The healthcare industry will have to wait for a court to answer the question of whether the United States Federal Trade Commission (the “FTC”) has authority to regulate data security practices of entities covered by the Health Insurance Portability and Accountability Act (“HIPAA”). On Monday, a federal district judge dismissed LabMD, Inc.’s case without reaching the merits, declining to disrupt the underlying administrative proceeding ...
Regional governments in Sweden are increasingly looking to leverage their purchasing power in order to secure discounts and rebates on the list prices of branded drugs. However, as noted by Elizabeth Eklund, Partner at leading commercial law firm Delphi, such agreements risk running foul of both Swedish and European Union (EU) law ...
Mexico’s Senate received on April 30, the first round of the long-awaited secondary legislation to implement the constitutional energy reform effective last December. This first legislative package includes 9 new laws and modifies 12 existing laws. We anticipate that the package will be discussed and voted on during the extraordinary legislative sessions by the end of June. Below we list some of the highlights ...
European Commission imposes fines of €302m on participants What does this mean for you? The decision The European Commission has imposed fines totalling just over €300 million on the participants in a cartel involving the supply of underground and submarine high voltage power cables for important high voltage power cable projects in the EEA (including large infrastructure and renewable energy projects such as offshore wind farms) ...
On April 22th, 2014, the Federal Electricity Commission announced an international public bid, which number is not yet assigned, for the construction of 5 gas pipelines. These five gas pipelines will have capacity, amongst all of them, for 5 thousand 650 million cubic feet per day, according to the following: The largest of the pipelines, which will go from El Encino in Chihuahua to La Laguna between Coahuila and Durango, shall be 423 kilometers in length and 1,500 million cubic feet per day ...
On April 1, 2014, the Superior Court issued an interesting decision respecting consent to care1. The Quebec City CHU petitioned the Superior Court in order to be authorized to provide care for a 60‑day period to a patient despite the refusal of her parents. On March 14, the 22 years old patient suffered cardiac arrest following an intravenous drug overdose ...
The Minister of Trade has promulgated Regulation No 04/M-DAG/PER/1/2014 on 11 January 2014 which lists: 1 - 186 refined and processed mining products which are restricted to be exported (Attachment I of the regulation), such as metallic minerals, non-metallic minerals and rocks (including silver, gold and copper which contain certain levels of certain mineral elements) ...
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 ...
On 26 November 2013 the Danish Government and the Government of Greenland handed over their scientific documentation for sovereignty over the continental shelf northeast of Greenland to the Commission on the Limits of the Continental Shelf (CLCS) and thereby submitted a claim for an area of approximately 62,000 square kilometres off the Greenlandic north coast between Greenland and Svalbard (Norway) ...
As of February 2014, Amendments to the Gas Market Act have become applicable in Croatia. The amended Act defines the new role of wholesale supplier of natural gas. Supplier should be company that domestic natural gas producers will sell the gas under regulated price and conditions and who will then resell the natural gas at another regulated distribution price to local suppliers that ultimately supply end users with natural gas ...
The underwriters have priced the deal. The underwriting agreement has been signed. The issuer has returned its focus to running its business and the underwriters have moved on to the next deal. All that is left is for the lawyers to document the terms and to ensure that the underwriters are in a position to move money at closing. Then, a day or two after pricing, the plant unexpectedly blows up ...
A little known provision contained in the EU’s internal energy market directives requiring Commission approval for ‘level playing field measures’ could prove to be a headache for policy makers looking to correct perceived imbalances between incumbent energy players and new entrants ...
As was recently announced, the European Commission has yesterday (22 January 2014) published its proposal for the regulation of unconventional fossil fuels and notably shale gas. Whereas both legislative and non-legislative options were on the table, the European Commission has chosen to adopt a non-legally binding “Recommendation” rather than a Directive ...
This past December 12, the Mexican congress finally approved a constitutional energy reform (the “Energy Reform”). As of today, the required majority of state congresses have also ratified it. What now remains is a declaration from the Permanent Commission of the Mexican congress, which is expected shortly ...
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 ...
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 ...
What is a PPA? The purpose of a Power Purchase Agreement (PPA) is to set out the terms and conditions for the sale of electricity between a producer (seller) and the take-off entity (buyer), particularly regulating important matters on timing and the initiation of production, the terms of delivery of electricity, payment mechanisms, force majeure clauses and the termination of sales and purchases. The PPA represents a crucial project document in a renewables project ...
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 August 6, 2013, the Quebec Court of Appeal rendered a very interesting decision in the case of Anglo Pacific Group plc v. Ernst & Young Inc., 9261-0690 Québec Inc., Northern Star Mining Corp. and Jake Resources Inc ...
In 1956, the American Association of Professional Landmen (“A.A.P.L.”) published the first version of its model form Joint Operating Agreement (“JOA”), which it later revised in 1977, 1982, and 1989 (the “A.A.P.L. form”). Since that initial publication, the oil and gas industry has universally adopted the A.A.P.L. form as its standard JOA. The industry has also since adopted horizontal drilling and development as a popular method to recover hydrocarbons ...
I. Introduction The development of projects and business opportunities, particularly in the natural resource industries, requires government decision making, from the issuance of resource tenures, through environmental assessment of proposed works and activities, and through licences, permits and authorizations ...
