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 Philippines recently enacted Republic Act 10667 or the Philippine Competition Act which defines, prohibits and penalizes anti-competitive agreements, abuse of dominant position, and anti-competitive mergers and acquisitions. It also creates the Philippine Competition Commission, which has original and primary jurisdiction to deal with cases involving violations of the Act. The Act was published on July 24, 2015 and took effect on August 8, 2015 ...
This year’s amendment of the Waste Act is forcing changes in the scheduling of incinerator projects. Target load start-up tests must be postponed until after the integrated permit is issued. This may give rise to claims by contractors for prolonging the project completion period because of a change in the law. In Poland there are currently six communal waste incineration plants under construction with EU funding ...
In this article, we provide a brief overview of the most important new rules applicable to Hungarian data protection laws after 1 October 2015. BCRs accepted after 1 October 2015 Binding corporate rules (BCR) have so far not been recognized by Hungarian law and, thus, could not be used whenever personal data were transferred to a non-EEA country ...
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 ...
SyCip Salazar Hernandez & Gatmaitan contributed the Philippines chapter of Herbert Smith Freehills’ Guide to anti-corruption regulation in Asia Pacific 2015. The Guide provides a practical approach to applicable anti-bribery legislation and enforcement regimes. Contributed by managing partner Rafael A. Morales, partner Russel L. Rodriguez, and associate Vera Marie H ...
Writer, Margaret Rouse, describes a social media policy as “a corporate code of conduct that provides guidelines for employees who post content on the internet, either as part of their job or as a private person”. Underestimating the significance of a sound social media policy may lead to dire consequences for an organisation ...
The Ecuadorian Civil Code is based in the code that made the great Chilean jurist Andrés Bello. The majority Civil Codes in Latin America are based in the Andres Bello Civil Code´s, which is based on the Civil Code of Napoleon Bonaparte. It has had several reforms over the time, on which attempt has been made to update to the reality and circumstances of each time. The Ecuadorian Civil Code is divided in four books: i) Persons; ii) Goods; iii) Succession upon death; and, iv) Obligations ...
Earlier this year, the UK government launched 'Tech Nation'; an interactive data project that shows the growth of digital businesses within specific areas/regions across the UK. The report is the first of its kind and ranked Belfast as the second highest region in the UK in terms of the highest average company turnover in this sector, with Greater Manchester securing the top spot and Sheffield, Inner London and South Wales coming third, fourth and fifth respectively ...
In this age of social networks, the dividing line between private life and public life seems more and more blurred. The same is true of the boundary between individuals' personal and professional lives. Indeed, headlines in the past few weeks remind us that the personal and professional aspects of an individual's life can sometimes become confused, at great cost to the individual ...
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 ...
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 ...
Ecuador is no stranger to the “State Capitalism” economic stream which prevailed in South America in the last two decades. This way to directly involve the central government to the country’s economy has triggered deep changes to the commercial relationships ...
When Congress passed the Medicare Access and CHIP Reauthorization Act of 2015, the elimination of the Sustainable Growth Rate—the so-called “Doc Fix”—received most of the attention. The fact that Congress had officially waded into the quagmire of health information technology interoperability, however, went largely unnoticed ...
Following President Obama’s announcement on December 17, 2014 of a policy to normalize relations with Cuba,the Department of Commerce’s Bureau of Industry and Security (BIS) amended its Export Administration Regulations (EAR) and the Department of the Treasury’s Office of Foreign Assets Control (OFAC) amended its Cuban Assets Control Regulations (CACR) on January 16, 2015, to implement the policy change ...
Download a free copy of the Philippine section of The Public-Private Partnership Law Review edition 1, which was contributed by the SyCipLaw Partners Marievic G. Ramos-Añonuevo and Arlene M. Maneja.Aside from the Philippines, other jurisdictions covered include Argentina, Australia, Belgium, Brazil, Canada, China, France, Ireland, Japan, Mozambique, Paraguay, Turkey, the United Kingdom and the United States ...
At first glance, "net neutrality" may seem a natural principle for the internet environment. This expression, however, gives rise to sometimes divergent interests and some concerns. As a general concept, net neutrality means an open Internet, through which consumers would be able to make their own choices about the content they wish to access and share, as well as the services and applications they want to use ...
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 ...
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 ...
The Chambers Asia-Pacific 2015 Guide is now available online and features an overview of the Philippinescontributed by SyCipLaw Managing Partner Rafael A. Morales.The guide is distributed to corporate counsel worldwide and is accessible through the Chambers website: www.chambersandpartners.com/guide/asia/8/172/1 ...
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 ...
