How Will They Delay The FMD?

There is now little doubt that the Falsified Medicines Directive (FMD) will need to be delayed.  The only question is, how will they do it?  Let’s look at some facts and try to come up with a possible answer.

I recently highlighted the news released by the European Medicines Verification Organization (EMVO) that, as of August 6th, only 42% of the anticipated drug manufacturers supplying FMD participating states have begun to onboard with the EMVO.  Manufacturers cannot comply with the FMD until they complete that process, which takes an average of six months to do.  I also talked about anecdotal evidence that shockingly few hospitals and pharmacies have prepared for their obligations under the FMD (see “EMVO Admits, ‘Insufficient Randomisation’ Warnings Can Be Ignored”).  In hindsight, this will take concerted effort to even make these dispensers aware that they are obligated to spend some money and meet the FMD.  But the EMVO’s primary focus is on drug manufacturers and other market authorization holders (MAH).  Educating dispensers has rightly been left to the Member States and their National Medicines Verification Organizations (NMVO), and I suspect they have failed to meet that need.

The bottom line is, not enough drug manufactures are going to be ready to fulfill their FMD obligations by February 9, 2019, and far from enough dispensers will be ready.  What does that mean?

If you only focus on the failure of dispensers to be ready on time you could possibly address that by expecting all wholesale distributors and the MAHs who ship drugs directly to dispensers to verify and decommission them in the local NMVO at the time of shipment.  That means these companies would need to do a lot more interactions with NMVOs than they were expecting and it means they would need to scan every unit they ship to these dispensers.  They could potentially use an “aggregated code” that the Delegated Regulation refers to for case-level shipments, but are many manufacturers adding case serial numbers and then capturing aggregation data (see “EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary”, “Serializing Product Groupings Under Global Regulations”, “The ‘Unique Identifier’ in the EU Delegated Act” and “Aggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under A Serialization Regulation”)?  And are they able to send that data to every wholesale distributor?  I don’t know, but I doubt it, since neither the EMVO nor the dozens of NMVOs appear to be coordinating that activity.

But the problem isn’t just the small number of dispensers.  It’s an overall lack of preparation by every segment.  So with that in mind, someone will need to delay the effective date.


But how?  That’s the real problem.  In the US, the FDA has nationwide responsibility and authority for enforcement of the Drug Supply Chain Security Act (DSCSA).  So when the time came last year to recognize that the drug manufacturers were not going to be ready to start enforcing their serialization and enhanced verification obligations by last November, it only took that one agency to make the call and announce a delay (see “FDA Delays Enforcement of DSCSA November Deadline: What It Means”).  But in the EU, the Delegated Regulation (EUDR) was delegated to each of the member states and any other countries in the region who wanted to participate (this includes non-EU members Norway, Switzerland and Iceland) to enact.  That means we are dealing with more than two dozen regulations, each one defining February 9, 2019 as the effective date (excluding Italy, Greece and Belgium which were given extra years) (see Article 50 of the EUDR).

No one agency has EU-wide responsibility and authority to enforce the FMD and EUDR, so no single agency can delay it’s effective date.  It will take efforts in every country that adopted the EUDR to set a delay.  Perhaps the EMVO can coordinate the selection of the new effective date so those local delay announcements can all use the same date.  In that case, the EMVO would first need to coordinate with the MAHs to find out when they can be ready.  No sense proposing a new date that has the same problem.

But then the problems begin to cascade.  For the FMD/EUDR to really make good on its promise to protect patients from counterfeits and other illegitimate drugs, it relies on all pharmacies, hospitals and other dispensers to start verifying and decommissioning the unique identifiers all at once (see “Decommissioning Under the FMD/EUDR”, “Drug Verification: EU Vs US” and “What’s So Hard About Unique Identifier Verification?”).  And the MAHs should not start putting the FMD unique identifier on drug packages too early or the advantage moves to the counterfeiters rather than patients (see “Insufficient Transitional Measures Doom The FMD-EUDA”).  The longer serialized drugs are on the market before dispensers begin decommissioning, the greater the advantage to counterfeiters (see “More Concerns With The FMD/EUDR Big Bang Start”).  Is there any doubt they will take advantage of it?

If wholesale distributors are called upon to begin verifying and decommissioning their shipments instead of dispensers, how safe is that for patients?  It may remove the possibility of counterfeiters copying real unique identifiers, but it actually opens the door to them making up their own.  Dispensers would assume they have already been verified/decommissioned by the wholesale distributor.  And this will make it hard to transition back to the originally envisioned state.

Ouch, I see nothing but trouble ahead for the FMD and patients who are counting on it for protection.