Advocate General Sharpston has recently expressed her opinion in the Commission v Republic of Finland case that ensuring a sufficient degree of transparency for the award of sub-threshold procurements should be determined by national law, rather than Community law. If these views were to be followed by the ECJ, it would provide renewed impetus to create national rules on low value awards and represent a meaningful evolution of the ECJ's past case law ...
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 ...
The U.S. Department of Justice’s revised corporate charging policy, which was named after deputy attorney general Paul McNulty, was unveiled in December 2006. In the wake of its predecessor document, the 2003 Thompson Memo, we have seen a steady increase in the resolution of corporate criminal investigations without indictments or trials ...
The President of the United States of America, George W. Bush, announced today the Implementation of the Dominican Republic-Central America-United States Free Trade Agreement, DR-CAFTA, with respect to the Dominican Republic. See press release from The White House http://www.whitehouse.gov/news/releases/2007/03/20070301.html#).The implementation of this free trade treaty opens a new era of commercial opportunities between the member countries to the DR-CAFTA ...
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 ...
In our November 2006 Asia IP Bulletin, we reported on a ground-breaking agreement (the "Agreement") signed by the Hong Kong and Mainland Chinese Governments, under which they agreed to recognise and enforce judgments made in each others courts. The Agreement followed four years of discussion and legislative changes are now underway in Hong Kong to implement the Agreement ...
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 ...
The Arbitration Institute of the Stockholm Chamber of Commerce upholds a strong position as one of the most important centres of international arbitration. The steady growth in the number of cases involving foreign parties that are administered by the Arbitration Institute convincingly demonstrates its worldwide popularity and reputation ...
The Federal Circuit, in an opinion written by Judge Rader and joined by Judges Lourie and Prost, has determined that a termination of a contract for the government’s convenience does not terminate obligations to perform warranty and software upgrade services under the contract. The Court of Federal Claims, in a well-reasoned opinion by Judge Miller, had determined otherwise ...
On 16 October 2006, the People’s Government of Guangzhou Municipality promulgated the Regulations of Guangzhou Municipality on Encouraging the Establishment of Headquarters and Regional Headquarters with Foreign Investment. The Regulations, which are effective for five years from the date of promulgation (i.e ...
The Ministry of Commerce issued the Provisional Measures on Tasks Related to Complaints from Foreign Investment Enterprises on 1 September 2006. Effective from 1 October 2006, the Measures establish a procedure pursuant to which foreign investment enterprises (FIEs) and foreign investors who feel their lawful rights have been infringed by an administrative agency may lodge a formal complaint ...
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 ...
Most of the attention at this week's ASEAN foreign ministers meeting in Manila focused on the failure of ASEAN to reach a definitive approach on establishing a human rights body for the grouping. The proposed ASEAN Charter is supposed to address human rights concerns through this new entity. Perhaps given the diversity in governance standards among members, this was to be expected ...
When August turns to September, 2007, a new market called NewConnect will open on the Warsaw Stock Exchange (WSE). It will support the trading of shares of small and medium-sized companies. The expectation is that issuers entering this new market will not be large companies (of market capitalization around PLN 20–30 million and with a public offer value from PLN several hundred thousand to several million) ...
Civil Dispute Resolution in TaiwanSeptember, 2007ForewordTaiwan is a civil law jurisdiction, and its courts are charged principally with interpreting statutory laws and have limited ability to create new remedies or laws where there is no statutory basis. Civil, criminal, and administrative cases fall under the jurisdiction of separate court systems. In addition to civil litigation, civil disputes can also be handled through arbitration, mediation, or settlement ...
On November 21, 2007, the Supreme Court of British Columbia released the decision of Mr. Justice Vickers in Tsilhqot’in Nation v. British Columbia(1). The decision dealt with a claim brought by Chief Roger William of the Xeni Gwet’in First Nation, on behalf of the Xeni Gwet’in First Nation and the Tsilhqot’in Nation ...
The rule that a party receiving documents in litigation holds them subject to an implied undertaking to use them only in the proceedings in which they were produced has been a fixture of practice in British Columbia since 1995. However, while the rule is easy to state, it often proves more difficult to apply in practice and carries with it the potential for very serious sanctions for breach ...
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 ...
Investors in Scottish commercial property have been warned that the sector may see a zero per cent rate of growth in 2008 as supply continues to outstrip demand.In comparison to the situation just 12 months ago, where there were ten buyers for every commercial property put on the market, now ten sellers exist for every purchaser, new research from industry consultants Drivers Jonas has revealed ...
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 ...
U.S. Court of Appeals for the District of Columbia Circuit Finds that Student Who Was Abused Multiple Times by Fellow Students Was Entitled to Multiple Per-Claim Limits Because Each Assault Was a Separate “Claim”.In Essex Insurance Co. v. Doe, No. 06-7163, 2008 U.S. App. LEXIS 94 (D.C. Cir. Jan ...
