Regulator wants less regulatory conservatism

Regulator wants less regulatory conservatism
Non-prescription medicines must be accompanied by accessible and understandable information, says Hugo Hurts, executive director of the Dutch Medicines Evaluation Board (MEB)

27 March 2019 - Deborah Wilkes

Regulators should "avoid the temptation to overexaggerate risks connected to medicines", according to Hugo Hurts, executive director of the Dutch Medicines Evaluation Board (MEB).

Speaking recently at a regulatory conference organised by the Association of the European Self-Medication Industry (AESGP), Hurts said the pharmacovigilance system produced signals that "may be interpreted as unacceptable and measures have to be taken". These measures, he added, might include removing medicines from the market or reverse-switching medicines from non-prescription to prescription status.

However, this was "not always a good solution", maintained Hurts, urging regulators not to "overreact".

Slow pace of switching

Hurts also highlighted the slow pace of switching medicines from prescription to non-prescription status through the European Union's centralised procedure – four in 10 years. Regulators were "cautious and have to be cautious", he acknowledged, but they were also "a bit conservative".

This regulatory conservatism was not exclusive to the area of OTC status, Hurts told delegates attending the conference in Amsterdam, the Netherlands. He said it was also apparent in regulatory optimisation initiatives.

"If Europe wants to remain an interesting place in the world for pharmaceutical innovation – and not be last in line – then we should change part of our regulatory habits," he maintained. "We really should invest more energy in things that add value and put less energy into purely administrative affairs."

Everyone would agree with this in principle, said Hurts, but discussing the details of what needed to change was a "lot more difficult".

He warned that without change Europe would "gradually start lagging behind other places in the world".

Important to regulators

Hurts told delegates that non-prescription medicines were important to regulators. "Not only do they allow patients to manage their own health as much as possible," he said, "but they also help relieve pressure on our healthcare systems."

However, Hurts had "one big but". "There should be accessible and understandable information for all of those who have to deal with non-prescription drugs," he said.

He pointed out the MEB was working on a number of initiatives to improve the information available to healthcare professionals and patients for both prescription and non-prescription pharmaceuticals. One of these projects, he said, involved easily accessible video presentations.

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