Protecting Patients from Falsified Medicines Online. Klaus Gritschneder Vice President EAMSP

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1 Protecting Patients from Falsified Medicines Online Klaus Gritschneder Vice President EAMSP

2 Who we are? Umbrella organisation for all European based mail order pharmacies 12 members from 6 European countries (D, NL, UK, SK, CH, B) Covering more then 90% of the European mail order market in sales for drugs (Rx and OTC) EAMSP RX-360 Cologne

3 Illegal and falsified drugs only a problem in Afrika? EAMSP RX-360 Cologne

4 Market size No real figures available in 2010 the value of falsified drugs wordwide was estimated by experts of more than 75 billions US $ No solitary offenders normally structures of organized crime, well known for drug trafficking, kidnapping, arms trade and other comparable offences Internationally operating structures makes it difficult for enforcement agencies to find the real offenders EAMSP RX-360 Cologne

5 Some examples from the European market easy-apotheke.com cialis20mgkaufen.net shopapothekeonline.de EAMSP RX-360 Cologne

6 The way, illegal traders work Website hosted outside Europe, e.g. China, Pakistan Owner protected by privacy protect companies No contact points besides callcenter or Logos copied from other websites Products from manufacturers outside Europe, mostly India Drop shippers in UK finalize the parcels for the customers Payment only via credit card, no invoice EAMSP RX-360 Cologne

7 What we will do Implementing the FMD Implementing.pharmacy TLD Supporting the activities of ASOP EAMSP RX-360 Cologne

8 Legal framework: FMD Falsified Medicine Directive 2011/62/EU Secure package and tracking system common logo Patient information and education Additional laws delegated acts and guidelines about good manufacturing practice EAMSP RX-360 Cologne

9 2D barcode - architecture EAMSP RX-360 Cologne

10 Secure packages delegated act expected first quarter 2015 mandatory in each member state until 2018 Germany is a forerunner with ist securpharm project But some aspects are not solved: e.g. the cross border trade between member states EAMSP RX-360 Cologne

11 barcode information Unique identifier (number) Manufacturer number (which product for which countries) National reembursement number (PZN in Germany) Expire date Charge number EAMSP RX-360 Cologne

12 status.pharmacy TLD.pharmacy is a Top-Level Domain like.com it`s not possible to copy.pharmacy The National Association of Boards of Pharmacy (NABP) is the administrative and responsible organization for.pharmacy EAMSP supports and works closely with the NABP to implement.pharmacy in Europe..pharmacy gives patients an easy way to access safe medicines and information legally EAMSP RX-360 Cologne

13 Set up initially as a project within the European Alliance for Access to Safe Medicines ( March 2012 Established a separate Legal entity not for profit Community Interest Company February 5th 2014 Articles of Association - Members and Observers Europa Transparency register EAMSP RX-360 Cologne

14 EAMSP RX-360 Cologne

15 activities Voluntary Activities: building support for CSIP's "Principles of Participation" with e-commerce companies in the US and EU ( ) Education: Patient and consumer awareness Google and Bing adwords support, patient groups and Italian educational website Advocacy: encouraging excellence in the implementation of the FMD's common logo and dotpharmacy Conducting research: Internet pharmacy activities in China and other APEC economies. Italian educational website EAMSP RX-360 Cologne

16 Internationale cooperations within ASOP EAMSP RX-360 Cologne

17 Memorandum of Understanding voluntary action of the signatories to improve patient safety by combating the illegal sale or supply of medicines online - Proactive measures - Reactive measures - individual annex - KPIs EAMSP RX-360 Cologne

18 lessons learnt EAMSP RX-360 Cologne

19 Thank you for your attention