Yep, €17.5Bn. That’s the estimate from (admittedly) the European medtech industry, of what a centralised PMA-style regulatory body would incrementally cost over and above the rest of the changes that are currently in train.
Perhaps its fair enough that new regulatory rules are likely to cost money, but where’s the payback? It doesn’t seem like it will come in the form of enhanced patient safety, because there’s no evidence that regulatory laxity is actually playing out in terms of poor outcomes. Quite the opposite in fact as new technologies get to market quickly and actually deliver better outcomes in themselves.
Anyway, we discuss in this week’s View from The Med, our regular editorially liberated foray into opinion and critique.
Find it here.