Show Notes
Products like ibuprofen and loratadine are now grabbed off a pharmacy shelf without a second thought, but both started out as prescription-only medicines. The process that moves a drug from one to the other, known as Rx-to-OTC switch, is one of the most reliable forms of innovation in self-care, and yet it happens less often than the industry would like. In this episode of Over the Counter, now also in video, HBW Insight talks to Christelle Anquez-Traxler, senior regulatory science and strategy lead at the Association of the European Self-Care Industry, AESGP, ahead of the association’s first switch conference, taking place in Brussels on 7 October. Anquez-Traxler argues that switch is still undervalued by regulators who tend to focus on the risks of reclassifying a medicine rather than the benefits, and that just one year of data protection in the EU, against three in the US and Japan, leaves companies with little reward for doing the work. We talk about what makes some switches harder than others, how approaches to evidence such as the BRASS model can help close the gap, and why recent national initiatives in France, Greece and Germany might point the way forward for the rest of Europe.
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