New amendments to the Regulation on Health Conformity of Dietetic Products have entered into force on 28 May 2012. Here are some of the most significant changes that are prescribed by these amendments to the Regulation. As a reminder, this is a regulation that introduced the obligation of the registration of dietetic products (including supplements) in July 2010, and is a regulation that regulates the issues of labelling and the composition of these products in details ...
The provision of gifts and hospitality to public officials has recently been the subject of a number of news stories in the Serbian media, covering not only the official reports on the variety of protocol gifts received by the high ranking officials from the leaders of other countries, but also the alleged corruption affairs involving the potential bribing of various lower-level officials by companies and individuals seeking an unfair advantage in the market ...
Three recent decisions bolster a generic manufacturer’s ability to challenge Orange Book listings and obtain ANDA approval through section viii “carve-outs.” In Caraco v. Novo Nordisk1 the U.S. Supreme Court unanimously held Caraco could use the Hatch-Waxman’s counterclaim provision to correct Novo’s overbroad use code. In AstraZeneca v. Apotex, the U.S ...
The Supreme Court has struck down the core provisions of the Trade Minister Regulation which allowed producers to import finished goods (No. 39/M-DAG/PER/10/2010). The regulation will cease to have legal effect as of 8 May 2012. The Ministry of Trade is reported to be currently considering an amendment which aims to accommodate the interests of both producers and traders but may have to draw it more narrowly than the original version. Decision No ...
What is CEPA? The Closer Economic Partnership Arrangement ("CEPA") is a free trade agreement between Mainland China and Hong Kong that offers Hong Kong products, companies and residents preferential access to the Mainland market. Many of the preferences go beyond China's WTO concessions. CEPA is not a closed agreement and both sides hold regular meetings on further concessions and the details for implementation ...
“A patent, trademark, or design registrationcan only be declared void by Federal courts”. Under this statement, theSuperior Court of Justice of Brazil has reaffirmed unanimously that defendantscannot argue unenforceability of a trademark registration as a defense argumentin an infringement lawsuit ...
In Greek mythology, Prometheus stole fire from Zeus to give to mankind. It seems that Zeus is now reclaiming some of that fire in the guise of Mayo Collaborative Servs. v. Prometheus Labs., Inc., No. 10-1150 (U.S. Mar. 20, 2012), the Supreme Court’s latest decision addressing patent-eligible subject matter. But a practical analysis of Prometheus reveals strategies one can use in drafting patent claims to keep those claims burning ...
The U.S. Fourth Circuit Court of Appeals has reversed a $44 million judgment against Tuomey Hospital in Sumter, South Carolina that arose from Tuomey’s employment arrangements with physicians that allegedly violated the federal Stark Law.1 The Stark Law prohibits hospitals from submitting claims to Medicare for designated health services that were referred by physicians with whom the hospital has a financial relationship, unless the relationship fits within an exception ...
After three days of historic oral arguments before the U.S. Supreme Court, the fate of the Affordable Care Act (ACA), the momentous 2010 health reform law, is uncertain, given robust questioning of the ability of Congress to force individuals to purchase health insurance ...
Law no.11/2012 of 8 March establishes new rules for prescription and dispensing of medicines. Prescriptions for medicines must now include the International Nonproprietary Name (INN) of the active substance,its pharmaceutical form, the dosage, the presentation and the posology. The prescription may also include a trade name by brand or indication of the name of the holder of the marketing authorisation ...
On 24 February 2012, Greece opened the Private Sector Involvement debt swap deal (PSI) to bondholders. Essentially the deal involved a swap that meant bondholders would have to accept a 53.5% cut on the face value of their bonds which, in real terms, meant a loss of approximately 75% on their investment. The deal will be the largest financial restructuring in history, dwarfing the Argentinean restructuring in 2005 valued at EUR 33 ...
The latest additions to the Greek debt saga and the Eurozone crisis are the Credit Default Swap holders and the ISDA. But who are they and what is their role? What is a Credit Default Swap (CDS)? A CDS is most simply described as a type of insurance against the risk of a default on a debt issued by a third party (the reference obligor) ...
On 2 March, 25 of the 27 EU members committed to the new "Fiscal Compact" concept, signed the Treaty on Stability, Coordination and Governance in the Economic and Monetary Union. The Treaty, which is technically an intergovernmental treaty and not an EU instrument (due to the UK and the Czech Republic not wishing to sign up to it), was introduced in December 2011 by Germany and France ...
Europe’s Finance ministers worked through the night of 20 to 21 February to hammer out the terms of the second Greek bail-out to the tune of EUR 130 bn. While the markets have responded coolly to the deal, ministers remain optimistic that enough has been done to stem the contagion to the rest of the Eurozone. Many experts remain skeptical as to whether the bail-out will be enough to save Greece from ultimately defaulting ...
The Centers for Medicare and Medicaid Services (CMS) on February 16, 2012 proposed rules1 implementing Section 6402(a) of the Affordable Care Act,2 requiring persons to report and return Medicare overpayments by the later of 60 days after an overpayment is identified or the date any corresponding cost report is due. Twice in the past, CMS had proposed rules requiring the return of Medicare overpayments, but did not finalize the regulations ...
Not long ago, returns on traditional investment products, for example term deposits, were quite low and did not generate a great deal of interest among those who could spare and would like to invest money with the prospect of some return. Alternatives nearly always carry a higher risk and the various solutions, such as mutual funds, were not well known and poorly understood ...
In its judgment of 19 January 2012 (case no. 08332/11), the Southern Central Administrative Court, decided that INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. (the national authority for medicines and healthcare products), is obliged to issue a certificate of subsidisation of the price of a medicine even when the person requesting the issue of the certificate was not the person who applied for the subsidy ...
The new abbreviated regulatory approval pathway for “biosimilar” and “interchangeable” types of biologic drug products was implemented in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) as part of the Patient Protection and Affordable Care Act of 2010. The details about the use of this pathway were left for further development through Food & Drug Administration (“FDA”) action ...
The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services has begun the pilot phase of HIPAA privacy and security audits of health care providers, health insurers and health care clearinghouses (“covered entities”) to assess HIPAA compliance efforts. Up to 150 covered entities will be subject to the initial audits, to be conducted by KPMG, LLP, the OCR audit contractor ...
In connection with the recent changes in legislation in the field of health, the Federal Commission for protection against health risks ("Cofepris") has taken various actions against the sale, distribution and advertising of the so-called "miracle products," which are distributed without scientific evidence to demonstrate its therapeutic properties ...
Pursuant to the 2011 General Rules on Foreign Trade, since January 2, 2012, holders of trademarks that have been registered with the Mexican Industrial Property Institute (“IMPI”) may request the listing of their trademarks at the Mexican Customs Office (“AGA”), through a database developed by AGA ...
<table border="0" width="780" cellspacing="2" cellpadding="0"> <tbody> <tr> <td> <p>To date, under Panama law (and ever since 1917<a name="_ftnref1"></a><a href="wsg_admin14 ...
The Centers for Medicare and Medicaid Services (CMS) has delayed the start date for data collection of payments made to physicians and teaching hospitals by drug and device manufacturers and group purchasing organizations (GPOs). Under the Physician Payment Sunshine Act (the “Sunshine Act”), such payments were to have been recorded beginning on January 1, 2012 ...
Given the ongoing worldwide economic concerns and discussion of another recession, it is hard to believe that major provisions of the 2009 Stimulus Act impacting employers have yet to be fully implemented ...
