National Blueprint System Slovakia Kick-Off Meeting

Transcription

1 National Blueprint System Slovakia Kick-Off Meeting Bratislava November 22th, 2017 Nov. 22th, 2017 Kick-Off SOOL 1

2 Agenda Arvato Architecture NMVS Web Service Interface Important Business Processes Project Plan high level Nov. 22th, 2017 Kick-Off SOOL 2

3 Bertelsmann at a Glance 17.0 billion Group revenues 2.6 billion Operating EBITDA 1.1 billion Group profit 116,434 Employees Nov. 22th, 2017 Kick-Off SOOL 3

4 Arvato A leading international service provider 3,838m Revenues 359m Operating EBITDA 68,463 Employees Service portfolio CRM solutions SCM solutions 170 million online credit checks performed per year more than 1,1 billion parcels delivered a year Financial services IT services Gütersloh Headquarters 600 million customers serviced in customer loyalty systems Runs more than 70 online shops for numerous international fashion brands Nov. 22th, 2017 Kick-Off SOOL 4

5 Arvato s NMVS Customers Estimating to cover more than 70% of all FMD packs within the EEA by 2019 Agreements and ongoing projects: Nov. 22th, 2017 Kick-Off SOOL 5

6 Agenda Arvato Architecture NMVS Web Service Interface Important Business Processes Project Plan high level Nov. 22th, 2017 Kick-Off SOOL 6

7 We have to master one central challenge But many stakeholders are involved in the establishment of a NMVS a) Organizer NMVO EMVO b) Primary distributors Marketing authorization holders Contract manufacturers Wholesalers Parallel distributors Public pharmacies Hospital pharmacies c) Software providers Solidsoft (EMVS/EU Hub) Arvato (NMVS) Pharmacy/hospital/wholesaler SW providers/it departments b1) Secondary distributors Army Prisons Airlines Nursing homes Drug treatment centers NGOs... d) Authorities Nov. 22th, 2017 Kick-Off SOOL 7

8 Dependencies have significant effects What is the time for a new serialized medicine to make its way from the manufacturer to the patient? Manufacturer MAH Wholesaler Pharmacy Patient How long it takes until new serialized medicines arrive at the pharmacies depend on several things. (In Germany ~140 days) How long will it take in Slovakia? Nov. 22th, 2017 Kick-Off SOOL 8

9 System Architecture Overview Decentralized integration scenario Pharmacy European Hub (EMVS) Product/ pack data upload National Repository (SOOL) Verification dispense,etc. Pharmacy Multi country requests Wholesaler Pharmacy Product/pack data upload Dispense (Web GUI) Wholesaler Pharmacy MAH MAH MAH Par. Distr. Par. (MAH) Distr. Disp. Doctor Disp. Doctor Disp. Doctor Hospital Pharmacy Legend Digital certificate, issued by Arvato Digital certificate, issued by EMVO Par. Distr. (Wholesaler) Hospital Hospital Legend Local pharmacy software installation, bundles communication with all dispense stations Local hospital software installation, bundles communication with all dispense stations Local wholesaler/par. distr. software installation, bundles communication with all local stations for verification etc. Nov. 22th, 2017 Kick-Off SOOL 9

10 Agenda Arvato Architecture NMVS Web Service Interface Important Business Processes Project Plan high level Nov. 22th, 2017 Kick-Off SOOL 10

11 Pack Status Transitions Verify Pack 1) Verify Pack 1) Exported Supplied (Dispensed) Dispense Export Check Out Checked Out Verify Pack 1) Verify Pack Undo Dispense Undo Export Undo Check Out Stolen Mark as Stolen 2) Active Undo Sample Sample Sample Undo Lock Undo Free Sample Destroy 2) Free Sample Legend Destroyed Lock Free Sample Active states Locked Inactive states Terminal inactive states 1) Verify Pack is available in all states 2) Undo destroy/stolen is technically available in Arvato s NMVS but will not be authorized for usage until the URS says so. Nov. 22th, 2017 Kick-Off SOOL 11

12 Status of a Pack (Serial Number) Extract from the EMVO URS: 1) Inactive 1) The expiry data can be extended or shortened by the MAH after the batch data have been submitted. Nov. 22th, 2017 Kick-Off SOOL 12

13 Transaction types Overview (1) Single Pack transactions Submit Single Pack Transaction Single pack transactions, e.g. Verify Single Pack, Dispense Single Pack, Destroy Single Pack Undo Single Pack Transaction Reverse single pack transactions, e.g. Undo Dispense (2) Homogenous Bulk transactions Submit Homogenous Bulk Transactions Bulk transactions are lists of transactions with the same product, batch id and transaction type. They are generated by wholesalers to handle large quantities of packs, e.g. Bulk Verify Packs, Bulk Export Packs. Request Homogenous Bulk Transactions Result Bulk transactions are processed asynchronously. These web services are used to fetch the results of previously submitted bulk transactions. (3) Mixed Bulk transactions Submit Mixed Bulk Transactions ( Offline Recap ) Offline bulk transactions contain transactions with heterogeneous products and transaction types. They are generated by pharmacies when the local transaction buffer is emptied after an offline period. Request Mixed Bulk Transactions Result ( Offline Recap ) Offline bulk transactions are processed asynchronously. These web services are used to fetch the results of previously submitted offline bulk transactions. Nov. 22th, 2017 Kick-Off SOOL 13

14 Agenda Arvato Architecture NMVS Web Service Interface Important Business Processes Project Plan high level Nov. 22th, 2017 Kick-Off SOOL 14

15 EU Hub Product Data Model Extract from EMVO User Requirement Specification (URS) : Only GTIN and PPN formats are possible A part of the product master data is to be provided per market Product master data (especially market specific data) may change over time. Nov. 22th, 2017 Kick-Off SOOL 15

16 Product Master Data & Market Data Distribution - Example Example: Multi-market product is available in FI, SE, and NO OBP 4) Product Master Data (Multi Market Product FI/SE/NO) European Hub (EMVO) Product Master Data 3) NMVS FI OBP uploads Product Master Data (product data common to all markets) Product per Market Data FI 1) 4) 4) MAH FI MAH SE MAH FI uploads Product per Market Data FI 1,2) to OBP system MAH SE uploads Product per Market Data SE 1,2) to OBP system OBP System With each change, the OBP system sends Product Master Data and Product per Market Data as a joint data set (all data need to be present before that) Product per Market Data SE 1) Product per Market Data NO 1) NMVS SE NMVS NO 4) MAH NO MAH NO uploads Product per Market Data NO 1,2) to OBP system EU Hub sends Product Master Data and Product per Market Data as a joint data set 1) Product per Market Data must contain the MAH Name of the corresponding MAH. 2) An OBP uploads Product per Market Data on behalf of the MAHs. 3) The EU Hub does not send the OBP ID to the National Systems. 4) An OBP (Onboarding Partner, e.g. Roche, Bayer) grants marketing rights for its own medicaments (patents, brand names) to local MAHs (Marketing Authorization Holders). See also What is an OBP? What is an MAH? Nov. 22th, 2017 Kick-Off SOOL 16

17 Batch and Pack Data Distribution Multi-Market Product Example: Multi-market product with GTIN = is available in FR and BE OBP European Hub (EMVO) Batch FRQXF NMVS FR Batch BET9K MAH FR 1) MAH BE 1) Batch and pack data (Batch ID FRXQF ) for product uploaded by French MAH via OBP system OBP System The EU Hub sends each batch of multimarket product to FR and BE, i.e. each market where it is available Batch FRQXF Batch BET9K NMVS BE Batch and pack data (Batch ID BET9K ) for product uploaded by Belgian MAH via OBP system 1) Both MAHs have marketing authorizations for the same product, but on different markets Nov. 22th, 2017 Kick-Off SOOL 17

18 What happens when a Multi-Market Pack is dispensed? Example: (2) Norwegian NMVS informs EU Hub about dispense of the multimarket pack European Hub (EMVO) Dispense pack XYZ/1234 National Repository Database entries:... XYZ = Multi market product... XYZ/1234 => Supplied (1) Norwegian NMVS sets pack status to supplied and detects that XYZ is a multi-market product. Dispense pack XYZ/1234 (3) EU Hub looks up in which other countries the multi-market pack would be dispenseable Database entries:... XYZ = Multi market product... XYZ dispenseable in Norway, Sweden, Finland... Dispense pack XYZ/1234 Dispense pack XYZ/1234 (4) EU Hub informs NMVS s in Finland and Sweden about the dispense of the multi-market pack somewhere else National Repository Database entries:... XYZ = Multi market product... XYZ/1234 => Supplied National Repository Database entries:... XYZ = Multi market product... XYZ/1234 => Supplied Dispense Product XYZ Serial Nr 1234 (0) Product XYZ is available in Norway, Finland, Sweden (5) Finnish and Swedish NMVS s set pack status to supplied. Nov. 22th, 2017 Kick-Off SOOL 18

19 What is an Inter-Market Transaction? Example: (3) EU Hub looks up in which other countries the product ABC is known (2) Norwegian NMVS reports dispense to EU Hub to check if product/pack is known elsewhere European Hub (EMVO) Database entries:... Product ABC dispenseable in Germany... Dispense pack ABC/5678 Report back ABC/5678 (4) EU Hub forwards dispense information to German NMVS Dispense pack ABC/5678 Report back ABC/5678 National Repository Database entries:... Product ABC unknown... (6) EU Hub reports back that pack was found in another NMVS National Repository Database entries:... ABC/5678 is dispenseable ABC/5678 => Supplied... (1) Norwegian NMVS cannot find product ABC in its database Dispense pack ABC/5678 (7) NMVS reports back that an Inter- Market Transaction was executed Dispense Product ABC Serial Nr 5678 (0) Pack ABC/5678 has been imported from Germany to cover a drug shortage. (5) German NMVS reports back that pack was found and that its status has been set to Supplied Nov. 22th, 2017 Kick-Off SOOL 19

20 Agenda Arvato Architecture NMVS Web Service Interface Important Business Processes Project Plan high level Nov. 22th, 2017 Kick-Off SOOL 20

21 Time Planning, High Level Perspective There are roughly 15 months left until medicine verification becomes mandatory in Europe This is our plan to complete the project within the available time frame from Slovakia: Nov. 1st, 2017 Feb 9, 2019 Phase 1 Initialization Preparation Phase 2 Ramp-up A Start onboarding of MAHs Phase 3 Ramp-up B Start onboarding of pharmacies/wholesalers and hospitals Phase 4 Ramp-up C Onboarding of remaining pharmacies/wholesalers and hospitals Phase 5 Production Onboarding of last minute stakeholders, official production start What are the results of each phase? Let s go through the five phases shown. Nov. 22th, 2017 Kick-Off SOOL 21

22 Planning, Detail View Phase 2: Ramp-up A (Mar 2018 Apr 2018) Phase 1 Initialization Preparation Phase 2 Ramp-up A Start onboarding of MAHs Phase 3 Ramp-up B Start onboarding of pharmacies/wholesalers and hospitals Phase 4 Ramp-up C Onboarding of remaining pharmacies/wholesalers and hospitals During phase 2, the highlighted information flows will be observed: Phase 5 Production Feb 9, 2019 MAH Data upload (products, packs) EU Hub (EMVS) Data upload (products, packs) National Blueprint System (SOOL) Parallel Distributor Nov. 22th, 2017 Kick-Off SOOL 22

23 Planning, Detail View Phase 3: Ramp-up B (Apr 2018 May 2018) Phase 1 Initialization Preparation Phase 2 Ramp-up A Start onboarding of MAHs Phase 3 Ramp-up B Start onboarding of pharmacies/wholesalers and hospitals Phase 4 Ramp-up C Onboarding of remaining pharmacies/wholesalers and hospitals Phase 5 Production Feb 9, 2019 During Phase 3, additional data flows will be included: MAH Data upload (products, packs) European Hub (EMVS) Data upload (products, packs) National Blueprint System (SOOL) Parallel Distributor Requests and pack status changes for multi-market products Requests and pack status changes Wholesaler Pharmacy Officine, hôpital Wholesaler software Web app Pharmacy software Web app Verification, dispense early birds Nov. 22th, 2017 Kick-Off SOOL 23

24 Planning, Detail View Phase 4: Ramp-up C (Jun 2018 Oct 2018) Phase 1 Initialization Preparation Phase 2 Ramp-up A Start onboarding of MAHs Phase 3 Ramp-up B Start onboarding of pharmacies/wholesalers and hospitals Phase 4 Ramp-up C Onboarding of remaining pharmacies/wholesalers and hospitals Phase 5 Production Feb 9, 2019 During Phase 4, the functionality of the various pharmacy and wholesaler software systems will be included: MAH Data upload (products, packs) European Hub (EMVS) Data upload (products, packs) National Blueprint System (SOOL) Parallel Distributor Requests and pack status changes for multi-market products Requests and pack status changes Wholesaler Wholesaler Pharmacy Officine, hôpital Pharmacy Wholesaler software Web app Pharmacy software Web app Verification, dispense Nov. 22th, 2017 Kick-Off SOOL 24

25 Planning, Detail View Phase 5: Production (Nov 2018 Feb 2019) Phase 2 Ramp-up A Start onboarding of MAHs Phase 3 Ramp-up B Start onboarding of pharmacies/wholesalers and hospitals Phase 4 Ramp-up C Onboarding of remaining pharmacies/wholesalers and hospitals Phase 5 Production Phase 1 Initialization Preparation Feb 9, 2019 Results until Feb 9, 2019: New functionalities The new developed pharmacy/wholesaler software systems have been installed at all pharmacies and wholesalers Utilization The verification of Medicines has become a routine at the pharmacies and wholesalers. Almost all medicament packs on the Slovakian market are now serialized. Nov. 22th, 2017 Kick-Off SOOL 25

26 Arvato Systems Heike Rikus Managerin Publishing Solutions Nikolaus Gouders Project Manager Phone: +49 (0) 5241/ Phone: +49 (0) 5241/ Nov. 22th, 2017 Kick-Off SOOL 26

27 Backup Nov. 22th, 2017 Kick-Off SOOL 27

28 Process Illustration Repackaging by Parallel Distributor Wholesaler MAH (1) Finnish MAH uploads package data for product A to EU-Hub (2) EU-Hub uploads package data for product A to Finnish NMVS National Repository (NMVS) (3) Finnish Wholesaler sells some packages of product A to Swedish Parallel Distributor (4) Parallel Distributor repackages A-packs into product B-packs with new serial numbers. 1) Par. Distr. European Hub (8) EU Hub sends status updates for repacked A-packs ( checked out ), i.e. serial numbers, to Finnish NMVS National Repository (NMVS) (5) Parallel Distributor uploads A-package data ( checked out ) and B- package data with new batch-id(s) and serial numbers incl. reference to original A-batches to EU Hub (7) EU Hub sends B- package data with new serial numbers to NMVS Sweden (6) EU Hub saves relationship between A-batches and B-batches in case a later recall of an A-batch should occur. 1) Important remarks: a) Both A-packs and B-packs may belong to several different batches but a 1:n relationship between A-batches and B-batches needs to be maintained. b) It is possible that only a part of an A-batch is sold to the Parallel Distributor, so other parts may remain in the original country, e.g. Finland. c) A cascading process is possible, i.e. the Parallel Distributor in Sweden might resell some packs of product B to a Parallel Distributor in Norway that repacks them into product C. Nov. 22th, 2017 Kick-Off SOOL 28

29 Process Illustration Recall of medicament supplied by Parallel Distributor (see also previous slide) (1) Some batches of product A of which parts were previously sold from a wholesaler in Finland to a Parallel Distributor in Sweden (that repacked them to product B) are called back by MAH MAH (2) For some batch(es) of product A, send status update to recalled to EU Hub (7) Inform MAH about markets potentially affected by the recall (Sweden in this case) (4) Look up which batches of product B were generated from recalled batches of product A (3) Update batches of product A to status recalled 1) National Repository (NMVS) (5) Parallel distributor decides that B-batches shall (or shall not) be recalled Par. Distr. (5) Inform Parallel Distributor about recall of product A (6) For B-batches, send status update to recalled to EU Hub European Hub (EMVO) (7) Update B-batches to status recalled 1) National Repository (NMVS) 1) Remarks: a) As the recalled A-batches may have been sold only partially from Finland to Sweden while other parts may have remained in Finland, the Finnish NMVS needs to be informed about their recall as well. b) Product B might as well be a multi-market product, so other countries beyond Sweden would be affected by step 4. Dito for product A and step 5. Nov. 22th, 2017 Kick-Off SOOL 29

30 Repacking Scenario (1) Wholesaler Par. Distr. sold to repacked to Product B, Batch ZZE Product A, Batch XQF Product B, Batch VUY Product A, Batch MGP sold to repacked to Product B, Batch T9K OK Nov. 22th, 2017 Kick-Off SOOL 30

31 Repacking Scenario (2) Wholesaler Par. Distr. sold to Product A, Batch XQF repacked to Product B, Batch T9K sold to Product A, Batch MGP Packs from different source batches must not be repacked into the same destination batch. Otherwise, a recall of one source batch (e.g. A-XQF) could indirectly affect another source batch that was not recalled (e.g. A-MGP). Nov. 22th, 2017 Kick-Off SOOL 31