In Esso Australia Pty Ltd v The Australian Workers' Union [2015] FCA 758, the Federal Court upheld the validity of some, but not all, orders made by the Fair Work Commission (FWC) against industrial action at Esso's Longford Plant in Victoria ...
On September 25, 2015, the Texas Board of Pharmacy (“TBP”) issued proposed rules that will allow pharmacists to substitute interchangeable biological products for brand name drugs. Currently, Texas regulations only allow for the substitution of lower-priced, generically equivalent drugs instead of certain brand name drugs. In contrast, the proposed rules allow pharmacists to dispense interchangeable biological products ...
In a short three-week period, the U.S. Department of Justice announced three large, multi-million dollar False Claims Act settlements involving Stark Law violations. Each of the three cases alleged that health systems compensated physicians in excess of fair market value, and in excess of collections for services personally performed by those physicians, in order to induce referrals ...
On August 18, 2015, the Tribunal administratif du Québec (TAQ) confirmed the decision of a health institution to not renew the status and privileges of one of its physicians after he refused to undergo refresher training to acquire skills that were necessary to perform his new duties.1 The physician in question, a hematology specialist, had been hired as a researcher several years ago ...
The FDA recently issued final guidance regarding the size, shape, and other physical characteristics of generic-manufactured tablet and capsule dosage forms. The guidance noted that differences in physical characteristics of a dosage form could affect patient compliance and acceptability of medication regimens, or could lead to medication errors. The main reason for the FDA’s guidance appears to be that many patients can experience difficulty swallowing tablets and capsules ...
The Seventh Circuit has revived a class action against Neiman Marcus for losses customers allegedly suffered as a result of a data breach involving payment card information. A federal district court had dismissed the claims, finding – consistent with federal courts around the country – that the plaintiffs lacked standing because they failed to allege they suffered concrete harm from the breach ...
It’s been widely reported that various luxury brand owners have brought legal proceedings in the USA against Alibaba, the Chinese online shopping giant that recently listed on the New York Stock Exchange. The claim is that Alibaba has knowingly made it possible for companies to sell counterfeit products on its platform ...
In a decision rendered on April 30, 20151, the Administrative Tribunal of Québec (the "ATQ") upheld a decision of the board of directors of a university hospital centre that refused to renew the status and privileges of a physician who failed to fulfill the obligations associated with the enjoyment of these privileges. Firstly, it should be noted that the applicant's clinical competence was not questioned in this case ...
Is your business affected by counterfeiting? If so, you are not alone. A newly released study shows that almost all intellectual property dependent companies listed on the NASDAQ OMX Stockholm 30 Index have been affected. Moreover, most expect that the problem will continue to grow. Better political support is required to stem this development, but companies already have several weapons available to use against the counterfeiters ...
On June 6th, 2015, Law No. 20,850, which creates the Financial Protection System for Diagnostics and Treatment of High Costs, and pays posthumous tribute to Luis Ricarte Soto Gallegos, has been published. This law creates a financial protection system for diagnostics and high cost treatments which will be defined by the Ministry of Health by means of a Supreme Decree ...
In a judgment handed down on January 30, 2015, the Court of Québec held that the failure to respect the prescribed time limits or the violation of a patient’s fundamental rights and freedoms does not lead to the automatic exclusion of a psychiatric examination report concluding that the patient should be confined ...
The Court of Appeal of Quebec has issued an important judgment pertaining to a franchisor’s implicit obligations towards its franchisees. In June 2012, the Superior Court of Quebec ordered Dunkin’ Donuts Brands Canada Ltd. (“Dunkin’ Donuts”) to pay an amount of $16.4M (plus interests and costs) to 21 of its franchisees in Quebec the sum of $16 ...
On April 10, 2015, the Texas Medical Board (“TMB”) voted in favor of adopting amendments to the rules governing telemedicine. The revised rules, which will significantly limit the ability to treat patients via telephone and video consultation, take effect June 3, 2015. TMB took its first steps to curb telemedicine in January 2015 by passing an emergency measure that prohibited prescribing drugs without an initial in-person visit ...
In recent remarks to a compliance conference for the pharmaceutical industry, the SEC’s Director of Enforcement, Andrew Ceresney, addressed FCPA issues that commonly arise in the industry. According to Ceresney, the SEC is continuing to focus on pharmaceutical companies because their operations typically pose a high risk for FCPA violations ...
Understanding the Texas Attorney General’s efforts on enforcement of healthcare fraud and abuse matters often is challenging. Recent activities, however, give physicians and other providers insight into the agency’s priorities ...
On March 10, 2015, the Centers for Medicare & Medicaid Services (CMS) Innovation Center released its newest model in alternative care delivery: the Next Generation ACO Model. This new version of accountable care organization (ACO) builds upon the experiences from the Pioneer ACO Model and the Medicare Shared Savings Program (MSSP) to set more predictable financial targets, enable providers and beneficiaries to better coordinate care, and provide overall high quality care ...
In an opinion that will certainly cause Texas hospitals, physicians, nursing home operators and other healthcare providers to consider whether they should insert standard arbitration clauses into their pre-treatment agreements, the Texas Supreme Court held last week that the Federal Arbitration Act (“FAA”) preempts the more stringent arbitration requirements set forth in the Texas Medical Liability Act (“TMLA”).The Fredericksburg Care Co., L.P. v. Juanita Perez et al, No. 13-0573, 2015 Tex ...
On February 26, 2015, the Supreme Court of Canada dismissed Dr. Gilbert Liu's application for leave to appeal a Court of Appeal decision concerning the time limit for handling complaints from users of health institutions ...
Download a free copy of the Philippine section of Getting the Deal Through: Life Sciences 2015, which was contributed by SyCipLaw partners Rose Marie M. King-Dominguez and Carlos Roberto Z. Lopez with senior associate John Paul V. de Leon and associate Mark Xavier D. Oyales.This chapter is reproduced with permission from Law Business Research Ltd ...
In a recent judgment on the merits, the president of the Brussels Commercial Court held that the X shape of Mars's Dentastix dog food (see Figure 1 below) constituted a valid three-dimensional (3D) Community trademark and a valid Benelux design. Both IP rights had been invoked cumulatively against a Belgian company commercialising similar X-shaped chew sticks for dogs (Figure 2) on the European market. View More
The Parliament passed a bill on halal products in September 2014 and on 17 October 2014 the President enacted the bill as Law No. 33 of 2014 on Guaranty for Halal Products (Law 33 of 2014). Law 33 of 2014 requires that all products imported, distributed, or traded in Indonesia bear a halal certificate ...
Under Regulation No. 122/M-IND/PER/12/2014 on Delegation of Authority to Grant Industrial Business Licenses to the Head of the Capital Investment Coordinating Board, the MOT has delegated its authority to issue certain licenses to BKPM. Business licenses delegated consist: 1. Industrial Business License and/or Expansion Licenses as follows: a. alcoholic beverages industry; b. valuable paper industry; c. weapons and ammunition industry; d ...
The Head of the National Agency for Food and Drug Control (BPOM) has issued Regulation No. 11 of 2014 on The Procedure for the Certification of Good Manufacturing Practices, ensuring compliance with the applicable standards for processed food. Regulation 11 has been in force since 5 August 2014 ...
On December 1, 2014, the Department of Health and Human Services Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule that included numerous changes for accountable care organizations (“ACOs”) participating in the Medicare Shared Savings Program (“MSSP”) in light of the experience CMS gained during the first two years of the program ...