1. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar © APB 2012 Association of the Pharmacists of Belgium Dr. Guido Hoogewijs Patient Protection in Belgian Pharmacies Using Online Authentication

2. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Association Pharmaceutique Belge National federation of professional associations of independent community pharmacies Representing >90% of independent pharmacies and >80% of all public pharmacies Role: support, develop and promote the community pharmacist s added value to the benefit of his patients health

3. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar

4. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar

5. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar

6. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar 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. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Presentation Outline Belgian community pharmacies have an anti- counterfeiting system in operation What and how ? Whats the fit with European Legislation Plans? Whats the fit with Pharma Industry Plans? Whats the fit with other Stakeholder Plans?

8. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Presentation Outline Belgian community pharmacies have an anti- counterfeiting system in operation What and how ? Whats the fit with European Legislation Plans? Whats the fit with Pharma Industry Plans? Whats the fit with other Stakeholder Plans?

9. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Belgium : a unique country 1885 The Pharmaceutical Practice Law introduces the principle of « NO FAULT responsibility » The pharmacist has the final responsibility for every product (s)he delivers

10. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Belgium : a unique country 1885 The 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-war fraud of penicillin- containing pharmaceuticals

11. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Medicines Control Lab The MCL has become instrumental in guaranteeing the quality of all medicines delivered in Belgian pharmacies Unique model of auto-control Financed by all pharmacies through 0.015 per pack Staff : +/-60 (pharmacists & lab technicians)

12. © APB 2012 Independent quality control lab, operated by APB in conjunction with the National Drug Regulatory Agency Operates centralised recall procedure on behalf of MCL, DRA or the manufacturer 2011: 134 batches (of 45 products) recalled Medicines Control Lab

13. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar 1885 The 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-war fraud of penicillin-containing pharmaceuticals 2004 Healthcare Authorities introduce Unique Barcode per package Mass serialisation of reimbursed pharmaceuticals to combat healthcare insurance fraud Belgium : a unique country

14. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Unique Barcode permits to identify each single pack

15. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar 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 was really dispensed before reimbursing –pack was dispensed only once UBC introduced to combat reimbursement fraud UBC = basis for mass serialisation

16. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar 1885 The 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-war fraud of penicillin-containing pharmaceuticals 2004 Mass serialisation of reimbursed pharmaceuticals to combat healthcare insurance fraud 2006 APB and Aegate start collaboration Use existing mass serialisation to combat counterfeiting of medicines Prepare first launch worldwide of an authentication system Belgium : a unique country

17. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Authentication in the pharmacy : how does it work ? Pharmaceutical products Unique Barcodes Batch numbers Expiry dates Validated & dispensed Not validated & withdrawn Product dictionary Recalls

18. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar pharmaceuticals authenticated Real time product validation Mass serialised codes Authenticated Authentication in the pharmacy : in real time

19. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Authentication in the pharmacy: rapid alerts

20. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Authentication in the pharmacy : pharmaceutical care information

21. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Authentication in the Pharmacy: practical patient use information

22. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Authentication in the pharmacy: practical patient use information

23. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Authentication in the pharmacy: practical patient use information

24. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Authentication in the pharmacy : practical information

25. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar From authentication to info tool Originally : –Authentication system –Internet based –At point of dispensing –To combat counterfeiting Additionally: –Uploading expiry dates –Recall info (rapid alert) –Product- & therapy- related messages benefiting patient counselling –Value adding tool for pharmacy Not: –Data collection system ( only serial N° + pharmacy captured)

26. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar (Potential) Issues Buy-in and co-operation from pharmacy software providers Is Big Brother watching again ? Absolute need for strict and explicit pharmacy data protection Unique Barcode – based system (presently) limits authentication check to reimbursed products only Wait and see approach (manufacturers and pharmacists)

27. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Aegate enabled pharmacies October 2011

28. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar (Potential) Issues Buy-in and co-operation from pharmacy software providers Is Big Brother watching again ? Absolute need for strict and explicit pharmacy data protection Unique Barcode – based system (presently) limits authentication check to reimbursed products only Wait and see approach (manufacturers and pharmacists)

29. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Simple but effective tools

30. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar (Potential) Issues Buy-in and co-operation from pharmacy software providers Is Big Brother watching again ? Absolute need for strict and explicit pharmacy data protection Unique Barcode – based system (presently) limits authentication check to reimbursed products only Wait and see approach (manufacturers and pharmacists)

31. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar August 2012 report Response time : 0.206 sec N° products that can be authenticated : 1228 N° UBC in database : 113.56 mio N° recalled products currently 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 Already dispensed elsewhere : 794 (5 suspicious)

32. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar The June 2009 case

33. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Duplicate Scan Events 2011 ProductDate first alert raised Duplicate UBC Scans Issue identified ImpactStatus Antibiotic23/03/201110Labelling error Quality control procedures improved Closed Hormone replacement 14/03/20116Labelling error Quality control procedures improved Closed Anti- hypertensive 13/05/2011286Entire Batch Labelled with same UBC Pharmacists can not get reimbursed by national sick fund Batch Recall (16/05/2011) Closed

34. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Summary points Last check at time of dispensation provides ultimate patient safety Effective, simple, user-friendly and flexible system Based on existing pharmacy practice and tools No interference with workflow (time !) Acceptable infrastructure needs Authentication + expiry date + recall check + product messages, but NO data collection Helps protecting patients (but pharmacists, wholesalers and manufacturers as well) Operational in daily practice in 2500+ pharmacies Reliability and relevance is function of rapid and full roll-out (manufacturers, software providers, pharmacists)

35. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Belgian community pharmacies have an anti- counterfeiting system in operation What and how ? Whats the fit with European Legislation Plans? Whats the fit with Pharma Industry Plans? Whats the fit with other Stakeholder Plans? Presentation Outline

36. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar EU Directive on Falsified Medicines Tamper evidence and unique identification Authenticity to be verified by persons supplying medicines to the public All prescription medicines included, unless case for exemption Repackers must replace with equivalent safety features Safety Features National and EU list of approved on-line pharmacies EU logo to be used by approved pharmacies Public awareness campaigns Internet Mandatory registration of API producers in non EU countries Brokering of medicines a recognised within the legislation and subject to regulation New rules for medicines entering the EU solely for export Regulatory Criminal penalties to be enforced for infringements of the directive Penalties

37. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar 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. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Harmonisation of the data carrier 1D, 2D or RFID1D, 2D or RFID Spain? Italy France Belgium Turkey Greece Germany

39. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar 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. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Belgian community pharmacies have an anti- counterfeiting system in operation What and how ? Whats the fit with European Legislation Plans? Whats the fit with Pharma Industry Plans? Whats the fit with other Stakeholder Plans? Presentation Outline

41. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Need for harmonisation ! 1.The data carrier 2.The numbering sequence within the serialisation code 3.The database or databases that authenticate the serialisation codes

42. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar EFPIA Database Model EU Central Hub Greenfield countries system Re-packer Manufacturer 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 National System1/ Regional National System n/Regional

43. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar EFPIA Database Model = ESM EU Central Hub Greenfield countries system Re-packer Manufacturer 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 National System1/ Regional National System n/Regional

44. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar 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. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Possible implications for the Belgian System Operational Belgian system is compliant with EU-legislation What we have to (consider to) change: –Migrate from 1D to 2D –Migrate from UBC to GS1 DataMatrix (harmonisation & multipurpose) –Safety feature on all Rx medicines What we want to preserve: –Transactional data are the property of the pharmacy – Ensure optimal use of extremely valuable communication tool (auxiliary advantages for patient safety) –Authentication in the pharmacy just prior to dispensation that provides optimal patient safety

46. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Belgian community pharmacies have an anti- counterfeiting system in operation What and how ? Whats the fit with European Legislation Plans? Whats the fit with Pharma Industry Plans? Whats the fit with other Stakeholder Plans? Presentation Outline

47. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar eTACT : EDQM traceability project Manufacturer Distribution Pharmacies Internet / Mail order pharmacies Patients Generate unique identity Verification of unique identity Tracing and Verification of unique identity EDQM as an intergovernmental organisation guaranteeing sustainable confidentiality of data EDQM data repository Phase 1: Concept development Dec 09-March 2010 Phase 2: System development Live demo Apr 2010 – 2012 Phase 3: Service development From 2012

48. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar 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. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar 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. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Recommendations Authentication in the pharmacy just prior to dispensation ultimately provides patient safety Full track & trace (e-pedigree) is of no value to patient & pharmacist Authentication system should be 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 extremely valuable communication tool/moment Keep Belgian system in operation (compliant with upcoming EU- legislation and EAEPC + EFPIA + GIRP + PGEU initiative) Migrate from UBC to GS1 DataMatrix (harmonisation & multipurpose)

51. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar NOT

52. © APB 2012 GH – 16 th October 2012, Birmingham Annual Seminar Thank you ! guido.hoogewijs@apb.be Guido Hoogewijs General Manager APB Archimedesstraat 11 1000 Brussels Belgium Telephone: +32 2 285 42 18 Mobile: +32 478 49 08 84 guido.hoogewijs@apb.be www.apb.be