Same Structure, Different Processes, and Trajectories

Abstract

Abstract This chapter shows that, to regulate European pharmaceutical markets from the mid-1990s to the present date, the same experimentalist structure (the European Medicines Authority, EMA) has been used less for conventional medicines (namely, hydroxyethyl starch (HES) infusion solutions) than for innovative ones, including the COVID-19 vaccine most used in the European Union. The chapter further highlights that once employed, experimentalist processes can take both self-limiting and self-reinforcing trajectories. This variation in processes as well as trajectories is inconsistent with distributions of legal power, which were identical and firmly multipolar. Instead, it is in line with both uncertainty and opposition, which varied. For innovative medicines such as COVID-19 vaccines, the European Commission recognized its uncertainty and sought consensus with the EMA and the national authorities composing it. For conventional infusion solutions containing HES, by contrast, by the late 2010s, the Commission could rely both on an earlier blueprint—which reduced uncertainty—and a strong coalition led by Germany—which ensured comitology approval despite deviation from the scientific opinion of the EMA and most of the regulators sitting therein. To avoid breakdown, finally, in this case, experimentalist processes depended exclusively on the penalty-default mechanism.