According to recent reports, it seems to be that an exciting update in the aviation world might be waiting around the corner. More precisely, it has been circulated in the media that the global giant and world's fastest growing airline, Turkish Airlines, is contemplating the acquisition of Croatia's national carrier – Croatia Airlines ...
As the overall level of convergence between industries in the business world keeps increasing, it is only logical for the related legal aspects to follow suit every step of the way ...
On May 12th, Governor Snyder issued Executive Directive No. 2016-1 ("ED 2016-1"), which seeks to improve infrastructure in the State by utilizing the Michigan Department of Transportation ("MDOT") in multiple ways. ED 2016-1 requires MDOT to work with a number of agencies, including coordinating with: - The Michigan Department of Environmental Quality to identify and address major infrastructure projects where inadequate facilities could cause threats to water or wastewater services ...
1 Which legislation sets out the regulatory framework for the marketing, authorisation and pricing of pharmaceutical products, including generic drugs? Which bodies are entrusted with enforcing these rules? The relevant legislation includes the following: • Law on Medicines 1996;
In the late 1980s, stories of garbage hauled in the same trucks regularly used to transport fruits and vegetables caused public outrage. Outbreaks of foodborne illnesses, including a salmonellosis outbreak that affected 224,000 consumers, have been attributed to contamination of transportation vehicles. Recently, a major U.S. foodservice distributor was penalized after its practice of storing seafood, milk and raw meat in unrefrigerated sheds was uncovered ...
On April 19, 2016 Association of European Business (hereinafter – “AEB”) and the Russian Federal Antimonopoly Service (hereinafter – the “FAS”) presented the Code of Good Practice in the Pharmaceuticals Industry (hereinafter – the “Code”). The full text of the Code (both in Russian and English) is available at the official web-site of the antimonopoly authority (http://fas.gov.ru/documents/documentdetails.html?id=14513). Below is short outline of the Code. 1 ...
On April 18, the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services issued revised guidance regarding exclusions imposed under section 1128(b)(7) of the Social Security Act ...
Last January 14, the Communications and Transportation Ministry published the prequalification rules pertaining the international open tender number PO-009000988-N1-2015 awarding the construction of a high speed train project that will run in the route Mexico, D.F. - Santiago de Querétaro, Querétaro, including the definitive executive program, construction, supply, set up and extended testing of a railway track, rolling stock, equipment, systems and other components ...
On January 4th, 2016, the President of the Republic introduced a series of amendments to the bill of law that, “modifies the Health Code in order to regulate generic bioequivalent pharmaceutical products and prevent the vertical integration of pharmaceutical laboratories and pharmacies”, – Bill No. 9914-11- (“Pharmaceutical Bill II”) ...
Increased deal activity is likely in Australia's health and aged care sector in 2016, driven by:• investment interest from China• Australian players targeting outbound opportunities through joint ventures and partnerships; and• consolidation in the aged and home care services areas.Rapidly ageing populations across our region are driving demand for high quality health care, especially in countries such as China and Japan ...
1. Introduction On 21st January 2016, the Italian Cabinet gave the green light for the “Reorganization, rationalization and simplification of Port Authorities” decree (the “Ports Decree”), which reviews a system which has been in place for over 20 years. The Ports Decree is part of the re-launch of ports and logistics in Italy promoted by the Ministry for Infrastructure and Transport (“MIT”) ...
The Modern Slavery Act 2015 introduces a new area of compliance for commercial organisations. The Act is amongst the toughest anti-slavery and human trafficking legislation in the world. Although legal penalties are restricted, interest from patients, consumers, investors, NGOs, pressure groups and brand risk is expected to enforce compliance ...
After a long wait, on February 12, 2016, the Centers for Medicare & Medicaid Services for HHS (“CMS”) issued a final rule that clarified the obligations of Medicare providers and suppliers to report and return overpayments within 60 days (the “Rule”).1 The Rule becomes effective on March 14, 2016. The Rule, which applies only to Medicare Part A and B providers and suppliers, enforces a statutory requirement from 2010 implemented by the Affordable Care Act (“ACA”) ...
Over the past year, the Tribunal administratif du Québec (TAQ) has issued several rulings dealing with oversight of the medical practice of professionals working in health and social services institutions. Several of these rulings will be of interest to institutions since they set out principles that tend to confirm the existence of a form of management rights over physicians, despite the lack of the traditional relationship of subordination between such institutions and their physicians ...
CMS and OIG Finalize Waivers for ACOs in the Medicare Shared Savings Program Effective October 29, 2015, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) of the Department of Health & Human Services (“HHS” or “the Department”) finalized the waivers of certain fraud and abuse laws to specified arrangements involving accountable care organizations (“ACOs”) in the Medicare Shared Savings Program (“MSSP”) ...
Under Minister of Transportation of the Republic of Indonesia Regulation No. PM 3 of 2015 dated 7 January 2015 on the Implementation of One-Stop Integrated Services in the field of Transportation at the Indonesia Investment Coordinating Board (BKPM) (“Regulation 3/2015”), the Minister of Transportation has now delegated its authority to issue transportation business licenses for capital investment to the Head of BKPM. The Business Licenses which have been delegated are: 1 ...
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 ...
After eight years of operation, the International Registry established pursuant to the Cape Town Convention and the Aircraft Protocol (in force in Quebec since April 1, 2013) has undergone a significant update. The Registry’s website has undergone a complete overhaul in two phases, the first of which was launched in September 2013 ...
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 ...
Despite the apparent opening of the door for foreigners to engage directly in retail trading in Myanmar under the Myanmar Investment Commission (MIC) Notification No 49 of 2014, in practice this door was still closed to foreigners in the new car sales sector. With limited exceptions (discussed below), foreigners could not, even on the basis of Notification 49: (i) import new cars (ii) register new cars in their name (iii) sell those cars or (iv) own and operate a new car showroom ...
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 ...
There have been recent interesting developments in Latin American aviation. Set forth below is a discussion of some of them. Topics include: General Outlook Key Mexican Reforms U.S. and European Expansion Mexico: Dynamic Aviation Sector The Venezuela Crisis Excerpted from Latinvex. To read the full article, click here ...
