A plague on pharma? Where and why reimbursement has become such a hurdle, and the keys to overcoming it

Much like a soccer player having to adapt his game when he goes to play in a different national league, pharma companies need a different approach to gaining regulatory approval and reimbursement in different major markets.

The first part – getting regulators on board by showing them a medicine’s benefits – has arguably become easier as the likes of the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) offer expedited pathways and sometimes approve drugs without as much data as was required previously, when they understand its potential.

Reimbursement, however, is now far from a formality following on from that regulatory approval, and it is becoming something of a dirty word in pharma.