In 2019, the European Union will implement a pharmaceutical verification system mandated by the Falsified Medicines Directive (FMD); a law passed by the European Commission five years ago. The system aims to reduce the quantity of counterfeit drugs entering legitimate supply chains by attaching anti-tamper proof devices and 2D barcodes to each medicine pack. These barcodes contain pack-specific information that is entered into databases that allow products to be monitored from manufacturer to user. Greg Noone talks to Martin Sawer and Jerome Bertin about what the new directive means for drug manufacturers, wholesalers and pharmacies.
Staff at Cardarelli Hospital in Naples, Italy, are used to seeing strange things. During an operation on a patient with a brain tumour, one of the surgeons suffered a heart attack, but insisted on finishing the procedure before admitting himself for emergency treatment. On another occasion, a man and a woman drove a yellow Ferrari straight into the emergency room after being shot; she wounded in the foot, and he in the legs and testicles. Two years later, Gennaro Cotroneo, a member of the local mafia, died on the premises. A mob proceeded to storm the hospital under the cover of night, before stealing away with his body.
Deceased mafia members aren’t the only things that have been stolen from Cardarelli Hospital. In October 2013, the institution suffered a major theft of pharmaceutical drugs. Coverage of the incident was patchy – the hospital described the medicines as “expensive”, but did not offer much more detail than that – but could easily be linked to a spate of similar thefts across southern Italy that year. Many have been linked with the Camorra, the same organisation that Cotroneo belonged to, but most of the thieves left barely any evidence behind; in one case, the intruder’s only calling card was a small hole drilled through a wall.
Italy is not the only country afflicted with this problem. Across Europe, criminal gangs are busy attempting to steal high-value pharmaceutical drugs, either for resale on the black market or to introduce into legitimate supply chains. The Falsified Medicines Directive (FMD), which will come into force in 2019, was passed into law by the European Commission to tackle this growing problem. The regulation introduces a new verification system that tracks the route of individual medicines from the manufactures to the user.
As Europe’s population ages – and life expectancies rise – there is an increasing demand for the entire spectrum of pharmaceutical drugs to be immediately available, placing intense pressure on manufacturers. The regulation aims to get ahead of a problem that is only going to get worse.
The Third Man
As far as crimes go, stealing prescription medicines is not a glamorous one. Indeed, one of the only points of reference for many people concerning medicine fraud remains the film The Third Man (1949), in which the slippery antagonist, Harry Lime, buys up the majority of the Viennese supply of penicillin, only to water it down, sell it on and leave dozens of patients with life-changing injuries.
The Europe of today bears little resemblance to the shattered continent portrayed in director Carol Reed’s masterpiece. But even so, the primary motivation for criminals who steal prescription drugs and sell them on remains unchanged. Broadly speaking, there are two choices: sell them on the black market, usually via dubious internet sites, or slip them into legitimate supply chains with the aid of corrupt individuals in manufacturing companies, wholesalers, pharmacies and hospitals.
It is this latter of these two choices that the FMD was designed to tackle. After a decade of consultation with a range of stakeholders in the pharmaceutical industry, the decision was made.
“It was agreed that the best way, and perhaps most practical way, of implementing this would be to have a verification system,” says Martin Sawer, an executive director with the Health Distribution Association. He is joined by Jerome Bertin, general manager of SecureMed, an organisation funded by manufacturers tasked with building the new verification database in the UK. New rules surrounding the scanning and authentication of packs mandated by the FMD will come into force across the EU, the UK and several countries outside of the union on 9 February 2019.
“It’s Switzerland, Iceland and… ?” Sawer asks Bertin. “There’s four actually,” Bertin replies, before adding Norway and Liechtenstein to the list.
“The UK can continue to be a member of the FMD even after Brexit if it wanted to, because of these countries that are not in the EU,” he adds.
Each nation is obliged to set up its own national verification database, all of which are linked under the aegis of the European Medicines Verification System (EMVS). The verification process itself begins with drugs manufacturers. The new rules are applicable to all market authorisation holders, from large branded manufacturers to genetic manufacturers and parallel distributors, who buy medicines in one country and sell them in another where they can command a higher price.
“They’ve got to add an anti-tamper-proofing device onto it,” explains Bertin. “This allows whoever is handling the medicine – whether it’s the wholesaler or the pharmacy – to check that the pack hasn’t been opened or tampered with.” A 2D barcode will be added that includes the product code, its batch number, expiry date and unique serial number.
Once all of this is added to the pack, the data about the medicine is uploaded by the manufacturers to the EMVS, which in turn passes this information to the relevant National Medicines Verification System (NMVS). While this is happening, the pack is in an active, ‘commission’ mode. As it passes from the manufacturer to the wholesaler, it is scanned by the latter to ensure that all the information contained in the 2D matrix complies with what has been recorded on the NMVS. If it does not, an alert is triggered and the wholesaler is obliged to take the medicine out of the supply chain.
Throughout this process, the medicine remains in ‘commission’ mode. Only once it reaches an official dispenser – usually a pharmacist – does the pack become ‘decommissioned’ from the system, a status change achieved by being scanned and, after being verified again by the NMVS, handed to the patient. In addition to being another drug-authenticity checkpoint, this helps pharmacists deal with the occasional recall of faulty merchandise by the manufacturers.
“They don’t have to look at each pack and a bunch of emails giving precise information about which batches cannot be sold,” says Bertin. “The system will actually tell them which product’s being recalled so they can return it to the wholesaler.”
Costs and debts
The new verification system mandated by the FMD is designed to be more efficient than current measures for checking the authenticity of pharmaceuticals, and cheaper than the alternatives. In fact, the new regulations were written to avoid the kind of expense associated with track and trace; a type of verification currently being trialled in the US.
Even so, the question remains as to what actual impact this new system will have on reducing the influx of counterfeit drugs into legitimate supply chains. After all, current data on the phenomenon remains scant at best. The most reliable global estimate of counterfeit drugs came from a World Health Organization (WHO) report in 2006, where it was estimated that up to 10% of all sales involved counterfeit drugs. However, this proportion varies wildly between countries.
“In the UK, we dispense approximately two billion packs of medicines a year,” says Bertin. “If it were the case that 1% were counterfeit, that would equate to 20 million medicine packs.”
With such a high quantity of fake products in circulation, one would expect there to be more reports on how this has affected the public. The fact that there have been no health emergencies caused by these counterfeit products is down to the strength of the British supply chains. What fake drugs do filter into the supply chains are often but single doses, which limits the impact on patient health. More often than not, the counterfeit drug is taken and the effects remain unnoticed.
“A person takes their medication, and it’s working well,” says Bertin. “They take the next batch, and it doesn’t work so well. Then they take the following batch, and it works well again.”
Even so, with the theft of pharmaceuticals on the rise in countries such as Italy and Romania – and the passing of these into the supply chains of other nations where the resale price is much higher – the issue of falsified medicines begs a decisive response from governments across Europe. The FMD is that response. The only significant question that remains is a vexing one for most stakeholders in the pharma sector: who is going to pay for it?
“Obviously there will be costs, [such as] investments in new IT systems, but the companies have anticipated that and are prepared for it,” says Sawer, referring to the outlays associated with placing the new 2D matrix codes onto packs. It’s a little more difficult for wholesalers, and especially pharmacists, who will have to install new systems to verify the packs.
“Wholesalers are reasonably clear and supportive,” explains Sawer. Pharmacists, however, will have to decommission every prescription medicine that passes through their hands. “There are huge implications for workflow and investment in systems within the pharmacies, and they…are concerned about the impact on their processes.”
Discussions are also still ongoing between stakeholders, regulators and the European Commission about flexibility in the dispensation of these verified medicines, and other practicalities of implementing the FMD. Sawer and Bertin, however, agree that there is one aspect of the transition to the new rules that observers needn’t worry about.
“The FMD doesn’t need to be affected by [Brexit],” affirms Sawer. “We – the stakeholders in the UK – will be continuing discussions with the government to make sure that it is supported by government, because clearly – as we’ve seen from the public domain – we’re not quite sure what shape Brexit is going to take.”
The relevant ministries have, however, been making very positive sounds. Sawer and his colleagues at the HDA were encouraged by a letter put out by the secretaries for health and business in the Financial Times supporting the alignment of medicine regulations beyond Brexit. The likelihood of avoiding the implementation of the FMD in the UK at the last minute is further lessened by the fact that the British government passed the regulation into law in 2013.
“We would hope that the government would maintain that line, and we will keep up the pressure to make sure [it] does,” says Sawer. “There’s no reason for them not to.”