Abstract
This paper outlines some of the challenges faced by regulation of genetic biobanking, using case studies coming from the Italian legal system. The governance of genetic resources in the context of genetic biobanks in Italy is discussed, as an example of the stratification of different inputs and rules: EU law, national law, orders made by authorities and soft law, which need to be integrated with ethical principles, technological strategies and solutions. After providing an overview of the Italian legal regulation of genetic data processing, it considers the fate of genetic material and IP rights in the event of a biobank’s insolvency. To this end, it analyses two case studies: a controversial bankruptcy case which occurred in Sardinia, one of the first examples of private and public partnership biobanks. Another case study considered is the Chris project: an example of partnership between a research institute in Bolzano and the South Tyrolean Health System. Both cases seem to point in the same direction, suggesting expediency of promoting and improving public-private partnerships to manage biological tissues and biotrust to conciliate patent law and public interest.
Highlights
The governance of biological materials and related data stored in genetic biobanks depends on the typology of the biobanks, on the anticipated use, on legal frameworks where nationally and internationally binding and non-binding rules apply and, last but not least, on the limits set by consent and agreements with individuals and groups
We have considered a series of case studies, in the light of the legal framework of genetics biobanks in Italy
We have focused on the European and Italian legal framework, analysing in particular the entry into force of the new EU General Data Protection Regulation (Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016) and its impact on the Italian legal system
Summary
This article is part of the Topical Collection on Citizen’s Health through public-private Initiatives: Public health, Market and Ethical perspectives. With regard to informed consent, the General Authorization states that “genetic data may be processed and biological samples used exclusively for the purposes specified on condition the person concerned has provided his/her written informed consent thereto” and “information notices shall include (...) a detailed list of all the specific purposes to be achieved” (Points 5 and 6) This provision clearly disregards the possibility of developing research tracks following further purposes, not fully identifiable at the time of data collection. The collected and catalogued genetic material should be considered as a vehicle for both personal information and potential public interest in pursuing the research aim In this case, the whole set of EU rules concerning the protection of sensitive data and the management of biological samples may be applied. Publicprivate partnership might respond to the converging interests—public and private, economic and scientific research oriented—and to the need for flexibility of regulation of these complex objects, which are the biological samples and the precious information they contain
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