As we near the end of 2014, several important pharma traceability deadlines around the world are approaching. Besides the U.S. Drug Supply Chain Security Act (DSCSA), these include deadlines in Brazil and South Korea. Of course, each regulation is different. Now that the initial implementation of the exchange of transaction data in the U.S. is widely being implemented in Electronic Data Exchange (EDI) Advance Ship Notices (ASNs), the next hurdle for drug manufacturers will be to deploy serialization technologies on their U.S. and Korea market packaging lines. The data exchange technology problem will shift to Brazil, and that’s where I see trouble.
The Rx-360 Traceability Data Exchange Architecture Group, formed at the end of the summer (see “Pharma Supply Chain Companies Organize To Establish Global Traceability Data Exchange Architecture”), intends to develop an industry consensus model for supply chain traceability data exchange that can be voluntarily adopted by companies so those who choose to follow it can interoperably exchange the data necessary to comply with the various country-specific regulations. One problem they will need to work around is that some of their participants will only want to focus on the U.S. DSCSA because that’s where their businesses are impacted. Everyone in that group sells large volumes into or through the U.S. market, but not all of them sell into markets like Brazil, South Korea, China and others that have deadlines that are closer than in the U.S. or E.U.
The fact that the U.S. and E.U. markets are larger than any other can lead to blind-spots in the solutions that people want to talk about and pursue. This problem has cropped up many times over the years in the GS1 US and global groups that have worked on this issue. Group leaders need to always keep this in mind and try to keep their groups focused on the global picture.
The problem is, Brazil’s law requires a very sophisticated technical solution that must be interoperable across the entire supply chain and used by all members of the supply chain, but the regulatory body, ANVISA, has no intention of defining what that system must be and how it must be constructed. This is very similar to what the California Board of Pharmacy did before their law was preempted by the DSCSA (see “Preemption: What Does It Mean?”). Like California, ANVISA says that is up to the industry to figure out.
The industry is lucky that the DSCSA preempted the California law before the major deadlines. Well, actually, everyone is lucky it happened that way. And I guess luck had little to do with it, considering the organized lobbying effort the industry mounted to achieve it (see “An Industry Protection Bill Concealed Under The Veil Of Patient Protection”). Had California stayed on track, the first serialization deadline would occur on January 1. That would have required serial numbers on 50% of the drugs each manufacturer distributes into California. Most people have probably already forgotten, but for those same drugs the manufacturer would have also been required to start a pedigree and pass it to the buyer. Because the State of California was leaving the technology up to the industry to figure out, of course, there were two incompatible approaches being pursued by “the industry”.
But that’s the problem. If the California experience taught us anything, it is that it is nearly impossible to organize “the industry” enough to agree on a single technology approach needed to meet—really meet—a regulatory requirement that is not popular. There is no organization that can seek consensus on an interoperable data exchange technology, but once a solid majority (two-thirds?, three-fifths?) agree, then force the selection on all companies in the supply chain so that you avoid competing, incompatible and non-interoperable approaches.
No company can do that, but a government can. In effect, this is the authority the DSCSA seems to give to the FDA for selecting the technical approach to the Enhanced Drug Distribution Security (EDDS) phase that starts in 2023. But that won’t happen for quite a few years. I think we will still be debating alternatives right up to the end of 2022.
But long before that time, manufacturers will be dealing with the data exchange model that Brazil is about to require. It sounds like a semi-centralized model, mandated on drug manufacturers and importers, but with no guidance on technical specifics. Those companies will be required to collect information about each change of ownership in the supply chain from each downstream owner of their drug products. That will require supply chain-wide interoperability, but the government of Brazil has no intention of defining how it is supposed to work. Again, that’s up to the industry.
Could you meet the requirements with a distributed model? I don’t think so, but maybe you could. Will some companies want to go down that path? Maybe.
And by the way, for Brazil, companies must serialize and track 3 lots of product before December 10 of next year, and all lots of all drugs by December 10 of 2016. That’s aggressive. And any company that makes, imports or sells drugs in Brazil will need to make aggressive moves to make sure they are able to meet these deadlines. But what technology will be used? EDI? GS1 EPCIS? Something else? According to ANVISA, The industry needs to figure that out, and fast!
Normally I would provide you with hyperlinks to the regulations I write about so you can check them yourself, but, outside of the United States and Europe, government regulatory documents are not always posted on the open internet. Even if they are, they are posted in the native language. That’s the case with Brazil. I rely on documents and translations provided by GS1 Healthcare (and some help from Google Translate). I can’t provide you with copies of those documents because you must be a member of that private industry group to get access to their global public policy document library. It’s a great resource.
[NOTE: Thanks to Lars Olsen, here is the ANVISA document link.]
Will the Rx-360 Traceability effort play a role in defining the approach needed for Brazil? Will whatever is implemented in Brazil lead companies to support the same approach in the U.S. and E.U., since those regulations will take effect much later? Leave a comment below and tell me what you think will happen.