The Challenge of Taking on Falsified Medicines in Europe

Attention in Europe has drifted away from the problem of counterfeit and falsified medicines since the creation of a novel cooperation between authorities, manufacturers, wholesalers, and pharmacists to protect patients against dubious products. But four years on, although fewer falsified medicines are getting through, the pioneering European Medicines Verification Organization (EMVO) admits that its complex system is still not functioning properly.

As is so often the case in Europe, the widely-applauded initiative is another victim of the region’s innate diversity. Despite the obligations that governments and drug suppliers are under (e.g., the European Union [EU] legislation demanded a clean-up in 2011), the reality is that some national authorities are still interpreting the rules their own way. Thus, their involvement in the pan-European system is, to say the least, uneven.

Some regulators see great potential in the system. Philip Buck, an official at Belgium’s Federal Agency for Medicines and Health Products, says it could be helpful in product tracing, investigations, supervision, pharmacovigilance, and even in combating reimbursement fraud. But he has also underlined that despite the sophisticated IT network that has been set up as a cross-border watchdog, the legal supply chain is still prey to the most simple local flaws—such as local pharmacies departing from agreed-upon procedures in the event of stock returns. EMVO’s intricate real-time linkage of each pharmacy to a national hub and then to a remote European cross-checking facility based on the unique product-identifying bar-code required on each pack serves for nothing if procedures are neglected.

Meanwhile, Italy and Greece—who initially didn’t sign up to the scheme—are not expected to be fully engaged in it until 2025. EMVO’s general manager, Andreas Walter, told a Brussels conference in February: “EMVO strongly encourages Greek and Italian stakeholders to fully commit to establishing the national system, contributing to a safer medicines supply chain in Europe.” Among the key risks for the future identified by the current president of EMVO, Kasper Ernest, the system “will be challenged by diverging wishes from national regulators,” citing the menace of “fragmentation.”

Walter underlines that “the complexity of a project of this nature requires the efforts and commitment of all national stakeholders from an early stage.” However, compliance, too, raises its own problems since the system is prone to generate a disturbingly high level of false alarms—often from minor technical glitches in software, scanners, and coding, arising from persistent incompatibilities between national systems and among the stakeholders.

The system is subject to another innate diversity—that of a range of differing interests and priorities. For most community pharmacists across Europe, the system still needs to prove itself, according to Ilaria Passarani, who heads their main lobby group. It imposes a heavy administrative and financial burden “for pharmacists who are trying to make it work without disrupting every pharmacy practice,” she says. Community pharmacies also claim that the supply chain in Europe is already “very safe.” The new system misses what they believe should be the principal target: “The main source of falsified medicines remains the internet,” and the system “can do nothing to tackle the real cause of the problem.”

But while all the participating organizations say there should be better compliance, the divergences are not hard to perceive on just who should be complying more. Medicines for Europe, the generic industry association, points to delays by hospital and community pharmacies in some member states. Ernest, who represents Europe’s parallel traders, highlights “lack of enforcement.” Wholesalers blame delays on particular stakeholders and national authorities. Marco Farinelli of the European Federation of Pharmaceutical Industries and Associations (EFPIA) believes “we should have been stricter during the early days of the system going live when it comes to enforcement of obligations” and more forceful at “overcoming national peculiarities.” But Passarani defends her pharmacy members, who face “a heterogeneity of software landscapes and difficulties in implementation.” She says the EU legislation seriously underestimated the risk of alerts. As a result, better communication is needed on handling alerts and the reverse logistics they provoke, “especially for very small businesses like pharmacies.” She warned that if pharmacists are paralyzed by stock retentions as a result of false alerts, “everyday, thousands of patients across Europe will not get the medicines they need.”

Reflector is Pharm Exec’s correspondent in Brussels.