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 promotion of research, development and innovation (R&D&I) has been identified as a key obligation by both the European Union as well as it member states in recent years ...
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 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 ...
An Illinois federal district court held, in Massachusetts Bay Ins. Co. v. Faber Bros., Inc., No. 04 C 5160, 2007 WL 1029366 (N.D. Ill. March 30, 2007), that a distributor of firearms is not covered under general liability insurance contracts for claims alleging that its sales of firearms created a public nuisance that led to bodily injuries. Factual BackgroundThe insured, Faber Bros., Inc., is a distributor and wholesaler of firearms ...
Can the cost of remedying a manufacturing defect be considered as damage resulting from an “accident” covered under a liability insurance policy? This is the question the Quebec Court of Appeal considered in CGU, Compagnie d’Assurance du Canada v. Soprema Inc., [2007] QCCA 113 ...
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 ...
Each time we give up a bit of information about ourselves to the Government, we give up some of our freedom. For the more the Government or any institution knows about us, the more power it has over us. When the Government knows all of our secrets we stand naked before official power.” [Introductory remarks of Senator Sam Ervin on S3418, Legislative History of the Privacy Act of 1974 ...
We are pleased to advise you of recent Quebec Superior Court judgments rendered in favour of our clients. Two motions for authorization to institute a class action were recently denied by the Court, which should be a matter of interest to decision-makers and lawyers dealing with issues involving competition, environment and natural resources as well as class actions generally ...
It is known that an insurer has a considerable duty to inform in group insurance. The Superior Court, in a decision by Justice Hélène Langlois, specified the extent of this duty in Tanguay et al v. L’Ordre des ingénieurs du Québec and The Manufacturers Life Insurance Company of North York, doing business under the name Manulife Financial(1) ...
The Court of Appeal rendered an important decision on October 31, 2006, which dealt with the liability of manufacturers and professional sellers, as well as several other related issues, in the case of The Boiler Inspection and Insurance Company of Canada and Prima Viande Ltd v. Manac inc./Nortex (manufacturer of the Arcoplast product) and Systèmes intérieurs Atlas inc ...
In December last year, the House of Lords handed down its judgment in the case of R (on the application of Laporte) v Chief Constable of Gloucestershire. The case considered the proper balance to be struck between an individual's Article 10 and 11 rights to freedom of expression and freedom of assembly and association under the European Convention on Human Rights ('ECHR'), and the Police's powers to prevent breaches of the peace ...
This month the Legislative and Regulatory Reform Act 2006 ('the Act') comes into force. It is one of the Government's key legislative proposals for 2006, designed to promote productivity and ease the burden of regulation. The Act replaces the Regulatory Reform Act 2001 and is part of the UK Government's Better Regulation Action Plan 2005 ...
On October 31, 2006, the Court of Appeal rendered two key decisions on the issue of neighbourhood annoyances in Quebec. It is greatly to their credit that these two judgments represent a return to more reasonable legal bases on this issue. The decisions are Ciment du Saint-Laurent inc. / St. Lawrence Cement Inc. v. Barrette and Cochrane(2) (hereinafter “St. Lawrence Cement”) and Comité d’environnement de Ville-Émard (C.E.V.E.) and Michaud v ...
Amendment (6) to the Criminal Law of the People's Republic of China was adopted at the 22nd Session of the Standing Committee of the 10th National People's Congress of the People's Republic of China on 19 June 2006 and promulgated by President Hu Jintao on 29 June 2006. The Amendment, which entered into effect on the date it was promulgated, introduces penalties for a range of economic crimes ...
As concerns the contents of the Act, we can say primarily that certain proven principle and institutes reappeared known from original Act No. 199/1994, Coll., on Public Procurement which Act No. 40/2004, Coll ...
The Sappier Decision: Supreme Court of Canada Recognizes Aboriginal Right to Timber for Domestic Purposes and Clarifies Requirements for Establishing an Aboriginal RightOn December 7, 2006, the Supreme Court of Canada handed down its decision in the cases of Gray v. R and R. v. Sappier and Polchies ...
On October 18th, 2006, the Quebec Court of Appeal rendered a much-awaited decision regarding class actions. In Bouchard v. Agropur Coopérative et al,(1) the province’s highest court was called upon to rule on the issue of whether, when there is a multiplicity of defendants, it is necessary that a legal relationship exist between the petitioner applying for authorization to bring a class action and each defendant ...
Assuming that a foreign court exercises the power to issue letters rogatory or to appoint a commission to examine a witness in Quebec and to ask him to produce some documents, how can that be carried out in Quebec and is there a «blocking statute» protecting some of the documents?The Special Procedure Act (R.S.Q. c. P-27)The Special Procedure Act, Division VI (the «S.P.A.») governs rogatory commissions within Quebec for the purposes of a foreign lawsuit ...
The legal systems of the nations that comprise the Gulf Cooperation Council -- Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and the United Arab Emirates -- have undergone dramatic, radical and progressive change and development in the past 25 years, which is continuing ...
On 4 December 2006 the Disability Equality Duty will come into force. It will join the broadly similar Race Equality Duty, which has existed under the race relations legislation since 2001. Meanwhile, an analogous Gender Equality Duty is due to come into force in April 2007.The intention behind the creation of these new duties is to ensure that bodies which exercise public functions “mainstream” equality issues when exercising those functions ...
Bolivia has just culminated the step that will have the greatest impact in the process of creating a new constitution for Bolivia. On Sunday July 2, Bolivia elected the constituents to the assembly that will be in charge with providing structure and substance to the new constitutional norm ...
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 revelations of the intercepted phone messages from Prince Harry and Prince William earlier this year are a reminder of how vulnerable personal data can be. Proposed changes to the law will mean that those who hold confidential personal information must be even more vigilant about what they do with that data. Most businesses will be familiar with the Data Protection legislation but it is important not to be complacent ...
