The pharmaceutical supply chain in most markets is complex, but in my view, the one in the European Union easily takes the prize for being the most complex of any other. The addition of unit-level serialization and verification of authenticity to that supply chain over the next few years as required by the Falsified Medicines Directive (FMD) and the Delegated Act (EUDA) is going to be difficult (see “Breaking News: The EC Has Published The Delegated Act“). It represents a huge change to the way drugs are packaged and how they are handled by each entity in the supply chain. It is vital that the transition from the way the supply chain operates today to the way it needs to operate once these regulations go into effect proceed as smoothly as possible. To be successful, this transition should be carefully designed and choreographed with precision. The problem is, when I read these regulations, I don’t see any of that.
All I see is a very brief Article 48, called “Transitional Measures”. Here is the entire Article:
“Medicinal products that have been released for sale or distribution without the safety features in a Member State before the date in which this Regulation becomes applicable in that Member State, and are not repacked or relabelled thereafter, may be placed on the market, distributed and supplied to the public in that Member State until their expiry date.”
This is what is generally known as a “grandfather clause”. It appears to allow drug manufacturers to continue selling non-serialized drug packages from their distribution centers after the law goes into effect in early 2019 (early 2025 for Italy, Belgium and Greece since they already have some kind of authenticity verification systems in place). In other words, after the effective date, any drug packages those companies package and “release for sale or distribution” must have the two safety features on them, but any drugs that were packaged and released for sale or distribution—even the day before that date—may be sold into the supply chain without those features. The two safety features defined in the EU Delegated Act (EUDA) are:
- an anti-tampering device, and;
- a Datamatrix barcode that encodes a product code, unique serial number, batch number and expiration date, and where required locally, a national reimbursement number (see “The ‘Unique Identifier’ in the EU Delegated Act”).
As a grandfather clause, I cannot complain, it does the job for manufacturers, but is that it? What about wholesale distributors and pharmacies? How are they to know which packages should have safety features and which are exempt due to Article 48 of the EUDA? Since the effective date is a “big-bang” in each market, these downstream entities must begin complying on the same date as the manufacturers, but not every drug they have in stock or receive after that date will contain those safety features until perhaps years later. So the only drug packages that pharmacies (and wholesalers, when required) will be able to authenticate are those in their possession that actually contain the Datamatrix barcode. That could potentially be very few products on the effective date.
“BIG-BANG” IS A PROBLEM
The early state drug pedigree laws in the United States, including Florida and California, were “big-bang” regulations. That is, everyone had to begin complying on a single day. But beginning in 2008 policymakers in California came to realize that “big-bang” doesn’t really work because there would be an indeterminate period of time when downstream trading partners would have to deal with a mix of some pedigreed, and/or serialized products, and some not. That would have led to confusion, and that confusion could have actually encouraged illegitimate activity by providing it cover.
So in that year, when they pushed out the effective date of their ePedigree law, they switched from a single date for all segments, to four separate dates: January 1, 2015 and January 1, 2016 for manufacturers, July 1, 2016 for wholesale distributors, and January 1, 2017 for pharmacies (see “Will The California ePedigree Dates Slip Again?”, but remember, that law is now obsolete and preempted by the federal Drug Supply Chain Security Act, the DSCSA). In addition, the California Board of Pharmacy developed a very detailed grandfathering provision that explained how they expected each segment to handle non-pedigreed / non-serialized product (see “The New Grandfathering Provisions Of The California Pedigree Law”).
Then, when the US Congress passed the DSCSA in November of 2013—the law we are currently under in the United States—it defined widely separated dates for each segment to begin dealing with the new DSCSA Product Identifier (serialization):
- November 27, 2017 for manufacturers;
- November 27, 2018 for repackagers;
- November 27, 2019 for wholesale distributors, and;
- November 27, 2020 for dispensers.
With these wide separations in dates, grandfathering became much less important because the supply chain in each step should be pretty well primed with serialized product before the next segment’s deadline. Even so, the DSCSA also requires the FDA to publish guidance by November 27, 2015 (…by the end of this week!…) identifying which products will be eligible for grandfathering status. This is about as far from a “big-bang” as you can get.
The EU regulators and the companies in the EU pharma supply chain could go through some interesting/confusing times with this “big-bang” regulation. Let’s hope the criminals don’t take advantage of any ensuing confusion.