EFPIA, the voice of the research-based pharmaceutical industry in Europe, is pleased to announce that on 27 April 2012 its Board formally adopted a Memorandum of Understanding (MoU) on medicines verification developed jointly with key supply chain partners representing pharmacists (PGEU), wholesalers (GIRP), and parallel distributors (EAEPC) at EU level.

EFPIA Director General, Richard Bergström, says: “The EFPIA Board endorsement illustrates the strong commitment of the industry in setting up a harmonised system across the EU based on international standards that provides a high level of security for patients while being cost-effective and integrating into existing structures in the distribution chain.”

The joint MoU outlines the provisions of the stakeholder vision for establishing a modern technology solution for point of dispensing verification of pharmaceutical products in Europe. The aim of this European Stakeholder Model (ESM) is to set up a cost-effective and scalable system to meet the requirements of the EU Falsified Medicines Directive (FMD) and ensure patient safety.

The system has the potential to generate additional benefits in the future. These benefits include the possibility for automated checking of expiry dates, better pharmacovigilance, a reduction in the number of fraudulent reimbursement claims, higher effectiveness in preventing recalled products from reaching the patient, more efficient handling of product returns, and improved stock management processes for pharmacies. The ESM also envisions working closely with governments in order to ensure that all these benefits come alive. 

In their joint response to the European Commission’s public consultation on the Delegated Act on safety features, the stakeholders specified the technical components of their proposed ESM while highlighting the inherent cost-effectiveness of the system. Thorough cost estimates indicate overall system cost (annually and EU wide) at €120m to €205m, with an estimated per pack price between €Cent 1.3 - 2.2, for a system covering all prescription products, generics included. “The ESM stakeholders are confident that the system could be delivered against these estimates. Indeed, the costs have been established through the use of actual real life examples rather than theoretical estimates”, says Richard Bergström.

EFPIA is convinced that the way forward to ensure patient safety in the EU is to make sure that the legitimate supply chain is as safe as possible. All prescription-only medicines must therefore bear safety features. “It seems outdated to sustain that only high-priced products should be protected. Indeed, the cost of manufacturing falsified medicines is close to zero, therefore any medicinal product, no matter its price, is likely to generate a profit for the counterfeiter”, underlines Richard Bergström.

Last month, EFPIA and its partners launched the tendering process for key components of their European medicines verification system.

Contact

Richard Bergström, Tel: (+32) 2 626 25 55
E-mail: newsroom@efpia.org

Useful links
www.efpia.eu

About EFPIA:

EFPIA represents the pharmaceutical industry operating in Europe. Through its direct membership of 31 national associations and 35 leading pharmaceutical companies, EFPIA provides the voice of 2,000 companies committed to researching, developing and bringing new medicines to improve health and quality of life around the world.

EFPIA members are committed to delivering innovative medicines to address unmet needs of patients and reducing the burden of chronic diseases for Europe’s ageing population. EFPIA believes in close cooperation with its stakeholders to help create sustainable healthcare systems and to develop prompt responses to health threats in Europe.

The pharmaceutical sector directly employs some 640,000 people in Europe including 115,000 working in research and development in 2010. The industry also generates around three to four times more employment both upstream and downstream.

Europe’s research-based pharmaceutical industry generates a substantial trade surplus, estimated at about €46,800 million in 2010, and has contributed significantly to reducing the European Union’s trade deficit in high-tech products. € 27,000 million were spent on research and development in Europe in 2010. Almost a quarter of the EU’s high-tech exports are pharmaceutical products.

Media Contact:

Nicholas Elles
Communications Manager
EFPIA 
Rue du Trone, 108
1050 Brussels
TEL:  +32 (0)2 626 24 79
Email : communications@efpia.eu