Ukraine medicines traceability pilot to start next month?

Ukrainian flag on medicinesUkraine has said it will be ready to pilot a traceability mechanism for medicinal products in the market from next month, after completing systems testing in the summer.

Information published on the Ukraine government website* towards the end of last week suggests that the pilot will involve an overseas pharmaceutical manufacturer, a domestic manufacturer, a wholesale distributor and pharmacies, with medicines tracked through the supply chain via a GS1-compliant 2D datamatrix code.

[* Ed - Please note this article is relying on Google Translate for some information. We have contacted the SAUMP for additional details and will update readers when this is received].

The State Administration of Ukraine on Medical Products (SAUMP) indicates that the objective is to prevent counterfeit medicines entering the supply chain, although the stakeholders taking part in the pilot - and the medicines that will be tracked - have yet to be decided. 

The operation of the system runs as follows (see image below):

1. The manufacturer produces a batch of drugs
2. The manufacturer communicates with centralised database
3. The manufacturer ships the batch to the distributor
4. Distributor accepts batch of drugs
5. Distributor records receipt via database
6. Distributor ships drugs to pharmacy
7. Pharmacy accepts batch of drugs
8. Pharmacy records receipt via database

Ukraine schematic

A proposed schedule for rolling out the system envisages the completion of a national database for medicine codes and the pilot this year. A second phase (2013-2014) sees pharma manufacturers and distributors start to participate in the system, followed by a third phase bringing pharmacies into the picture in 2015 and 2016.

At the moment it is not stated explicitly that the system will eventually include pack-level verification of medicines at the point of dispensing to patients, although the third phase suggests it will be used to control prescription and reimbursement costs, which implies this will be the case.

Ukraine is putting a deadline of 2017 to expand the pilot into a full, national medicines traceability scheme, which would coincide with the expected implementation date of the EU's falsified medicines directive (FMD).

The SAUMP press release suggests that the pilot is being implemented in alignment with the European Directorate for the Quality of Medicines and Healthcare (EDQM) - which is developing a track-and-trace system for medicines called eTACT, with the help of IBM.  The EDQM had not responded to requests for comment by the time this article went to press.

Ukraine's pharmaceutical market has been growing strongly, with 625m packages sold domestically in the first six months of the year worth a total of UAH 14.6bn ($1.8bn), up nearly 16 per cent over the same period of 2012 in value terms. Imports account for around 70 per cent of the total market.

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