EPCIS woes continue.....

Another day…another woefully non-compliant EPCIS message supported by some of the ‘biggest’ players in the space.  Most will say  “Hey Scott, lighten up, it gets the job done so who cares if a few things here-and-there are not compliant”     

So as a year-end message I’ll get back on my soapbox again-   The reality is most of these ‘infractions’ (except the last one discussed below) likely don’t have a material impact on how the EPCIS communicates the necessary information from point A to point B….  the real risk/concern is this is yet again just one small example in an absolute ocean of examples where the industry is not just lax in its attempts to strictly adhere to EPCIS but is fully welcoming of it.

I’m not some private investigator with special tools that can detect these issues- I’ve praised/linked to the FREE tool that will reveal most of the issues below in a matter of seconds (https://epcisworkbench.gs1.org/ui/home)….so this can’t be about it being too hard to root out non-compliance…its simply that:

1) To this point, there hasn’t been an overwhelming reason to be air-tight on EPCIS compliance-   No EPCIS police to come around and stop product from flowing and not nearly enough interconnectivity across the industry for these issues to start causing bigger issues.

2) It’s hard to push back when some of the ‘biggest’ players in the space are the ones openly generating non-compliant EPCIS and/or willing to accept non-compliant EPCIS

Previously I’ve raised the notion of one simple way that non-compliance with EPCIS directly impacts the industry:

Take the last issue highlighted below.  Its black-and-white- both entries are simply not compliant.   But it’s happening out there in the wild (which by the way I would be interested to know if either the sending or receiving vendors are ‘certified’ by an EPCIS conformance testing service) which means the system generating this EPCIS was built in such a way that allows that to happen and, even worse, the system receiving these messages either A) didn’t catch these as issues and/or B) was built (and even possibly ‘enhanced’) to support receiving these messages.   The development it takes to support not only compliant EPCIS but now also the ocean of non-compliant EPCIS costs money.  And do you think the vendors just eat those costs?  Of course not, it goes back on the industry through increased annual fees or baked into some new ‘module’ that will be marketed.  

Now extrapolate that out over the massive number of ‘connections’ that have to be put in place by 2023 for the US market to achieve compliance.    If every vendor can go off and define what they feel is acceptable use of EPCIS then it’s the pharma industry who ultimately feels the pain.

In this space, 2021 will be the year of collaboration (or non-collaboration depending on how it plays out).   The technical issues below are likely viewed by many (not me) as minor, but what needs to be in focus is whether the industry maintains the mindset that’s been attached to EPCIS compliance…. There should be no ‘minor’ or ‘major’ non-compliance- it needs to be black-and-white… you’re either compliant or you’re not….and unfortunately, we are long past the point where non-compliant practices have become the norm.

I wrote a blog post nearly a year and a half ago that pondered whether EPCIS had lost its value as a standard within pharma serialization….  Instances such as below would seem to indicate nothing has really changed….and I still think we are just at the tip of the iceberg when it comes to understanding the impact that these seemingly insignificant and incredibly detailed ‘misses’ will have when trying to accomplish end to end traceability in pharma.

My last few posts have focused on the need for the industry to do a reality-check on whether we are moving forward with serialization/traceability in pharma in the best way possible.  Non-compliance with EPCIS is yet another reason why this reality check is needed.

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Note: X’s are mine- used to preserve confidentiality

Quick Thoughts on HDA's EPCIS Implementation Guidance....

Quick thoughts on the EPCIS implementation strategy released by the HDA in September... (https://www.hda.org/~/media/pdfs/government-affairs/position-statements/2020-09-29-getting-ready-for-epcis.ashx)

Few important highlights for me, with one being especially timely given my last post regarding the necessity for options centered around open governance industry networks.

Currently, EPCIS is the only internationally recognized standard that will meet these DSCSA requirements. 

Always good to to see the commitment to standards and specifically EPCIS.   Yet still amazing how many current connections across the industry (and even new connections continue to be established) which either do not use EPCIS or use a non-compliant EPCIS structure.

An additional complicating factor is that given the many supply chain entities that must meet the DSCSA’s 2023 requirements, competition for the services of the limited number of experts and consultants to advise on EPCIS execution will be keen. We anticipate a very high demand for this expertise -- potentially limiting trading partners’ ability to obtain the timely help they need just as they face the DSCSA’s critical deadline.  

Of course as a consultant myself I have to biasedly agree with this.     But, in my opinion, the real importance of this statement is not that I'm going to be busy the next 3 years, but rather what am I going to be busy doing?    My guess is most people read that paragraph and think "Yea think of all the connections that have to be set up between every manufacturer and their wholesalers and the wholesalers and pharmacy/hospitals.   Yikes that's a lot of work!!!"

And in fact that's exactly where the HDA guidance continues to....

At the outset, the bulk of this implementation will center on each manufacturer achieving successful EPCIS data exchange with each of its wholesale distributor trading partners. 

We encourage each pair of manufacturer and wholesale distributor trading partners to work together to establish a joint implementation plan for EPCIS execution that builds in adequate time for putting the necessary infrastructure in place, evaluating data quality, onboarding, testing, and stabilization.

And here is where my opinion starts to diverge...

The statement above sends a very clear message to the industry that we will follow the same path as we've been on for the past 10+ years...spending the dollars and resources to set up connections between each partner.   As I said in my last post- if that is the direction the industry chooses to go then c'est la vie.   I wish the guidance here wouldn't explicitly assume that's the best path forward....

My central point is-  We will have missed the boat again if we spend the next 3 years setting up integrations between each trading partner.   Those dollars and resource time should instead be allocated to deploying an open, industry governed collaborative network  (and no, despite whatever claims might be made, none of the traditional solutions/vendors fit this mold today).    Take the learnings from the last 10 years- recognize the good parts but also own up to the bad parts- and simply just look to improve over the next 3 years...staying on the same path isn't improvement....   As stated in my last post- that's the industry's call to action.....   

But there also is a call to action for solution providers.....   In HDA's defense, it would have been hard to even make reference to an open industry network in this guidance because, frankly, we havent heard nearly enough about them yet..... The messaging is starting, as we saw from the Linux Foundation announcement last month, but we need more info, more education and more tangible understanding of exactly how such a network operates and can meet the needs of 2023.... and we need all of that ASAP.

My view is, at a bare minimum, we at least owe ourselves the time/effort to more deeply consider the open network concept before assuming its not an option at all....So while I fully agree that it will take a lot of work to achieve 2023 compliance I hope that work is focused on the right efforts...

A must read article for anyone in pharma serialization/traceability...

Last night I came across a fantastic post by Robert Miller.  If you are not familiar with Robert's work, he has a great depth of knowledge and experience focused on the intersection of technology and healthcare.   In particular, many of Robert's recent articles have centered on healthcare (communication/collaboration) networks and the consideration (my interpretation: importance) that these networks are neutral and open.

Here is Robert's Newsletter:  https://bert.substack.com/

And the link to the specific article:  https://bert.substack.com/p/the-linux-foundations-open-governance

As is often the situation, when a subject matter (pharma serialization in this case) is evolved only by those who are uber-focused in that singular area it has the tendency to lose perspective of the bigger picture.   We often hear of the benefit to bringing in a 'fresh-set-of-eyes' to review a challenge and get new perspectives.    I think that is the critical point that pharma serialization is, and has been, at for some time now.   I am the first to admit that my blinders are often on when it comes to my work in this space- but fortunately there have been a few experiences over the past year which have made me recognize the value of 'new' voices entering into the mix.   This article is one of those experiences.

I've had the chance to speak with Robert in the past and discuss my impressions of how his articles so accurately describe both the big challenges ahead, but also some of the key missteps that (in my opinion) the industry has made with implementing serialization/traceability.   Robert will be the first to admit he has not been knee-deep in pharma serialization for years and years- and I cannot stress enough how GOOD that is.

So reading his article last night was once again a breath-of-fresh-air that I hope other folks like myself who have been knee-deep in this space will intently read.    In my opinion, the 'test' here is quite easy-  Read this article and form a clear Yes/No opinion on whether you think pharma serialization is on the path that Robert describes (and share your thoughts/opinion in the comments).  I'll provide my answer at the end of this post.

The goal here is to let Robert's article shine-  so the following are my favorite excerpts (bold/underline added by me for emphasis):

In several industries domain, like pharma supply chain traceability, there are many different networks all vying to become the network for the entire industry. Each of these networks is backed by a business that seeks to not only provide a solution to the immediate problem, like tracing prescription drug supply chains, as well as a more general platform for others to build on. But this structure poses two potential issues related to the neutrality of the business creating the platform.

[SP]: Fortunately, Robert uses our exact industry/use case as his example- and sets up the key premise for the article.....which is....

First, the end user of these platforms worry about being locked into using a single platform: without competition the platform creator may seek undue rents. Alternatively, the platform creator may pivot and shut their platform down, leaving users scrambling to find an alternative

[SP]: Three paragraphs in and, for me, he's already highlighted one of the most critical, yet also one of the most ignored, risks facing pharma serialization...   Take this statement in the context of a post I made a year ago on this topic-  "Consider the reality that some vendors are arbitrarily raising their annual fees year over year for no justifiable reason while customer’s feel ‘trapped’." (http://www.lifescienceserialization.com/2019/10/what-history-tells-us-about-why-future.html)

The vision of Open Governance Networks is that competing businesses will collaborate together on open source software instead of building distinct, competing, and proprietary platforms and networks....... Businesses could then build and sell proprietary applications on top of the open source core technology, and they would be able to deploy them to a ready-made network instead of standing up their own network. All of this allows businesses to focus on building applications instead of competing on creating platforms or convening networks.

Open Governance Networks would allow companies to focus on building value-adding apps instead of the underlying pipes.

In many cases platforms will need to be credibly neutral to gain adoption. 

[SP]: The article concludes with what I consider to be a slam-dunk- Simultaneously offering a vision for how pharma serialization/traceability should operate in the future while also providing a measuring stick for how well the industry has adopted this vision thus far.

Remember the 'test' I noted earlier? Read this article and form a clear Yes/No opinion on whether you think pharma serialization is on the path that Robert describes  

My answer-  A resounding No.  Why?   Think about the state of pharma serialization currently: 

• Most participants largely locked into one, or a few, vendors.   
• Emphasis still placed on achieving minimal compliance while disregarding long term implications.   
• A misperception that the industry has somehow already achieved significant interconnectivity when in reality the industry is only scratching the surface in terms of exchanging data with partners.  
• Many participants are literally unable to source complimentary/ancillary solutions from an open market because their primary enterprise serialization vendor either cannot support or will not allow integrations with 3rd party solutions    (Not sure what I mean by this one?  As a solution provider myself I see first-hand the true 'openness' of the enterprise serialization vendor landscape and happy to share my experiences)
• We are operating in an environment where certain participants can exert significant influence over who their immediate partners should select as their serialization vendor- simply based on who they've 'connected' with in the past. (Think CMOs 'suggesting' vendors to their manufacturing customers)  That is absolutely bonkers- but it happens everyday and is simply proof that we are not operating in a open, standards-based, neutral-governance ecosystem.

I'm encouraged that at least one initiative (that I'm aware of) which could make a play in the pharma serialization/traceability space is involved with the Linux Foundation.  Having said that- the time is now for these initiatives to become more visible and start educating the industry.  That's the vendor's call-to-action.

What is the industry's call-to-action you might ask? As a very first step I think the industry needs to put a stake in the ground on this decision:  

• Either continue down the path of proprietary and commercially-backed networks and accept the higher costs, lower competition and inflexibility that brings

-OR-

• Recognize the vision of open, neutral-governed platforms as laid out in Robert's article and start moving in that direction. Accept that the best chance to not only achieve serialization compliance but also actually realize other value opportunities on top of that comes by commoditizing the collaboration layer and opening up competition to those who can best extract value from the data.

Probability right now says the industry chooses Option #1 simply because it's the easy choice.   Either the industry can explicitly choose Option #1 or the industry makes no choice and Option #1 becomes reality by default. And if that's how it plays out then c'est la vie.

But if the industry takes a stand and genuinely wants to choose Option #2 then it cannot be done through words or endless roundtables/meetings or intent alone.  It must be through action.  Companies need to start taking positions, as we speak, to ensure their strategies and vendors/partners are aligned to Option #2.    And maybe here is the real true test-  for a large number of companies out there- manufacturers, CMOs, 3PLs, wholesalers and pharmacies- if you think your vendors are already aligned to Option #2, I'm sorry to be the bearer of bad news but in fact you just made the decision for Option #1.   

The industry has already spent so many years and so many millions (billions?) of dollars rolling out serialization/traceability- the presence of serialization 'fatigue' is real-  but to get anywhere close to the vision Robert lays out- now, maybe more than ever, is the critical time for the industry to get on the right path.