EFPIA reports progress with medicine verification scheme

The European Federation of Pharmaceutical Industries & Associations (EFPIA) has formally adopted a Memorandum of Understanding (MoU) on medicines verification developed jointly with EU groups representing pharmacists, wholesalers and parallel distributors.

The agreement specifies the previously-described European Stakeholder Model (ESM) for point-of-dispensing verification of pharmaceutical products in Europe as a "cost-effective and scalable system to meet the requirements of the EU Falsified Medicines Directive (FMD) and ensure patient safety," says EFPIA.

EFPIA's joint response to the public consultation on the FMD - prepared alongside parallel traders group the EAEPC, wholesalers body GIRP and PGEU representing the pharmacy trade - predicts that its ESM system will cost around €120m-€150m a year to implement with a pack price of 1.3 to 2.2 cents.

"The ESM stakeholders are confident that the system could be delivered against these estimates," said EFPIA Director General, Richard Bergström, who noted this model covers all prescription pharmaceutical products, including generic drugs.

Last month, EFPIA and its partners launched the tendering process for key components of their European medicines verification system, which envisages placing 2D datamatrix codes bearing GS1-compliant serialised codes onto packs at the point of manufacture, and verifying them in the pharmacy as they are being dispensed to patients.

…while EDQM steers clear

Among those invited to tender is the European Directorate for the Quality of Medicines and HealthCare (EDQM), which is in the process of setting up a pilot traceability system called eTACT. However, in a recent statement the EDQM rebuffed EFPIA's overture, insisting that the development and operation of a medicine traceability system "cannot lie entirely in the hands of the industry and business stakeholders," and says that as a result it cannot enter into the tender process.

It also said it considered EFPIA's "insufficient, particularly as it does not include the possibility for patients to verify the authenticity of any pack of medicines they receive."

EFPIA maintains that its approach is more than sufficient to protect the safety of patients, and could have additional benefits, such as "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."