Vienna, Austria, 3 rd June 2014
the European Association of Pharmaceutical Full-line Wholesalers (GIRP) in collaboration with European Stakeholder Model (ESM) partners: EAEPC (The European Association of EuroPharmaceutical Companies), EFPIA (European Federation of Pharmaceutical Industries and Associations, and PGEU (Pharmaceutical Group of the European Union) hosted a national workshop on the pan- European Medicines Verification System (EMVS).
The workshop is taking place at the occasion of GIRP’s 55th Annual General Meeting business conference. The aim of the workshop is to present to national stakeholders progress in terms of the ESM project’s development, appeal to national stakeholders for faster progress in the development of national systems and set out what stakeholders can expect from 2017 onwards. Opening the workshop Mr. Stefano Soro, Head of Unit, Directorate General for Health and Consumers, European Commission, provided a progress update on the status of the drafting of the delegated acts. He explained to workshop attendees that the Commission is right in the middle of drafting the text and consulting with Member States. While not going into specific details about the wording he did however outline further on the announced policy options for inclusion into the delegated acts:
- Harmonisation of the composition of the verification number and the data carrier
- Systematic verification of the safety features at the dispensing point and risk-based verification by wholesale distributors
- Establishment and management by stakeholders with supervision by the relevant competent national authorities.
Representative from all stakeholder organisations spoke about the system – GIRP Director General, Ms. Monika Derecque-Pois, Dr. Heinz Kobelt, European Affairs Director for EAEPC; EFPIAs market access Director Mr. François Bouvy, and Mr. John Chave, Secretary General of PGEU – during a joint presentation which outlined the legal framework for the system, design and architecture, governance approach and the cost effectiveness of the approach. The ESM partners have joined forces to develop a safe, cost-effective and partnership based pan-European medicines verification system to combat falsified medicines and ensure patient safety. The founding principle of the ESM approach is that each pack of medicine is checked individually before it is dispensed to the patient, ensuring that the patient receives a genuine product. Since 2010, the ESM partners have developed and tested an interoperable and scalable pan-European medicines verification system. It uses an internationally recognised 2D barcode (data matrix) to verify medicines at the point- of-dispensing. The Data Matrix carrier contains a code with five key main elements: product number, batch number, expiry date and random serial number, and a national number (eg. for reimbursement) where it exists. The data matrix also has the capacity to contain other information such as national codes and meet the needs of national authorities. The codes are generated and applied by manufacturers and parallel distributors using the 2D data matrix barcode and are uploaded to a European Hub, established as an interface to regional or national databases. Pharmacies and wholesalers connect to these databases in order to authenticate medicines: pharmacies at goods entry but at the latest at the point of dispensing, while wholesale distributors will also perform risked based authentication. By simply and systematically scanning the barcode, any unregistered code will immediately alert the user to the possibility of a falsified product.