Europe : Falsified Medicines Directive could wipe some medicines off the market

The new EU directive requirements come with a significant price tag, but the EU has not made extra money available. As well as fronting the money to develop EU and national databases, companies have to redesign packaging and buy new hardware and software that can add expenses of around €500,000 per packaging line, according to the generics drug lobby Medicines for Europe. In the Netherlands, where prices are low in part because health insurers are allowed to pick the cheapest version of a medicine, these additional costs are affecting business decisions. “There’s not enough margin in our prices to overcome these costs,” said a spokesperson from the Dutch association for generic drug makers. “If there is no solution for these extra costs, there will be the risk that the companies will withdraw their products.” Older generics, that have been on the market for decades and are sold for pennies, such as many antibiotics, could be hit particularly hard – as could medicines made by smaller companies producing less than 100,000 units.

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