In recent months, the Senate passed the Act to prohibit and prevent genetic discrimination (Genetic Non-Discrimination Act). This Act also amended the Canada Labour Code and the Canadian Human Rights Act. The new Act aims to regulate the use of genetic tests, namely, tests that analyze the DNA1, RNA2 or chromosomes of a person for predictive or monitoring purposes or for establishing a diagnosis or prognosis, mainly within a contractual framework ...
The Australian life sciences and biotech sector is likely to continue its resurgence over the next twelve months, with global trends driving strong M&A activity in life sciences and biotech M&A. We have identified 6 key themes for activity in this sector. Opportunities and Challenges – 6 Key Themes Three Key Opportunities 1 ...
In recent months, in a unanimous decision authored by Justice Thomas, the Supreme Court issued its much-awaited decision in Sandoz Inc. v. Amgen Inc. et al., No 15-1039, considering two critical questions in the biosimilar approval mechanisms adopted in the Biologics Price Competition and Innovation Act of 2009 (“BPCIA” or “Biosimilars Act”) ...
Long-term care (LTC) facilities received a boost last week when the Centers for Medicare and Medicaid Services (CMS) reversed its position regarding the use of arbitration agreements in this setting. On June 8, 2017, CMS published a proposed rule amending LTC facilities’ conditions of participation in the Medicare and Medicaid programs to remove prohibitions on binding pre-dispute arbitration agreements ...
“It is a treasured value in humanity … that no parent would want her child to grow up thinking that she (the child was) a mistake." - Justice Choo Han Teck In 2010, a Chinese woman, trying to conceive a child with her Caucasian husband, underwent an in vitro fertilisation (“IVF”) procedure at a clinic. Like the previous time she bore a child through IVF at that clinic in 2006, no third party’s gametes were meant to be used ...
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 Danish Government's Growth Team has just Presented its Recommendations for how to Strengthen Denmark's International Position within Life Science. This happened at a Press Conference with the Participation of the Chair of the Growth Team, Kåre Schultz and the Minister for Industry, Business and Financial Affairs, Brian Mikkelsen ...
Today, we are at a time where two-generation professionals are actively developing and competing with each other within their own career. The well-known "millenials" or generation "Y", born according to some analysts between the years 1981 to 1999, and where the majors of this generation are already in the 36 years of life, and those of the generation X ...
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 ...
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 ...
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 ...
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 ...
On October 3rd ALRUD Law Firm Partner Anton Dzhuplin joined a workshop of international Conference “What is happening in pharmaceutical market?”, which took place at “PHARMASTRATEGIES-2017” summit. The conference annually brings together Country managers, CEOs, top-managers of pharmaceutical manufacturers, distributors and retailers, heads of associations, representatives of regulatory authorities, professional and business media ...
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 ...
