The Transplant Law

Original Language Title: transplantační zákon

Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=53599&nr=285~2F2002~20Sb.&ft=txt

285/2002 Sb.



LAW



of 30 March 2004. May 2002



for a donation, subscriptions and transplantation of tissues and organs and amending

Some laws



(the transplant law)



Change: 228/2005 Sb.



Modified: 296/2008 Sb.



Change: 129/2008 Sb.



Change: 41/2009 Sb.



Change: 281/2009 Sb.



Change: 375/2007 Sb.



Change: 44/Sb.



Parliament has passed the following Act of the United States:



PART THE FIRST



THE DONATION, SUBSCRIPTIONS AND THE TRANSPLANTATION OF TISSUES AND ORGANS



TITLE I OF THE



GENERAL PROVISIONS



§ 1



The subject of the edit



(1) this Act incorporates the relevant provisions of the European Union ^ 21) and

lays down rules to ensure the quality and safety of human organs

(hereinafter referred to as the "authority") intended for transplantation into the human body for the purpose of

ensure a high level of protection of human health, and that when their

the donation, testing, characterisation, sampling, preservation, transportation and

transplant.



(2) this Act also governs the terms of the donation, donations and transplantation

of tissues, cells and organs carried out solely for the purpose of providing

health services ^ 1). With regard to the quality and safety of tissues and cells,

proceed according to the law governing human tissues and cells ^ 7a).



§ 2



Basic concepts



For the purposes of this Act, means the



and a separate and viable) part of the human body, formed by

a structured arrangement of various tissues, which has zachovánu its

structure, blood supply and capacity to develop physiological functions with

an important level of autonomy; the authority shall also be considered as part of the authority,

where in the human body serve the same purpose as the entire organ, when

keeping the requirements on structure and blood supply,



b) tissues and cells of human body parts, including the remains of the

obtained for surgical operations, blood-forming cells derived from

bone marrow transplantation, peripheral and umbilical cord blood, with the exception of the organs, blood and

of its constituents, ^ 2) cells, embryonic and foetal tissues and

organs, hair, nails, the placenta and the waste products of any bodily

metabolism (hereinafter referred to as "tissue"),



(c) the possible donor patient) where, with regard to his health

death and assumes the possibility of tissue or organ, or the body of the deceased

of the person which has been demonstrated by the death and that foresees the possibility of subscription

tissue or organ,



d) donor, the person who donates body or tissue, whether to donate an

during the life of this person or after her death,



(e) the death of the irreversible loss of function) of the entire brain, including the brain stem,

or irreversible collateral blood circulation,



(f) a person registered in an expectant) National Register of persons waiting to

organ transplantation,



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



(h) the collection of all procedures required) for obtaining the tissues or organs intended

for a transplant including examination in order to assess health

eligibility of donors and its preparation for the collection,



I) the donation of the organ or tissue donation for transplantation,



j) process to restore transplant-specific functions

the human organism by transferring the organ or tissue from a donor into the body

the recipient,



donor characterisation Assembly) relevant information on the

the characteristics of the donor needed to assess its

medical certificate for donation organ or tissue for the purpose of

the implementation of proper assessment and minimisation of risks for the recipient and

optimization allocation of authority



l) characterizing the institution gathering relevant information about

the characteristics of the institution, which are needed to assess its

suitability for transplantation in order to assess and minimise the risk of

for the recipient and optimise the allocation of authority



m) preservation using chemical agents, alterations in environmental conditions or

other means in order to prevent biological or physical

damage to authority or a slowdown of such damage from the time of collection to the

transplantation,



n) serious adverse event any adverse and unexpected

events related to the donation, procurement, testing, characterisation,

preservation or transporting the body designated for transplantation and

Transplant authority, which could lead to the transmission of a portable

the disease, to death or life-threatening, damage to health or

restrictions for patients or which might result in, or

extend the period of hospitalization or illness,



o) serious adverse reaction an unexpected response of the living donor or

the recipient, including a portable diseases that could be related to

the donation, procurement, testing, characterisation, preservation or

transporting the body designated for transplantation and transplantation authority that

results in death, life-threatening, damage to health or restrictions

ability or will result in, or prolong, hospitalisation or his

disease,



p) workflows written instructions describing each stage of the

the process from donation after an organ transplant, including the materials and methods

to be used, and the expected overall result,



q) traceability option



1. determine the place where the institution is located, and identify it during each

stage of treatment with him, and find out whether or not the place of disposal,



2. identify a living or deceased donor,



3. identify the providers of health services, which carried out the subscription

authority,



4. key in the recipient's transplant center and



5. find and identify all the necessary data about products and

materials that come into contact with the body,



r) person a relative in the ascending line, the spouse, registered partner,

sibling, or the person sešvagřená.



TITLE II



COLLECTION OF TISSUES AND ORGANS



Part 1



Tissue and organs from living donors



§ 3



The admissibility of the collection of tissues and organs from a living donor



(1) subscription to the tissues or organs ("subscription") from a living donor, if

Additionally, unless otherwise specified, you can only do this if



and) is done solely in the interest of treatment benefit for recipients



(b)) at the time the subscription is not available suitable tissue or organ from a deceased

the donor and there is no other treatment method of equivalent effect,



(c) the person is an eligible donor) is put in the manner prescribed by this Act

a free, informed and specific consent (section 7), and this consent

actually said, and



(d)) this is a renewable tissue, or one of the paired organs function.



(2) the organ from a living donor, unless otherwise specified,

You can do this for the benefit of the recipient who



a) is close to the donor if the donor expressed a free, informed

and specific consent (section 7) in relation to that person,



(b) a person who is close to the donors), only under the conditions that



1. the donor expressly manifested a provable way will give your

authority of the recipient; the explicit expression of the will (hereinafter referred to as "observations") must

be made in writing and must have a certified signature of the donor; representation is

an integral part of the medical records of the donor,



2. with this donation in favour of the Ethics Committee pursuant to § 5 para. 5 (b). and)

consent.



(3) Subscription from living donors cannot be performed if the



a) can reasonably be expected that the subscription could serious

way to endanger the health or life of the donor,



(b)) is the donor a person located in the imprisonment or

in custody in the performance of security detention or in a protective treatment, with

the exception of organ donation among children and parents, siblings and spouses,

or



(c)) was established on the basis of an assessment of the medical fitness of the donor have reasonable

the suspicion that the donor is suffering from the disease or condition that might endanger

the health or life of the recipient. This does not apply if the health risk

the recipient is negligible compared to the life-saving

transplantation. Conditions for the prevention of human immunodeficiency virus infection

lays down specific legislation. ^ 4)



§ 4



Protection of minors, persons deprived of legal capacity

and persons with regard to their current health status, are not

able to consider all the consequences of the implementation of renewable tissue sampling for

your own health



(1) from the donors, who are minors, ^ 5) persons with reduced

competences the legal capacity or a person deprived of legal

capacity in full ^ 6) (hereinafter referred to as "detainee") or

persons who have expressed agreement with the collection, but with regard to their

the current state of health can reasonably be expected, despite the full

lessons to assess or not to consider all the consequences associated with

the collection of renewable tissue for own health (hereinafter referred to as "the person incapable

agree "), you can perform subscription-only renewable tissues, if it is not

unless provided otherwise below, and only if



and) there is no suitable donor who is able to give an express and

specific consent,



(b) the recipient is a sibling of the donor),



(c)) is the ability to life-saving donation recipient,



(d)) the legal representative of the donor, which is a minor or a person exempt from

competence, pursuant to § 7 para. 4 with this subscription agreement,



(e) the Ethics Committee voted, according to) § 5 para. 5 (b). (b)) with this collection

consent, and



(f)) this does not occur with a donation by the donor.



(2) the provisions of paragraph 1 (b). (b)), and (c)) shall not apply to cells,


If this subscription is only a minimal risk to health and life

the donor.



§ 5



The Ethics Committee



(1) the Ethics Committee is an independent Commission, which establishes and repealing

the statutory body of healthcare providers performing subscription

organ donors for the benefit of the recipient who is not his person [section 3

paragraph. 2 (a). (b))], or a renewable tissue minors, persons

deprived of their competence or persons unable to consent (section 4).

The Ethics Committee may be established as a fixed Commission or as needed to

the various cases.



(2) the Ethics Committee has at least 5 members; It is made up of doctors, one

clinical psychologist and lawyer. At least two-thirds of the members of the ethical

the Commission may not be in employment or similar relationship to the provider

health services referred to in paragraph 1. The Chairman and other members

ethical Commission appoints and dismisses the statutory authority of the provider

health services, in which the Commission was established. The Chairman and the

members of the Ethics Committee in the performance of the activities of the Ethics Committee are not bound by

instructions statutory authority providers of health services or instructions

other executive employees of providers of health services. The members of the

the Ethics Commission may be the only natural persons without a personal interest or

participation in the implementation of the subscription



and the authority for the benefit of the recipient), who is not close to the donors, or

on the transplantation of that authority,



b) renewable tissue, minor person devoid of distinctive character or

a person unable to consent or to transplant the tissue.



(3) the members of the Ethics Committee are required to maintain the confidentiality of all

the facts, which they learned in connection with the performance of their functions,

with the exception of cases when such fact shall be communicated with the consent of the donor,

the beneficiary or legal representative of a minor or a person deprived of

eligibility or on the basis of the exemptions required to maintain confidentiality.

The fact can be with the consent of the persons referred to in the first sentence to communicate so

It was not possible to obtain information about other people and that the

respected the anonymity between donor and recipient (section 20). For exemption

regarding members of the Commission shall apply specific legal

Regulation ^ 1) which sets out the rights and obligations of health care workers

in the provision of health services. Activity of the members of the Ethics Committee is

any other act in the general interest, which provides employees

time off work with wage compensation in the amount of average earnings in ^ 7) necessarily

extent necessary.



(4) the hearing of the Ethics Committee governed by the President. The Ethics Committee decides

a majority vote of its members. In case of equality of votes

of the President.



(5) the Ethics Committee grants on the basis of a written application submitted by the

the statutory body of providers of health services, which the Commission

established, the written approval or disapproval with the subscription



and donors for the benefit of) a beneficiary who is not the person,



b) renewable tissue, minor person devoid of distinctive character or

a person unable to consent.



Consent to or opt-out is part of the medical

documentation for anyone wishing to donate the organ or tissue donor,

minors, persons deprived of or persons unable to

agree to. The Ethics Committee shall within 7 days of the consent or

a copy of the Charter opt MRCC

transplantation.



(6) the request for consent shall contain the



and) health information provider, minors, persons deprived of

eligibility or persons unable to consent, that are applicable

for an assessment of potential renewable tissue sampling,



(b) a clinical psychologist) observations of the ability of the minor, the person

devoid of distinctive character or a person unable to consent to comment

Subscribe to pull doctor posuzujícím medical fitness of that person,



c) health information the recipient institution or renewable tissue,



(d) a copy of the full guidance and) informed consent of the donor of the authority or

the donor's legal representative (§ 7 para. 1 and 2), where expression

minors or persons devoid of competence (§ 7 para. 6),



(e) a copy of the full guidance and) the consent of a person unable to consent,



(f) a copy of the observations made by the donor) pursuant to § 3 (2). 2 (a). (b)), and



g) deadline by which the Ethics Committee is obliged to communicate consent or

opposition to the performing body donor or subscription renewable tissue

minors, persons deprived of the eligibility of a person unable to give or

consent.



(7) if necessary, the Ethics Committee may invite to the meetings on the granting of

affirmative or negative with the donor or of the legal representative

minors or persons devoid of competence, where appropriate, whether or not this

person. The Ethics Committee to act always invited



and) minor or person divested in the event that

a clinical psychologist has stated in its observations, that this person is able to

say you subscribe to,



(b) a person unable to consent),



(c)) the donor institution referred to in section 3, paragraph 3. 2 (a). (b)); in this case, in addition to

health aspects of the Ethics Committee ascertains and assesses whether or not the reasons

that led to the donation of the organ donor.



(8) the Ethics Committee in the case of consent referred to in paragraph 5 shall exercise

supervision over the course of the subscription and the maintenance of the rights of the donor, a minor,

a person deprived of or persons unable to consent.



(9) the Ethics Committee must keep essential records properly on its activities,

in particular, the written work procedures, list of members, together with their

professional competence, submitted by the application and the supporting documents, minutes of meetings,

reports and correspondence concerning its activities and the examination of applications

for at least 10 years, and that the providers of health services

which is established is established. In the case of the demise of the Ethics Commission shall ensure

proper storage of documentation of the statutory authority of the provider of health

services in which the Ethics Committee was established.



§ 6



Assessment of the medical fitness of a living donor



(1) prior to the collection from living donors must be evaluated by the health

eligibility for the donation of tissue or organ. For this purpose shall be carried out

such medical examinations and procedures to assess the health status of the

a living donor and the potential risks to health and life associated with donor

tissue or organ donation. At the same time, such procedures must be laid down,

that all available ways of limiting the risks to the health and life of the donor,

the removal of tissue or organ represents, without

compromised the quality and viability of removed tissues or organs.

An integral part of the assessment of the medical fitness of the donor is

characterization of the donor and the characterisation of the authority.



(2) for the assessment of medical fitness to the donor organ donation is

responsibility of the provider of health services, which performs the subscription. In

the case of the donation of tissues, an assessment of the medical fitness of the donor

proceed according to the law on human tissues and cells ^ 7a).



(3) the Examining doctor will carry out an assessment of the medical fitness record

the donor with the extent of the assessment and with the conclusion of the eligibility or

the incapacity of the donor. This entry stvrzený signature

assessing physician and date is an integral part of health care

documentation of the donor. Assessing physician passes within 7 days of the assessment

health donor listing from medical records in the

the extent of the record under the first sentence MRCC transplantation.



(4) the provider of health services, which carried out the collection, ensuring donors

provision of preventive health care.



(5) Further conditions of the medical assessment, the scope of the examination

a living organ donor, and the range of data for the characterization of this

the donor and to characterise organs from the same donor provides the Ministry of

health care (the "Ministry") by Decree.



(6) the donor or the legal representative of the minor, or the legal representative of the

persons deprived of the eligibility, if the donor of that person, may request

another doctor, who is not on a subscription or to other procedures the United

with the transplants involved, on the assessment of health risks of collection for the person

the donor. For this assessment does not apply the provisions of paragraphs 1 to 5.



§ 7



The full guidance and consent



(1) the doctor assessing the medical fitness of a living donor is obliged to

to provide donors a full lesson on the purpose, nature and consequences of the donation

tissue or organ, and about possible risks associated with it, including the risks

long-term. If the donor is a minor, or a person exempt from

competence, shall provide this information to her legal representative. Lessons

must be understood. The donor and the legal guardian of the minor or

the legal representative of a person deprived of competence has the right to ask questions,

to the extent provided in the first sentence, and the doctor is obliged to answer.

Part of the lesson is also the submission of information on the rights and protection of donor

laid down in this law.



(2) the donor and the legal representative of the minor, or the legal representative of the

persons deprived of the eligibility may require when instruction was present

Another witness. About this possibility shall inform in advance the physician providing the

complete the lesson. The doctor will perform a full record shall be drawn up lesson with his


concise content and this entry with an indication of the date when it was a lesson

done, signed by all interested parties. The record of the full lessons

the donor, or the legal guardian of the minor or of the legal representative

persons deprived of the eligibility is an integral part of the medical

documentation of the donor.



(3) the procurement by a doctor is obliged to immediately before performing the

subscription complete lessons, under the conditions laid down in paragraph 1.



(4) the consent of the donor or of the legal representative of the minor, or

the legal representative of a person deprived of the eligibility of the authorization on the basis of

full instruction referred to in paragraph 1 must be free, informed and

specific. Must be made in writing, confirmed by a signed and dated

and based on the medical documentation of the donor. Part of the consent of the

in connection with the collection of tissues is the definition of the purpose of its

the use of the.



(5) the donor or the legal representative of the minor, or the legal representative of the

persons deprived of competence may at any time withdraw your consent. Doctor

procurement is obliged to respect this appeal, unless they have been

made for the collection of irreversible acts whose interruption would mean

threat to the health or life of the donor.



(6) if they are minors or persons deprived of the eligibility of the capable

to an extent sufficient to understand the consequences of implementation or non-implementation of sampling

for themselves or for the recipient, it is necessary to provide them full lessons.

If the person referred to in the first sentence of the said opposition to the donation, it is

the opt-out must be respected.



(7) the provider of health care services, in the case of consent when I say in

connection with the collection of tissues, shall provide a copy of this consent, or

his amendment, a tissue establishment ^ 7a), which passes the tissue. The conformity of the copy

consent to the original provider of health confirms the relying

services.



§ 8



The making of the collection from a living donor



(1) a subscription to authority from a living donor can only be performed for the benefit of the person,

the donor has specified (section 3 (2)). If a living donor of tissue shall make the

their subscription donation to a person, this subscription can be done only in

the benefit of that person.



(2) in the case where the removed tissue or organ will not be implanted

the designated person, it is necessary to ask, before you make a subscription for use

This tissue or organ donor consent for another person. The reasons that

led the doctor to decide that the removed tissue or authority could be

implant donor designated person shall be recorded in the medical

documentation of the donor and the persons designated by the donor.



§ 9



The transplantation of tissues or organs removed for any reason other than for

the purpose of transplantation



(1) if the tissue or organ of the patient are removed for any reason other than

for the purpose of transplantation, they can be implanted only recipients

If the patient has been on the consequences and possible risks of removal

instructed and before or after the removal of tissue or organ expressed with their

the use of consent for transplantation.



(2) the implementation of lessons learned and obtain the consent referred to in paragraph 1 shall

the provisions of § 7 shall apply mutatis mutandis.



Part 2



Subscription from deceased donors



§ 10



The admissibility of a subscription from a deceased donor and the findings of the death



(1) a subscription from a deceased donor can be done only if it was found to death.

If the subscription should be from a deceased donor is executed before the expiry of the 2

hours after death, can detect this subscription, execute first after signing

the Protocol referred to in paragraph 2. The doctors, who are discovering the death, shall not be

attend a subscription from a deceased donor transplantation and may not be

nurturing doctors considered the recipient.



(2) the findings of the death of a potential donor must always be carried out at least 2

doctors with the appropriate specialist qualifications, who have examined the donor

independently of each other. The findings of the death of a potential donor, in the case

prediction of the subscription before the end of 2 hours from this finding

be recorded in the log, which is an integral part of the medical

documentation of the donor. Protocol for the detection of death signed by doctors who

they found death.



(3) death [§ 2 (b), (e))] is determined by demonstrating



and a pledge of irreversible bloodstream), or



b) irreversible loss of function of the entire brain, including the brain stem in the

where are the functions of breathing or blood circulation maintained artificially

(hereinafter referred to as "brain death").



(4) in the event of death proof of irreversible collateral blood circulation

You can perform a subscription before the end of 2 hours from this finding,



and time if known) findings of death, and death was detected in

medical facility



1. at the intensive care unit,



2. the Department of Anaesthesiology and resuscitation Department



3. in the operating room,



4. on the Revenue Department or the ambulance to the hospital, income



(b)) if the death was determined on the basis of their unsuccessful resuscitation.



(5) the death of the brain may be established, if



and the patient) located in the State, on the basis of which can be considered

the diagnosis of brain death, and



(b)) can be demonstrated clinical signs of the death of the patient's brain, on the

can be used to make a diagnosis of brain death, supplemented by examination of the

confirming the irreversibility of death of the brain.



(6) status on the basis of the diagnosis may be considered the death of the brain

clinical signs of the death of the patient's brain, on the basis of which can be determined

the diagnosis of brain death examination is demonstrating and certifying examination

irreversibility of the death of the brain are listed in the annex to this Act.



(7) the Ministry shall determine the scope of data necessary to characterise the

deceased donor and to characterise organs from a deceased donor,

the elements and the presentation of the report on the findings of the death and the specialized

competence of doctors and physicians engaged in ensuring the death of examination

confirming the irreversibility of death by Decree. The Ministry may lay down

more detailed conditions about how to carry out the examination to demonstrate the death,

Tests confirming the irreversibility of the collateral blood circulation or death

the brain and the conditions for their implementation of the Decree.



section 10a



The admissibility of a subscription from a deceased donor, who is a stranger



(1) aliens ^ 9) in which it can be assumed according to the tissue or organs

This law, can be done in the case of subscription, if a holder of a

valid proof of positive expression of will to break up the donation of tissues

or authorities issued to the competent authority of the State of which the foreigner

citizen (hereinafter referred to as ' donor card ').



(2) in the case of an alien who is in possession of the donor card and for which

You can assume tissue or organs under this Act, shall take

Transplant coordination centre based on the complaint of the provider

health services, a written question to the competent authority of the State of which he is

the alien's nationality, whether the alien



and has not made a declaration of will) towards the expression of disagreement with the posthumous

the collection of tissues or organs, or



(b)) gave its assent to the donation tissues or organs, if the State

the stranger is a citizen of, applying the principle of the envisaged

disagreeing.



(3) when establishing contact to a person close to foreigners in order to meet

obligations under article 15, paragraph 2. 1 take the transplant coordination centre

on the initiative of the healthcare providers written for query

competent authority of the country of which the alien is a citizen.



(4) is received by the provider of health services to 72 hours information

the facts referred to in paragraph 2, or if you cannot inform a person close to

aliens under § 15 para. 1, it is considered that the conditions for the subscription are not

met.



§ 11



The inadmissibility of a subscription from a deceased donor



(1) a subscription from a deceased donor is excluded, if the



and) the deceased during his lifetime, or the legal representative of the deceased, who was

a minor or a person divested,

proven to be disagreement with the posthumous collection of tissues and organs (article 16),



(b)) cannot be based on the assessment of medical fitness to exclude that

the deceased had been suffering from the disease or condition that might endanger the health or

the life of the recipient; for the assessment of the medical fitness of a deceased donor

authorities responsible provider of health services procurement; in

the case of the donation of tissues, an assessment of medical fitness

deceased donor shall proceed according to the law governing human tissues and

the cell, or



(c)) of the deceased could not be identified.



(2) the Examining doctor will carry out an assessment of the medical fitness record

deceased donor with the delimitation of the scope of the assessment and with the conclusion of the

eligibility or ineligibility of a deceased donor. This entry with

the date of carrying out the assessment, assessing the signature of doctor stvrzený is

an integral part of the medical records of the deceased donor.



(3) Further conditions for medical assessment, and the scope of

examination of the deceased organ donor establishes a Ministry decree.



§ 12



The removed tissues and organs



(1) the doctor who performed the taking of tissue or organ, captures the enumeration

the removed tissues and organs and the expected purpose of their use in

the medical records of the donor.



(2) providers of health services, who are involved in the subscription

the organs or tissues from a deceased donor and transplant,

They shall inform each other without delay on delay detection of health

the incapacity of a deceased donor, and also without delay inform in the same


the scale and Coordination Center.



(3) the tissue removed under the law governing the management of human

tissues and cells that have not been used for a transplant, you can

further testing, processing, preservation, storage, preparation margin and

distribution pass only a tissue bank.



section 13 of the



The autopsy



(1) on the body of the deceased, which was done, is always done

autopsy under special legislation. ^ 10)



(2) an autopsy of the deceased, which was carried out the collection, shall be carried out at the time of what

short as possible so that in the case of the additional finding that the deceased

He suffered from illness or condition that might endanger the health or life

the recipient could be concluded about the incapacity of the deceased.



(3) in the event that the physician conducting an examination of the deceased suspects

that death occurred under unclear circumstances or violent deaths, including

suicide or murder, can be performed only on the condition that it will not

thwarted by the purpose of the autopsy ordered under special legislation. ^ 11)

At the same time, it is necessary for the purposes of the investigation, to inspect the

subscribed tissue or organ, and also the part of the body from which they were removed so

to the outcome of the inspections could become part of the autopsy protocol.



(4) if the doctor who performed the autopsy, on the basis of the results of the autopsy

It finds that the deceased suffered from a disease or condition that might endanger

the life or health of the recipient, shall notify this fact immediately

the providers of health services, which carried out the taking of tissue or

authority. If it was on the basis of the autopsy made additional findings

incapacity of the deceased donor and the organ or tissue collected from

This has already been a donor transplant recipients, the provider of health

the service, which carried out the transplant without delay precautionary measures to

the prevention of threats to the life or health of the recipient, where appropriate, ensure that

recipients to provide the necessary health care, and shall notify the

MRCC transplantation without delay.



§ 14



Respect for the human body



When you perform a subscription from the deceased and carrying out post-mortem examinations must be

to deal with the body of the deceased with respect and all tasks must be carried out

so that the body was adjusted as far as possible to its original form.



Part 3



The communication of the intended person and in opposition of the subscription with the posthumous

collection



§ 15



(1) the attending physician of the patient, in which tissue can be expected

or authorities under this Act, shall notify the persons close in an appropriate manner,

If the patient has not specified under § 19 (hereinafter referred to as the "designated person"),

estimated subscription option, provided that the designated person

interest of the patient and the patient during his lifetime, demonstrable

way mentioned the prohibition of disclosure of information about your health.

If the patient is referred to in the first sentence of a minor or a person

stripped of eligibility, the possibility of attending physician shall communicate its subscription

legal representative and shall instruct him about the possibility of utter demonstrable

disagreement with the collection according to § 16 para. 1 (b). (c) in this case.)

do not apply the condition expression of interest of the patient. The attending physician at the same time

the designated persons, or legal representative will explain the scope and purpose of

the projected collection, respecting the anonymity of the recipient.

The designated person, or legal guardian have a right to ask questions,

the exception of the query to the recipient. If the specified person or legal

the representative of the fourth sentence explanation refuses, her treating physician

refusal to respect and this fact makes the record to the

the medical records of the patient.



(2) if the deceased, in which tissue can be expected

or authorities under this Act, it shall submit the information and if the deceased

a minor or a person stripped of eligibility whether or not lessons, according to the

paragraph 1, the doctor responsible for the statutory body of the providers of health

services, in which the deceased is located.



(3) the information submitted in accordance with paragraph 1 shall be a doctor writing in

medical documentation of the patient or of the deceased.



section 16 of the



(1) a subscription from the body of a deceased person may be made only if the

the deceased during his lifetime, or the legal guardian of the minor or

the legal representative of a person deprived of the eligibility of the mentioned the proven

the opposition. The opposition is considered a proven thing, if



and deceased) is a registered in the national register of persons who

the posthumous collection of tissues and organs, or



(b)) the deceased during his lifetime, yet right in the clinic before the

the treating physician and one witness States that he does not agree with the collection

in the event of their death, or



(c)) the legal representative of the minor, or the legal representative of a person deprived of

competence right in the clinic before the treating physician and

one witness States that he does not agree with the collection; This statement can be

make in case of death of a minor or a person deprived of the eligibility

even in her lifetime, or even after the death of that person.



(2) a disagreement with any collection referred to in paragraph 1 (b). b) or c)

writing without delay, which is part of the medical records. This

writing signed by the patient, the attending physician and the witness, and if the patient with

regard to their State of health could not sign, endorse the expression of his

will yet another witness. If it is a minor or a person

divested, sign and write her legal representative

the treating physician or a physician referred to in § 15 para. 2. The minutes shall

indicate also the date and hour when the Declaration was made. A copy of the minutes of the

the Declaration referred to in paragraph 1 (b). (b) a copy of the registration statement) or

made on death pursuant to paragraph 1. (c)) is a provider of

health services shall, within 3 days from his writing to send to the national

Register of persons who by the posthumous collection of tissues and organs.



(3) if it is not established that the deceased during his lifetime expressed

proven to be disagreement with the posthumous collection, with the collection

agrees.



TITLE III



The RECIPIENT



§ 17



(1) choosing the recipients of organs is based on the principle of

medical urgency, waiting and equality; When medical

the urgency of the account also of the overall time of the registration in the national

Register of persons waiting for an organ transplant.



(2) the provisions of paragraph 1 shall not apply to the taking of organs from living

donors.



(3) the beneficiary or his legal representative must give to the implementation of

the transplantation of the informed written consent of the authorization on the basis of the full

the lessons provided by the recipients of the doctor posuzujícím his health

capacity, or a doctor performing the transplant recipients; When

provide complete lessons and voicing the informed written consent of the

the provisions of § 7 shall apply mutatis mutandis. If it is not possible to request due

the State of health of the recipient's written consent or the consent of his

legal representative and, if the emergency power required transplantation

to save the life or health of the recipient, this consent is assumed. About

the reasons for that approval was not obtained pursuant to the preceding sentence,

does the record into the medical records of the recipient.



(4) the part of the beneficiary's medical records and data on the

State of health of the donor associated with the collection. Medical documentation

containing information on the State of health of the donor must be conducted so as to

anonymity of the donor.



TITLE IV



THE NATIONAL HEALTH REGISTRY RELATED TRANSPLANT



section 18



(1) part of the national health registries ^ 12) is a national register of persons

dissenting with the posthumous collection of tissues and organs, national register

organ donors, national registry of people waiting for an organ transplant, and

National registry of organ transplants carried out. These registers shall be established

the Ministry under special legislation. ^ 12)



(2) for the keeping of registers, data collection and handling

data applies a special law, ^ 12) ^ 13) If this law does not

otherwise.



(3) the tasks relating to the management of the national organ donation registry,

The national registry of people waiting for an organ transplant and the national

the registry carried out organ transplants fulfils coordination centre

Transplantation (section 25), which is under a special legal regulation ^ 1)

the processor of the personal data held in these registers. The tasks of the

related to the administration of the national register of persons who

the posthumous collection of the tissues and organs carries out the Coordination Centre for the

departmental health information systems. ^ 12) Centre referred to in the sentence

the second is for the purposes of keeping of registers personal data processor referred to in

special legislation. ^ 13)



(4) To the national registry of people complaining with the posthumous collection of the tissues

and authorities, compulsory lists the first and last name, social security number and address

residence of a person disagreeing with the posthumous collection of tissues and organs and

necessary information about the extent of the disagreement. The national registry of donors of tissues

and bodies and the national registry of people waiting for an organ transplant

It is mandatory to indicate the necessary identification data of the donor, the person pending

on organ transplant, persons who transplant was performed, and


the necessary information about the State of health of such persons. Details of the extent and

the content of the mandatory data to the national registry of persons who are

with the posthumous collection of tissues and organs, the national registry of organ donors,

The national registry of people waiting for an organ transplant and the national

the registry carried out organ transplants and the file data passed from the

These registers into the national health information system ^ 12)

the Ministry shall determine by Decree. The Ministry may also Decree

establish a set of data passed by the Centre to search for donors

stem cell registry of potential donors of hematopoietic cells to

The national health information system. ^ 12)



(5) for the purposes of carrying out the tasks



and) national register of organ donors, the donor also means the donor tissue,



(b)) the national registry of people waiting for an organ transplant, the person

waiting for transplant also means a person waiting for a transplant

tissue,



(c)) the national registry carried out organ transplants are carried out

transplantation of tissue transplants carried out also means.



TITLE V OF THE



OBLIGATIONS OF THE PROVIDERS OF HEALTH SERVICES IN THE PROVISION OF HEALTH

SERVICES IN CONNECTION WITH THE DONATION AND TRANSPLANTS OF TISSUES AND ORGANS



§ 19



Synergies in the provision of the data of the basic registers and other

information systems in public administration



(1) the Coordination Center and the Coordinating Centre for the

departmental health information systems make use of the basic

the population register for the performance of tasks in the management of national health

the registers kept under this Act, the following reference data:



and) surname,



(b) the name or names),



(c) the address of the place of stay), where appropriate, the address to which they are to be

documents can be delivered by a special legal regulation,



(d)) of the date, place and County of birth, for the data subject, who was born in

abroad, the date, place and the State where he was born,



(e)) of the date, place and County of death, in the case of the death of the data subject outside the territory

The United States, date of death, place and the State on whose territory the death

has occurred; If it is issued the Court's decision on the Declaration of death, day,

that is the decision, listed as the day of death, where appropriate, as the day on which

did not survive, and the date of the legal force of the decision.



(2) the Coordination Center and the Coordinating Centre for the

departmental health information systems make use of the information

system of population register for the performance of tasks in the management of the national

health registers kept under this Act, such a reference

details:



and the name or names), surname, maiden name,



(b)) date of birth,



c) gender,



d) place and County of birth and a citizen who was born abroad, instead of

and the State where he was born, citizen



(e)), social security number,



(f) the address of the place of residence), and the address to which they have

to be served documents according to a special legal regulation,



(g)) the beginning of permanent residence or cancellation date data on the place of

permanent residence or the date of their permanent residence in the territory of the United

Republic,



h) date, place and County of death; in the case of the death of a citizen outside the United

Republic, date of death, place and the State on whose territory the death occurred,



I) day, who was in the Court decision on the Declaration of death listed

as the day of death, or as a day that did not survive, and the date of acquisition

the decision of the Court on the Declaration of death.



(3) the Coordination Center and the Coordinating Centre for the

departmental health information systems make use of the information

of aliens for the performance of tasks in the management of national health

the registers kept under this Act, the following reference data:



and the name or names), surname, maiden name,



(b)) date of birth,



c) gender,



(d)) instead, and the State where the alien was born; in the case that he was born on

the territory of the United States, place and County of birth,



(e)), social security number,



(f)) the type and address of the place of residence on the territory of the Czech Republic, or

the address to which the documents are to be delivered by a special

legislation,



(g)) of the date, place and County of death; in the case of the death of foreigners outside the territory of the United

the Republic, the State in which the death occurred, or the date of death,



h) day, who was in the Court decision on the Declaration of death listed

as the day of death, where appropriate, as the day on which the stranger declared dead

did not survive.



(4) the Coordination Center and the Coordinating Centre for the

departmental health information systems use native from the registry

the numbers for the performance of the tasks in the management of the national health registries

conducted under this Act, the following reference data:



and social security number),



(b)) in the event of the original social security number, personal identification number,



(c) the name or names), surname, maiden name, where applicable, the bearer of the

social security number,



(d)) of the date, place and County of birth, and social security number for the bearer,

He was born in a foreign country, the place and the State in whose territory he was born.



(5) the data referred to in paragraphs 1 to 4 may be applied in a particular case always

only such data which are necessary for the performance of the task. Data,

that are kept as reference data in the base the population register,

to make use of the information system of the population register or an information

of foreigners only if they are in the shape of the preceding the current

status.



section 20



Respect for the anonymity of donors and recipients and information obligation

providers of health care services



(1) providers of health care services are required to maintain the anonymity of the



a) deceased donor tissues or organs to a recipient



b) living donor tissue or organ against the person referred to in § 3 (1). 2,

If the donor wishes,



(c) donor) of renewable tissues, if it is not a person referred to

in section 3, paragraph 3. 2.



(2) the provider of health services for conducting the subscriptions and transplantation

tissues, transplant centers and transplant coordination centre

record and maintain a social security number for identification purposes of the donor. For

to this end, the provider is entitled to require health care services

production of a document, in which the social security number. Social security number giver

shall be kept for the purposes of traceability.



(3) providers of health care services are required to immediately inform the

about the potential donors of organs transplantation centre concerned (section 22).



section 21



Provider of health services for conducting tissues and subscriptions

tissue transplantation



Provider of health services for conducting tissues and subscriptions

the transplantation of tissues, that is not a transplant Centre (section 22), it is

In addition to the obligations arising from a special legal regulation ^ 15)

shall be obliged to



and the persons to whom the report) was sampled in the national registry of donors

authorities,



(b) report to the transplantation) conducted the national registry

organ transplants,



c) in the case of tissues, provide data which will require coordination centre

transplantation,



d) receive information from the national registry of persons who

the posthumous collection of tissues and organs for the purposes of the implementation of the subscriptions from

deceased donors and respect as follows when I say disapproval with the collection,



e) verify the other ways of voicing disagreement with the demonstrable

the posthumous collection established by this Act and respect the following thing

disagreement,



(f) documentation of the performed) to keep subscriptions and transplantation and

waste taken from tissues or organs to log on

the final destination of tissues or organs, were removed.



g) to ensure the health of the living donors and recipients



h) have to import or export, import or export permit (sections 26a to

26 g).



section 22



Transplant Center



(1) the Transplantation Centre means a provider of health services,

who has been granted the status of highly specialized care center ^ 22) and that

on this basis, it can make donations and transplantation of hematopoietic

of cells, organs and tissues that have not been transmitted to the tissue bank in accordance with § 12

paragraph. 3. The transplant centre fulfils the obligations under section 21 and

obliged to



and to report to the indicated person) transplantation of tissues and organs to the national

Register of persons waiting for an organ transplant,



(b)) to carry out the transplantation of tissues and organs exclusively to recipients

registered in the national registry of persons waiting for a transplant

authorities,



(c)) work with transplant coordination centre in the selection

the most suitable recipients of organs,



d) on receipt of information pursuant to section 20 (2). 3 to determine whether they are fulfilled

the conditions for the subscription (10 to 11),



e) after finding that the conditions for the subscription to inform about possible donors

Transplant coordination centre,



(f)) to verify that it was done and recorded health assessment

eligibility of donors, including a complete characterisation of the organ and donor



(g)) to verify that the supplied authorities complies with the conditions of preservation and

transport,



(h)) to keep documentation on subscriptions and transplants carried out and

the management of the authorities taken to log on the final

the determination of the authorities, were removed.



I) report any serious adverse reactions and serious adverse reactions


MRCC of transplantation and medical providers

intercepting services subscriptions of tissues and tissue transplants or other

transplantačnímu Centre of performing subscription or transplant



j) report measures carried out for the solution of serious adverse reactions and

the reaction of MRCC transplantation.



(2) the transplant center is further obliged to



and to handle and maintain internal) system to ensure the quality and safety of

for all phases of the process from donation, transplant



(b)) for the purposes of traceability to use donor identification system and

of the beneficiaries, through which you can identify each donation, each

the associated authority and each recipient is associated with it; data needed

in order to ensure the traceability of the transplant center must keep at least

for 30 years,



(c)) apply workflows for the collection, preservation, packaging and

labelling authorities



(d)) apply the procedures for the reporting, investigation, registration and

the transmission of information about any serious adverse events that may have

effect on the quality and safety of organs, which can be caused by

the investigation, characterization, collection, preservation and transfer of organs, and

also information on any adverse reactions observed during

or after transplantation which may be associated with these activities,



(e)) ensure the application of working procedures to ensure the integrity

Authority during the transfer and an appropriate period of transport,



(f)) to ensure that healthcare professionals directly involved in the process

from donation after transplantation or disposal of organ or tissue should

the appropriate qualifications or training, they were technically eligible to

the profession and are adequately trained.



(3) the transplant center, performing the transplantation of hematopoietic cells

fulfils the obligations pursuant to article 21 (b). (c)), and (g)), it is required to cooperate

with the search for donors of hematopoietic cells (§ 24) when selecting

the most suitable unrelated donor hematopoietic cells and potential

performs the final selection of a suitable donor hematopoietic cells for a specific

of the recipient.



§ 22a



The Protocol for the handling of tissues and organs



Healthcare professionals who participated in the collection or transplantation

tissues and organs, any waste taken from tissues or organs

in the log, which is attached to the removed tissue or organ. Into this

the log is recorded, in particular, the date and place of sampling, and the final destination

the removed tissue or organ. If the removed tissue or body shall apply

for transplant, the log will record the date, the place and the person to whom

the transplant was performed. If it was decided that the removed tissue

and the authorities are not suitable for transplant, the log is recorded

the reason why they were found unfit, and way more load with them.

Provider of health services shall ensure that the send log

MRCC transplants within 7 days from the date when the

the final destination of the removed tissue or organ.



Article 23 of the



Tissue Bank



(1) the Tissue Bank is intended to provide donations, further processing,

the investigation, preservation, storage and distribution of tissues for

transplantation; in these activities it shall proceed according to the law of human

tissues and cells.



(2) the tissue banks are required to



and in the Organization of tissues), cooperate with the departments of Pathology

of forensic medicine, departments of obstetrics-porodnickými providers

health services, devices and services with the providers of blood transfusion

health services referred to in paragraph 21 and 22,



(b)) use the information the national registry of persons who

the posthumous collection of tissues and organs and the national registry of organ donors,



c) lead the documentation on the samples taken and received tissues, carried out

measurements taken of the tissue, the prepared transplantabilních

tissue štěpech that they have in stock, and štěpech issued by the

departments performing the transplant.



section 24



Centre for stem cell donation



(1) the Center for stem cell donor search is intended for

search for unrelated donor transplants of hematopoietic cells, investigation and

mediation of transplantation of hematopoietic cells from unrelated donors.

Centre for the search of hematopoietic cells can only be established with the

the consent of the Ministry. ^ 17)



(2) the Centre for stem cell donation in particular



and documentation of the performed) is conducting studies of the potential donors

hematopoietic cells and hematopoietic transplantation mediation

cells,



(b)) maintains a registry of potential donors of hematopoietic cells,



(c)) provides on request of providers of health services

information on potential donors of hematopoietic cells, and this in terms of

assessment of their suitability for a particular recipient,



(d)) provides and coordinates international cooperation in the implementation of the exchange of

hematopoietic cells for transplantation,



e) provides information to the public about the importance of and how to donate

hematopoietic cells in engaging new donors and ensures

the lessons of potential donors of hematopoietic cells of

the facts related to the voluntary donation,



(f) carrying out the assessment) ensures the health of potential

donors prior to their inclusion into the registry of potential donors

hematopoietic cells,



g) searches the registry of potential donors of hematopoietic cells suitable

an unrelated donor hematopoietic cells for a particular recipient,



h) provides health monitoring unrelated donor transplants after the collection,



I) ensures the release of unrelated donor for further examination.



(3) the Centre for stem cell donors search for leadership

the registry referred to in paragraph 2 (a). (b)) implement and maintain an information system

Enabling trace the potential donors of hematopoietic cells. Data on the

potential donors will be kept for registration of donors in the registry,

However, a minimum period of 30 years from the date of collection of hematopoietic cells.

The consent of the potential donor with the management of the data concerning him in the register

must be written.



(4) the Centre for stem cell donor search processes to 1.

March of each year an annual report on the activities of the Centre for the search

stem cell donors for the previous calendar year. The annual

report no later than that date, shall be published in a manner allowing

remote access and submit it to the MRCC transplantation.



§ 25



Transplant coordination centre



(1) the Ministry of health establishes a coordination centre

transplants for the performance of the tasks referred to in paragraph 2. When you sign up

Ministry of transplant coordination centre shall proceed to

its independence has been maintained at transplant centers, from

the perspective for the 3-d, substantive and technical equipment and the location of the

of the Centre.



(2) the Coordination Center carries out the following tasks:



and the national registry of persons) waiting for an organ transplant,



(b)), national register of organ donors,



(c)) leads national registry carried out organ transplants,



d) coordinates sampling and transplant teams each

transplant center,



(e)) is choosing recipients for the removed organs; the selection is

carried out exclusively from the national registry of persons waiting for a transplant

authorities on the basis of a written allocation algorithm, defined in advance



f) methodically coordinates the activities of the Centre for the donor search

hematopoietic cells,



g) provides and coordinates international cooperation in the implementation of the exchange of

organs for transplantation (section 26),



h) works with the Ministry to ensure the quality and safety of

organ transplants,



I) performs tasks related to the exchange of organs between Member States

The European Union (hereinafter referred to as "Member State") and between the Member States and the

third countries,



j) enters into a written agreement with the European organisations for the exchange of organs,

If such organisations ensure compliance with the requirements laid down in this

by law,



to) processes for more workflows



l) performs other tasks specified by the Ministry.



(3) part of the transplant is the central coordination centre

monitoring unit that handles the summary data on the

subscriptions, transplants and their results for each calendar year, and

a report on how the Ministry no later than 31 passes. March

the following calendar year.



(4) the requirements for the establishment of working procedures to ensure

the system of quality and safety of organs, and for the collection, preservation,

packaging, labelling and transportation of organs, traceability and for Administration

accurate, rapid and verifiable reporting of serious adverse

the effects and reactions, and solution of serious adverse events and reactions,

the Ministry shall determine by Decree.



TITLE VI OF THE



INTERNATIONAL COOPERATION



section 26



(1) the international exchange of tissues and organs for transplantation is permissible

only, provided that its objective is to find the best

the recipient or transplant waiting rescue, whose life is


immediately at risk, and assuming that tissues and organs meet

quality and safety requirements and that it is their

traceability.



(2) authority to a foreign country in the framework of international exchange of organs according to the

paragraph 1 is only possible if the Czech Republic is not in the

The national registry of persons waiting for a transplant recorded suitable

candidate or a procedure within the membership of the international

Transplant organizations.



(3) tissues and organs for transplantation can be from abroad in the framework of the exchange of

tissues and organs referred to in paragraph 1 shall be taken only in the case that was

made to the eligible provider of health services and

in a way that is in accordance with the applicable legislation of the country of origin. Must

be demonstrated that prior to collection was evaluated by the medical fitness

the donor, and the donor's medical records associated with the collection must be

retrievable.



(4) the conditions for international cooperation in the transplantation of hematopoietic

cells may provide a Ministry decree.



Section 26a



(1) for importation of tissues in the United States or to their export from the United

Republic or the import or export of organs in the framework of international exchange

or offers in accordance with § 26 para. 1 and 2 (hereinafter referred to as "the import or export of tissues

or bodies ") are issued by the Ministry of an import or export permit. About

applications for import or export permit, the Ministry shall decide within 90 days

from the date of its submission.



(2) an application for an import or export permit shall, in addition

the General requirements under the administrative code include



and desetimístnou of subheading of the combined nomenclature) of the common customs

tariff and its name indicating the specified tissues or organs,

the import or export, import or export authorization requests

provided for by regulation of the Government,



(b) the proposed maximum amount) tissues or organs or cells

in millilitres,



(c) the proposed period of validity) of import or export permit



(d)) the purpose of the import or export of



(e) the name of the State or States) origin of tissues or organs in the case of imports,

the name of the State (s) of destination of tissues or organs in the case of exports.



(3) the application for an import or export authorisation, the applicant

connects



a) extract from the commercial register or a certified copy of the provisioning

of the Charter,



(b)) and the specifications of the species exported to enumerate or imported tissues or

authorities,



c) in the case of export document or its certified copy of the release

national authority confirming that this is a health provider

services authorized to carry out subscriptions to tissues or organs.



(4) in the event that the importation of authority within the United States or the export authority from

The Czech Republic is necessary because of the life-saving done in less

than 90 days, the Ministry of the import or export of approve additional

After its implementation. This additional approval request authority to import

The United States or export authority from the United States, the Ministry of

served immediately after its implementation.



section 26b



(1) the decision on the import or export permit, in addition to

the General requirements under the administrative code contains



and) registration number of the import or export permit



(b) subitem) the combined nomenclature of the customs tariff and its name

that indicates the tissue or authorities on the import and export of import or

the export authorisation is granted,



(c)) the period of validity of import or export permits, including the authorised

the maximum quantity of pieces of the organs or tissues or cells in millilitres,

You can import or export,



(d) the name of the State or States) origin of tissues or organs in the case of imports,

the name of the State (s) determine the tissues or organs in case of export, the



e) instruction on the obligation to return a copy of the written copy of the import

or export permit within 10 working days after it is exhausted or

its expiry (section 26e)



(f)) the purpose of the import or export of



g) annex to the decision; in each Annex is defined instead of for the record

the identification data of the providers of health services, which carried out the

taking of tissue or organ, and for the records of the Customs authorities on the use of

granted by the import or export permit (amount, date, imprint

stamp, signature); the number of attachments, the number of allowable maximum

imports or exports referred to in subparagraph (c)).



(2) the Ministry shall grant an import or export permit for a maximum period of 12

months.



section 26 c



(1) the Ministry shall authorise the import or export permit, if it

require the security interests of the United States (the possibility of threats

health and life of the population).



(2) the Ministry shall withdraw the import or export permit, if



and) import or export authorisation was granted on the basis of false

or incomplete information, the



(b)) have not been met or range of conditions laid down therein, or



(c)) required the security interests of the United States.



(3) an appeal against a decision to withdraw the import or export

the authorisation referred to in paragraph 2 does not have suspensory effect.



(4) the Ministry and the Directorate-General of Customs shall be provided between

data relating to the import or export permit, to the extent

the data referred to in the decision under section 26b. They shall immediately

informed of the facts relevant for the administrative procedure for granting,

refusal or withdrawal of an import or export authorisation under this

law, shall check compliance with the conditions laid down in the import or

export permits and impose sanctions.



section 26 d



(1) the import or export of tissue or organ under section 26a para. 1 in a particular

the case and the import or export of the authority under section 26a of the paragraph. 4 can be made

only with the consent of the transplant coordination centre that can

the consent of the



and export to a particular grant), if in the Czech Republic is not in the

National registry of people waiting for an organ transplant are registered

a suitable candidate,



(b)) to a specific importation, grant, if the organ or tissue intended for

a particular recipient.



(2) the Coordination Center works to

ensuring traceability with the Directorate-General of customs.



section 26e



Import or export permit cannot be transferred or is transferred to a legal

the successor. Provider of health services, which import or

the export authorisation, such authorisation to the Ministry is obliged to return the

within 10 working days after its exhaustion or termination of its validity, and

including the records of the Customs authorities about his use of, and the list of people in the

foreign countries approved by the State authority, to which the authorities or

tissue from the United States to be exported or from which organs or tissues

imported into the United States.



section 26f



cancelled



section 26 g



For the import or export of tissues or organs between the Czech Republic and

the Member States, the provisions of section 26a to 26 d shall apply mutatis mutandis.



TITLE VII



OTHER ACTIVITIES RELATED TO THE DONATION, PROCUREMENT AND TRANSPLANT



section 27 of the



The Ministry of



The Ministry of



and provides information to the public) about the importance of and how to donate

tissues and organs, and especially stem cell donation, how

disagreeing with the posthumous collection and about the importance of transplantation;

in doing so, cooperate with other regulatory authorities and institutions of the territorial

Government, with health insurance companies, health care providers

services, professional organisations in health and other authorities and

institutions,



(b)) at the request of the European Commission or another Member State

informs you about the



1. the conditions that must be fulfilled in accordance with the legislation of the provider

health services, which intends to provide health services in accordance with

This law,



2. the activities of the health service providers engaged in the collection and

transplantation under this Act, the aggregate number of living and

deceased donors, the type and number of transplanted or destroyed

authorities, including the provision of a report pursuant to § 25 para. 3.



section 28



Prohibition of financial gain or other benefits, and dealing with tissues and

the authorities of the



(1) the human body and its parts shall not, as such a source of financial

benefits or other benefits; This is without prejudice to the provisions of section 28a-

28 d.



(2) the donor or any other person shall not make any claim against the recipient.



(3) for the purpose of advertisement and advertising demand or supply authorities are

disabled. For the advertisement and the advertisement does not constitute the procedure under section 27.



(4) Trading with tissues and organs collected for the purpose of transplantation

is prohibited.



section 28a



Contribution to the costs of the funeral



(1) the person who arranged the funeral of deceased donors, which was carried out

subscription to the authority belongs to the contribution to the costs associated with the dispatching

the funeral in the amount of CZK 5,000.



(2) a request for payment of the contribution to the costs of the funeral shall, in addition to the General

requirements under the administrative code include



and) proof of payment of funeral costs, donors



b) data relating to deceased donors, and that the name or names,

last name, date of birth and date of death,



(c) the name and address of the provider) of health services, in which it was

collection authority,



(d)) to determine the manner in which the amount is to be paid.



(3) if the request is submitted to the Ministry, 12 months from the date of dispatch of the


the funeral of the deceased donors are entitled to a contribution to the cost of the funeral shall cease to exist.



(4) the Transportation of the body from the place of the autopsy of the deceased donor to the place of burial shall be borne by

the recipient's health insurance company.



§ 28b



Compensation awarded to living organ donors



(1) the Donors body belongs to a replacement reasonably and demonstrably incurred

the expenditure (hereinafter referred to as "reimbursement of expenses"), and the difference between the loss of earnings and

received wage compensation, salary or remuneration, and received sickness from

health insurance, which was a temporary incapacity for work

in connection with the procurement authority and the provision of health services, which

This subscription's requested (hereinafter referred to as "loss of earnings").



(2) an application for the payment of compensation for expenses and loss of earnings, shall, in addition

the General requirements under the administrative code include



and the date of collection of the authority) and the period in which he has provided

health services associated with the procurement authority



(b)) name and address of transplant centers, which made the collection, and

address of the provider of health care services, in whose clinic

health services have been provided to donors associated with the procurement authority



(c) a document certifying the amount of usefully) and demonstrably incurred expenditure and

the amount of lost earnings, or a certified copy thereof,



(d) a certified copy of the document of) their temporary incapacity

associated with the collection; the person to whom it is issued, the proof of the temporary

incapacity for work, showing a written statement of the provider

health services for the period for which he could not carry on business, for which the

requires compensation for loss of earnings.



(3) the Ministry will ask the transplant center, which made the collection, and

providers of health services, which ensures the provision of

health services to donors, for confirmation of the facts referred to in paragraph 2

(a). (b)), and a statement whether the required expenses and loss of earnings

agrees with the period when it was done, and the donors of the institution when he was

provided with the collection of related health services. Transplant

Center and provider of health services are required to provide

the information you requested within 10 days from the date of receipt of the request.



(4) if the request for the payment of compensation for expenses or loss of earnings is submitted

within 24 months from the date of implementation of collection authority, entitled to a refund of their

ceases to exist.



(5) the donors will pay the expenses and loss of earnings in the amount of proven,

a maximum of twice the average wage in the national economy

the declared and published by the Ministry of labour and Social Affairs in the collection

for the purposes of employment laws ^ 23). To compensation for expenses is not counted

the refund of travel expenses to be paid by the donor under the law governing

public health insurance.



(6) the provider of health care services is required to ensure that the donor

prior to collection of the authority shall be informed of the possibility of requesting a refund of expenditure and

loss of earnings, and to that end submit a request referred to in paragraph 2. A record of the

This information, signed a medical professional, and the donor is

an integral part of the medical records kept by the donor.



section 28 c



The Ministry will decide on the contribution to the costs of the funeral, pursuant to section 28a or

compensation provided under section 28b. In the case of the procedure under section 28b of para. 3

the deadline for a decision is extended by 30 days.



section 28 d



The Ministry may delegate the performance of transplant coordination centre

scope according to § 28a to 28 c.



TITLE VIII



The FINE



section 29



(1) for failure to comply with or breach of obligations or prohibitions laid down

This Act (hereinafter referred to as "infringement") saves a penalty. Fine

stores,



a) in the case of an offence under section 10a, 22, § 24 para. 2 to 4 and §

26 d of paragraph 1. 1, Ministry,



(b)), unless the infringement referred to in subparagraph (a)),



1. the Regional Office of the provider of health services, which has granted pursuant to

special legal regulation the permission to the provision of health

Services ^ 1)



2. the Regional Office of legal persons with the address of the registered office in its territory, and

individuals doing business in its own name with the address of permanent residence

in its territory, not the providers of health services.



(2) a fine may be imposed



and providers of health care services)



1. to the amount of 100 000 EUR for non-compliance with or breach of the obligations laid down

in section 3, 4, § 6 (1). 1 and 4, § 8 para. 1, § 10 para. 1, 2 and 4, section 10a, 11,

13, § 16 para. 1 and 2, section 20 (2). 1 and 3, § 21, 22, § 23 para. 2, section 24

paragraph. 2 to 4, § 25 para. 2, § 26 para. 1 and 3, § 26 d of paragraph 1. 1 or § 28

paragraph. 1, 3 and 4,



2. the amount of $ 50,000 for failure to comply with or breach of the obligations laid down

in section 6 (1). 3, § 7 (2). 1 to 3, 6 and 7, § 8 para. 2, § 9 para. 1, § 12,

14, § 15 para. 1, § 16 para. 3, § 22a or § 25 para. 3,



3. that the imported or exported by the authorities without import or export

authorization to the above 5 000 000 CZK



4. which imported or exported contrary to authorities granted the import or

the export permit to the amount of $ 1 000 000



(b)) legal persons and natural persons operating on their own behalf to

the amount of 500 000 CZK for a violation of the prohibition in § 28 para. 3.



(3) the infringement referred to in paragraph 2 is repeated, if it

provider of health services, the legal person or natural person

doing business on their own behalf, committed at the time within 1 year after the previous

the offence, for which he was found guilty, fined by the

of paragraph 2.



(4) For repeated infringement to increase the upper limit of fines

referred to in paragraph 2 by half.



section 30



(1) the administrative authority, which imposed a fine of providers of health care services,

It shall send a copy of the decision imposing a fine under this Act health

the insurance company with which it has concluded a health care services provider

contract for the provision of health services.



(2) the procedure for the imposition of fines can be initiated within 1 year from the date of the

administrative authority empowered to imposition of a fine or a municipality entitled to save

fines for offences brought to their attention, but not later than within 3 years from the

the date on which the infringement occurred.



(3) when saving penalties and the determination of its amount takes into consideration the severity of the

the infringement caused by the effect, the degree of fault and

circumstances in which the infringement occurred.



(4) a fine collected and enforced by the administrative authority which it has saved, or municipality,

that it imposed. The fine imposed by the Ministry of State revenue

the budget, the fine imposed on the region, the regional budget income is fine

stored is income of the budget of the municipality.



(5) if the infringement referred to in § 29 para. 2 bases

merits of infringement under other legislation

and the competent administrative authority under another law proceedings

the imposition of fines has already started, the proceedings for the imposition of a fine under this Act

stops.



TITLE IX OF THE



COMMON AND TRANSITIONAL PROVISIONS



section 31



If this Act uses the term "donor" or "donation"

do not apply general legal regulations governing the donation and the formalities with the

related. ^ 20)



§ 32



(1) Medical collectors and transplantation,

transplant centers, tissue banks and the Centre for the donor search

hematopoietic cells and components of the national health registries (section 18)

must meet the conditions established by this Act not later than 2 years after the

the effective date of this Act.



(2) the Ministry shall publish the establishment of a national register of persons

dissenting with the posthumous collection of tissues and organs, and how to register

citizens in this registry, in a way which ensures that these

really fit in the widest possible audience. Until the establishment of the register

the disagreement with the posthumous collection follows the

the existing legislation, with the exception of cases, when a citizen of your

demonstrable opposition expressed according to § 16 para. 1 (b). (b)).



PART TWO



cancelled



§ 33



cancelled



PART THREE



Amendment of the Act on public health insurance



§ 34



Act No. 48/1997 Coll., on public health insurance and amending and

certain related laws, as amended by Act No. 242/1997

Coll., Act No. 2/1998 Coll., Act No. 125/1998 Coll., Act No. 225/1999

Coll., Act No. 363/1999 Coll., Act No. 18/2000 Coll., Act No. 132/2000

Coll., Act No. 155/2000 Coll., Constitutional Court No. 167/2000 Coll.

Act No. 220/2000 Coll., Act No. 258/2000 Coll., Act No. 458/2000 Coll.,

Act No. 176/2002 Coll. and Act No. 198/2002 is amended as follows:



1. In section 13(2). 2 letter a) including footnote No. 23a):



"and out-patient treatment and) constitutional (including diagnostic care,

rehabilitation, care for the chronically ill and health care for the donor of tissues

or institutions related to their subscription), ^ 23a)



23A) Law No 289/2002 Coll., on donation and transplantation subscriptions

tissues and organs and on amendments to certain acts (the transplant law). ".



2. In § 13 para. 2, letter d) the following point (e)), which read as follows:



"e) tissue or organs for transplantation, and the necessary

waste management (storage, storage, processing and

examination), ^ 23a) ".



Subparagraph e) to (j)) shall become letters (f)) to).



3. In § 13 para. 2, the letter i) the following new letters j) to (l)),

are added:




"j) transport living donor to the sampling point and from there, to the point of

the provision of health care associated with the collection and from this place and

reimbursement of travel costs,



to transport a deceased donor) to the place of collection and from this place,



l) transport the removed tissues and organs (article 36, paragraph 4), the ".



Subparagraph (j)) and to) are known as letters m) and (n)).



4. under section 35, the following new section 35a, which including the title reads as follows:



"section 35a



The transplantation of tissues and organs



Health care for the living donor associated with the collection of tissues and organs,

collection of tissues and organs from living or deceased donors, necessary

waste taken from tissues and organs and transport living donor or

compensation for travel expenses and transport a deceased donor shall be borne by

health insurance, which the insured person is a living donor or the

insured person was deceased donor. ".



PART FOUR



cancelled



§ 35



cancelled



PART FIVE



cancelled



section 36



cancelled



PART SIX



cancelled



§ 37



cancelled



PART SEVEN



Amendment of the Act on the Czech Medical Chamber, the Czech dental Chamber and

Czech pharmacy Chamber



§ 38



In the Act No. 220/1991 Coll., on the Czech Medical Chamber, the Czech dental

the Chamber and the Czech Chamber of pharmacists, as amended by Act No. 160/1992 Coll., section

2 (2). 1 letter c) is added:



"(c)) shall consider and defend the rights and professional interests of its members".



PART EIGHT



The EFFECTIVENESS of the



§ 39



This Act shall take effect on 1 January 2000. September 2002, with the exception of part five

points 3 and 5, which will become effective on 1 January 2004. March 2003.



Klaus r.



Havel, v. r.



in the financial times in the r..



Annex



The discovery of death proof of death in the cases of the brain



And.



The State, on the basis of the diagnosis may be considered brain death



The State, on the basis of the diagnosis may be considered the death of the brain, is a condition

When



and the patient is not doubt) about the diagnosis of structural brain damage

or about his exploration, and



(b)) the patient is in a deep coma, on artificial pulmonary ventilation and is

excluded that the unconscious at the time of examination of the involved



1. intoxication,



2. buffer and relaxing effects of pharmaceuticals,



3. metabolic or endocrine disruption, or



4. primary hypothermia.



(B).



Clinical signs of brain death and the examination is proving



1. Clinical signs of brain death, on the basis of the proof can be

the diagnosis of brain death, are



areflexie, zornicová and)



(b)) were areflexie,



(c)) vestibulookulární areflexie,



(d)) the absence of any motor response to algický the initiative applied in

inervační area of the cranial nerves,



e) absence of kašlacího reflex or any immediate motor

responses to deep suction, tracheobronchial



f) perpetual arrest spontaneous breathing proven apnoickým test,



g) deep unconsciousness.



2. The examination to demonstrate clinical signs of brain death (

"the examination of the clinical signs of brain death") performs 2 wearing

independent doctors, and to the extent provided for in point 1.



3. In children under 1 year of age, the examination of the clinical signs of brain death in

extent specified in paragraph 1 shall carry out at least twice every 48 hours.



4. The reasons for which cannot be examination of the clinical signs of brain death

referred to in point 1, perform, record the doctor conducting the examination

the clinical signs of brain death in a log about the discovery of the death.



(C).



Tests confirming the irreversibility of the clinical signs of brain death



1. Examinations, confirming the irreversibility of the death of the brain are



and cerebral arteries, angiography)



(b) the brain and/or perfusion scintigraphy),



(c) a computerized tomography angiography),



Transcranial Doppler ultrasonography d), or



e) examination hearing stem evoked potentials (BAEP).



2. For deceased people with clearly objectively proven severe structural

infratentoriální lesions are performed only by clinical examination.



Annex 2



cancelled



Selected provisions of the novel



Article. (II) Act No. 44/Sb.



Transitional provisions



1. the data held in the registry made the transplantation of hematopoietic cells

before the date of entry into force of this Act shall transmit to the Czech haematological

Society of the Czech Medical Society of Jan Evangelista Purkyně in

cooperation with the coordination centre in the National Transplantation

the registry carried out organ transplants, within 12 months from the date of

entry into force of this Act.



2. providers of health services will begin to supply data on donors

tissues, people waiting for transplants of tissues and persons who have been

made of tissue transplants, including the necessary information about their

health in national health registers maintained under

Act No. 285/2002 Coll., in the version in force from the date of entry into force of

This Act, not later than 6 months from the date of entry into force of

of this Act.



3. compensation for expenses and loss of earnings under section 28b of the Act No 291/2002 Coll.,

in the version in force from the date of entry into force of this Act, is

living donors, if at the time of entry into force of this Act has already been

living donor in the incapacity to work. In this case, it is

replacement from the date of incapacity for work in full.



4. the Centre for stem cell donation processes annual

report pursuant to § 24 para. 4 of law no 289/2002 Coll., in the version in force from

the effective date of this Act, for the first time to the 1. March 2013.



5. The transplant centers are required to process internal system

ensure quality and safety for all phases of the process from donation after

pursuant to section 22(1) of the transplant. 2 (a). and Act No. 285)/2002 Coll., on

the version in force from the date of entry into force of this Act, and within 12 months

from the date of entry into force of this Act.



1) Law No. 372/2007 Coll., on health services and conditions of their

provision (law on health services).



2) Act No. 20/1966 Coll., as amended.



Act No. 79/1997 Coll., on pharmaceuticals and on amendments and additions to some

related laws, as amended.



4) Act No. 258/2000 Coll., on the protection of public health and amending

some related laws, as amended.



5) section 8 of the civil code.



6) § 10 of the civil code.



7) § 124 para. 2 and section 275 of the labor code.



7A) Act No. 297/2008 Coll., on ensuring the quality and safety of human

tissues and cells intended for human applications and amending related

laws (law on human tissues and cells).



9) Act No. 326/1999 SB. on residence of aliens in the territory of the Czech Republic and

amendments to certain laws, as amended.



10) section 28 of Act No. 20/1966 Coll., as amended.



Decree No 19/1988 Coll., on the procedure on the death and the funeral industry, as amended by

Act No. 257/2001 Coll.



11) § 105 and 115 criminal procedure.



12) section 70 of Act No. 372/2007 Sb.



13) Act No. 101/2000 Coll., on the protection of personal data and on amendments to certain

laws, as amended.



15) for example, law No. 372/2007 Coll., Act No. 297/2008 Coll., as amended by

amended, Act No. 48/1997 Coll., on public health

insurance and amending and supplementing certain related laws, as amended by

amended.



17) section 70 para. 2 of Act No. 20/1966 Coll., as amended.



20) for example, the civil code, Act No. 357/1992 Coll., on income tax, inheritance

the gift tax and real estate transfer tax, as amended

regulations.



21) directive of the European Parliament and of the Council 2010/53/EU of 7. July

2010 on the quality and safety standards for human organs intended for

transplant.



22) section 112 of the Act No. 372/2007 Sb.



23) Act No. 435/2004 Coll., on employment, as amended

regulations.