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 ...
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 ...
With food and nutrition key issues for growing markets such as China, investment in Agribusiness is about supporting Asian partner objectives to grow "safe food" and "harvest protein", according to Adam Handley, President of the Australia China Business Council (WA) and a senior partner at law firm Minter Ellison ...
After 80 years using a very old Dutch trade law (Bedfrijfsreglementerings Ordonnantie 1934, Staatsblad 1938 Number 86), Indonesia has finally introduced its own Bill on Trade. The Bill on Trade was passed by the House of Representatives on 11 February 2014 and will come into effect on 13 March 2014 at the latest ...
SerbiaIncreased number of applications for industrial property protection It seems that the promotional efforts of the Intellectual Property Office of Serbia have been effective. According to statistics from the IP Office for 2013, the number of trademark applications increased by 40%, the number of patent applications increased by 5% and industrial design applications increased by 42% compared to last year ...
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 ...
On 14 February 2014 the South African Department of Trade & Industry (DTI) gave notice of its intention to prohibit the use of a large number of European food and drinks names in terms of section 15 of the Merchandise Marks Act (MMA) - confusingly the notice also makes reference to section 13 of the MMA, a section that no longer exists ...
On February 28, 2014, the Colombian Government issued Decree 456 of 2014, whereby it established special tariffs applicable to the imports of clothing and shoes. The measure is a compound ad valorem (10%) and specific tariff (US$5) for imports of products classified under chapters 61, 62 and 62 of the Colombian Tariff Code, with prices under US$10 per kilogram, and to imports of products classified under chapter 64, with prices under US$7 per pair ...
In one of the few decisions of its kind, the UK High Court recently assessed the damages to be paid to a generic pharmaceutical company under a cross-undertaking in damages. While some aspects of the decision are specific to the UK pharmaceutical reimbursement scheme, the judgment will be a useful reference point for parties involved in similar litigation in Australia ...
The Central Bank of Brazil initiated a public hearing on 6 February to facilitate foreign investment. The Internet-delivered hearing will end on 7 April. The idea is to include under a single normative act the scattered provisions relating to fixed and variable income investment, as well as to portfolio investment. The measure is one of initiatives taken by the Central Bank within its Otimiza-BC program of cost reduction ...
In a decision that will please rights holders, the Court of Justice of the European Union (‘CJEU’) ruled last week that goods sold by a website based outside the EU are protected by EU intellectual property law if they are sold to a person in the EU. Mr Blomqvist lived in Denmark. He ordered a watch described as a Rolex from a Chinese website which was then sent to him from Hong Kong. The Danish customs authorities held the parcel on suspicion that it was a counterfeit ...
Strategic Investment Act: The new Act on Strategic Investment in Croatia has achieved its goal of reducing administrative procedures and ensuring the speedy realisation of strategic projects in Croatia. In order to declare a project “strategic,” it must meet several criteria. Foremost, the project must be in accordance with spatial planning regulations. Also, the total amount of capital expense must be HRK 150 million (approx. EUR 19.6 million) or more ...
Physician-owned distributorships (PODs) and other physician-owned entities (POEs) have emerged as a favored vehicle to reduce costs, but the popularity of PODs and POEs has led to increased scrutiny by federal regulators. In June 2011, the United States Senate called on the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) and Centers for Medicare & Medicaid Services to investigate the proliferation of PODs and corresponding utilization practices ...
Negotiation of the proposed EU Data Protection Regulation has faltered. While there is still a possibility that the Regulation could be passed before the May 2014 European elections, that looks increasingly remote. The main stumbling block appears to be the difficult issue of the ‘one stop shop’, which has produced deadlock within the Council of Ministers. The ‘one stop shop’ proposal is inherently difficult, but until now has been referenced in somewhat superficial terms ...
The Romanian Government has approved the necessary legislative amendments to create a holding regime in Romania, the ordinance being published in the Official Gazette on Friday, November 15, effective as of January 1st, 2014. The ordinance includes profits tax exemptions for Romanian holding companies as regards revenues from dividends received, revenues from the sale of shares and revenues from the liquidation process ...
On October 18, 2013, the Centers for Medicare & Medicaid Services (CMS) published Survey & Certification Letter 14-01-NM, which clarified the obligations of a skilled nursing facility (SNF) or nursing facility (NF) (collectively “nursing homes”) to provide cardiopulmonary resuscitation, or CPR, to its residents ...
In a statement issued by the National Regulatory Agency, Control and Surveillance (ARCSA), drugs that are sold in Ecuador must have labels stating the words 'generic', otherwise it can not be marketed as of January 24, 2014 ...
The Turks and Caicos Islands (TCI) has just enacted a revamped investor residency programme, entitling successful applicants to a permanent residence certificate (PRC). The Qualifying criteria are: Villas a. Investment of not less than $300,000 in actual construction of a new home, or in renovation of a distressed property as a home for the applicant and his or her dependants, on the islands of Grand Turk, Salt Cay, South Caicos, Middle Caicos or North Caicos; or b ...
Never has there been a more controversial law in the past decade than the Reproductive Health Law (“RH Law”). After a long and contentious battle in Congress, the law was finally passed. But the fervent opposition by the so-called Pro-life groups (chief among them the Catholic Church) endures. Four days after the approval of the law’s Implementing Rules and Regulations (“IRR”), the Supreme Court on March 19, 2013, halted its implementation, issuing a 120-day status quo ante order ...
BackgroundFollowing much anticipation on the part of health care industry members, CMS released its long-awaited final rule on the Physician Payment Sunshine Act in February 2013, supplying clarification and guidance on new financial disclosure requirements governing pharmaceutical and medical device manufacturers. The rule includes extensive and potentially time-consuming mandates for drug and device companies, including reporting of annual payments to physicians and teaching hospitals ...
Introduction:The Consumer Protection Act, Cap. 326D (‘the Act’) aims at protecting consumer rights by, among other things, prohibiting and penalizing the use of unfair contract terms by suppliers of services. The Act is administered and enforced by the Fair Trading Commission (‘the FTC’). This article summarises the effect of the Act on how service providers can legally contract with their customers. This article does not focus on suppliers of goods ...
In Novozymes A/S v. DuPont Nutrition Biosciences APS, 2012-1433 (Fed. Cir. July 22, 2013), the Federal Circuit affirmed the district court’s grant of DuPont’s post-trial motion for judgment as a matter of law holding that Novozymes’ U.S. Patent No. 7,713,723 (“the ’723 patent”), directed to a variant of alpha-amylase, was invalid under 35 U.S.C. § 112, first paragraph, for failing to satisfy the written description requirement.2 (Slip op. at 18) ...
After a slight pause, the Baltic States – Estonia, Latvia and Lithuania - are continuing on their path to entering the euro zone, which was first entered by Estonia in 2011 ...
