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Legal issues in governing genetic biobanks: the Italian ...uu.diva- 1143042/FULLTEXT01.pdf · PDF fileinstance depending from funding availability or bankrupt, in fact, raises important

Feb 15, 2019

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ORIGINAL ARTICLE

Legal issues in governing genetic biobanks: the Italian frameworkas a case study for the implications for citizens healththrough public-private initiatives

Cinzia Piciocchi1 & Rossana Ducato1,2 & Lucia Martinelli3 & Silvia Perra4 &Marta Tomasi5 & Carla Zuddas4 & Deborah Mascalzoni6,7

Received: 5 May 2017 /Accepted: 3 September 2017 /Published online: 18 September 2017# The Author(s) 2017. This article is an open access publication

Abstract This paper outlines some of the challenges faced byregulation of genetic biobanking, using case studies comingfrom the Italian legal system. The governance of genetic re-sources 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, technolog-ical strategies and solutions. After providing an overview of theItalian legal regulation of genetic data processing, it considersthe fate of genetic material and IP rights in the event of abiobanks insolvency. To this end, it analyses two case studies:a controversial bankruptcy case which occurred in Sardinia, oneof the first examples of private and public partnership biobanks.

Another case study considered is the Chris project: an exampleof partnership between a research institute in Bolzano and theSouth Tyrolean Health System. Both cases seem to point in thesame direction, suggesting expediency of promoting and im-proving public-private partnerships to manage biological tis-sues and biotrust to conciliate patent law and public interest.

Keywords Biobanking . Genetic data . Informed consent .

Gene patent . Data protection . Privacy . Bankruptcy .GeneralData Protection Regulation . Italian law

Introduction

The relationship between law, science and technology is a mul-tifaceted interaction, which has increased in complexity overthe last 20 years (Rodot 1995; Jasanoff 1995; Brownsword2008). Advances in bioinformatics and genomics and the pos-sibility of access to several networks, infrastructures, and data-bases have reshaped our notions of doing biomedical researchon the one hand (Trinidad et al. 2010) and on informational riskon the other, leading to the idea that anonymity in research maywell be a chimera (Kaye 2012). The attempt to regulate researchin genomics and biobank activities has impacted heavily ontraditional legal concepts and categories such as property, pri-vacy and informed consent (Kaye 2012; Kaye et al. 2015).

The studies of population genomics aim at understandinghuman health and gene environment interaction in the develop-ment of diseases, with the long-term goal of helping the discov-ery of targeted diagnostics and therapies. In order to achievethis objective, there is a need for large-scale collection of dataon phenotypic traits (health data, lifestyle, behaviours) andwideavailability of genomic data to carry out research into geneticvariability and gene environment interaction across whole pop-ulations (Kaye et al. 2009; Mascalzoni et al. 2014a; Knoppers

This article is part of the Topical Collection on Citizens Health throughpublic-private Initiatives: Public health, Market and Ethical perspectives

This article is based upon work from COST Action IS1303 'CitizensHealth through public-private Initiatives: Public health, Market andEthical perspectives, supported by COST (European Cooperation inScience and Technology) (http://www.cost.eu)

* Cinzia [email protected]

1 Faculty of Law, University of Trento, Trento, Italy2 Institut pour la recherche interdisciplinaire en sciences juridiques,

Universit Catholique de Louvain, Louvain-la-Neuve, Belgium3 MUSE Science Museum, Trento, Italy4 Faculty of Economics, Law and Political Sciences, Department of

Law, University of Cagliari, Cagliari, Italy5 Faculty of Economics, Free University of Bozen-Bolzano,

Bolzano, Italy6 EuraC Resarch, Bolzano, Italy7 CRB, Uppsala University, Uppsala, Sweden

J Community Genet (2018) 9:177190DOI 10.1007/s12687-017-0328-2

http://orcid.org/0000-0002-2418-7442http://www.cost.eumailto:[email protected]://crossmark.crossref.org/dialog/?doi=10.1007/s12687-017-0328-2&domain=pdf

and Abdul-Rahman 2008). For these purposes, populationbiobanks have become a necessary infrastructure basis for lifescience innovation on an international basis and the recipient ofconsiderable funding. The governance of biological materialsand related data stored in genetic biobanks depends on thetypology of the biobanks, on the anticipated use (different rulesapply to the collections of biosamples used in different settings,as for instance in a clinical setting or for research, from patientsor healthy individuals), on legal frameworks where nationallyand internationally binding and non-binding rules apply and,last but not least, on the limits set by consent and agreementswith individuals and groups.

As defined by the Council of Europe (2006), populationbiobanks are collections of human biological materials on apopulation basis derived from or destined for research pro-jects, which contain biological materials and associate per-sonal data, which may include or be linked to genealogical,medical and lifestyle data and which may be regularly up-dated. The large amount of samples and data required toachieve statistical significance has led, in the past decade, toa great increase in national and international biobanking cre-ation, both commercial and public. Another phenomenonwhich has posed a great challenge to local and internationalregulation is the rise of worldwide consortia (GIANT, Rd-Connect, BioSHaRE, just to name a few) (Knoppers et al.2011) aiming at information sharing (Budin-Ljosne et al.2014) and at adopting common operating procedures, includ-ing approaches to ethical and legal requirements (Knopperset al. 2014), such as consent (Gainotti et al. 2016), data pro-tection (Budin-Ljosne et al. 2015) and privacy. Biologicalsamples are collected from participants or patients, whose in-formed consent is needed for storage and use in genetic inves-tigation, retaining an interest in the biomaterials and in theassociated data. It is therefore controversial to apply tradition-al legal categories, such as property (Tallacchini 2005;Yassin et al. 2010) to determine the interests associated withbiosamples, genetic data and the protection of research resultslinked to proprietary interests such as intellectual property orpatents. Therefore, such traditional categories run the risk ofbeing inadequate and new definitions, or at least new interpre-tations, are needed.

In setting up and formalizing networks of collection, storageand exchange of biomaterials and genetic data, biobanking ac-tivity has become a noteworthy example of the controversialrelationship between research institutions and civil society, feed-ing into the wider debate on the oversight, governance, supervi-sion and accountability of biological innovation. Indeed, thelegal regulation of genetics biobanks is at the centre of differentdisciplines and opposing interests that need to be balanced.

One of the most controversial issues concerns the legalnature of the subject-matter of the biobanking activity, i.e.the biological sample (Macilotti 2013). The latter is a res,a tangible good, which traditionally attracts the category of

property rights. At the same time, it is the carrier of geneticinformation that relates to the person who has donated thatbiological material. Furthermore, such information presentsa challenging scenario, because its processing is likely to af-fect persons other than the data subject, namely his/her rela-tives and the whole biological family (Rodot 2006). Groupsand individuals, in fact, are linked by genetic information,even if they ignore their reciprocal family bonds, thus framingprivacy in a new way (Mascalzoni et al. 2014b). It is thereforecrucial that research activity is carried out taking into accountthe rights and the dignity of all subjects involved.

With regard to patients and research participants, geneticsholds new implications for informed consent procedures. Onthe one hand, it allows for new possibilities but, on the other, itraises critical issues, such as the right to know or not to know,the right to obtain only partial information with appropriatecounselling, the right to control the use of samples for a spe-cific study, excluding other aims or investigations and theproblems surrounding the return of incidental findings, familyimplications, international use and secondary uses of data(Burke et al. 2013; Budin-Ljosne et al. 2017).

Another critical point concerns the balancing between, onone side, property and intellectual property rights over biolog-ical collections and publications/inventions derived from themand, on the other, the public interest, i.e. the societal right tobenefit from scientific progress.

Such competing demands illustrate the complexity ofgoverning genetic biobanks and of drawing a line betweenpublic and private interests in this field. Here, public trustand civic engagement are particularly important issues, alsobearing in mind the future-oriented features of this infrastruc-ture which requires consensus on the governance of biologicalmaterial deposited for future use and in the hands of brokers oran intermediary (often the biobank itself) supplyingbiospecimens to different researchers (Rothstein 2005) fordifferent projects.

To manage controversial issues around the storage of bio-logical materials of human origin, the Council of Europe hasadopted recommendations (2016) oriented to protect the dig-nity and identity of all human beings and guarantee everyone,without discrimination, respe

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