Germany hosts European pilot scheme to fight drug counterfeiting
The authenticity of medicines will be checked at the point of dispensing
Source: Christian Husar
A system to identify counterfeit medicines is to be rolled out in pharmacies across Germany as a stepping-stone to Europe-wide protection for patients against the danger of fake prescription drugs.
Details of the pilot verification scheme were discussed at a workshop in Vienna last week. From July 2014, medicines at hundreds of German pharmacies will be checked against a novel Europe-wide database at the point of dispensing. Within years, predictions suggest, every pharmacy in Europe will have adopted the system – under development by a consortium of pharmacists, full-line wholesalers, drug manufacturers and parallel traders.
German pharmacies will check the authenticity of medicines they are about to dispense through a live link to a computerised hub. Pharmacists will obtain an instant read-out of whether a product in their hand is exactly what its label claims.
The system is being set up in response to a European Union law adopted in 2011 to protect patients from falsified medicines. The EU has set the objective and a deadline of 2018, but the healthcare sector is providing the mechanisms to achieve the goal. The workshop, held during the annual general meeting of the European Association of Pharmaceutical Full-line Wholesalers (GIRP), gave a chance for stakeholders to discuss details. The Pharmaceutical Group of the European Union (PGEU) is a central player in setting up the system and its secretary general, John Chave, told delegates it was vital that pharmacists should be fully represented in each national market as it is developed and rolled out.
The EU obligation demands that each packet of a prescription medicine should bear a unique number to identify individual packs. Pharmacies will need to be equipped with a scanner and a rapid link to a central computer, where an instant read-out will authenticate the unique identifier, or set off an alarm if an inconsistency is detected.
The market authorisation holder, the manufacturer or the parallel trader — if the product is repackaged — will affix a 2D matrix on each pack, containing a manufacturer’s product code and a randomised unique serial number (as well as the expiry date and the batch number). These data will provide reference for the central hub. A falsified medicine — inevitably lacking the unique serial number — will set alarm bells ringing.
The scheme, known as the European Stakeholder Model, is regarded as the only choice by EU officials responsible for making sure the legislation meets the 2018 deadline, but even its most enthusiastic proponents agree the scale of the scheme will present challenges. The German pilot programme will flag operational problems.
Stefano Soro, the head of unit for medicines in the European Commission’s health directorate general, told the workshop that, in principle, it was acceptable for stakeholders to run the scheme themselves, as long as adequate arrangements could be made for supervision by national authorities.
Chave said that he expected the consortium to expand as details were ironed out. Talks are underway with the European grouping of hospital pharmacists. And Europe’s generic manufacturers, who have long resisted proposals for the system because of concerns over its likely costs, are moving closer towards joining, with crucial board meetings scheduled for the coming weeks. It is thought a more inclusive consortium will mean lower costs and better prospects of a joined-up and user-friendly system.
The workshop raised many questions regarding access to data that will be generated by the system. A balance will need to be struck between effective operation of the scheme and the intervention rights of supervisory national authorities. The size of the task — requiring continuity between 28 member state systems that are fully integrated nationally and can talk to one another across borders — means the 2018 deadline for implementation is tight. Monika Derecque-Pois, GIRP director general, told delgates: “We are appealing to national stakeholders for faster progress in the development of national systems.”
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11139005
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