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.