Drug verification specialist Aegate files for insolvency

After 13 years of operations, Aegate Ltd has filed an application for insolvency, with a creditor meeting scheduled for 23 June, according to a notice in The Gazette.

The Cambridge, UK-based company – one of the three contract partners nominated by the European Medicines Verification Organization (EMVO) to provide the IT platforms for the verification of drugs in accordance with the requirements of the Falsified Medicines Directive/Delegated Regulation on safety feature – filed for insolvency on June 5.

It seems that Aegate was unable to win any contracts with the national medicine verification organizations (NMVOs) tasked with setting up the national systems that will link to the central EU hub, with all the contracts agreed to date going to rival providers Arvato and SolidSoft Reply.

SolidSoft said recently it had signed seven contracts – with the NMVOs in Sweden, Denmark, Ireland, Slovenia, Bulgaria, Lithuania and the Czech Republic. Arvato will not divulge its contracts, but the remaining established NMVOs – according to the EMVO website – include Austria, Belgium, Croatia, Estonia, Finland, Germany, Iceland, Latvia, Netherlands, Norway, Spain, Switzerland and the UK.

The FMD will introduce a system in February 2019 to help track medicines from manufacturers to patients. Manufacturers will be obliged to apply safety features to each pack – namely a tamper-proof security seal and a 2D barcode. The barcode enables each pack to be serialised with a unique randomised number, which will be authenticated before dispensing.

The identification data will be stored in the centralized hub operated by the EMVO, with the NMVOs recording national transactions and linking to the hub. Solidsoft was previously selected by the EMVO to implement the European hub, enabling medicine manufacturers and parallel distributors to upload their pack data which is then routed to appropriate national systems.

At the moment it isn't clear what the impact will be on Aegate's older verification systems installed in pharmacies in Belgium and Greece, which have been given an extension on the FMD deadline as they have legacy systems in operation.

Commenting on the development, independent digital pharma consultant Mark Davison of Blue Sphere Health said it would be sensible for EMVO to have two or three extra system providers.

"Contingency planning, if not already done, would be sensible," he said. "There are vendors who could step up relatively quickly to fill the gap or to help spread the load on existing projects."

"This is big ticket IT, implemented in a very short timeframe," he added. "It simply must not fail and it now relies on only two NMVO blueprint providers. They are undoubtedly competent but even the best companies have problems when they stretch to service major projects."

There have been press reports two other providers – TraceLink and Kamsoft – were in the running to become accredited EMVO providers following Aegate's demise.TraceLink told us that it was considering accreditation but has not made any decision to go forward as yet.