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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
