As part of a response to the 2011 EU Falsified Medicines Directive, an EU-wide serialisation system has been created to ensure drugs dispensed at pharmacies are genuine. Solidsoft has been selected to provide a software solution which will be powered using Microsoft’s Windows Azure cloud platform,
Mark Smith, Director for Health & Life Sciences at Microsoft UK, told in-Pharmatechnologist.com:“The European Hub will be connected to a series of national data repositories, which serve as verification platforms, and can be used by pharmacies and other registered parties to check a product’s authenticity.”
As for EMVS security, Smith said data will only ever reside within Microsoft managed, monitored, and administered data centres within the EU which comply with key industry standards.
Solidsoft was selected after a 15 month tender process from 20 providers by the European Stakeholder Model (ESM), launched in 2012 to incorporate the European Federation of Pharmaceutical Industries and Associations’s (EFPIA) and a number of other industry bodies.
The point-of-dispensing verification programme has been developed to combat fake drugs in the EU and incorporates a Europe-wide serialisation system and a 2D barcode (data matrix) generated by drug manufacturers which will, according to the ESM, when scanned alert the pharmacist to any unregistered medicines.
For “sensitive data, such as the unique serial numbers of packs of medicines,” Smith added, “[these] are encrypted while being passed in messages and stored in the database.
“Access to data storage is mediated by a data access component which prevents arbitrary queries, and supports segregation of data so that one manufacturer’s data is isolated from that of another.”
Cloud-Based Solutions
Garth Pickup, Solidsoft’s CEO, said this project will deal with over 10bn transactions per year and the use of cloud-based technology “means that this massive project can be delivered to the EFPIA at much lower cost than on-premises.”
This is not the first use of cloud technology in the fight against counterfeit drugs. A global authentication service was launched in 2011 by HP with an initial trial in Africa, before being rolled out in India to combat fakes.
There have also been moves into anti-counterfeiting solutions using both cloud-based solutions and text message verification by Sproxil and Orange, with Africa once more the initial target.
Away from fake drugs and more companies within the pharma world are looking towards cloud-based technology to manage regulatory and clinical trial data. At this year’s DIA, it was the talk of the show – reported Outsourcing-Pharma.com - as companies including Novotech and INC Research showed off their cloud-based tech solutions.