Keeping safety in proportion
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Most of the meeting was concerned with efforts to protect the legitimate supply chain. In particular, it addressed the Commission's call for safety features "making it possible to ascertain identification, authenticity and traceability of medicinal products". Beyond mentioning product seals and individual codes that can be read by authorised parties in the supply chain, the proposed directive is reticent about which technologies will best achieve these goals. It does suggest taking a risk-based approach that would incorporate factors such as price, public health implications and past incidence of counterfeiting.
Monika Derecque-Pois, director general of the European Association of Pharmaceutical Full-line Wholesalers (GIRP), believes a 2D-matrix barcode incorporating a randomised serial number, national identification number, batch number and expiry date is "the only way forward". Radio frequency identification technology could be a "very interesting" proposition in the future but at the moment it "doesn't work", Derecque-Pois said, citing inaccuracies at low frequencies and product interference from ultra-high frequency tags. For wholesalers, speed of delivery is key. The average warehouse handles 115,000 articles a day, processing them at speeds of four or even eight a second, Derecque-Pois pointed out.
Whatever system does emerge needs to be fully integrated into the pharmacy workflow, Chave added. Moreover, costs should be minimised "sensibly and proportionately, compatible with an effective system". It is in no-one's interests to push up the prices of medicines, he said.
While there is a case for a single harmonised pack code, Chave said, member states should be free to choose the authentication system for verifying that code, be it a track-and-trace approach or the kind of end-to-end system already operated in four European markets by Aegate.
Another important consideration is data protection, which Matias acknowledged as "a key issue" in the debate. Information generated by an authentication or tracking system needs to be stored independently and questions of data ownership clarified, she told the meeting.
This applies both to personal and transactional data. Personal data are already subject to data protection laws and "all that must remain sacrosanct", Chave emphasised. Transactional data are "essentially the property of the pharmacist", a view shared by Aegate. There may be viable uses for these data within social security systems but "commercial exploitation by third parties is a serious danger", Chave warned.
There is, nonetheless, a general consensus among stakeholders that counterfeits require a multifaceted approach, ranging from security features to tightening up the supply chain, improving education and awareness, collaboration between industry, regulators and law enforcement bodies, and meaningful criminal penalties for drug counterfeiting.
Much of this is already happening. But the proposed directive will have to determine how these various components can slot into place within a harmonised EU infrastructure, and how much weight they are given - not to mention, who will foot the bill.