EFPIA is committed to securing the supply chain against counterfeit medicines. EFPIA is actively developing a coding solution that will enable medicine packs to be verified at the point of dispensing. The system was piloted in Sweden in 2009 and is now being developed in partnership with pharmacists, wholesalers and other stakeholders to meet the requirements of the EU Falsified Medicines Directive.

Recent studies on dispensing and dosing errors, reimbursement issues, and cases of counterfeits in the legitimate supply chain have highlighted the need to establish more clearly and effectively the identity of each medicine pack.

Various coding solutions have been implemented by Member States, each with their own objectives and motivation. The coexistence of these different systems constitutes an obstacle to full verification of medicines at an EU level and adds production costs for manufacturing.

This has led EFPIA in partnership with key stakeholders to work toward the implementation of a standardized identification solution for pharmaceutical products across Europe. From September 2009 till February 2010 the EFPIA solution was successfully tested through a pilot project in Sweden in partnership with Swedish retail pharmacy chain Apoteket AB and local wholesalers Tamro and KD.

The EFPIA solution is an end-to-end point-of-dispense coding and serialisation system which allows pharmacists to check a unique identification code on each individual pack when it is dispensed to the patient. These codes are generated and applied by manufacturers using a simple 2D data matrix barcode, which contains a unique serial number. The scan will reveal any duplication of data on packs and will trigger the system to immediately alert the pharmacist to the possibility of a counterfeit product.

The coding solution provides an efficient and cost-effective method to meet the EC's requirements for pack identification put forth in the recently adopted Falsified Medicines Directive (published in the Official Journal of the European Union on 1 July 2011 and part of the so-called "Pharmaceutical Package" launched by the Commission in December 2008).

EFPIA together with its partners (GIRP & PGEU, the Wholesalers and Pharmacists at EU Level) has 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 Board endorsement by the three organisations, is based on a joint "10 core principles document".
In short, EFPIA, GIRP and PGEU are calling for :

  • A harmonized coding & serialisation system across Europe for greater patient safety;

  • A stakeholder governed point-of-dispense system for cost-effectiveness;

  • A 2D data matrix based on international standards as unique identifier for interoperability.

Anti-counterfeiting measures on packaging such as holograms do already exist. But these can be copied, and therefore cannot provide an insurmountable barrier to counterfeiting of medicines. This fact has made it increasingly clear that other solutions are required. The EU Falsified Medicines Directive (FMD) establishes a framework for pack level serial numbers and verification of each pack at the point of dispense.
 
The key stakeholders in manufacturing, distribution and dispensing of medicines developed a technology-based solution that meets the requirements of the Directive. It consists of individually marking each medicine pack with a unique code at the point of manufacture, and verifying this code in the pharmacy immediately prior to the release of the pack to the patient. This is known as the “Point-of-Dispense (PoD) Verification” concept. Such a solution would provide the end user with more confidence in the supply chain and the product, and facilitates the establishing of routine activities under the Directive.