EFPIA for Greater Patient Safety

The threat of falsified medicines penetrating the European supply chain is substantial and growing. According to statistics from European Customs, the number of medicines seized at the point of entry into the EU rose three-fold over the period 2006–2009 to some 7.5 million items. In 2010 alone, more than 3.2 million medicines were confiscated, representing more than 3% of all items seized at EU borders. How many falsified medicines have actually effectively penetrated the supply chain is a matter of conjecture in the absence of an effective tool to prevent their entry.

The adoption on July 1, 2011 of the "Falsified Medicines Directive" (FMD) is an important step in better protecting patients from counterfeit medicines. The Directive introduces mandatory, harmonised pan-European safety features in the form of tamper-evident packaging and a "unique identifier" that will be applied to all prescription medicines, subject to possible exclusions based on risk assessment. Tamper-evidence features together with a unique serial number on each medicine pack will enable pharmacists to check whether a pack has been tampered with and previously dispensed, alerting them to any risk of counterfeiting. To ensure maximum effectiveness, however, it is vital that all medicine packs are verified systematically at pharmacy level.

The European Commission (EC) will define the mechanics of how this system will work in Delegated Acts that are to be adopted by the end of 2012. The Delegated Acts will define the characteristics and technical specifications of the "unique identifier", which will enable identification of individual packs, and the accessibility of national product databases or repositories to verify each dispensed pack.

EFPIA, together with GIRP (Groupement International de la Répartition Pharmaceutique) and PGEU (Pharmaceutical Group of the European Union), the respective European organisations of wholesalers and pharmacists at EU level, fully support this legislation and will be pleased to work with the EC in establishing an effective system in the interests of patient safety. To this end, they have proactively initiated a project to identify concrete options for establishing a stakeholder-governed model for the verification of pharmaceutical products in Europe. The aim is to set up a cost effective and scalable pan-European product verification system that is to be run by stakeholder organisations on a non-profit basis.

The proposed system comprises a European central hub connected to a series of national or regional data repositories that serve as the verification platforms, which pharmacies and other registered 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 traded products through the European central hub. The European central hub will also enable the effective performance of key tasks such as the proper handling of multi-country packs. In addition, it will also offer those countries who do not want to set up their own regional or national system the opportunity to join an existing product verification infrastructure.

Figure 1: Pan-European verification system components.

Although there is no suggestion that legitimate parallel traders are responsible for counterfeits, there is evidence of counterfeiters exploiting repackaging as an entry point into the distribution chain. Some of the millions of packs discarded by parallel traders, or the serial numbers contained on them, may be used by counterfeiters, and parallel traders themselves have expressed concerns about the activities of unlicensed traders. The highly complex distribution system for medicinal products is only as strong as its weakest link. The proposed system should accommodate different needs in different regions, while be based on common principles to ensure mandatory coding and verification of products in line with a harmonised coding system.

Properly structured, the proposed system ensures verification of product authenticity by professionals at the point of dispense and provides a modern technology solution that will enhance patient safety as well as having the potential to generate additional spillover benefits in the future. Potential advantages include the possibility of allowing for the automated checking of expiry dates, better pharmacovigilance, a reduction in the number of fraudulent reimbursement claims, higher effectiveness in preventing recalled products from being supplied to the patient, more efficient handling of product returns and improved stock management processes for pharmacies.