FMD, One Year Out

Last Friday marked one year to go for the start of the Falsified Medicines Directive (FMD) and the Delegated Regulation (EUDR) in the European Union (EU) (see “More Concerns With The FMD/EUDR Big Bang Start”).  With the one year delay in the serialization and verification requirement of the Drug Supply Chain Security Act (DSCSA) in the US, the deadlines for these two markets are only about 10 weeks apart, assuming there won’t be any more delays.  I don’t expect another delay in the manufacturer’s serialization and verification deadline in the US, and I haven’t talked with anyone who expects any EU-wide delays in the effective date of the FMD/DR.

Any delay in the FMD/EUDR would likely come from individual EU Member States if the setup of their National Medicines Verification System (NMVS) is running late.  Or perhaps if not enough pharmacies are ready to connect to the verification service.  I assume those would be localized delays, if they occur.

I was very surprised to read an article on the SecuringIndustry website last week that said securePharm, the NMVO for Germany, has only a single hospital pharmacy connected, after being in business since 2013 and being now only 12 months before all of them must be connected (see also the securPharm press release dated 2/8/18).  Yes, pharmacies are not required to verify all drugs prior to dispensing until on or after February 9, 2019, but I am surprised there isn’t a larger set connected by now.  By comparison, 200 non-pharmacy, supply chain companies have signed up.  I assume this is some mix of manufacturing authorization holders, parallel importers and wholesale distributors.  We’ll have to closely watch the rate of pharmacy onboarding throughout the FMD countries as time goes on.

Now, you may remember that I published an essay here in RxTrace called “Insufficient Transitional Measures Doom The FMD-EUDA”.  Am I still predicting “doom”?  “Doom” is such a strong word, perhaps only suitable in a headline for drawing attention to potential problems.  No, I’m sure the FMD-EUDR will go into effect on February 9, 2019, and yes, there will be problems—some we can predict, some we can’t.  But the EU pharma supply chain will survive all that.  Over time problems will be fixed and things will improve.  Doom?  Nah, Probably not.