Medicines verification in EU: a cloud with an Azure lining

The EU drug industry has turned to Microsoft's Azure cloud computing platform as the engine for its proposed medicines traceability system.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and other stakeholders who form the European Stakeholder Model (ESM) awarded the main tender for the European medicines verification system (EMVS) to SolidSoft back in April, and it was confirmed today that Azure will power the solution.

With SolidSoft and Microsoft now selected work has already begun on building the EMVS platform with the aim of starting live trials later this year, according to Garth Pickup, SolidSoft's chief executive. 

The EMVS takes a gatekeeper approach to medicines verification, with unique serial numbers applied to each pack of medicine at the point of manufacture which are then verified in pharmacies at the point they are dispensed to the patient.

The overarching idea is that with each pack individually and uniquely coded, it will become much harder for counterfeiters to inveigle products into the legitimate pharmaceutical supply chain, as packs with duplicate serial numbers, for example, should be picked up by pharmacists before they are dispensed to patients.

EFPIA tested the feasibility of the verification model in a pilot in Sweden which concluded in 2010, and has been lobbying to have the approach adopted at the European level to satisfy the safety feature requirements of the 2011 Falsified Medicines Directive (FMD).

The specifics of these are in the process of being developed via the EU delegated acts procedure, so remain somewhat in a state of flux, although most observers predict that serialised pack coding will be required, most likely using 2D datamatrix codes.  Public consultation on the delegate act closed last year and final publication is not expected until 2014.

It is almost inevitable however that the EU will require some form of European hub to handle the transactional data generated in the system, for example recording product serialisation data as it is applied and read.

The ESM's model envisages a hub, provisionally called the European medicines repository, and this forms the core of the SolidSoft/Microsoft project as it will be designed to interface with existing databases operated by pharmaceutical manufacturers, parallel importers and national governments (see ESM image below).



The partners will also develop a 'blueprint' version of the national repository - also running on Windows Azure - that will interface with the European hub on one side and wholesaler/pharmacy systems on the other. Member states who wish to will be able to adopt that 'vanilla' version of the national system, or adapt their own existing systems to suit, Pickup told SecuringIndustry.com.

Some EU countries, notably Belgium, Italy and Greece, have already rolled out some form of point-of-dispensing verification of medicines.

SolidSoft has the right to develop, operate and support the EMVS for an initial five-year period, and the fact that it was the only bidder to propose a solution using a full cloud-based back-end infrastructure is thought to have been a key factor in the ESM's decision to award the contract.

Use of a public cloud means that the charges generated by the EMVS will be on a sliding scale based on consumption levels, which provides opportunities to reduce costs. For example, capacity can be tailored to the level required - for example starting at a low level if one country is on board and ramping up as others join. It can also be reduced overnight when dispensing levels are expected to be low, said Pickup.

It also allows capacity to be ramped up very quickly, for example if a number of member states decide to wait until the last minute before implementing the system. The FMD stipulates a three-year timeframe for implementation after the delegated act is finalised.

"I believe that was one of the major attractions of our bid," said Pickup. "Our solution is easy to deploy, very flexible and the client does not have to buy equipment and licenses - they simply pay for it as they use it."

Once fully rolled out the EMVS will have to be able to handle more than 10 billion medicine dispensing records each year.

The Azure-based solution is a true platform-as-a-service (PaaS) system which allows for the creation of additional software modules, and this means that it will be able to accommodate slight modifications required in an individual country, for example variations in the coding system being used for medicines.  It also makes it feasible to bolt on other functions beyond verification, if that were required by the various stakeholders.

Pickup noted for example that Germany is already in process of developing its own national system (securPharm), and while this will kick off with serialisation data feeding in directly from the pharma manufacturers it is expected that this will in time be routed via the EMVS.

"The ESM has been a long time in gestation and is a well-thought-through solution to a problem that satisfies the requirements of the 2011 FMD, but also preserves the modus operandi of the pharmaceutical industry as it stands today with minimal impact," said Pickup.

"It's good for the citizen and it's good for industry," he added.

The ESM is not the only game in town, however, given that the Council of Europe's European Directorate on the Quality of Medicines & Healthcare (EDQM) is developing an alternative model called eTACT with the help of IBM that tries to include all nodes in the supply chain - even Internet pharmacies - and is closer to a full track-and-trace model.

It is recognised that this approach likely poses greater challenges in terms of system complexity and the volume of data generated, although legislators may find it appealing in that it is based on public governance rather than being an industry-led approach.

eTACT is currently at the demo phase and in May a point-of-sale element was incorporated and demonstrated to experts in pharmacy IT dispensing systems.