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LEGAL ACTS OF THE REPUBLIC OF LATVIA
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Text consolidated by Valsts valodas centrs (State Language Centre) with amending laws of:

21 September 1995 [shall come into force on 1 November 1995];
6 December 2001 [shall come into force on 1 January 2002];
2 June 2004 [shall come into force on 30 June 2004];
13 November 2008 [shall come into force on 1 July 2009];
28 October 2010 [shall come into force on 1 February 2011];
21 June 2012 [shall come into force on 27 August 2012];
16 May 2019 [shall come into force on 13 June 2019];
29 October 2020 [shall come into force on 13 November 2020].

If a whole or part of a section has been amended, the date of the amending law appears in square brackets at the end of the section. If a whole section, paragraph or clause has been deleted, the date of the deletion appears in square brackets beside the deleted section, paragraph or clause.

The Supreme Council of the Republic
of Latvia has adopted a law:1

On the Protection of the Body of Deceased Human Beings and the Use of Human Tissues and Organs in Medicine

Chapter I
General Provisions

Section 1. Purpose of the Law

The purpose of the Law is to protect the body of a deceased human being from undignified and illegal actions therewith. The Law prescribes the procedures by which the tissues and cells (hereinafter - the tissues) and organs of living or deceased human beings may be used for scientific research and study purposes, transplantation, manufacture of medicinal preparations and bioprostheses.

Within the meaning of this Law, the use of tissues and organs shall mean any activities involving tissues and organs, including selection of tissue and organ donors, procurement, removal, testing, processing, preservation, labelling, documentation of processes, storage, distribution (also export and import), transportation, and transplantation of tissues and organs.

[21 June 2012]

Section 2. Priority Right of a Human Being to his or her Body

The body, tissues, and organs of a deceased human being may be used only in accordance with the procedures laid down in this Law according to the will of the deceased human being expressed during his or her lifetime. The will of the human being must be respected by all medical treatment, educational, and scientific institutions regardless of the type of activity and jurisdiction thereof unless it is in contradiction with the laws in force.

Any person of legal age during his or her lifetime is entitled to express his or her will to prohibit or permit the use of his or her body, tissues, and organs after death, inter alia, indicate the purpose of use thereof by making a note in the unified electronic information system of the health sector (hereinafter - the health information system).

One of the lawful representatives of a minor has the right to express the will to prohibit or permit the use of the body, tissues, and organs of the minor after death by making a note in the health information system or by expressing the relevant will to a medical treatment institution (tissue and organ procurement centre).

A person is entitled to change his or her will expressed during lifetime with regard to prohibiting or permitting the use of his or her body, tissues, and organs after death.

The Ministry of Health shall develop and make available free of charge information materials on the possibilities of using human body, tissues, and organs and on legal aspects, and shall also perform regular information campaigns.

[2 June 2004; 16 May 2019 / Amendments to Paragraphs two and three with regard to making a note in the health information system on prohibition or permission to use the body, tissues, and organs of the deceased human being after death shall apply from 1 February 2021. See Paragraph 6 of Transitional Provisions]

Section 3. Drawing up of Prohibition or Permission

[16 May 2019 / See Paragraph 7 of Transitional Provisions]

Section 4. Rights of the Next of Kin and Presumed Consent

If there is no information in the health information system on the will of the deceased human being expressed during his or her lifetime to prohibit or permit the use of his or her body, tissues, and organs after death, the medical treatment institution (tissue and organ procurement centre) has the obligation to clarify the information on the will of the deceased human being expressed during his or her lifetime to prohibit or permit the use of his or her body, tissues, and organs after death, by turning to the present next of kin (spouse, parents, adult child, brother, sister, or a contact person of the deceased human being indicated in the health information system).

If none of the next of kin is present, the medical treatment institution (tissue and organ procurement centre), shall ascertain, as far as possible, in cooperation with State and local government institutions and using State information systems, by turning to the next of kin, the will of the deceased human being expressed during his or her lifetime to prohibit or permit the use of his or her body, tissues, and organs after death.

The information provided by the next of kin shall be recorded in the medical documents of the deceased human being.

If the relevant State information system does not contain information on the will of the deceased human being expressed during his or her lifetime to prohibit or permit the use of his or her body, tissues, and organs after death, and it is not possible to ascertain from the next of kin according to Paragraphs one and two of this Section the will of the deceased human being expressed during his or her lifetime to prohibit or permit the use of his or her body, tissues, and organs after death, it shall be presumed that the deceased human being during his or her lifetime has expressed the permission to use his or her body, tissues, and organs after death.

If the information provided by the next of kin on the will of the deceased human being expressed during his or her lifetime to prohibit or permit the use of his or her body, tissues, and organs after death is conflicting, it is prohibited to use his or her body, tissues, and organs.

After establishing biological death, until ascertaining the will of the deceased human being expressed during his or her lifetime, the medical treatment institution (tissue and organ procurement centre) is permitted to perform the necessary medical manipulations aimed at maintaining in the body the functions and vitality of the tissues and organs of the deceased human being without commencing the operation of extracting tissues or organs.

The medical treatment institution (tissue and organ procurement centre) shall inform the next of kin present of the use of the body, tissues, and organs of the deceased human being and the legal aspects thereof.

[16 May 2019 / Amendment to Paragraph one with regard to making a note in the health information system on prohibition or permission to use the body, tissues, and organs of the deceased human being after death shall apply from 1 February 2022. See Paragraph 6 of Transitional Provisions]

Section 4.1 Authorisation to Use Tissues and Organs

The medical treatment institution which has the authorisation to use tissues or organs issued by the State Agency of Medicines has the right to use tissues and organs.

Use of the tissues and organs of a living human being and the body of a deceased human being for medical studies and in professional development programmes of medical practitioners is permitted when implementing an accredited medical study programme or a professional development programme of medical practitioners in a higher education institution which has the authorisation to use tissues or organs issued by the State Agency of Medicines. It is permitted to use only such tissues and organs of a living human being for medical studies and in professional development programmes of medical practitioners that are postoperative material and the use of which for medical studies and in professional development programmes of medical practitioners has been consented by the person. The consent by the person shall be confirmed by an entry in the medical documents of the person.

If the authorisation to use tissues or organs is damaged, destroyed, lost, or stolen, the legal persons referred to in Paragraphs one and two of this Section shall receive a duplicate of the relevant authorisation in the State Agency of Medicines.

The Cabinet shall determine the following:

1) procedures for issuing an authorisation to use tissues or organs or a duplicate thereof to a medical treatment institution and a higher education institution that implements an accredited medical study programme and a professional development programme of medical practitioners, and for cancelling the authorisation, suspending it and renewing the validity thereof;

2) requirements to be complied with in order to receive an authorisation to use tissues or organs and conditions for the use of tissues and organs;

3) a sample form of the authorisation to use tissues or organs;

4) procedures for the assessment, supervision, and control of the use of tissues and organs.

The State Agency of Medicines shall, according to the price list of the paid services, evaluate the compliance of the medical treatment institution and the higher education institution that implements an accredited medical study programme and a professional development programme of medical practitioners with the requirements laid down for the use of the tissues and organs, and shall also issue an authorisation to use tissues or organs and a duplicate thereof. The State Agency of Medicines shall take the decision on issuing an authorisation or refusal to issue the authorisation within three months after the day of receiving an application.

[21 June 2012; 16 May 2019; 29 October 2020]

Chapter II
Pathological-anatomical and Forensic Examination

Section 5. Provisions for Pathological-anatomical Examination

A pathological-anatomical examination (autopsy) of a deceased human being can be performed if he or she has permitted it during his or her lifetime by making a note in the health information system. If the deceased human being, during his or her lifetime, has prohibited to perform pathological-anatomical examination after his or her death, by making a note in the health information system, it is allowed only in the cases referred to in Section 6.

In cases when the will of a deceased human being expressed during his or her lifetime is unknown and the deceased does not have next of kin, the issue regarding the performance of a pathological-anatomical examination shall be decided by the head of the division of a medical treatment institution if the human being has died in the medical treatment institution, or by the attending physician or the physician who has established the fact of death if the human being has died outside a medical treatment institution.

[16 May 2019 / Amendments to Paragraph one with regard to making a note in the health information system on prohibition or permission to perform a pathological-anatomical examination (autopsy) shall come into force on 1 February 2022. See Paragraph 8 of Transitional Provisions]

Section 6. Pathological-anatomical and Forensic Examination without Taking into Account the Will of a Deceased Human Expressed during his or her Lifetime

A pathological-anatomical examination shall be performed mandatorily without taking into account the will of a deceased human expressed during his or her lifetime if:

1) the possible cause of death is an infectious disease;

2) the cause of death is a disease non-diagnosed or complications of prophylactic measures, medical treatment, or a disease non-diagnosed during his or her life;

3) the weight of a stillborn child exceeds 500 grams.

Forensic examination shall be performed mandatorily without taking into account the will of a deceased human expressed during his or her lifetime if:

1) the weight of a stillborn child exceeds 500 grams;

2) the forensic examination is requested by the performer of an inquiry, investigator, or prosecutor.

[16 May 2019]

Section 7. Establishing the Fact of Death

The procedures for establishing the fact of brain death and biological death and transferral of a deceased human being for burial shall be determined by the Cabinet.

[6 December 2001; 2 June 2004]

Section 7.1 Cremation

A merchant who has received a special permit (licence) has the right to perform cremation - burning of the body of a deceased human being in special furnaces.

The Cabinet shall determine the procedures for licensing merchants for the performance of cremation, and also the procedures by which the State fee for the issuance of a special permit (licence) shall be paid and the amount thereof.

The documents necessary for the performance of cremation of a deceased human being, the procedures for the submission of the documents, and also the procedures for the performance of cremation and keeping of records related thereto, shall be determined by the Cabinet.

[13 November 2008]

Section 8. Forensic Examination

[6 December 2001]

Chapter III
Use of the Body, Tissues, and Organs of a Deceased Human Being

[16 May 2019]

Section 9. Removal of Tissues and Organs during Pathological-anatomical and Forensic Examination

Samples of tissues and organs may be taken during a pathological-anatomical and forensic examination for laboratory diagnostic investigations without taking into account the will of the deceased human being expressed during his or her lifetime. Organs and samples of tissues for scientific research and study purposes may be taken in cases where the deceased human being has permitted it during his or her lifetime, the will of the deceased human being expressed during his or her lifetime is unknown, and also the will of the deceased human being expressed during his or her lifetime is unknown and he or she does not have next of kin.

[16 May 2019]

Section 10. Possibility of Transplantation

Removal of tissues and organs of a deceased human being for the purpose of transplanting them into other human beings for the treatment of diseases and injuries (transplantation) may be performed if the fact of brain death or biological death of the potential donor has been established.

Section 11. Provisions for Transplantation in Case of the Death of a Donor

The next of kin have the right to express to the medical treatment institution (tissue and organ procurement centre) information on the will of the deceased human expressed during his or her lifetime to prohibit or permit the use of his or her body, tissues, and organs after death until the start of the relevant operation of extracting tissues and organs. It is prohibited to use the body, tissues, and organs of a deceased minor unless one of the lawful representatives of the minor has permitted it in writing.

[16 May 2019]

Section 12. Competence of the Cabinet in the Field of the Legal Framework on Use of the Body, Tissues, and Organs of a Deceased Human Being

The Cabinet shall determine the following:

1) procedures for the transplantation of the organs of a deceased human being and also quality and safety standards of the organs of a deceased human intended for transplantation;

2) quality and safety standards for the use of the tissues of a deceased human being;

3) procedures by which the body of a deceased human being is used for medical studies and in professional development programmes of medical practitioners.

In performing a transplantation, the medical treatment institution shall ensure mutual anonymity between the donor and the recipient (the person to whom tissues or organs have been or will be transplanted), except for cases when the donor and the recipient are next of kin.

[21 June 2012; 16 May 2019; 29 October 2020]

Chapter IV
Procurement of Tissues and Organs from a Living Donor

Section 13. Provisions for Removal of Tissues and Organs from a Living Donor

Removal of tissues and organs from a living donor shall be possible only upon his or her written consent, allowing a minimum risk to the health of the donor and notifying the donor of the purpose, nature, consequences, and risk of the respective intervention.

Only tissues with the capacity to restore may be taken from a living donor. Removal of one kidney for the purposes of transplantation shall be permissible in exceptional cases.

[6 December 2001]

Section 14. Use of Tissues and Organs of a Living Donor

The Cabinet shall determine the following:

1) procedures for the transplantation of the organs of a living human being and also quality and safety standards of the organs of a living donor intended for transplantation;

2) quality and safety standards for the use of the tissues of a living donor;

3) procedures by which the tissues and organs of a living human being are used for medical studies and in professional development programmes of medical practitioners.

[21 June 2012; 29 October 2020]

Section 15. Anonymity Between the Donor and the Recipient

In performing a transplantation, medical staff shall ensure anonymity between the donor and the recipient, if they are not next of kin.

[21 June 2012]

Section 16. Inheritance of Blood and Placenta Secreted after Labour

[2 June 2004]

Chapter V
Protection of the Body of Deceased Human Beings, Inadmissibility of Commercial Transactions

Section 17. Protection of the Body of Deceased Human Beings and Use of Human Tissues and Organs in Medicine as the State Function

The protection of the body of a deceased human being and the use of human tissues and organs in medicine shall be the State function implemented by the Ministry of Health.

The Health Inspectorate and the State Agency of Medicines according to their competence shall supervise the compliance of medical treatment institutions and medical practitioners with the requirements of this Law.

[6 December 2001; 2 June 2004; 21 June 2012; 16 May 2019]

Section 18. Prohibition of Commercial Transactions

Removal and use of tissues and organs from the body of a living and deceased human being shall serve for medicine and the development of medicine and it shall be profitless by nature. Any removal of tissues and organs from the body of a living or deceased human being shall be done by strictly respecting the expressed prohibition or permission, and the selection, sending, and use of these tissues and organs as a commercial transaction is prohibited.

[21 June 2012]

Advertising or public distribution of any information which offers tissues or organs of a living or deceased human being for the purpose of gaining financial benefit or equivalent advantage or which expresses interest in obtaining tissues or organs of a living or deceased human being is prohibited. Only information measures to improve public awareness of the need for and importance of donation of human body, tissues, and organs are permitted.

Supervision of the restriction laid down in Paragraph three of this Section shall be performed in accordance with the Advertising Law.

The Health Inspectorate has the right to obligate the distributors of information to stop public distribution of information which offers tissues or organs of a living or deceased human being for the purpose of gaining financial benefit or equivalent advantage or which expresses interest in obtaining tissues or organs of a living or deceased human being. The Health Inspectorate has the right to lay down a term for the execution of the obligation imposed on the distributors of information.

The recipient of the decision of the Health Inspectorate taken when exercising the rights laid down in Paragraph five of this Section may appeal it to the District Administrative Court in accordance with the procedures laid down in laws and regulations. Appeal of the decision of the Health Inspectorate shall not suspend the validity thereof.

[21 September 1995; 6 December 2001; 21 June 2012; 16 May 2019]

Section 19. State Allowance and Reliefs for Donors

A living organ donor has the right to receive the State guaranteed medicinal aid free of charge until the end of his or her life.

[2 June 2004]

Section 20. Liability for Non-compliance with the Law

The natural persons and legal persons who fail to fulfil the requirements of this Law shall be held liable as specified by the Law pursuant to the degree of danger of the offence.

Section 21. Control of the Implementation of this Law

[21 June 2012]

Chapter VI
Application of International Legal Norms

Section 22. Priority of International Legal Norms

If international or cross-border agreements and also conventions, the member state of which is the Republic of Latvia, provide for other provisions than this Law, the international legal norms shall be applied.

Transitional Provisions

[6 December 2001]

1. The note made in the passport of a person until 31 December 2001 regarding the prohibition or permission of the person to use the tissues and organs from his or her body after his or her death shall have legal effect until a new passport is received or a written submission of the person is submitted to the Office of Citizenship and Migration Affairs by which he or she prohibits or permits the use of his or her body or tissues and organs from his or her body after his or her death.

2. The Cabinet shall issue the regulations referred to in Sections 7, 12, and 14 of this Law until 30 November 2004.

[2 June 2004]

3. Until coming into force of the relevant Cabinet regulations, but not later than until 30 November 2004, Order No. 278 of the Ministry of Health of 3 October 2003, Regarding the Use of Tissues and Organs of Deceased Human Beings in Medicine, shall be in force insofar as it is not in contradiction with this Law.

[2 June 2004]

4. Special permits (licences) for the performance of cremation which have been issued to merchants until 30 June 2009 shall be valid until the expiry of the term of validity of the relevant licence, but not longer than until 1 July 2010.

[13 November 2008]

5. Tissue procurement and storage centres included in the register of tissue procurement and storage centres before 26 August 2012 are entitled to use tissues and cells until the end of the term specified in the register, but not later than until 26 August 2013.

[21 June 2012]

6. Amendments to Section 2, Paragraphs two and three and Section 4, Paragraph one of this Law with regard to making a note in the health information system on prohibition or permission to use the body, tissues, and organs of the deceased human being after death shall apply from 1 February 2022. Until 31 January 2022, the will of a person to prohibit or permit the use of his or her body, tissues, and organs after death shall be recorded in the Population Register by submitting an application to the Office of Citizenship and Migration Affairs. Until 31 January 2022, the medical treatment institution (tissue and organ procurement centre) has an obligation to clarify the will of the deceased human being expressed during his or her lifetime to prohibit or permit the use of his or her body, tissues, and organs after death, by looking into the Population Register.

[16 May 2019; 29 October 2020]

7. The deletion of Section 3, Paragraphs one and three of this Law shall come into force on 1 February 2022.

[16 May 2019]

8. Amendments to Section 5, Paragraph one of this Law with regard to making a note in the health information system on prohibition or permission to perform a pathological-anatomical examination (autopsy) shall come into force on 1 February 2022.

[16 May 2019; 29 October 2020]

Informative Reference to European Union Directives

[21 June 2012]

The Law contains legal norms arising from:

1) Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells;

2) Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation.

Chair of the Supreme Council of the Republic of Latvia A. Gorbunovs

Secretary of the Supreme Council of the Republic of Latvia I. Daudišs

Rīga, 15 December 1992


1 The Parliament of the Republic of Latvia

Translation © 2022 Valsts valodas centrs (State Language Centre)

 
Document information
Title: Par miruša cilvēka ķermeņa aizsardzību un cilvēka audu un orgānu izmantošanu medicīnā Status:
In force
in force
Issuer: Supreme Council Type: law Adoption: 15.12.1992.Entry into force: 01.01.1993.Theme: Healthcare, pharmacyPublication: Latvijas Republikas Augstākās Padomes un Valdības Ziņotājs, 1/2, 14.01.1993.; Diena, 4, 08.01.1993.
Language:
LVEN
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