Europe Fights Back against Counterfeit Medication with the European Falsified Medicines Directive (2011/62/CE)

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1 Europe Fights Back against Counterfeit Medication with the European Falsified Medicines Directive (2011/62/CE) The instances of falsified medicines in Europe are increasing at a dramatic rate. Medication represents the second largest category of falsified items imported into Europe today. This trend is not limited to Europe. All over the world, anyone can come across medication that seems to be packaged properly, but which actually does not contain the correct ingredients or, even worse, highly toxic substances. Counterfeit medicines represent an enormous public health challenge. Here some startling statistics: The World Health Organization (WHO) estimates approximately 30% of the drugs distributed in Asia, Africa, and Latin America are counterfeit. The WHO estimates that over 50 percent of medication purchased online where the doctor's name is concealed is counterfeit. A 2010 survey conducted by Pfizer in 14 European countries indicated that more than 10.5 billion (U.S. $14 billion) was spent each year on illicitly-sourced prescription drugs. Many of the drugs were for weight loss, influenza and erectile dysfunction; many of these drugs were counterfeit.

2 Worldwide sales of counterfeit drugs is in excess of $75 billion annually, according to the World Health Organization, General information on counterfeit medicines. Approximately 1% of counterfeit drugs have penetrated the supply chain in developed countries. 10% of all pharmaceuticals distributed worldwide are counterfeit. The rise in counterfeit medication in Latin America is a regional trend. In some markets where cocaine consumption has fallen, such as the United States, use of prescription drugs has risen sharply. This has led organized crime from Latin America to move into the multi-billion dollar trade, with Mexican cartels already involved. These falsifiers are in fact murderers - they are causing death, says Jim Herrington, executive director of the Gillings Global Gateway at the University of North Carolina s Gillings School of Public Health. The impact of fraudulent drugs on patients is significant, resulting in: failure to treat minor symptoms, failure to treat critical illnesses, drug resistance caused by long-term exposure to reduced active ingredients, or even death. Each year, as many as 1 million people die from counterfeit drugs (Southwickz, Natalie, Counterfeit Drugs Kill 1Mn People Annually: Interpol, InSightCrime.org, October 24, 2013). The fight against counterfeit drugs mobilizes an increasing number of stakeholders, governments, healthcare authorities, police organizations and customs officials. In industrialized nations like the United States, Canada, most EU countries, Australia, New Zealand and Japan where median income is higher, the pharmaceutical supply chain is better protected. Stronger customs, import and regulatory controls, and law enforcement are more aggressive; the occurrence of counterfeiting is statistically reduced to 1% or less. Almost 14,000 websites hosted by illegal online pharmacies were identified and shut down and more than 530,000 packages were inspected by customs and regulatory authorities worldwide ( Counterfeit Drugs: Fighting Illegal Supply Chains, as per Lev Kubiak, Director National Intellectual Property Rights Coordination Center, Homeland Security Investigations, U.S. Immigration and Customs Enforcement). Of these, almost 42,000 packages containing everything from antibiotics, cancer medication and antidepressants to erectile dysfunction medication and dietary supplements were seized.

3 To further increase security against counterfeits, many countries issue guidelines to support the serialization of pharmaceutical products. The following charts illustrate the progress of each country in the implementation of the serialization process:

4 Regarding Europe in particular, risk to public health and safety has steadily increased. Therefore, the European Commission's Directorate for Public Health and Risk Assessment issued Directive 2011/62/EU of June 8, 2011 (amending Directive 2001/83/EC), preventing entry of falsified medicinal products into the legal supply chain. The European Stakeholder Model (ESM), a cloud-based point-of-dispensing verification system, was created to implement 2D data matrix bar codes for authentication of medication, ensuring that patients receive a genuine product. The codes include a randomized serial number, product number, batch number and expiration date. Scanning of these codes allows pharmacists to identify counterfeit medicine, as well as genuine material that is recalled, expired or should not be dispensed for some other reason. The European Medicines Verification Organization (EMVO), a non-profit organization, oversees the system and manages the European Hub, linking national systems throughout the Europe Union.

5 To help in the fight against counterfeit medication, Datalogic offers a wide range of scanners and mobile computers that can be used by pharmacies and hospitals to read the 2D codes placed on the packages. Easy, fast and efficient scanning at the Point of Dispense can be obtained by using the compact, light and robust Memor X3 mobile computer, the ergonomic Lynx PDA or the Gryphon imager. The Gryphon imager is also available in a special Healthcare version with Disinfectant-Ready enclosures treated with anti-bacterial additives that help reduce the transmission of infection. Sources: European Commission General information on counterfeit medicines, World Health Organization, WHO 2014 Southwick, Natalie, Counterfeit Drugs Kill 1 Mn People Annually: Interpol, InSightCrime.org, October 24, 2013 Impact: International Medical Products Anti-Counterfeiting Taskforce Counterfeit Drugs: Fighting Illegal Supply Chains, a report by Lev Kubiak, Director National Intellectual Property Rights Coordination Center, Homeland Security Investigations, U.S. Immigration and Customs Enforcement, February 27, 2014 European Directorate for the Quality of Medicines & Health Care (EDQM)

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