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
"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
Traceability initiatives in the EU, USA and
elsewhere will require pack-level coding (serialization) for
prescription pharmaceuticals. SecuringPharma
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
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
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
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