The German securpharm Initiative. Christian Riediger, Bayer Pharma AG

Transcription

1 The German securpharm Initiative Christian Riediger, Bayer Pharma AG

2 securpharm - Stakeholders Page 2 The German securpharm Initiative

3 securpharm - Goals EU Directive tamper evident closure technical feasibility study processes feasibility study two ways of coding errors start of rollout real counterfeits Page 3 The German securpharm Initiative

4 The occasion: EU-directive 2011/62/EU + 3 years delegated acts = years to fulfill the obligations = 2017 Page 4 The German securpharm Initiative

5 Objective of the EU-directive Main objective Increase protection of patients against counterfeited drugs Approach Making counterfeits unprofitable Additional benefits Precise callbacks Optimized goods management with machine-readable product data Optional: Reimbursement Product number Batch number Expiry date Serial number Page 5 The German securpharm Initiative

6 securpharm - Concept Data Matrix Code Split Database End-to-endverification Stakeholder Governance Page 6 The German securpharm Initiative

7 Data Ownership Analysis Advisory board controlling executive Manufacturer System Pharmacy System European HUB Wholesaler (pilot phase) Page 7 The German securpharm Initiative

8 securpharm - End-to-end-principle Manufactuer Wholesaler Pharmacy / Hospital Patient with recipe shipment shipment Sale PPN / NTIN Storing the serial numbers of each pack with DataMatrix-Code Optional: Verification of single packs Verification of each pack No Sale, Investigation! Manufacturer`s database 1. Request 2. Response 3.Disposal Pharmacy database Page 8 The German securpharm Initiative

9 Coding with Data Matrix Code Today In plain text Machinereadable Future In plain text Machinereadable PZN-7 PZN-8 Ser.Nr. Batch Batch Expirydate Expirydate Page 9 The German securpharm Initiative

10 Timeline Apr-11 Decision for stakeholder model in Germany July-11 EU directive Nov-11 Memorandum of Understanding Mar-12 Foundation of securpharm Apr 12 Dec 11 System concept Kick-off pharmacy system Aug-12 Kick-off manufacturer system Jan-13 Start field test Apr-13 Further development Apr-11 Dec-11 System Design Phase Jan-12 Dec-12 Implementation / Test Jan-13 Field test / Rollout The field test is the start of the rollout! Page 10 The German securpharm Initiative

11 Status March manufacturers are participating with 86 products (different PZNs) more than 3 million packs already serialized no directed distribution every wholesaler supplies coded products wholesaler checks code (optional) approx. 200 pharmacies are currently registered with 8 software products full integration into day-today business Manufacturer Wholesaler Pharmacies Page 11 The German securpharm Initiative

12 Status March 2013 Stakeholder system is up and running since Datamatrix Code is the appropriate data carrier approx successfull verification scans average system response time securpharm system: 100 ms system availability: 99,9 % (some downtimes due to updates) registered pharmacies (source: Google) Page 12 Introduction into securpharm-projects

13 securpharm Partner - Status Q1/2013 Page 13 Introduction into securpharm-projects

14 Page 14 The German securpharm Initiative Thank you!

15 Forward-Looking Statements This presentation may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer s public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Page 15 The German securpharm Initiative