Adaptive Pathways Regulations for Stem Cells: Accelerating Access to Medicine or Deregulating Access toMarkets?

Abstract

In response to calls for faster access to innovative biomedicines, the European Medical Agency ran a two-year pilot program known as the “Adaptive Pathways” (AP) scheme. Under this approach, evidence is gathered and evaluated iteratively for license adaptation to reduce uncertainties rather than in an accumulative phased trial process. With the European Medicines Agency (EMA) aiming to mainstream the AP scheme, the regulatory approach of accelerating the approval process for novel biomedicines is in need of critical evaluation and should be viewed with some caution. Focusing on the recent market authorisation of a stem cell product, we scrutinise the legal and ethical merits of this programme. We draw attention to how the AP scheme will grant conditional marketing approval to medicinal products with limited clinical benefits. In response to the identified weaknesses of the AP scheme, we propose procedural safeguards which are in keeping with the EMA’s public health missions.