Pharmaceutical Safety ePedigree Pilot Launched by SecureTrace Consortium


A consortium of ten U.K.-based companies, led by Authentix (an authentication and brand protection firm), aims to provide secure serialization and track and trace capability for the pharmaceutical industry. Their solution uses a combination of 2D barcodes, RFID, authentication, serialization, ePedigree, and wireless/mobile technologies to track and validate drugs as they move from the manufacturing plant, through the warehouse/distribution channel, and to the retail drug store or other point of dispensing. This should be helpful in anti-counterfeiting, reducing diversion, and improving drug safety. We’ve seen this movie before (at least a similar one) with California Express, but there are differences too.


Pilot Aims to Provide Authentication Across the Supply Chain

SecureTrace’s pilot project, described in Authentix March 10th press release, was implemented on a high-speed pharmaceutical packaging line at Reckitt Benckiser, a global home, health and personal care products company based in the U.K.In the pilot, the first step is printing and applying secure, serialized, 2D barcodes labels on individual pharmaceutical containers. The ink used on these labels contains difficult-to-forge authenticating markers that can be used in the field to verify the authenticity of the label. In addition, a “natural fingerprint” is generated using Laser Surface Authentication, providing another layer of verification. Pack data is aggregated to the carton and pallet levels. Then barcode labels and RFID tags are applied to cartons and the information is stored in a database. Readers throughout the supply chain can provide authentication of the product as it travels to its final destination. The pilot is described further in a brief case study on the SecureTrace website.

It Takes a Village – or At Least a Coalition – to Provide the Whole Solution

This is not the first time we’ve seen an alliance of several companies formed to provide a comprehensive serialization/ePedigree solution for the pharmaceutical industry. In 2007, SupplyScape (ePedigree/track and trace), Nosco (item-level serialization), and Systech International (Packaging Execution System) announced “the first integrated, seamless solution to address the growing global problem of counterfeiting and product diversion in the pharmaceutical industry.” They called their coalition the “California Express” and were holding workshops on how to meet the impending (we thought) ePedigree requirements of California. In short order, the founding group of companies realized they needed a few other pieces to round out the solution, including systems integration from HP, a warehouse/distribution solution from Acsis, and wireless/mobility solutions from inCode. Though the California imperative has been repeatedly postponed (largely due to industry resistance), this group of companies still has a website promoting the total solution they offer.

The truth is, end-to-end serialization and ePedigree for manufacturing, distribution, and retail environments, is still an emerging market and there is no single company today that provides all of the pieces. Partnerships between providers of the various components are needed and it is a natural step for vendors to formalize and market these partnerships as a branded coalition or alliance. In this case the new coalition, SecureTrace, incorporates technologies from several solution providers:

· Authentix – Forensic signature inks to print barcodes and enable authentication, authentication of product via serial code and covert technology at multiple points in the supply chain

· Ingenia Technology – Laser Surface Authentication

· Imsol and Loughborough University – High speed reading of multiple barcodes

· AND Automation – Manufacturing automation and control systems

· Pera Innovation – Business process consultants

Including a Customer as a Member Makes This a Different Kind of Coalition

This alliance is different from California Express, because it includes a customer.This is an interesting and possibly shrewd move. By including the customer, as well as a university, it gives the group more of the appearance of an industry consortium, rather than a “bunch of vendors who’ve cobbled together a solution. Still, there is no expressed intention for this to be any sort of standards body or actual industry organization. It may be simply a way to try to bring the voice of the customer more directly into the coalition from the inside, rather than from the outside. It will be interesting to see if SecureTrace can entice more companies to join; to not only become customers of the group, but also lend their name and reputation to the consortium as members.

Branding Seems to Target the End Consumer

It is noteworthy that the press release and branding highlights pharmaceutical safety, rather than anti-counterfeiting or diversion prevention. Of course they are related, but the difference in spin is significant. Drug companies care about anti-counterfeiting for reasons of both revenue loss and upholding their brand reputation, and they care about diversion to prevent reduced profitability. However, those issues are not central for the end consumer who cares more about safety. So it seems that the branding is aimed more at the customers’ customers (i.e. the end consumers), rather than at SecureTrace’s customer (the drug companies). It is unclear though, whether SecureTrace will make the considerable investment needed to create (and sustain over a long period of time) the public’s awareness of their brand, in order to create brand pull from end consumers.(We wrote a short piece about the challenges of succeeding at an “Intel Inside” branding approach).

Multi-layered Approach Enables High-confidence Authentication Across the Supply Chain

A central tenet in security is that if you want strong protection, you need multiple layers of security (e.g. the lock on the exterior doors to the building + lock on the lab + locked cabinet… or biometric + password + smart card).This consortium brings together a novel mix of technologies to achieve that higher level of security.

If You Build it, Will They Come?

California Express lost a lot of momentum once the deadlines for compliance were pushed out. Regulatory compliance can be a driver of adoption, but it is unpredictable and usually very slow.So, the real question is whether SecureTrace can convince pharmaceutical companies about the brand benefits and performance improvements from adopting their solution. We will stay tuned and let you know.

To view other articles from this issue of the brief, click here.

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