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 ...
Private Actions in Competition Law: Effective Redress for Consumers and BusinessResponse by Shepherd and Wedderburn LLP1. Introduction1.1 Shepherd and Wedderburn LLP welcomes the opportunity to comment on the issues raised by the OFT in its April 2007 Discussion Paper: Private Actions in Competition law: Effective Redress for Consumers and Business (the Discussion Paper). 1 ...
Ten years ago, we would not have been discussing this topic with the Chairman of the then Monopolies and Mergers Commission. Ten years ago, the MMC was a very different animal from today's Competition Commission. Ten years ago, the MMC was largely outside of the daily media spotlight, less transparent and much closer to government ...
Romania¡¦s yearly economic growth has triggered in the past few years an increased interest for investment in the existing domestic companies. Most of the financial investors seek to leverage their acquisitions and expect the possibility to use the target companies¡¦ assets to such purpose. This article will briefly review corporate limits and prevailing interpretation.Prohibition of financial assistanceRomania has implemented the provisions of art ...
The purpose of this article is to provide a short update as to the legal and policy developments in the area of private enforcement of competition law. Regulatory scrutiny and judicial developments continue to be principally focussed on the issue of follow-on damages actions for infringements of competition law, especially in the cartel arena. However, as can be seen in the English High Court's recent judgement in SanDisk Corporation vs ...
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 ...
In a previous article on this site , I suggested that the impact of Placanica was to leave the national courts in a bit of a hole ...
Enforcement of competition law by means of private actions (particularly private damages actions) is a hot topic. The European Commission has a stated policy objective of encouraging private actions and, at the UK level, private actions are becoming more prevalent in both the courts and before the Competition Appeal Tribunal. In particular, the English High Court's decision in Provimi has led to England being seen as an attractive jurisdiction for damages claims ...
With competition authorities across Europe increasingly keen to demonstrate their toughness when it comes to market-sharing and price-fixing, cartel-busting is very much flavour of the month. The European Commission is imposing larger and larger fines in order to ramp up its cartel-busting activities ...
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 ...
The Companies Act 2006, which is likely to come into force towards the end of 2007, represents the first attempt to codify directors' duties in UK law. In broad terms, a director's duties currently include the requirement to exercise reasonable skill, care and judgement, not to exceed the powers given to him/her, to avoid conflicts of interest and to act in good faith and in the interests of the company ...
In the context of Romania's accession to the European Union and in response to the World Bank's reports on the compatibility of the country's legislation with the principles of the Organization for Economic Cooperation and Development (OECD), which indicated a number of deficiencies in Romania's corporate governance regulations, the government introduced major changes to the Company Law (31/1990) with effect from December 1 2006 ...
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 ...
The Companies Act 2006, which is likely to come into force towards the end of 2007, represents the first attempt to codify directors' duties in UK law. In broad terms, a director's duties currently include the requirement to exercise reasonable skill, care and judgement, not to exceed the powers given to him/her, to avoid conflicts of interest and to act in good faith and in the interests of the company ...
IntroductionThe ECJ's decision in Placanica has quite rightly generated a lot of comment in this publication and in the press more generally. As the dust settles three views have emerged as to the potential impact of the judgement ...
The long-awaited revision to the United States federal franchise regulation which requires presale disclosure throughout the country will become effective July 1, 2007, the Federal Trade Commission (“FTC”) January 23. The FTC Franchising Trade Regulation Rule (“FTC Rule”), initially adopted in 1979, has been under review since the early 1990s. Although the focus was upon making the disclosures and compliance burdens more relevant to changes in the U.S ...
It is generally accepted that mentoring is important to the retention and professional development of attorneys – particularly minority attorneys. However, despite touting their mentoring programs, it appears that few, if any, law firms and corporations “get it right.” Assigning a mentor often results in a few lunches between two people who may or may not have anything in common ...
The European Commission continues its interest in the energy sector in 2007 by imposing record fines on participants in a gas insulated switchgear cartel and carrying out unannounced inspections on several power transformer manufacturers suspected of participating in a cartel. Siemens and ABB confirm involvement in both investigations. A record fine of EUR 992 for a lifts and escalators cartel has also been announced ...
Following a year and half long market investigation, the OFT published on 7 December 2006 its report on the commercial use of public sector information (PSI). The report makes a number of recommendations aimed at increasing "fair" access to PSI, particularly where the public sector body holding the information is itself active in providing value added products to end users ...
The CAT has confirmed, with the Court of Appeal's blessing, that it will not only srcutinise a regulator's decision but that it will also, in certain cases, substitute the regulator's decision with that of its own without remitting the case back to the regulator for a second bite at the cherry.The CAT's approach offers possibilities for both a complainant and for those companies subject to regulatory investigation ...
In recent years, we have seen a surge in co-productions in Asia, whether in the form of co-productions between parties from different parts of Asia (which would normally involve both financial and production contribution from all parties), or co-productions between Western and Chinese parties ...
When the company was purchased, you will have entered into a Share Purchase Agreement. If you think that there might be potential for a warranty claim, you need to revisit the agreement to establish the basis of your claim and the manner in which it requires to be processed. The warranties in your agreement amount to assurances from the seller with regards to the condition of the business and outstanding liabilities at the time the deal was completed ...
Legislation and jurisdiction1. What is the relevant legislation and who enforces it?Competition is regulated under Competition Law no. 21/1996, as subsequently amended andsupplemented (the Competition Law), and under Competition Council regulations andguidelines. The Romanian competition legislation generally follows the provisions of EuropeanCommunity legislation ...
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 ...
