Change The Transplant Law And Other Related Laws

Original Language Title: změna transplantačního zákona a dalších souvisejících zákonů

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LAW



of 31 March 2004. January 2013,



amending the Act No 291/2002 Coll., on the donation, subscriptions and

transplantation of tissues and organs and on amendments to certain laws

(the Transplant Act), as amended, and other

related laws



Parliament has passed the following Act of the United States:



PART THE FIRST



Change the transplant law



Article. (I)



Law no 289/2002 Coll., on the donation, subscriptions and transplantation of tissues and

authorities and on amendments to certain acts (the Transplant Act), as amended by

Act No. 228/2005 Coll., Act No. 297/2008 Coll., Act No. 129/2008 Coll.,

Act No. 41/2009 Coll., Act No. 281/2009 Coll. and Act No. 375/2007 Coll.

is amended as follows:



1. § 1, including title and footnotes 21 and 1 is:



"§ 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).



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.



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

provision (law on health services) ".



2. In article 2, subparagraph (a) at the end of the text), the words "; for the authority

also considered part of the body, in the human body to serve the same

purpose as the entire organ, while maintaining the requirements on structure and vascular

supply ".



3. In paragraph 2 (d)):



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

during the life of this person or after her death, ".



4. In article 2, subparagraph (e) at the end of the text), the words "or non-refundable

stopping blood circulation ".



5. in paragraph 2 of the letter g) is added:



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



6. In paragraph 2 (a). (h)), the words "human consumption" shall be replaced by the word "obtain".



7. in paragraph 2 of the letter i) and (j)):



"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 ".



8. In paragraph 2, the following points (k)) to r) are added:



"the 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 person sešvagřená. ".



9. Footnote 3 shall be repealed, including links to a comment

below the line.



10. in § 5 para. 2 the words "medical equipment" shall be replaced by

"healthcare providers".



11. in § 5 para. 5 the final part of the provision, the words "health

documentation ", the words" a person who intends to give the authority or

the tissue ".



12. In paragraph 5, at the end of paragraph 5, the following sentence "the Ethics Committee shall within

7 days of giving consent or opt-out a copy of the Charter

MRCC transplantation. ".



13. in section 6 is at the end of paragraph 1, the following sentence "an integral part of the

assessment of the medical fitness of the donor and donor characterisation is

characterization of the authority. ".



14. in section 6 is at the end of paragraph 3 the following sentence "the Examining doctor passes

within 7 days of the assessment of the medical fitness of donor extract from

the medical records to the extent of the record in the first sentence

MRCC transplantation. ".



15. in section 6 (1). 5, the word "and" is replaced by a comma and the words "donor

the authorities "with the words" and the range of the data necessary to characterise the

This donor and to characterise organs from this donor. "



16. in section 7 (2). 7, the term "medical equipment" shall be replaced by

"Provider of health services" and the words "medical devices"

replaced by the words "health services provider".



17. in section 10, paragraph 2 reads as follows:



"(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

see death. ".



18. in section 10, paragraph 1. 3 (b). a) after the word "circulation" is inserted after the word "or".



19. in section 10, paragraph 1. 4 (b). (b)), the words "that failed to restore

heart activity or it can effectively support, carried out by the doctor in the length of the

at least 30 minutes; resuscitation is performed at the same time by the artificial

breathing and heart massage "are deleted.



20. in section 10, paragraph 1. 6, the words "No. 2" shall be replaced by the words "this Act".



21. in section 10, paragraph 7 is added:



"(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. "



22. under section 10, the following new section 10a, including title:



"§ 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. ".



23. in article 11, paragraph 4 shall be deleted.



24. in section 12 paragraphs 2 and 3 shall be added:



"(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 tissue bank. ".



25. in section 13, paragraph 1, the following paragraph 2 is added:



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

as 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. ".



The former paragraph 2 becomes paragraph 3.



26. in article 13, the following paragraph 4 is added:



"(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. ".



27. in article 15, paragraph 2. 2, the words "If the deceased is a minor or

a person stripped of eligibility, whether or not the lessons under "are replaced by the words" and, where

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

According to ".



28. in section 18 para. 1, the words ", where appropriate, the additional registers intended for

records of the data related to the donation of organs "shall be deleted.



29. footnote # 12:



"12) section 70 of Act No. 372/2007 Sb.".



30. in section 18 para. 3, the words "with the operation" shall be replaced by "Administration".



31. in section 18 para. 4, after the words "social security number and the word" address ".



32. In article 18, the following paragraph 5 is added:



"(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. ".



33. section 19, including the title reads as follows:



"§ 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. ".



34. In article 20, paragraph 1, the following paragraph 2 is added:



"(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. ".



The former paragraph 2 becomes paragraph 3.



35. In section 20 (2). 3, the word "nearest" is replaced by "appropriate".



36. section 21 and 22, including headings and footnotes 15 and 22 shall be added:



"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.



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.



22) section 112 of the Act No. 372/2007 Sb. ".



37. The footnote No 14 and 16, including links to notes below

line deleted.



38. under section 22 shall be added to § 22a is inserted:



"§ 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. ".



39. In § 23 para. 2 (a). a), the words "medical devices"

replaced by the words "health service providers" and the words "

medical devices "are replaced by the words" with the providers of

health services ".



40. In paragraph 24, at the end of paragraph 2, the period is replaced by a comma and the following

letters e) to (i)), which read as follows:



"e) provides information to the public about the importance and possibilities of

stem cell donation in engaging new donors and

provides guidance for 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. ".



41. In section 24, the following paragraphs 3 and 4 are added:



"(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. ".



42. In § 25 para. 1, the first sentence is replaced by the phrase "the Ministry

Health transplant coordination centre shall be established for the performance of

the tasks referred to in paragraph 2. ' and the last sentence shall be deleted.



43. In § 25 para. 2 at the end of the text of the letter e), the words "on

written in advance of a defined allocation algorithm ".



44. In § 25 para. 2 (f)) repealed.



Subparagraph (g))) to (i) shall become points (f) to (h)).)



45. In § 25 para. 2, letter g) the following points (h)) to)

are added:



"h) cooperates 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 ".



Letter h) is referred to as the letter l).



46. In article 25, paragraph 2, the following paragraph 3 is added:



"(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. '.



47. In article 25, paragraph 3, the following paragraph 4 is added:



"(4) File requests to create workflows 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. "



48. In § 26 paragraph 1 reads:



"(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. ".



49. In article 26, paragraph 3 shall be deleted.



Paragraphs 4 and 5 shall become paragraphs 3 and 4.



50. in section 26 para. 3, the word "institutions" shall be replaced by ' tissues and organs "and

After the word "Exchange" with the words "tissues and".



51. Section 26a and 26b shall be added:



"§ 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. ".



52. In section 26 c of paragraph 1 reads:



"(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) ".



53. In section 26 c, paragraph 4 shall be deleted.



The present paragraph 5 shall become paragraph 4.



54. section 26 d is added:



"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. ".



55. In section 26e, the words "medical facilities" shall be replaced by the word "persons".



56. section 26f shall be deleted.



57. In paragraph 26, the words "European Union member countries" shall be replaced by

"the Member States".



58. section 27 including the title reads as follows:



the "section 27



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. ".



59. In paragraph 28, the end of the text of paragraph 1, the words "shall be added; This does not

without prejudice to the provisions of section 28a to 28 d ".



60. in paragraph 28, the following new section 28a to 28 d, including headings and

footnote # 23:



"§ 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.



23) Act No. 435/2004 Coll., on employment, as amended

regulations. ".



61. In section 29, paragraph 1 reads:



"(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. ".



62. In section 29 para. 2 (a). and) points 1 and 2 shall be added:



' 1. the amount of 100 000 EUR for non-compliance with or breach of duties

set out in § 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, section 23

paragraph. 2, § 24 para. 2 to 4, § 25 para. 2, § 26 para. 1 to 3 of section 26 d

paragraph. 1 or § 28 para. 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. "



63. Annex 1 is replaced by Annex to read as follows:



"Appendix to Act No. 285/2002 Sb.



64. Annex 2 shall be deleted.



Article. (II)



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.



PART TWO



Amendment of the Act on income taxes



Article. (III)



Act No. 586/1992 Coll., on income taxes, as amended by Act No. 35/1993

Coll., Act No. 96/1993 Coll., Act No. 156/1993 Coll., Act No. 196/1993

Coll., Act No. 323/1993 Coll., Act No. 42/1994 Coll., Act No. 85/1994

Coll., Act No. 114/1994 Coll., Act No. 266/1994 Coll., Act No. 32/1995

Coll., Act No. 87/1995 Coll., Act No. 118/1995 Coll., Act No. 149/1995

Coll., Act No. 247/1995 Coll., Act No. 314/1996 Coll., Act No. 18/1997

Coll., Act No. 151/1997 Coll., Act No. 209/1997 Coll., Act No. 209/1997

Coll., Act No. 227/1997 Coll., Act No. 111/1998 Coll., Act No. 148/1998

Coll., Act No. 167/1998 Coll., Act No. 333/1998 Coll., Act No. 63/1999

Coll., Act No. 129/1999 Coll., Act No. 144/1999 Coll., Act No. 169/1999

Coll., Act No. 222/1999 Coll., the Constitutional Court declared under no.

3/2000 Coll., Act No. 17/2000 Coll., Act No. 27/2000 Coll., Act No.

72/2000 Coll., Act No. 100/2000 Coll., Act No. 101/2000 Coll., Act No.

121/2000 Coll., Act No. 132/2000 Coll., Act No. 242/2000 Coll., Act No.

340/2000 Coll., Act No. 492/2000 Coll., Act No. 115/2001 Coll., Act No.

120/2001 Coll., Act No. 239/2001 Coll., Act No. 452/2001 Coll., Act No.

483/2001 Coll., Act No. 50/2002 Coll., Act No. 128/2002 Coll., Act No.

198/2002 Coll., Act No. 210/2002 Coll., Act No. 260/2002 Coll., Act No.

309/2002 Coll., Act No. 575/2002 Coll., Act No. 161/2003 Coll., Act No.

362/2003 Coll., Act No. 441/2003 Coll., Act No. 19/2004 Coll., Act No.

47/2004 Coll., Act No. 49/2004 Coll., Act No. 256/2004 Coll., Act No.

280/2004 Coll., Act No. 359/2004 Coll., Act No. 360/2004 Coll., Act No.

436/2004 Coll., Act No. 561/2004 Coll., Act No. 628/2004 Coll., Act No.

669/2004 Coll., Act No. 676/2004 Coll., Act No. 179/2005 Coll., Act No.

217/2005 Coll., Act No. 340/2005 Coll., Act No. 361/2005 Coll., Act No.

441/2005 Coll., Act No. 530/2005 Coll., Act No. 545/2005 Coll., Act No.

552/2005 Coll., Act No. 56/2006 Coll., Act No. 57/2006 Coll., Act No.

109/2006 Coll., Act No. 112/2006 Coll., Act No. 179/2006 Coll., Act No.

189/2006 Coll., Act No. 203/2006 Coll., Act No. 223/2006 Coll., Act No.

245/2006 Coll., Act No. 262/2006 Coll., Act No. 262/2006 Coll., Act No.

29/2007 Coll., Act No. 67/2007 Coll., Act No. 160/2007 Coll., Act No.

261/2007 Coll., Act No. 296/2007 Coll., Act No. 362/2007 Coll., Act No.

126/2008 Coll., Act No. 306/2008 Coll., Act No. 482/2008 Coll., Act No.

2/2009 Coll., Act No. 87/2009 Coll., Act No. 216/2009 Coll., Act No.

221/2009 Coll., Act No. 227/2009 Coll., Act No. 281/2009 Coll., Act No.

289/2009 Coll., Act No. 303/2009 Coll., Act No. 304/2009 Coll., Act No.

326/2009 Coll., Act No. 362/2009 Coll., Act No. 199/2010 Coll., Act No.

346/2010 Coll., Act No. 348/2010 Coll., Act No. 73/2007 Coll., the award

The Constitutional Court declared under no 119/2007 Coll., Act No. 188/2011

Coll., Act No. 329/2011 Coll., the Act No. 353/2011 Coll., Act No. 355/2011

Coll., Act No. 370/2007 Coll., Act No. 375/2007 Coll., Act No. 420/2011

Coll., Act No. 428/2007 Coll., Act No. 458/2011 Coll., Act No. 466/2011

Coll., Act No. 470/2011 Coll. and Act No. 192/2009 Coll., is amended as follows:



1. In section 4, paragraph 4. 1 the letter j) is added:



"j) income in the form of efficiently, economically and demonstrably

incurred expenses associated with the donation and collection of blood and its

folders, tissues, cells or organs, if this remedy is provided under

other legislation ".



2. in article 15, paragraph 2. 1 at the end of the fourth sentence of the text, the words "and

the value of the collection authority from a living donor is valued at the amount of CZK 20,000. "



Article. (IV)



Transitional provision



The provisions of § 15 para. 1 of Act No. 586/1992 Coll., in the version in force from

the effective date of this Act, apply for the tax for the first time

period calendar year 2013.



PART THREE



Amendment of the Act on public health insurance



Article. In



In section 35a of the Act No. 48/1997 Coll., on public health insurance, and about

amendments to some related laws, as amended by Act No.

285/2002 Coll., Act No. 461/2003 Coll. and Act No. 369/2011 Coll., the words

"the donor's health insurance fund" shall be replaced by "health insurance company

the recipient ".



Article. (VI)



Transitional provision



If it was before the date of entry into force of this Act, has embarked on one of the

processes or activities referred to in section 35 of Act No. 48/1997 Coll., as amended by


effective before the date of entry into force of this Act, it shall pay, as well as

all of the other provisions referred to in this activity and how to apply

This started a transplant even if they were initiated or completed

After the effective date of this Act, the health insurance fund referred to in section

35A of the Act No. 48/1997 Coll., in the version in force before the date of entry into force of

of this Act.



PART FOUR



Amendment of the Act on the subsistence minimum



Article. (VII)



In § 7 para. 2 (a). h) Act No. 110/2006 Coll., on life and existence

a minimum, as amended by the Act No. 261/2007 Coll. and Act No. 458/2007 Coll., section

10:



"10. income in the form of efficiently, economically and demonstrably

incurred expenses associated with the donation and collection of blood and its

folders, tissues, cells or organs, if this remedy is provided under

other legislation ".



PART FIVE



REGULATION (EEC)



Article. (VIII)



Government Regulation No. 436/2002 Coll., implementing Act No. 285/2002

Coll. on the donation, subscriptions and transplantation of tissues and organs and amending

Some laws (transplant law), is hereby repealed.



PART SIX



The EFFECTIVENESS of the



Article. (IX)



This Act shall take effect on the first day of the second calendar month

following the date of its publication.



Němcová in r.



Klaus r.



Nečas in r.

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