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Pharmaceutical Market Europe - April 2019

PME March

#OrkambiNow?

The long-running row between Vertex and NHS England and NICE over Orkambi has been a low point in the world of UK market access – and a tragedy for many cystic fibrosis patients and their families over the last three years. Is the end in sight? And if it is, what lessons can be learnt? Read our analysis starting on p18.

Brexit

Another tragedy (or black comedy, depending on your mood), Brexit is sadly also nearing its third birthday, with only the faintest glimmerings of light at the end of the tunnel. There is renewed hope, however, that the threat of a deeply damaging no-deal Brexit will be conclusively written off. If and when this comes, it will be great news for patients in the UK and Europe. But a soft Brexit could still leave the UK in a “stay and pay but have no say” regulatory space that would disadvantage its life sciences sector. Time to ‘put it to the people’, now that the choices behind Brexit are a little clearer than in 2016.

Gottlieb: a class act

Earlier this month Scott Gottlieb departed from the top job at the FDA, leaving behind a legacy of a reinvigorated and respected world-leading medicines regulator.

A Trump nominee, expectations were low for Gottlieb when he took the role less than two years ago. However, he proved to be an outstanding FDA Commissioner; leading change at the agency to meet the rapid evolution of pharma science and championing innovation, but also speaking out fearlessly and acting swiftly against anti-competitive behaviour. A true public servant, he will be a hard act to follow. From a trans-Atlantic perspective, it’s hard not to wonder what such a figure might achieve in Europe – but also conclude that the EU currently lacks this kind of leadership.

View PME April 2019 online


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