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)
