The Federal Trade Commission’s increased focus on the antitrust implications of healthcare mergers and acquisitions has been widely publicized. While scrutiny has largely been directed toward hospital and health system transactions, a recent case in Nevada indicates that the FTC is now taking an interest in relatively small provider combinations in highly concentrated markets ...
Between 22 May 2012 and 4 June 2012, staff teams from the European Commission, European Central Bank and International Monetary Fund (“IMF”) visited Lisbon to conduct the fourth review (the “Review”) of Portugal’s economic programme (the “Programme”). A copy of the initial statement can be downloaded here:http://ec.europa.eu/economy_finance/articles/financial_operations/2012-06-04-portugal_en.htm And a copy of the full report can be downloaded here: http://ec.europa ...
China has traditionally restricted foreign investment in the retail and wholesale sectors with the aim of nurturing strong domestic players before their foreign counterparts would be allowed to enter the country. Since becoming a member of the World Trade Organisation, China has gradually opened up its distribution sector to foreign investment ...
On January 24, 2011 the Attorney General of the Federal Republic of Brazil signed a document restricting the powers of ANVISA (Brazil’s regulatorybody) in the examination of pharmaceutical applications, giving the rights to the Brazilian PTO to do so without any interference of ANVISA. The dispute between ANVISA and the Brazilian PTO in the examination of pharmaceutical applications had apparently been solved ...
In the history of the Eurozone crisis, Spain has been a special case. It was always the "teachers pet" when it came to sovereign debt, that is, until recently. On 9 June 2012, Spain received an offer of up to EUR 100 bn in financial support from the EU for its ailing banking sector. What does that mean for Spain and the rest of the Eurozone and how did Europe’s fourth-largest economy find itself in this state? BACKGROUND Spain has been unlucky in many respects ...
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 ...
The Stage 2 Meaningful Use requirements proposed last week by CMS as part of the Medicare and Medicaid incentive programs to expand the use of Electronic Health Record (EHRs) maintain the same core and menu structure as the Stage 1 criteria. The proposed rule, however, gives providers an additional year, until 2014, to implement Stage 2 criteria ...
Healthcare providers and other HIPAA covered entities have until Wednesday, February 29, 2012 to submit notice of breaches of unsecured Protected Health Information which affected fewer than 500 individuals during 2011. Notice must be submitted electronically to the Secretary of Health & Human Services, and separate forms are required for each data breach occurring in the course of the calendar year ...
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 ...
Only two days after the government’s announcement that it recovered a record-breaking $4.1 billion from its healthcare fraud enforcement efforts in 2011, the Centers for Medicare and Medicaid Services (CMS) published a draft regulation in today’s Federal Register implementing the Affordable Care Act’s (ACA) 60-day overpayment report and return provision ...
