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 main characteristic of Third Generation services (3G) is to permit voice, data and image transmissions at substantially higher speeds than traditional technologies (like 2G and 2.5G). This capability makes 3G the appropriate standard for mobile multimedia applications and wireless broadband data transmissions, allowing subscribers to be connected without interruption to the mobile web ...
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 ...
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 ...
There is a distinct (and dynamic) overlap between competition law and intellectual property rights, no more evident than from the European Commission's investigations into, and the European Court's judgement in, Microsoft. In a similar vein, the Commission is investigating each of Qualcomm and Rambus for potential abuses of a dominant position (through the allegedly unlawful exploitation of IP rights) in the standard setting arena. No doubt buoyed by U.S ...
Minnesota Federal Court finds no coverage under technology errors and omissions policy because claims did not arise out of a “Wrongful Act” as defined in the policy ...
Under Austrian law software (object code, source code and engineering material) is subject to the strict protection under the Copyright Act ("UrhG")if a minimum of intelletual workmanship was involved in its creation ...
The soon-to-come public bid for the distribution of third generation ("3G") mobile telephony licenses has generated an interesting discussion in the Chilean telecommunications market ...
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 ...
1 Framework 1.1 When did Germany first liberalise telecommunications networks and/or services? In 1989 the markets for telecommunications end-user devices, data and value added services, satellite and mobile communications were liberalised. The first mobile communications licence was awarded to a private entity in 1989 (Mannesmann Mobilfunk, now Vodafone) ...
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 ...
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 ...
At the beginning of this year the Supreme Court delivered a decision of principle interest regarding a computer software distributor’s right to severance pay (case no. T 930-06). Through the decision, the court has clarified that the Commercial Agency Act (1991:352) ( “Agency Act”) can be applied analogously to marketing and collecting of orders for computer software, despite the fact that computer software does not constitute goods under the act ...
The Internet is a growing medium in the marketing of funds in Hong Kong. However, its use as a distribution channel for funds in Hong Kong is still relatively low. This chapter describes the rules applicable to the use of the Internet in marketing and distributing hedge funds in Hong Kong.There are different considerations for funds authorized by the Securities and Futures Commission (SFC) and for unauthorized funds ...
Electronic commerce started its rapid development approximately 30 years ago, when the era of paperless transactions began. While many business transactions are still executed in paper form, the advantages associated with e-commerce continue to grow, including greater speed, efficiency, traceability, accuracy, and so forth ...
In 1986, Congress passed the Health Care Quality Improvement Act (HCQIA). One of its principal provisions offers immunity to both individuals and institutions involved in professional review actions (PRAs) ...
The Court of Appeal (CA) judgment in Symbian Limited v Comptroller General of Patents (2008) EWCA Civ 1066 was issued on 8 October. This has upheld a High Court decision to overrule the UK Intellectual Property Office's (UK-IPO) rejection of a computer program on a conventional computer as non-patentable ...
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 ...
By decision rendered June 25, 2008, in K. B. & UAB Restoranu Grupe FORTAS v. AB Ragutis (Case No 3K-3-160/2008), the Supreme Court of Lithuania ruled that a component of a trademark that infringes an author’s copyright may not be disclaimed in the trademark registration.The plaintiffs, K. B. and UAB Restoranu Grupe FORTAS, sued one of the oldest breweries in Lithuania, AB Ragutis, for copyright infringement ...
The Government of the Republic of Indonesia ("GOI") understands that Indonesia is becoming part of the globalization of information. Consequently many new forms of legal actions which were not covered by current Indonesian laws and regulations now have to be regulated. On 21 April 2008, after being approved by the House of Representatives, the GOI enacted Law No 11 of 2008 regarding Information and Electronic Transactions ("Law No 11 of 2008") ...
Solicitor and commercial specialist Ross Woodham takes a technical and commercial look at Voice over Internet Protocol (VoIP), as it grows in popularity. VoIP has existed since the early 1980’s, but was only given serious commercial attention in the late 1990’s, since when the use of VoIP-based technology has grown steadily ...
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 ...
Anybody who has ordered their Christmas shopping online or installed software will have encountered so-called 'clickwrap' agreements. With clickwrap, before being able to complete the order or install the software, you must indicate acceptance of the service provider's terms and conditions – with a simple click on the I agree button – before being able to proceed. This is the stark choice of “take it or leave it” for the digital age ...
What Happened Last week, the chairman of Satyam Computer Services Ltd., India's fourth largest information technology company, admitted to a stunning fraud. Fraudulent entries in the company's financial statements totaled in excess of US$ 1 billion, as compared to the actual financial state of the company. In response to the fraud, DSP Merrill Lynch Ltd., a local affiliate of Bank of America Corp ...
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 ...
