GE has told the EC the need to test how RFID affects biologic stability means it is too costly to use in anti-counterfeiting.
The European Commission (EC) mooted the possibility of using radio-frequency identification (RFID) as a carrier in its anti-falsified medicines push but GE Healthcare and others are worried about costs. As well as the costs of tags and readers GE thinks spending on RFID-related stability tests is needed.
“Perhaps the greatest cost for incorporating RFID carriers onto pharmaceutical product labelling is related to the evaluation of how RFID technology may impact the stability and product quality of some classes of medicine products, especially biologicals”, GE Healthcare told the EC .
Sanofi also noted the “compatibility [of RFID] with biologicals is not yet proven” in its list of reasons why RFID cannot be considered a universal track and trace technology. Other perceived weaknesses include a lack of harmonised standards and interference with metals that affects the read rate.
GE and Sanofi were writing in response to a concept paper published by the EC last November. The paper called on drugmakers and other stakeholders to help shape the implementation of serialisation requirements brought in with the falsified medicines directive.
In the paper the EC raised many of the same concerns about RFID. “At present, it is relatively expensive in comparison with other carriers. Moreover, little is known about how the RFID technology may interfere with the quality of certain medicines”, the EC wrote.
Despite these obstacles RFID still has its advocates. In feedback to the EC the European Directorate for the Quality of Medicines (EDQM) wrote that RFID offers huge advantages and, if cost concerns mean it is overlooked now, should be considered in the future.
“The EDQM feels that it will be important to facilitate implementation of RFID tagging in a phased manner as the technology matures, especially to allow more efficient handling of aggregation and better returns on investment for business stakeholders.”