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Regulating Genetic Data in Insurance and Employment: The Italian “Upstream” Way

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Genetic Testing and the Governance of Risk in the Contemporary Economy

Part of the book series: Ius Comparatum - Global Studies in Comparative Law ((GSCL,volume 34))

Abstract

The regulatory approach to the collection, use, and disclosure of genetic data is paradigmatic of the difficult choices lawmakers face when confronting multifaceted issues. Within that broad frame, the processing of genetic data by insurance companies and employers creates specific issues and concerns. Lawmakers have to find the right balance among the interests of various stakeholders, avoiding both discrimination and over-protection. The Italian law on data processing for employment and insurance purposes takes a rather different approach from those chosen by other legal orders. This paper analyses the peculiarities of the Italian system, related in particular to the source of law adopted to regulate the issue, the “comprehensive” consideration of different kinds of genetic information, and the narrow exceptions to the general prohibition. The consideration of Italy’s privacy-based, precautionary, and exceptionalistic approach permits a reflection, more broadly, on other rights connected to the treatment and flow of genetic information.

The article, updated as of November 2018, has already been published in the Annuario di diritto comparato e di studi legislativi (2018) and represents the fruit of joint reflections by the two authors. Nevertheless, Sects. 1–3 were written by Carlo Casonato, Sects. 4–8 by Marta Tomasi. The final section is coauthored.

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Notes

  1. 1.

    Brownsword et al. (1998), pp. 593–597 and, on biobanks, Mauron (2008), p. 1.

  2. 2.

    Dierickx and Borry (2009).

  3. 3.

    Casonato (2017).

  4. 4.

    Clayton (2015), p. 2225.

  5. 5.

    Klitzman et al. (2014), p. 1855:

    Treating genetic information differently from other data with predictive value utilized by life insurers is warranted by a combination of factors: the desire to avoid disincentives for potentially valuable genetic testing in medical contexts; the extent to which genetic predispositions are out of a person’s control (in contrast, e.g., to smoking or obesity); and the concern about the implications of genetic information for family members.

  6. 6.

    MacDonald and Williams-Jones (2002), p. 235.

  7. 7.

    Mayor (2003), p. 702.

  8. 8.

    Vos (2008), p. 155.

  9. 9.

    Benschop and de Vries (2008), p. 138.

  10. 10.

    Nill et al. (2019). The article deals with five public policy options on genetic testing information: Full information ban; No restrictions; Limited voluntary disclosure; Codes of Conduct; and, Duty to Disclose.

  11. 11.

    The previous regime was based on Law 675 of 31 December 1996. See Gerards et al. (2005).

  12. 12.

    General Authorization for the processing of genetic data, 22 February 2007, Official Journal of the Italian Republic no 65, 19 March 2007.

  13. 13.

    See the English version of the website of the Garante: http://www.garanteprivacy.it/home_en/italian-legislation. The translated version is that of 2014, which is basically identical to that of 2016, currently in force.

  14. 14.

    See point 9 of the General Authorization.

  15. 15.

    On the relevance of re-contacting and other critical issues of the restrictive model see Gibbons (2009) and Otlowsky (2012).

  16. 16.

    See point 10 of the General Authorization.

  17. 17.

    On differences in terminology, see Knoppers and Saginur (2005). On the UNESCO Declaration, see among others Langlois (2013) and Bagheri et al. (2016).

  18. 18.

    UNESCO International Declaration on Human Genetic Data, adopted unanimously and by acclamation on 16 October 2003 by the 32nd session of the General Conference of UNESCO, Recital: “Recognizing that genetic information is part of the overall spectrum of medical data and that the information content of any medical data, including genetic data and proteomic data, is highly contextual and dependent on the particular circumstances.”

  19. 19.

    In Italian, in the current common language, genetic information is often used as a synonym for genetic data.

  20. 20.

    General Authorization No 8/2016 for the Processing of Genetic Data, 15 December 2016, Official Journal of the Italian Republic no 303, 29 December 2016.

  21. 21.

    See point 3 of the General Authorization.

  22. 22.

    See point 3.1 of the General Authorization.

  23. 23.

    For some considerations about the relationships between rules of medical ethics and the Italian legal system, see Petrini and Ricciardi (2016).

  24. 24.

    Code of Medical Conduct, approved by the National Federation for the Orders of Doctors and Dentists on 18 May 2014. The original Italian text of article 46.3 provides that “Il medico non prescrive né esegue test predittivi richiesti e prodotti a fini meramente assicurativi od occupazionali.”

  25. 25.

    Law no 300 of May 20, 1970, Rules on the protection of the freedom and dignity of workers and of trade union freedom and union activity in the workplace, and rules on the public employment service, Official Journal of the Italian Republic no 131, 27 Mayo 1970.

  26. 26.

    For one possible exception in the employment context, see below Sect. 6.

  27. 27.

    The original Italian text (2014) provides that “Il medico non prescrive né esegue test predittivi richiesti e prodotti a fini meramente assicurativi od occupazionali.”

  28. 28.

    The original Italian text (2006) provides that “Il medico non deve eseguire test genetici o predittivi a fini assicurativi od occupazionali se non a seguito di espressa e consapevole manifestazione di volontà da parte del cittadino interessato che è l’unico destinatario dell’informazione.”

  29. 29.

    See point 3.2, b) of the General Authorization.

  30. 30.

    General Authorization no 1/2016, point 3.2, letter b) (translation provided by the Garante):

    This authorisation shall also be granted if the processing of genetic data is indispensable: (…) To fulfil specific obligations or ensure that specific obligations are fulfilled, or to discharge specific tasks as set forth expressly in Community instruments, laws and/or regulations applying to social security and welfare, occupational and/or population safety and hygiene, also without the data subject’s consent, in compliance with the limitations laid down in the Garante’s general authorisation for the processing of sensitive data in the employment context.

  31. 31.

    See point 5 of the General Authorization No 8/2016 for the Processing of Genetic Data, 15 December 2016, Official Journal of the Italian Republic no 303, 29 December 2016.

  32. 32.

    Council of Europe, Committee of Ministers, Explanatory Memorandum to Recommendation No R(97)5 on the Protection of Medical Data, adopted by the Committee of Ministers on 13 February 1997 at the 584th meeting of the Ministers’ Deputies, Appendix to the draft recommendation, para 58.

  33. 33.

    See Andorno (2004) and, more recently, Chadwick et al. (2014).

  34. 34.

    Gerards et al. (2005).

  35. 35.

    Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, adopted 4 April 1997, entered into force since 1 December 1999, CETS no 164.

  36. 36.

    UNESCO International Declaration on Human Genetic Data, adopted unanimously and by acclamation on 16 October 2003 by the 32nd session of the General Conference of UNESCO.

  37. 37.

    Charter of Fundamental Rights of the European Union, OJ C 326/391, 26 October 2012.

  38. 38.

    Law no 145/2001, Official Journal of the Italian Republic no 95, 24 April 2001.

  39. 39.

    Charter of Fundamental Rights of the European Union, OJ C 326/391, 26 October 2012, Art 21(1):

    Any discrimination based on any ground such as sex, race, color, ethnic or social origin, genetic features, language, religion or belief, political or any other opinion, membership of a national minority, property, birth, disability, age or sexual orientation shall be prohibited.

  40. 40.

    See the reports (in Italian) of the discussion of the Assemblea costituente at www.nascitacostituzione.it (17–18 April 1947).

  41. 41.

    See articles 2 and 3 of the Constitution of The Italian Republic (Official Journal of the Italian Republic, no 298, 27 December 1947).

    Article 2:

    The Republic recognizes and guarantees inviolable rights of man, for the individual, and for social groups where personality is expressed, and demands the fulfilment of the fundamental duties of political, economic, and social solidarity.

    Article 3:

    All citizens have equal social dignity and are equal before the law, without distinction as to sex, race, language, religion, political opinions, or personal or social condition.

    It is the duty of the Republic to remove those obstacles of an economic and social nature that, by in fact limiting the freedom and equality of citizens, impede the full development of the human person and the effective participation of all workers in the political, economic and social organization of the country.

  42. 42.

    For this distinction see the Privacy Commissioner of Canada’s speech “Privacy Upstream, Discrimination Downstream: The (Un)Intended Consequences of Data Analytics”, given at the Reboot 18th Annual Privacy and Security Conference, 10 February 2017, https://www.priv.gc.ca/en/opc-news/speeches/2017/sp-d_20170210_pk/.

  43. 43.

    Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and the free movement of such data, and repealing Directive 95/46/EC, OJ L 119/1, 4 May 2016.

  44. 44.

    The latest version of the General Authorization (2016) states that the GDPR is applicable as of 25 May 2018 “except for modifications the Garante intends to adopt as a consequence of relevant modifications of the law and measures necessary to apply the Regulation.” Correspondingly, point 9.4 of the GDPR allows Member States to “maintain or introduce further conditions, including limitations, with regard to the processing of genetic data, biometric data or data concerning health.”

  45. 45.

    Rawls (1999), p. 11.

  46. 46.

    In this sense, see Rao (2006).

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Author information

Authors and Affiliations

  1. Free University of Bozen-Bolzano, Faculty of Economics, Bolzano, Italy

    Marta Tomasi

  2. University of Trento, Faculty of Law, Trento, Italy

    Carlo Casonato

Authors
  1. Marta Tomasi
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  2. Carlo Casonato
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Correspondence to Marta Tomasi .

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Editors and Affiliations

  1. Faculty of Law, McGill University, Montreal, QC, Canada

    Lara Khoury

  2. Faculty of Law, McGill University, Montreal, QC, Canada

    Adelle Blackett

  3. Faculty of Law, McGill University, Montreal, QC, Canada

    Lukas Vanhonnaeker

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Tomasi, M., Casonato, C. (2020). Regulating Genetic Data in Insurance and Employment: The Italian “Upstream” Way. In: Khoury, L., Blackett, A., Vanhonnaeker, L. (eds) Genetic Testing and the Governance of Risk in the Contemporary Economy. Ius Comparatum - Global Studies in Comparative Law, vol 34. Springer, Cham. https://doi.org/10.1007/978-3-030-43699-5_9

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