44/Sb.
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.