© Springer Science+Business Media Dordrecht 2015Deborah Mascalzoni (ed.)Ethics, Law and Governance of BiobankingThe International Library of Ethics, Law and Technology1410.1007/978-94-017-9573-9_5
Consent, Privacy and Property in the Italian Biobanks Regulation: A Hybrid Model Within EU?
Faculty of Law, University of Trento, Trento, Italy
It has to be pinpointed that, even within a general context of co-elaboration, agreement and sharing of the contents and opinions expressed within this text, the first paragraph has to be ascribed to Marta Tomasi (Ph.D. candidate, Department of Legal Sciences, University of Trento), the second one to Simone Penasa (Ph.D., Fellow researcher in Comparative Public Law, Department of Legal Sciences, University of Trento) and the third one to Matteo Macilotti (Ph.D., Fellow researcher in Comparative Private Law, Department of Legal Sciences, University of Trento).
The discussion about genetic information and about the related possibility of storing DNA samples and associated data into an organised database has, in Italy, only recently developed and for sure it did not outline all the core problems and possible questions to be answered yet. The stage of finding solutions seems to be, therefore, quite far away by now.
Anyway, the advent of DNA analysis and the improvement of techniques which allow a protracted conservation of biological samples and the capacity of simultaneously processing a lot of information, gave also Italian researchers the possibility of pushing their work even further. In this specific field of scientific research, public support for better medical diagnosis and treatments has to be balanced with anxieties and concerns: when DNA samples and genetic information are collected and subsequently used, ethical and legal issues about informed consent, confidentiality, individual identity, discrimination, self determination, secondary use of samples and data, return of results and data sharing have to be faced. Quick and often overwhelming scientific developments have, therefore, to be dealt with and to be properly regulated.
In general, scientific research is usually assisted by a variety of precautions and limits which, even if not absolute, are sufficient to assure the research subject’s interests to be protected and guaranteed. The traditional conflict between patients’ interests and scientists’ freedom of research is, in relation to biobanks, made even stronger by the elaboration of broader models of consent, by the possibility of considering biological materials property of the researchers or of the institutions,1 by the creation of national criminal DNA databases and, finally, by the intervention of private companies.2 As it has been observed: «DNA banking is quickly changing from an academic research activity to a governmental and commercial enterprise conducted by DNA brokers» (Roche and Annas 2006).
These are the main reasons of the need of reshaping the ordinary balance in the relationship among patients/donors, clinicians and researchers: this should be done both with legally binding measures or with softer regulations provided, for example, by advisory bodies, ethical review boards or professional organisations (Cambon-Thomsen et al. 2007).
While in many countries small collections of samples in academic or hospital settings are often side by side with large-scale national repositories, the Italian situation is characterized by a huge number of unofficial collections, frequently made up of previously collected materials and left-over samples from medical care, which obviously give rise to critical disputes about consent requirement.
The existence of multiple international and supranational documents dealing with research biobanking and the absence, in Italy, of a specific statutory law highlight the necessity of defining the regulatory framework of this field of biolaw. It is important to be stressed how, abroad, requests for a down regulation and for a “softer” strategy based on traditional instruments and ethical principles are showing up, while, in Italy, the matter had not been directly approached yet.3
The first paragraph of this brief analysis aims at outlining the regulatory framework of biobanks’ governance in Italy, which comprehension is essential for any further consideration. The second paragraph focuses on the legal consequences of the multidimensional nature of genetic information, with special regard to its legal object (sample regulation and data protection), the involved subjects (“source” subject and the so called co-subjects) and the normative instruments of regulation (legislative and not legislative sources). The last part is dedicated to the analysis of the issues related to property of human tissues starting from the consideration of their bi-dimensional nature (molecular aggregates and sources of personal data).
2 Legal Italian Framework
In many cases, the lack of a specific statutory regulation about biobanks implies that their discipline springs out of the combination and the coexistence of a variety of disparate rules aiming at the protection of different interests and addressing the topic from different viewpoints. Thus, in Italy, different sets of rules having reference to different layers have to be taken into account: on the one hand, biological samples should be considered in their material dimension and rules about, for example, storing and patents become relevant. One the other hand, these rules are to be necessarily balanced and harmonised with those protecting the “informational” dimension, made up of genetic data. At the same time also indications about best practices for researchers have to be involved in this process of shaping a regulatory framework.
Therefore, postponing to next paragraphs some reflections about the relationship between the material and the informational dimension, it is by now important to underline that different guidelines, coming from different bodies and characterised by different levels of binding strength (hard law and soft law. For a definition of soft law see Senden 2005), have to be considered and combined in order to understand the Italian discipline of biobanking for research purposes.
2.1 The International Level: Between Hard and Soft Law
First of all, at the international level, general principles can be found in two documents adopted by UNESCO, respectively in 1997 and in 2003. The first article of the “Universal Declaration on the Human Genome and Human Rights” highlights the relevance of this topic affirming that the «human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity». This first provision has to be read together with the fundamental role played by scientific research in our society, recognised by article 12, (b): «(f)reedom of research, which is necessary for the progress of knowledge, is part of freedom of thought. The applications of research, including applications in biology, genetics and medicine, concerning the human genome, shall seek to offer relief from suffering and improve the health of individuals and humankind as a whole». In any case, research purposes should not prevail on «rights, fundamental freedoms and human dignity of individuals or, where applicable, of groups of people» (art. 6).
These provisions, generically related with genetic data treatment, have to be highly regarded even when dealing with matters of management and organisation of biobanks.
Similar provisions, together with the requirement of a «prior, free, informed and express consent» in order to lawfully collect, use and store genetic data and biological samples (art. 8), can be found as well in the text of the “International Declaration on Human Genetic Data”.4
More recently, similar contents can be found in the text of the Recommendation on Human Genetic Research Databases, approved by the Organisation for Economic Cooperation and Development5 in 2009.
On the contrary, binding relevance should be ascribed to the “Convention for the protection of Human Rights and dignity of the human being with regard to the application of biology and medicine: Convention on Human Rights and Biomedicine” (Ovideo Convention). This Convention of the Council of Europe aims at the protection of dignity and identity of all human beings and at a full respect of rights and fundamental freedoms with regard to the application of biology and medicine. It sets, therefore, some limits within which scientific research can fairly develop: these borders are represented by respect of relevant professional obligations and standards (art. 4), the principle of free and informed consent (art. 5), respect for private life (art. 10) and a specific clause against genetic discriminations (art. 11). Even if not explicitly, the Convention addresses biobanks in requiring for the storing and use of biological tissues6 written consent and proper information of the donor.
The main problem about this document is that Italy did not complete the procedure necessary for the ratification of an international treaty. Italy subscribed the Convention and the Parliament adopted a statute for the authorisation to its ratification, but that law was never delivered to the Council of Europe: this means that the so called Oviedo Convention can not be considered properly binding within the Italian legal system (Penasa 2007)7. Following the opinion of the Court of Cassation, anyway, even if the provisions of the Convention should bend in front of the existence of contrasting national rules, nonetheless they must be used in order to choose the interpretation of internal norms which is the closest to that expressed by the text of the Convention.8
It is also important to take into consideration the additional Protocol concerning Biomedical Research, adopted in Strasbourg on January 25, 2005. The main question about the usefulness of the rules in it contained, beyond procedural considerations, is that this Protocol expressly limits its field of application to the «range of research activities in the health field involving interventions on human beings» (art. 2.1.). Parts separate from the human body seems therefore to be excluded. Thus, even if general principles informing scientific research have to be highly regarded, it is quite evident that broad statements such as that contained in art. 3 about the primacy of human being9 should be reconsidered and rebalanced, bearing in mind the different object of the research.
Even more restrictive is the 4th additional protocol to the Convention concerning Genetic Testing for Health Purposes,10 which explicitly excludes from its field of application genetic tests carried out for research purposes (art. 2.b.).
In the European context, the Committee of Ministers of the Council of Europe gave some guidelines with the Recommendation R(2006)4.11 This document, strictly applicable to the topic we’re dealing with,12 beyond setting rules about consent, non discrimination, prohibition of financial gain, common to other instruments,divides «unlinked anonymised materials»13 from «linked anonymised materials»14 and from «materials».15 This kind of detailed classification is very difficult to be applied in Italy where, as we will underline, normative provisions barely distinguish the informational dimension from the material one.
With specific regard to the “informational” dimension, rules set by the “Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data”16 of the Council of Europe have to be taken into account.
2.2 The European Union Context: Indirect Relevance of EU Directives
The need for a unified framework which ensures high standards of quality and safety in the testing, processing and storing of tissues and cells within the European community is at the base of two directives, one by the European Parliament and Council and the other by the Commission. The first one, of 2004,17 aims at «standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells»,18 while the latter19 is aimed at the implementation of the former, with regard to certain technical requirements. Problems similar to those underlined talking about the additional Protocol to the Oviedo Convention arise: the first directive clarifies that it «tissues and cells intended for human applications»20 and does not apply to «research using human tissues and cells, such as when used for purposes other than application to the human body».21 It is hence clear that only a few biobanks are established for the pursuit of such purposes.22
It is worth noticing, also to emphasise the Italian attitude towards these matters, that while the first directive, that of 2004, was implemented within the Italian legal system with the adoption of legislative decree n. 191/2007, Italy failed to acknowledge the second one and was condemned on November 12th, 2009 by the European Court of Justice.23 The directive was finally implemented in 2010 with the legislative decree n. 16.
The regulation and organisation of biobanks should also consider Directive 98/44/EC on the legal protection of biotechnological inventions which provides that national patent law remain the essential basis for the legal protection of biotechnological inventions and that States shall, if necessary, adjust their national regulation to take account of the provisions of the Directive.24
2.3 The National Level: Legislator’s Apathy and Other Sources’ Intervention
Turning to the national level, relevant but non binding guidelines were given by two governmental advisory bodies.
The National Committee for Biosafety, Biotechnologies and Life Sciences (Comitato Nazionale per la Biosicurezza, le Biotecnologie e le Scienze della Vita)25 intervened in 2006 with a document containing useful information for the creation and acknowledgment of biobanks. Paragraph 2.3.1. is specifically dedicated to genetic biobanks which are considered to be different from the others (tissue biobanks) because of the necessity of maintaining a link among the sample and family and clinical information in order to guarantee the possibility of creating a complete genetic profile and of obtaining essential follow up results. Rules about the protection of personal data are therefore indispensable. With specific regard to consent, it has to cover all the steps of collection, storing and use of the sample.
In 2008 a second document was adopted in which, after a global reconnaissance of the general problem, the analysis of the Italian situation and a comparison with other realities, the Committee strongly endorses an intervention of the legislator on these matters.
A couple of months after the publication of the former document, the Italian Committee on Bioethics (Comitato Nazionale per la Bioetica)26 delivered and opinion about that document and about the Recommendation of the Council of Europe.27 This document highlights the fil rouge which connects the additional Protocol to the Oviedo Convention on biomedical research, the Recommendation of the Council of Europe and the Italian guidelines given by the other Committee. The National Bioethics Committee substantially agrees with the principles and rules outlined by the Council of Europe and by the Committee on Biosafety and Biotechnologies with regard to consent, right to access, information, non discrimination and gratuity, underlining the necessity for a precise regulation, even if recognising the impossibility of setting too strict rules.
In the absence of a statutory law addressing to research biobanks, attention has to be focused, generally speaking, on genetic data treatment. Considering properly binding provisions, in Italy, the general discipline of personal data is contained into a single code,28 which specifically attributes to an independent administrative authority,29 which aims at the protection of fundamental rights and freedoms and at guaranteeing the respect of human dignity in the treatment of personal data, the task of regulating that particular category of sensitive data, made up of genetic information.
Following this legislative indication of 2003, in 2007 the privacy Authority released a General Authorisation for the Treatment of Genetic Data (which effects have been extended until the end of 2010).
First of all a consideration has to be made about the peculiar administrative nature of this document: such a kind of choice should reflect the need for down regulation cited above but, considering the stage of discussion about these topics in Italy, it turns out to be quite peculiar into a legal system where the legislator often intervenes with really strict provisions about biolaw.30
Moreover, with regard to the contents’ profile, it has to be stressed that the same rules are set both for the biological samples and for related information, with no kind of distinction. More precisely, the text considers the two entities as separate elements and gives singular definitions, but this distinction is never recalled in the following provisions and biosamples are scarcely ever recalled. This monistic approach is possibly to be regarded as an outcome of the inactivity of the legislator and of the subsequent subsidiary role played by the Authority. On these aspects further considerations will follow in the next paragraph.
The analysis of the first provisions of this Authorisation immediately outlines that scientific and statistic research, if aiming at the protection of public health, are considered to be lawful purposes to be pursued through the treatment of genetic information. Compelling, in this case, is the principle which requires the consent of the “donor” (paragraph 3 c).
Another general rule is that identifiable data should be used only if anonymised data are not feasible for the pursued aim (paragraph 3).
If genetic information or biological samples are contained into a genetic database, they should be coded and the donor will be recognised only if necessary (paragraph 4.3.)31 in order to avoid risks and abuses.
Moreover, according to paragraph 4.2., scientific research and statistics have to be realised through the elaboration of a detailed project, which helps in the identification of the aims pursued and in which rules about data treatment will be outlined, in order to make the provisions of the privacy Code and of the Authorisation concrete.
Trace of the monistic approach, which unifies the material and the informational dimension, can be also found in the extension of some requirements originally set by the provisions of the Code of privacy for the treatment of genetic profiles, also to biological samples (paragraph 4.2. or 4.3.).
A further profile which heavily affects the discipline of biobanks is that of consent process: the 2007 Authorisation openly embraces a quite narrow conception of consent procedures. In establishing the content of the information that must be given to the donor/patient, which draws the borders of the consent, paragraph 5 requires an analytic and detailed description of all the pursued finalities and the possibility for the subject of limiting the use of its samples and data, excluding some purposes. This kind of individual and restrictive approach has to be compared with frequent voices abroad, claiming for an opener view, embracing also third subjects’ interests,32 and for the adoption of a broad consent based model (Otlowski 2009; Hansson et al. 2006). In Italy, anonymisation seems to be the only mean possible to overcome the strict rule of consent and it needs to be applied to both samples and data.
This reconnaissance of the regulatory framework of biobanks in Italy clearly outlines the difficulty of singling out the concrete provisions which affect and orientate the discipline of this topic. Moreover, it is quite clear that biological samples often find themselves floating into a vacuum between rules about scientific research on human being and rules set for the protection of the informational dimension of genetic data.
3 Italian Biobanks Regulation. Issues at Stake
One of the main features of genetic data is their complexity. This complexity is due to its multidimensional nature (Jiménez 2006), which calls for new protection mechanisms which go to integrate traditional “property based” means. Biobanks regulation is deeply related and conditioned—oriented—by the special nature of genetic information. The multidimensional nature of the latter finds an equivalent in the former, which is characterised by a heterogeneous structure and nature, depending from its concrete content. The summa divisio between genetic data and biological samples emerges in all its normative conditioning power of the biobanks regulation. It clearly testifies the separation between the samples’ source and the persons potentially affected by the genetic data treatment. The multidimensional nature of genetic data involves also biobanks regulation. From this perspective, it is possible to isolate three different levels of complexity within biobanks regulation.
3.1 The Legal Object from Biological Dispositions to Genetic Rules
According to international legal sources and national regulations (Gibbons 2007), it seems to emerge a trend toward a normative distinction between tissue regulation and data protection, in order to guarantee the effectiveness of legal regulation and the harmonisation within the EU legal framework (see Data Protection Working Party—article 29, Directive 45/96/CE). This distinction may represent a shared ground in order to achieve «a common understanding of the different issues relating to the processing of genetic data» (Document on “Genetic Data”, by the Data protection Working Party, 2004). The need for a harmonic distinction derives directly from the special nature of genetic information, which represents a further derivation of genetic data treatment (the so-called “genetic knowledge”). This special nature derives from the singularity of genetic information (“genetic rules”), compared with the classical personal/sensitive data, due to its double nature which expresses an intrinsically relational construction which does not characterise the “biological provision” (human tissue).
The Italian model can be defined as a “hybrid-integrated model”. Apparently, the distinctive approach finds a concrete application within the Italian legal system, coherently with the need for a harmonious distinction between data protection and tissue regulation. On the one hand, there is a set of systematic rules specifically dedicated to genetic data, deriving from both legislative—the Code of privacy, art. 9033—but also administrative-secondary sources, such as the cited General Authorisation for the Genetic Data Treatment provided by the Italian Authority for Personal Data Protection (2007). On the contrary, with regard to the tissue regulation, it has been chosen a “sectional” regulative approach, according to which it has been regulated specific kinds of biological samples for specific aims of utilisation34 but a coherent legal intervention is lacking in the field of samples collection, storage and utilisation for research purposes.35
The General Authorisation of 2007 partially covers this regulative vacuum, combining data and samples regulation within the same general principles and operative means. It seems that tissue regulation is attracted by and dissolved into the data protection, as if a double relation inspires the regulatory structure, which influences the same legal relevance of the former one: a chronological precedence of biological sample, in reason of its nature of source of genetic information; a functional subordination, revealing the exploitable character of biological samples compared to data protection (Macilotti et al. 2008).
The Authorisation of 2007 expressly identifies a normative ground for this methodological option, even though it derives from a soft law source. The document on “Genetic Data” provided by the Data protection Working Party in 2004 recommends that, in prescribing genetic data protection measures, it is essential to take into account and regulate also biological samples’ status, because of their attitude to become sources of personal data.
Recently, the trend toward this regulative distinction has been put in doubt. It has been debated «whether continuing to regulate data and tissue separately—particularly for biobanks—is the most sensible or desirable approach» (Gibbons 2009), arguing that a «bifurcated situation» in regulating data protection and human tissues is not fully satisfactory «due to inconsistent legal standards, duplication, cost, confusion, and discordance with biobanking practice and professionals’ own understandings» (Gibbons 2009). Significantly, the Authorisation defines both genetic data («the data which, independently from its typology, is related to person’s genotypic constitution or to genetic characters transmissible within a blood-related group») and biological sample («any biological sample which contains genotypic information characterising an individual») because of both constitute the Authorisation object without providing a differentiated regulation.
This approach may potentially engender a state of legal uncertainty and a lack of regulative efficacy. This is not due to an overlap between legal issues (data protection and tissue regulation) which can be regulated differently, but to an “a-systematic approach” to tissues’ regulation. Within the main, even though not legislative, source in this ambit—the Authorisation of 2007—the principles related to tissue regulation emerge in an apparently “intermittent” and subsidiary way compared to data protection. It is formally absent with regard to the aims of the treatment, exclusively dedicated to genetic data, but it re-appears in the sections entitled to «and safety procedures» (point 4), «counselling and consent process» (points 5 and 6) «data and tissues preservation and circulation» (points 8 and 9).
The need for a new normative framework exclusively dedicated to biobanks for research purposes has been stressed also by the National Committee for the Biosafety, the Biotechnology and the Life Sciences, in the above cited Document of 2008. In this Document, which goes to integrate—even if it lacks of legal binding power—the biobanks regulation, the Committee declares that a legislative act is essential also for the biobanks for research purposes, in order to clarify primarily that biological samples have to be preserved and utilised exclusively for the common good of the community.
3.2 The Involved (Co?) Subjects. The Necessary Relation Between The (Health) Purposes and the (Informed) Consent Process
The need for a consistent distinction between tissue regulation and data protection derives also from the special nature of genetic information, within which it has to be drawn a distinction between the «source»-subject, from whom biological material is derived, and other subjects («co-subjects») (Hondius 1997) directly involved in genetic data treatment since they belong to the same biological family. With regard to the former one (source-subject), it is identifiable a mono-dimensional legal approach, because of a concentration in the same person of the need for his/her right protection (individual ownership of the biological samples); the latter (co-subjects) have a multi-dimensional approach, due to the plurality of subjects potentially involved in the genetic data treatment (genetic data co-holders) (Liao 2009).
Is a new, legally relevant, social group emerging, as the international level seems to suggest?36 Does the Italian regulatory framework take into account this new level of normative criticism?
We face the inadequacy of traditional concept of “third subjects” with regard to the shared nature of genetic information: an intermediate legal category, constituted by all individuals sharing the same genetic line, to which a hybrid legal protection seems to be recognised (Santosuosso 2002).37 Even stressing the potential ambiguity of the attribution of legal relevance to a group of people, it is at the same time remarkable how the emerging relation of interests among individuals belonging to the same genetic line is legally relevant, although exclusively at the “individual” level more than a “communitarian” one. From an “Italian centred” perspective, more than a direct reference to the constitutional status and protection of the family guaranteed by art. 29 of Italian Constitution,38 it is more proper to refer to the “social group” recognised by art. 2 of the Italian Constitution39