption in the claim submission and payment cycles because the health care industry remains substantially non-compliant ...
With the passing of April 14, 2003, large health plans (those with more than $5,000,000 in annual receipts) became subject to the privacy regulations issued under the Health Insurance Portability and Accountability Act (HIPAA). However, more HIPAA deadlines loom on the horizon ...
Supreme Court resolves Circuit split by setting forth standard that owners of famous trademarks must prove “actual dilution” as opposed to “likelihood of dilution” in order to prevail on a Federal Trademark Dilution Act (FTDA) claim.The Supreme Court handed down its decision in the Moseley dba Victor’s Little Secret v ...
The recent accounting frauds and corporate scandals have many in-house counsel, as well as directors and officers, re-examining their responsibilities, obligations, and potential liabilities. New legislation, SEC regulations, stock exchange listing standards and public, media and shareholder scrutiny are imposing new or expanded processes for corporate accountability, financial reporting and business practices ...
Introduction Although companies may understand the importance of protecting their original ideas, many of them do not know how to do so most effectively. Without an effective intellectual property management system, such companies may be squandering business opportunities and allowing competitors to misappropriate their intangible assets. An intellectual property (IP) audit is a necessary first step for all companies interested in evaluating and maximizing their IP assets ...
A PowerPoint presentationcovering the following: Senate Report on Board's Role in Enron's Collapse Typical Accounting Allegations Reasons for Restatements 1997-2000 Securities Suit Catalysts Messages to the Market... ...
Approaching Compliance with Privacy Regulations Under the Health Insurance Portability and Accountability Act of 1996, including Final Modifications In 1996, Congress passed the Health Insurance Portability and Accountability Act (“HIPAA”). In 2000, the Department of Health and Human Services issued final regulations under HIPAA establishing privacy standards for certain individually identifiable health information ...
