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 ...
In a surprise announcement on 21 March 2014, the Zambian government with immediate effect abolished exchange control regulations introduced in 2012 and 2013 in an attempt to halt the rapid devaluation of the Kwacha. When the Movement for Multiparty Democracy (MMD) came to power in Zambia in 1991, the new government’s priorities were the restoration of economic future growth and employment through liberalising the economy and allowing market forces a greater role ...
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 ...
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 ...
New Regulations Governing Consumer Claims and Language Use in Consumer Information The Croatian Consumer Protection Act has recently updated how customer claims are to be handled. The receipt of complaints must now be confirmed in writing without delay ...
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 ...
The rapid expansion of brands in the Chinese foreign market has problems relating to the protection of these arise and hence of their owners. The last amendment to the Trademark Law of China reflects one of the main problems that foreign companies often face in China which is "brand hijacking." The records of "bad faith" requested by the opportunists of fashion brands block applications for registration of trademarks by their rightful owners ...
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 ...
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 ...
Jack Wills, the clothing company that markets itself as “outfitters to the gentry” has enjoyed recent success in its action against House of Fraser regarding the use of its logo. Jack Wills complained that the rights in its logo comprising a silhouette of a pheasant wearing a top hat and holding a cane had been infringed by House of Fraser’s use of a logo on its own Linea brand of casual clothing that comprised a profile of a pigeon wearing a top hat and bow-tie ...
In 2012 the Western Cape High Court handed down a trade mark judgement that raised eyebrows. The facts were that the owner of a farm called Zonquasdrift had a trade mark registration for the mark Zonquasdrift covering wine (but not grapes). The owner of another farm in the area sold wine grapes under its name, Zonquasdrif Vineyards (no ‘t’ at the end) ...
The authorities seem to have gone on the offensive on the issue of counterfeits. In the run-up to Christmas, the Department of Trade and Industry (DTI) has called on South Africans not to buy counterfeit goods, even if they are cheaper than the originals (as they invariably are) ...
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 ...
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 highly-anticipated and extremely significant pair of decisions for businesses and consumers alike, the Supreme Court of Canada (“SCC”) ruled on Thursday (October 31, 2013) that the ultimate consumers at the end of a supply chain can effectively leap-frog the supply chain by having direct legal recourse in a class action against a manufacturer who illegally overcharged for the product supplied ...
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 ...
On October 25, 2013, the Standing Committee of the National People’s Congress of the People’s Republic of China passed an amendment to the P.R.C. Law on the Protection of Consumer Rights and Interests (the “Amendment”) ...
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 ...
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) ...
The Minister of Finance has issued Regulation No. 37/PMK.04/2013 on Duty-Free Shops on 27 February 2013, which implements Article 48 of Government Regulation No. 32 of 2009 on Bonded Storehouses (Tempat Penimbunan Berikat). The Regulation will effectively be applied 90 days since the issuance date ...
Minister of Health Regulation No. 30 of 2013 on The Inclusion of Information on Sugar, Salt, and Fat Content, and Health Impact Messages for Processed and Fast Foods is aimed at lowering the exposure of the public to the risk of non-contagious disease such as hypertension, stroke, diabetes and heart attacks, which can be caused by the excessive consumption of processed or fast foods ...
The Minister of Health has issued Regulation No. 28 of 2013 on Affixing Health Warnings and Information on Tobacco Product Packaging which came into force on 12 April 2013, as a further implementation of Government Regulation No. 109 of 2012 on Control of AddictiveSubstances in the Form of Tobacco Products. The Regulation requires tobacco producers and importers to affix pictorial health warnings and health information on their tobacco products packaging ...
The Head of the National Drug and Food Control Agency (Badan Pengawas Obat dan Makanan – “BPOM”) recently issued Regulation No. 27 of 2013 on The Supervision of Drugs and Food Imports into Indonesian Territory which came into effect on 28 May 2013. This Regulation repeals and replaces the previous regulations on Imports of Processed Foods, Cosmetics and Drugs ...
