Ensuring patients have access to safe medicines A European Medicines Verification System Fighting counterfeit medicines to ensure patient safety in Europe Speaker: Ms. Monika Derecque-Pois Event: Scientific Support for Public Health: existing actions, new challenges and European added value Date: 14 th November 2013, Brussels
The European Stakeholder Model (ESM) for medicines verification The threat of falsified medicines penetrating the European supply chain is substantial and growing The European Stakeholders who will use it day-to-day have brought together their expertise in the development of the ESM GIRP is one of the initial 4 Stakeholders developing the ESM solution Talks ongoing with EGA, AESGP, EAHP and HOPE AESGP EAHP EGA GIRP HOPE PGEU Association of the European Self-Medication Industry European Association of Hospital Pharmacists European Generic Medicines Association European Association of Pharmaceutical Full-line Wholesalers European Hospital and Healthcare Federation European Association Representing Community Pharmacists 2
What is the ESM? A cost-effective solution for medicines verification Run on a non-profit basis An interoperable, pan- European system called the EMVS (European Medicines Verification System) enabling medicines to be verified at point of dispensing with risk based checks on wholesale distribution level Immediate verification of the pack (in milliseconds with one scan) Ensures safe access to medicines for patients Fully integrated in pharmacy workflow ESM A medicines verification system for Europe 3
ESM view on implementation of the FMD Safety Features Combine tamper-evident packaging and a unique randomised serial number Verify product authenticity by checking each pack against a central database at the point of dispensing System Design Harmonised standard coding system across the EU that allows national codes to be incorporated as necessary Sufficient flexibility to implement national or multi-country solutions within an overall EU technical framework Data Governance Manufacturers do not seek, and will not have access to, individual patient / prescribing profile information Transactional data belongs to stakeholder that created it e.g. pharmacists for dispensing data Systems should be established and managed by the stakeholders that will use them day-to-day Systems governed by independent non-profit organisations jointly managed by relevant stakeholders, Government involvement foreseen according to the terms of the Directive
Model and process European Hub Upload Data National System 1 - n Verification upon Dispense to Patient Product # Batch Expiry S/N Product Flow random/ risk-based verification by Wholesale distributors Pharmaceutical Manufacturer and Parallel Distributor Wholesaler Wholesaler Pharmacist Patient 5
Infrastructure overview Pharmaceutical Manufacturer European Hub Q1 14 Parallel Distributor National System 1 National System (Blueprint) National System 2 Q2-Q3 14 Pharmacy Wholesaler Pharmacy Wholesaler Pharmacy Wholesaler Parallel Distributor: mandatory verification + data upload Manufacturer: data upload + voluntary verification Periodic cross-region update Pharmacy: mandatory verification Wholesaler: voluntary verification System design for interoperability and efficiency 6
The Benefits of a European Hub The EU Hub is essential for interoperability between national systems in EU member states Secure platform for reconciliation of products traded across borders Effective handling of multi country packs A single interface for manufacturers European Hub infrastructure able to technically manage national data repositories (Blueprint systems) Avoiding 28 Interfaces with manufacturing authorisation holders 7
Phased Implementation First steps towards the implementation of the EMVS have been initiated in 2012 Timeline 04/2013: Contract awarded to Solidsoft and start of implementation project 08/2013: Completion of specification phase 11/2013: Standard for connected systems available 01/2014: User acceptance testing 03/2014: European Hub running July 2014: Connection to the SecurPharm system 8
Commitment to work with public authorities Ensure an effective and efficient system that responds to public needs Consistent with authorities rights under the FMD Reimbursement and Pharmacovigilance purposes (product recall) Dialogue with authorities during the development phase Provide consultation and access when the system is in use Authorities right to attend EMVO meetings Enable auditing activities as required Dialogue with end users including patients 9
Ensuring patients have access to safe medicines Thank you http://www.esm-system.eu