HARMONIZATION OF CLINICAL RESEARCH CONTRACTS IN QUEBEC OLGA FARMAN and MARIE-ÈVE CLAVET [email protected] [email protected] Over the past few decades, a high-quality system of research and innovation has been built in the Province of Quebec. The contractual research conducted by university-affiliated health-care institutions in Quebec has become a fundamental scientific, economic and social activity ...
As part of the Medicare hospital outpatient prospective payment system and ambulatory surgery center payment system final rule for calendar year 2011 (the “Final Rule”), the Centers for Medicare and Medicaid Services (CMS) recently issued final regulations that implement the changes that were made to the whole hospital exception by the Patient Protection and Affordable Care Act and the Health Care Education and Reconciliation Act of 2010 (collectively, the “Acts
In Sweden, the directive has been implemented through amendments to the Medical Devices Act (1993:584), and through the regulation which the Medical Products Agency has issued in connection with this Act and the directive. The revised directive contains some clarifications but also some news ...
After decades of debate, US healthcare reform became a reality in 2010 when President Obama signed the Patient Protection and Affordable Care Act (ACA) in March. Yet public opinion remains sharply divided on the merits of this sweeping legislation, both in terms of its ability to address the problems of access to, and the rising cost of, healthcare services and in terms of the financial burden on the federal and state governments of implementing ACA ...
Hunton & Williams announced today the launch of its new website — the Hunton & Williams Health Care Reform Center, huntonhealthcarereform.com ...
The hospital has lost lengthy legal proceedings about the uninsured patients from the governments of the Netherlands Antilles and Curaçao. The governments are not obligated to write a “blank check”, as it were, for the costs Sehos had to incur for uninsured persons that cannot be recovered, according to judge Van Schendel yesterday ...
The U.S. Department of Health and Human Services, the U.S. Department of Labor and the U.S. Department of Treasury have released another set of interim final regulations (the “IFR”) regarding the coverage of preventive care without cost sharing. As with all guidance, the IFR cannot be considered in isolation ...
Referring to Newsletter Issue No. 12 in relation to the Health Bill, the new Health Law No. 36 of 2009 was finally issued on 13 October 2009. Under the Health Law, mothers must breastfeed their babies exclusively from birth until 6 months old. It is expected that family members, the Government, Regional Governments and communities will support lactating mothers by providing time and space for them to breastfeed their babies in work places and public areas ...
Providers of a advanced diagnostic imaging services, including physicians, who bill for the technical component must become accredited by a designated accreditation organization by Jan. 1, 2012 in order to be reimbursed by Medicare, according to a notice from CMS published in the Federal Register ...
The U.S. Department of Justice recently announced an enforcement initiative targeting the pharmaceutical industry for investigations and prosecutions under the Foreign Corrupt Practices Act (FCPA). The FCPA prohibits improper payments to foreign government officials for the purpose of obtaining or retaining business and mandates that companies that issue securities take affirmative measures to prevent such payments ...
Under the Tobacco acT (r.s.Q., c. t-0.01), employers mUst prohibit their employees from smoKing inside their establishments. howeVer, the act is mute on no smoKing oUtside, on the company’s land ...
by Bryan G. Scott and Elizabeth K. Strickland Few areas of law have proven more dynamic over the last few years than the interplay between state tort laws and the federal regulation of pharmaceutical drugs and medical devices ...
Over the past few years, the Ukrainian agromarket has been rapidly developing. The vast potential of our nation's agricultural sector together with the intensifying situation in the global foodstuffs market has furthered this process. Both international and domestic players have played an active role ...
On July 24, 2009 the Colombian Congress approved the bill "by virtue of which new regulations are issued for the protection of competition". Some of the relevant provisions incorporated in the bill are the following: Single Antitrust Authority. The Superintendence of Industry and Commerce (“SIC”) is appointed as the only Antitrust Authority in Colombia ...
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 ...