On September 9, 2014, the U.S. Food and Drug Administration (FDA) published the inaugural “Purple Book,” a list of approved or “licensed” biological products, including all biosimilar and interchangeable biological products. The Purple Book is more formally known as “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.” The Purple Book is meant, at a fundamental level, to be the biological equivalent of the “Orange Book ...
On October 3, 2014 the Department of Health and Human Services, Office of Inspector General (“OIG”), released a proposed rule to add new safe harbors to the Anti-Kickback Statute (“AKS”) and to amend the definition of “remuneration” in the Civil Monetary Penalties (“CMP”) regulations. The OIG additionally solicited comments on same which must be submitted no later than 5 pm EST on December 2, 2014 ...
On October 3, 2014, the Supreme Court of Canada, by a majority decision of 5 to 4,1 confirmed that a disposition ordering the treatment of an accused who is found unfit to stand trial requires the prior consent of the designated hospital to all the terms of the disposition order, inclusive of the date on which the treatment is to begin ...
The Ministry of Finance announced that an improvement in the online inquiry concerning the value of declared merchandises intends to reduce under-declaration in 20%. For the purpose of establishing better controls on imported merchandises, the National Service of Customs of the Ministry of Finance has intensified and integrated software tools to apply in a more efficient and effective manner instruments of control over the value declared for the entry and exit of goods ...
On 25 June 2014 the European Commission announced adoption of the Commission Communication “Notice on agreements of minor importance which do not appreciably restrict competition under Article 101(1) of the Treaty on the Functioning of the European Union (De Minimis Notice).” The De Minimis Notice was published in the Official Journal on 30 August 2014 (OJ C 291/1). The De Minimis Notice follows the existing practice of the Commission and the case law of the European Court of Justice ...
In an unanimous decision dated September 4, 20141 , the Court of Appeal confirmed that the 45-day time limit under the Act Respecting Health Services and Social Services2 (ARHSSS) to allow the medical examiner and the local service quality and complaints commissioner to process a user complaint is not mandatory but rather serves to indicate that the Legislator intends the complaint to be diligently processed ...
PLMJ has launched the new version of its Portugal Investment Guide, which reflects PLMJ’s experience in handling innumerable investment projects in Portugal in a range of sectors, throughout its 45-year history.This Investment Guide proves that Portugal has increasingly competitive conditions – in terms of technology, workforce, infrastructure, logistics, geography, law and tax – to continue to attract large-scale investment projects ...
After signing the Bilateral Investment Treaties (“BITs”) with Turkey on July 28 and with France on July 10, and ratifying the BIT with Japan on June 25, Colombia significantly moves forward on the protection of foreign investments. These agreements pursue the establishment of a fair, safe and transparent juridical framework in order to draw foreign investors to Colombia and bolster Colombian investments abroad ...
The draft regulations for OTC derivatives have been released, which means that change is in the air. The government is stepping forward into unchartered territory and is set to regulate an area which has never been regulated before. Following our recent breaking news on the draft regulations, ENSafrica will, over the coming weeks and months, unpack the regulations for you, highlighting all the essentials. What follows is a sneak peak at affected areas and a snapshot of the bigger picture ...
Protection of the use of the term “Rooibos” has long been a topical issue. However, an economic partnership agreement between Southern African nations and the European Union (EU) has recently been signed which will secure geographic indicator status for rooibos tea in the EU. This is the latest in a number of acts by the South African government which has secured intellectual property protection for the indigenous brew ...
Almost exactly a decade ago, on August 5, 2004, the United States signed the Dominican Republic-Central America-United States Free Trade Agreement ("DR-CAFTA") with the Dominican Republic and five Central American counties (Costa Rica, El Salvador, Guatemala, Honduras, and Nicaragua)> The DR-CAFTA, which was the very first free trade agreement between the United States and a group of smaller developing economies, entered into force for the United State, El Salvador, Guatemala, Honduras,
On July 16, 2014, the Sixth Circuit Court of Appeals confirmed that a “health care provider can bring the Medicare Secondary Payer Act’s (“MSP’s”) private cause of action against a non-group health plan that denies coverage for a reason besides Medicare eligibility.” In Michigan Spine & Brain Surgeons, PLLC v. State Farm Mutual Automobile Insurance Co., the Court clarified a key holding in its prior decision in Bio-Medical Applications of Tennessee, Inc. v ...
The Anti-Monopoly Bureau (AMB) of the Ministry of Commerce of China (MOFCOM) has recently published the following provisions and guidelines relating to the review procedure for merger clearance with AMB (AMB Clearance): (1) "Tentative Provisions on Standards for Simple Cases of Concentration of Undertakings " (Standards), published on 11 February 2014; (2) Trial Guidelines on Notification of Simple Cases of Concentration of Undertakings" (Trial Guidelines) , published on 18 April 2014; and (3) R
In 2014, China’s Premier Li Keqiang chose Africa as the destination for his very first foreign trip, marking a milestone in China-Africa cooperation. His travels commenced on 4 May and included countries such as Ethiopia, Nigeria, Angola, and Kenya. Premier Li’s visit undoubtedly reflects the emphasis China is placing on Africa ...
In a recent judgement delivered by the Commercial Division of the Supreme Court in Atelier Etude Limousin & Ors vs BPCE International Et Outre Mer & Anor 2014 SCJ 166 the court confirmed the prevailing practice that foreign companies could be granted fixed or floating charges by Mauritian entity as security for a financing ...
New technology is most often associated with telecommunications, IT or robotics. Food is seen as a group of products in which innovation is little important, because it is believed that consumers are mostly concerned with prices and quality, but not innovations. However, the dynamic growth in market share of functional foods calls for a critical review of myths that have arisen around R&D projects in the food sector ...
This year marks the 30th anniversary of the passage of the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act). Considered to be one of the most successful pieces of legislation ever enacted, the Hatch-Waxman Amendments created the modern generic drug industry, which is responsible for dramatically increasing the availabilty of low-cost generic drugs and saving the U.S. healthcare system billions of dollars ...
Presidential Regulation No. 39 of 2014 on The List of Business Fields that are Closed or Conditionally Open for Investment (the Negative Investment List/daftar Negatif Investasi (DNI)/“Negative List”) was issued recently and became effective on 24 April 2014. This new negative investment list revises and replaces the 2010 regulation. The new Negative List revises the components of the 2010 list classified as: a) closed for investment; and b) conditionally open for investment ...
In recent years, Nicaragua has experienced sustained economic growth, as a result of a strict management of its fiscal, financial, monetary and exchange policies. Its business-related administrative procedures and laws have contributed to a strong inflow of direct foreign investment, so much that the country intends to exceed this year an amount of 1500 million in investments in sectors such as: power, manufacture, agriculture, tourism and others ...
LabMD, Inc. renewed its argument that the FTC lacks authority to regulate the data security practices of HIPAA covered entities by appealing the dismissal of its case for lack of jurisdiction (see our coverage here) to the Eleventh Circuit. LabMD also filed an emergency motion seeking expedited briefing and requesting an order enjoining the administrative proceedings until the appellate court rules on the merits of its argument ...
The healthcare industry will have to wait for a court to answer the question of whether the United States Federal Trade Commission (the “FTC”) has authority to regulate data security practices of entities covered by the Health Insurance Portability and Accountability Act (“HIPAA”). On Monday, a federal district judge dismissed LabMD, Inc.’s case without reaching the merits, declining to disrupt the underlying administrative proceeding ...
Regional governments in Sweden are increasingly looking to leverage their purchasing power in order to secure discounts and rebates on the list prices of branded drugs. However, as noted by Elizabeth Eklund, Partner at leading commercial law firm Delphi, such agreements risk running foul of both Swedish and European Union (EU) law ...
The movement of information across national borders drives today’s global economy. Cross-border data transfers allow businesses and consumers access to the best available technology and services, wherever those resources may be located around the world. The free-flow of data across borders benefits all industry sectors, from manufacturing to financial services, education, health care and beyond ...
