On Wednesday, April 26, 2017, the Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. et al., a landmark case that many hope will provide clarity and guidance for consumers and the pharmaceutical industry on the regulatory approval pathway for biosimilar drugs under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA” or “Biosimilars Act”) ...
The Oberlandesgericht Celle has recently adopted a decision that is likely to be of particular interest to hospitals which are not, in principle, public contracting authorities within the meaning of the law, but which are used by public authorities to pay more than 50 percent for the construction of hospitals pursuant to Section 99, 4 of the GWB (decision ref. 13 G 8/16). In the decided case, the client planned to modernize a hospital in three construction phases ...
Upon reconsideration in Gerard v. Orange Coast Memorial Medical Center, Case No. G048039 (March 21, 2017) (Gerard II), the Fourth Appellate District decided that IWC Wage Order 5 is valid and that healthcare employees may waive one of their two required meal periods on shifts longer than 8 hours ...
Resale price maintenance and price-fixing has been and still is under scrutiny by the Croatian Competition Agency (the "Agency"). Carrying on from a number of high-profile cases, in February 2017 the Agency fined Gorenje Zagreb, a subsidiary of Slovenia's premier manufacturer of household appliances for HRK 1,557,000 (approximately EUR 206,000) ...
The Treasury Department has announced further extensions for medium-sized and large-sized employers for compliance with the “employer mandate” of the Affordable Care Act (“ACA”). The employer mandate requires employers with a threshold level of employees to provide affordable health insurance to 95% of their full-time employees. Under the ACA, a full-time employee is defined as any employee who works on average 30 or more hours per week ...
Industrial facility owners and operators in West Virginia should be aware of new reporting requirements that will soon go into effect. In addition to currently mandated notifications to federal, state, and local agencies after certain events occur, some facilities will soon be required to notify the state within 15 minutes of discovering specific types of emergency events or be subject to a fine of up to $100,000 ...
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. During its last two terms, the United States Supreme Court has issued three separate opinions addressing federal preemption of state law claims under the Federal Food, Drug, and Cosmetic Act ...
The Patient Protection and Affordable Care Act ("ACA") has significantly changed the healthcare industry in the United States. Among the many changes is the new requirement that healthcare providers must provide all "Food and Drug Administration approved contraceptive methods, sterilization procedures, and patient education counseling for all women with reproductive capacity."77 Fed. Reg. 8725 (Feb. 15, 2012); see 42 U.S.C. 300gg-13(a)(4), 45 C.F.R. § 147.130(a)(1)(iv) ...
The September 23, 2013 deadline for covered entities, business associates and their subcontractors to implement the new HIPAA rules is approaching quickly. In case you missed it, on January 25, 2013, the U.S. Department of Health and Human Services issued an omnibus final rule modifying the Health Insurance Portability and Accountability Act of 1996 ...
by Eric E. Kinder President Bush signed the ADA Amendments Act into law. The ADAAA significantly increases the scope of the Americans with Disabilities Act of 1990 as it has been interpreted by federal courts by overturning several United States Supreme Court decisions regarding the Act. According to the Congressional Committees that oversaw the passage of the ADAAA, these amendments will restore the original Congressional intent behind the ADA ...
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 ...
The recent Supreme Court of Appeal (“SCA”) case of Transnet v Total is important not only for those in the petroleum industry, but also, more generally, when it comes to aspects of competition and discrimination, as well as the impact of changes in the law on existing contracts and vested rights ...
The European Commission has opened an in-depth merger investigation into the planned acquisition of Cemex Croatia by Duna-Drava Cement ('DDC'). Registered in Hungary, DDC is jointly controlled by German construction material producers HeidelbergCement and Schwenk. DDC inter alia operates a cement plant in Kakanj, Bosnia and Herzegovina. Cemex Croatia, an arm of the international cement heavyweight Cemex, controls three cement plants in the Croatian coastal city of Split ...
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 ...
Media reports are letting us know that the "Serbia - A Strategic Crossroads between Western and Eastern Europe," conference was held in Paris on 15 September, where the French companies were presented with the political and economic environment in Serbia, as well as with the ensuing investment opportunities and the possibility of financing economic projects ...
The contemporary business world has become fundamentally tied in with the progress of globalisation, and for anyone involved in it, that is no secret. Anybody would be hard pressed to find an industry that can exist and sustain itself in a purely national context, without – at least in some regard – relying on either a piece of legislation or a practice trend that is related to whatever kind of international functioning ...
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 ...
Recent news reports from Bosnia tell us that the BiH government, represented by the federal prime minister for economic issues and investments, Suvad Osmanagic, paid a visit to Bihac with Ludovico Camozzi, the president and owner of Camozzi – an Italian company that produces industrial automation machinery. The main purpose of this visit was to see Kombiteks, a textile production company that has been in bankruptcy and in and out of operation for the past 15 years ...
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 ...
