The EU Directive on Falsified Medicines
The “EU Directive on Falsified Medicines” (Directive 2011/62/EU) was published in July 2011. The European Commission has been mandated via a “delegated act” to work out the technical details with the delegated act to be published in 2014 which would mandate the execution three years later, so 2017. To ensure that the directive can be implemented throughout Europe 2 projects have been kicked off. One is driven by the pharmaceutical supply chain members (EFPIA etc.) while the other is driven by the EU Directorate. This blog provides an overview on the different approaches and some links to deep dive if you are intested. .
EFPIA and the Stakeholder Model
EFPIA (European Federation of Pharmaceutical Industries and Associations) is the representation of the pharmaceutical industry in Europe. Together with other organizations representing wholesalers (GIRP), re-packagers (EAEPC) and pharmacies (PGEU) they have established the so-called European Stakeholder Model (ESM). The ESM partners have built an “EU-wide coding and serialization system”, the EMVS (European Medicines Verification System) and are trying to set the standard for “Serialized Track and Trace” in the European Union and probably beyond. The EMVS is intended to allow verification of packages at the point of dispensing; however any member of the supply chain may verify the originality of a package at any point. EMVS allows for national systems that may reflect special national requirements to be connected via a pan-European hub. This would allow any member of the supply chain to check the originality of any pharmaceutical product against one single access point regardless of in which country the data reside. The model currently only looks at the verification of single units without the ability for a full pedigree which would require serial number aggregation. A nice overview on the overalls etup can be found here.
EFPIA has scheduled 2 pilots so far, the first one in Sweden and the second one in Germany. It is expected that the German pilot (securpharm) will stay and become productive and will be the German implementation of the EMVS.
The EDQM (European Directorate for the Quality of Medicines and Healthcare) is a directorate of the “Council of Europe” which is the continent’s leading human rights organization with 47 member states, 28 of which are members of the European Union. EDQM has launched Project eTACT which also is aimed to establish a pan-European system for tracking serialized packages of medicine. It’s scope is a little larger to that of EFPIA as it includes patients, consumers and internet pharmacies and in addition provides the option for serial number aggregation.
With 2 approaches being developed in Europe the question will be which one will prevail. Right now it seems like both approaches are converging towards a common approach. EFPIA as well as EDQM are following the GS1 Standard, especially promoting the 2D Matrix Code. At the same time, both systems embrace the use of national identifiers according to national law (NTINs). Both systems embrace a central hub or central system. The question remains who shall run this system and who should pay form it! It may be that the delegated act will provide some clarity…we will see in 2014! Again, please let me know your thoughts.
Update (Nov. 14, 2014)
In the meantime the European Commission has clarified some details. The most important is probably that the EC clearly favors a Stakeholder Model as proposed by EFPIA and the other industry organizations. Therefore EDQM has stopped any investments into a central infrastructure.