Sunday, February 11, 2018

Lawsuit against HDA dropped.

Notice that Tracelink dropped its lawsuit against the HDA regarding the Origin service was released this week.  Read the press release here (Link).

The absolute correct outcome, in my opinion.   From the start this lawsuit misrepresented the scope of Origin and read more like a bloated piece of marketing material.  I think of no other term but ‘frivolous’ when I see it publicly stated this case was based on ‘misunderstandings’.

The practice of wholesalers/organizations setting the tone for track & trace adherence in the industry is nothing new.  If this practice caused such an anti-competitive environment for L4/L5 solution providers why didn’t we see lawsuits three years ago when T3 electronic exchange was ‘forced’ by some wholesalers even though not required by DSCSA?   The answer is because, at that time, providing electronic lot level T3s actually kept some of these same solution providers in business.   Seemed a little too convenient to start complaining about this practice now. 

My personal experience has been nothing but openness and collaboration with the HDA/ValueCentric teams who position the Origin service as a very complementary offering to L4/L5 solutions.   I look forward to my future efforts with them. 

The fact is the Origin service offers a very real and necessary function which is to guarantee the accuracy of product identification (GTINs) and related attributes.   We just saw how well DSCSA barcoding is progressing (Link) so services like Origin attempt to ensure we don’t repeat the same utter failure when it comes to DSCSA data.  Unfortunately, it only addresses one piece of the puzzle- product master data- so many data issues will still arise. Moreover, everyone should recognize Origin is not the only service that can meet this need.  Data pools, like GS1's GDSN, have for years been providing master data collaboration for numerous industries and across all segments (manufacturing, distribution, retail).  However, the reality is most pharma companies have not advanced to the point of adopting GDSN as part of a master data strategy and thus why services like Origin fill a specific and immediate need.

As for the press release, I’m encouraged by the mention of aligning with standards but unfortunately believe this is just marketing fluff once again- I’m happy to be proven wrong but don’t quite see the need for more workgroups/new standards when no less than two GS1 standards which support master data exchange have existed for 10+ years.  For me this, again, falls into the category of being a little too ‘convenient’- making public claims of alignment with GS1 standards for the marketing credit but then do little to actually deliver support in solutions.  It certainly wouldn’t be the first time this has happened- and continues to be pervasive- with numerous solution providers in this space.  

So, what does this all mean going forward?  For many this lawsuit was an interesting side-story to keep an eye on, but others may have some very real impacts and questions to be answered.  We now have one of the major track & trace providers who has undoubtedly caused many key wholesalers (who also operate many of the largest 3PLs) and their primary industry association to expend significant time and money to defend against this lawsuit. Do we really think that relationship is all warm-and-fuzzy?

Why is this important?  To this point there has been a practice for many pharmas to select L4/L5 vendors simply based off who their packaging provider/CMO recommended- but now the focus is rapidly shifting to integration with the same distribution/3PLs and wholesalers named in this lawsuit- all in support of the next wave of DSCSA milestones in 2019.  So now these pharmas, who took a short-term view into serialization compliance by focusing on packaging only, are left to wonder how the next phase of their serialization program will play out.  

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