Last year, the European Commission initiated an inquiry into the pharmaceutical industry, claiming that there were indications that competition in the industry was not working as well as it should. Although responses to the preliminary report have been rather critical, from both the legal community and the industry itself, there are a few conclusions worth noting ...
The liability to remedy contamination is not limited in time but is only limited by the Environmental Code’s transitional rules, where a business operator can be held liable to take remedial actions if the actual operation of the business has been carried out after 30 June 1969. Further, a business operator can be held liable to take remedial actions if the operator has acquired contaminated property after 1 January 1999 ...
Six months on from the implementation of sections 20 and 21 of the Road Safety Act 2006, and occupational road safety remains a significant cause for concern for employers. The Act introduced two new offences of causing death by careless driving and causing death whilst unlicensed, disqualified or uninsured, with offenders finding themselves facing up to five years’ imprisonment for what could be a momentary lapse of concentration ...
A new regulation has been issued by the Minister of Health, namely Regulation of the Ministry of Health No. 1010/MENKES/PER/XI/2008 regarding the Registration of Medicines (“Regulation 1010/2008”). Regulation 1010/2008 revokes previous Ministry of Health Regulation No. 949/Menkes/Per/VI/2000. Under Regulation 1010/2008, a medicine to be distributed in Indonesia must first be registered before a Distribution License (Izin Edar) can be applied for ...
The Supreme Court of Canada ended a lengthy legal saga on November 20th(1) when it ordered St. Lawrence Cement Inc. to compensate residents of Beauport living near its cement plant. Comments on prescription, the assessment of damages and the granting of future damages follow. The facts “Dust they are, and unto dust they shall return, yet human beings have difficulty resigning themselves to living in dust ...
On May 22, 2008, the Supreme Court of Canada rendered its decision in a case involving the notion of reasonable foreseeability in negligence actions. This judgment, written by the Chief Justice, confirms that tort law must compensate harm done on the basis of reasonable foresight, and must not be considered as insurance ...
Government Regulation No. 2 of 2008 regarding the Types and Rates of Non-tax State Revenue Derived from the Utilization of Forest Areas for the Development of Non-forestry Activities Applicable to the Department of Forestry ("GR No. 2/2008") introduces a new scheme of forest exploitation fees for non-forestry companies such as those engaged in mining, oil and gas, geothermal power and telecommunications companies conducting activities in forest areas ...
A new Act which comes into force on 16 January 2009 imposes serious new penalties for directors, employers and employees who are convicted of a health and safety offence. The Bill received Royal Assent on 16 October 2008 and unlike the Corporate Manslaughter and Corporate Homicide Act, this has had a relatively easy journey through the parliamentary stages ...
On September 23, 2008, the Western Climate Initiative (“WCI”) released its Design Recommendations for the WCI Regional Cap-and-Trade Program (the “Program”) ...
Concerns over global climate change have sparked a series of legislative and policy responses on the provincial, federal, regional, and international levels. The challenge of complying with climate change policy is that different governments have invoked a number of different policy tools to respond and adapt ...
On May 27, 2008, Line Beauchamp, Minister of Sustainable Development, Environment and Parks, announced an envelope of $60 million under the Assistance program to reduce or avoid greenhouse gas emissions by implementation of intermodal projects in freight transportation, to fund new projects aimed at reducing greenhouse gas emissions ...
On May 9, 2008, the Ministère du Développement durable, de l’Environnement et des Parcs (MDDEP) presented its new pricing system for applications for environmental authorizations. The Order-in-Council provides for a rate grid based on the nature of the work covered by the application for authorization. The base rate is $500, unless another rate is stipulated in the rate grid ...
On April 29, 2008, the Minister of Sustainable Development, Environment and Parks, Line Beauchamp, announced the adoption of new measures to improve water quality and reduce greenhouse gas emissions. An amount of $16.4 million has been allocated to enable agricultural operations to intensify their actions favouring the preservation and improvement of water quality ...
Prohibition of Certain Toxic Substances Regulations 2008 - Environment Canada Consultation DocumentEnvironment Canada hold consultations in January 2008 on modifications to the Prohibition of Certain Toxic Substances Regulations, 2005 that would prohibit the manufacture, use, sale, offer for sale and importation of certain toxic substances. The modified regulations would replace the Prohibition of Certain Toxic Substances Regulations, 2005 ...
In the autumn of 2007, the rules in the Environmental Code on liability for environmental damage in the form of pollution were made more stringent. The changes were due to the EC directive on environmental liability (1). The liability of businesses operators and property owners has thus become more extensive. Amendments have, inter alia, been made to chapter 10 of the Environmental Code ...
CMS recently released new regulations intended to curb the ability of a physician to earn a profit on either the technical component (TC) or professional component (PC) of tests ordered by the physician, but performed by another party. The regulation is effective January 1, 2008 and applies to all Medicare-covered diagnostic tests including imaging and anatomic pathology, but excluding clinical laboratory tests ...
Savings and expected recoveries of $43 billion were reported by the Department of Health and Human Services Office of the Inspector General (OIG) in its Semiannual Report to Congress on December 14, 2007, for fiscal year 2007 (October 2006 – September 2007). This represents $2.18 billion in investigative recoveries, $1 ...
On Nov. 20, 2007, the Department of Homeland Security (DHS) officially published “Appendix A” of the Chemical Facility Anti-Terrorism Standards (CFATS) in the Federal Register. This comes as part of the DHS’s ongoing efforts to ensure the adequate security of chemical facilities in the United States. Appendix A, which is an addendum to 6 C.F.R. § 27, identifies over 300 chemicals perceived by the DHS to create a significant threat to human life or health if mishandled ...
On certified questions from the United States District Court for the District of New Hampshire, the New Hampshire Supreme Court has decided that New Hampshire will allocate liability for long-tail environmental claims pro rata by years and limits among triggered policies. See EnergyNorth Natural Gas, Inc. v. Certain Underwriters at Lloyd’s, No. 2006-745 (N.H. Oct. 18, 2007). BackgroundEnergyNorth Natural Gas, Inc ...
The Environmental Liability Directive aims to establish a common framework of environmental liability across the EU to prevent and remedy certain types of environmental damage. The framework is based on the “polluter pays principle”. The implementation date for member states was 30 April 2007. Ireland has not complied with this transposition date and will not have transposed it as a current estimate until early 2008 ...
This paper will address the varying requirements for fair market value in transactions involving physicians and hospitals and other health care providers. The paper will first examine the Stark law and how and when transactions may satisfy Stark’s requirements for fair market value. Second, the use of fair market value for compliance with the federal Anti-Kickback statute will be addressed ...
In the past few years China has introduced significant regulatory changes in an effort to modernize its pharmaceutical industry and bring it in line with international standards. These include reorganizing the former State Drug Administration into the State Food and Drug Administration (SFDA), thoroughly amending drug regulation and good manufacturing practice (GMP), enhancing intellectual property protection and changing drug import licensing ...
