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LAW ON GENETIC DATA PROTECTION
Published in the "Official Gazette of Montenegro", No. 25/2010
I. BASIC PROVISIONS

Article 1
Collection, use, processing and storage of genetic data obtained
genetic testing and analysis of genetic samples performed for medical purposes,
types of genetic testing, genetic information and counseling, as well as other issues from
significance for genetic tests, protection and use of data obtained from those tests,
is regulated by this law.
Article 2
The provisions of this law apply to genetic testing and genetic analysis
performed as part of genetic testing in humans, including prenatal genetic
embryo and fetal examinations during fertilization and pregnancy.
The provisions of this law do not apply to the determination of paternity or maternity, as well as
of scientific research work.
Article 3
In the process of genetic testing, everyone is guaranteed the right to dignity,
protection of identity, respect for personal integrity, fairness, equality, freedom
decision - making and self - determination, including the right to genetic information before and
after the interrogations, as well as the protection of other personal rights and freedoms.

Article 4
Any kind of discrimination and stigmatization of persons on the basis of data on is prohibited
genetic traits or based on the genetic traits of its relatives.
The collection of genetic data and samples for the purpose of acquiring property or
any other benefits, as well as advertising these activities in the media or on any other
to the bearer of the advertising message.
Everyone is entitled to fair compensation for the damage caused as a result
genetic testing.

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Use of gender sensitive language
Article 5
All terms used in this law for natural persons in the masculine gender include
expressions in the feminine.
Article 6
Procedure for genetic testing and collection of genetic data and samples from
which are encouraged by these data can be done only in the health care institutions that meet
prescribed conditions (hereinafter: authorized health institution).

Article 7
The terms used in this law have the following meaning:
1) Genetic testing is any testing aimed at:
a) genetic analysis to determine genetic traits,
b) an assessment of each prenatal risk including an assessment of the results obtained;
2) genetic analysis is:
a) analysis of the number and structure of chromosomes (cytogenetic analysis),
b) analysis of the molecular structure of deoxyribonucleic acid (hereinafter:
DNA) or ribonucleic acid (RNA) - molecular genetic analysis,
c) an analysis of any other element providing equivalent information
information obtained as in the analyzes under a and b,
d) analysis of nucleic acid-protein products (analysis of gene product);
3) genetic traits are genetic information inherited from parents during
fertilization or acquired in the development of the embryo and fetus until birth;
4) genome is the total hereditary matter of a human represented by DNA;
5) genetic sample is any biological material of human origin taken for the purpose
conducting genetic analyzes or on which such analyzes have been performed;
6) genetic data are all data on hereditary traits of individuals obtained
by some genetic testing or genetic analysis within the genetic
tests;
7) consent is specific, explicit, on previously provided information
based and freely given the consent of a person to his genetic samples and genetic data
be collected, processed, used and stored or destroyed, and the results of genetic
tests and analyzes published, ie destroyed;
8) medical genetics is a medical science that deals with the examination of variations and
abnormalities in the human genome and examines the causes of hereditary diseases and
human health disorders;
9) clinical genetics is a medical science that deals with establishing a diagnosis,
prognosis, prevention and treatment of hereditary diseases and health disorders in
individuals and their families and descendants;
10) responsible doctor is a doctor of medicine specializing in human / medical and / or
clinical genetics, ie a specialist in the field of genomic medicine who owns
appropriate knowledge in the field of medical and clinical genetics (hereinafter:
responsible doctor);

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11) genetic testing for medical purposes is any diagnostic or predictive
genetic testing;
12) diagnostic genetic testing is testing with the aim of:
a) identification of an existing genetic disease or health disorder
in an individual,
b) assess whether there are genetic traits that together with the action
certain environmental factors or foreign substances can cause disease or
health disorder,
c) assessments of whether there are genetic traits that may affect the action
some medicine,
d) assessments of whether there are genetic traits that can fully or partially
prevent the onset of any disease or health disorder;
13) predictive genetic testing for medical purposes is any testing with
in order to predict or estimate:
a) any genetic disease or health problem that may occur in
future,
b) the existence of carriers of a genetic trait that would cause disease or health
problem with offspring - preconception genetic testing;
14) prenatal risk assessment is any examination of the embryo and fetus by which
determines the likelihood of the existence of certain genetic traits of importance to someone
disease or health disorder of the embryo or fetus, or future child
(offspring);
15) mass genetic testing - screening is a genetic testing in medical
purposes offered to the entire population or a particular population group, and that code
persons when the examination is performed there is no necessary reason to assume that it
possesses genetic traits that are searched by mass testing;
16) data related to an identifiable person are data that contain
information, such as name, date of birth and address, with which the person from
whom the data stimulates can be identified;
17) data that are not related to an identifiable person are data that
they are not associated with an identifiable person, a complete replacement or segregation
of all identifying information about that person using a code;
18) data that cannot be connected to an identifiable person are data
which can in no way be associated with a person who can be identified for complete
destroying the link of any identifying information about the person from whom the sample was taken.

IV.

HEALTH INSTITUTIONS IN WHICH GENETIC IS CARRIED OUT
TESTING AND COLLECTION OF GENETIC DATA AND SAMPLES

Article 8
Genetic testing and collection of genetic data and samples are performed
authorized health care institutions that have a decision of the state administration body in charge
for Health Affairs (hereinafter: the Ministry).
Authorized health care institutions may also perform storage operations,
storage and transport of genetic samples, based on the decision of the Ministry.

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Closer requirements in terms of space, staff and equipment that they must meet
authorized health care institutions, as well as the manner of performing quality control of the work of these institutions,
prescribed by the Ministry.
Article 9
Genetic tests can also be performed by a health institution outside Montenegro, with
by which the Ministry concluded the contract.
Article 10
Authorized health institutions form a medical board and an ethics committee, in
in accordance with the Law on Health Care.
The medical board must have a specialist doctor
medical and / or clinical genetics, as well as experts in psychology or psychiatry.
Article 11
Introduction of new genetic tests and collection of genetic data and samples
an authorized health institution may perform on the basis of the consent of the Ministry.
The consent referred to in paragraph 1 of this Article shall be given by the Ministry upon the proposal of the authorized person
health institution, with which it submits the opinion of the medical board and the ethics committee.
Article 12
On the establishment, work, checking the control of work and other issues relevant to the work
the provisions of the Law on Health Care apply to authorized health care institutions,
unless otherwise provided by this law.

IV. GENETIC TESTS
COLLECTION OF GENETIC DATA AND SAMPLES

IV.

Conditions for genetic testing and collection
genetic data and samples
Article 13

Genetic testing and collection of genetic data and samples in diagnostic,
predictive, preventive or therapeutic purposes, is performed on the basis of established medical
indications, namely:
- in accordance with the rules of the medical profession and ethical standards;
- if it is required by justified health reasons of the person, ie in order to avoid it,
prevented or treated a genetically determined disease or health disorder
the examined person or his relatives;
- if the risk and severity of the intervention when taking the sample are minimal for the face code
when testing in relation to the expected benefit, and
- on the basis of written consent.

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Genetic testing and collection of genetic data and samples is performed if
diagnostic, predictive, preventive or therapeutic purpose cannot be achieved without it
tests and if the risk and severity of the intervention are minimal for the person being tested
in relation to the expected clinical benefit.
Article 14
Genetic testing in a minor and an adult who is unable to
understand the essence, meaning and scope of genetic testing and make the appropriate decision,
it can also be performed when justified by the health reasons of the genetic relative, if
offspring (pregnancy) are planned with a genetic relative, according to generally accepted principles
science and technology cannot otherwise determine the risk of occurrence genetically
conditioned illness or health disorder of the offspring, provided that the person who
being examined neither mentally nor physically must not be burdened by the results of the examination.
Prior to the genetic examination of the person referred to in paragraph 1 of this Article, depending on the degree of maturity,
years of life and the possibility of understanding, his opinion is appreciated, in accordance with
rules of the medical profession.
Article 15
Genetic testing, collection of genetic data and samples and genetic
information and counseling is performed by the responsible doctor.
Medical indications for collecting genetic data and samples, performance
genetic testing and implementation of genetic information and counseling referred to in paragraph 1
of this article is determined by the responsible doctor.
The analysis of the sample within the genetic test is performed by the responsible doctor or the person who is
determined by an act of an authorized health institution.
Article 16
Genetic testing and collection of genetic data and samples can be performed
only after obtaining the written consent of the person when the examination is performed, ie
legal representative of a minor or guardian of an adult who is unable to
understand the essence, meaning and scope of genetic testing and make the appropriate decision.
The written consent referred to in paragraph 1 of this Article may be revoked at any time, a
the revocation must be in writing.
Notwithstanding paragraph 2 of this Article, the consent may not be revoked in the case when
these are data that cannot be linked to an identifiable person.
In the event of revocation of written consent, genetic data and samples may not be allowed
to use.
A minor and an adult for whom written consent has been given may be revoked
consent given in the event of reaching the age of majority or the ability to give consent.
The responsible doctor is obliged to keep the written consent, as well as the revocation of the consent
medical records of the person to whom the genetic testing relates.
The form of written consent and revocation of consent is prescribed by the Ministry.

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2. Genetic information
Article 17
Before giving consent for genetic testing and collection of genetic
data and samples, the responsible doctor is obliged to conduct genetic information of the person
to which the genetic testing refers, ie the legal representative of the minor
or the guardian of an adult who is not capable of giving consent and explaining everything
facts of importance for the essence and scope of genetic testing, the way of taking genetic
sample as well as risk assessment.
Genetic information is neutral and non-suggestive and includes in particular:
- clarification of the purpose, type, scope and significance of genetic testing, including
expected results that can be achieved by available test methods,
the significance of the genetic traits being examined and their influence on the occurrence of the disease or
disorders as well as the ability to avoid, prevent or treat these disorders;
- clarification of possible health risks associated with taking
genetic pattern or by knowing the results of genetic testing, including
risks of embryo or fetus in prenatal genetic testing of pregnant women;
- a detailed explanation of the possible medical, psychological and social implications in
in connection with the undertaking or non-undertaking of genetic tests, his
existing or possible test results;
- clarification of the intended use of the genetic sample and the genetic results
tests;
- informing about the right that the person referred to in paragraph 1 of this Article, at any time can
revoke the given consent and may request that the results of the examination be given to him
(in part or in full) do not communicate, but to be destroyed.
The person referred to in paragraph 1 of this Article must be given a reasonable time to make a decision, whose
the length depends on the type and significance of the genetic test, in accordance with the medical
indications.
The responsible doctor is obliged to compile information on the content in writing
genetic information and to keep it in medical records.

3. Genetic counseling
Article 18
After completing the diagnostic genetic testing, the responsible doctor is obliged
to perform genetic counseling of the person to whom the genetic testing refers, ie
legal representative of a minor or guardian of an adult who is unable to
understand the essence, meaning and scope of genetic testing and make the appropriate decision.
In the case of predictive genetic testing, the person referred to in paragraph 1 of this Article, if not
abandoned genetic testing, is entitled to genetic counseling by
responsible doctor, after obtaining the results of genetic testing.
Article 19
Genetic counseling is performed by a responsible doctor in an understandable, neutral and
non-suggestive form and is obliged to explain the results of the research in detail, as well as to indicate

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to the possibility of professional support if there is a physical or mental burden on the person
which examination relates or members of his family, because of the results obtained
testing.
In the procedure of genetic counseling, with the consent of the person referred to in paragraph 1 of this Article,
a doctor specializing in certain areas of medicine may be involved, when this is important
for further treatment, in order to prevent or treat a genetic disease or disorder.
If it is determined that the relatives of the examined person are possible carriers of genetic traits
which are relevant to an avoidable or treatable disease or medical disorder,
genetic counseling also includes a recommendation that these relatives be given genetic care
examination.
The responsible doctor is obliged to compile information on the content in writing
genetic counseling and to keep it in medical records.

4. Communication of genetic test results

Article 20
The results of the genetic test are communicated only to the person who is genetically tested
examination of the relationship or legal representative of the minor, or guardian
an adult who is unable to comprehend the essence, meaning and scope of the genetic
examination and to make an appropriate decision.
The results referred to in paragraph 1 of this Article may be communicated only by the responsible doctor and in the case
when genetic testing is performed in other authorized health care institutions.
The responsible doctor can communicate the results of the genetic test to another person only
on the basis of the explicit written consent of the person referred to in paragraph 1 of this Article.

5. Prenatal genetic testing
Article 21
Prenatal genetic testing is performed in diagnostic, predictive, preventive or
therapeutic purposes, and only if it is aimed at certain genetic traits of the embryo
or fetuses that, according to the generally accepted level of science and medical practice, harm him
health during pregnancy or after birth or if treatment of the embryo is envisaged, or
fetus by a drug whose action is affected by certain genetic traits.
The examination referred to in paragraph 1 of this Article shall be performed only on the basis of written consent
pregnant women and the father of the future child, if the father is known.
In case of denial of consent for prenatal genetic testing referred to in paragraph 1
of this article by the father of the future child, and with the existing consent of the pregnant woman, the final
the decision is made by the Ethics Committee of the authorized health institution referred to in Article 9 of this Law.
Before prenatal genetic testing and after obtaining test results
pregnant women and the father of the future child must be provided with genetic information and counseling
in accordance with this law.
If during the examination referred to in paragraph 1 of this Article the sex of the embryo or fetus is determined,
this information can be communicated to the pregnant woman and the father of the future child after 12 weeks
pregnancy, unless a genetic test has been performed to determine sex
of the child, in accordance with the indications of the medical geneticist.

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6. Mass genetic testing - screening
Article 22
Mass genetic testing can only be performed when testing is needed
to determine whether the persons to whom the examination relates have genetic traits significant to
an illness or health disorder that is generally accepted at the medical level
sciences and practices can avoid, prevent or treat.
Mass genetic testing is proposed by authorized health institutions.
The institution referred to in paragraph 2 of this Article shall, in addition to the proposal for conducting the examination,
Submit to the Ministry evidence of the justification of that examination.
Mass genetic testing in terms of information, counseling, giving and
revocation of consent shall be performed in accordance with the provisions of this Law.

Article 23
The Ministry decides on the need for mass genetic testing, based on
opinions of the Commission for monitoring genetic testing, collection and protection of genetic
data and samples as an expert advisory body (hereinafter: the Commission).
The decision referred to in paragraph 1 of this Article shall contain the purpose and manner of implementation and participation in
mass genetic testing.
The decision on mass genetic testing is published in the "Official Gazette of Montenegro
Up. "
7 . Genetic testing of deceased persons
Article 24
Genetic testing and collection of genetic data and samples from a deceased person
it can be performed if there is a disease or health disorder in its members
families can be avoided, prevented or treated based on the test results obtained.
The genetic testing referred to in paragraph 1 of this Article may be performed in addition to the previously obtained one
consent of the medical board and the ethics committee of the authorized health institution, on
the basis of the written consent of his spouse, parents, children or relatives up to the third
degree of kinship or a person who was his legal representative or guardian, in accordance with
by this law.

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IV. PRESERVATION, USE AND DESTRUCTION OF GENETIC RESULTS
TESTS AND GENETIC SAMPLES
1. Preservation and destruction of genetic test results
Article 25
Results of genetic tests that can be associated with a person who can
identify, with family or group are a professional secret and are kept as personal data,
in accordance with the law.
The right to access the data has:
- the data subject, ie his / her legal representative or guardian,
if it is not data that cannot be linked to that person and / or if it is
that person has previously stated that he does not want access to the data and / or if he would disclose these
data endangered public health;
- responsible doctor;
- doctors of other specialties and selected doctor of the data subject, in
to the extent and to the extent determined by the responsible doctor, in addition to the previously obtained written one
the consent of the person to whom the genetic tests were performed, ie his
legal representative or guardian;
- a family member for whom the data are important for his health condition or for
the health condition of his offspring.

Article 26
The results of genetic tests must be kept by the responsible doctor for 10 years
medical documentation of the person on whom the examination was performed.
The responsible doctor is obliged to destroy the results of genetic tests as far as possible
within 30 days from the expiration of the deadline referred to in paragraph 1 of this Article.
The results of genetic tests may be destroyed before the expiration of the period referred to in paragraph 1 of this
member, if the person with whom the genetic examination was performed, ie the legal representative
a minor or guardian of an adult who is not able to understand the essence,
meaning and scope of genetic testing and to make an appropriate decision, stated that
these results destroy or if it has revoked consent for genetic testing.
When there are justified medical reasons to get the results of genetic testing
do not destroy, the responsible doctor will meet without delay, and no later than within 30 days
the person with whom the genetic examination was performed, ie the legal representative
a minor or the guardian of an adult who is not able to understand the essence,
meaning and scope of genetic testing and to make an appropriate decision, on the reasons for
keeping the results that are of interest for his life and health, about which he writes
genetic information stored in medical records.
If the person referred to in paragraph 3 of this Article does not give written consent for keeping the results
genetic tests, the responsible doctor destroys them without delay, and no later than within 30
days.
The responsible doctor is obliged to make a report on the destruction of the results of genetic tests
minutes.

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2. Use and destruction of genetic samples
Article 27
The genetic sample may be used for the purposes for which it was taken, based on consent
prescribed by this law.
Notwithstanding paragraph 1 of this Article, the genetic sample may be used for other purposes,
only after obtaining consent for use for those purposes.
The authorized health institution is obliged to, without delay, and no later than within
30 days, destroy the genetic sample when the need for testing ceases or if there is consent
for genetic testing revoked.
A record shall be made of the destruction of genetic samples.
V. COMMISSION
Article 28
The Ministry forms a Commission consisting of:
1) a representative of the Ministry;
2) doctor of medicine, specialist in human / medical and / or clinical
genetics, ie specialists in the field of human genomic medicine;
3) specialists in the field of human reproduction;
4) a representative of an authorized health institution;
5) an expert in the field of psychology or psychiatry;
6) a representative of the Medical Chamber of Montenegro, and
7) a representative of the Protector of Human Rights and Freedoms.
Article 29
The task of the Commission is to:
- gives an opinion on the fulfillment, ie termination of fulfillment of health conditions
institution for performing genetic testing and collecting genetic data and
samples;
- gives an opinion on the introduction of new genetic tests and the collection of genetic tests
data and samples;
- gives an opinion on the need and medical and ethical justification of mass genetic
tests;
- gives an opinion on the fulfillment of conditions for the application of generally recognized scientific and practical
experiences for genetic testing;
- reviews and evaluates reports of health institutions on genetic testing and
collecting genetic data and samples;
- participates in the drafting of regulations adopted on the basis of this law and initiates their
modification, in accordance with the development of human, medical and clinical genetics,
biomedical sciences, practices and ethical standards;
- provides expert advice to health care institutions at their request;
- proposes decisions on the collection of genetic data and samples and implementation
genetic testing, in terms of their significance for disease or health
disorders as well as opportunities to avoid, prevent or treat them;
- proposes a decision relevant to the effect of a drug during treatment,

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- performs other tasks determined by the act on formation of the Commission which are of importance
to conduct genetic testing and collect genetic data and samples.

VI. REGISTER AND RECORDS
Article 30
Authorized health care institutions keep records of every genetic practice
testing, collection of genetic data and samples, storage, preservation and transport
samples, the use of genetic test results and the destruction of genetic samples and
test results and other data, in accordance with a special law.
Institutions referred to in paragraph 1 of this Article shall submit reports on the collected to the Ministry
data by the end of the first quarter of the current year for the previous calendar year, and on
request of the Ministry and before.
Article 31
The Ministry keeps a register of authorized health institutions and mass results
genetic testing.
The manner of keeping and entering in the register referred to in paragraph 1 of this Article shall be prescribed by the Ministry.

VII. SUPERVISION
Article 32
Supervision over the implementation of this law and regulations adopted on the basis of this law
performed by the Ministry through the health inspection.

VIII. PENAL PROVISIONS
Article 33
A fine of two to three hundred times the minimum wage in
A legal entity shall be punished for a misdemeanor in Montenegro if:
1) does not form a medical board and ethics committee (Article 10, paragraph 1);
2) Introduce new genetic testing and collection of genetic data and samples without
consent of the Ministry (Article 11, paragraph 1);
3) does not perform genetic testing, collection of genetic data and samples and genetic
informing and advising the responsible doctor (Article 15, paragraph 1);
4) written consent, as well as revocation of consent, is not kept by the responsible doctor
medical documentation of the person to whom the genetic examination refers (Article 16, paragraph
6);
5) the responsible doctor before giving consent for genetic testing and collection
genetic data and samples do not conduct genetic information of the person to whom they are
refers to genetic testing, ie the legal representative of a minor or
the guardian of an adult who is not capable of giving consent (Article 17, paragraph 1);

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6) the responsible doctor does not explain all the facts relevant to the essence and scope
genetic testing, the method of taking a genetic sample, as well as risk assessment (Article
17 paragraph 1);
7) the responsible doctor does not compile and keep written documents in the medical documentation
information on the content of genetic information (Article 17, paragraph 4);
8) the responsible doctor does not perform it after the completion of the diagnostic genetic examination
genetic counseling of the person to whom the genetic testing relates, ie
legal representative of a minor or guardian of an incapacitated adult
to understand the essence, meaning and scope of genetic testing and to make the appropriate one
decision (Article 18, paragraph 1);
9) the responsible doctor does not perform genetic counseling in an understandable, neutral and

non-suggestive form and does not explain in detail the results of the research (Article 19, paragraph 1);
10) the responsible doctor does not indicate the possibility of professional support if there is physical support
or the mental burdens of the person to whom the examination relates or members of his family,
due to the obtained test results (Article 19, paragraph 1);
11) the responsible doctor does not compile and does not keep written information about the content of the genetic
consultations (Article 19, paragraph 4);
12) the responsible doctor does not keep the results of the genetic examination in the medical school for 10 years
documentation of the person who was examined (Article 26, paragraph 1);
13) the responsible doctor does not destroy the results of genetic tests within 30
days from the expiration of the period of 10 years (Article 26, paragraph 2);
14) the responsible doctor does not meet the person with the code without delay, and no later than within 30 days
when a genetic test has been performed, ie the legal representative of a minor or
an adult caregiver who is unable to grasp the essence, meaning and scope
genetic testing and to make an appropriate decision on the reasons for data retention
which are of interest to his life and health (Article 26, paragraph 4);
15) the responsible doctor does not compile and does not keep written genetic information in the medical
documentation (Article 26, paragraph 4);
16) the responsible doctor does not make a report on the destruction of the results of genetic tests (Article
26 paragraph 6);
17) does not destroy the genetic sample without delay, and no later than within 30 days when it ceases
the need for testing or if the consent for genetic testing has been revoked (Article 27
paragraph 3);
18) does not keep records of every genetic testing, collection of genetic tests
data and samples, storage, storage or transport of samples, use of results
genetic testing or destruction of genetic samples and test results (Article 30
paragraph 1),
19) does not submit to the Ministry reports on the collected data by the end of the first quarter
current year for the previous calendar year (Article 30, paragraph 2);
The responsible person in the legal entity shall also be punished for the offenses referred to in paragraph 1 of this Article
a fine of ten to twenty times the minimum wage in
Montenegro.

IX. TRANSITIONAL AND FINAL PROVISIONS
Article 34
Regulations for the implementation of this law shall be adopted within six months from the date
entry into force of this law.

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Article 35
Health care institutions that perform genetic testing as part of their activities and
collection of genetic data and samples are obliged to harmonize the organization and the way of work
with the provisions of this law within nine months from the date of entry into force of this
of the law.
Article 36
This Law shall enter into force on the eighth day from the day of its publication in the "Official Gazette
Montenegro ".

