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.