Limits to the validity of contracts on human tissue in Italy, England and the EU
|PhD ceremony:||Mr O.E. (Enrique) Santamaría|
|When:||April 20, 2020|
|Supervisors:||prof. mr. dr. A.J. (Albert) Verheij, A.L.B. (Aurelia) Colombi Ciacchi, Prof|
|Where:||Academy building RUG|
The development of new technologies in genetic research and the increasing understanding of the human genome has led, in the last decades, to an increase in the use of human tissue in the fields of research, diagnosis and medical treatment. Several legal models have been proposed for the protection of the rights of the original source of the tissue and for the circulation and use of this material for research.
The main aim of this thesis is to explore the so-called contractual model. According to this model, the conclusion of contracts on human tissue could protect better than any other mechanism the rights and interests of the parties involved in the circulation of tissue for research.
For this purpose, the objective of this thesis is to answer the following research question: what are the limits to the validity of contracts on human tissue in the Italian, English and EU legal system? In order to establish such limits, this study focuses on the following possible cases of contractual relations for the transfer and use of human tissue: a) Gratuitous contracts between the first transferor and the first recipient of human tissue; b) Non-gratuitous contracts between the first transferor and the first recipient; c) Contracts between the first and subsequent recipients.
The research was carried out using two different legal methods. Firstly, the doctrinal research method was used to investigate the scope and content of the multi-level sources of law (national, supranational and international) that constitute the legal framework for the determination of the limits to the validity of contracts on human tissue. Secondly, the functional approach was used for the comparative analysis of the national legal systems of Italy and England. The research concludes that it is desirable to regulate, via contract law legislative provisions, the tissue transfers for the purposes of research. This regulation should place on the first recipient a clear set of information duties towards the first transferor of the tissue. In addition, such regulation should include mandatory and default rules for contracts between the first transferor and first recipient. The interaction between mandatory norms and default rules could achieve a strengthened protection of the autonomy of the first transferor of tissue.
This research also demonstrates that the conclusion of sales and other non-gratuitous contracts on human tissue between first transferor and the first recipient should not be prohibited.