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 ...
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 ...
This paper will address the varying requirements for fair market value in transactions involving physicians and hospitals and other health care providers. The paper will first examine the Stark law and how and when transactions may satisfy Stark’s requirements for fair market value. Second, the use of fair market value for compliance with the federal Anti-Kickback statute will be addressed ...
Savings and expected recoveries of $43 billion were reported by the Department of Health and Human Services Office of the Inspector General (OIG) in its Semiannual Report to Congress on December 14, 2007, for fiscal year 2007 (October 2006 – September 2007). This represents $2.18 billion in investigative recoveries, $1 ...
CMS recently released new regulations intended to curb the ability of a physician to earn a profit on either the technical component (TC) or professional component (PC) of tests ordered by the physician, but performed by another party. The regulation is effective January 1, 2008 and applies to all Medicare-covered diagnostic tests including imaging and anatomic pathology, but excluding clinical laboratory tests ...
According to statistics, 76% of the leading 100 UK retailers have plans to replace at least one of their core IT systems in 2008. Ensuring that your IT system is up to date is vital. Using outdated software packages often results in poor service delivery and inefficient business management. Many old systems are not capable of meeting current legislation requirements or are not able to deliver reports to demonstrate compliance ...
Patents offer useful services. With them, the holder can prevent competitors from offering products using the patented technology. In addition to the rights that a patent holder has had up until now (injunction, disclosure, indemnification), now a fourth right is joining in on the action and is continuously gaining in significance. This right involves the right to inspection. It is especially important in the case of process patents and at trade shows ...
In one of the first decisions in Quebec since the landmark Domtar case(1), the Québec Court of Appeal has refined the parameters of the liability of a professional vendor and of a manufacturer for a latent defect. In this case,(2), Joseph Élie Limitée (“Élie”) had sold an oil tank manufactured by Réservoirs d’acier Granby (“Granby”), and supplied the oil to its customer, who was insured by Federation Insurance Company of Canada (“Federation”) ...
In one of the first decisions in Quebec since the landmark Domtar case(1), the Québec Court of Appeal has refined the parameters of the liability of a professional vendor and of a manufacturer for a latent defect. In this case,(2), Joseph Élie Limitée (“Élie”) had sold an oil tank manufactured by Réservoirs d’acier Granby (“Granby”), and supplied the oil to its customer, who was insured by Federation Insurance Company of Canada (“Federation”) ...
One more lengthy battle in a legal saga has just come to an end. Indeed, on June 4, 2008, the Court, comprised of Quebec’s Chief Justice, Michel Robert, and Justices Jacques Chamberland and Louis Rochette, rendered a unanimous judgment.(1)To set the stage, consider a salmonella outbreak in Abitibi, some premature deaths, dozens of persons poisoned, three producing farms.. ...
The increasing number of recalls of consumer products in recent years is indicative of a trend that has raised concerns for governmental authorities. In response, the Canadian government announced, on April 8, 2008, a reform of the existing legislation to strengthen the protection of human health and safety. The first step was the introduction of the Canada Consumer Product Safety Act (Bill C-52) and the second, the reform (Bill C-51) of the Food and Drugs Act (R.S.C ...
A new Act which comes into force on 16 January 2009 imposes serious new penalties for directors, employers and employees who are convicted of a health and safety offence. The Bill received Royal Assent on 16 October 2008 and unlike the Corporate Manslaughter and Corporate Homicide Act, this has had a relatively easy journey through the parliamentary stages ...
Since the establishment of the Dubai International Financial Centre (DIFC) in late 2004, banks and other financial-service providers established or registered within the DIFC have been restricted to operating only in the wholesale market. From July 1, 2008 it has, however, been possible to provide financial services to retail customers in or from the DIFC. Initially, the DIFC was described as a wholesale financial-services environment ...
The three major automobile manufacturers in the United States, General Motors, Ford and Chrysler, have indicated that without significant financial assistance from the government a filing for reorganization under Chapter 11 of the United States Bankruptcy Code is likely. Such a filing would have a significant impact on car dealers ...
On May 22, 2008, the Supreme Court of Canada rendered its decision in a case involving the notion of reasonable foreseeability in negligence actions. This judgment, written by the Chief Justice, confirms that tort law must compensate harm done on the basis of reasonable foresight, and must not be considered as insurance ...
A new regulation has been issued by the Minister of Health, namely Regulation of the Ministry of Health No. 1010/MENKES/PER/XI/2008 regarding the Registration of Medicines (“Regulation 1010/2008”). Regulation 1010/2008 revokes previous Ministry of Health Regulation No. 949/Menkes/Per/VI/2000. Under Regulation 1010/2008, a medicine to be distributed in Indonesia must first be registered before a Distribution License (Izin Edar) can be applied for ...
Consumers currently spend €24bn every year in cross-border transactions, but this is only a fraction of the potential market.Many individuals are dissuaded from spending more by doubts over issues such as delivery timescales and after-sales service.EU forecasters expect online revenues within Member States to grow by 230% in the next five years, but only if the way is smoothed by the adoption of a new Consumer Rights Directive ...
But which practical actions could add up to substantial cost savings in the current climate and for the future?: try to capitalise on potential rent savings in volatile markets look to release funds from the portfolio - sweat the assets make sure that service charges are kept in check act quickly on sub-tenant default These are the key messages:
Six months on from the implementation of sections 20 and 21 of the Road Safety Act 2006, and occupational road safety remains a significant cause for concern for employers. The Act introduced two new offences of causing death by careless driving and causing death whilst unlicensed, disqualified or uninsured, with offenders finding themselves facing up to five years’ imprisonment for what could be a momentary lapse of concentration ...
The Advocate General of the European Court of Justice (ECJ) expressed her opinion in respect of a reference for a preliminary ruling from a German court. The main proceedings before the German court concern a German distance retailer who tried to charge the customer of a second-hand laptop for the eight months of use she had ...
Last year, the European Commission initiated an inquiry into the pharmaceutical industry, claiming that there were indications that competition in the industry was not working as well as it should. Although responses to the preliminary report have been rather critical, from both the legal community and the industry itself, there are a few conclusions worth noting ...
A campaign that ran throughout March has been extended into April, and will focus on refurbishment, repair and maintenance works. Statistics show that more than half of workers who died on construction sites in recent years were working on refurbishment projects ...
