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 ...
British Airways' 14-year long wrangle with Virgin and the European Commission ended yesterday, when Europe's highest court confirmed that the Commission was right in fining BA EUR6.8m. For BA this comes at an inopportune moment, as it is currently under investigation by both the US Federal Trade Commission and the EU Commission for alleged breaches of anti-cartel provisions ...
The European Court of Justice (ECJ) has ruled that motor vehicle distribution agreements may benefit from the exemption in Regulation 1400/2002 (Block Exemption) even if the supplier can terminate the agreement without notice in certain circumstances. The Block Exemption applies to such agreements provided the supplier gives reasons for the termination which are subject to review by an independent expert or arbitrator ...
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 ...
Pursuant to the Act on Budget Rules for Public Administration, the Ministry of Transport, Posts and Telecommunications of the Slovak Republic, by this Ruling, enlarged the scope of persons entitled to subsidies ensuring higher penetration of broadband internet access ...
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 main legal acts regulating the registration of seagoing ships in Lithuania are the Law on Merchant Shipping, the Rules for Registration of Seagoing Ships in Lithuania approved on 4 July 2005 by order No. 3-301 of the Minister of Transport and Communications, and the Decision of the Government of Lithuania “On the Register of Seagoing Ships of the Republic of Lithuania”. The following ships can be registered at the Register of Seagoing Ships of the Republic of Lithuania (the Register): 1 ...
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 ...
Purchasing a yacht should be a pleasurable experience given that the craft in question is most likely to be used for the owner’s leisure pursuits. Yachts, however, whether they are second-hand, new, large or small, have one thing in common. They are expensive. However, many purchasers whether they are paying £10,000 or £1,000,000 are sometimes less cautious than perhaps they should be when buying what is in effect a “toy” ...
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 ...
Captains of private and commercial yachts (and owners) have civil and criminal law duties most of which are concerned with the safe operation of the vessel. As the captain is regarded in law as being the owner’s agent, he is the person unfortunately on the spot. It is the captain who becomes personally liable in the first instance for any fine imposed on the vessel. Owners or charterers have no legal obligation to compensate him even though the offence may have occurred due to their fault ...
The legal concept that one can arrest a vessel and prevent it moving is unusual to say the least. An arrest in the UK (and other jurisdictions) is practically undertaken by serving upon the vessel a “Warrant of Arrest”, a very similar concept to criminal proceedings albeit this form of arrest is a civil law admiralty procedure and for very different reasons ...
Captains of private and commercial yachts (and owners) have civil and criminal law duties most of which are concerned with the safe operation of the vessel. As the captain is regarded in law as being the owner’s agent, he is the person unfortunately on the spot. It is the captain who becomes personally liable in the first instance for any fine imposed on the vessel. Owners or charterers have no legal obligation to compensate him even though the offence may have occurred due to their fault ...
In April 2005 a new Disability Discrimination Act was passed by Westminster. The Act extends existing non-discrimination legislation, primarily the Disability Discrimination Act 1995. While some provisions of the Act came into force in December 2005, many others will be coming into force over the course of 2006. It is essential that businesses are aware of their new responsibilities under the Act and prepare for its implementation ...
Judgement of the European Court of Justice in case C-212/03 – Commission v. France, dated 26 May 2005 The Commission acted against France on the grounds that certain French rules on the importation of medicines are contrary to Article 28 of EC Treaty on the free movement of goods. The relevant national rules and administrative practice required a licence for the importation of medicines for personal use in France ...
On June 28, 2005, amendments to Articles 420 and 421 as well as the addition of a new Article 414bis of the Health Law were published in the Federal Official Gazette, entering into force the following day. Article 414bis provides that herbal products, food supplements, perfumes and beauty products may be seized, as a precautionary measure, when they have been improperly advertised by being held out as medicines or as having characteristics or therapeutic qualities which they do not have ...
Judgments of the European Court of Justice in Merk, Sharp & Dohme BV v. Etat Belge (C-245/03) and Glaxosmithkline SA v. Etat Belge (C-296/03) of 20 January 2005 Directive 89/105, on the transparency of medicines pricing and reimbursement rules (hereinafter the “Directive”) was first interpreted in 2001 and 2002, when the European Court of Justice (hereinafter the “ECJ”) rendered two decisions regarding the implementation of the Directive in Austria and in Finland ...
Introduction: On June 9, 2005 the Supreme Court of Canada released its landmark decision in Chaoulli v. Quebec (Attorney General) in which a majority of the Court struck down provisions of Quebec’s Health Insurance Act and Hospital Insurance Act which prohibit private insurance for health care services that are available in the public health care system ...
On May 20, 2005, the Supreme Court issued its judgment in the Smith & Nephew Inc. v. Louise Glegg and Christopher Carter and Gilles Dextradeur v. Louise Glegg cases1 ...
Introduction Advocate General Jacobs, in delivering his Opinion in Syfait and others v Glaxosmithkline (Case C-53/03, 28 October 2004), has found in favour of Glaxosmithkline (GSK) by stating that the refusal by a dominant pharmaceutical company to fulfil all orders from wholesalers does not automatically constitute an abuse of a dominant position, despite such refusal clearly limiting parallel trade of the products in question ...
In November the UK government bowed to pressure from unions and bereaved relatives and announced its intention to produce a draft bill on corporate killing for England and Wales. This bill, if successful, would have enabled companies to be prosecuted for management failures that resulted in a person's death. No such government bill has however, been forthcoming. Nor is it likely that any such government bill will appear before the 2005 general election ...
