Global Serialisation Developments and the Need for Convergence. Ulrike Kreysa, Vice-President, GS1 Global Office 3 rd June 2015

Transcription

1 Global Developments and the Need for Convergence Ulrike Kreysa, Vice-President, GS1 Global Office 3 rd June 2015

2 Developments across the world Regulatory bodies need to address Public Health issues one important being counterfeiting of drugs Ensuring supply chain security and visibility can help to address this, but deviations from a global harmonised approach make implementation costly and complex 2

3 Pharma World (including Europe) coding & serialisation requirements Cyprus 2010 Product Code USA 2010 FDA SNI guidance Denmark 2011 Product Code Canada 2012 Vx Batch Variable Argentina st product group France 2011 Batch Variable China 2012 Phase I Argentina nd product group India Jan for export - 2 nd level Korea 2013 Batch Variable Ethical drugs Argentina rd product group Korea Oct,2014 plan Kenya 2014 KEMSA Barcoding India 2015 for export Mono-carton Korea 2015 Phase 1 India 2015 Saudi Arabia 2015 Data DataMatrix reporting Philippines 2015 GTIN Argentina 2 March 2015 China 2015 Phase III (all products) Italy 2015 New Bollino Saudi Arabia 2017 Brazil 2016 ANVISA Track & Trace regulation (all pharmaceuticals) Jordan 2017 Europe 2018 Implementation FMD Turkey 2010 Track & Trace Serbia 2010 Traceability regulation Europe 2011 European Legislation India 2011 for export 3rd level Colombia: traceability req, discussed Libya: serialisation, timeline tbd South Africa: traceability, timeline tbd UAE: traceability, timeline tbd India 2012 Identification for tender requirements Korea 2012 Batch Variable Specified drugs Nigeria 2013 MAS all anti-malarial / MAS all antibiotics Japan 2012 Revised MHLW Barcode Guidelines Chile 2013 Identificatio n & traceability China 2013 Phase II England/N HS 2014 GTIN, GLN and product data Denmark 2014 AMGROS: DataMatrix or bar code Singapore 2014 Barcoding on injectable Iran 2015 Scratch labels Japan 2015 Barcoding primary level USA 2015 DSCSA - Product Tracing Requirements Brazil 2015 Track & Trace Ukraine 2016 (manf. & wholesal.) Taiwan 2015/2016 Draft Regulation Barcode req. - Mexico 2014 (3 batches) Phase 2 Draft Regulation (end) Europe Q on traceability Delegated acts Argentina Argentina 30 April August 2015 Argentina 30 June 2015 Ukraine 2017 (retailers) USA 2017 DSCSA - Serialised product identifiers Korea 2015 Korea 2016 Aggregation (optional) Slovenia 2018 DataMatrix USA 2023 DSCSA - Pkg (item-level) traceability Regulated req, Tender req, Important dev, Emerging req.

4 EU Commission proposal on Delegated acts (DA) for FMD Objective: Protection of patients from counterfeited medicines in the legal distribution chain Scope: prescription drugs only (white/black list) Timeframe: DA to be adopted Q and published end of Implementation 3 years after publication (6 years for MS with preexisting measures) The composition, format and carrier of the unique identifier will be fully harmonised across the EU. The unique identifier will be placed in a 2D barcode and contain the manufacturer code, a serialisation number, a national reimbursement number (if present), the batch number and the expiry date. Tamper evidence needed. Medicine authenticity will be guaranteed by an end-to-end verification system supplemented by risk-based verifications by wholesale distributors. Medicines will be systematically verified before being dispensed to patients. Medicines at higher risk of falsification (returns or medicines not being distributed directly by manufacturers) will be additionally checked at wholesaler level. The repository containing the unique identifiers will be set up and managed by stakeholders. National competent authorities will be able to access and supervise the database. 4

5 Full operation phase: Who will have to pay? Installations for pack coding Installations for pack verification Repository system (Hub & national systems) Pharmaceutical Manufacturer European Hub Parallel Distributor Pharmacy Wholesaler Marketing Authorisation Holders Pharmacists, wholesalers, Marketing Authorisation Holders Jan 2015

6 Pan-European System: National Systems connected by the European Hub National System National System National System National System Pharmaceutical Manufacturer European Hub Parallel Distributor Pharmacy National System Wholesaler National System Jan 2015 Coding & Page 6

7 Harmonisation in Europe The move towards harmonisation and GS1 standards in Europe = country accepts GTIN = country requires national ID # 37

8 GS1 DataMatrix: favoured data carrier for pharmaceuticals Product Identifier (GTIN) Serial Number Expiry date Batch/Lot number 8

9 of pharmaceuticals Country requiring serial number Country developing requirements for serial number

10 requirements beyond Europe Argentina: Full traceability system in place with central portal and serialization since 2011 India: for exported drugs in place track & trace portal gets implemented now national market next Saudi-Arabia coding now with GTIN, loot and expiry date serialization March 2017, portal under development US SNI guidance already published, required for 2017 Brasil serialization needed, but time lines and model unclear China national serialization number and central portal implemented Turkey first country to implement serialization central portal Egypt, Jordan, Colombia, Peru who will be next? will enable many business processes beyond preventing counterfeiting but we need a global harmonized approach in regulations and implementations 10

11 The bigger picture? E.g. Turkey s implementation roadmap E-leaflet? Other type of e-services? 2015+? AOB??? 2014 App for patient verification Patients Reach out to public E-prescription / e-invoicing Tracking & Tracing Verification at dispensing + scanning based Re-imbursement Barcoding & Item Serialization In scope Stakeholders: Hospitals, Health Centers, Family Physician Centers, Pharmacies and Pharmacy,warehouses, Manufacturers, Importers, Reimbursement Institutions Source: F. Hoffmann-La Roche Ltd All Health providers Wholesalers Pharmacists Onboard & Connect Onboard & Connect Build IT infrastructure & Database Pharma Industry Apply 2D Barcode / Technical features Figures & Facts Number of drug types in İTS: Number of drug unıts in İTS: Number of daily operations in İTS: Number of operations per second in İTS: Response time of system: < 1 sec

12 APEC Roadmap for Global Medical Product Integrity and Supply Chain Security 5-year project sponsored by the APEC LSIF (Life Science and Innovation Forum) and the APEC RHSC (Regulatory Harmonization Steering Committee) approved in beginning of work groups covering the scope e.g. Single Point of Contact, Distribution and Manufacturing practices, importing and exporting practices, Detection technologies, Internet sales, Product Identification, Authentication and Track and trace systems Conduct of a gap assessment between APEC member economies that will evaluate a number of important supply chain areas Development of guidelines covering best practices, tool kits and other training materials Development and initiation of a training program Track and Trace Work Group facilitated by GS1 will be providing a 2 days training during the APEC SOM 3 in Cebu (Philippines) on August

13 ABAC Global Data Standards Pilot: Supply Chain Integrity for pharmaceuticals APEC Business Advisory Committee (ABAC) proposal Phase I feasibility analysis conducted by University of Tennessee Life Science Center. Completed in Q1 2015, soon to be published, recommending the use of GS1 standards as Global Data Standards for the pilot phase II. Phase II development and implementation of the pilot involving 2 or more APEC economies (interest from Philippines, Singapore, Chinese Taipei, China, Peru, Malaysia, Thailand and Korea) to demonstrate the benefits of Global Data Standards in ensuring supply chain integrity for drugs. 13

14 Ultimately, it s all about PATIENT SAFETY! 14

15 THANK YOU 15

16 Contact Details Ulrike Kreysa Vice President Healthcare GS1 Global Office E ulrike.kreysa@gs1.org W 16