On February 21, 2017 the Ninth Circuit Court of Appeals in the case San Luis and Delta-Mendota Water Authority v. Haugrud found that water releases under California Fish and Game Code Section 5937 to keep fish in "good condition" creates an exception to the requirement to obtain a water right permit change from the State Water Resources Control Board (SWRCB). The Haugrud case addresses the Bureau of Reclamation (BOR) 2013 release of Trinity River water from the Lewiston Dam ...
View the February 2017 Health Law Vitals Newsletter PDF. Final Guidance Sheds Light on Medical Device Reporting Requirements In November 2016, the U.S. Food and Drug Administration issued a final guidance on medical device reporting for manufacturers ("Final MDR Guidance") ...
Just weeks into the new Administration, perhaps the only certain thing is that there will be uncertainty as the Administration makes its mark and works to fulfill campaign promises. Meanwhile, restaurant chains and food companies are trying to allocate resources to best address business priorities and hot legal issues ...
The current EU regulations for medical devices and in vitro diagnostics are from the 1990s. The rapid technical developments in the health care system in recent years as well as the increased cross-border trade urgently require a modernization of the current legal framework. Now the adoption of new EU legislation is imminent. This article provides a brief overview of the planned content and the likely entry into force of the Regulations ...
As the American press focuses on the dismantling of the Affordable Care Act, the wheels have been set in motion to implement new health care legislation that enjoys strong bipartisan support. The 21st Century Cures Act (the “Act”), signed by President Obama on December 13, addresses a broad range of health care priorities, including drug innovation, biomedical research, and mental health reform ...
Under the Affordable Care Act (“ACA”), large employers (generally those with 50 or more full-time employees or full-time equivalents) must report annually to the IRS information about the health coverage offered to their full-time employees during the prior year. Employers also must provide copies of the reports to their full-time employees ...
Karanovic & Nikolic provided complete legal support to Affidea, a largest European medical service provider with respect to opening the first foreign hospital located in Belgrade. Our services consisted of extensive regulatory and corporate advice related to formation and start of operations of Affidea&s first hospital in Serbia. Affidea is one of the largest healthcare investors and operates over 180 Diagnostic and Cancer Treatment Centers in 15 countries across Europe ...
For about two years now, most renewable energy projects, particularly wind farm projects, have been financed using a so-called “hybrid” model, i.e. a combination of medium-term bank debt and long-term financing or private placements. The term “hybrid” is derived from the vocabulary of the Public-Private Partnerships industry, particularly projects involving an operational and maintenance component as part of a long-term concession ...
A federal appeals court has rejected two challenges to the environmental review of the Los Angeles County Metropolitan Transportation Authority's (Metro's) planned subway expansion in Downtown Los Angeles. The "Regional Connector" project, approved in 2012, will create a three-station, underground link through Downtown that will allow passengers to travel from points on the Metro Gold Line to the Blue and Expo lines without having to transfer trains ...
1. Pharmaceutical market players mostly deal with two regulators These are the Ministry of Healthcare of Ukraine (MOH) and the State Administration of Ukraine on Medicinal Products and Narcotic Drugs Control (SAUMP). The MOH is responsible for state registration of medicines, while the SAUMP deals with licensing, evaluation of good manufacturing practice (GMP) compliance, control over quality of medicines, and regulation of medical devices. 2 ...
Last June 16, the Superior Court of Québec1 rendered a safeguard order in an injunction proceeding in favour of a health-care institution the purpose of which was to set conditions for the visits of the daughter of a user of the institution who was an incapable person lodged there, as well as her interactions with the user and the staff ...
In the last several years, Texas has generated significant news stories related to the disagreements between the Texas Medical Board (“TMB”) and Teladoc, a telehealth medical provider. The original dispute centered around the right of telemedicine providers to treat Texas residents without an initial in-person visit, which some would argue circumvents the establishment of the practitioner-patient relationship ...
Consent to End-of-Life Care Article 11 of the Civil Code of Québec1 states that no one can be made to undergo care without his consent. The Act respecting end-of-life care2 ("the Act"), passed by the National Assembly of Québec, came into force on December 15, 2015. Since that date, a person can give or refuse consent to specific forms of end-of-life care, provided he has given advance medical directives ("AMDs") for that purpose ...
For far too long, Africa has been plagued by the demon of conflict minerals, which have played a key role in fuelling conflict and extensive human rights violations. The terrible scenes in Sierra Leone, Liberia and the Democratic Republic of Congo (DRC) remain vivid in the mind. In the history of conflict minerals, diamonds occupy the highest spot. They are valuable, portable and easily tradeable ...
On July 25, 2016, China Food and Drug Administration (“CFDA”) published the latest "Measures for the Administration of Drug Registration (revised draft)” (“Latest Revised Draft”) for public comments1 ...
On June 25th, 2016, Law No. 20,930 that establishes the environmental conservation right was published in the Official Gazzette. The purpose of this law is to create a mechanism to simplify and promote the participation of private parties in the conservation of the environment, as a complement to the work done by the State in these matters. This right has its origin in Comparative Law ...
The Health Care Arbitral Tribunal (Arbitral Tribunal) has pronounced a decision on a dispute between an independent medical specialist and a Medical Specialist Company (MSC) for the first time since the introduction of the comprehensive rates on 1 January 2015. Although neither party has terminated the existing (membership) agreement between them, the Arbitral Tribunal is of the opinion that termination of membership and deregistration of the specialist from the members' register are justified ...
The Environmental Evaluation Service (SEIA) has published the “Guide for Determination of the Ecological Flow for Hydropower Plants”.The objective of the Guide is to establish uniform criteria for determining the environmental flow regime in hydropower plant projects that are evaluated by the SEIA. The Guide incorporates the use of hydrological criteria, valuation of ecosystem services and anthropic uses, while also taking into account the particular project’s specific characteristics ...
On May 10, 2016, the Québec Court of Appeal1 confirmed a Superior Court decision allowing an application for authorization of treatment and placement to a patient. The application had been brought by the Douglas Mental Health University Institute, commonly known as the Douglas, or the Douglas hospital ...
In a unanimous decision rendered on May 16, 2016,1 the Québec Court of Appeal confirmed that the delivery of ophthalmic lenses purchased online from suppliers who are not members of the Ordre des optométristes (Order of Optometrists) (?Order?), or the Ordre des opticiens d?ordonnances (Order of Dispensing Opticians), does not violate the Optometry Act 2(?OA?) or, by necessary extension, the Dispensing Opticians Act ...
Today, Wednesday, June 1st, the Framework Law for the Management of Waste, Extended Liability of the Producer and Promotion of Recycling No. 20,920 (the “Law”) was published.PurposeThe Law seeks to reduce the generation of waste and encourage its reuse, recycling and other types of recovery ...
Today, Wednesday, June 1st, the Framework Law for the Management of Waste, Extended Liability of the Producer and Promotion of Recycling No. 20,920 (the “Law”) was published.PurposeThe Law seeks to reduce the generation of waste and encourage its reuse, recycling and other types of recovery ...
As the overall level of convergence between industries in the business world keeps increasing, it is only logical for the related legal aspects to follow suit every step of the way ...
On May 12th, EPA issued two rules that will significantly impact the oil and gas industry nationally. The first rule, an outgrowth of the President’s Climate Action Plan, establishes new source performance standards (“NSPS”) to curb emissions of methane, as well as volatile organic compounds (“VOCs”), from new natural gas and oil well sites and from new natural gas production gathering and boosting stations, processing plants, and transmission compressor stations ...
