Wait. I thought the Falsified Medicines Directive and its companion Delegated Regulation (FMD/DR)—which has been in effect since February 9, 2019—was a mandate that would be enforced. Turns out, it was apparently just a suggestion. No actual government enforcement. In fact, according to new estimates by the European Medicines Verification Organization (EMVO) and the National Medicines Verification Organizations (NMVOs), only 60% of drug manufacturers and 75% of “other” supply chain actors (pharmacies, hospitals, wholesalers, dispensing doctors etc.) have connected to the medicines verification systems (the “system of repositories” mandated in the FMD/DR). A partial result is that one out of every 33 verification attempts at pharmacies and hospitals who are connected result in a ‘false alert’. That is, an alert that the drug being verified is not in the repository or the scan is not being interpreted correctly.
How they can be confident that every one of these alerts are ‘false’ is a concern. If the FMD/DR were enforced, these drugs could not be dispensed/administered to the patient. But, of course, to avoid shortages, drugs are not being withheld. So what’s the point of all that money spent by the 60% of drug manufacturers who are operating under the regulation?
Now, in a statement published on July 10, 2019, the EMVO and its “stakeholders” (including full member organisations EAEPC, EFPIA, GIRP, Medicines for Europe and PGEU), are calling upon the National Competent Authorities (NCAs)—the country-specific healthcare regulatory agencies of each of the EU member states—to begin enforcement.
Is anyone surprised? Maybe we shouldn’t be (see “How Will They Delay The FMD?” and “FMD: Denmark Moves To Solve FMD Dilemma”). The “big bang” start of the FMD/DR requirements was a bad idea from the start, but I guess you have to start somewhere, somehow (see “Insufficient Transitional Measures Doom The FMD-EUDA” and “More Concerns With The FMD/EUDR Big Bang Start”). But now, five months after the “big bang”, the EMVO proposes a rational “stepwise/phased approach” to enforcement and inspections by the NCAs.
The statement expresses disappointment that the reporting functions of the NMVO software will not be ready until later in 2019, and in some cases, not until April next year (see “V 1.6 EMVS Functionality Matrix”). As they point out, these functions will significantly empower NCAs to supervise the system because they will provide them with a window into the operation of the full system of repositories. The FMD go-live date should have been delayed until these functions were fully implemented and the NCAs were ready to use them, but that’s water under the bridge.
The statement calls for a 100-fold reduction in the number of false alerts before drugs should be withheld from patients. And I am glad to see the EMVO and their stakeholders recognize just how very close they are to the total and permanent collapse of the FMD.
“…the EMVO stakeholders consider there is a significant risk towards descending into a downward spiral in which alert levels remain high, so stabilization periods are extended, removing the pressure for improved compliance, and resulting in persistent high levels of ‘false’ alerts. Needless to mention, such a breakdown will lead to a dysfunctional system, wasted investment, reduced trust and confidence especially for patients, who should be the main beneficiaries of this effort.”
It would also lead to criminals taking advantage, which would result in more criminal activity and less security of the EU drug supply chain—exactly the opposite of the hope and intention of the FMD.
As a step toward preventing that future, the statement encourages the NCAs to “…start enforcing the primary requirements of the FMD and DR and undertake inspections on all supply chain actors.”
The only thing they forgot to say was: And do it ASAP!