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 (2017) 14:1 SCRIPTed 81 82 to the identified weaknesses of the AP scheme, we propose procedural safeguards which are in keeping with the EMA's public health missions.
Research using three-dimensional neural tissues derived from human pluripotent stem cells—known as ‘human brain organoids’—has progressed rapidly in recent years. Although related ethical issues have been intensively discussed, legal issues have only been sparsely examined compared with the related ethical issues. In this paper, we explore a fundamental issue concerning the legal status of human brain organoids: whether they can be considered legal persons. We clearly distinguish between two types of legal personhood: ‘natural person’ as a human legal person and ‘juridical person’ as a nonhuman legal person. By examining natural and juridical personhood separately, we point out the bias and confusion in the remarks on the legal personhood of human brain organoids and provide a more comprehensive picture of the problem.
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