Best Initiative of the Year in Pharmacy awarded to EFPIA-GIRP-PGEU for their core principles on European medicines verification
Representatives from three European associations (EFPIA, GIRP and PGEU) were in Madrid, Spain last Monday, to receive awards for the “2011 Best Pharmacy Initiatives of the Year”. The awards are given out by the Spanish newspaper Correo Farmaceutico in recognition of the EFPIA/GIRP/PGEU Ten Core Principles for their European Stakeholder Model (ESM).
EFPIA, GIRP and PGEU are jointly working on the ESM, a European medicines verification project with the aim of preventing falsified medicines from entering the European supply chain and improve patient safety. More recently, EAEPC, the association representing parallel distributors joined the project.
“This award is an important mile stone for our joint efforts and demonstrates clear recognition of the distinct advantages of the European pharmaceutical supply chain stakeholder model. The stakeholders vision is to develop a harmonised system that provides a high level of security for patients, while being cost effective and integrating into existing structures in the distribution chain”, said EFPIA Director General Richard Bergström.
“ESM which is under development by the four organisations represents a practical means of implementing the requirements of the EU Falsified Medicines Directive and is the least burdensome solution available for all parties involved” adds Monika Derecque, Director General of GIRP.
The Secretary General of PGEU, John Chave further underlines: “Timely, secure and cost-effective implementation of a product verification system is best assured with a system that is designed and run by those who will use it day-to-day, such as pharmaceutical manufacturers, pharmacists, wholesalers as well as parallel distributors”.
“We are pleased that the three founding organisations have been publically recognised for their efforts to date and it is extremely encouraging to see the initiative is already the winning approach”, Richard Freudenberg , Chief Executive of the EAEPC said on hearing the news of the awards.
The stakeholders thank the Correo Farmaceutico newspaper for the vote of confidence in their approach.
The Best Pharmacy Initiatives of the Year award by Correo Farmaceutico recognises the daily work of people, firms or institutions that, with their contribution, have helped to improve the world of pharmacy, pharmaceutical care and health throughout 2011.
Contact
Richard Bergström, Director General, (EFPIA)
Tel: +32 2 626 25 55,
E-mail: newsroom@efpia.org
Richard Freudenberg , Chief Executive , (EAEPC)
Tel: +32 2 280 4524
Email:heinz.kobelt@eaepc.org
Monika Derecque-Pois, Director General, (GIRP)
Tel: +32 2 777 99 77
Email: girp@girp.org
John Chave, Secretary General, (PGEU)
Tel: +32 2 238 0818
Email: pharmacy@pgeu.eu
Useful links
About the project
The solution proposed under the European Stakeholder Model (“ESM”) is an end-to-end, point-of-dispense coding and serialisation system, which allows pharmacists and other dispensing professionals to check a unique identification code on each individual pack when it is dispensed to the patient. The codes are generated and applied by manufacturers using a 2D data matrix barcode, which contains a unique serial number. The ESM solution provides an efficient and cost-effective method to meet the requirements for pack identification put forth in the recently adopted Falsified Medicines Directive and will be presented to the European Commission in the consultation on the Delegated Acts.
The system is composed of a European central hub connected to a series of national or regional data repositories that serve as the verification platforms that pharmacies and other authorised parties can use to check a product’s authenticity. The system will be interoperable between the various countries and will allow for the reconciliation of parallel distributed products through the European central hub.
The European central hub will also allow the performance of key tasks such as the proper handling of multi-country packs. Specifically, the system will constitute an end-to-end, real-time verification tool enabling manufactures to upload serial data; healthcare professionals throughout the supply chain (i.e. wholesalers, pharmacists or hospital pharmacists, dispensing doctors and parallel distributors) to verify that a product is genuine, for parallel distributors to decommission individual codes and upload new codes (linking the new code to the old code at batch level), and dispensing pharmacists, doctors and hospital pharmacists to decommission individual codes. The proposed system should accommodate different needs in different regions, but be based on common principles to ensure mandatory coding and verification of products in line with a harmonised coding system.
The European central hub will be established and managed by a not-for-profit stakeholder organisation referred to as the European Medicines Verification Organisation (“EMVO”). The stakeholders have elaborated and tentatively agreed a Memorandum of Understanding (“MoU”) which outlines the proposed solution and steps for implementation including:
- Unique Identifier for medicinal products;
- Modalities for verifying the safety features;
- Provisions on the establishment, management and accessibility of the repositories system;
- Lists of products to be covered by the safety features.
The MoU, currently awaiting official approval by the four organisations, is based on a joint "10 core principles” document for which the award is being given.
About EAEPC
EAEPC regroups the European licensed parallel distribution industry. Through national associations and individual company membership, it encompasses over 70 firms from 20 countries in the European Economic Area (EEA). All products handled by EAEPC members have national or EU regulatory approval and are exclusively sourced from and sold to EEA countries using authorised trade channels.
About GIRP
GIRP is the European umbrella organization of pharmaceutical full-line wholesalers. Pharmaceutical full-line wholesalers ensure the safe, efficient and timely delivery of all medicines whenever and wherever they are needed. GIRP and its members play a vital role in the healthcare supply chain, by supplying about 170,000 retail pharmacies as well as hospitals and other healthcare professionals with more than 100,000 different medicinal products.
About PGEU
The Pharmaceutical Group of the European Union (PGEU) is the European association representing more than 400,000 community pharmacists. PGEU’s members are the national associations and professional bodies of pharmacists in 31 European countries, including EU Member States, EEA members and EU applicant countries.
About EFPIA
EFPIA represents the pharmaceutical industry operating in Europe. Through its direct membership of 31 national associations and 38 leading pharmaceutical companies, EFPIA is the voice on the EU scene of 2,000 companies committed to researching, developing and bringing to patients new medicines that improve health and the quality of life around the world.
Media Contact:
Nicholas Elles
Communications Manager
EFPIA
Rue du Trone, 108
1050 Brussels
TEL: +32 (0)2 626 24 79
Email : communications@efpia.eu