What is Act No. 285 / 2002 Coll.?

Act No. 285 / 2002 Coll., on Donation, Collection and Transplantation of Tissue and Organ and on the Amendment of Certain Laws (Transplant Act) — Law on donation, collection and transplantation of tissues and organs and on the modification of certain laws (transplant law).

When it became Act No. 285 / 2002 Coll. effectiveness?

Act No. 285 / 2002 Coll. became effective 01.09.2002.

Is Act No. 285 / 2002 Coll. still valid?

Yes, Act No. 285 / 2002 Coll. is still valid and effective.

How many times was it Act No. 285 / 2002 Coll. amended?

Act No. 285 / 2002 Coll. has 20 time versions of the text.

Act No. 285 / 2002 Coll. - Law on donation, collection and transpla...

285

THE LAW

of 30 May 2002

on donation, collection and transplantation of tissues and organs and on amending certain laws (transplant law)

Parliament has decided on this law of the Czech Republic:

ČÁST PRVNÍ

DONATION, COLLECTION AND TRANSPLANTATION OF THE PRESSURE AND AUTHORITIES

HLAVA I

GENERAL PROVISIONS

§ 1

Subject matter

(1) This Act implements the relevant provisions of the European Union21 and lays down rules for ensuring the quality and safety of human organs (hereinafter referred to as the "Authority") intended for human body transplantation in order to ensure a high level of human health protection, in their donation, investigation, characterisation, collection, preservation, transport and transplantation.

(2) This law further regulates the conditions of donation, collection and transplantation of tissues, cells and organs carried out solely for the provision of medical services (1). When it comes to the quality and safety of tissues and cells, the law governing human tissues and cells7a is followed.

§ 2

Basic concepts

For the purposes of this Act:

(a) an organ of a separate and viable part of the human body consisting of a structured arrangement of different tissues to preserve its structure, vascular supply and the ability to perform physiological functions with a significant degree of autonomy; part of an organ shall also be considered as an organ if it is to serve the same purpose as the whole organ in the human body, while maintaining the requirements for structure and vascular supply,

(b) tissues and cells of the building component of the human body, including relics obtained from surgical operations, haematopoietic cells derived from bone marrow, peripheral and cord blood, excluding organs, blood and its components, sex cells, embryonic and foetal tissues and organs, hair, nails, placenta and waste products of body metabolism (hereinafter referred to as "tissue"),

(c) a possible donor to a patient who, in view of his health, is expected to die and be able to collect tissue or organ or the body of a deceased person who has been proven to have died and who is expected to be able to collect tissue or organ;

(d) by donor, the person who donates the organ or tissue, whether the donation takes place during or after the life of the person;

(e) death, irreversible loss of function throughout the brain, including brain stem, or irreversible arrest of blood circulation,

(f) the candidate is a person registered in the National Register of Persons Waiting for Organ Transplants;

(g) the recipient of the person receiving the transplanted organ or tissue;

(h) by taking all the procedures necessary to obtain tissues or organs intended for transplantation, including an examination to assess the health of the donor and prepare for collection;

(i) donation of organ or tissue for transplantation,

(j) the transplantation process to restore specific functions of the human organism by transferring the organ or tissue from the donor to the recipient's body;

(k) characterisation of the donor by collecting relevant information on the donor characteristics needed to assess its medical fitness for organ or tissue donation in order to carry out an appropriate assessment and minimisation of the risk to the recipient and optimisation of the organ allocation;

(l) characterisation of the organ by collecting relevant information on the organ characteristics needed to assess its suitability for transplantation in order to assess and minimise the risk to the recipient and optimise the organ allocation;

(m) preserving the use of chemicals, changes in ambient conditions or other means to prevent or slow down biological or physical damage to the organ during the period from collection to transplantation;

(n) a serious adverse reaction of any adverse and unexpected event related to the donation, investigation, characterisation, collection, preservation or transport of an organ for transplantation and transplantation of an organ that could lead to the transmission of a communicable disease, to death or to life-threatening, harm to health or limitation of the ability of the patient, or which could cause or prolong its hospitalisation or disease;

(o) a serious adverse reaction of an unexpected response by a living donor or recipient, including a communicable disease that could be related to the donation, investigation, characterisation, collection, preservation or transport of an organ intended for transplantation and the transplantation of an organ that results in death, life hazard, health damage or impairment of abilities, or results in or prolong its hospitalisation or disease;

(p) working procedures, written instructions describing the stages of the process from donation to organ transplantation, including materials and methods to be used, and the expected overall result;

(q) traceability possibility

1. identify the place where the authority is located and identify it during each stage of treatment and identify the place of its liquidation,

2. identify the living or deceased donor;

3. identify the health service provider that has performed the organ procurement;

4. identify the recipient in the transplant centre; and

5. find and identify all necessary data concerning products and materials that come into contact with the authority;

(r) a person close to a relative in a direct line, a spouse, a registered partner, a sibling or a person married at the first stage of the relationship.

HLAVA II

COLLECTION AND AUTHORITIES

Díl 1

Tissue and organ removal from living donors

§ 3

Admissible tissue and organ collection from a living donor

(1) The collection of tissues or organs (hereinafter referred to as "collection") from a living donor, unless otherwise specified, may be carried out only if:

(a) is carried out solely in the interests of the therapeutic benefit to the recipient;

(b) no appropriate tissue or organ from the deceased is available at the time of collection and no other treatment method of comparable effect exists;

(c) the donor is a person capable of giving free, informed and specific consent in the manner laid down by this law (§ 7) and has actually given such consent; and

(d)

1. part of an organ capable of regeneration or adaptation ("renewable tissues"),

2. one of the functional couple's organs; or

3. The uterus as regards the treatment of infertility caused by a dysfunctional or missing uterus.

(2) The collection of organs from a living donor, unless otherwise specified, may be carried out in favour of a recipient who:

(a) is a person close to the donor if the donor has given free, informed and specific consent (§ 7) to that person;

(b) is not a person close to the donor, only on condition that:

1. the donor has demonstrated explicitly the will to donate its organ to the recipient; the explicit expression of will (hereinafter referred to as "expression ') must be made in writing and have an officially certified signature of the donor; the statement is an integral part of the donor's medical documentation,

2. The Ethics Commission has agreed to this donation in accordance with Article 5 (5) (a).

(3) Collection from a living donor may not be carried out if:

(a) it may reasonably be assumed that the execution of the collection could seriously jeopardise the health or life of the donor;

(b) the donor is a person who is in the exercise of a prison sentence or in custody or in the exercise of security detention or protective treatment, except for donation between children and parents, siblings and between spouses; or

(c) there are reasonable grounds for suspecting that the donor is suffering from a disease or condition likely to endanger the health or life of the recipient, based on an assessment of the health of the donor. This does not apply if the risk of injury to the recipient is negligible compared to life saving transplantation. The conditions for the prevention of infection with the human immunodeficiency virus are laid down in specific legislation. 4)

§ 4

Protection of persons who have not acquired full capacity, persons with limited capacity and persons who are unable to consider any consequences of carrying out the collection of renewable tissue for their own health in view of their current health

(1) Donors who are persons who have not acquired full incapacity or persons with limited incapacity (hereinafter referred to as "persons who are not fully incompetent") or persons who have given their consent but with regard to their current state of health, it can reasonably be assumed that, despite the full instruction, they have not considered or could not consider any consequences associated with the collection of renewable tissue for their own health (hereinafter referred to as "person unable to consent"), only the collection of renewable tissue may be carried out, unless otherwise specified, only if:

(a) there is no suitable donor able to give explicit and specific consent;

(b) the recipient is the donor's sibling,

(c) donation represents the possibility of saving the life of the recipient;

(d) a legal representative of a donor who is a person who is not fully self-employed has given his consent to this collection pursuant to Article 7 (4);

(e) the Ethics Commission has given its assent to this collection in accordance with Paragraph 5 (5) (b); and

(f) this donor does not show any opposition.

(2) The provisions of paragraph 1 (b) and (c) do not apply to the collection of cells where such collection represents only a minimum risk to the health and life of the donor.

§ 5

Ethics Committee

(1) The Ethics Commission is an independent commission established and repealed by the statutory body of the health service provider carrying out the procurement of a donor body for the benefit of a recipient who is not close to it (§ 3 (2) (b)) or renewable tissue to persons who are not fully competent or unable to give consent (§ 4). The Ethics Committee may be established as a permanent commission or, as appropriate, on individual cases.

(2) The Ethics Committee shall have at least five members; is made up of doctors, one clinical psychologist and a lawyer. At least two thirds of the members of the Ethics Commission shall not be in employment or similar relations with the health service provider referred to in paragraph 1. The Chairman and other members of the Ethics Commission shall be appointed and withdrawn by the statutory body of the health service provider in which that committee was established. The Chairman and members of the Ethics Commission in the performance of the work of the Ethics Committee shall not be bound by the instructions of the statutory body of the health service provider or by the instructions of other heads of staff of the health service provider. Only natural persons without personal interest or participation in the collection process may be members of the Ethics Committee.

(a) an authority in favour of a recipient who is not a person close to the donor or for a transplant of that authority;

(b) renewable tissue to a person who is not fully competent or unable to give consent or to a transplant of such tissue.

(3) The members of the Ethics Commission are required to maintain confidentiality of all facts which they have learned in connection with the performance of their duties, except where they communicate such facts with the consent of a donor, recipient or legal representative of a person who is not fully independent or on the basis of an exemption from compulsory secrecy. The facts may be communicated, with the consent of the persons mentioned in the sentence first, in such a way that information on other persons cannot be obtained from them and that anonymity between the donor and the recipient is respected (§ 20). Special legislation shall apply in order to exempt members of the commission, 1) which lays down the rights and obligations of health professionals in the provision of health services. The activities of the members of the Ethics Commission are another act of general interest in which the staff member is granted leave of absence with compensation for the salary of the average wage (7) to the extent strictly necessary.

(4) The meetings of the Ethics Committee shall be chaired by the President. The Ethics Committee shall act by a majority of its members. In the event of a tie, the chairman shall vote.

(5) The Ethics Committee, on a written request submitted by the statutory body of the health service provider set up by the Commission, grants written consent or disapproval to carry out the collection

(a) a donor body to a beneficiary who is not close to him;

(b) renewable tissue to a person who is not fully competent or unable to give his consent.

The granting of consent or the expression of opposition shall be part of the medical file of the person who intends to donate the organ or tissue, the donor, the person who is not fully qualified or unable to give consent. The Ethics Committee shall send a copy of the instrument to the Coordination Centre of Transplants within 7 days of the consent or expression of opposition.

(6) The request for consent must include:

(a) information on the health status of the donor, a person who is not fully competent or unable to give consent which is relevant for the assessment of the possible collection of renewable tissue;

(b) a statement by a clinical psychologist of the ability of a person who is not fully competent or unable to give consent to comment on a request from a medical doctor assessing the medical fitness of that person;

(c) information on the health status of the recipient of the body or of the renewable tissue;

(d) a copy of the full instruction and informed consent of the donor of the organ or legal representative of the donor (§ 7 (1) and (2)), or, where appropriate, the expression of a person who is not fully qualified (§ 7 (6)),

(e) a copy of the complete instruction and consent of the person unable to give his consent;

(f) a copy of the donor's statement made pursuant to Article 3 (2) (b); and

(g) the period by which the Ethics Committee is obliged to give consent or disagreement to the removal of the donor body or of the renewable tissue of a person who is not fully competent or unable to give consent.

(7) Where necessary, the Ethics Committee may invite a person who is not fully competent or, where appropriate, that person to negotiate the consent or non-consent of a donor of an organ or legal representative. The Ethics Commission will always invite

(a) a person who is not fully incompetent, in the event that the clinical psychologist stated in his observations that he was able to express himself to be taken;

(b) a person unable to give his consent;

(c) a donor to the body referred to in Article 3 (2) (b); In this case, in addition to the health aspects, the Ethics Committee also ascertains and assesses the reasons that led the donor to donate the organ.

(8) The Ethics Committee shall, in the event of the consent referred to in paragraph 5, supervise the collection and maintenance of donor rights, a person who is not fully competent or unable to give consent.

(9) The Ethics Committee shall keep a significant record of its activities, in particular written working procedures, a list of members, stating their competence, submitted applications and supporting documents, minutes of meetings, reports and correspondence concerning its activities and the assessment of applications for at least 10 years, for the health service provider with which it is established. In the event of the disappearance of the Ethics Commission, the statutory authority of the health service provider in which the Ethics Committee was established shall ensure proper preservation of the documentation.

§ 5a

If the uterus is taken for the benefit of a recipient who is close to a living donor, Section 5 shall apply mutatis mutandis.

§ 6

Assessment of the medical fitness of a living donor

(1) Prior to collection from a living donor, its fitness to donate tissue or organ shall be assessed. To this end, medical examinations and procedures shall be carried out to assess the health of the living donor and the potential risks to the health and life of the donor associated with the donation of tissue or organ. At the same time, procedures shall be established to limit the risks to the health and life of the donor, which constitutes the removal of the tissue or organ for him without compromising the quality and viability of the tissues or organs collected. An integral part of the donor medical assessment is the characterisation of the donor and the characterisation of the organ.

(2) The donor health assessment for organ donation shall be carried out under the responsibility of the recipient health service provider. In the case of tissue donation, the assessment of donor medical fitness shall be carried out according to the Human Tissue and Cell Act 7a).

(3) The assessor shall record the assessment of donor medical fitness with a definition of the extent of the assessment and a conclusion on the eligibility or incapacity of the donor to be taken. This entry confirmed by the signature of the judging physician and the date is an integral part of the donor's medical documentation. The assessor shall, within 7 days of the assessment of donor medical fitness, send a statement of the medical documentation to the extent of the record according to the sentence of the first Coordination Centre of Transplants.

(4) The health service provider that made the procurement will ensure that the donor provides preventive health care.

(5) The Ministry of Health (hereinafter referred to as "the Ministry of Health") of the Ministry of Health (hereinafter referred to as "the Ministry") of the Ministry of Health (hereinafter referred to as "the Ministry") provides for closer conditions for the assessment of medical fitness, the extent of the examination of the living organ donor and the extent of the data needed to characterise that donor and to characterise the organs from that donor.

(6) The donor or legal representative of a person who is not fully incompetent, if the donor is that person, may ask another doctor who is not involved in the collection or in other procedures associated with the transplantation to assess the health risks of the collection for the donor. The provisions of paragraphs 1 to 5 shall not apply to this assessment.

§ 7

Full lessons and consent

(1) A physician assessing the medical fitness of a living donor is required to provide the donor with full guidance on the purpose, nature and consequences of the donation of tissue or organ and on the potential risks associated with it, including the long-term risks. Where a donor is a person who is not fully incompetent, he shall provide such advice to his legal representative. The lessons must be understood. The donor and legal representative of a person who is not fully competent shall have the right to ask questions, to the extent set out in the first sentence, and the doctor shall answer them. The lesson also includes the provision of information on the rights and protection of the donor provided for by this law.

(2) A donor and a legal representative of a person who is not fully qualified may require that another witness be present at the hearing. They shall be informed in advance of this possibility by the physician providing full guidance. The doctor shall record the completion of the complete instruction with its concise content and shall sign all persons involved, indicating the date on which the instruction was made. A record of the full instruction of the donor or legal representative of a person who is not fully qualified is an integral part of the donor's medical documentation.

(3) The doctor responsible for the collection shall repeat the full instruction immediately before the collection is carried out under the conditions laid down in paragraph 1.

(4) The consent of a donor or legal representative of a person who is not fully arbitrary on the basis of the full instruction referred to in paragraph 1 must be free, informed and specific. It shall be carried out in writing, signed and dated and shall be based on donor medical documentation. Part of the consent expressed in connection with tissue collection is the definition of the purpose of its use.

(5) The donor or legal representative of a person who is not fully competent may withdraw his consent at any time. The medical practitioner shall respect this appeal if it has not been carried out in the collection of irreversible acts the interruption of which would pose a risk to the health or life of the donor.

(6) Where persons who are not fully competent are able to sufficiently understand the consequences of the execution or non-execution of the collection for themselves or for the recipient, full guidance shall be provided. If the person mentioned in the first sentence disagrees with the donation, that disagreement must be respected.

(7) The health service provider, if consent is given in relation to the collection of tissues, shall provide a copy of that consent or, where appropriate, its modification, to the tissue establishment (7a) to which it transmits the tissues. A copy of the consent to the original shall be confirmed by the donor health service provider.

§ 8

Condition of sampling from living donor

(1) The collection of an organ from a living donor may only be carried out for the benefit of the person designated by the donor (§ 3 (2)). If a living tissue donor makes their collection conditional on a given person's donation, such collection may only be made for the benefit of that person.

(2) In the case where the tissue or organ collected cannot be implanted to a designated person, the donor's consent shall be requested before the collection is carried out, for use by that tissue or organ for another person. The reasons which led the competent physician to decide that the tissue or organ collected cannot be implanted by a donor to a designated person shall be recorded in the donor's medical documentation and in the donor's designated person.

§ 9

Transplant tissues or organs collected for reasons other than transplantation

(1) If tissue or organ has been removed from the patient for a reason other than transplantation, the recipient may only be implanted if the patient has been instructed about the consequences and potential risks of this removal and has given consent to their use for the transplant before or after removal of the tissue or organ.

(2) Paragraph 7 shall apply mutatis mutandis in the course of the training and obtaining consent referred to in paragraph 1.

Díl 2

Collection from deceased donors

§ 10

Acceptance of collection from a deceased donor and the necessity of finding death

(1) Collection from a deceased donor may only be carried out if death has been detected. Should the removal from the deceased donor be carried out before the expiry of 2 hours after the detection of death, such collection may be carried out not earlier than after the signature of the protocol referred to in paragraph 2. Physicians who detect death shall not take part in the collection of the deceased donor or transplant and shall not be the treating physician of the intended recipient.

(2) The detection of the death of a potential donor shall always be carried out by at least two doctors with appropriate specialised competence who examined the donor independently of each other. The detection of the death of a potential donor shall be recorded in the protocol, which is an integral part of the donor's medical documentation, in the case of anticipated collection before 2 hours after that finding. The death report will be signed by doctors who discovered death.

(3) Death [§ 2 (e)] is ascertained by proof

(a) irreversible pledges of blood circulation; or

(b) irreversible loss of brain function, including brain stem, where respiratory or blood circulation functions are maintained artificially (brain death).

(4) If death is detected by evidence of irreversible blood circulation, the collection may be carried out before 2 hours after the detection,

(a) if the time of detection of death is known, and if death has been detected in a medical facility

1. in intensive care unit,

2. the anaesthesia-resuscitation department,

3. in the operating room,

4. to the reception ambulance of the ward or the hospital reception department,

(b) if death has been detected on the basis of an end to unsuccessful resuscitation.

(5) Brain death is demonstrated if

(a) the patient is in a state by which a diagnosis of brain death can be considered; and

(b) clinical signs of death of the patient's brain can be demonstrated, on the basis of which a diagnosis of brain death can be established, supplemented by an examination confirming the irreversible death of the brain.

(6) The condition on the basis of which diagnosis of brain death can be considered, clinical signs of brain death of the patient, on the basis of which diagnosis of brain death can be established, testing is proving and testing confirming the irreversible death of the brain are listed in the Annex to this law.

(7) The Ministry shall determine the extent of the data needed to characterise the deceased donor and to characterise the organs from the deceased donor, the formalities and model of the death report and the specialised competence of the medical practitioners investigating death and of the medical examiners carrying out the examination confirming the irreversible death by decree. The Ministry may lay down detailed conditions on the manner in which the examination of evidence of death is carried out, the examination of the irreversible nature of the blood circulation or death of the brain and the conditions under which it is carried out by decree.

§ 10a

Acceptance of collection from a deceased donor who is a stranger

(1) Aliens 9) which may be expected to collect tissues or organs under this Act may be collected if the alien holds a valid document of consent to donate tissues or organs to be donated to him by the competent authority of the State of which the alien is a citizen (the donor card).

(2) If there is a stranger who does not hold a donor card and who can be expected to collect tissues or organs under this law, the health service provider shall ask a person close to a stranger if he is aware that:

(a) Alien

1. did not express the will to oppose post-mortem tissue or organ sampling; or

2. agree to the donation of tissues or organs, if the principle of presumed opposition is applied in the State of which he is a citizen; and

(b) agree to the postmortem collection of tissues and organs from a stranger.

(3) Where, in accordance with the procedure referred to in paragraph 2, a health service provider finds that a removal from a stranger may be carried out, it shall also ensure that the obligation under Article 15 (1) is fulfilled.

(4) If the health service provider cannot make a query pursuant to paragraph 2 directly to a person close to a stranger referred to in paragraph 2, it shall, on its initiative, identify the Coordination Centre of Transplants

(a) with the competent authority of the State of which the alien is a citizen, the information referred to in paragraph 2 (a); and

(b) at the diplomatic mission or consular post of the State of which the alien is a citizen, contact with a person close to a stranger.

The coordination centre of transplantation shall immediately transmit contact to a person close to and identified information to the health service provider.

(5) Where the facts established in accordance with paragraph 4 (a) permit the removal from a stranger, the provider of health services shall establish with a person close to a stranger whether he agrees to the post-mortem collection of tissues and organs from that stranger and, in the case of consent, ensure that the obligation under Article 15 (1) is fulfilled.

(6) The statement of close proximity and the information from the competent authority of the State of which the alien is a citizen shall be recorded in the medical documentation of the alien in accordance with paragraph 4 (a).

(7) If, within 72 hours, a health service provider does not receive information on the facts referred to in paragraphs 2 or 4 and 5, or if it is unable to inform a person close to a stranger referred to in paragraph 2, as referred to in Article 15 (1), the conditions for withdrawal shall be deemed not to be met.

§ 11

Inadmissibility of collection from a deceased donor

(1) Withdrawal from the deceased donor is excluded if:

(a) the deceased, in his lifetime or the legal representative of the deceased, who was a person who was not fully incompetent, has shown his opposition to post-mortem tissue and organ collection (§ 16);

(b) it cannot be excluded, on the basis of a medical assessment, that the deceased has suffered from a disease or condition which could endanger the health or life of the recipient; the medical assessment of the deceased organ donor is the responsibility of the procurement health service provider; in the case of tissue donation, the assessment of the medical fitness of the deceased donor shall be carried out according to the law governing human tissues and cells; or

(c) the deceased cannot be identified.

(2) The assessor shall record the medical assessment of the deceased donor with a definition of the extent of the assessment and a conclusion on the eligibility or incapacity of the deceased donor to be taken. This entry with the date of the assessment, confirmed by the signature of the judging physician, is an integral part of the medical file of the deceased donor.

(3) The closer medical assessment conditions and the extent of the examination of the deceased organ donor are laid down by the Ministry by decree.

§ 12

Selected tissues and organs

(1) The doctor who has collected the tissue or organ shall record the list of tissues and organs collected and the intended purpose of their use in the donor's medical documentation.

(2) Health service providers involved in the collection and transplantation of organs or tissues from and transplants of the deceased shall inform each other without delay of the additional findings of the medical incompetence of the deceased donor, and shall inform the Coordination Centre of transplantation without delay to the same extent.

(3) The tissues collected under the law governing the management of human tissues and cells not used for transplantation can only be passed on to the tissue bank for further examination, processing, preparation, preservation, storage and distribution.

§ 13

Autopsy

(1) An autopsy shall always be carried out on the body of the deceased in accordance with specific legislation. 10)

(2) The autopsy of the deceased who has been collected shall be carried out as short as possible so that, in the event of an additional finding that the deceased has suffered from a disease or condition which could endanger the health or life of the recipient, the conclusion on the medical incompetence of the deceased may be reached.

(3) In the event that a doctor performing the examination of the deceased suspects that the death occurred in unclear circumstances or violent deaths, including suicide or murder, may be collected only on condition that the purpose of the autopsy ordered under a specific legislation is not undermined. 11) At the same time, it is necessary to carry out an examination of the tissue or organ collected for further investigation, as well as the part of the body from which it was collected so that the result of the examination can be part of the autopsy protocol.

(4) If, on the basis of the results of that autopsy, a doctor who has performed an autopsy finds that the deceased has suffered from a disease or condition which could endanger the life or health of the recipient, he shall immediately notify the health service provider who carried out the collection of the tissue or organ. If, following an autopsy, an additional detection of the medical incapacity of the deceased donor has been made and the organ or tissue collected from that donor has already been transplanted, the provider of the health services that performed the transplant shall immediately take precautionary measures to prevent the life or health of the recipient, or ensure that the recipient receives the necessary health care, and shall notify the Coordination Centre without delay of the transplantation.

§ 14

Respect for the human body

The body of the deceased shall be treated with due respect when performing the collection of the deceased and the autopsies and all operations shall be carried out in such a way that the body can be adapted to its original appearance.

Díl 3

Communication of the intended collection to a close person and disagreement with the postmortem sampling

§ 15

(1) The treating physician of a patient who may be expected to receive tissues or organs under this Act shall, in an appropriate manner, notify persons close to him, unless otherwise specified by the patient (hereinafter referred to as "the designated person"), the intended option, provided that the designated person shows an interest in the patient and the patient has not, in his life, stated a prohibition on communicating information on his or her health. If the patient referred to in the sentence is the first person who is not fully self-employed, the doctor shall inform his / her legal representative of the possibility of receiving and, at the same time, shall instruct him / her of the possibility of expressing a demonstrable disagreement with the sampling provided for in Article 16 (1) (c). In this case, the condition of the patient's interest does not apply. The treating physician shall at the same time explain to the designated persons and, where appropriate, to the legal representative the extent and purpose of the intended collection, while respecting the anonymity of the recipient. The designated persons and, where appropriate, the legal representative shall have the right to ask questions, with the exception of a question to the recipient. If the designated person or, where appropriate, the legal representative refuses to explain in accordance with the fourth sentence, the attending physician shall respect his refusal and record this in the patient's medical file.

(2) In the case of a deceased who may be expected to receive tissues or organs under this law, he shall provide information and, if the deceased is a person who is not fully qualified, also a lesson, as referred to in paragraph 1, by a doctor authorised by the statutory authority of the health service provider in which the deceased is located.

(3) The information submitted under paragraph 1 shall be provided by the physician in the patient's or the deceased's medical file.

§ 16

(1) Withdrawal from the body of a deceased person may be effected only if the deceased has not demonstrated his or her opposition in his or her lifetime or the legal representative of a person who is not fully arbitrary. Non-consent shall be deemed to be demonstrably pronounced if:

(a) the deceased is registered in the National Register of Persons not in agreement with post-mortem tissue and organ sampling; or

(b) the deceased, while still alive, in a medical facility in front of the attending physician and one witness, declares that he does not agree to be taken in the event of his death; or

(c) a legal representative of a person who is not fully independent in a medical institution before the attending physician and who declares that he does not agree to the removal; Such a declaration may be made in the event of the death of a person who is not fully competent in his or her lifetime or after the death of that person.

2. (b) or (c) the entry forming part of the health file shall be made without delay. This entry shall be signed by the patient, the attending physician and the witness, and, if the patient cannot sign with regard to his medical condition, another witness shall confirm his will. In the case of a person who is not fully independent, the registration of his / her legal representative and of the attending physician or, where applicable, the doctor referred to in Article 15 (2) shall be signed. The date and time of the declaration shall also be indicated in the minutes. A copy of the declaration referred to in paragraph 1 (a). (b) or a copy of the declaration made in the event of death referred to in paragraph 1 (b). (c) the health service provider shall be obliged to send to the National Register of Persons not in agreement with post-mortem tissue and organ sampling within 3 days of its listing.

(3) If it has not been demonstrated that the deceased has expressed a demonstrable opposition to the post-mortem sampling in his lifetime, he agrees to the sampling.

Date of Promulgation	28.06.2002
Effective from	01.09.2002
Effective until	-
Status	Valid

Act No. 285 / 2002 Coll.

Law on donation, collection and transplantation of tissues and organs and on the modification of certain laws (transplant law)

Contents