Abstract

Italian regulation has recently recognized, in the Decree of the Ministry of Health November 30, 2021, the right for a scientific research center to «transfer trial data to the pharmaceutical company for registration purposes». In this context, the aforementioned Decree also regulates the so called «contratti di supporto alla ricerca» i.e. grants by which a pharmaceutical company, without consideration, makes an attribution in cash or in kind (i.e. drugs or other pharmaceutical products) to the research promoter. The legal nature of these grants was analyzed, in light of Italian and French doctrine on the subjective element of donation, and it was held that they do not constitute donative acts within the meaning of Article 769 of Italian Civil Code, lacking the «animus donandi». Therefore, it was held that such acts may not have the solemn form prescribed by Italian law for donation, and that they fall within the group of «atypical gratuitous contracts», admitted by Italian jurisprudence since early 2000s. In conclusion is discussed the case where this grant («supporto alla ricercar») is stipulated in parallel with an option, or pre-emption contract, or a preliminary contract having as its object the (future) transfer of the trial data to the pharmaceutical company, for registration purposes. It was argued that the case is probable to constitute «linked contracts», unless, based on the will of the contractors, the (future) data transfer is ment as consideration to the cash or kind disbursement