CONFIDENTIALITY IN INTERNATIONAL CONTEXT
EUROPEAN EXPERIENCE
Lukás Prudil
Medical Faculty, Masaryk University, Brno, Czech Republic
Tel./fax: +420 542 120 166, e-mail: lukas@prudil.cz
Introduction
It has become quite normal that genetic data are collected for medical purposes. Typically
during prenatal genetic screening, genetic tests of parents, seeking for genes influencing
certain diseases. Such data are then stored. Several international documents have
recognized that human genetic data have a special status on account of their sensitive
nature. Data may contain information which significance is not necessarily known at the
time of the collection of the biological sample or of data.1
Sometimes it happens that data are needed for different purposes than for those they were
collected. We will discuss to what extent international (especially European) documents
cover such situations and under which conditions data can be used for different purposes.
If we think about common usage of genetic data different from medical reasons, we can
find at least following purposes:
- Research,
- Identification of persons,
- Criminal investigation,
- Historical purposes,
- Statistical purposes,
- Public health purposes,
- Parentage testing,
- Public interest purposes2.
We can see that purposes for which data can be used are quite broad. Research purposes
enable to improve our knowledge of genetics, help us to prevent various diseases. Similarly
statistical collection of data makes further research easier. On the other hand, influence of
identification of persons, criminal investigation or historical purposes is more disputable,
benefit for public can be questionable.
What we want to clarify is to what extent genetic data can be used under the regulation
given by international documents. Purpose of this paper is not to investigate single national
legal documents.
United Nations
United Nations documents clearly must be very general. United Nations bodies, especially
UNESCO, have recently elaborated various documents on genetic data.
1 See e.g. Article 4 para a/iii of the International Declaration of Human Genetic Data
2 Public interest is not precisely defined. It can cover variety of purposes.
993
In 1997 it was Declaration on the Human Genom and Human Rights. But the most
important one is the International Declaration of Human Genetic Data adopted in 2003,
in which especially Article 14 requires our attention.
Article 14 reads as follows:
"(a) States should endeavour to protect the privacy of individuals and the confidentiality of
human genetic data linked to an identifiable person, family or, where appropriate, group,
in accordance with domestic law consistent with the international law of human rights.
(b) Human genetic data, human proteomic data and biological samples linked to an
identifiable person should not be disclosed or made accessible to third parties, in
particular, employers, insurance companies, educational institutions and the family,
except for an important public interest reason in cases restrictively provided for by
domestic law consistent with the international law of human rights or where the prior,
free, informed and express consent of the person concerned has been obtained provided
that such consent is in accordance with domestic law and the international law of human
rights. The privacy of an individual participating in a study using human genetic data,
human proteomic data or biological samples should be protected and the data should be
treated as confidential.
(c) Human genetic data, human proteomic data and biological samples collected for the
purposes of scientific research should not normally be linked to an identifiable person.
Even when such data or biological samples are unlinked to an identifiable person, the
necessary precautions should be taken to ensure the security of the data or biological
samples.
(d) Human genetic data, human proteomic data and biological samples collected for
medical and scientific research purposes can remain linked to an identifiable person,
only if necessary to carry out the research and provided that the privacy of the individual
and the confidentiality of the data or biological samples concerned are protected in
accordance with domestic law.
(e) Human genetic data and human proteomic data should not be kept in a form which
allows the data subject to be identified for any longer than is necessary for achieving the
purposes for which they were collected or subsequently processed."
The aim of the Declaration is to promote single states to adopt legislation ensuring adequate
protection of human genetic data when public interest is at stake. The whole Declaration
including its preamble defines fundamental boundaries in which national legislations have
to be kept. Restrictions are imposed on using of data for different purposes than for those
they were collected. On one hand, it allows data disclosure for important public interest
reasons (clearly and restrictively provided for by domestic law) but on the other hand it
restricts storing of data linked to identifiable person longer than is necessary for achieving
the purposes for which they were collected or subsequently processed.
Reading the Article 14 of the International Declaration of Human Genetic Data we can
easily imagine that domestic law will define statistical, scientific and historical purposes
and need to identify a person as public interest purposes. Defining criminal investigation as
public interest will be more complex for having troubles to say that any collected genetic
data can be used for tracing offender of crime. UNESCO beard in mind complexity of
criminal investigation purposes and therefore the International Declaration of Human
Genetic Data sets it in its Article 1 (c) that provisions of Declaration do not apply to the
994
collection, processing, use and storage of human genetic data, human proteomic data
and biological samples, in the investigation, detection and prosecution of criminal
offences and in parentage testing. These purposes are subject to domestic law that is
consistent with the international law of human rights. More precisely it is expressed in the
Article 12 stating when human genetic data or human proteomic data are collected for
the purposes of forensic medicine or in civil, criminal and other legal proceedings,
including parentage testing, the collection of biological samples, in vivo or post-
mortem, should be made only in accordance with domestic law consistent with the
international law of human rights. UN calls for clear domestic legal boundaries for using
genetic data for mentioned purposes but domestic legislation must be in accordance with
ethical framework set by the Declaration. There appears explanatory problem since the
Declaration in Article 1 (c) states that it does not cover investigation, detection and
prosecution of criminal offences and in parentage testing but Article 12 sets obligations of
states in this field. It should be understood that the Declaration codifies minimal standard
that must be followed in any treatment of genetic data.
Article 6 (d) of the Declaration imposes duty to provide clear, balanced, adequate and
appropriate information to the person whose prior, free, informed and express consent is
sought. Such information shall, alongside with providing other necessary details, specify
the purpose for which human genetic data and human proteomic data are being derived
from biological samples, and are used and stored. So, the person must be clearly informed
about all the purposes for which data are collected and he/she has to give his/her informed
consent to all procedures with biological samples and genetic data derived from those
samples.
We can not find any ex lege exceptions in the Declaration which enables usage of genetic
data or biological samples for purposes different from those they were collected. The
Declaration only takes into account that need of such usage may occur and asks for clear
domestic legal regulation of this field.
In European region we have to check two formally different approaches. First one has its
asis in Council of Europe a
b
nd second one in European Union.
Council of Europe
Council of Europe made an important step in information protection by adopting
Convention for the protection of human rights and dignity of the human being with
regard to the application of biology and medicine. Up to date it has been ratified by 19
states. Article 10 (1) stipulates that everyone has the right to respect for private life in
relation to information about his or her health. This provision covers also genetic data
information and sets minimal standard for collecting and further using of genetic data.
Data protection is specifically regulated by the Convention for the Protection of
Individuals with Regard to Automatic Processing of Personal Data (ETS No. 108).
According to Article 3 para 2c this it is up to the Member States to apply this Convention also
to personal data files that are not processed automatically. The Convention prohibits
preservation of data in form that permits identification of the data subjects for longer than is
required for the purpose for which those data are stored. Such principle has to be applied also
for genetic data. Member States may derogate from this provision in the interest of protecting
995
state security, public safety, the monetary interests of the state or the suppression of
criminal offences. Derogation must be provided for by the law and has to constitute a
necessary measure in a democratic society.
More detail provisions are given in the Recommendation No. R (97) 5 of the Committee of
Ministers to Member States on the Protection of Medical Data. According to Article 1 of
the Recommendation it applies also to genetic data and Articles 4.7., 4.8. and 4.9. contain
special provisions concerning treatment of genetic data. Similarly as in the International
Declaration on Human Genetic Data Article 4.7. asks for informed consent of data subject
concerning purpose for which data are collected. It sets in 4.7 that "genetic data collected
and processed for preventive treatment, diagnosis or treatment of the data subject or for
scientific research should only be used for these purposes or to allow the data subject to
take a free and informed decision on the matters". But Recommendation No. R (97) 5 has
also more specific provisions concerning processing of genetic data for purposes different
from those they were collected. As other international documents it requires clear domestic
legal regulations especially when data are used for the purposes of judicial procedure or
criminal investigation. Expressis verbis it allows these data to establish whether there is a
genetic link in the framework of adducing evidence to prevent a real danger or to suppress
a specific criminal offence. During such procedure they should not be used to determine
other characteristics which may be linked genetically. We can conclude that the
Recommendation admits usage of once collected data for different purpose (prevent real
danger, suppress a specific offence). On the other hand, we can not find adequate conditions
for conservation of data. Generally, data can be conserved no longer than necessary to
achieve the purpose for which they were collected and processed. When, in the legitimate
interest of public health, medical science, the person in charge of the medical treatment or
the controller of the file, in order to enable him/her to defend or exercise a legal claim, or for
historical or statistical reasons, it proves necessary to conserve medical data that no longer
serve their original purpose, technical arrangements shall be made to ensure their correct
conservation and security, taking into account the privacy of the patient (Article 10.2). This
article does not enable data controller to keep data for prevention of real danger or to suppress
a specific offence.
Under the Article 4.9. of the Recommendation for other than medical, research, judicial and
criminal investigation purposes, collection and processing of genetic data should only be
permitted for health reasons and in particular to avoid any serious prejudice to the health of
the data subject or third parties.
Under the Article 7.3. of the Recommendation, medical data (including genetic data) can be
communicated if they are relevant and:
a. if the communication is provided for by law and constitutes a necessary measure in a
democratic society for:
i.
public health reasons; or
ii.
the prevention of a real danger or the suppression of a specific criminal offence;
or
iii.
another important public interest; or
iv.
the protection of the rights and freedoms of others; or
b. if the communication is permitted by law for the purpose of:
i.
the protection of the data subject or a relative in the genetic line;
ii.
safeguarding the vital interest of the data subject or a third person; or
996
iii.
the fulfilment of specific contractual obligations; or
iv.
establishment, exercising or defending a legal claim; or
c. if the data subject or his/her legal representative, or an authority, or any person or body
provided for by law has given his/her consent for one or more purposes, and in so far as
domestic law does not provide otherwise; or
d. provided that the data subject or his/her legal representative, or an authority, or any
person or body provided for by law has not explicitly objected to any non-mandatory
communication, if the data have been collected in a freely chosen preventive, diagnostic or
therapeutic context, and if the purpose of the communication, in particular the provision of
care to the patient or the management of a medical service operating in the interest of the
patient, is not incompatible with the purpose of the processing for which they were collected.
Under conditions given in the Article 8.2., there can be refused, limited or delayed access to
medical data by data subject. Such refusal, limitation or delay does not constitute opposite
right, i.e. to make data accessible for purpose different from that they were collected.
Similarly as in the Convention for the Protection of Individuals with Regard to Automatic
Processing of Personal Data, medical data cannot be kept longer than necessary to achieve the
purpose for which they were collected and processed. Article 10.2. says that "when, in the
legitimate interest of public health, medical science, the person in charge of the medical
treatment or the controller of the file, in order to enable him/her to defend or exercise a
legal claim, or for historical or statistical reasons, it proves necessary to conserve medical
data that no longer serve their original purpose, technical arrangements shall be made to
ensure their correct conservation and security, taking into account the privacy of the
patient.".
European Union
Basic standard for collecting and processing of genetic data is given by Directive 95/46/EC
on the protection of individuals with regard to the procession of personal data and on
the free movement of such data (hereinafter "the Directive"). Directive is concerned, as is
all the work of the European Union, primarily in creating single economic market across
Europe. The Directive facilitates this through creating conditions of protection of the
fundamental rights and freedoms of individuals and especially the right to privacy, thus
enabling the free transfer and use of personal data between Member States within an
environment of assured minimum acceptable protection.3
It is commonly accepted that genetic data must be treated as sensitive personal data. In the
member states of European Union, both legal and ethical requirements for medical
confidentiality and data protection requirements of sensitive health data apply if genetic
data are collected by health care personnel for health care purposes. If genetic data are
collected by health care personnel for other than health care purposes, than at least on
3 Townend, D.: Overriding Data Subjects´ Rights in the Public Interest. In: Beyleveld, D.-Townend, D.-
Rouillé-Mirza, S.-Wright, J. (eds.): The Data Protection Directive and Medical Research Across Europe.
Ashgate Publishing Limited, Aldershot. 2004. p. 93.
997
medical confidentiality requirements apply, but the applicability of the restrictions on
processing sensitive data under the Directive 95/46/EC is less clear.4
According to definition of personal data given in the Article 2 of the Directive, it is
applicable also on genetic data since they can be understood as information related to
identified or identifiable natural person (data subject). Directive does not apply to the
processing of personal data in the course of an activity which falls outside the scope of
Community law and in any case to processing operations concerning public security,
defence, state security and the activities of the state in areas of criminal law.
Basic criteria for processing of personal data are similar as those described above. But
special conditions are given inter alia to data concerning health (Article 8 para 1), their
processing has to be, generally, prohibited by member states. These conditions meet also
genetic data originally collected for medical purposes. Prohibition of processing does not
apply where processing of the data is required for the purposes of preventive medicine,
medical diagnosis, the provision of care or treatment or the management of health-
care services, and where those data are processed by a health professional subject under
national law or rules established by national competent bodies to the obligation of
professional secrecy or by another person also subject to an equivalent obligation of
secrecy. Processing of data relating to offences, criminal convictions or security
measures may be carried out only under the control of official authority, or if suitable
specific safeguards are provided under national law, subject to derogations which may be
granted by the Member State under national provisions providing suitable specific
safeguards (Article 8 para 5).
Additionally, Member States of the European Union may adopt legislative measures to
restrict certain rights (inter alia duty to inform data subject about purpose of data
processing, recipients of the data) when such restrictions constitutes a necessary measures
to safeguard:
a) national security,
b) defence,
c) public security,
d) the prevention, investigation, detection and prosecution of criminal
offences, or of breaches of ethics for regulated professions,
e) an important economic or financial interest of a Member State or of the
European Union, including monetary, budgetary and taxation matters,
f) a monitoring, inspection or regulatory function connected, even
occasionally, with the exercise of official authority in cases referred to in (c)
, (d) and (e),
g) the protection of the data subject or of the rights and freedoms of others.
4 Lehtonen, L.A.: Genetic Information and the Data Protection Directive of the European Union. In:
Beyleveld, D.-Townend, D.-Rouillé-Mirza, S.-Wright, J. (eds.): The Data Protection Directive and Medical
Research Across Europe. Ashgate Publishing Limited, Aldershot. 2004. p. 107.
998
Conclusions
Reading above mentioned international documents, especially those adopted in Council of
Europe and European Union we can come to following conclusions:
1) They set up basic principles for collecting, storing and using of data. These
documents are applicable also on genetic data since they fall into the scope of
definition of data.
2) As basic principle these documents require to inform data subject about the purpose
of collecting of data, about the following usage and about the conditions under
which they can be used for different purposes.
3) As basic principle data cannot be stored longer than it is necessary for fulfilment of
purpose for which they were collected. At least they cannot be stored in the form
that enables identification of data subject or privacy of data subject must be
safeguarded.
4) International documents try to enable promote research in the field of genetics and
health care protection, try to enable improvement of public health. Such public
interest must be accompanied by adequate protection of rights of data subject.
Confidentiality of data must be safeguarded or/and identification of data subject has
to be disabled.
5) International documents admit that there may be reasons to use data for different
purposes for which they were originally collected. When data have to be used for
purpose different from the purpose they were collected, such usage must be clearly
regulated by law, giving appropriate safeguards to protect rights and freedoms of
data subject. International documents concerning data protection admit that special
measures can be adopted in the cases of national security, public security, defence,
prevention, investigation, detection and prosecution of criminal offences.
Discussion
We can see that within the boundaries given by international documents there is a quite
broad space left for national legal measures to regulate usage of genetic data. It would be
useful to, step by step, adopt international documents giving standards for every single
usage of data collected for one purpose and then used for different purpose. Personally, I
am convinced that such standards have to be primarily elaborated for public health purposes
(especially medical research) and for investigation of crimes. In both these fields
international exchange of data is more and more needed and unified legal measures would
make such exchange easier.
999