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 ...
The Police and Justice Bill was put before the House of Commons on 25 January 2006. The main aim of the Bill is to improve the powers and scope of the police force but there are a number of sections which look to update the Computer Misuse Act 1990 (CMA) and in particular to make Denial of Service (DOS) Attacks illegal. DOS attacks can take many forms but are essentially an attempt to disrupt the use of a computer, server or website ...
TABLE OF CONTENTS I. INTRODUCTION II ...
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 ...
On 2 November 2005, the Legislative Council enacted the Revenue (Abolition of Estate Duty) Ordinance ("RAEDO"). It came into operation on 11 February 2006. RAEDO, among other things: (i) abolishes estate duty as proposed in the 2005 - 2006 Budget; and (ii) empowers the Secretary for Home Affairs ("SHA") to release money from bank accounts of deceased persons and allow inspection of bank safe deposit boxes ...
The Cabinet Office's Better Regulation Executive (BRE) is currently undertaking a review of penalties for businesses that fall foul of the law and business should ensure their views are heard. This spring, a consultation paper will be released which will be the final opportunity for stakeholders and interested parties to contribute to the review before it makes its recommendations to the Government in late 2006 ...
March of 2006 will make a mark in history as the date in which the people of Bolivia have manifested, through the National Congress, their irrevocable and unequivocal decision of modifying the political structure of the Republic by simultaneously calling to a Constituent Assembly, with the purpose of designing a new Political Constitution, and to a binding referendum on departmental autonomies. Six presidents have passed since the beginning of the new millennium ...
Scotland's new procurement regulations came into force on 31 January 2006, meaning the country is covered by a separate set of procurement rules than the rest of the UK. This is a major change from the previous regime. The Public Contracts (Scotland) Regulations and the Utilities Contracts (Scotland) Regulations, both 2006, were introduced to ensure the procurement regime in Scotland complies with the European Union's new directives on procurement in the public and utilities sectors ...
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 ...
On 13 December 2005, the European Court of Justice ("ECJ") found Marks and Spencer plc ("M&S") could claim group tax relief from UK tax authorities in relation to the losses incurred by its former European subsidiaries that had ceased trading in Belgium, France and Germany in 2001. M&S argued that just as UK resident companies in a group may set off their profits and losses among themselves, so the same should be possible for the losses of foreign subsidiaries ...
In order to speed up the application in Mexico of the concept of “immunity” proposed in a recent bill containing amendments to the Federal Economic Competition Law (the “Law”), a full session of the Commission, on January 26, 2006, approved the “Internal Policies to Grant Immunity to Those Cooperating in Investigations of Monopolistic Practices.” The policy will work as follows: 1 ...
On December 1, 2005, the second paragraph of section III of Article 31 of the Income Tax Law became effective and requires taxpayers seeking to deduct the purchase of gasoline to pay with the taxpayer’s check payable to the seller, with a credit, debit or services card, or with a prepaid card, authorized by the Tax Administration Service. On January 25, 2006 a new amendment to Rule 3.4 ...
Great fanfare surrounded the introduction of the Freedom of Information Act and the Freedom of Information (Scotland) Act 2002 a year ago. The FOI legislation was hailed as a success in changing the culture of government. But while most public sector organisations have now come to grips with the workings of the FOI legislation, many have overlooked an associated set of regulations that came into effect at the start of this summer ...
The 18th Session of the Standing Committee of the 10th National People’s Congress adopted the amended Company Law of the of the People’s Republic of China on 27 October 2005. President Hu Jintao promulgated the Law on the same date. The Law, which enters into effect on 1 January 2006, is a significant reform of the Company Law. It simplifies company establishment requirements and statutorily expands the rights of shareholders in PRC companies ...
At the 18th Session of the Standing Committee of the 10th National People’s Congress held on 27 October 2005 amendments to the Securities Law of the of the People’s Republic of China were adopted. The amendments, which were promulgated by President Hu Jintao on 27 October 2005 and enter into effect on 1 January 2006, represent a significant reform of the Law which was first promulgated in 1999 ...
At the 18th Session of the Standing Committee of the 10th National People’s Congress held on 27 October 2005 amendments were adopted to the Individual Income Tax Law of the People's Republic of China. The amendments were promulgated by President Hu Jintao on 27 October 2005 and enter into effect on 1 January 2006. Tax free allowance A first amendment raises the tax free allowance applicable to wages and salaries from RMB 800 to RMB 1,600 ...
The State Council passed the Regulations of the People's Republic of China for the Administration of Production Licences for Industrial Products on 29 June 2005. The Regulations were promulgated by premier Wen Jiabao on 9 July 2005 and entered into effect on 1 September 2005. The Regulations repeal the Trial Regulations for Industrial Product Production Permits promulgated by the State Council on 7 April 1984 ...
The State Administration for Taxation issued the Reply of the State Administration of Taxation on Issues relating to Tax Refund for Reinvestment by Foreign Investors on 20 October 2005. The Reply explains the conditions under which a foreign investment enterprise (“FIE”) can obtain a rebate on its enterprise income tax (“EIT”) for re-investment of its profits if such re-investment is made in instalments or in phases ...
The State Council Information Office and the Ministry of Information Industry issued the Regulations for the Administration of Internet News Information Services on 25 September 2005. The Regulations, which entered into effect on the date of their promulgation, impose licensing and recordal requirements on providers of online news information services in China ...
Great fanfare surrounded the introduction of the Freedom of Information Act and the Freedom of Information (Scotland) Act 2002 a year ago. The FOI legislation was hailed as a success in changing the culture of government. But while most public sector organisations have now come to grips with the workings of the FOI legislation, many have overlooked an associated set of regulations that came into effect at the start of this summer ...
On December 6, 2005 the British Columbia Supreme Court handed down its decision in the case of Hupacasath First Nation v. British Columbia(1). In this decision, the court held that Crown’s duty to consult with first nations, as articulated by the Supreme Court of Canada in Haida Nation(2) and Taku River,(3) extends to government decisions regarding planning, development and use of private land ...
TABLE OF CONTENTS I. Introduction II. Recent and Proposed Governance Changes III. Institutional Scrutiny and Accountability IV. Inherent Governance Tensions V. Governance Regulation I. Introduction Corporate governance continues to be a hot topic. In Canada, we are at the stage of implementing a number of initiatives that have been enacted to follow the US lead in the Sarbanes-Oxley legislation ...
Hong Kong is a Special Administrative Region of the People's Republic of China which is governed by the Basic Law which forms a mini constitution for Hong Kong. Under the Basic Law, Hong Kong enjoys a high degree of autonomy except in relation to matters such as defence or foreign affairs. It has its own executive, legislative and independent judicial power including that of final adjudication ...
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 ...
