Presentation

 

Research biobanks today are proliferating in big research centers and secondary hospitals serving peripheral areas. Alongside this development, huge population biobanks - where biological materials of entire communities are gathered, catalogued and studied - are being established in a growing number of countries all over the world. Private companies offering biobanking services are emerging as flourishing new businesses. Just recently, the Report on a “National Cancer Plan 2010/2012”, issued by the Italian Ministry of Health in January 2010, stresses the role that a network of Italian biobanks will play in developing a national strategy for cancer research.

The biobanking boom of recent years has prompted a lively debate on a host of interrelated legal issues: 1) the Gordian knot of the ownership of biological materials; 2) the privacy concerns raised by the difficulty of accepting that biological samples must be completely anonymous without incurring the practical impossibility of exploiting their information potential, since biological and genetic data retain such potential only if they can be traced to the evolving clinical history of the original donor; 3) the delicate role and the changing content of the donor’s “informed consent”, as the main legal tool which may serve to link the privacy and property interests of the donor with the research interests and the set of principles that should inform the functioning of the biobank; 4) the IP issues and the patentability of biological samples and the protection of databases storing genetic information obtained from the samples. Responding to these problems will be crucial for pursuing the optimal allocation of the benefits that can be obtained by exploiting the scientific research carried out on the biological samples stored in biobanks.

The conference on “Comparative Issues in the Governance of Research Biobanks: Property, Privacy, Intellectual Property and the Role of Technology” is aimed at exploring, from a comparative viewpoint, the extent to which digital technology may assist in tackling the many regulatory issues raised by the practice of biobanking for research purposes, issues which may be considered and analyzed under the traditional paradigms of Property, Privacy, Informed Consent and Intellectual Property (Patents). These different theoretical legal facets of biobanking activity are strictly interconnected and must be analyzed taking such interconnection into consideration. A holistic consideration of the issues involved in research biobanking appears to be the only way in which an optimal regulatory governance of biobanking activity can be successfully pursued. This perspective highlights the importance of digital technology as the element capable of providing the infrastructure that may help to coordinate the different interests involved in biobanking activity, at the same time (1) enabling the infrastructure in itself to implement the regulatory standards and (2) providing an environment where the self determination of the donors can find its real expression without incurring transaction costs which may be impossible to sustain.