Redirecting the traffic

Posted on April 13, 2010

With the trade in black market medicines now nearing epidemic proportions, can recently introduced EU pharmaceuticals packaging legislation drive counterfeiting off the world’s highways? Sam Cole investigates.

According to the UN, an estimated 30% of anti-infective treatments in Africa and South-East Asia are fakes, including half of the anti-malarial drugs sold in Africa (valued at over €300 million/year). Nor is counterfeiting just a third world problem, says the European Federation of Pharmaceutical Industries and Associations (EFPIA) in reporting that over 11 million illegal medicines were stopped at EU borders in 2009.

This isn’t just about dodgy Viagra over the internet. Many of these fakes are poorly made, containing the wrong dose of the active ingredient. If taken instead of the real thing, these fakes can turn a treatable disease into one with far-reaching and unnecessarily expensive consequences. At the least they can foster drug resistance among germs; at the worst they can prove fatal. Unofficial estimates produced by the World Health Organisation indicate that counterfeit drugs could be directly responsible for the deaths of over 100,000 people each year.

Estimates vary as to the value of the worldwide counterfeit drugs trade from between €75 – €145 billion. Closer to home, however, it is possible to be more precise: it is reckoned that 30% of all prescription drugs dispensed throughout the UK is formulated in rogue laboratories. A research programme recently carried out by Pfizer found that almost 20% of respondents across 14 different European countries had acquired medicines through illicit channels in 2010, making the EU black market alone worth €13 billion.

Cracking down on counterfeiting

A critical first step has now been taken towards harmonisation of security strategies via approval given in February to the EU Falsified Medicines Directive, which calls for the packaging of all prescription medicines produced within the community to be issued with a unique non-predictive alphanumeric number supported by tamper evident labelling.

Directive 2001/83/EC is mandatory and will be obligatory on the outer packaging of prescribed medicines. This covers all manufacturers (including generics), contract packers, re-packers and importers. Apart from Belgium, Italy and Greece, where there are complications specific to existing systems, the Directive is expected to be fully implemented within the next 18 months at a likely cost to manufacturers and importers of medicinal products of between €6.8 billion – €11 billion, depending on the safety technique chosen.

Although the final details have yet to be ratified, it is almost certain that the unique number will be represented in human readable and ECC200 2D data matrix format, considered to be a proven, reliable technology requiring least change to the production and supply chain infrastructure, says Domino’s Global Life Sciences Sector Manager Craig Stobie. “Mass serialisation effectively enables the manufacturer to hide his security in the open and enable consumers to authenticate products for themselves. But it is not about putting in a single system, and this is the challenge to manufacturers, as they have to look at this holistically.

“There are essentially three building blocks: a coding device; a vision device to check that the codes are readable – also that the production process is behaving as it should – and efficient mechanical handling. The system is only as good as the worst of those three.

“Whilst serialisation becomes the minimum standard; thereafter, it’s down to how far the product security route the manufacturer wants to go. The next level is aggregation – informally referred to in the sector as the ‘parent/child/grandchild’ relationship between serial numbers – which basically means that it’s only necessary to look at one number in order to get to the others to which it links.”

Although Domino is an established market leader in alphanumeric coding it has had to go back to the drawing board to hone a technology capable of delivering the optimum combination of human readable text and a machine readable 2D barcode, says Mr Stobie. “It’s taken us four years to get this to meet the required standards. We’ve had to invent new inks and new ways of putting them down. Also, if you increase the resolution of print by a factor of two, it pretty much follows that you’ll have to increase the requirements for handling it by a factor of four. It’s actually harder to manage the data than it is to make the product.”

Even so, the Directive’s endorsement of what is in essence the tried and tested method of product authentication will be seen by some as a rejection of smarter, more sophisticated technologies such as RFID, which is already struggling to achieve an affordable cost/volume ratio.

While it has been recently championed by the likes of IBM, and 3M working in conjunction with Abbott Laboratories, its application as a unit pack authentication mechanism is in conflict with its track and trace capabilities; for example, consider the logistical improbabilities of an RFID tagged outer carton containing innumerable similarly equipped individual packs. In any case, 2D barcoding is quite literally adept at track and trace as well.

Industry out of step

While welcoming the Directive, there is some indication that it is more of a ‘rubber stamp’ than a cure-all. Having been alerted to a thriving black market in its HIV treatment drug Serostim, US pharmaceuticals manufacturer Merck Serono adopted one of the industry’s earliest data matrix coding strategies, which included an individualised identification number for each pack via a randomised, seven-digit serial that was scanned and logged at the point of dispensing; the net result being the total elimination of further counterfeits in the supply chain within less than two years.

Meanwhile, although many countries feel that a 12-character data matrix code is sufficient, the French have gone one number further by implementing the Club Inter Pharmaceutique CIP 13 system as of 1 January this year. In addition to adding a batch number expiry date, CIP 13 essentially replicates the human readable data into a data matrix reader, thereby necessitating that the packaging line is appropriately fitted with a device that can not only read the data matrix code but that also verifies that it can indeed be read by the human eye.

The addition of an extra digit is not so critical from a coding equipment perspective, as the same laser or a high resolution thermal inkjet technology would still be required to meet local conditions. Nevertheless, with three European countries (Belgium, Italy and Greece) already having been given six years to implement Directive 2001; one of the EU’s major prescription medicine markets out of step; and similar anomalies and variations on the theme elsewhere, the message being sent to counterfeiters is still a long way from being consistent.

From counterfeiting to compliance

However welcome or laudable the drive towards determining common standards might be as a deterrent to counterfeiting, by stopping short at the pharmacy they are still a long way from engaging the consumer in the overall authentication process.

“All of these schemes with aggregation are fine as far as getting to the distributor, and thence to the individual pharmacist; but that’s where it stops,” observes Brecon Pharmaceuticals’ Business Development Director Steve Kemp. ‘The debate now must be how to extend it beyond the pharmacist to the consumer as, when all’s said and done, the only way any drug will succeed depends upon the patient’s compliance.”

The dream ticket as far as the supply chain is concerned would be for track & trace, authentication and compliance to be wrapped up within one technology. As the sole European Burgopak licensee, Brecon is already well advanced in that direction. Looking further down the road and with some packs already programmed to conduct a basic interaction with consumers, the likelihood is of a cure-all becoming a reality in the not so distant future, says Mr Kemp.

“The opportunities for packaging technology are legion, since it would clearly be impractical to authenticate down to each individual pill. What’s actually holding back track and trace or the way in which its potential could be increasingly realised isn’t so much the capability or the reach of the technology but arguably just the data protection act,” says Mr Kemp.

Whilst the barcode in tandem has been determined as the first line of defence, a range of other technologies can still provide useful support, says carton manufacturer Firstan’s Sales Manager Ian Nurse, whose company was the first in the UK to gain ISO 1578 accreditation.

“Many of these measures within the EU Directive are in place already within ISO 1578, so they won’t make much difference to us,” says Mr Nurse. “For example, we’ve been operating the alphanumeric system for one particular client for some time now – it is good that they’re looking to tighten up on counterfeiting where they can.

“There are lots of different things that can be employed as well: some of these are visible, for example security tagging; holographic labelling; coin-activated inks or individual print icons. Others are entirely covert as far as the consumer is concerned: light-sensitive inks that can only be picked up under a UV reader; micro text and so forth.

“There really is so much in play to try to stop counterfeiting. How much of it is deployed depends upon how the customer perceives the necessity for it; and thereafter, whether it’s an almost obligatory service to be offered, or a service that’s chargeable,” concludes Mr Nurse.