Marketing authorisation holder (MAH) data uploaded to national data banks via Europe’s central data router – known as the EU Hub – has enormous potential value, the organisation’s national policy liaison told us at the Adents Serialization Innovation Summit last week.
Belgian-based European Medicines Verification Organisation (EMVO) set up the EU Hub in response to the 2011 Falsified Medicines Directive (FMD), which comes into effect on February 9, 2019.
The directive is designed to help European supply chain stakeholders prevent fake medicines entering the supply chain by ensuring the “implementation of functioning, secure, interoperable and cost effective system across Europe.”
According to Verhaeghe, all stakeholders could benefit from commercialising national repository data: “From the beginning, we have been saying ‘why not look at other uses for the data?”
Companies regularly buy data reports from contract research organisation (CRO) IQVIA, so “if we can reduce costs by adding extra income from this system, then why not?” he told us.
While of course the cost of serialisation serves a purpose, industry cannot recuperate costs by raising drug prices, he explained.
“What we are saying, is if all supply chain stakeholder of the different aspects of the data commonly agree, it’s possible to use the data in other ways.”