SCRIP World Pharmaceutical News reports that, “The European pharmaceutical industry association, EFPIA, today launched its anti-counterfeiting pilot project in Sweden, raising concerns among parallel traders that should it be rolled out across the EU, the scheme's central database may be misused by manufacturers to curb sales to certain wholesalers.”) This follows up on the commission's legislative proposal for some sort of authentication process, but which stopped short of recommending an actual type.
The pilot scheme involves 25 pharmacies in the Stockholm area. Pharmacists will be scanning about 110,000 pharmaceutical packs that have a special two-dimensional barcode (similar to those found on airline boarding passes) using a scanning device at the point of dispensing.
The scanned product would be checked against the manufacturer's records in a central database to verify whether it is genuine, as the product would have a unique serial number. The data matrix would be enough to individually code each medicine pack with information including a product code, batch number, expiry date and a unique serial number.
The system has proven to be a cheaper and easier solution to implement than other authentication schemes such as track and trace and RFID tagging, believes EFPIA. It also offers advantages such as reducing dispensing errors and reimbursement fraud.
Heinz Kobelt, secretary general of the European parallel traders association, the EAEPC, is concerned about who is "master of the data" in the central database. "If pharmaceutical manufacturers get free access to the data, they can use it against parallel traders. We need an independent agency to run the central database."
Colin Mackay, EFPIA's spokesperson, told Scrip that it was uncertain who would fund the scheme if it were rolled out across Europe, but financers should include all stakeholders, including the pharmaceutical industry, wholesalers, pharmacists, parallel traders and member states.
The EFPIA system is being piloted in collaboration with the European wholesaler trade association, GIRP, and local Swedish full-line wholesalers Tamro and Kronans Droghandel. EFPIA has said that accredited full-line wholesalers would be able to access the database to check the status of the product at any time.
The European Parliament's Committee on the Environment, Public Health and Food Safety is expected to issue a report on the Commission's counterfeiting proposals next month. EFPIA plans to issue the results of the completed pilot early next year.
The pilot scheme involves 25 pharmacies in the Stockholm area. Pharmacists will be scanning about 110,000 pharmaceutical packs that have a special two-dimensional barcode (similar to those found on airline boarding passes) using a scanning device at the point of dispensing.
The scanned product would be checked against the manufacturer's records in a central database to verify whether it is genuine, as the product would have a unique serial number. The data matrix would be enough to individually code each medicine pack with information including a product code, batch number, expiry date and a unique serial number.
The system has proven to be a cheaper and easier solution to implement than other authentication schemes such as track and trace and RFID tagging, believes EFPIA. It also offers advantages such as reducing dispensing errors and reimbursement fraud.
Heinz Kobelt, secretary general of the European parallel traders association, the EAEPC, is concerned about who is "master of the data" in the central database. "If pharmaceutical manufacturers get free access to the data, they can use it against parallel traders. We need an independent agency to run the central database."
Colin Mackay, EFPIA's spokesperson, told Scrip that it was uncertain who would fund the scheme if it were rolled out across Europe, but financers should include all stakeholders, including the pharmaceutical industry, wholesalers, pharmacists, parallel traders and member states.
The EFPIA system is being piloted in collaboration with the European wholesaler trade association, GIRP, and local Swedish full-line wholesalers Tamro and Kronans Droghandel. EFPIA has said that accredited full-line wholesalers would be able to access the database to check the status of the product at any time.
The European Parliament's Committee on the Environment, Public Health and Food Safety is expected to issue a report on the Commission's counterfeiting proposals next month. EFPIA plans to issue the results of the completed pilot early next year.
