Association of the Pharmacists of Belgium Dr. Guido Hoogewijs

1. Association of the Pharmacists of Belgium Dr. Guido Hoogewijs • Patient Protection in Belgian Pharmacies Using Online Authentication

2. Association Pharmaceutique Belge • National federation of professional associations of independentcommunity pharmacies • Representing >90% of independent pharmacies and >80% of all public pharmacies • Role: support, develop and promote the communitypharmacist ‘s added value to the benefit of his patient’s health

6. Belgian pharmacies have an anti-counterfeiting system in operation Our rationale for implementing an online authentication system in October 2006 : 1. PATIENT SAFETY IS PARAMOUNT 2. OUR INTEGRITY AS HEALTHCARE PROVIDER IS AT STAKE 3. COUNTERFEITING MEDICINES IS ON THE RISE 4. EUROPE AND BELGIUM ARE NOT IMMUNE 5. MANUFACTURERS’ INITIATIVES LACKING OR UNSUITABLE 6. HEALTHCARE AUTHORITIES ARE LATE AND SLOW 7. TIME FOR ACTION !!!

7. PresentationOutline Belgian community pharmacies have an anti- counterfeiting system in operation • What and how ? • What’s the fit withEuropeanLegislation Plans? • What’s the fit with Pharma Industry Plans? • What’s the fit withotherStakeholder Plans?

8. PresentationOutline Belgiancommunity pharmacies have an anti- counterfeiting system in operation • What and how ? • What’s the fit withEuropeanLegislation Plans? • What’s the fit with Pharma Industry Plans? • What’s the fit withotherStakeholder Plans?

9. Belgium : a unique country 1885 • The Pharmaceutical Practice Law introduces the principle of « NO FAULT responsibility » • The pharmacist has the final responsibility for everyproduct (s)hedelivers

10. Belgium : a unique country • 1885The Pharmaceutical Practice Law introduces the principle of « NO FAULT responsibility » • 1952 • Start-up by APB of the Medicines Control Laboratory (MCL – DGO – SCM) • To combat post-warfraud of penicillin-containingpharmaceuticals

11. Medicines Control Lab • The MCL has become instrumental in guaranteeing the quality of all medicinesdelivered in Belgian pharmacies • Unique model of auto-control • Financed by all pharmacies through 0.015 € per pack • Staff : +/-60 (pharmacists & labtechnicians)

12. Independent quality control lab, operated by APB in conjunctionwith the National Drug RegulatoryAgency Operatescentralisedrecallprocedureon behalf of MCL, DRA or the manufacturer 2011: 134 batches(of 45products) recalled Medicines Control Lab

13. Belgium : a unique country • 1885The Pharmaceutical Practice Law introduces the principle of « NO FAULT responsibility » • 1952Start-up by APB of the Medicines Control Laboratory (MCL – DGO – SCM) to combat post-warfraud of penicillin-containingpharmaceuticals 2004 • HealthcareAuthoritiesintroduce Unique Barcode per package • Mass serialisation of reimbursedpharmaceuticals to combat healthcareinsurancefraud

14. Unique Barcodepermits to identifyeach single pack

15. Unique Barcode • 16 digits (7=CNK national code + 8 serial + 1 control) • CNK identifies product, dosage & pack size (determined by APB/IMS) • serial : determined by manufacturer • Allows National Sickfunds Organisation to check : • pack wasreallydispensedbeforereimbursing • pack wasdispensedonly once • UBC introduced to combat reimbursementfraud • UBC = basis for mass serialisation

16. Belgium : a unique country • 1885The Pharmaceutical Practice Law introduces the principle of « NO FAULT responsibility » • 1952Start-up by APB of the Medicines Control Laboratory (MCL – DGO – SCM) to combat post-warfraud of penicillin-containingpharmaceuticals • 2004Mass serialisation of reimbursedpharmaceuticals to combat healthcareinsurancefraud 2006 • APB and Aegatestart collaboration • Use existing mass serialisation to combat counterfeiting of medicines • Prepare first launchworldwide of an authentication system

17. Authentication in the pharmacy :how doesitwork ? Pharmaceutical products Unique Barcodes Batch numbers Expiry dates Validated & dispensed Product dictionary Not validated & withdrawn Recalls

18. Authentication in the pharmacy :in real time Authenticated authenticated pharmaceuticals Real time productvalidation Mass serialised codes

19. Authentication in the pharmacy: rapidalerts

20. Authentication in the pharmacy :pharmaceutical care information

21. Authentication in the Pharmacy: practical patient use information

22. Authentication in the pharmacy: practical patient use information

23. Authentication in the pharmacy: practical patient use information

24. Authentication in the pharmacy :practical information

25. Fromauthentication to info tool • Originally : • Authentication system • Internet based • At point of dispensing • To combat counterfeiting • Additionally: • Uploadingexpiry dates • Recall info (rapidalert) • Product- & therapy- related messages benefiting patient counselling • Value addingtool for pharmacy • Not: • Data collection system ( only serial N° + pharmacycaptured)

26. (Potential) Issues • Buy-in and co-operationfrompharmacy software providers • Is Big Brother watchingagain ? • Absoluteneed for strict and explicit pharmacy data protection • Unique Barcode – based system (presently) limitsauthentication check to reimbursedproductsonly • Wait and seeapproach (manufacturers and pharmacists)

27. Aegate enabled pharmacies October 2011

28. (Potential) Issues • Buy-in and co-operationfrompharmacy software providers • Is Big Brother watchingagain ? • Absoluteneed for strict and explicit pharmacy data protection • Unique Barcode – based system (presently) limitsauthentication check to reimbursedproductsonly • Wait and seeapproach (manufacturers and pharmacists)

29. Simplebuteffectivetools Packs with UniqueBarcode Prescription with Doctors’ unique bar-coded ID-number Social Identity Card (chip card with patients’ certified identity data)

30. (Potential) Issues • Buy-in and co-operationfrompharmacy software providers • Is Big Brother watchingagain ? • Absoluteneed for strict and explicit pharmacy data protection • Unique Barcode – based system (presently) limitsauthentication check to reimbursedproductsonly • Wait and seeapproach (manufacturers and pharmacists)

31. August 2012 report • Response time : 0.206 sec • N° productsthatcanbeauthenticated : 1228 • N° UBC in database : 113.56 mio • N° recalledproductscurrently live : 58 • N° product messages added : 1124 • N° pharmacies scanning : 2627 • N° items authenticated : 1246174 • Notification expired : 2051 • Notification soon to expire : 5123 • Notification has been recalled : 2731 • Alreadydispensedelsewhere : 794 (5 suspicious)

32. “The June 2009 case”

33. Duplicate Scan Events 2011

34. Summary points • Last check at time of dispensation providesultimate patient safety • Effective, simple, user-friendly and flexible system • Based on existingpharmacy practice and tools • No interferencewithworkflow (time !) • Acceptable infrastructure needs • Authentication + expiry date + recall check + product messages, but NO data collection • Helpsprotecting patients (but pharmacists, wholesalers and manufacturers as well) • Operational in daily practice in 2500+ pharmacies • Reliability and relevance isfunction of rapid and full roll-out (manufacturers, software providers, pharmacists)

35. PresentationOutline Belgiancommunity pharmacies have an anti- counterfeiting system in operation • What and how ? • What’s the fit withEuropeanLegislation Plans? • What’s the fit with Pharma Industry Plans? • What’s the fit withotherStakeholder Plans?

36. EU Directive on Falsified Medicines

37. EU Directive on Falsified Medicines • Mandatory harmonized pan-European safety features • unique pack serialisation number • with tamper evident packaging • Applied to all prescription medicines (subject to possible exclusions based on risk assessment) • The Commission will define the mechanisms of how this system will work in Delegated Acts that are expected to be adopted within the next 18-24 months • the characteristics and technical specifications of the unique serial number • the establishment, management and accessibility of national or regional product databases that allow verification of each dispensed pack • interoperability between regional systems.

38. Harmonisation of the data carrier • 1D, 2D or RFID France Germany Spain? Turkey Italy Greece Belgium

39. Harmonisation of the number sequence The numbering sequence within the serialisation code is important 23/27 member states have national product codes for reimbursement purposes Necessity for collaboration with GS1 to create a harmonised approach

40. PresentationOutline Belgiancommunity pharmacies have an anti- counterfeiting system in operation • What and how ? • What’s the fit withEuropeanLegislation Plans? • What’s the fit with Pharma Industry Plans? • What’s the fit withotherStakeholder Plans?

41. Need for harmonisation ! • The data carrier • The numbering sequence within the serialisation code • The database or databases that authenticate the serialisation codes

42. EFPIA Database Model EU Central Hub Manufacturer Re-packer Greenfield countries system National System1/ Regional Pharmacy National System n/Regional Pharmacy Pharmacy: mandatory verification transaction Wholesaler: voluntary verification transaction Manufacturer; data upload + voluntary verification transaction Periodic cross-region update Re-packer: mandatory verification transaction + data upload Wholesaler Wholesaler Wholesaler Pharmacy

43. EFPIA Database Model = ESM EU Central Hub Manufacturer Re-packer Greenfield countries system National System1/ Regional Pharmacy National System n/Regional Pharmacy Pharmacy: mandatory verification transaction Wholesaler: voluntary verification transaction Manufacturer; data upload + voluntary verification transaction Periodic cross-region update Re-packer: mandatory verification transaction + data upload Wholesaler Wholesaler Wholesaler Pharmacy

44. EAEPC + EFPIA + GIRP + PGEU Are collaborating on the development of • a cost effective • scalable system • run by a stakeholders statutory organization on a non-profit basis • such that it justifies the costs of establishing such a system • 10 core principles agreement • MoU

45. Possible implications for the Belgian System • Operational Belgian system iscompliantwith EU-legislation • Whatwe have to (consider to) change: • Migratefrom 1D to 2D • Migratefrom UBC to GS1 DataMatrix (harmonisation & multipurpose) • Safetyfeature on all Rxmedicines • Whatwewant to preserve: • Transactional data are the property of the pharmacy • Ensure optimal use of extremelyvaluable communication tool (auxiliaryadvantages for patient safety) • Authentication in the pharmacyjustprior to dispensation thatprovides optimal patient safety

46. PresentationOutline Belgiancommunity pharmacies have an anti- counterfeiting system in operation • What and how ? • What’s the fit withEuropeanLegislation Plans? • What’s the fit with Pharma Industry Plans? • What’s the fit withotherStakeholder Plans?

47. eTACT : EDQM traceability project EDQM data repository Manufacturer Distribution Pharmacies Internet / Mail order pharmacies Patients Generate unique identity Tracing and Verification of unique identity Verification of unique identity “EDQM as an intergovernmental organisation guaranteeing sustainable confidentiality of data” Phase 1: Concept development Dec 09-March 2010 Phase 2: System development Live demo Apr 2010 – 2012 Phase 3: Service development From 2012

48. EDQM statements • “a “Track and Trace” system for medicines project” • Cost estimation: €10 billion investment + €500 million operational costs • Estimates for end to end authentication range from €200m to €500m • Multiple day delivery would be impossible if every pack has to be verified in the supply chain and distribution costs would become unacceptable • “a Single European Database” • Leads to a single point of failure • EAEPC + EFPIA + PGEU + GIRP : 10 principles agreement for stakeholder led national or regional systems

49. EDQM statements * "Patients should be included in the process, otherwise it will not be effective in protecting them against potentially counterfeit products purchased in the illegal supply chain" • Patients should be discouraged to purchase medicines in the illegal supply chain • Patients should be encouraged to use the legal and professional supply chain, where on top of genuine products they can expect the pharmacist to counsel them * “EDQM has demonstrated its ability to act as a guardian of commercially-sensitive information . EDQM's work on certification over the last 15 years proves that we can hold highly-sensitive data in a secure way” • Transaction data are the property of the pharmacies that generate them

50. Recommendations • Authentication in the pharmacyjustprior to dispensation ultimatelyprovides patient safety • Full track & trace (e-pedigree) is of no value to patient & pharmacist • Authentication system shouldbe open to all medicines, all pharmacies and all wholesalers. Not to patients! • Over-sophistication is a burden to • utilisation by the end-user • costs (drugbill !) • Dispensing data are the property of the pharmacy • Ensure optimal use of extremelyvaluable communication tool/moment • Keep Belgian system in operation (compliantwithupcoming EU-legislation and EAEPC + EFPIA + GIRP + PGEU initiative) • Migratefrom UBC to GS1 DataMatrix (harmonisation & multipurpose)