Abstract
This paper highlights some crucial problematic nodes linked, on the one hand, to the total absence of a specific regulation of genetic data, derived from a considered and scientifically based choice, and on the other, to the lack of harmonization on the European level able to assure in the future an adequate and uniform protection of the individual rights at stake, and guarantee the best possible circulation of the outcomes of scientific research.
This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsNotes
- 1.
The main international agreements that establish the fundamental principles concerning genetic research are: the United Nations Convention on Biological Diversity (1992), the Universal Declaration on the Human Genome — UNESCO (1997), the Resolution on the ethical, scientific and social implications of cloning in human health - WHO (1998), Agreement on Trade-Related Aspects of Intellectual Property Rights (1995), Convention on Human Rights and Biomedicine (1997) and the relative Additional Protocol (1998) — Council of Europe.
- 2.
working party set up within the European Union in accordance with art. 29 of Directive 46/95/EC, having as its goal the protection of individuals with regard to the processing of personal data. On 14 March 2004 in Brussels, the Group adopted the Working document on genetic data, which far from having binding legal efficacy within the European system, merely has the function of identifying and drawing attention to the sector’s problematic nodes, with a view to favouring a more uniform approach, above all, on the part of internal law (see, pp. 3–4 of the Document).
- 3.
Document cit. at 3.
- 4.
Ex art 41 e ss. of regulation 45/2001/EC a Guarantor for data protection was instituted; the subsequent decision 1247/2002/EC of the European Parliament, of the Council and of the Commission, made effective the Guarantor’s functions and forms of intervention.
- 5.
B. De Witte, Diritti europei delle minoranze, in M. Cartabia (Ed.) Diritti in azione, Bologna, 2008. See, also, Report on the social, juridical, ethical and economic implications of human genetics of the temporary Committee on human genetics and other new technologies of modern medicine instituted the European Parliament, 26 July 2001, at 19.
- 6.
Article 95, par. 1 TEC, now art. 114 TfEU, envisages the adoption of “measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States”. It is an actual community competence on the basis of which is it possible to adopts rules and directive relating to question covered by the mandate of the temporary committee on human genetics and other new technologies in the sector of modern medicine, to the extent in which, obviously, such provisions impact on the functioning of the internal market.
- 7.
Title XIX, art. 179 first para. TfEU.
- 8.
Art. 179 second para. TfEU.
- 9.
Art. 180 TfEU.
- 10.
Art. 181 first para. TfEU.
- 11.
Art. 182, fifth para., TfEU. In 2000 the European Research Area (ERA) was created. See the European Commission website http://ec.europa.eu/research/era/index en.htm.
- 12.
The Commission’s 5th Framework Programme, approved by Decision 182/1999/EC (GUUE L26 del 1.2.1999), foresees, among its lines of action, “genomic research and genetic hillness”, with reference to “new technologies”, which should favour the exploitation of information contained in the genome for the benefit of healthcare, industry and the environment on the European level.
- 13.
Art. 5 TEU affirms for the first time that “ The limits of Union competences are governed by the principle of conferral”; thus, the competences of the Union are distinguished between an exclusive one (art. 3 TfEU) and a shared one (art. 4 TfEU). Added to this, is a further competence of support, coordination and supplement of the actions of Member States, disciplined by art. 6 TfEU. See U. Draetta, Le competenze dell’Unione nel trattato di Lisbona, in Diritto comunitario e degli scambi internazionali, II, 2008, at 246 and ss.
- 14.
Art. 6 TfEU. The abrogated art. 3 letter p) of the old TEC, listed among the Community’s general objectives, a generic “a contribution to the attainment of a high level of health protection”.
- 15.
New art. 168 TfEU abrogates and replaces the previous art. 152 TEC, introducing some important modifications.
- 16.
C. Casonato, La discriminazione genetica: una nuova frontiera nei diritti dell’uomo? in I diritti fondamentali in Europa. 15 colloquio biennale, Atti del convegno Taormina-Messina 2001, Torino, 2002.
- 17.
The principle of non-discrimination on the basis of genetic heritage is sanctioned by the Convention on human rights and biomedicine approved at Oviedo in 1997, which also authorises the performance of genetic testing only for medical purposes. Currently, it is the only international character with legally binding effect; however, to date, Italy has not set up the instruments of ratification and therefore the Charter does not have legally binding force in our system, being considered only in hermeneutical terms. On this point, see S. Penasa, Alla ricerca dell’anello mancante: il deposito dello strumento di ratifica della Convenzione di Oviedo, in www.forumcostituzionale.it.
- 18.
In this sense, the guidelines provided in the document Dalla Biobanca alla Bioteca di ricerca: raccomandazioni etico-giuridiche, drafted by the Comitato di scrittura, appointed by the Comitato Etico Indipendente of the Istituto Nazionale dei Tumori di Milano. The document can be consulted on line at the website of the Scienzainrete association: http://www.scienzainrete.it/contenuto/rs/dalla-biobancaalla-bioetica-di-ricerca.
- 19.
Charter of Fundamental Rights of the European Union, signed at Nice on 7 December 2000 and modified at Strasburg on 12 December 2007. However, although art. 6. 1 TEU states that the Charter has “which shall have the same legal value as the Treaties”, doubts have been raised as to the real efficacy of this act. Firstly, the Charter is not annexed to the Treaty, but is merely cited in Declaration no. 1 annexed to it, and it is therefore outside the ordinary system of Treaty revision. Moreover, Great Britain, Poland and the Czech Republic have declared their non adherence to the Charter. This has raised many perplexities with regard both to its use by the European Union Court of Justice as an effective parameter of the legitimacy of institutional acts, and the use of the Charter by the same Court for legitimising its own actions, given that not all States have adhered to it.
- 20.
Art. 8, D 46/95/EC.
- 21.
Art. 6 of the Directive cit.
- 22.
Art. 8 third para. Directive cit.
- 23.
One the specific characteristic that distinguish genetic from medical data see Documento cit. of Group 29.
- 24.
Art. 2 of Directive 44/98/EC.
- 25.
Twenty-sixth whereas clause of the directive cit.
- 26.
On this point, recommendation (2006) 4 of the Council of Europe, distinguishes between material that, alone or associated to personal data, render the patient unidentifiable (unlinked anonymised biological materials), and identifiable materials that alone or in association with personal data allow the patient’s identification. In the case of the former, proecssing is envisaged for scientific research purposes, provided that such purpose does not elude the consent expressed by the patient prior to anonymisation; with regard to identifiable materials, express, specific consent is always required prior to research and for any new subsequent research.
- 27.
17th march 2004, no. 12178/03/EN, WP91.
- 28.
As mentioned in the premise, anonymisation of the biological materials collected is a requisite for the application of different rules from those applying to human experimentation. However, it seems a contradiction terms to affirm that a genetic sample can be rendered anonymous. In effect, by its mere existence, biological material carries with it a “genetic address” which will always lead to a particular person. Thus, anonymisation is a technical fiction masking or rendering unknown to users the anagraphic-genetic information on the tissue’s origin. The level of security of the anonymity is therefore commensurate with the objective difficulty of tracing the data to the source subject. Art. 3 of Recommendation R(2006)4 of the Council of Europe distinguishes between the regimes of identifiable and encoded tissues, necessarily linking anonymity to the various hypotheses of informed consent.
- 29.
See M. Tallacchini, La costruzione giuridica della scienza come co-produzione tra scienza e diritto, in Notizie di Politeia, 2002, p. 126 and ss.
- 30.
Art. 2 of the directive cit.
- 31.
Art. 8 of the directive cit.
- 32.
Art. 6 of the directive cit.
- 33.
Art. 12 of the directive.
- 34.
European Court of Justice, case C-553/07, Rijkeboer.
- 35.
The directive in question was assimilated into Decree Law no. 3 of 2006 and subsequently converted into law by l. no. 78 of 2006.
- 36.
De Cupis, I Diritti Della Personalité. In Cicu, Messineo Eds., Trattato di diritto civile e commerciale, Milano, 1985 p. 157; M. Macilotti, U. Izzo, G. Pascuzzi, M. Barbareschi, La disciplina giuridica delle biobanche, in Pathologica 2008, 86.
- 37.
This is witnessed also by the efforts invested by the National Human Genome Research Institute (NHGRI) of the National Institute of Health (NIH), by the Joint Genome Institute of the U.S. Department of Energy (DOE), and by the Sanger Center (supported in the UK by theWellcome Trust) in the ambitious Human Genome Project. The scientific outcomes of this project, while not having disclosed the answers to many of the questions posed by modern genetics (i.e. the cause and function of so-called junk DNA are yet to be discovered, see D. Clark, Molecular biology, 2005, Elsevier Academic Press, p. 420 and ss.), constitute to date the necessary basis of any aetiological study aimed at identifying the genetic matrix of certain serious illnesses. For an update on the development of scientific research in this specific area, see, http://www.genome.gov.
- 38.
In this sense, according to the Science and Technology Committee of the English House of Lords, biobanks are collections of genetic sequence information of human tissue, thus attributing pre-eminence to the informational content of the sample over its materiality. See http://www.parliament.uk/business/committees/committees-a-z/lords-select/science-and-technologycommittee.
- 39.
M. Macilotti, La disciplina giuridica, cit., 85 and ss.
- 40.
Supreme Court of the United States, case Diamond v. Chakrabarty, 447 U.S. 303, 1980. Even more relevant in this regard are the pronouncements on the cases Kuehmsted v. Farbenfabriken of Elberfeld Co., 179 F. 701 (7th Cir. 1910); Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95 (S.D.N.Y.1911), aff’d, 196 F. 496 (2d Cir. 1912). See S. Jasanoff, La scienza davanti ai giudici, 2001, at 241.
- 41.
DoJ brief issued on 29/10/2010. At the core of the brief is the distinction between patentability of genetic sequences in nature/isolated and the patentability of genes or sequences processed/manipulated by man. The DoJ points out that “the “pure” human BRCA1 polynucleotide is structurally identical to the DNA segment that occurs in the human body, apart from the fact of its isolation itself. Indeed, the structural identity of the isolated gene and the wild-type gene is the very point of the patent. As the district court noted, “the entire premise behind Myriad’s genetic testing is that the claimed isolated DNA retains, in all relevant respects, the identical nucleotide sequence found in native DNA,” thereby rendering it valuable for medical diagnostic and therapeutic applications. […] Under these circumstances, the contention that a “purified” gene is patent-eligible merely because it does not occur in “pure” form in nature is essentially indistinguishable from the “isolation” rationale, and fails for the same reasons. A product of nature is unpatentable because it is not the inventive work of humankind. That essential rule cannot be circumvented by drafting claims for the same natural product removed from its natural environment and proclaiming the result “pure”.
- 42.
Brief filed 25 September 1996.
- 43.
As also noted by Adv. Gen. F. Jacobs in his conclusions on case C-377/98 Netherlands v. Parliament and Council.
- 44.
ECJ, case C-377/98, Netherlands v. Parliament and Council.
References
B. De Witte, Diritti europei delle minoranze, in M. Cartabia (Ed.) Diritti in azione, Bologna, 2008. See, also, Report on the social, juridical, ethical and economic implications of human genetics of the temporary Committee on human genetics and other new technologies of modern medicine instituted the European Parliament, 26 July 2001, at 19.
C. Casonato, La discriminazione genetica: una nuova frontiera nei diritti dell’uomo? in I diritti fondamentali in Europa. 15 colloquio biennale, Atti del convegno Taormina-Messina 2001, Torino, 2002.
M. Tallacchini, La costruzione giuridica della scienza come co-produzione tra scienza e diritto, in Notizie di Politeia, 2002, p. 126 and ss.
De Cupis, I Diritti Della Personalité. In Cicu, Messineo Eds., Trattato di diritto civile e commerciale, Milano, 1985 p. 157; M. Macilotti, U. Izzo, G. Pascuzzi, M. Barbareschi, La disciplina giuridica delle biobanche, in Pathologica 2008, 86.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2012 Springer-Verlag Italia
About this paper
Cite this paper
Lorenzon, S. (2012). Genetic Research and European Integration. In: Bin, R., Lorenzon, S., Lucchi, N. (eds) Biotech Innovations and Fundamental Rights. Springer, Milano. https://doi.org/10.1007/978-88-470-2032-0_18
Download citation
DOI: https://doi.org/10.1007/978-88-470-2032-0_18
Publisher Name: Springer, Milano
Print ISBN: 978-88-470-2031-3
Online ISBN: 978-88-470-2032-0
eBook Packages: Humanities, Social Sciences and LawLaw and Criminology (R0)