Piracy & Counterfeit Products · PRIVILEGED AND CONFIDENTIAL. Public & Government Affairs. HBB is a bulk seller on DNM who was arrested in June 2017. Claimed to be largest Xanax seller
Counterfeit MedicinesThreat to Patient Health and Safety
Lev KubiakVice President & Deputy Chief Security Officer PfizerJuly 2018
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Good morning / afternoon. For Pfizer, counterfeit medicines are first and foremost a matter of patient health and safety. Counterfeiting is a crime of fraud and deceit. Counterfeiters “trick” patients into buying from them by falsely representing that the products they sell are safe, effective and genuine … but counterfeiters are more concerned with the appearance than the efficacy of their products. They trick patients into believing that the products they sell will provide the therapeutic benefit they require, although they know that the products they produce contain none of the active ingredients they require.
Protecting Patients from Counterfeit Pfizer Medicines
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Prevented 239M counterfeit doses from reaching patients
2017 49 countries seize 12M doses
95 Rx medicines in 113 countries
66 Rx in 62 legitimate supply chains
Trained authorities from 156 countries
11,749 internet “pharmacies”
96% not compliant
89% no prescription required
$1,000 investment = $500,000 profit
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IRACM also reported that for every US $1,000 invested in the trafficking of counterfeit “blockbuster” medicines (i.e., medicines generating sales of more than one billion dollars for the pharmaceutical company), criminal organizations can generate a profit in the range of US $500,000. “Counterfeit Medicines and Criminal Organizations,” Eric Przyswa, International Institute of Research Against Counterfeit Medicines (IRACM), September 2013.
Counterfeit distributors leverage 4 distinct web platforms to promote sales offers to patients and sellers
1. Open Source 2. Social Media
4. Darknet3. Business to Business
Availability on the Web
• Internet provides desired anonymity
• Open Source (e.g. OLPs) garners most traffic, but poses greatest risk to sellers
• Appeals b/c of prices, no Rx required
• Presently, SM primarily redirects traffic to established outlets
• B2B and Darknet caters to buyers seeking bulk transactions
Platforms
“Canadian” Websites
Copyright Pfizer 2016
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Many patients are lulled into a false sense of security when they go on line and order from what appears to be a “Canadian” pharmacy. A visitor to this website, for example, may think he is ordering from a pharmacy in Canada and receiving medicines intended for the Canadian market. To the contrary…
“Canadian” Medicines
Copyright Pfizer 2016
Public & Government Affairs
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96%Counterfeit
5Authentic PFE Xanax
257Samples Received
Global Activity Summary
Pfizer has assisted in the seizure of over 3M counterfeit Xanax since 2017
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Less than 5% of samples received thus far are authentic
PRIVILEGED AND CONFIDENTIAL 9
• Identify Dark Net vendors• Conduct Test Purchase (Bitcoin/WU)• Receive Package• Collect Shipping Intelligence• Complete Lab Analysis• Produce Affidavits/Lab Reports• Produce Cease and Desist Orders• Testify• Consult LE• ID Target• Background/SW• Prosecution• Forfeiture
Investigative Process
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FITZGERALD Arrested on State Charges 10 Counts CSP Coordinating with State Prosecutor FITZGERALD Willing to Cooperate Willing to Help Identify Supplier Industry U.S. Department of Homeland Security U.S. Postal Inspection Service State and Local Police Industry: Investigative Leads Test Purchases (Independent of the Government) Analysis and Testing of Suspected Counterfeit Products Production of Affidavits and Lab Reports Production of Cease and Desist Orders U.S. Department of Homeland Security: Title 21 Authority (Drugs) Title 19 Customs Warrantless Border Search Authority Title 8 Immigration Authority Administrative Subpoena/Summons Authority Industry Access through IPR Center Access to CBP’s National Targeting Center (NTC) Target International Shipments Access to Automated Targeting System (ATS) Import History Access to Prior CBP & HSI Seizure Notifications Resources at Attaché Offices in Foreign Countries State and Local Police: Title 21 Authority (Drugs - State) Plain View Seizures and Probable Cause Arrests For Smaller Quantities of Contraband State Search Warrants For Smaller Quantities of Contraband Possible Violations: 18 USC 2320 – Trafficking in Counterfeit Goods or Services 18 USC 545 – Smuggling Goods into the U.S. 18 USC 1343 – Wire Fraud 18 USC 1341 – Mail Fraud 18 USC 371 – Conspiracy 18 USC 1956 – Money Laundering
PRIVILEGED AND CONFIDENTIAL
Public & Government Affairs
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HBB is a bulk seller on DNM who was arrested in June 2017. Claimed to be largest Xanax seller operating on darknet w/ earnings about £1M HBB purchased by barrels of 100k tablets at a cost of £27,000. HBB sold in the region of 700,000 tablets a month. Offered CFT Pfizer Genotropin, Greenstone Xanax, counterfeit Novartis GG249 (Xanax).
PRIVILEGED AND CONFIDENTIAL
• Increase State Government Awareness
• Additional Doctor/Patient Awareness/Outreach
• Collaboration/Training - State/Local Law Enforcement
• Talk to College bound students and parents of those!
