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 ...
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 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 ...
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 ...
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 ...
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 ...
In our July 2006 legal update, we reported on a ground-breaking agreement (Agreement) signed by the Hong Kong and Mainland China Governments, under which they agreed to recognise and enforce judgments made in each others courts. Legislative changes are now underway in Hong Kong in order to implement the Agreement ...
Intellectual Property is important. Although never at the forefront of our thinking (IP Lawyers aside) the role of patents, trade marks and copyright in shaping the business and leisure aspects of our lives is immense ...
On 26 October 2006, the Antitrust Court issued a decision, from a defense of competition perspective, in connection with the legality of the behaviors between Voissnet S.A. ('Voissnet') and Compañía de Telecomunicaciones de Chile S.A. ('CTC-CHILE'). Voissnet, a company that provides telecommunication services consisting of Voice over Internet Protocol (VoIP), accused CTC-CHILE of performing acts against free competition ...
He may be a knight, one of the most successful music artists and a noted viniculturalist, but Sir Cliff Richard is not resting on his laurels. Add legal reform campaigner to this list as the Peter Pan of Pop leads the quest to change UK copyright law.Copyright can be deceptively simple on the face of it, but scratch the surface and you reveal the complexity of co-existing legal rights. Take Sir Cliff's 1959 best selling single 'Living Doll' ...
A spectacular smash-up always draws a crowd. In the outsourcing world, where the wreckage is nearly always kept under wraps, that’s even more true. When a problem deal does break into view, it’s always worth watching for lessons in how to manage – or how not to manage – these complex transactions ...
The cause of an action in defamation exists to provide some recourse and remedy to victims of falsehoods which can and do cause injury to reputation. In a classic formulation, recently adopted and approved by Geopel J ...
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 ...
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 ...
The House of Lords has clarified what makes a message sent by means of a public electronic communications network "grossly offensive" and therefore capable of amounting to a crime under the Communications Act 2003 ("Act") ...
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 ...
On 14 July 2006, the Hong Kong and Mainland China Governments signed a ground-breaking agreement, rather lengthily entitled "An Arrangement on Reciprocal Enforcement of Judgments in Civil and Commercial Matters by the Courts of the Mainland and of the Hong Kong Special Administrative Region pursuant to Choice of Court Agreements between Parties Concerned" (Arrangement), under which they agreed to recognise and enforce judgments made in each others courts ...
Although the United Kingdom comprises England, Scotland, Wales and Northern Ireland, this guide relates only to the current position in England and Wales because Scotland and Northern Ireland have their own individual legal systems. The rules and procedure of the Civil Courts in England and Wales are contained in the Civil Procedure Rules (CPR) which were introduced in 1999 and which lay down the framework within which all civil litigation must be conducted ...
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 ...
Certificate of Need Strategies for New Nursing Home Beds Special Population Beds are Re-Approved At its March 2006 meeting, the Michigan Certificate of Need (“CON”) Commission took action to re-approve several state-wide pools of nursing home beds that are set aside to serve special populations, including: Alzheimer’s Use 60 beds Hospice 30 beds Religious Use 20 beds The Commission reserved 22 special population beds on a non-specified basis for future use ...
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 a long-awaited judgment, the Court of First Instance of the European Communities (“CFI”) partially upheld on December 14, 2005, the European Commission’s decision of July 3, 2001 to block the proposed acquisition of Honeywell International Inc. (“Honeywell”) by General Electric Company (“GE”). In its decision, the Commission had considered that the merger should be blocked for three sets of reasons ...
