Policy & Regulation
The pharma industry faced minimal risks under Donald Trump's first term as US president but had a strained relationship with Joe Biden's legislative introductions. Some hope for better fortunes with Trump's return, even with Robert F. Kennedy Jr. overseeing the FDA. In Europe, as EU reform talks progress, drug firms may face delays in learning about future regulatory data protection and orphan market exclusivity periods.
The pharma industry arguably suffered none of the downside risks that were possible during the first Trump administration, and their relationship with Biden could not have gone much worse. And while they may hope a Trump return could help their fortunes, having RFK Jr. supervising the FDA is likely not the prescription they want.
Reflecting on 40 years of EU medtech regulation makes me realize how incredibly far we have come. But have we come full circle and replaced the frustrations of four decades ago with a different, but equally challenging, set of problems?
As talks continue on the EU pharmaceutical legislative reform proposals, drug firms may have to wait some time before they find out what the future periods of regulatory data protection and orphan market exclusivity will be.
It is time for companies to take part in cross-country health technology assessments and stop only asking “what’s in it for me?”