Experience with Serialization Implementation as one powerful measure to protect our patients. Françoise Hirth

Transcription

1 Experience with Serialization Implementation as one powerful measure to protect our patients Françoise Hirth

2 Objectives Supply Chain integrity & product security A worldwide concern Pharma Industry s position We take action and are willing to be part of the solution Suggested way forward for Regulators A collaborative approach based on implementation of international standards

3 Supply chain complexity and lack of control facilitate criminal activities, lead to medication error and ultimately harm patients and healthcare systems

4 Today, Mass Serialization & Traceability is a reality. Globally. Regulators continue to take action. So does Roche. Russia 2017 Ukraine Turkey 2010 EU 2019 Jordan 2018 USA 2017 Korea 2016 Algeria India China 2015 Taiwan 2018 Colombia Nigeria 2015 Pakistan UAE Philippines 2016 Brazil 2016 Egypt Saudi Arabia 2015 Draft or In preparation Published Argentina 2013 Singapore Market Response: There has been a rigorous international response to counterfeiting from governments, law enforcement agencies, healthcare organizations and pharmaceutical companies. 4

5 Implementation of safety measures

6 Roche s company standards are based on GS1 1. Codification Primary pack Secondary pack GTIN + required variable data GTIN + required variable data 2. Serialization Secondary pack GTIN + S/N + required variable data 3. Aggregation Tertiary pack Shipping units SSCC SSCC GTIN: Global Trade Item Number SSCC: Serial Shipping Container Code GS1: Global Standards

7 How will our products look like in future? Tamper Evidence, Authentication, Serialization Serial Number A unique number assigned to a single unit A randomized numeric code Material Number GTIN Data Carrier Machine readable Requirements vary per country Human Readable Information Tamper Evidence (Glued or Label) 7

8 The Pharma Industry is investing heavily globally in Mass Serialization technologies since 2010 Serialization allows for patient verification Tamper evidence ensures pack integrity Aggregation allows for Tracking & Tracing

9 The example of Turkey illustrates the transformational effect mass serialization can trigger on Healthcare What s next? E-leaflet? Figures & Facts today 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: 520 Response time of system: < 1 sec 2015+???? 2014 App for patient verification Patients Reach out to public 2013 E-prescription / e-invoicing All Health providers Onboard & Connect 2012 Tracking & Tracing / Chain of Custody Wholesalers Onboard & Connect 2011 In scope Stakeholders Hospitals 2010 Health Centers Family Physician Centers Pharmacies and Pharmacy Warehouses Manufacturers Importers Reimbursement Institutions Verification at dispensing + scanning based Re-imbursement Barcoding & Item Serialization Pharmacists Pharma Industry Equivalent developments can be observed whenever a country decides to implement mass serialization MoH builds IT infrastructure & Database Apply 2D Barcode / Technical features

10 Technical Challenges Equipment Reliable vendors specialized in serialization are facing high demand and leadtime can be now up to 2 years Labelling Installation can be complex depending on the variety of the portfolio Considerations of the project engineering, down time for installation and validation, training, documentation IT software It can be very expensive depending on the level of integration Reliable IT provider is important

11 Work Together with All Stakeholders to Codevelop the National Verification / Traceability Health Authorities What needs to be DEFINED Standard Data Carrier Manufacturers Standard Data Construct Access to Data Pack Coding Reporting needs National database Implementation Timelines The challenges are important Standards National Database Processes Pharmacies Wholesalers Distributors Tools & Capabilities Solution vendors 3PL s Success through a collaborative approach Manufacturers, Health Authorities, Associations, Peers, Trading Partners, Solution Vendors

12 Recommendations

13 Do or Will you have draft regulations? For which problem? What do you exactly want to achieve? How can we contribute? Medicines verification? Codification + serialization e.g. Europe Tracking & Tracing? Codification + Serialization+ aggregation e.g., China, Turkey Requirements to MoH Be clear about the requirement to be fulfilled. Articulate upfront! What s the problem? (counterfeit, reimbursement ) Be mindful of implementation timelines: scale-up, run pilots Realistically a 4-5 years horizon Develop and implement an adaptable/ scalable technical solution based on international standards (GS1)

14 All Key areas Takeaway are impacted Messages In case your country implements serialization/aggregation, A country specific make-up is mandatory leading to: Local Regulatory high workload increase for Master data, Artworks, Regulatory activities Use global data standards Distribution /Storage processes have to be adapted IT capabilities of your distributor, in your warehouse (scanner, interface) Collaborate with all stakeholders Special processes have to evaluated and adapted Redressing, local CMO, export Define clear objectives Get familiar with: Serialization, Aggregation, Traceability and Global standards concepts to be Customer achievedservices, Medical Services to be informed Communication, Hotline

15 Doing now what patients need next