EU trade groups take issue with eTACT in position paper02-Mar-2012
The eTACT medicines traceability system
in development at the European Directorate for the Quality of
Medicines and Healthcare (EDQM) has come under fire from trade
organisations representing Europe's pharmaceutical manufacturers,
wholesalers, parallel traders and pharmacists.
A joint position paper - drafted by drugmakers organisation EFPIA, parallel traders group the EAEPC, wholesalers body GIRP and PGEU representing the pharmacy trade - welcomes EDQM's involvement in the fight against counterfeit medicines but argues that their own model is more likely to succeed in this effort than eTACT.
Some of the concerns about eTACT have already been addressed in our earlier coverage of the EDQM's January workshop to introduce the project to stakeholders (see EDQM showcases eTACT traceability system).
The position paper makes much of the fact that the European Stakeholder Model (ESM), which has grown out of the model piloted by EFPIA in Sweden in 2010, has the support of the stakeholders who will be tasked with using and adhering to the system on a day-today basis.
"The ESM represents "a practical and cost-effective" means of implementing the requirements of the EU Falsified Medicines Directive (FMD) in Europe, according to the document.
A second ESM pilot is due to be launched in Germany in 2013, in part to take into account the fluidity of the situation with regard to the requirements of the FMD, given that a significant level of detail is still to be elucidated via the EU's delegated acts process.
Traceability initiatives in the EU, USA and elsewhere will require pack-level coding (serialization) for prescription pharmaceuticals. SecuringPharma's recently-published executive briefing explains these requirements, how they will affect your global supply chain, and what action you need to take. Order your copy here.
One issued raised by the partners is that there is already a good deal of data from the Swedish pilot on the cost-effectiveness of the system, while the eTACT system "is currently untested and uncosted beyond a meeting room-level prototype."
In essence the ESM is an end-to-end system, in which serialised codes are added to drug packaging at the time of manufacture and read at the point the medicine is dispensed to a patient, with transactions recorded via a single data repository. eTACT has greater ambition - envisaging a track-and-trace approach that would also include interim stages of the supply chain.
EFPIA et al also maintain that the ESM has a decentralised structure that will permit "highly flexible implementation at national level within a structure that guarantees high levels of security and robust legal principles for data protection."
Adding to the complexity facing EU lawmakers as they start to consider the nuts and bolts of a pan-EU medicine traceability system is a third project - due to get underway next year in Germany - called securPharm.
Like the EFPIA model this is an end-to-end system, but differs in one fundamental aspect in that will make use of not one but two separate databases, one accessible to the pharmaceutical manufacturers and the other to the pharmacists, who have traditionally resisted ceding control over the ownership of prescribing data.
EFPIA's decision to operate a single database was one of the reasons why its pilot was swapped to Sweden from Germany and - it is argued in some quarters - why the securPharm consortium has been set up. The FMD itself does not stipulate either a single pan-European database or a series of linked national systems.
"A stakeholder-driven approach as put forth by the proposed ESM clearly offers distinct advantages in terms of efficiency and expertise to run the system," noted the position paper.
"It also provides additional benefits such as verification by legitimate online pharmacies, batch recall, counterfeit reporting information and the ability to expand geographically and evolve with technical advancements including the future possibility of patient verification."
Stakeholders have until April 2012 to comment on the EU's first concept paper on one element of the FMD related to safety features and drug authentication, namely the "unique identifier" that should be used on individual medicine packs (see EC seeks comment on unique medicine identifiers).
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