I’m pretty excited about the kickoff this Wednesday of the GS1 EPCglobal Software Action Group (SAG) Discovery Services Work Group which will take the business and technical requirements that were collected by an earlier group and turn them into an actual standard.  This will be the first new major technical standard GS1 has started for quite a few years.  The most recent kickoff I can remember was the GS1 Drug Pedigree Messaging Standard (DPMS) which kicked off back in late 2005 and completed in January 2007.  The GS1 Electronic Product Code Information Services (EPCIS) standard effort kicked off in late 2004 and completed in April 2007.  That gives you an idea of how long these things take.

The effort to create the business and technical requirements for Discovery Services started just about two years ago and completed this past December.  How long will it take to get to a ratified standard?  The GS1 Discovery Services Work Group Charter predicts it will be done in June of 2011, but predictions in charter documents are notoriously optimistic.  The EPCIS Charter predicted that standard would be ratified in August of 2005, for example—one third the time it actually took. 

This is not a bad thing in my opinion.  A Charter document needs to estimate how long the effort will take, but once things get rolling, GS1 EPCglobal takes as long as needed to get the standard right.  So how long will this one take?  Based on how long the requirements took, I’m guessing the development of this standard will take some time.  Right now, I’d guess it will be complete sometime in early 2012.  That would be two years.  Hmmm….  Almost feels too short.  We’ll see.

Standards development can be contentious.  If it’s done right, that is.  I’m talking about contentiousness along the lines of the Lincoln-Douglas debates or the crafting of the U.S. Constitution, only pitting different technical approaches against each other.  The GS1 EPCglobal SAG facilitation crew really knows what they are doing when it comes to facilitating contentious groups so the blood, sweat and tears invested are directed in a positive direction and results in a valuable standard in the end.  I worked with Mark Frey in the development of DPMS and I just can’t say enough good things about him.  According to the charter document, Mark will be involved in the Discovery Services group, as will Giselle Ow-Yang—a great start.  From these choices you can tell GS1 EPCglobal places a lot of importance on the success of this effort.

BUT WILL DISCOVERY SERVICES HOLD ANY VALUE FOR PHARMA?

Right now, I don’t think the pharma supply chain will be able to make use of Discovery Services for regulatory compliance with current or even future pedigree laws.  As far as I can tell, I’m the only person I know who sees it that way so let me explain.  It comes down to what Discovery Services is aimed at and how that differs from what pedigree laws are trying to accomplish.  There seems to be a disconnect between what people think a pedigree law is trying to accomplish and the reality.  That leads them to the misconception that something like Discovery Services has value for compliance.

I reach this, perhaps shocking conclusion from the following analysis.

FUNDAMENTAL LAW OF COMMERCE

In my first substantive essay in this blog I pointed out what I called a fundamental law of commerce.  That is, when regulations mandate that a product’s value is determined by the ability to show, at any time, specific information about the product’s history, then the buyer of that product must receive all of the necessary information from the seller at the same time the product is received.  That information is so intertwined with the product’s value that it actually becomes part of the product itself, and needs to move with it.  Supply Chain companies who buy products can’t rely on previous owners to hold information on their behalf without a contract to do so if the total value of those products depends entirely on the instant availability of that information at any unpredictable moment. 

This is the case with drugs in supply chains that operate under pedigree regulations.  If a regulatory inspector arrives at the door of one of these companies and asks to see the pedigree of any item they happen to pick randomly from the inventory, and the company cannot produce the pedigree because they are unable—for any of a myriad of reasons—to collect it from remote databases controlled by upstream trading partners, that item has zero value and the company should expect to be fined, or worse. 

When this scenario happens, more than likely the pedigrees of a lot of other units will also be unavailable at the same time for the same reason.  This single inspection at the wrong time–when an earlier owner’s database is, coincidentally, unavailable–could result in a significant part of the company’s inventory being impounded, large fines imposed and the opening of a wider investigation.  All because essential information was not in the control of the party that was responsible.

So, a distributed pedigree doesn’t work in a regulated supply chain.  But why doesn’t this issue get discussed more in industry groups that are trying to figure out how to create an interoperable, standard approach for the industry to follow to meet the current and future pedigree laws?  It’s because of a very interesting thing about this “fundamental law”:  for the most part, it has no impact on drug manufacturers. 

They don’t buy drugs, so, even if a distributed pedigree were selected as the industry solution, they would almost never need to access data on anyone else’s server to reconstruct a pedigree.  All pedigrees from their perspective are entirely stored on their own servers because they start them.  Because of this fact, drug manufacturers won’t “feel” this problem with a distributed pedigree.  Only wholesalers and pharmacies will “feel” it because they buy drugs from upstream trading partners.  Right now the pharmacies are not participating much in the search for a solution, and the number of wholesalers involved is not great.  The largest representation is from the manufacturing segment.

THE DEPUTIZED SUPPLY CHAIN

More recently I posted an essay on the “deputization” of the pharmaceutical supply chain by regulators.  This is a recent phenomenon where regulatory agencies have begun to require supply chain member companies to monitor the supply chain themselves.  It comes from the realization of two things by the regulators:

1. the supply chain is too massive for regulatory enforcement officers to inspect anywhere near enough transactions to detect illegitimate behavior;
2. the responsibility for supply chain security rests with the participants and not just with the regulators.

When you put these two concepts together, the only natural conclusion is that supply chain participants must self-monitor and report suspicious activity.

You can see this deputization in the way the Florida and California Pedigree Laws are written.  They both require companies who buy drugs in the supply chain to receive a pedigree for every drug purchased (although in Florida, wholesalers who buy directly from the manufacturer are allowed to initiate pedigrees).  They also require the recipient to check those received pedigrees for errors, inconsistencies and omissions—all before they are allowed to put the drugs they purchased into regular inventory.  Any irresolvable discrepancies must be reported and the drugs must be quarantined pending further investigation.

I hope it’s obvious to you that the buying company must have all of the prior supply chain history—the pedigree— of every drug before they can properly perform this analysis and before they can confidently place it into usable inventory.  Theoretically you could accomplish this with a network of distributed information servers, but the full set of pedigree data would also have to be passed down the supply chain, along with the drug, in addition to it being distributed.  However, the official pedigree—the one that companies and regulators would rely on—would remain the information that is passed.

THE POINT OF DISCOVERY SERVICES

On their website, GS1 EPCglobal answers the question, “What is ‘Discovery’?” this way:

“’Discovery’ is finding and obtaining all relevant visibility data, of which a party is authorized, when some of that data is under the control of other parties with whom no prior business relationship exists.”

They view the benefits of Discovery Services to include:

“Enable trading partners to discover all of the resources who may have information about things (who has data about EPCx? Where is their EPCIS located so I can ask about this data about EPCx?)                  

“Enable trading partners to exchange data in a secure way with parties that they may not have a prior direct business relationship                  

“Will ensure each party retains rights of ownership of its visibility data                  

“Will ensure that queries are authorized and authenticated”                  

Clearly Discovery Services has a value if your supply chain can get away with distributing visibility data across the supply chain, but I’ve already dismissed the utility of this approach for pedigree compliance above.  But if a push-model is used for compliance instead, what value are these benefits? 

THE TRUE VALUE OF DISCOVERY SERVICES IN THE PHARMACEUTICAL SUPPLY CHAIN

When you look at the future Discovery Services standard through this analysis, how can you conclude that it will contribute any value to pedigree compliance?  I don’t, but lots of other people, who have not seen my analysis, do.  But how about value from non-compliance uses?

When you think about it, the concept of pedigree—or chain-of-custody/ownership—is a historical view back “up” the supply chain, as viewed from the perspective of where a drug is right now.  That fulfills one side of the concept of “track and trace”.  Different people define that concept in different ways, but I subscribe to the group that believes that “trace” is the capability that is encased in the concept of “pedigree” (thus the name of my blog:  RxTrace).  In my view, a push-model pedigree completely fulfills the definition of a “trace”, but it does nothing to enable the other side of the coin:  “track”. 

“Track”—a consolidated forward view of exactly where drugs are right now in the supply chain from the perspective of previous owners—has value for things like recalls, regional emergency response, manufacturer production planning and wholesaler purchase planning to name a few. 

Tracking drugs may also make an important contribution to supply chain integrity by helping to detect diversion, theft and duplication of unique identifiers by counterfeiters, depending on the adoption model.  This is where the real value of Discovery Services lies for the pharma supply chain.  But tracking of drugs, and the use of Discovery Services as part of the implementation, has some thorny data ownership issues that will have to get solved.

So why am I so excited about the kickoff of the Discovery Services standard development work group?  I want to help find a way to solve those thorny data ownership issues that stand in the way of some of these “track” applications.  I think they will exist in all supply chains but perhaps pharma’s use case has the most thorns.  If we can find the right technical solution to that issue I think the supply chain will find the value in Discovery Services… It just won’t come from pedigree compliance. 

If you’ve stayed with me by reading this far, then you should join me on the work group.

The original California Pedigree Law was passed back in 2004 and it was subsequently modified by the State Legislature in 2006 and again in 2008. In all three instances, I understand that members of the legislature and the Governor’s office worked closely with the State Board of Pharmacy to develop the final content and language.

I heard that one of the goals was to create a better law than the one in Florida. Did they succeed? In order to find out, let’s take a closer look at how they compare.

The law that is currently on the books in California differs from the Florida Pedigree Law in the following ways:

1. It is fully electronic (it is NOT paper-based)
   The law and all of the discussion of the law by the Board of Pharmacy make it clear that the only acceptable form of a pedigree is electronic. This make it much more reasonable to implement because supply chain members can make use solely of computers to exchange, store and validate pedigrees, without fear that their trading partners can only handle paper pedigrees.
2. Pharmacy returns must be reflected on pedigrees
   This was an original requirement of the Florida Pedigree Law too, but it was removed under pressure from lobbyists before the law went into effect. So far, it remains intact in California, but the law is not yet in effect. What it means is that when a pharmacy buys drugs from someone and they return those drugs, regardless of how little time has transpired, they must provide a pedigree update so that subsequent buyers of those drugs can see their purchase, and return transactions. This is no different from the requirements faced by all other segments.
3. It starts with the manufacturer
   In Florida the first wholesaler started the pedigree. In California, the pedigree must be started by the manufacturer or it is not valid. If you are looking to expose the full history of package of drugs, how could you not start with the manufacturer? I even think the manufacturers generally agree with that notion.Interestingly, the Law doesn’t actually require anything of the manufacturers directly. It is directed at wholesalers who are licensed to operate within the state. Distribution of a drug without a pedigree that was started by the manufacturer is illegal and subject to penalties, but it is the wholesaler who violates the law and is punished, not the manufacturer. Thus, if a given manufacturer fails to provide California wholesalers with serialized product and compliant pedigrees by the time the law goes into effect, it will be up to the wholesaler to decide not to distribute those drugs within California in order to avoid violation of the law and avoid the associated penalties. The only risk a manufacturer takes on is that their drugs may no longer reach patients in California (and the subsequent PR firestorm that would follow).
4. It requires item-level serialization
   California is very clear that they consider the concepts of “electronic track and trace” and “item-level serialization” as being inseparable. That is, if you have one but not the other, then you don’t have a pedigree system. Every drug package must have a unique identifier on it, applied by the manufacturer or repackager, and that UID must be included in the pedigree (the electronic record). This is a substantial difference from the Florida law which has no such requirement.
5. No holes designed to accommodate special interests
   I’m not aware of any special treatment in the Law for any particular segment of the supply chain. Florida opened several holes that seriously compromise the intent of their law. So far, California has resisted opening holes, unless you consider pushing back the effective date to 2015-2017 a “hole”.

Attentive readers will notice that I have listed these differences in the same order as my list of failures of the Florida Pedigree Law in my earlier post about the Florida Law. This is my way of showing that California has, so far, created a pedigree regulation that does not have any of the major failures of the Florida regulation.

These are the major differences, but what about the common characteristics? Here are the key things that the California Law has in common with the Florida Law:

• Reliance on Digital Signatures
  Florida allows a pedigree to be created, stored and passed in electronic form, though they don’t require it. But if a Florida pedigree is in electronic form, digital signatures are required for the same purpose as a hand-executed signature on a paper document. The digital signature legally binds the signing person or entity to the content of the electronic document. Florida identified some specific standards that ensure that the digital signatures possess the all-important quality of non-repudiation. The California Pedigree Law does not, itself, specify any standards for digital signatures, but the Board of Pharmacy’s Q&A (see their Q72) calls out the fact that the California Code of Regulations identifies the specific characteristics that must result from a compliant digital signature architecture for electronic documents. The digital signature standards that are compliant in Florida would also be compliant in California.The fact that California included the use of digital signatures is significant because it ensures that each pedigree can stand on its own as a self-contained, self-secure package. This maximizes the value of the entire pedigree architecture because the security mechanism that prevents tampering goes with the package itself. No one has to rely on the access security of a given server or group of servers to prevent tampering. And, if tampering does occur, it can be easily detected, unlike tampering of pedigree approaches that rely solely on server access security. In that case, if server security is breached, you can’t tell which pedigrees were modified and which were not, rendering them all suspicious.
• It distributes responsibility for monitoring supply chain security to all supply chain participants
  This is the one genius concept of the Florida Law and California retained it, thus qualifying those involved for genius status as well. It’s a regulatory approach that is relatively new but is likely to become much more common in the face of perpetual budget “crises” in state and federal government agencies. Instead of requiring trading partners to simply keep records of their own buying and selling history for each drug so that they can be audited by an inspector at some later date, these laws require them to check the validity of the full pedigree at the time of each purchase transaction, in near real-time.Notice the difference. In the first instance, it is up to the State Board of Pharmacy inspector to detect suspicious activity in the supply chain. But how often will a state inspector visit, and how many records will they be able to review? It’s inconceivable that this approach would result in the detection of illegitimate activity.But when every purchase of a drug as it passes down the supply chain requires the buyer to run a validity check on the full transaction history of that specific bottle, it greatly increases the odds that most suspicious transactions will be detected. And for most suspicious events in the history there will normally be multiple opportunities for detection. Here, digital signatures are the enabling technology. They allow all of this supply chain monitoring activity to occur reliably and automatically inside computers that are distributed throughout the supply chain, without human intervention and without slowing the movement of drugs.

So did California succeed in creating a better law than Florida? I propose that there is almost no comparison so the question may be moot. The California Pedigree Law is so much more far-reaching than the one in Florida. While Florida focused on disrupting some very troublesome practices being performed by a few nefarious licensed and unlicensed wholesalers, California’s law is designed to cause a major reorientation of the pharmaceutical supply chain approach to security, monitoring and policing (see also The Deputized Supply Chain). This has major implications that go well beyond those of the Florida law.

Faced with that, it is not surprising that it was necessary to push out the effective dates to 2015-2017. Transformation this big takes time to implement.