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 ...
Scope of this treatiseThe purpose of this discussion is to address those cases which are most likely to have a significant effect for those practicing in the chemical, pharmaceutical and biotech areas ...
In April 2005 a new Disability Discrimination Act was passed by Westminster. The Act extends existing non-discrimination legislation, primarily the Disability Discrimination Act 1995. While some provisions of the Act came into force in December 2005, many others will be coming into force over the course of 2006. It is essential that businesses are aware of their new responsibilities under the Act and prepare for its implementation ...
The courts have always considered Quebec’s class action legislation to be strictly procedural and not modifying substantive law. Normally a person can only sue if he has a legal relationship with the defendant, meaning that he has a personal right of action. Thus, in the case of Bouchard v. Agropur coopérative et al,1 Mr. Justice J. Viens refused to authorize Bouchard to institute a class action against dairies from which he had not purchased milk. However, Mr. Justice M ...
On December 31, 2005, amendments to Ontario’s Securities Act will come into effect to provide investors with a new recourse against companies and their directors, officers, employees and consultants for any misrepresentation in their public documents or public oral statements, or for failure to make timely disclosure of material changes in the company’s circumstances ...
The recent decision of the Court of Quebec, Small Claims Division, in the case of Spénard v. Promutuel Bois-Francs, société mutuelle d’assurance générale,1 revisited the issue of the right of an insurer to seek the nullity of an insurance policy based on an insured’s failure to disclose a prior conviction under the Young Offenders Act. The Plaintiff claimed $5,100 from his insurer for property stolen from his home between January 24 and January 27, 2003 ...
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 ...
On April 4, 2005, the Court of Appeal issued its decision in CGU v. The Wawanesa Mutual Insurance Company and Axa Insurance1, which sheds new light on the right of a subrogated insurer to institute legal proceedings directly against the insurer of the person allegedly responsible for the loss. The decision also contains a discussion of the concept of solidarity between insurer and insured for the purposes of the interruption of prescription ...
On February 2, 2005, the Court of Appeal rendered judgement in L’Union-vie, compagnie mutuelle d’assurance v. Laflamme1, and allowed the appeal of Union-Vie, the defendant in the case. In the court of first instance, Union-Vie had been ordered to pay insurance proceeds of $200,000 further to the death, on September 27, 2001, of the Plaintiff’s spouse, pursuant to a life insurance policy issued on the basis of an insurance application dated October 23, 1998 ...
On March 18, 2005, the Quebec Court of Appeal handed down an important decision confirming that the evidence relating to the behaviour and practices of a “reasonable insurer” need not be provided by an expert witness. In CGU Compagnie d’assurances du Canada v. Sylvain Paul et al., (J.E. 2005-705), Justices Louise Mailhot, René Dussault and Marie-France Bich dealt with this issue in connection with an objection to evidence made by the attorney representing the insured, Mr ...
Armando Aznar J. of the Court of Québec recently rendered a harsh judgment against an insurance company.1 Although the amounts at stake were minimal, the decision may have a significant impact on insurers. This is one of the rare judgments where an insurer was ordered to pay exemplary and moral damages for having made allegations in the pleadings based on unjustified suspicions resulting in damages to the integrity and honesty of its insured ...
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 ...
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 ...
On May 10, 2005, the Court of Appeal held in Pierre Roy & Associés Inc. v. Bagnoud [2005] QCCA 492, that sums transferred by Ms. Bagnoud to Investors Services Ltd. (“Investors”) were a trust according to the agreements entered into between Ms. Bagnoud and Investors. This decision is one of the first interpretations by the Court of Appeal of the Supreme Court decision in Bank of Nova Scotia v. Thibault.1 Facts In July 1998, after her employment was terminated, Ms ...
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 ...
On February 8, 2005, the Court of Appeal issued two judgments1 that clarify the burden of proof of the parties with respect to the nullity of an insurance contract. These two judgments are all the more interesting given that they deal with the issue of the impact of criminal history on the moral risk that the insured or the prospective insured poses for an insurer. The Rouette judgment, written by Mr ...
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 ...
On May 14, 2004, the Superior Court rendered judgment in Landry vs. L’Union Vie, Compagnie mutuelle d’assurance1 and allowed the action of the Plaintiff, Ms. Lucie Landry, in which she claimed $50,000 in insurance proceeds following the death of her brother on October 26, 2000, pursuant to a life insurance policy issued by Union Life on July 28, 2000. The case is currently under appeal. The Facts On July 28, 2000, Union Life Mutual Assurance Co ...
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 ...
In The Euromoney Global Insurance Handbook 2004, Delphi & Co worked on the Swedish Ministry of Justice’s bill for a new Insurance Contract Act, which was heavily criticised in Sweden at the time. On May 19, 2004, after more than 10 years of processing, the Swedish Government presented a slightly modified bill for the Swedish Parliament (“the Bill”) ...
Foreign insurers are currently permitted to provide services in 15 major Chinese cities; all geographical restrictions should be removed by the end of the year. Domestic insurers are now permitted to establish sales and distribution outlets in all locations where they have branches ...
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 ...
