As you no doubt already know, the Pharmaceutical Industry in Argentina is a strictly controlled industry. Said control is held by the ANMAT Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) and it spreads from the first authorisation of a laboratory to act as such in the country, moving through the authorisations to commercialise products, up to pharmacovigilance of products that have already been commercialised ...
In one of the few decisions of its kind, the UK High Court recently assessed the damages to be paid to a generic pharmaceutical company under a cross-undertaking in damages. While some aspects of the decision are specific to the UK pharmaceutical reimbursement scheme, the judgment will be a useful reference point for parties involved in similar litigation in Australia ...
Administrative fines and increased fees for exploitation of the environment are increasingly included in environmental regulations as sanctions. Lawmakers in Poland more and more often provide for administrative financial sanctions for environmental violations because they are more convenient to enforce than criminal sanctions, which require proof of fault on the part of a specific perpetrator. Moreover, criminal liability may be imposed solely on individuals ...
Sierra Club v. Bostick (W.D. Oklahoma) In June 2012, environmental groups filed suit in the US District Court for the Western District of Oklahoma challenging the US Army Corps of Engineers’ issuance of Nationwide Permit (NWP) 12 for utility line projects, and use of NWP 12 for the Keystone Pipeline Gulf Coast Project.Sierra Club v. Bostick, 5:12-cv-00742-R (W.D. Oklahoma) ...
In the United States, new rules will soon be taking effect making consideration of vapour intrusion risk a mandatory step in the Phase I environmental site assessment (ESA) process. Companies should review their real estate portfolios and consider whether properties may be at risk. In Canada, mortgage financing and asset sales are expected to be affected by the new diligence standard (that includes checking for vapour intrusion risks) in the near future ...
The federal Endangered Species Act is designed to prevent the taking of endangered species and imposes a regulatory program geared toward the protection and conservation of federally listed species and their critical habitat ...
Physician-owned distributorships (PODs) and other physician-owned entities (POEs) have emerged as a favored vehicle to reduce costs, but the popularity of PODs and POEs has led to increased scrutiny by federal regulators. In June 2011, the United States Senate called on the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) and Centers for Medicare & Medicaid Services to investigate the proliferation of PODs and corresponding utilization practices ...
THE 1979 STATUTE It is well known that, under the legal regime for the protection of agricultural lands, the acquisition of agriculturally zoned lands with a surface area of four hectares or more by a person not residing in Quebec is subject to the authorization of the Commission de protection des terres agricoles. This is the object of the Act respecting the acquisition of farm land by non-residents (CQLR chapter A-4.1) (the “Act”), which has been in force since December 21, 1979 ...
Purchasers and lessees of commercial or industrial properties know to obtain Phase I environmental site assessments to identify the presence of contamination - so-called recognized environmental conditions (RECs) - because of the very substantial liabilities these conditions may create. And their lenders generally require them. The industry standard for Phase I’s is based on EPA regulations that flesh out Superfund’s “all appropriate inquiry (AAI)” standard ...
Introduction Last week, the federal government took a big step toward bringing the Fisheries Act (Canada) and its application into line with the federal government’s responsible resource development plan ...
The European Parliament’s Auken Report made it clear that Spain is coming up short as far as protecting its coastline is concerned. Application of Coastal Law 22/1988, of July 28, 1988, fast-tracked in recent years, not only brought with it no little confusion for all concerned, it also failed to contribute to the protection of the coastline, which clearly leaves a great deal to be desired along certain stretches of the Spanish coast ...
On October 18, 2013, the Centers for Medicare & Medicaid Services (CMS) published Survey & Certification Letter 14-01-NM, which clarified the obligations of a skilled nursing facility (SNF) or nursing facility (NF) (collectively “nursing homes”) to provide cardiopulmonary resuscitation, or CPR, to its residents ...
On 3 October 2013, DG Environment of the European Commission published its final report following the public consultation on ‘Unconventional fossil fuels’ (e.g. shale gas). Since this is an important stage in the legislative process, the purpose of this note is to provide you with a brief outline of its findings and follow up. Importantly, the European Commission has announced that in December 2013 the impact assessment will follow ...
In a statement issued by the National Regulatory Agency, Control and Surveillance (ARCSA), drugs that are sold in Ecuador must have labels stating the words 'generic', otherwise it can not be marketed as of January 24, 2014 ...
On October 17th, 2013, the Supreme Court of Canada released its long-awaited decision in Castonguay Blasting, commonly referred to as the fly-rock case. To summarize, Castonguay was doing some blasting work and rock was unexpectedly projected outside the work site, landing on someone’s property and damaging a home and a vehicle. No one was hurt and there was no environmental damage ...
In September 2013, the Texas Commission on Environmental Quality updated its guidance on the use of the Texas Environmental, Health, and Safety Audit Privilege Act to reflect changes recently made by the 83rd Texas legislature to allow prospective purchasers of facilities to take advantage of the protections afforded by the Act ...
In June 2013, the Land and Environment Court handed down a judgment in a case concerning parent company liability for environmental pollution caused by a subsidiary, (Case No. M 11429-12). Initially, we give a brief description of the term operator followed by an account of the judgment in question ...
Never has there been a more controversial law in the past decade than the Reproductive Health Law (“RH Law”). After a long and contentious battle in Congress, the law was finally passed. But the fervent opposition by the so-called Pro-life groups (chief among them the Catholic Church) endures. Four days after the approval of the law’s Implementing Rules and Regulations (“IRR”), the Supreme Court on March 19, 2013, halted its implementation, issuing a 120-day status quo ante order ...
BackgroundFollowing much anticipation on the part of health care industry members, CMS released its long-awaited final rule on the Physician Payment Sunshine Act in February 2013, supplying clarification and guidance on new financial disclosure requirements governing pharmaceutical and medical device manufacturers. The rule includes extensive and potentially time-consuming mandates for drug and device companies, including reporting of annual payments to physicians and teaching hospitals ...
he designation of critical habitat under the Endangered Species Act (ESA) can result in significant and costly consequences for landowners, industry, government, and other entities—often with little if any evidence of a commensurate benefit to the species involved. In Critical Habitat and the Challenge of Regulating Small Harms, Professor Dave Owen provides a valuable contribution to assessing the role of critical habitat during consultation on federal agency actions under ESA section 7 ...
In Novozymes A/S v. DuPont Nutrition Biosciences APS, 2012-1433 (Fed. Cir. July 22, 2013), the Federal Circuit affirmed the district court’s grant of DuPont’s post-trial motion for judgment as a matter of law holding that Novozymes’ U.S. Patent No. 7,713,723 (“the ’723 patent”), directed to a variant of alpha-amylase, was invalid under 35 U.S.C. § 112, first paragraph, for failing to satisfy the written description requirement.2 (Slip op. at 18) ...
In 1989 the eminent South African jurist (the late) Prof.Dennis Cowen expressed the view that, by the end of the 1980s, South African environmental law was “a subject struggling to be born”. Nearly a quarter of century later South African environmental law is thriving as a “subject” in a manner that Prof. Cowen is unlikely ever to have anticipated. In addition, the business of environmental law has, in recent years, witnessed a rapid evolution ...
South Africa has a rapidly evolving climate change policy environment, which is in-keeping with the country¡¦s view of itself as a developing country leader in the climate change arena. Part of the policy environment includes attention to financial mechanisms that can be marshaled in support of the response to climate change. Flowing from the notion of using financial mechanisms in this manner, the National Treasury has taken initial steps towards the implementation of carbon taxation ...
