Originally filed in October 2014, the long-running and high-stakes battle between two powerhouse companies, Amgen and Sandoz, continues to lay out the ground rules for a growing biosimilar industry. The Federal Circuit’s first decision under the Biologics Price Competition and Innovation Act (BPCIA) involved Zarxio, Sandoz’s Neupogen biosimilar product. Amgen v. Sandoz, 794 F.3d 1347 (Fed Cir. 2015) ...
Earlier this year, Decree No. 1 of the Ministry of Health (herein, the "Decree") was published on the Official Gazette. The Decree sets forth the graphic characteristics of the message for the promotion of healthy life habits that must be included in the advertisement of foodstuff products established in Article 5 of Law No. 20,606 -those that qualify as "High in" one or more critical nutrients- made through mass communication ...
How new technologies and changing consumer expectations is signaling disruption to the health industry and the importance of finding ways to better measure and translate patient satisfaction and outcomes. Do you know if your clinician is doing a good job? What about the track record of your surgeon? Should you be entitled to know as a consumer? The industry is being disrupted – no longer is the family GP the dispenser of all health advice ...
One step closer to implementation of the reforms relating to EU data protection regulation, this article looks at some of the implications that the reforms are likely to have for SMEs. Key progress was made in the reform of EU data protection regulation on 12 March 2014 with the European Parliament voting in support of reform and the draft General Data Protection Regulation (the "Regulation"). The Regulation must now be adopted by the Council of Ministers in order to become law ...
Cloud computing, along with Big Data, social media, and mobility, is one of the current megatrends that will drive huge changes to the business ecosystem in the upcoming decade. Surveys held over the recent years unanimously confirm that organisations across the globe are rapidly and continuously moving to the cloud ...
The Ohio General Assembly voted unanimously in 2015 to pass House Bill 207, which created a rating exception rule where a state-funded employer would not be adversely impacted by claims arising from motor vehicle accidents caused by third parties ...
On December 14, 2017, in a pair of employer-friendly decisions, the National Labor Relations Board overturned its momentous 2015 Browning-Ferris Industries[1] joint-employer decision, as well as its 2004 Lutheran Heritage Village-Livonia[2] standard for weighing the legality of employee handbook policies. In Hy-Brand Industrial Contractors Ltd. and Brandt Construction Co ...
The National Labor Relations Board (NLRB) released several significant decisions last week affecting all employers and their obligations under the National Labor Relations Act (NLRA). First, the NLRB overruled Lutheran Heritage and established a new standard for determining whether facially neutral workplace policies unlawfully interfere with Section 7 rights ...
At a time when tolerance seems to be an increasingly precious commodity, society can celebrate an awakening intolerance for sexual harassment. For all of the scandal and salacious detail dominating the media in recent months, there is the hope that victims of depravity can find empowerment and healing, if not justice, too ...
Effective January 1, 2018, the State minimum wage increases to $11.00 per hour for employers with 26 or more employees, and $10.50 per hour for employers with 25 or fewer employees. Several California cities and counties have passed their own minimum wage ordinances with a more aggressive schedule of minimum wage increases. Local minimum wage increases that go into effect on January 1, 2018 include the following: Locality Minimum Wage Eff. 1/1/18 Cupertino $13 ...
The past year has seen a number of high-profile instances of employees resigning, allegedly to avoid disciplinary proceedings against them. This issue was dealt with in the case of Mtati v KPMG Services (Pty) Limited.The employee in this matter was informed by her employer that an investigation was being conducted into allegations of misconduct levelled against her. She then provided her employer with a letter in which she tendered her notice of resignation ...
On 17 November 2017, the National Minimum Wage Bill was gazetted for public comment. Given that the Bill was the subject of negotiation and agreement at the National Economic Development and Labour Council (“NEDLAC”), its progress through the legislative process is likely to be fairly smooth. The Bill envisages that it should be in force by 1 May 2018. We highlight its most important provisions below ...
On December 11, 2017, the U.S. Supreme Court refused to accept an application to appeal the court of appeals decision in Evans v. Georgia Regional Hospital, leaving unresolved a circuit split on whether federal law prohibits employment discrimination based on sexual orientation.[1] In Evans, the plaintiff, a security officer at a Georgia hospital, claimed she had been harassed and passed over for a promotion because she was homosexual ...
Ohio prescribers need to be aware of new rules for prescribing controlled substances that will take effect on December 29, 2017. First, prescribers will be required to include the first four characters of the ICD-10 diagnosis code or the full CDT procedure code on all prescriptions for opioids.[1] Similarly, beginning June 1, 2018, prescribers will need to include the ICD-10 diagnosis or CPT procedure code on prescriptions for all other controlled substances ...
Holiday parties are a great time for colleagues to close out the year while getting to know each other better outside of the office. However, a good party comes with certain risks, and it is important for employers to plan ahead to limit legal exposure and ensure their employees are safe. As you plan your year-end celebration, consider the following: Managing alcohol consumption: One person overindulging can create problems for everyone ...
The Bavarian Data Protection Authority ("BayLDA") has published an online test on its website that can be used by companies to determine how well they are prepared on key topics of the General Data Protection Regulation ("GDPR"). The GDPR will apply directly in the member states of the European Union with effect from May 25, 2018. This will result in significant changes to data protection law in many areas ...
Governor Jerry Brown approved California Senate Bill 798 on October 13, 2017. One provision of this bill imposes penalties for failure to file required reports under Business and Professions Code Section 805.01. Beginning January 1, 2018, individuals and entities with reporting obligations under Section 805.01 are subject to fines of up to $100,000 per violation for willful failures to file a Section 805 ...
The term “dawn raid” refers to an unanticipated visit to commercial premises by a regulatory authority. Examples of this could include a squad of policemen entering a warehouse, a team from a financial-services regulator checking trading records at a bank, or an official from the UAE Ministry of Human Resources and Emiratisation entering your office to check the work permits of all employees present there (an increasingly common practice) ...
The National Employment Service changed its years-long practice regarding the extension of work permits for persons on secondment. In particular, pursuant to Article 19 of the Law on the Employment of foreigners, work permits based on secondment are obtained for a period of the duration of an agreement between the local employer - who is the service user, and a foreign employer, but no longer than for one year ...
The revised Phase 2 Requirements of Participation for long-term care facilities will go into effect November 28, 2017. While multiple provider groups have requested a delay of some of the rule's provisions to allow time for additional revisions, officials at the Centers for Medicare and Medicaid Services ("CMS") have indicated that they will not act on those requests at this time and plan to move forward with the November 28, 2017, implementation date for Phase 2 ...
IRS Announcement 2017-15 provides relief to employees who have been adversely affected by the recent wildfires in Northern California by allowing them to take loans or distributions from retirement plans to alleviate hardships caused by the wildfires. The Announcement also provides relief from verification procedures required under retirement plans with respect to loans and hardship distributions ...
OSHA "Injury Tracking Website" Presents Issues as Employer Deadline for Compliance Looms On August 1, 2017, the U.S. Occupational Safety and Health Administration ("OSHA") launched the "Injury Tracking Application" for Electronic Submission of Injury and Illness Records to OSHA in an effort to comply with its electronic record-keeping rule ...
Most of holidays and national mourning that are covered by Article 46 of the Labor Code of the Republic of Panama are in November, December and January. In fact, they are considered as such, November 3, 5, 10 and 28; December 8 and 25; and on January 1 and 9 ...
On October 13, 2017, Governor Brown signed SB 798, amending Business and Professions Code Section 805, Civil Code Sections 43.7 and 43.8, and Evidence Code Section 1157 to include licensed midwives within their scope. Notably, these changes only apply to licensed midwives, those professionals who pass the North American Registry of Midwives examination and are licensed by the Medical Board of California ...
The resurgence of the #MeToo campaign highlights that sexual harassment comes in all variations, affects all classes of people, and cuts across all industries. While employers could dismiss the social media moniker as a “them” not an “us” problem, they do so at their peril. People, some of whom may be your employees, are talking, posting, and tweeting, and employers would be wise to listen and revisit their anti-harassment policies ...
