The provision of gifts and hospitality to public officials has recently been the subject of a number of news stories in the Serbian media, covering not only the official reports on the variety of protocol gifts received by the high ranking officials from the leaders of other countries, but also the alleged corruption affairs involving the potential bribing of various lower-level officials by companies and individuals seeking an unfair advantage in the market ...
Three recent decisions bolster a generic manufacturer’s ability to challenge Orange Book listings and obtain ANDA approval through section viii “carve-outs.” In Caraco v. Novo Nordisk1 the U.S. Supreme Court unanimously held Caraco could use the Hatch-Waxman’s counterclaim provision to correct Novo’s overbroad use code. In AstraZeneca v. Apotex, the U.S ...
On 23 February 2012, Government Regulation No. 27 of 2012 on Environmental Licenses (“GR 27/2012”) was issued to regulate AMDAL, UPL & UKL, and the contamination and destruction of the environment. GR 27/2012 is the implementing regulation for Articles 33, 41, and 56 of Law No. 32 of 2009 on Environmental Protection and Management which replaced Government Regulation No. 27 of 1999 on Environmental Impact Analysis ...
For the past two years so-called 'monster rain' has hit Copenhagen in summer. The rain has flooded large areas in Copenhagen and neighbouring towns, and caused substantial damage to properties in the flooded areas, as well as closing major radial routes into Copenhagen. This update examines the ways in which the authorities intend to prevent damage caused by monster rain in future ...
Energy security is ability of the State to choose how and under what conditions local consumers are to be provided with energy and energy resources. This ability is mainly determined by alternatives for usage of local energy sources, diversified imports, integrity of energy systems, and market-based formation of energy prices ...
On April 17, 2012 the federal government announced its Plan For Responsible Resource Development, setting out further details on steps to implement proposals for streamlining the federal environmental assessment (“EA”) process. This Plan follows on the heels of the federal budget and the Statutory Review of the Canadian Environmental Assessment Act,[1] which both suggested that these streamlining reforms would be forthcoming ...
In order to comply with a court-ordered schedule, EPA Administrator Lisa Jackson on April 17, signed final rules that subject additional oil and gas operations, including hydraulic fracturing, to air quality regulation under the New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAPs) programs, and impose new and amended requirements under both programs ...
In Greek mythology, Prometheus stole fire from Zeus to give to mankind. It seems that Zeus is now reclaiming some of that fire in the guise of Mayo Collaborative Servs. v. Prometheus Labs., Inc., No. 10-1150 (U.S. Mar. 20, 2012), the Supreme Court’s latest decision addressing patent-eligible subject matter. But a practical analysis of Prometheus reveals strategies one can use in drafting patent claims to keep those claims burning ...
The U.S. Fourth Circuit Court of Appeals has reversed a $44 million judgment against Tuomey Hospital in Sumter, South Carolina that arose from Tuomey’s employment arrangements with physicians that allegedly violated the federal Stark Law.1 The Stark Law prohibits hospitals from submitting claims to Medicare for designated health services that were referred by physicians with whom the hospital has a financial relationship, unless the relationship fits within an exception ...
After three days of historic oral arguments before the U.S. Supreme Court, the fate of the Affordable Care Act (ACA), the momentous 2010 health reform law, is uncertain, given robust questioning of the ability of Congress to force individuals to purchase health insurance ...
In response to a court order, EPA has announced proposed rules that would establish new source performance standards (“NSPS”) applicable to greenhouse gas emissions from new, fossil fuel-fired power plants (“power plants”). The proposal is a highly controversial one, which will effectively prohibit the construction of coal-fired power plants that do not capture carbon ...
On March 26, 2012, the Fifth Circuit Court of Appeals (“the Court”) vacated and remanded EPA’s disapproval of Texas’s request for approval of the minor source standard permit for pollution control projects (“PCP”) as part of its air quality state implementation plan (“SIP”). The Court’s reasoning may also affect other pending disputes between EPA and Texas regarding air quality permitting and other issues ...
On Wednesday, March 22, the United States Supreme Court ruled that a compliance order issued under EPA’s Clean Water Act enforcement authority to individuals for allegedly filling part of their property without the necessary “dredge and fill” permit could be challenged in federal district court. The ruling marks a major loss for EPA’s enforcement practices under the Clean Water Act ...
Law no.11/2012 of 8 March establishes new rules for prescription and dispensing of medicines. Prescriptions for medicines must now include the International Nonproprietary Name (INN) of the active substance,its pharmaceutical form, the dosage, the presentation and the posology. The prescription may also include a trade name by brand or indication of the name of the holder of the marketing authorisation ...
On March 13, 2012, the Standing Committee on Environment and Sustainable Development issued recommendations for improving the Canadian Environmental Assessment Act (CEAA) process (click on Print Format for the complete report). The recommendations focus on: improving timeliness; decreasing duplication with provincial processes; improving aboriginal consultation processes; and improving outcomes ...
On March 21, 2012, the United States Supreme Court issued a unanimous decision in the much-publicized case of Sackett v. EPA (No. 10-1062), less than three months after oral argument, holding that the Sacketts were not precluded from judicially challenging EPA’s issuance of an administrative compliance order ...
The Stage 2 Meaningful Use requirements proposed last week by CMS as part of the Medicare and Medicaid incentive programs to expand the use of Electronic Health Record (EHRs) maintain the same core and menu structure as the Stage 1 criteria. The proposed rule, however, gives providers an additional year, until 2014, to implement Stage 2 criteria ...
On February 24, 2012, two years after oral argument, the Texas Supreme Court issued its watershed decision in Edwards Aquifer Authority (the “Authority”) v. Day. The Court’s long-awaited decision included two significant pronouncements on groundwater that are likely to have ripple effects throughout the water community and could open the flood gates to a wave of litigation ...
Healthcare providers and other HIPAA covered entities have until Wednesday, February 29, 2012 to submit notice of breaches of unsecured Protected Health Information which affected fewer than 500 individuals during 2011. Notice must be submitted electronically to the Secretary of Health & Human Services, and separate forms are required for each data breach occurring in the course of the calendar year ...
The Centers for Medicare and Medicaid Services (CMS) on February 16, 2012 proposed rules1 implementing Section 6402(a) of the Affordable Care Act,2 requiring persons to report and return Medicare overpayments by the later of 60 days after an overpayment is identified or the date any corresponding cost report is due. Twice in the past, CMS had proposed rules requiring the return of Medicare overpayments, but did not finalize the regulations ...
Only two days after the government’s announcement that it recovered a record-breaking $4.1 billion from its healthcare fraud enforcement efforts in 2011, the Centers for Medicare and Medicaid Services (CMS) published a draft regulation in today’s Federal Register implementing the Affordable Care Act’s (ACA) 60-day overpayment report and return provision ...
On November 15, 2011, existing facilities subject to the federal Spill Pollution Control and Countermeasure Rule (“SPCC Rule”), 40 C.F.R. Part 112, were required to finalize and implement a plan—known as an “SPCC plan”—detailing the equipment, workforce, procedures and steps to be taken to prevent, control and provide adequate countermeasures to a discharge of oil to navigable waters of the United States or adjoining shorelines ...
The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services has begun the pilot phase of HIPAA privacy and security audits of health care providers, health insurers and health care clearinghouses (“covered entities”) to assess HIPAA compliance efforts. Up to 150 covered entities will be subject to the initial audits, to be conducted by KPMG, LLP, the OCR audit contractor ...
In its judgment of 19 January 2012 (case no. 08332/11), the Southern Central Administrative Court, decided that INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. (the national authority for medicines and healthcare products), is obliged to issue a certificate of subsidisation of the price of a medicine even when the person requesting the issue of the certificate was not the person who applied for the subsidy ...
In connection with the recent changes in legislation in the field of health, the Federal Commission for protection against health risks ("Cofepris") has taken various actions against the sale, distribution and advertising of the so-called "miracle products," which are distributed without scientific evidence to demonstrate its therapeutic properties ...
