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Human Genes Research Act

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Human Genes Research Act - content
Issuer:Riigikogu
Type:act
In force from:15.03.2019
In force until: In force
Translation published:08.04.2019

Human Genes Research Act

Passed 13.12.2000
RT I 2000, 104, 685
Entry into force 08.01.2001

Amended by the following legal instruments (show)

PassedPublishedEntry into force
14.02.2007RT I 2007, 22, 11101.04.2007
10.06.2010RT I 2010, 37, 22109.07.2010
19.02.2014RT I, 13.03.2014, 401.07.2014
19.06.2014RT I, 29.06.2014, 10901.07.2014, official titles of ministers replaced on the basis of subsection 107³ (4) of the Government of the Republic Act.
20.02.2019RT I, 13.03.2019, 215.03.2019

Chapter 1 GENERAL PROVISIONS  

§ 1.  Purpose and scope of application of Act

 (1) The objectives of this Act are to regulate the establishment and maintenance of a Gene Bank, to organise the genetic research necessary therefor, to ensure the voluntary nature of gene donation and the confidentiality of the identity of gene donors, and to protect persons from misuse of genetic data and from discrimination based on interpretation of the structure of their DNA and the genetic risks arising therefrom.

 (2) The following are provided for in this Act:
 1) the conditions for processing tissue samples, descriptions of DNA, descriptions of state of health and genealogies in the Gene Bank and the composition of data;
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]
 2) the rights and obligations of gene donors, the controller and processor of the Gene Bank and genetic researchers relating to tissue samples, descriptions of DNA, descriptions of state of health and genealogies;
 3) the conditions for the establishment and maintenance of the Gene Bank;
 4) the restrictions on the use of tissue samples, descriptions of DNA, descriptions of state of health and genealogies collected in the Gene Bank;
 5) the conditions for genetic research relating to the Gene Bank and the organisation of administrative supervision thereof.
[RT I, 13.03.2014, 4 - entry into force 01.07.2014]

§ 2.  Definitions

  In this Act, the following definitions are used:
 1) “DNA” means a molecule of deoxyribonucleic acid which contains the genetic information of a human being;
 2) “tissue sample” means cells, intercellular substance and body fluids taken from a human being for the purposes of genetic research;
 3) “description of DNA or gene map” means a digital model of DNA created as a result of genetic research, containing the set of genetic variants represented in the human genome, which forms the input for the preparation of genetic risks report of a gene donor;
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]
 4) “gene donor” means a person who provides a tissue sample in accordance with this Act and with regard to whom a description of state of health and genealogy are prepared;
 5) “description of state of health” means data collected for use in genetic research which reflects the state of health of a gene donor, illnesses he or she has suffered from and treatment thereof, and his or her lifestyle, physical and social environment and hereditary characteristics;
 6) “genealogy” means information in the Gene Bank concerning the names, dates of birth and blood relationships of the ascendants and descendants of a gene donor;
 7) “genetic research” means the scientific study and description of DNA, other constituents of tissue samples, descriptions of state of health and genealogies and determination of the links between them with the purpose of obtaining data on the genes, gene products and hereditary characteristics of human beings;
 8) “genetic researcher” means a natural or legal person or a state or local government agency who performs genetic research;
 9) “genetic data” means data concerning the genes, gene products or hereditary characteristics of a human being, including a description of DNA or a part thereof, which is obtained as a result of genetic research;
 10) “Gene Bank” means a database established and maintained by the controller consisting of tissue samples, descriptions of DNA, descriptions of state of health, genealogies, genetic data and data enabling the identification of gene donors;
 11) “pseudonymisation” means the replacement with a unique code of such data of a tissue sample, description of DNA, description of state of health or genealogy which enables the identification of the person;
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]
 12) “de-pseudonymisation” means the reverse identification of a gene donor through the unique code given to a tissue sample, description of DNA, description of state of health or genealogy or the identification of the tissue sample, description of DNA or description of state of health of a gene donor based on the identity of the gene donor;
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]
 13) “genetic risks report” – part of the description of state of health prepared on the basis of description of DNA data on different diseases, conditions and other characteristics.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

§ 3.  Controller of Gene Bank

 (1) The controller of the Gene Bank is the University of Tartu whose objective as the controller of the Gene Bank is to:
 1) promote the development of genetic research;
 2) collect information on the health of the Estonian population and genetic information concerning the Estonian population;
 3) use the results of genetic research to improve public health.

 (2) The controller has the right to organise the taking of tissue samples, to prepare descriptions of state of health and genealogies, to pseudonymise, de-pseudonymise, store, destroy and issue descriptions of state of health and genealogies, to perform genetic research and to collect, store, destroy and issue genetic data.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (3) The controller has the right to delegate the rights of processing, except for pseudonymisation and de-pseudonymisation, to a processor on the basis of a contract in the cases and under the conditions prescribed in this Act.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

§ 4.  [Repealed – RT I 2007, 22, 111 – entered into force 01.04.2007]

§ 5.  Processor of Gene Bank

  A processor of the Gene Bank is a natural or legal person or an Estonian state agency or local government agency who may receive all processing rights, except the right to pseudonymise and de-pseudonymise, from the controller on the basis of a contract. The requirements for processors shall be established by a regulation of the minister responsible for the area.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

§ 6.  Genetic research and genetic testing

 (1) Genetic research relating to the Gene Bank is permitted in order to study and describe the links between genes, the physical and social environment and the lifestyles of people, to find medicinal products or methods of treatment on the basis thereof, to assess individual health hazards and to prevent illnesses.

 (2) Genetic testing to which the provisions of Chapters 2, 3 and 4 of this Act do not apply may be performed pursuant to the procedure and for the purposes provided by law. Tissue samples taken from people in the course of genetic testing and the results of research performed on such samples shall not be added to the Gene Bank.

§ 61.  Data processed in Gene Bank

 (1) The following data shall be processed in the Gene Bank:
 1) general data of the person;
 2) data on ascending and descending relatives based on the statements of the person;
 3) health data of the person;
 4) data on the person’s health behaviour and personal characteristics;
 5) results of tissue sample analysis.

 (2) The specific composition of data processed in the Gene Bank shall be established by the controller of the Gene Bank.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

§ 7.  Application of provisions which regulate processing of personal data

 (1) [Repealed - RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (2) The provisions regulating the processing of personal data do not apply to the processing of pseudonymised tissue samples, pseudonymised descriptions of DNA and pseudonymised descriptions of state of health if such tissue samples, descriptions of DNA and descriptions of state of health are processed as a set of data and on the condition that the set of data to be processed contains DNA samples, descriptions of DNA or descriptions of state of health of at least five gene donors at a time.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

Chapter 2 RIGHTS OF GENE DONORS  

§ 8.  Confidentiality of identity of gene donors

 (1) The identity of a gene donor shall remain classified after pseudonymisation.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (2) A gene donor has the right to permit disclosure of his or her identity.

 (3) The fact of a person being or not being a gene donor shall remain classified. Only a person himself or herself has the right to disclose the fact of being or not being a gene donor and the circumstances thereof, unless otherwise prescribed by law.

 (4) Pseudonymisation and de-pseudonymisation shall be performed in accordance with the requirements of this Act.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019].

§ 9.  Voluntary nature of gene donation

 (1) It is prohibited to take a tissue sample and prepare a description of state of health or genealogy without the specific knowledge and voluntary consent of the person.

 (2) It is prohibited to influence a person’s decision to become a gene donor, including by threatening the person with negative consequences, promising material benefits or providing subjective information.

 (3) The controller and processor are permitted to disseminate only general information concerning the Gene Bank and genetic research.

§ 10.  Right to apply for destruction of material

 (1) Pursuant to the provisions of § 21 of this Act, gene donors have the right to apply, at any time, to the controller for the destruction of data which enables de-pseudonymisation.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (2) If the identity of a gene donor is unlawfully disclosed, the gene donor has the right to apply to the controller for the destruction of the tissue sample, description of DNA and description of the state of health pursuant to the provisions of § 21 of this Act.

§ 11.  Other rights of gene donors

 (1) Gene donors have the right not to know their genetic data.

 (2) Gene donors have the right to access personally their data stored in the Gene Bank. Gene donors do not have the right to access their genealogies.

 (3) Gene donors shall not be charged for accessing their data stored in the Gene Bank and for the issue of data thereto.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (4) Gene donors have the right to counselling upon accessing their data stored in the Gene Bank.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (5) Gene donors have the right to submit additional information on themselves to the controller.

 (6) Gene donors have the right to prohibit the supplementation, renewal and verification of descriptions of their state of health stored in the Gene Bank.

§ 12.  Consent to become gene donor

 (1) A person’s consent to provide a tissue sample, to have a description of the state of health or the genealogy of the person prepared, to entry of the description of the state of health or the genealogy in the Gene Bank in pseudonymised form and to use thereof for genetic research, assessment of personal health risks and prevention of diseases, public health research and statistical purposes shall be prepared in writing and shall be signed by the person who becomes a gene donor.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (2) Partial or conditional consent is not valid.

 (3) [Repealed - RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (4) The controller or processor shall inform a person, prior to the person granting consent, of the following facts:
 1) grant of the consent specified in subsection (1) of this section is voluntary;
 2) the gene donor is not entitled to request a fee for providing a tissue sample, preparation and study of a description of his or her state of health or genealogy, or use of the research results;
 3) data on hereditary characteristics and genetic risks obtained as a result of genetic research may be unpleasant for the gene donor;
 4) the gene donor has the right not to know his or her genetic data;
 5) the gene donor has the right to know his or her genetic data, except genealogy;
 6) the gene donor has the right to apply to the controller for the destruction of data which enables de-pseudonymisation or, upon unlawful disclosure of his or her identity, for the destruction of the tissue sample, description of DNA and description of his or her state of health;
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]
 7) a gene donor has the right to withdraw his or her consent at any time. Withdrawal of consent shall not have retroactive effect.
[RT I 2010, 37, 221 - entry into force 09.07.2010]

 (5) The controller or processor to whom a person who is about to become a gene donor submits his or her consent is required to provide the gene donor promptly with a copy of his or her consent.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (6) The controller shall preserve the consent of a gene donor for as long as the tissue sample, description of state of health or description of DNA are stored, except in the case provided for in subsection 10 (1) of this Act.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (7) The format of consent to become a gene donor and the procedure for the completion and preservation thereof shall be established by a regulation of the minister responsible for the area.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

§ 13.  Persons with restricted active legal capacity and persons without capacity to exercise will

 (1) The consent of a person with restricted active legal capacity to become a gene donor shall be deemed valid if the following conditions are met:
 1) the person with restricted active legal capacity and his or her legal representative or guardian have been given the information provided for in subsection 12 (4) of this Act;
 2) the legal representative or guardian has expressed the consent provided for in subsection 12 (1) of this Act;
 3) the person with restricted active legal capacity is not opposed to providing a tissue sample or to the collection of descriptions of his or her state of health.

 (2) Persons who are unable to understand the content and meaning of consent shall not be gene donors. In the case of doubt, it is presumed that the person is temporarily unable to understand the content and meaning of consent.

Chapter 3 PROCESSING OF GENE BANK  

§ 14.  Taking of tissue samples and preparation of descriptions of state of health

 (1) The controller shall organise the taking of tissue samples and the preparation of descriptions of state of health itself or through a processor.

 (2) Taking a tissue sample is a medical procedure that shall be performed by a health care provider of the Republic of Estonia on the conditions and pursuant to the procedure provided for in the Health Services Organisation Act.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (3) A description of state of health shall be prepared and supplemented by the controller or processor on the basis of statements by the gene donor and data on the gene donor stored in medical institutions. Only data on illnesses suffered from by the gene donor himself or herself may be collected from a gene donor. A gene donor may be asked questions about habits or illnesses which have occurred in his or her family. Such questions shall not enable the identification of a certain person or generation.

 (4) The controller or processor may prepare a genealogy on the basis of the results of questioning a gene donor and on the basis of other databases and genetic research.

 (5) A person taking a tissue sample and a person preparing a description of state of health shall maintain the confidentiality of the identity of the gene donor, his or her tissue sample, the description of his or her state of health and his or her genealogy and shall deliver the personal data of the gene donor, the tissue sample, the description of his or her state of health and his or her genealogy to the controller or a processor designated by the controller as soon as possible.

§ 15.  Right of ownership of tissue samples and right to use descriptions of state of health genealogies and personal data connected therewith

  [RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (1) The controller’s right of ownership of a tissue sample is created from the moment the tissue sample is taken. The controller’s right to use the description of state of health, genealogy and written consent of a gene donor and the right to process the personal data contained therein is created at the moment of preparation thereof.

 (2) Tissue samples in the ownership of the controller are not transferable. Upon termination of activity of the controller, the right of ownership of tissue samples, descriptions of state of health, genealogy and written consents of gene donors in the possession of the controller and the right to process the personal data connected therewith shall transfer to the Republic of Estonia.

 (3) Before transfer of the rights specified in subsection (2) of this section, the controller of the Gene Bank shall notify the gene donor of the new controller by either using the contact details of the gene donor or other means such as a national newspaper or the official publication Ametlikud Teadaanded for the notification.

 (4) A gene donor is not entitled to request a fee for providing a tissue sample, preparation and study of a description of his or her state of health or genealogy, or use of the research results.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

§ 16.  Permission to use Gene Bank

 (1) The Gene Bank may be used only for scientific research, research into and treatment of illnesses of gene donors, public health research and statistical purposes. Use of the Gene Bank for other purposes, especially to collect evidence in civil or criminal proceedings or for surveillance, is prohibited.

 (11) The objectives specified in subsection (1) of this section do not restrict the use of data by a gene donor for other objectives upon his or her consent.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (2) The doctor of a gene donor has the right, pursuant to clause 24 (2) 7) of this Act, to obtain the de-pseudonymised description of the state of health of the gene donor from the Gene Bank in order to treat the gene donor.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

§ 17.  Permission to use genealogy

 (1) Genealogies may be used only within the Gene Bank for structuring tissue samples, descriptions of DNA and descriptions of state of health on the basis of blood relationships.

 (2) The controller may issue, to a gene researcher, the link between pseudonymised tissue samples, pseudonymised descriptions of DNA and pseudonymised descriptions of state of health based on blood relationships in adherence with the requirements provided for in subsection 22 (4) of this Act.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

§ 18.  Storage of tissue samples, descriptions of DNA and descriptions of state of health

 (1) Tissue samples, descriptions of DNA and descriptions of state of health shall be preserved in pseudonymised form or unpseudonymised form without a term if these must not be destroyed in the form provided for in subsection 21 (1) or (2) of this Act.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (2) Pseudonymised DNA samples, pseudonymised descriptions of DNA and pseudonymised descriptions of state of health may also be stored by a gene researcher who has the resources and conditions necessary for storage. The conditions for preservation shall be established by a regulation of the minister responsible for the area.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (3) In order to organise storage, the controller shall enter into a contract with a processor or gene researcher which shall set out the following:
 1) the tissue samples, descriptions of DNA and descriptions of state of health handed over for preservation;
 2) the time of delivery of the tissue samples, descriptions of DNA and descriptions of state of health to the processor or gene researcher and the manner of supplementing the tissue samples, descriptions of DNA and descriptions of state of health;
 3) the place and term of storage;
 4) the method of storage;
 5) the security measures to be applied by the storer;
 6) the procedure for the copying, distribution, destruction and issue of tissue samples, descriptions of DNA or descriptions of state of health and for the return thereof to the controller or processor;
 7) the liability of the processor or gene researcher.

 (4) All tissue samples shall be preserved in the territory of the Republic of Estonia. The University of Tartu senate may, if good reasons therefor become evident, grant permission for tissue samples to be preserved and studied outside the territory of the Republic of Estonia if the tissue sample is issued in unpersonalised form and the controller ensures effective control over the tissue samples and that the tissue samples cannot be used in a manner prohibited by legislation.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (5) In order to enable an efficient control over the use of tissue samples outside the territory of the Republic of Estonia, the controller shall notify to the Ministry of Social Affairs in January each year the following information on the previous calendar year:
 1) the cases that have become known to the controller when tissue samples preserved outside Estonia have been used in a manner prohibited by the Estonian law, and upon violations connected with the cases the activity undertaken and planned by the controller;
 2) the number of tissue samples, destination and reasons of preservation of tissue samples preserved outside Estonia;
 3) agreements entered into for preservation of tissue samples outside Estonia, including agreements that may cause the need to preserve tissue samples outside Estonia.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

§ 19.  Rights related to results of genetic research

 (1) A processor or gene researcher shall unconditionally deliver descriptions of DNA or parts thereof to the controller. The controller may grant a processor or gene researcher the right to use a description of DNA or a part thereof for a charge. The controller shall grant gene researchers who are legal persons in public law or state agencies of the Republic of Estonia the right to use descriptions of DNA or parts thereof for a charge which covers the expenses related with the issue.
[RT I 2007, 22, 111 - entry into force 01.04.2007]

 (2) Results of genetic research not specified in subsection (1) of this section and intellectual property rights related thereto shall be provided by law.

§ 20.  Issue of tissue samples, descriptions of DNA and descriptions of state of health, and records of issue

 (1) The controller shall issue tissue samples, descriptions of DNA and descriptions of state of health from the Gene Bank only in pseudonymised form, except upon the issue of data on a gene donor to the gene donor or to the doctor of the gene donor in the cases provided for in subsections 11 (2) and 16 (2) of this Act.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (2) Upon the issue of a tissue sample, description of DNA or description of state of health, the issuer shall prepare a record of issue in which the tissue samples, descriptions of DNA and descriptions of state of health issued and received and the manner and date of delivery are indicated. The record of issue shall be signed by the representatives of the issuer and receiver.

 (3) If the issuer is a processor, the issuer shall promptly send a copy of the record of issue to the controller.

 (4) The procedure for issuing tissue samples, descriptions of DNA and descriptions of state of health, including the format of the record of issue and the procedure for the completion and preservation thereof shall be established by a regulation of the minister responsible for the area.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

§ 21.  Destruction of data which enables de-pseudonymisation, tissue samples, descriptions of DNA and descriptions of state of health, and records of destruction

  [RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (1) If a gene donor applies to the controller for the destruction of data which enables de-pseudonymisation, the controller is required to destroy the data which enables de-pseudonymisation within two weeks as of the receipt of the corresponding written application from the gene donor.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (2) If a gene donor applies to the controller for the destruction of a tissue sample, description of DNA or description of his or her state of health due to unlawful disclosure of his or her identity, the controller is required to organise the destruction of the tissue sample, description of DNA and description of state of health within one month as of the receipt of the corresponding written application from the gene donor unless the controller proves that the identity of the gene donor was disclosed as a result of the gene donor’s own behaviour.

 (3) The controller may organise the destruction of tissue samples, descriptions of DNA and descriptions of state of health on the basis of records of issue prepared pursuant to § 20 of this Act, in which case the controller shall issue a destruction order to the receiver specified in the record of issue.

 (4) All persons who have a specific tissue sample, description of DNA or description of state of health in their possession are required, on the order of the controller, to destroy the specific tissue sample, description of DNA or description of state of health promptly and at their own expense.

 (5) Upon the destruction of data which enables de-pseudunymisation, tissue samples, descriptions of DNA or descriptions of state of health, the destroyer shall prepare a record of destruction which sets out the destroyed object and the manner, place and date of destruction. If the destroyer is not the controller, the destroyer shall promptly send a copy of the record of destruction to the controller.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (6) The procedure for destroying data which enables de-pseudonymisation, tissue samples, descriptions of DNA and descriptions of state of health, including the format of the record of destruction and the procedure for the completion and preservation thereof shall be established by a regulation of the minister responsible for the area.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

Chapter 4 DATA PROTECTION  

§ 22.  General requirements for data protection

 (1) Data in the Gene Bank shall be processed in compliance with the highest standard of data protection.

 (2) [Repealed - RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (3) The controller shall appoint the specific persons who perform pseudonymisation and de-pseudonymisation, who have access to the consent of gene donors, to the collection of tissue samples and descriptions of DNA, to descriptions of state of health and to genealogies, and who issue pseudonymised or de-pseudonymised tissue samples, descriptions of DNA or descriptions of state of health.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (4) The controller may issue tissue samples, descriptions of DNA or descriptions of state of health from the Gene Bank only in pseudonymised form, as a set of data and on the condition that samples or data concerning at least five gene donors are issued at a time. The cases provided for in subsections 11 (2) and 16 (2) of this Act constitute an exception.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (5) In order to verify the authenticity of data to be entered in the Gene Bank before pseudonymisation, the controller and processor are permitted to compare such data with data stored in other databases and to correct the data if necessary.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

§ 23.  Pseudonymisation

  [RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (1) The controller shall give each tissue sample, description of DNA, description of state of health and genealogy a unique code consisting of at least sixteen random characters immediately after receipt of the tissue sample, description of DNA, description of state of health or genealogy in the Gene Bank. The controller shall obtain the approval of the data protection supervision authority for the method of generating the codes.

 (2) The controller shall replace with a code all data concerning a tissue sample, description of DNA and description of state of health which enables the reverse identification of the gene donor, including the name, personal identification code, date of birth and residence.

 (3) The controller shall indicate the code given to a tissue sample, description of DNA, description of state of health or genealogy on the written consent of the gene donor. The controller shall store the written consent together with the code indicated thereon in the database of the Gene Bank and it shall be the only possible key for de-pseudonymisation.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (4) In the interests of greater security, the controller may give an additional code to a pseudonymised tissue sample, pseudonymised description of DNA, pseudonymised description of state of health or pseudonymised genealogy and this code shall replace the initial code given to the tissue sample, description of DNA, description of state of health or genealogy. The controller shall make a record of the link between an initial code and an additional code in a database used solely for that purpose.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (5) The controller, processors and genetic researchers are required to encode tissue samples, descriptions of DNA, descriptions of state of health and genealogies only with the code given to the tissue samples, descriptions of DNA, descriptions of state of health or genealogies by the controller.

§ 24.  De-pseudonymisation

  [RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (1) Only persons appointed pursuant to subsection 22 (3) of this Act may gain access to written consent with a code indicated thereon and have the technical possibility to de-pseudonymise data.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (2) The controller is permitted to de-pseudonymise data only in the following cases and for the following purposes:
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]
 1) in order to destroy a tissue sample, a description of DNA or a description of state of health or data which enables de-pseudonymisation;
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]
 2) in order to enable access to data on a gene donor stored in the Gene Bank, except genealogies, at the written request of the gene donor;
 3) in order to renew, supplement or verify a description of the state of health of a gene donor without contacting the gene donor unless the gene donor has prohibited the supplementation, renewal or verification of the description of his or her state of health;
 4) in order to identify a gene donor on the proposal of the controller and with the consent of the Ethics Committee, to contact the gene donor and to renew, supplement or verify a description of his or her state of health with his or her written consent;
 5) in order to identify a gene donor and, with the gene donor’s written consent, to take a new DNA sample if a tissue sample has been destroyed or does not contain sufficient DNA;
 6) in order to identify a gene donor within the Gene Bank and amend his or her genealogy if the results of DNA research contradict the previously known genealogy or provide new information concerning the genealogy;
 7) in order to issue a description of the state of health of a gene donor to the doctor of the gene donor at the request of the doctor of the gene donor and with the consent of the gene donor or, in urgent cases where a gene donor is unable to grant consent and has no legal representative or guardian or if the legal representative or guardian of the gene donor is unavailable, without the consent of the gene donor but in his or her interests and according to his or her presumed intentions.

Chapter 5 PROHIBITION ON DISCRIMINATION  

§ 25.  Prohibition on discrimination

 (1) It is prohibited to restrict the rights and opportunities of a person or to confer advantages on a person on the basis of the structure of the person’s DNA and the genetic risks resulting therefrom.

 (2) It is prohibited to discriminate against a person on the basis of the person being or not being a gene donor.

§ 26.  Discrimination in employment relationships

 (1) Employers are prohibited from collecting genetic data on employees or job applicants and from requiring employees or job applicants to provide tissue samples or descriptions of DNA.

 (2) Employers are prohibited from imposing discriminatory working and wages conditions for people with different genetic risks.

§ 27.  Discrimination in insurance relationships

 (1) Insurers are prohibited from collecting genetic data on insured persons or persons applying for insurance cover and from requiring insured persons or persons applying for insurance cover to provide tissue samples or descriptions of DNA.

 (2) Insurers are prohibited from establishing different insurance conditions for people with different genetic risks and from establishing preferential tariff rates and determining insured events restrictively.

Chapter 51 FINANCING OF CONTROLLER OF GENE BANK  
[RT I 2007, 22, 111 - entry into force 01.04.2007]

§ 271.  Financing of controller of Gene Bank

 (1) The activity of the controller of Gene Bank upon maintaining and preserving the Gene Bank shall be financed from the state budget through the Ministry of Social Affairs.

 (2) The activity of the controller of Gene Bank upon taking of tissue samples, preparation of descriptions of state of health and genealogies, pseudonymisation and de-pseudonymisation thereof and genetic research shall be financed from the state budget according to the volume provided for in the state budget and from other funds.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (3) The direct costs related to the issue of information on health and tissue samples shall be covered by the genetic researcher.
[RT I 2007, 22, 111 - entry into force 01.04.2007]

Chapter 6 ADMINISTRATIVE SUPERVISION AND RESOLUTION OF AFFAIRS  
[RT I, 13.03.2014, 4 - entry into force 01.07.2014]

§ 28.  Data protection supervision authority

  Administrative supervision over the collection of descriptions of state of health and genealogical data, the pseudonymisation and de-pseudonymisation of tissue samples, descriptions of DNA, descriptions of state of health and genealogical data, and the processing of tissue samples, descriptions of DNA, descriptions of state of health and genealogical data shall be exercised by the data protection supervision authority.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

§ 29.  Research Ethics Committee

  [RT I, 13.03.2019, 2 – entry into force 15.03.2019]

 (1) The processing procedures of the Gene Bank shall be assessed by an independent Research Ethics Committee composed of scientists and representatives of different fields of life.

 (2) The aim of the Research Ethics Committee’s work is to ensure the preventive protection of fundamental rights of persons, harmonise the assessment principles applied to research to ensure the protection methods of rights and the obligations of the researchers to comply with the protection methods.

 (3) The Research Ethics Committee shall act pursuant to the ethical rules established for the area, international conventions, and also pursuant to Regulation (EU) 2016/679 of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 04.05.2016, p 1–88) as well as the principles provided for in special acts.

 (4) The Research Ethics Committee evaluates the compliance of research to the requirements provided for in § 6 of the Personal Data Protection Act, the extent of ethical risks and the background of the person conducting the research, by finding a balance between the protection of fundamental rights and the purposefulness of the research.

 (5) The Research Ethics Committee shall be founded and the rules of procedure thereof, the number of members and procedure of appointment thereof and the rates of review of research shall be approved by a regulation of the minister responsible for the area.
[RT I, 13.03.2019, 2 – entry into force 15.03.2019]

§ 30.  Resolution of appeals arising from employment and insurance relationships

 (1) Complaints concerning discrimination occurring in employment relationships due to genetic risks shall be adjudicated by the Labour Inspectorate, if necessary with the assistance of the controller or experts from the data protection supervision authority in investigating and deciding the matter.

 (2) [Repealed – RT I 2010, 37, 221 – entered into force 09.07.2010]

Chapter 7 IMPLEMENTING PROVISIONS  

§ 31. – § 33. [Omitted from this text]

§ 34.  [Repealed – RT I 2007, 22, 111 – entered into force 01.04.2007]

§ 35.  Transfer of right of ownership of tissue samples, descriptions of state of health and genealogies to University of Tartu

 (1) The right of ownership of tissue samples, descriptions of state of health, other personal data and genealogies which the controller of the Gene Bank, Estonian Genome Foundation, has acquired shall transfer to the University of Tartu as of 1 April 2007.

 (2) A person who has given his or her consent for becoming a gene donor to the Estonian Genome Foundation on the basis of § 12 of this Act has the right to apply, until 1 July 2008, to the University of Tartu as the controller of the Gene Bank for the destruction of the tissue sample, description of DNA and description of the state of health pursuant to the procedure provided for in § 21 of this Act.
[RT I 2007, 22, 111 - entry into force 01.04.2007]

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