Italy

• Italian data protection information at Privireal

Language of privacy

The concept of “privacy” – which has been translated into several Italian words, meaning more specifically “confidentiality” or “discretion” – is not clear-cut, nor are there clear-cut guidelines to establish whether a person’s privacy has been violated; indeed, this assessment is often based on the balancing of the interests at stake following a case-by-case analysis.

The concept of privacy developed thanks to case law, in particular with regard to freedom of expression and – more specifically – freedom of the press. The development took place in the context of the broader concept of “personal rights” – which is somewhat blurred as a definition.

The overwhelming majority of scholars (and judicial decisions) relied on Article 2 of Italy’s constitution as the foundation of privacy, regarded as an inviolable right.

However, privacy as a personal right had to carve out its place among the principles recognised by case law in Italy. Initially, the view taken by courts was mostly that “no legal provision allows us to believe that there exists a general principle stipulating the absolute respect for one’s private life.” (Decision by the Court of Cassation dated 22 December 1956, no. 4487 and decision by the Court of Cassation dated 7 December 1960, no. 3199.). It was only after 1963 that privacy – meaning the “right to free self-determination in man’s development as an individual” - was recognised in connection with some leading cases; however, in 1975 the Italian Supreme Court (Court of Cassation) ruled that it was inappropriate “to set out stringent, detailed features for the right to privacy, because they would hamper the flexibility required for adjusting the specific contents of that right to the different requirements arising out of different circumstances, areas and periods.”

As for definitions, the recognition by law of the “right to privacy” became finally a reality when the Italian data protection Act was passed (Act 675/1996); however, the Act specifically addressed a different subject matter, i.e. the protection of personal data – according to the so-called “informational privacy” approach, which is other than the conventional “disclosural privacy”.

In Italy’s legal system, informational privacy is basically shaped similarly to what is the case in other European countries, partly because the relevant provisions are modelled after EC Directive 95/46 and had already been influenced by Convention 108/1981 of the Council of Europe. Conversely, the regulations applying in Italy to disclosural privacy as related to – in particular – journalism (section 137 of the Italian DP Code) provide that “the limitations imposed on freedom of the press to protect the rights as per Section 2, in particular concerning materiality of the information with regard to facts of public interest, shall be left unprejudiced. It shall be allowed to process the data concerning circumstances or events that have been made known either directly by the data subject or on account of the latter’s public conduct.” Additionally, section 139 of the DP Code provides that the processing operations performed for journalistic purposes are to be regulated by a code of practice approved by the Italian data protection authority.

General information on privacy, bio-banks and genetic databases

Genetic privacy and bio-banking have not been the subject of widespread discussion in Italy.

However, this has not prevented the issues in question from being addressed in specialised sectors – in particular, the medical, scientific, bio-ethical, and institutional sectors.

In several documents, the National Bio-Ethics Committee has dealt with the issues related to human genetics. A document dated 18 July 1992 addressed “Prenatal Diagnosis”, whilst the “Human Genome Project” was the subject of a study carried out in 1995 (published on 18 March 1995).

Ever since those early studies it was clarified that:

• The prenatal diagnosis of hereditary and/or congenital diseases must be preceded and – where necessary – followed by genetic counselling;
• The prenatal diagnosis of hereditary and/or congenital diseases must be grounded on specific indications resulting from criteria developed by medical and scientific societies;
• The conditions must be fulfilled for the couple to make free, informed reproductive choices, and the couple must be adequately informed on all possible consequences of the diagnosis;
• Prenatal genetic screening programmes may be taken into consideration if they do not translate into automatic negative eugenetics mechanisms and are part of a broader framework focusing on primary prevention, in which pre-conception genetic counselling should play a fundamental role.

Failing general provisions on bio-banks, more concrete guidance on this point was developed recently by the “National Bio-Security and Bio-Technologies Commission” and the “Istituto Superiore di Sanita’”; initially they drafted “Guidelines for Genetic Testing” (Working Group Report dated 19 May 1998) and subsequently addressed bio-banks, which were defined as “non-profit service units pursuing the collection and preservation of human biological materials to be used for diagnostic purposes, bio-diversity studies, and research purposes.”

The above initiative were followed by the general authorisation issued by the Italian data protection authority in pursuance of section 90 of Italy’s data protection Code (196/2003), which ultimately regulates the processing of genetic data in Italy’s legal system.

It should be pointed out that the authorisation also contains provisions that are likely to impact on use of biological samples; the latter are defined as follows: “any sample of biological material containing information on an individual’s genotypic characteristics.”

As for bio-banks, the National Bio-Security and Bio-Technology Commission issued their own guidelines in 2006. They are aimed at:

• Providing a definition of “bio-bank”;
• Laying down the criteria for setting up and organising a bio-bank;

• Suggesting suitable standards to ensure respect for sample donors’ rights, co-ordination of bio-banks’ activities, co-ordination between bio-banks and researchers, and dissemination of appropriate information on their functions among the public opinion.

The National Bio-Ethics Committee issued a favourable opinion on the Guidelines in question.

The Italian data protection authority sent a report to Parliament and Government concerning the forthcoming regulation of DNA databases to be set up for purposes of justice (under section 154(1), letter f., of the DP Code). The report mentions the following issues to be addressed on a priority basis:

a) Purposes to be achieved and institutional competences;

b) Preconditions for including DNA data in a database;

c) Need for actually respecting data subjects’ dignity;

d) Retention arrangements and period as for profiles and biological samples;

e) Protection of specific medical data;

f) Access to the database(s) and security measures;

g) Mechanisms for data subjects to exercise their rights;

h) Safeguards applying to the mandatory collection of DNA samples;

i) Supervision by the Italian data protection authority;

j) Monitoring by Parliament.