On December 1, six months after the last major announcement from the US Food and Drug Administration (FDA) regarding progress towards “e-pedigrees” in the pharmaceutical supply chain, the eyes of the RFID industry will again turned towards Rockville, Maryland in the US. That's when the FDA will reveal its preferred technological solution for preventing counterfeiting by electronic tracking and tracing of medical products at every step of the chain, from manufacture to consumption.
Smart RFID professionals in Europe, however, should mark the day before in their diaries, and start sorting travel plans to Dublin - because on Thursday November 30 the Irish capital will host a premium quality conference on this hottest topic in healthcare product distribution. “Securing the European Healthcare Supply Chain - Where does RFID/EPC fit?” is presented by the GS1 Europe European Healthcare Initiative in conjunction with EPCglobal's Healthcare & Life Sciences business action group, and sponsored by Domino's Integrated Solutions Group.
The conference has attracted high calibre authorities from the international product coding and tracking communities but, given the conference's fortuitous timing ahead of the FDA announcement, the participation of John M. Gray, president and ceo of the Healthcare Distribution Management Association, stands out as a major coup for the organisers.
The HDMA is the US's leading representative body for the healthcare distribution industry and, as such, boasts a network of contacts with decision-makers that no European body can yet match. While we cannot expect Mr Gray to “scoop” the FDA news machine, it will be invaluable to hear the views of so important a body on the likely route map that the world's most influential regulator will follow towards e-pedigrees.
The conference is bound to see considerable speculation regarding the FDA's announcement the following day, which will concern the key issue of which technology, or combination of technologies, the administration chooses as the backbone of the e-pedigree infrastructure. In the light of the FDA's impact on supply chain integrity to date, it's hard to over-emphasise the importance of its decision. So, what can we expect to hear?
Looking back to the FDA's last announcement, I think we can make some educated guesses. Readers may recall that in June that the FDA concluded that, due to a slower-than-anticipated adoption of RFID, non-electronic, paper 'pedigrees' would be enforced from December. It was a decision that surprised practically nobody in the RFID community, because it reflected the emerging consensus among developers and purchasers of supply chain technology that, in current circumstances, RFID is set to fulfil its potential in combination with other coding technologies.
In the intervening six months, the signs are that this consensus in favour of what I call the “holistic” approach has grown stronger. In Europe in particular, systems integration has a strong influence on thinking about track-and-trace solutions, driven by a combination of businesses' natural desire to integrate the “new” RFID technology with their existing manufacturing and distribution systems, and increased appreciation of the substantial role that can be played by internationally-recognised alphanumeric and 2D solutions such as barcodes and Data Matrix. You need only look at the groundbreaking scheme which delivers 100% track-and-trace of Clotting Factor Concentrates (CFCs) administered to haemophilia patients at Dublin's St James's Hospital as well as at their homes in Ireland.
A further high-profile solution - Pfizer's item-level RFID tagging of packages of Viagra at its plant in Amboise, France - is another 'hybrid' combination of RFID and alternative data-carriers, in this case the two-dimensional Data Matrix code. More recently Domino's Integrated Solutions Group has led the development of a software solution that enables camera mobile phones to verify a product's unique serialised barcode and so assure end-users of its authenticity, or alert them to possible fraud. Any camera-phone programmed with specially adapted decoding software can scan serialised barcodes from linear to 2D Data Matrix codes. The software analyses the image of the code captured by the camera-phone, identifies the code and translates it into its unique alphanumeric serial number and streams the data to a secure database for checking against pre-set identification criteria.
In these and other applications I believe we can clearly see the shape of the track-and-trace world that is coming to pass - one in which the building blocks of the evolving global supply chain will be inter-operable, interchangeable data carriers that meet global compliance regulations. Essentially, the key requirement in any coding and traceability system is to capture, move and read the data, and some technologies do this better than others in certain supply chains, or at different points in the supply chain. As to which is chosen for a particular application, it will be “horses for courses”.
By accepting, in June, that non-electronic, paper pedigrees had a contribution to make, the FDA showed that its vision of the future of track-and-trace embraced more than RFID alone. Earlier this year, at RFID World in March, an FDA spokesman stated that “hybrid technologies, such as two-dimensional barcodes combined with RFID…might provide both identification and electronic pedigrees even without RFID being universally adopted”.
I believe these are clear signals as to what we can expect to hear on December 1. RFID and other coding technologies are not like separate trains running on parallel tracks, destined never to meet; they are converging. The challenge for all of us is to make sure we don't miss the train they create - which is why it's so important to be in Dublin on November 30.
For more information on the Dublin conference, contact John Jenkins, GS1 Europe Healthcare Initiative; T: +44 (0)118 903 4073; E: john.Jenkins@jjassociates.com
To enrol visit: www.gs1health.net
