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 ...
February 2007 UK retail sales rose 0.6% on a like-for-like basis against a weak comparative in February 2006, when sales had fallen. The three-month trend rate of growth weakened in February to 0.9% from 1.1% in January for like-for-like sales, but rose to 4.2% from 3.6% for total sales, reflecting the continued growth of retail space.Clothing and footwear were still difficult but food sales improved, helped by Valentine’s Day, after a flat January ...
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 Federal Trade Commission yesterday published its long awaited revisions to the FTC’s Franchising Rule. The new disclosures may be used effective July 1, 2007 and must be used for all franchises offered or sold after July 1, 2008. The Amended Rule prescribes a disclosure format which largely mirrors the Uniform Franchise Offering Circular ("UFOC") format, and modifies it in certain places by adding new disclosures ...
Broadband providers will be required to ensure that their ten million UK customers can more easily take advantage of cheaper broadband deals in an increasingly competitive market, under new regulations proposed by the UK communications industry watchdog OFCOM on 17 August 2006 ...
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 ...
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 ...
The English Court of Appeal has thrown out an attempt to appeal a decision in favour of Dyson about spare parts for Dyson vacuum cleaners. Dyson sued spare parts supplier Qualtex for infringement of Dyson's unregistered design rights (UDR) in 14 spare parts manufactured by Qualtex. The spare parts were deliberately designed to look like the originals, known as "pattern parts" in the trade ...
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 ...
Keeping in Shape – Trademark Protection of Product ConfigurationsThe development of unique and distinctive product configurations allows the producer of the product to achieve more bang for its marketing dollar. The consumer not only cognitively associates the manufacturer’s word mark with the product, but also its configuration. In this context, the oft cited example is the Coca-Cola bottle shape ...
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 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 ...
In our previous ezines we tracked the progress of the Alcohol Products (Control of Advertising, Sponsorship and Marketing Practices/Sales Promotions) Bill. The Bill was set to have a major impact on the relationship between alcohol advertising and sport in Ireland but a recent controversial turnabout by the Government means that the Bill may never be enacted ...
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 ...
Directive of the European Parliament No. 2004/27EC of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ EU [2004], L 136, p. 34) Scientific progress and the development of new types of products explain the rise in issues regarding the legal qualification of so-called “borderline” products ...
Commission Guidelines for the Notification of Dangerous Consumer Products to the Competent Authorities of the Member States by Producers and Distributors in accordance with Article 5(3) of Directive 2001/95/EC (Commission document No ...
