During the last 10 years there has been a significant market debate about the position Chile should take in connection with open digital television. This debate is all teh more significant because this service may predominate in the future because of its ability to allowing users to better administer the content they wish to watch. Since the beginning of the debate, different countries have tried to introduce their respective technologies in Chile ...
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 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 ...
There is currently a war being waged between publishers and celebrities both relying on conflicting aspects of the European Convention of Human Rights (ECHR). The Two SidesThere is currently a war being waged between publishers and celebrities both relying on conflicting aspects of the European Convention of Human Rights (ECHR) ...
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 ...
The controversial Indian Premier League (IPL) is now underway, with English cricket stars conspicuous by their absence. They have been banned from both the IPL and its rival tournament, the Indian Cricket League (ICL), by the England and Wales Cricket Board (ECB). Players competing in the ICL will receive a 12 month ECB ban, from all forms of English Country cricket ...
The US judge who presided over the nation's only successful copyright infringement case for file-sharing by an individual, has declared it a mistrial. He said he had committed a "manifest error" in his instructions to the jury and the award of damages of $222,000 was "unprecedented and oppressive" ...
On 1 July 2008 a new Marketing Practices Act entered into force. The new act implements Directive 2005/29/EC on unfair commercial practices and implies some new aspects for Swedish companies to take into consideration. These include a new way of qualifying commercial practices and the fact that marketing statements can, in the final instance, be subject to assessment by the European Court of Justice ...
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 ...
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 ...
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 ...
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 ...
One of the most talked about eHealth initiatives is the introduction of a national electronic health record for all Australians. Having a centralised database of electronic health records will greatly improve access to accurate and up-to-date data by health care workers, including doctors, hospital staff and emergency service providers ...
We are increasingly being asked: “Is it more likely that individuals rather than companies will be prosecuted under the new Health and Safety Offences Act 2008?”. The new Act, which came into force in January 2009, did not introduce any further duties on either organisations or individuals, but it did dramatically increase the penalties that can be imposed for breaches of existing health and safety legislation ...
Media organisations and journalists will now need to be more cautious when entering into contracts with third parties for interviews and information, following the decision of the High Court in ACCC v Seven Network. The court held that section 65A of the Trade Practices Act (TPA) will not afford protection to a media organisation against section 52 of the TPA when it engages in chequebook journalism ...
