Norway Model Offers Key To Unlock More Complex Switches
Norway's move to encourage more innovative Rx-to-OTC switches has begun to bear fruit with the recent reclassification of Pfizer's Viagra. The country's decision to introduce a new non-prescription drug category to promote switching can be used as a model for securing a new wave of more complex switches elsewhere around the world.
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Australia's Therapeutic Goods Administration has introduced a set of criteria introducing additional controls for medicines rescheduled from ‘Schedule 4’ (prescription-only) to ‘Schedule 3’ (non-prescription, pharmacist-only) status, intended to facilitate more innovative prescription-to-OTC switches in the future.
Pfizer has taken the first steps towards turning its Viagra erectile dysfunction treatment into a pan-European OTC brand by taking advantage of Norway's new "non-prescription medicines with guidance" category to secure the Rx-to-OTC switch of the product. Norway will be the second European market where Viagra is available OTC after the UK switched the drug in 2017.
Three- to five-year market exclusivity periods for switched products would not only incentivize consumer healthcare firms but also enable pre- and post-switch data to be generated more easily, thus improving the quality of switch applications, explains global switch expert Dr Natalie Gauld in the final part of our exclusive interview.