Congressional inaction on drug pricing legislation has meant the Trump Administration is pursuing a menu of regulatory approaches. For the most part, that means slower and incremental change.

Changing US drug rebating policy is like throwing an activated grenade into the middle of the American drug distribution system. Yet, increasingly it seems the US drug market is poised for a big shake up when it comes to the way pharmaceuticals manufacturers price their drugs, negotiate market access with payers, and pay back-end discounts to offset the cost of their products. 

As more and more immuno-oncology products reach the market, the sustainability challenge persists: biopharmaceutical companies are seeking fair reimbursement deals that recognize their innovations, and struggling health care systems worldwide are pushing the burden of proof back onto the shoulders of drug developers.

Medtech stakeholders were reminded at the UK's largest regulatory forum that, for business in general, and medical technology manufacturers in particular, those willing to make the best of Brexit are still having to work in the dark. The lack of useful government outreach is frustrating most efforts to secure business continuity. And that is without factoring in the huge regulatory changes that the EU's twin medical device regulations – the MDR and IVDR – will bring.

Providing access to novel medicines through early access programs or supplying markets where medicines remain unlicensed has key benefits for the innovative drug development industry; revealing market insights and strategic opportunities.