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"Pharma Anti-Counterfeiting" 21st Aug 2017

News Highlights
Customs seizing large amounts of anti-HIV drug being ordered online Customs are intercepting and seizing large amounts of a revolutionary anti- HIV drug, Pre-Exposure Prophylaxis (PrEP), which is being ordered by people online. It is understood other manufacturers are seeking to supply generic versions of the drug which would significantly reduce the price but these efforts are being challenged in court by PrEP’s manufacturer, Gilead Sciences.
Falsified medicine — tackling a serious threat to public health Though no reliable figures exist on the actual scale of the problem, Interpol suggests that falsified medical products, which include medicines and medical devices and equipment, could account for as much as 30 percent of the market in some countries in Asia, Africa and Latin America. Anti-infectives such as antimalarial medicines and antibiotics are particularly prone to falsification, given the weak regulatory and enforcement mechanisms in countries where these diseases are present.
FDA sues 25 pharmacies for selling fake medical products In Myanmar, Dr Than Htut said the 25 pharmacies recently sued did not have valid licenses to sell medicines and medical products. Last year, the FDA sued 99 pharmacies for the same violations. “It is a big amount. Every township in Myanmar has substandard, falsified and illegal medical products entering the market,” he told reporters during an exhibition which showed the risks of using substandard medical products. The FDA is advising people to ensure that the medication they buy in pharmacies bears a Myanmar Registration Number and that it has not passed its expiry date.
Do EU policymakers really value intellectual property? In spite of the mounting and substantiated evidence on the dangers of IP infringements and the pressing need to counter this problem, the Council of the EU believes that it is not that much of a serious crime. It seems that the Council favoured an approach that focuses on ‘more serious crimes’, such as drug trafficking, terrorism, and cybercrime, rendering counterfeiting as a milder issue. However, financial losses incurred by European businesses and dangerous substances circulating freely in the Internal Market are a priority that must be addressed
To Catch a Counterfeiter - Nearly all the world’s fake products come from China. America’s oldest private detective agency is on the case Counterfeiting is a $400 billion industry in China. Fakes account for some 20 percent of all name-brand products sold in China each year, damaging the reputations of legitimate retailers and taking a sizable bite out of their revenues. China’s counterfeiting industry is the largest in the world. This story is about the world famous Pinkertin Detective Agency being hired by Fortune 1000 companies to combat it
Brand Protection
Customs seizing large amounts of anti-HIV drug being ordered online
Customs are intercepting and seizing large amounts of a revolutionary anti- HIV drug, Pre-Exposure Prophylaxis (PrEP), which is being ordered by people online. It is understood other manufacturers are seeking to supply generic versions of the drug which would significantly reduce the price but these efforts are being challenged in court by PrEP’s manufacturer, Gilead Sciences.
Trade body urges more action to tackle global counterfeiting hotspots
The commercial hologram industry welcomed a new report predicting ‘impressive’ growth for pharmaceutical authentication technologies but warns that more still needs to be done to tackle global counterfeiting ‘hotspots’. Growth in anti-counterfeiting devices appears strong says the IHMA in the face of increasing incidences of global counterfeiting and higher levels of technology awareness among regulatory authorities. But the trade association wants those with anti-counterfeiting responsibilities to remain ‘extremely vigilant’
To Catch a Counterfeiter - Nearly all the world’s fake products come from China. America’s oldest private detective agency is on the case
Counterfeiting is a $400 billion industry in China. Fakes account for some 20 percent of all name-brand products sold in China each year, damaging the reputations of legitimate retailers and taking a sizable bite out of their revenues. China’s counterfeiting industry is the largest in the world. This story is about the world famous Pinkertin Detective Agency being hired by Fortune 1000 companies to combat it
Packaging
Malaysia pilots barcoding to fight falsified medicines
A pilot project intended to show how 2D datamatrix codes can help track medicines through the supply chain has been carried out in Malaysia. The pilot is important "in light of the many counterfeit pharmaceutical products currently flooding the Malaysian market and the high instances of theft while products are in transit".
IP Theft
Do EU policymakers really value intellectual property?
In spite of the mounting and substantiated evidence on the dangers of IP infringements and the pressing need to counter this problem, the Council of the EU believes that it is not that much of a serious crime. It seems that the Council favoured an approach that focuses on ‘more serious crimes’, such as drug trafficking, terrorism, and cybercrime, rendering counterfeiting as a milder issue. However, financial losses incurred by European businesses and dangerous substances circulating freely in the Internal Market are a priority that must be addressed
Supply Chain
Blockchain-powered supply chain tracker
Keeping control of the supply chain is key for customer satisfaction and to control goods; for pharmaceuticals it is also a regulatory requirement. A new high-tech sensor has been developed for product medicines.
Barcode Quality: Ignore It at Your Peril
Drug makers and packagers cannot afford to take barcodes for granted: a poorly printed barcode can wreak havoc in the pharmaceutical supply chain, interrupting product supply and hampering drug makers’ business performance. Barcode quality is more important than ever as anti-counterfeiting regulations will require application of a serial number and unique 2D barcode (the GS1 DataMatrix) on every saleable prescription drug container to be sold.
Crunch time — discussing the impact of serialisation on packaging operations
Deadlines for including unique product identifiers on prescription drugs are putting a strain on multiple parts of the industry, much of which is ill-prepared to meet the targets. Recognising this lack of readiness, the FDA has now extended its deadline for the US Drug Supply Chain Security Act (DSCSA) for another year to November 2018. European regulations will come in two years. Companies cannot afford to wait to adapt their supply chains to ease the complicated and challenging transition to serialisation.
Drug Supply Chain Tracking Challenges FDA and Manufacturers
Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward, despite multiple hurdles for regulators, manufacturers, and distributors. FDA recently announced that it would delay enforcement of requiring manufacturers to add product identifiers to drug packaging, a key step for establishing an interoperable drug tracking system by 2023 that will reduce drug diversion and the influx of counterfeit medicines into the United States
Policy & Regulation
Importing prescription drugs could worsen opioid crisis
Law-enforcement officials already struggle to contain the flood of illegal drugs coming into the US, but a proposal under serious consideration in Washington, D.C., could inadvertently make the problem much worse. Bills before Congress would end a longstanding ban on the import of prescription medicines not previously cleared by the FDA. Although the proposals were floated to curb rising drug prices, the unintended side effects of this policy would pose a daunting challenge for law enforcement
FDA sues 25 pharmacies for selling fake medical products
In Myanmar, Dr Than Htut said the 25 pharmacies recently sued did not have valid licenses to sell medicines and medical products. Last year, the FDA sued 99 pharmacies for the same violations. “It is a big amount. Every township in Myanmar has substandard, falsified and illegal medical products entering the market,” he told reporters during an exhibition which showed the risks of using substandard medical products. The FDA is advising people to ensure that the medication they buy in pharmacies bears a Myanmar Registration Number and that it has not passed its expiry date.
Washington must slam door on imported counterfeit drugs
Bills before the US Congress would remove many of the license and oversight requirements on the drugs imported into the United States by lifting various barriers, inviting an influx of bogus pharmaceutical products from the same crime rings that are selling these drugs in other countries around the world that would love better access to the U.S. market. Law enforcement would inevitably be tasked with policing the problem, at a time when most prosecutors and law enforcement officials have their hands full with the growing opioid crisis.
User fee legislation to reach president’s desk without drug importation amendment
An amendment to significantly expand drug importation, introduced by U.S. Sen. Bernie Sanders (I-VT), was ultimately left out of the FDA Reauthorization Act (FDARA) passed by the U.S. Senate last week, allowing the House of Representatives’ version to proceed relatively unchanged. Sanders has touted his amendment as a solution to the high cost of drugs in the United States. APhA and other pharmacy groups had spoken out against Sanders’s amendment on the basis that it could threaten the health and safety of patients and the health care system.
Cybercrime
Online shoppers duped into buying fake medicines, makeup
New research finds counterfeit goods still pose a significant risk to consumers. More than one-quarter of respondents (27%) said they had unwittingly purchased non-genuine consumer goods online. This included makeup (32%), skincare (25%), supplements (22%) and medication (16%). Brand websites were most trusted (89%), followed by online marketplaces (74%), online pharmacies (67%) and mobile apps (67%).
Opinion: 'Fake medicines are a growing problem, around 7% of the global market'
Fake medicines bypass tough safety and quality controls that apply to legitimate products so the person taking them has no assurances that the medicine is safe to take and puts their health at risk as a result. As falsifications become more sophisticated, the risk of fake medicines reaching patients in Europe increases every year. All types of medicines can be “falsified” – branded products, generic products, life-saving medicines and so-called “lifestyle” drugs. People assume that fake medicines only come from illicit sources such as unregulated websites, and this is largely true as the internet offers endless possibilities for criminals to sell illegal medicines for profit.
Dark Web drug network operated from gated community in Altadena, feds say
A group of Southern Californians have been accused of operating a multimillion-dollar drug distribution network on the dark Web from a gated community in Altadena, federal prosecutors said. According to investigators, the group ran two underground drug distribution businesses. In the four years the network operated, the group sold drugs for more than $7 million worth of Bitcoin, the semi-anonymous digital currency, prosecutors said
Counterfeit Drugs
Dubai Customs seize counterfeit goods worth Dh72 million
Dubai Customs seized 133 counterfeited items worth Dh72.584 million, for infringing the Intellectual Property Rights (IPR), in the first half of 2017. Yousef Ozair Mubarak, director of Dubai Customs' IPR Department, said they take a firm stand against intellectual property rights infringements, to protect the economy from the harm caused by counterfeit goods. The seized goods included electronics, watches, eyewear, clothing, fabrics, perfumes and cosmetics, medicines and medical equipment, tyres, auto spare parts, telephones and accessories, computers and other imports.
Enelamah: Feeling the Pulse of Local Manufacturers
Worried by the influx of fake drugs in the market, the Nigerian trade minister asked Fidson Healthcare how the issue of substandard drugs is affecting them, and they said that the threat came from internationally made fake drugs, and that they are in the process of engaging NAFDAC very aggressively.
Shop owner fined over sale of illegal prescription drugs
In Ireland, a woman who admitted selling illegal prescription drugs from a Lisburn shop has received a £750 fine; she pleaded guilty to three counts of possession and supply of the fake medicines from her eastern European convenience food store. Enforcement officers from the Department of Health seized 3,000 tablets from the Tonagh Drive shop last September after it emerged they were of Lithuanian and Russian origin.
Feds take down opioid ring and shut down its pill lab
Federal investigators have shut down a ring that reportedly put hundreds of thousands of potentially deadly, fake prescription pills laced with fentanyl on the streets of San Antonio and across the country. It is alleged to have manufactured pain and anxiety pills laced with fentanyl or other drugs using commercial pill presses obtained from China, the U.S. Drug Enforcement Administration said. The ring was believed to have obtained the fentanyl from the black market in China
Falsified medicine — tackling a serious threat to public health
Though no reliable figures exist on the actual scale of the problem, Interpol suggests that falsified medical products, which include medicines and medical devices and equipment, could account for as much as 30 percent of the market in some countries in Asia, Africa and Latin America. Anti-infectives such as antimalarial medicines and antibiotics are particularly prone to falsification, given the weak regulatory and enforcement mechanisms in countries where these diseases are present.
US doc gets six years for in unapproved cancer drug case
A Florida doctor has been sentenced to nearly six years in prison for smuggling misbranded and unapproved cancer drugs into America, some of which were likely counterfeit, and administering them to patients. Diana Anda Norbergs, MD, (61) was initially convicted last November by a jury for receipt and delivery of misbranded drugs, smuggling goods into the US, healthcare fraud and mail fraud. The court heard that the owner of East Lake Oncology, in Palm Harbor, Florida, had been ordering cheap drugs – such as MabThera, Ribomustin and Zometa – from unlicensed overseas distributors, including from the UK and Canada, since 2009