Last Friday a new committee formed by Rx-360 held their first meeting of parties interested in identifying architectures—or at least “conceptual models”—useful for efficiently meeting the full diversity of pharmaceutical track and trace regulations around the globe. Rx-360 is a non-profit organization “…formed in 2009 to support an industry-wide commitment to ensure patient safety by enhancing quality and authenticity throughout the pharmaceutical supply chain”, according to their press releases.
The new committee is called the “Traceability Data Exchange Architecture Work Group” and it seeks participation by anyone with knowledge of global pharma supply chains, country-specific regulations, serialization and track & trace technology and related standards. This is the sweet-spot of RxTrace and my own personal interests so I was very happy to find that the group is open to people like me. See the original press release about the group here.
Prior to this announcement Rx-360 has focused primarily on the safety and security of the supply chain for pharmaceutical and biotech ingredients where the drug manufacturer is the buyer—the endpoint of the ingredients chain of supply. This appears to be their first step into the pharma and biotech finished/packaged goods supply chain, where the manufacturers are the beginning of the chain of supply and pharmacies clinics, physicians and dentists—all known as “dispensers” in the U.S. Drug Supply Chain Security Act (DSCSA)—are the endpoint. In their short life (formed about the same time RxTrace began publication), Rx-360 has developed a reputation as the source for high quality ideas and information. This new venture is right in line with that reputation and I look for good things to come out of it. I have joined the group.
If you would like to join, I’m told you can send an email to Alexis Robertson and let her know you are interested. There is no charge to participate and you do not need to be a member of Rx-360, but be ready to hit the ground running. The goal is to develop a white paper on the merits of various models for the exchange of serialized supply chain information by the end of this year. The leaders acknowledge that is an aggressive schedule.
The ultimate goal of an effort like this is to develop an industry consensus model for supply chain traceability data exchange that can be voluntarily adopted by companies so those who choose to follow it can interoperability exchange the data necessary to comply with the various country-specific regulations. For that to work, all companies in the supply chain would probably eventually need to buy or build solutions that are compatible with the consensus model. That would likely be the only way they could remain compliant with the traceability laws in certain countries and therefore remain a participant in those markets. Multiple solution vendors are sure to offer those compatible solutions.
I have never met anyone who did not believe that GS1 standards would be at the center of whatever model(s) meet(s) that consensus, but GS1 standards do not deal with actual data exchange, beyond a specific data format. The data exchange transmission technology, where the data resides and the sequence of events in implementing each business process are subject to choice by the model designers. Both GS1 Healthcare (global) and GS1 Healthcare US are working on various aspects of these models, but neither will likely go as far as the Rx-360 effort in recommending one or more actual models for the industry. The Rx-360 group clearly acknowledges, and even depends on the work of these standards-making groups and will collaborate with them. They will also collaborate with the Healthcare Distribution Management Association (HDMA) and others.
In the early spring I heard rumors of other, less public, efforts getting organized around similar goals, but I haven’t heard anything about them since that time so I assume they fell apart. In my view, a private effort–particularly one proposed mainly by solution vendors–is a waste of time. Only a public, inclusive, unbiased organization composed primarily of members of the global supply chain will be successful in this work. I originally thought the Prescription Drug Security Alliance (PDSA) would be the most likely organization to kick this off (the “heir presumptive”), but apparently this kind of thing is not in their DNA (see “DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure” from last November). Rx-360 is now the “heir apparent” and this group plans to grasp their inheritance and lead us forward. If you take an interest in the direction this kind of thing takes, then I suggest you join.