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.  

A precursor of what's to come? Barcode issues are only the start...

GS1 US recently released a telling article about the current state of barcoding for DSCSA compliance (Link).  A great review and opinion from Dirk Rodgers was also released on Monday.  A highly suggested read (Link).

The crux of the study is that approx. 6.6% of all serialized barcodes evaluated by two of the largest wholesalers met expected quality requirements and DSCSA compliance.  The results of this barcoding survey, in my opinion, are staggering to say the least.   

Let's put this in perspective- imagine if the results had come back that 50% of the barcodes did not meet DSCSA compliance?   If these results held true, that means that in just 10 short months half of all products distributed in the US should be set aside for non-compliance.  That would be catastrophic to the industry.

So that fact that only 6.6% of barcodes evaluated met two of the largest wholesaler's expectations for quality and DSCSA compliance isnt just staggering- it should be a signal to the entire industry that the traditional ways of approaching serialization simply are not working. 

But what may be more interesting is-  How does the pharma industry view these survey results?   I'd love to think the majority of the industry is gravely concerned.  My fear is most are not.  My fear is many take a position of either:  A) I don't care,  B) That can't possibly apply to me because I use all of the 'leading' vendors or C) If that many are non-compliant then I'm probably in the same boat as everyone else and therefore don't need to worry about it.

It would generally be 'easy' to pin the blame for these results on CMOs/packaging sites- but doing so would miss the mark.  Non-compliance of this magnitude indicates a failure at multiple levels- this is an issue with both business and technical involvement, regulatory interpretation, requirements gathering, GS1 Standards education and, certainly, execution.    I have no doubt the majority of these implementations were fully tested/validated- which means these implementations were doomed for failure before they even started because they were being tested/validated against requirements which were already non-compliant.    

Part of this blame certainly goes back on vendors who are depended upon to be experts in this space.  Vendors at all levels should be able to recognize the issues that led to 6.6% compliance- that's not situational failure, that's systematic failure.  Even enterprise vendors, where most of my experience is rooted, are subject.  If your enterprise vendor didn't recognize these issues-  red flag.

But vendors can't be the only ones in the cross-hairs.  Whether the industry wants to admit it or not there has long been a mentality towards serialization to do as little as possible, as fast as possible for as cheap as possible.   This can't be ignored as a contributing factor.   A lack of necessary oversight and attention to detail has put the industry in the current situation and the scariest part might be- how many companies don't even know they have issues or are led to believe everything is 'OK'?

We now have a clear indicator of how well that mentality is working out for the industry.  And (sorry for the doom-and-gloom) my estimate is its only going to get worse when the focus shifts from barcoding to serialization data.   

The results from the GS1 survey are more likely to be a telling indicator rather than an unexpected blip on the industry's march towards serialization compliance. Where we go from here is in the hands of the industry-  the documentation, tools and services exist to help pharma companies get this 'right'.   Whether the industry chooses to pay attention and take the necessary steps remains to be seen.    

A free service to expose the truth about your serialization implementation

Drawing upon over 10 years of experience implementing almost every major serialization solution on the market today Jennason is offering a free evaluation of your serialization implementation- focusing on its adherence to GS1 standards and its ability to meet global regulations.

The reason for offering this service now is simple:  the industry is being significantly mislead through false claims and misinformation about the proper implementation of GS1 standards which are a necessity to make industry collaboration possible.  By offering a free service my hope is companies see no barrier in looking further into the problems which are besieging their implementation.

Reach out to Jennson to learn more about this free offering and to hear actual use cases of pharma companies who confronted these issues and took action to get their implementations back on track. 

Learn About Enterprise Serialization Systems at IQPC Next Week

Join me on May 23, 2016 at the IQPC Traceability Forum in Philadelphia where I'll be giving a presentation on best practices for enterprise serialization systems. (http://goo.gl/pybOnw)

As many pharmaceutical companies are just starting to develop their education and strategy around serialization this session is focused on providing the groundwork for how an enterprise serialization system fits into the big picture of enabling serialization at a pharma manufacturer or CMO.

We'll review common approaches the industry is taking to leverage an enterprise system to facilitate integration with packaging and distribution partners, customers and government repositories to enable a flexible and scalable serialization capability.

We'll also focus on the key features/functionality which an enterprise system must provide including:

• Serial Number Management
• Serialization Data Management
• User Reporting
• Partner Integration

Finally we'll zero-in on some lessons learned from Jennason's nearly 10 years of experience evaluating and implementing enterprise systems.  We'll identify the pitfalls which companies must be aware of in order to make a vendor selection that best fits their specific serialization needs including:

• The importance of deep-rooted support for standards (EPCIS)
• Recognizing the value of customer-controlled flexibility
• The need for out-of-the-box reporting and analytics

Many thanks to IQPC for this opportunity to present and to Verify Brand (www.verifybrand.com) for their sponsorship.   If you are interested in attending and haven't yet registered email me (scott.pugh@jennason.com) for a discount code.

An Important Fact about 'One-Off' GLNs

Up until recently GS1 US (and likely other GS1 organizations) offered a 'One-Off' GLN Subscription service to help organizations obtain GLNs at a reduced cost.   The key difference with the GLNs which were allocated through this service is they did not contain a Global Company Prefix specific to the organization.   On the surface this causes issues when trying to translate the 13-digit GLN Element String into its corresponding URN format, such as urn:epc:id:sgln:0614141.12345.400.

GS1 US recently stopped offering the 'One-Off' GLN and instead restructured its pricing so that companies who only needed a small number of GLNs could obtain a valid GS1 Global Company Prefix at a very reasonable price.

However, if your organization is dealing with CMO,3PL or other supply chain suppliers/partners which obtained their GLNs through the 'One-Off' subscription service then ensure you follow the rules below provided by GS1 Global:

One off GLNs are handled as though they have a 12-digit GCP.

Example 1:

“one-off” GLN: AI (414):  0312345678913

Extension:  AI (254):  none

implied 12-digit GCP:  031234567891

EPC Pure Identity URI:   urn:epc:id:sgln:031234567891..0

Example 2:

“one-off” GLN: AI (414):  4012345678918

Extension:  AI (254):  4711ekW

implied 12-digit GCP:  401234567891

EPC Pure Identity URI:   urn:epc:id:sgln:401234567891..4711ekW

As companies move into later stages of implementation these are the details which can cause frustrating issues and delays.  Ensure your serialization systems are configured properly to parse these GLNs using the rules above.   And of course reach out if you'd like any more insight....

A Plea, A Hope and A Fear for Pharma Track and Trace

In general I try to stay out of the political on-goings at the Federal, State, and international level in regards to pharma serialization and track & trace regulations primarily because there are plenty of other folks who are involved in that space and they do it quite well.   

But over the last few days I too have found myself listening in to the CA board meeting and checking the house/senate schedule for when pharma supply chain security will be discussed.   I have no more insight into what will happen in the coming days/weeks/months than anyone else but I do have a plea, a hope, and a fear for the pharma industry in expectation that a Federal bill will pass and California E-Pedigree rides off into the sunset.

A Plea
Re-evaluate strategically.  Should California go away and be replaced with federal regs that push serialization timelines out a number of years every pharma is going to have to analyze their own situation- Are they subject to enough international regulations that it makes sense to push forward with a global solution?  How to harvest value out of what's been done to this point?   Would the Federal Bill be a get-out-of-serialization-hell-for-free card?

I certainly couldn't blame the pharmas who decide to shut everything down and re-allocate serialization funds elsewhere- let's be blunt- in general I don't get the warm-and-fuzzy from those in industry that they were really excited about serialization in the first place so why should things suddenly change?

But therein lies my plea-  I challenge the industry to change the tune of serialization and do a reality check.   The concept of serialization and traceability isn't the problem here, the problem has been the constant up-and-down, on-and-off wrangling of politics.

My plea is for the industry to demand more.....demand more in understanding how serialization and traceability can actually help you, not hinder you

• Implement serialization because you understand how it will help your patients
• Implement serialization because you understand how it can differentiate your product
• Implement serialization because you understand its importance to your supply chain's future

I think the big players in the industry are already somewhat down this path- but I can't say its true for the majority of the industry.  

A Hope

I think its safe to say that most in the industry never really viewed the Pedigree Document model as the best way to achieve traceability in a supply chain.  Moreover, I was never a fan of the GS1 Implementation guideline that came out in last year which proposed how to use EPCIS to meet Pedigree requirements.   So my hope is in fact the Federal Bill does pass so that the industry can reach a more comprehensive understanding for how to implement product traceability (the right way).   As we speak, the industry is barreling down a path of procuring and building solutions based so heavily on Pedigree and so heavily on the GS1 Implementation guideline.   Don't get me wrong- I am a huge supporter of GS1- but if you blindly think the world will always follow GS1 you're backing yourself into a corner.

I'm a big fan of EPCIS, but a fan of pure EPCIS, not one that is bloated with master and transactional data.   Here's just a tiny glimpse of what I'm saying-  there are 3 major data sets in play in any serialization and traceabilty implementation  1) Traceability data   2) Master Data   and 3) Transactional Data.    EPCIS, GDSN, GS1 Business XML and/or EDI represent these data sets that must work hand-in-hand in order to provide complete visibility.

My hope is someday enterprise solutions will enable the collaboration between these three data sets while also maintaining there independence and integrity because that is the key to scalability and value in traceability solutions.  And oh by the way- if the day comes that solutions reach this level of maturity- the ability to meet new regulations, even as complex as E-Pedigree, becomes a much simpler effort.

A Fear

The fear is quite simple- that history repeats itself.  That the industry turns it's back on serialization and decides to play out this scenario again in 4 years.   The fear is that interest in the concept is lost, people move on, knowledge dies, and solution's capabilities essentially remain stagnant.  If that in fact happens then passing a federal law giving people another 4 years really does nothing at all.  Again let's be honest- it's a very distinct possibility that I could write this exact same post in the Fall of 2017-2018 and it be just as relevant.   That would be unfortunate.   But there could be a unique difference 5 years from now.  It's highly likely that 5 years from now people will be buying everything from computers to mattresses to coffee and have the ability to see that specific product's entire history- from manufacturing to your doorstep. Think its far fetched?  For some companies its already a reality today.  So when that becomes the norm- even for consumer goods- can you imagine the reaction when people learn that a majority of our most life-saving drugs don't offer the same clarity?   Why must we reach the point that things have to be 'inexcusable' or 'inexplicable' before we do something about it?     

Should be a fun ride over the next month.....

Don't Slack on Your Serial Number Manager

In the early days of enterprise pharma serialization solutions the Serial Number Manager (SNM) component was somewhat of an after-thought.    SNMs were typically looked upon to provide ranges of sequential numbers with an ability to report which ranges were allocated to which locations.  The prevalence of GS1 standards pushed SNMs to have native support for GS1 SGTINs and SSCCs but little flexibility beyond that.  

As long as SNM didn't allocate duplicate numbers everybody was happy. 

As I've stated in the past the big issue I see with most pharma serialization solutions is they are so specific to GS1 and so specific to E-Pedigree.  As serialization implementations heat up, whether it be for the US or abroad, the industry may be in for a rude awakening.

International regulatory requirements for randomization (EU), non-GS1 support (China), and support of serialization pre- SNM have introduced use cases for Serial Number Managers that many solution providers are struggling to keep up with.

A few key requirements that I consider to be must-haves in any SNM:

• Must offer a non-pattern based Randomization option- Seems obvious but some leading providers don't utilize true randomization.

• Complete control over the length and composition of Serial Numbers - Again seems like an obvious ones but too often pharma's are settling for solutions that limit the ability to generate SNs of specific lengths or using specific character sets.

• Ability to assign SN configuration at a product level (i.e GTIN in the GS1 world)- Global pharma manufacturers need to assign different SN compositions at a product level to deal with regulatory differences across markets.   SNMs must also provide simple mechanisms to account for SNs that were allocated prior to SNM implementation, again at a product by product level.

• Support for Non- GS1 keys- Understand that an SGTIN and SSCC are just two types of Unique Identifiers (UIDs) that exist in this world.   SNMs must be rooted in the ability to generate UIDs of any format or structure so that when something other than SGTIN or SSCC is needed it’s a matter of simple configuration. 

Contact me to review if your Serial Number Manager passes the test.