“Adaptive licensing” or “adaptive pathways”: Deregulation under the guise of earlier access

Joint briefing paper from Health Action International (HAI), The International Society of Drug Bulletins (ISDB), The Medicines in Europe Forum (MiEF), The Mario Negri Institute for Pharmacological Research, The Nordic Cochrane Centre and WEMOS.

"Adaptive pathways" raise numerous concerns from a public health perspective. The organisations that endorse this statement have closely monitored developments in EU pharmaceutical regulation for many years and put forward a critique of the "adaptive pathways concept". Implementing adaptive pathways could lead to a situation where premature marketing authorisations become the rule, even when no genuine public health need exists, therefore putting EU citizens' health unnecessarily at risk.

Attachment: europe_med_octobre_2015.pdf