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Practice Industry: Environmental, Healthcare & Pharmaceuticals
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Lavery Lawyers | May 2008

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 ...

Delphi | March 2008

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 ...

PLMJ | February 2008

The sector inquiries "into a particular sector of the economy or into a particular type of agreements  cross various sectors", set in Article 17 of EC Regulation 1/2003, are one of the tools available to the European Commission to enforce Competition Policy ...

Dykema | February 2008

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 ...

Waller | January 2008

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 ...

Waller | November 2007

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 ...

Hunton Andrews Kurth LLP | November 2007

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 ...

A&L Goodbody LLP | September 2007

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 ...

Haynes and Boone, LLP | July 2007

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 ...

Deacons | July 2007

On 10 November 2006, the State Administration for Industry and Commerce (SAIC) and the Ministry of Health (MOH) jointly promulgated the Measures for the Administration of Medical Advertisements, thereby revising 1993 regulations with the same title ...

Deacons | June 2007

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 ...

Haynes and Boone, LLP | April 2007

The purposes of this Health Care Alert are to: 1) summarize recently proposed federal regulations which will require physician disclosure of ownership interests in hospitals to patients; 2) remind health care providers of existing Texas laws requiring disclosure of ownership interests and 3) suggest best practices for disclosure of ownership interests ...

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 ...

Deacons | March 2007

A reputation for counterfeiting, poor quality control, ever-changing and inconsistent application of regulations and the challenges of ensuring that development does not unduly prejudice the welfare of the general population - this description of China’s pharmaceutical industry is representative of much that is good, bad and challenging in China’s recent regulatory and economic development ...

Currently Romania’s market is characterized by the implementation of two seemingly opposite sets of actions, one aimed at ensuring Romania’s transition to the market economy and the achievement of economic growth, while the other is targeting the environmental protection through promotion of energy efficiency and use of renewable energy sources for electricity generation ...

Lawson Lundell LLP | March 2007

On February 27 British Columbia issued “The BC Energy Plan: A Vision for Clean Energy Leadership” (Energy Plan 2007). The document is an extensive statement of provincial energy policy, and a roadmap for future government action in BC’s energy sector ...

Haynes and Boone, LLP | November 2006

The Texas Commission on Environmental Quality (“TCEQ”) is accepting comments on a draft guidance document that addresses air quality emissions and regulatory compliance for storage tanks using floating roofs ...

AELEX | November 2006

Dramatic changes in global climate have helped to wake up the consciousness of States on the significance of environmental issues in the last fourty years. Before then countries focused their energies on relentless industrial development with little or no attention to its impact on the environment. Scientific evidence has shown that unbridled development leads to loss of environmental capital, sometimes an irreversible phenomenon ...

Shepherd and Wedderburn LLP | November 2006

Since the entry into force of the Freedom of Information Act 2000 and the Freedom of Information (Scotland) Act 2002 on 1 January 2005, the general public and those in business seem, by and large, to be well aware of the potential benefits of the legislation. Information covering a plethora of topics has been accessed and used for a huge variety of purposes ...

Cechova & Partners | October 2006

Pursuant to the Act on Drugs, the Ministry of Health of the Slovak Republic has specified in annexes to this Decree details on forms to be used for prescriptions of drugs and medical aids. By this Decree, the Ministry also has set the sample forms of medical prescription, special medical prescription, medical reference, and extract from medical prescription, order and special order ...

Hunton Andrews Kurth LLP | September 2006

The federal Pipeline and Hazardous Material Safety Administration (PHMSA) has proposed new regulations for rural onshore low stress pipelines and rural onshore gathering lines. Although PHMSA has been anticipating further regulation of these types of lines for the past few years, the Agency acknowledges that the proposed rule is a direct response to legislative and media scrutiny of recent incidents that occurred in the Alaska Prudhoe Bay field ...

Shepherd and Wedderburn LLP | September 2006

In the world of information legislation in Scotland, the Freedom of Information (Scotland) Act 2002 ("FOISA") reigns supreme. But is this Act the most appropriate tool to use in all circumstances? The answer is most definitely no. Lurking behind this headline Act are two pieces of other information-related legislation that, in many circumstances, are more powerful tools to access and use certain information ...

Lavery Lawyers | September 2006

As the poultry farming crisis looms and countries are on the lookout for outbreaks of infection, scientists are closely following the evolution of the virus, which is moving to new sources of infection.Before a crisis is on our doorstep, businesses should prepare themselves for the consequences of a high rate of absenteeism. Without exaggerating the risks, they should adopt preventive strategies and become aware of the legal ins and outs of their actions ...

Interdisciplinary collaborations and partnering across the medical research and life sciences sectors are becoming increasingly common. Large corporations with good industry reputations and large research budgets are seeking to collaborate with smaller companies developing next-generation products. Equally, smaller companies are coming together to share complementary know-how and technologies and to work together in the global marketplace ...

Dykema | June 2006

ALERT Hospital May Be Excluded For Physician Recruiting On May 8, 2006 the OIG announced that it intends to exclude San Diego-based Alvarado Hospital from participation in Medicare, Medicaid and all other federal health care programs because of payments the Hospital made under relocation agreements involving placement of newly-recruited physicians in established physician practices ...

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