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Joint Strategic Plan on Intellectual Property Enforcement FIG. 24: Ingredients found in counterfeit medicines. Heavy Metals Actual poison Contaminants Common household items No drugs at all mercury aluminum lead cadmium arsenic chrome uranium strontium selenium PCBs benzopyrenes rat poison boric acid antifreeze road paint wall paint brick dust floor wax sheet rock paint thinner aminotadalafil homosildenafil xanthoanthrafil pseudovardenafil hongdenafil sibutramine haloperidol dextrose dextrin lactose starch saline sald Source: Adapted from the Partnership for Safe Medicines FIG. 25: Examples of Counterfeit Pharmaceutical Manufacturing Conditions. 95 Facilities in Columbia Facilities in Pakistan Source: International Intellectual Property Institute The medicines produced in (FIG. 24) for example, were reported to contain no active ingredient, and tested positive for such compounds as boric acid, brick dust, and paint. 93 To date, millions of counterfeit pharmaceutical products have been identified and seized in global markets. 94 Assessing the total size of the problem has proven difficult, but recent enforcement operations and surveys suggest that the problem is world-wide, requiring enhanced international attention and determination to eliminate illicit trade in medicines. In a 2007 report on counterfeiting and piracy, the OECD provided an extensive but non-exhaustive list of medicinal products that have been counterfeited, which included: medicines used for treating cancer; human immunodefiency virus (HIV); malaria; osteoporosis; FIG. 26: Can you tell which ones are fake drugs in each of these pairs?* SECTION 1 Source: CNN Source: Partnership for Safe Medicines *counterfeits on right 36
Office of the Intellectual Property Enforcement Coordinator diabetes; hypertension; cholesterol; cardiovascular disease; obesity; infectious diseases; Alzheimer's disease; prostate disease; erectile dysfunction; asthma and fungal infections; antibiotics; anti-psychotic products; steroids; anti-inflammatory tablets; pain medicines; cough medicines; hormones and vitamins; and treatments for hair and weight loss. 96 In 2013, the World Health Organization (WHO) launched a global surveillance and monitoring system to encourage countries to report “substandard, spurious, falsely labelled, falsified and counterfeit” (SSFFC) medical products in order to help develop a more accurate and validated assessment of the scope, scale, and harm caused by this issue. 97 Over 920 different medical products have been reported so far, representing every region of the world, affecting medical products from all main therapeutic categories, and representing both innovator and generic medicines. 98 Using intelligence from enforcement operations, INTERPOL coordinated a worldwide operation during a single week in 2015 resulting in a record 20.7 million fake and illicit medicines seized—including blood pressure medication, erectile dysfunction pills, cancer medication and nutritional supplements—and more than 2,410 rogue websites taken offline. 99 Ninety-seven percent of all counterfeit pharmaceuticals seized at the U.S. border in FY 2015 were shipped from four economies: China, Hong Kong, India, and Singapore. 100 Counterfeit drugs are manufactured to closely resemble the real thing, often making it virtually impossible for consumers to detect whether the medicinal products they are ingesting are genuine or counterfeit (FIG. 26). This can be especially dangerous if the counterfeit product appears as commonly prescribed opioid pain medication, such as oxycodone or hydrocone, yet the counterfeit actually contains illicitly produced fentanyl, a significantly more powerful synthetic opioid, because fentanyl can plunge users into overdose quickly. With a growing number of individuals shopping online for affordable medicine, consumers are now confronted with an alarming number of rogue internet pharmacy sites. 101 Criminal networks have become increasingly sophisticated, stocking rogue pharmacies with counterfeit medicines made all over the world and posing as legitimate pharmacies. 102 Yet, a review by the National Association of Boards of Pharmacy (NABP) has shown that as few as three percent (3%) of websites selling prescription drugs are legitimate pharmacies. 103 Counterfeit Automotive Parts. The circulation of counterfeit automotive parts in the United States and around the world gives rise to serious public safety concerns. 104 These illegal products are not made to the specifications of the original manufacturer, are not subject to quality control tests, and fail to perform as intended, resulting in catastrophic failures with potentially fatal consequences. Some of the most dangerous counterfeit products involve air bags that, during testing from U.S. Department of Transportation’s National Highway Traffic Safety Administration (NHTSA), demonstrated consistent malfunctioning of the air bag (FIG.27) ranging from non-deployment, to under-deployment, to over-deployment accompanied by an explosion of metal shrapnel. 105 FIG. 27: NHTSA Test of Counterfeit Air Bag. Source: NHTSA A wide variety of auto parts have been seized by law enforcement over the years. 106 While counterfeit auto parts may have been historically limited to “cosmetic” items like hood ornaments and decals, customs seizure statistics reveal that counterfeit safety components like brake pads, air bags, wheels, and suspension parts are becoming increasingly common. Additional counterfeit parts reported to have been seized by law enforcement include: seat belts, oil and air filters, brake rotors, control arms, windshields, bearings, steering linkages, ignition coils, microchips, spark plugs, solenoids, clutch housing, crankshafts, diagnostic equipment, suspension parts and oil pumps. 107 Put simply, almost every type of auto part can be and has been counterfeited (FIG 28). SECTION 1 37
Page 1: U.S. JOINT STRATEGIC PLAN ON INTELL
Page 6 and 7: B. In Furtherance of a Healthy Doma
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Page 14 and 15: INTRODUCTION IP-intensive industrie
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Page 25 and 26: INTRODUCTION The story of intellect
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3 SECURE AND FACILITATE LEGITIMATE
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INTRODUCTION U.S. and international
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ACKNOWLEDGEMENTS With thanks to, an
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