Online Pharmacy Guide for Acquirers
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Online Pharmacy Guide for Acquirers June 2015 Visa Inc. Online Pharmacy Guide for Acquirers Contents About this Guide ........................................................................................................................................................... iii 1. The Problem of Illegal Online Drug Sellers ........................................................................................................... 1 Beyond Fraud and Intellectual Property to Public Health .......................................................................................................................... 1 Acquirer Obligations and the Visa Core Rules and Visa Product and Service Rules .................................................................. 2 2. Definitions: When is a Merchant an Internet Pharmacy? ................................................................................... 4 Internet Pharmacy ............................................................................................................................................................................................................... 4 Prescription Drugs, Pharmacy-Only Drugs and Over-the-Counter Drugs ....................................................................................... 5 Prescription Drugs –– More Than Just Controlled Substances ............................................................................................................... 6 3. Core Principles of Internet Pharmacy Legitimacy ............................................................................................... 7 Rule #1: Prescription Requirement Based on In-Person Examination ................................................................................................. 7 Rule #2: Pharmacy Licensure ........................................................................................................................................................................................ 8 Rule #3: Drug Importation .............................................................................................................................................................................................. 9 Rule #4: Dual Jurisdictional Compliance ............................................................................................................................................................ 10 4. Acquirer Requirements and Best Practices ......................................................................................................... 11 Visa Inc. Requirement: High Brand-Risk Acquirer License ....................................................................................................................... 11 Model Policy ........................................................................................................................................................................................................................ 11 Underwriting an Internet Pharmacy ..................................................................................................................................................................... 12 Domain Name / Licensure Disclosure Requirement .................................................................................................................................. 14 Ongoing Monitoring: What to Look For and Pitfalls ................................................................................................................................... 15 A Word About Nutraceuticals ................................................................................................................................................................................... 17 5. Addressing Grey Areas: Salvageable or Not? ..................................................................................................... 19 6. Resisting Obfuscation Tactics ................................................................................................................................ 21 Internet Pharmacy Affiliate Marketing Networks .......................................................................................................................................... 21 Geo-targeting ..................................................................................................................................................................................................................... 21 The Bait and Switch ......................................................................................................................................................................................................... 22 Irrelevant or “International” Pharmacy Licenses ............................................................................................................................................ 23 False Representations About Customer Base ................................................................................................................................................. 23 Fake FAQs/Prescription Requirement .................................................................................................................................................................. 24 Red Flags: A Short List .................................................................................................................................................................................................... 24 7. Frequently Asked Questions ................................................................................................................................. 25 June 2015 i © 2015 Visa. All Rights Reserved. Online Pharmacy Guide for Acquirers Appendices ................................................................................................................................................................... 27 Appendix A: Model Terms and Conditions ...................................................................................................................................................... 28 Appendix B: Legitimate Internet Pharmacy Verification Resources .................................................................................................. 31 Appendix C: Where to Verify Pharmacy Licensure Status ....................................................................................................................... 34 Appendix D: Country Summaries ........................................................................................................................................................................... 38 ii June 2015 © 2015 Visa. All Rights Reserved. Online Pharmacy Guide for Acquirers About this Guide This document is a manual for acquirers who have boarded, or are considering boarding, an Internet pharmacy or Internet pharmacy referral merchant. Visa Inc. partnered with LegitScript (www.legitscript.com) to create this publication. LegitScript is a compliance firm that focuses on healthcare product merchants, including Internet pharmacy and dietary supplement (also referred to as nutraceutical) merchants. LegitScript maintains a master database of Internet pharmacies that is widely used by regulatory authorities, search engines, domain name registrars, and credit card networks (including Visa Inc.). Visa Inc. works closely with LegitScript to identify instances of non-compliance with the Visa Core Rules and Visa Product and Service Rules, and to analyze merchant compliance with applicable laws and regulations. Visa Inc. encourages acquirers to utilize LegitScript monitoring and analysis to ensure that Internet pharmacy and nutraceutical merchants are compliant with the Visa Core Rules and Visa Product and Service Rules with regard to Internet pharmacy-related requirements and applicable laws and regulations. The following resources are included in the appendices: • Model Internet Pharmacy Policy for Acquirers • Legitimate Internet Pharmacy Verification Resources • Where to Verify Pharmacy Licensure • Country Summaries: Legal Requirements in Major Internet Pharmacy Target Markets June 2015 iii © 2015 Visa. All Rights Reserved. Online Pharmacy Guide for AcquirersAbout this Guide iv June 2015 © 2015 Visa. All Rights Reserved. Online Pharmacy Guide for Acquirers 1. The Problem of Illegal Online Drug Sellers As access to the Internet has exploded, so has the demand for healthcare products sold online. The global market for prescription medicines alone is estimated to have reached $989 billion in 2013, and forecasted to reach an estimated $1,280 billion by 2018.1 Set to surpass $1 trillion annually, the size and growth of this market presents a real opportunity for acquirers. Unfortunately, alongside the legitimate market is a dangerous underground market of rogue Internet pharmacies which fail to comply with basic pharmacy licensure, drug safety, and patient safety laws and regulations. The exact size of this market is anyone’s guess, but rough estimates range from $75 billion to $430 billion. This estimate is in addition to the $989 billion legal-drug market.2 The ratio of legal-to-illegal merchants has an inverse relationship in the offline and online markets. Offline “brick-and-mortar” pharmacies, the physical pharmacy that patients walk into to fill a prescription, usually operate legally and safely. As in any industry, illegal transactions and criminal activity do occur, but tend to be the exception and not the rule. By contrast, 97% of Internet pharmacy websites