The Court of Justice has issued a judgment invalidating the European Commission’s Safe Harbour decision. This means that participation in the Safe Harbour programme by US entities is no longer grounds for European companies to transfer personal data of EEA citizens to the United States. On 6 October 2015, the Court of Justice of the European Union held that the European Commission’s decision approving the Safe Harbour programme is invalid (Schrems v Data Protection Commissioner, Case C-362/14) ...
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”) ...
The amendments to the Cuban Assets Control Regulations (CACR) since January 16, 2015 have expanded the scope of transactions that persons subject to the jurisdiction of the United States may undertake in relation to Cuba ...
Across Africa, investments in infrastructure have failed to keep pace with growth and demand, creating a tremendous infrastructure deficit. Less than 40pc of the population across the continent, and only 26pc of the population of sub-Saharan Africa, has access to electricity.Approximately, 34pc of the population has access to improved sanitation facilities, and 35pc lack access to clean drinking water ...
Italy and Turkey have had a strong and well-established economic partnership for decades, with a turnover of about USD 20 billion in 2014 and investment by Italian companies in Turkey in 2014 of around USD 4.5 billion ...
After a marathon weekend negotiating session in Atlanta, trade ministers from the United States and eleven other countries reached a final agreement on the terms and text of the Trans-Pacific Partnership (TPP). The TPP is a multi-faceted trade agreement among Pacific Rim nations that account for approximately 40 percent of world GDP ...
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 ...
Hunton & Williams is pleased to announce the release of its newly designed and mobile-responsive Immigration and Nationality Law Blog, www.huntonimmigrationlawblog.com. “Our immigration law blog has been a valuable resource for US employers,” said Ian Band, who heads the firm’s immigration and nationality practice ...
The U.S. Treasury Department Office of Foreign Assets Control (“OFAC”) has amended its Cuban Assets Control Regulations to, in OFAC’s words, “further implement elements of the policy announced by the President on December 17, 2014 to engage and empower the Cuban people.” In practice, the amendments make important changes to the Cuban Assets Control Regulations, originally liberalized in January of this year ...
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 ...
Bulgaria is the second largest producer of foie grasin the world (after France) with about 10% of the global production (approximately 2,600 tons per year). Furthermore, France is the largest consumer of foie gras globally, importing about 3,750 tons per year, 2/3 of which come from Bulgaria. Agroplasment-92-VJSC and Bulian SJSC are the leading Bulgarian producers of foie gras and other duck products. The two companies account for approximately 1/3 of all Bulgarian foie gras exports ...
Bulgaria is the second largest producer of raw tobacco in Europe after Italy and has been a leading exporter of cigarettes and tobacco products from the 1920s onward. Slance Stara Zagora Tabac is a leading Bulgarian producer of cigarettes and tobacco products with rich experience in the selection and skillful blending of classic American and Virginia blends ...
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 ...
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 ...
The Competition Commission of India (“CCI”) has revised the Competition Commission of India (Procedure in regard to the transaction of business relating to combinations) Regulations, 2011 (Combination Regulations), making them more forward looking, in keeping with some of the best practices in other jurisdictions. The instant revision is the fourth instance in the four years since the introduction of the merger control regime in India ...
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 ...
On June 29, President Obama signed the Trade Preferences and Extension Act of 2015, which significantly increases penalties for the failure to file correct information returns under I.R.C. § 6721 and the failure to furnish statements to payees pursuant to I.R.C. § 6722. The new law increases the penalty from $100 to $250 for each violation of either statute ...
Restraints of trade - Scope of rules: 1. Are restrictive agreements and practices regulated? If so, what are the substantive provisions and regulatory authority? Restrictive agreements and practices may qualify as anti-competitive concerted practices (that is, practices that resulted or may result in prevention, elimination or restriction of competition). There is a general prohibition of anti-competitive concerted practices, unless an exemption applies (see Question 3) ...
