Si caelum digito tetigeris. Osservazioni sulla legittimità costituzionale degli obblighi vaccinali

The Pandemic has made problematic many of the consolidated acquisitions about 'mandatory vaccination’, which is an institution traditionally present in the Italian legal system. Constitutional Court has developed since 2002, a specific judicial doctrine on the conditioning that technical-scientific evidences produce on legislative powers of Government and Parliament. This doctrine is different in itself from US Courts Frye and Daubert, given the different nature of Judicial Review of Legislation in the US and Italian legal orders. Rather, it resembles some feautures of the ‘rationale’ doctrine elaborated by US Courts to review agency decisions under US 1946 Administrative Procedures Act. This paper examines the European regulation of pharmaceutical marketing authorizations issued by the Commission under EU Reg.726/2004 and Reg. 507/2006 (Standard marketing authorization; Conditioned Marketing Authorization; Exceptional conditions Marketing Authorization). And questions the level of certainty of fast-track trials provided by EMA as a sufficient ‘rationale’ to impose a general mandatory vaccination Order. The two (apparent) paradoxes of 'impossible assessment' and 'endless trial’ express the conceptual frame of an hypotetic judicial review of a general mandatory Governmental Emergency Order, or legislation.