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 Scottish electorate has voted ‘no’ to independence. However, the ‘no’ vote will still result in constitutional change for Scotland, not least because of the pledge by all main UK political parties to devolve further powers to the Scottish Parliament. Additionally, key provisions of the Scotland Act 2012 will come into force over the next two years giving the Scottish government additional powers and a referendum on the UK’s membership of the EU is proposed for 2017 ...
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 ...
On 17 May 2011 the National Assembly adopted the Law on Notary Public (“the Law”), which came into effect on 1 September 2014. The new Law introduces the Notary Public into the Serbian legal system, which should help to relieve the judiciary, improve its efficiency, and improve legal security. A Notary Public is an independent and autonomous legal expert, who performs a service of public trust ...
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 ...
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 ...
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 ...
On 26 March 2014, the Minister of Law and Human Rights (“Minister”) issued Regulation No. 5 of 2014 on Validation of Foundations (“Regulation”). Briefly, the Regulation redefines the procedures and requirements for securing approval for the name of a foundation and its validation by the Minister ...
The Supreme Court of the Republic of Indonesia has issued Circular Letter No.2 of 2014 regarding Case Settlement in the Court of First Instance and Appeals in 4 (four) Justice Fields. The Supreme Court considers that since an electronically based management case system now exists in the courts of first instance and high courts, cases should be examined and ruled on quickly ...
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 ...
On April 1, 2014, the Superior Court issued an interesting decision respecting consent to care1. The Quebec City CHU petitioned the Superior Court in order to be authorized to provide care for a 60‑day period to a patient despite the refusal of her parents. On March 14, the 22 years old patient suffered cardiac arrest following an intravenous drug overdose ...
On March 28 2014 Law 642/2013 - a milestone of the government's anti-corporate raider policy - entered into force. Revival of the bill, which had previously gathered dust in parliamentary committees for several years, was a response to numerous calls from the international community to take measures to counter illegal takeovers and acquisitions of businesses ...
On April 9 last, the Superior Court of Québec issued its judgement1 on a motion for a declaratory judgment pertaining to trademarks in the English language on public signs and posters. The applicants, Magasin Best Buy Ltée, Costco Wholesale Canada Ltd, Gap (Canada) Inc., Old Navy (Canada) Inc., Corporation Guess? Canada, la Compagnie Wal Mart du Canada, Toys “R” Us Canada Ltée and Curves International Inc ...
Following the Supreme Court’s decision in Bridge Trustees in 2011 (see further here), the Government announced that it would legislate to directly counteract the effect of the judgement and make it clear that benefits under a pension scheme cannot be regarded as money purchase benefits if it is possible for a funding deficit to arise in respect of any of those benefits ...
The new EU Procurement directive was published in the Official Journal of the EU today (28 March 2014) and will come into force on 17 April 2014. This article summarises some of the key changes from the new Directive which are likely to be of interest to both the public and private sector. The UK will have 2 years to implement the Directive but the government has suggested that it will be implemented in a shorter timescale ...
The Executive Branch announced days ago the 3 main investment projects which will be promoted under the Public-Private Partnership regime in Paraguay. With the enactment in the month of March of the Regulatory Decree of the Public-Private Partnership Law (Law 5102/2013), the projects are expected to be advanced immediately ...
NEW CVM DECISION SIMPLIFIES TRANSACTIONS INVOLVING PRIVATE INVESTMENT IN PUBLIC EQUITY (PIPEs) At a meeting held on January 7, 2014, the majority of the Brazilian Securities and Exchange Commission (“CVM”) Board (Colegiado) accepted the appeal lodged by João Fortes Engenharia S.A., within the context of CVM Proceeding No ...
As you no doubt already know, the Pharmaceutical Industry in Argentina is a strictly controlled industry. Said control is held by the ANMAT Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) and it spreads from the first authorisation of a laboratory to act as such in the country, moving through the authorisations to commercialise products, up to pharmacovigilance of products that have already been commercialised ...
