About Research On Human Embryonic Stem Cells

Original Language Title: o výzkumu na lidských embryonálních kmenových buňkách

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Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=62632&nr=227~2F2006~20Sb.&ft=txt

227/2006 Sb.



LAW



of 26 March. April 2006



about research on human embryonic stem cells and related

activities and amending certain related laws



Change: 41/2009 Sb.



Change: 227/2009 Sb.



Change: 375/2007 Sb.



Change: 167/2009 Sb.



Change: 89/2009 Sb.



Parliament has passed the following Act of the United States:



PART THE FIRST



THE PRINCIPLES OF TREATMENT OF THE HUMAN EMBRYONIC STEM CELLS



TITLE I OF THE



GENERAL PROVISIONS



§ 1



The subject of the edit



This Act regulates the



and) conditions research on human embryonic stem cells,



b) enabling research on human embryonic stem cells,



(c)) the conditions for the implementation of activities related to research on human

embryonic stem cells,



(d)) the scope of the administrative and advisory bodies in specified regions,



e) check of the research on human embryonic stem cells and

related activities,



f) registration lines of human embryonic stem cells and the conditions

the leadership of their registry,



g) penalties for infringement of this Act.



§ 2



Definition of terms



In this Act shall mean the



research on human) embryonic stem cells a systematic

creative activities for the purpose of acquiring new knowledge or their

use the lines of human embryonic stem cells,



(b)) human embryonic pluripotent stem cells all

stem cells derived from human embryos, preimplantačních

created by mimotělně,



c) lines of human embryonic stem cells ("line")

all human embryonic stem cells, which are held in the

cultures or in connection with them are stored in thoroughly tested donors

the form,



d) human embryo totipotent cell or group of cells,

they are able to develop in the human individual,



(e) human embryo such unnecessary) human embryo, which was

created by fertilization of the discontinued for the purpose of assisted reproduction

and it was not used for these purposes,



f) activities related to the import, export, transit, as well as getting

human embryonic stem cells and cell lines; These activities

are not part of the research,



(g)) the registry list of basic identifying information line established for the

the purpose of identifying and tracing the lines of human embryonic

stem cells,



h) registrations listed in the registry,



I) import human embryonic stem cells ("import")

the entry of human embryonic stem cells on the territory of the Czech Republic,



j) export of human embryonic stem cells ("export")

the output of human embryonic stem cells from the territory of the Czech Republic.



TITLE II



CONDITIONS FOR RESEARCH ON HUMAN EMBRYONIC STEM CELLS AND

AUTHORISATION OF THIS RESEARCH



§ 3



Conditions for research on human embryonic stem cells



(1) research on human embryonic stem cells can be made

only on the basis of a permit issued by the Ministry of education, youth and

Sports (hereinafter referred to as "the Ministry"). This research can be carried out

only in workplaces, which are set out in the permit to conduct research on

human embryonic stem cells.



(2) research on human embryonic stem cells can be made

only



and on the imported lines,) if they have been obtained from human embryos

in a way that does not contradict to the legislation of the United States and the countries

origin, their importation was allowed by the Ministry and the only reason imports

the United States is their use for research purposes in accordance with this

of the Act, or



(b)) on lines derived from surplus human embryos for providers

health services in the Czech Republic, in which the assisted

reproduction by a special legal regulation ^ 1) (hereinafter referred to as "the Centre of

assisted reproduction ").



(3) during the research on human embryonic stem cells must not

occur to these cells, which would lead to the creation of a new

individuals (reproductive cloning).



(4) line as well as human embryos to obtain human embryonic

stem cells must be protected from theft or from their

use the activities that are in conflict with the law.



§ 4



The conditions for the issue of permits to conduct research on human embryonic

stem cells



(1) research on human embryonic stem cells can be made

only on the basis of authorisation issued by the Ministry of marked number

the authorization.



(2) the Ministry shall issue a permit to conduct research on human embryonic

stem cells only if it is satisfied that



and) research is used to obtain the essential scientific knowledge or to

extension of the medical expertise in the development of diagnostic, prevention

or therapeutic procedures which can be applied to humans,



(b)) according to present knowledge of science and technology research addresses the questions that

cannot be solved only on the in-vitro models with animal cells or when

experiments with animals,



(c) the anticipated scientific contribution) cannot be achieved in any other

in a way,



d) is guaranteed to support the level of research, in particular in professional publishing

activities, patents or patent applications and annual reports,



e) research project is ethically acceptable and



f) are satisfied the other conditions referred to in § 3 and 5.



§ 5



Application for a permit to conduct research on human embryonic stem cells



(1) an application for a permit to conduct research may only be submitted in writing in

paper or in electronic form, signed by a recognized electronic

signature ^ 2). The applicant can only be a legal person located in the United

Republic or the legal person that has its registered office, Central Administration

or principal place of business in the territory of another Member

State of the European Union ^ 3) and which has a unit in the Czech Republic

organizational folder you want as the subject of the activities mentioned research, with

the fact that this activity is mentioned in the founding or Charter,

the memorandum, articles of association or other document the incubator

the applicant is required by law or established by a special law, if

the applicant has been established.



(2) in the application for a permit to the applicant's research



and the business name or name), registered office and identification number of the person (hereinafter

"identification number") of the applicant and the addresses of the sites on which the

research is conducted,



(b)) the name or the name and address of the place of residence,

where appropriate, the address of the place of residence of persons who carry out the function of

the statutory body of the applicant or its Member,



(c) a detailed description of the research activity), stating the research objectives and methods.



(3) an application for a permit to the applicant submits proof of research



and documentation of previous research) a job applicant's areas of research

and development for research on human embryonic stem

cells,



b) proof integrity of the persons performing the function

the statutory body of the applicant or its Member under section 7,



(c) the documentation certifying the compliance with conditions) referred to in section 4, paragraph 4. 2.



(4) After receipt of the request, the Ministry of the Council without undue delay

for research and development ^ 4) (hereinafter referred to as "the Board") for a scientific opinion, which

The Council shall, on the basis of the examination of the application Bioetickou by the Commission. The Council of the

send this expert opinion to the Ministry within eight weeks from the date of delivery

the request for this opinion.



(5) in cases where the application for authorisation or notification of changes to its research

the focus according to § 6 paragraph 1. 4 immediately related to treatments

the Ministry will invite to the preparation of expert opinion, also the Ministry of

health care, which it will send within 8 weeks of receipt of this

opinion.



(6) the scientific opinion of the Council or the Ministry of health to uniquely

recommend or not recommend granting of the permit and shall state the reasons for

the recommendations and results from. The opinion also will assess whether

the request after technical and ethical page satisfies the conditions referred to in section 4, paragraph 4.

2.



(7) if the Ministry of the decision departs from the expert opinion

The Council or the Ministry of Health established pursuant to paragraph 5

or if you do not agree with this opinion, stating the reasons for the decision

for this fact.



§ 6



The issue of permits to conduct research on human embryonic stem cells



(1) the authorization of research on human embryonic stem cells

be issued for a period of 6 years, and only at the specific and detailed in the request

the described research activities. The Ministry shall decide within 3 months from the date of

receipt of the latest expert opinion pursuant to § 5 para. 4 to 6; If

expert opinion of the Council, where the Ministry of health,

granting an authorisation clearly recommend, and the applicant has met the other requirements of

under this Act, the Ministry of research will issue a permit.



(2) the Ministry shall indicate in the permit the



and the business name or name), registered office and identification number of the applicant,



(b)) the name or the name and address of the place of residence,

where appropriate, the address of the place of residence of persons who carry out the function of

the statutory body of the applicant or its Member,



(c) the address of the workplace), in which you can carry out this research,



(d) a description or definition) research activity that is allowed, and




(e)) the date by which the research is allowed,



(f) the authorisation number) research.



(3) a legal person entitled to under this Act may

ask for extension of the residence permit to research. The permit may be extended

not more than once, and it's about 4 years old. The application for extension shall decide

Ministry within 3 months from the date of receipt of the request. The request for extension

enabling research may not be earlier than 18 months before the expiry of

its validity period, but not later than 12 months prior to this date.



(4) a legal person entitled to under this Act, shall deliver

the Ministry without undue delay, request for permit changes focus

research, in particular changes to research objectives and methods. On the basis of such

the information Ministry authorisation decision may change or cancel.

To this end, the Ministry may ask the Council about the new opinion, which

the Ministry will send him within 8 weeks from the date of receipt of the request. The Ministry of

shall decide within 3 months from the date of service of the professional opinion of the Council, pursuant to section

5 (3). 4 and 5. Application for amendment of the authorisation may be filed no later than 12 research

months before the expiry of its validity.



(5) a legal person entitled to under this Act, without

undue delay, notify the Ministry of the premature termination of this

research.



(6) the Ministry shall decide on the revocation of the authorisation for research under this

the law, if the legal person authorized to stop

meet the conditions under section 3 to 6 or, in the last two years

committing an administrative offense under section 16(1). 1. in the decision to cancel the

permission to research on human embryonic stem cells shall be

the Ministry and the end date of this research.



§ 7



Demonstrate integrity



(1) for integrity, for the purposes of this Act, the person shall be deemed to

has not been lawfully convicted for an intentional criminal offence or a criminal offence

negligent committed in connection with the performance of the activities referred to in this

the Bill, if it does not look as if he has not been convicted.



(2) a citizen of the United States proves the integrity of the statement of registration

Criminal records ^ 5) not older than 3 months.



(3) a national of a Member State of the European Union proves the integrity of

an excerpt from the register of criminal records or equivalent issued by the competent

judicial or administrative authority of that State or of a Member State

the last stay. If the State does not issue the extract from the register of criminal offences or

an equivalent document, the person performing the function of the statutory

the authority of the applicant or its Member Declaration on good repute within the meaning of

special legal regulation ^ 6) made before a notary public or the body

the Member State of which he is a citizen of, or before a notary public or the body

the Member State of the last stay. These documents must not be older than 3

months and must be fitted with a notarized translation into the Czech language.

Document under this paragraph may be replaced by proof of recognition

If the qualification is a condition of good repute in accordance with

paragraphs 1 to 4.



(4) a foreign State other than those referred to in paragraph 2 or 3

integrity of the statement of evidence of criminal penalties and the relevant documents issued by the

the State of which he is a citizen of, or States in which more than 3 months

continuously in the last 3 years; These documents shall not be

older than 3 months and must be fitted with a notarized translation into the

the Czech language.



TITLE III



RELATED ACTIVITIES



§ 8



Obtaining human embryonic stem cells for research purposes from

of surplus human embryos



(1) Obtaining human embryonic stem cells for research purposes

from surplus embryos is possible, if



a) woman and man, from whom it was obtained, and the extra embryo donors

germ cells ^ 1) have given written consent to do so under section 9,



(b)) redundant human embryo was provided to the Centre of assisted

reproduction.



(2) human embryos to obtain human embryonic stem cells

the purpose of the research can only be granted to a legal person conducting

the research is allowed under this Act.



(3) to obtain human embryonic stem cells for research

purposes, you can use just such excess human embryos, which are not

older than 7 days, with the fact that the age of the embryo does not count towards the period of his

cryopreservation.



§ 9



Written consent to the use of surplus human embryos to obtain the

human embryonic stem cells



(1) the written consent under section 8 (2). 1 (b). and) can be granted if the

obvious that this is a redundant human embryo, and at the same time before the

its use to obtain human embryonic stem cells. Persons

pursuant to section 8 (2). 1 (b). and) must be prior to granting consent pursuant to sentences

the first word of mouth and in writing, clearly and adequately informed about

purpose for which it is to be a redundant human embryo is used.



(2) written consent under section 8 (2). 1 (b). and also contains an express)

consent to the use of redundant human embryo to create a human

embryonic stem cells for research purposes, and a statement that they were

familiar with the purpose of which will be redundant as the embryo is used. A written

consent must also contain the name or names and last names, address

the place of residence and signature of the persons referred to in the first sentence, the date of the grant

consent and the business name or name and address of the center of assisted

reproduction, in which instruction took place. The written consent referred to in this

paragraph holds the Centre for assisted reproduction for at least 30 years

from the date of its grant.



(3) The information referred to in the written consent under section 8 (2). 1 (b). and)

protected by a special legal regulation ^ 7).



(4) the written consent under section 8 (2). 1 (a)), each individually and

without giving a reason in writing to the appeal within 3 months from the date of grant,

If the embryo has already been used to obtain human embryonic

stem cells.



(5) A consent to the use of surplus embryos to obtain human

embryonic stem cells for research purposes shall not be granted

the persons mentioned in § 8 paragraph. 1 (b). and) reward.



(6) the costs associated with obtaining consent of using human embryos

embryonic stem cells will pay the center of assisted reproduction law

a person entitled to under this Act, that it intends to these cells

used to obtain human embryonic stem cells.



§ 10



Importation of human embryonic stem cells for research purposes



(1) human embryonic stem cells may be in the United States

imported for research purposes only in the form of their line. The import lines

is subject to authorisation of the Ministry. Imported lines may not be a source of

infectious disease.



(2) a permit to import human embryonic stem cell grants

the Ministry of legal person applying for a permit to conduct research on

human embryonic stem cells, or that it was issued

research permits under this Act, and at the same time, are met.

other terms and conditions referred to in paragraphs 3 to 6.



(3) for permission to import human embryonic stem cells can be

to apply at the latest 9 months before the expiry date of the authorisation of the research.



(4) the import of human embryonic stem cells will allow the Ministry of

only if this is necessary to ensure the needs of the research and development or

international cooperation in research and development. In the authorisation and shall determine the duration of its

the validity of which shall not be longer than one year and may not exceed a period of

the validity of the permit to conduct research on human embryonic stem

the cells.



(5) in the application for an import permit applicant shall indicate the



and the business name or name), registered office and identification number of the legal

the person carrying out the import lines,



(b)) the names of the countries where the line is registered, including the registration numbers and

the names of the registers and putting the name of the country of origin,



c) when imported lines for ongoing research into the identification number

enabling research and the name and address of the legal person, who research

be carried out,



(d) a brief justification for the request.)



(6) the request for admission of the applicant attaches



and officially certified with confirmation) a notarized translation into the

Czech language issued by the competent authority of the country of origin stating that imported

the line cannot be a source of infectious disease



(b)) a certified confirmation with a notarized translation into the

Czech language issued by the competent authority of the country of origin of that line

have been obtained in accordance with the laws of the country of origin.



(7) the Ministry shall decide on the application for an import permit within 3 months from

the date of its delivery. In the case of an application made at the time when the legal

the person referred to in paragraph 2 of the enabling research only calls cannot be issued

permit imports of previously, takes the decision to allow legal research

power.



§ 11



Export and transit of human embryonic stem cells for research

the purpose of the



(1) exports may make only legal person who has a valid permit

research under this Act.



(2) not later than 7 days prior to export, shall notify in writing the person referred to in paragraph 1

the Ministry of



and the line number assigned) registration by the Ministry under this Act,



(b) the date on which the line) leave the territory of the Czech Republic,



(c) the name and address of the recipient).




(3) Export line can only registered on the territory of the Czech Republic,

that have already been subject to research, and that's only for the purpose of further research.



(4) the Ministry shall include data on exports without delay lines in the registry.



(5) Transit line of the Ministry must be notified in writing to the carrier

at least 7 days before the date when they will be transported to the territory of the Czech line

of the Republic. In the notice of transit, in addition to unique identification

the shipper shall indicate the path along which the line will be on the territory of the Czech Republic

to move around, and the day when the line leaves the territory of the Czech Republic. The transit lines

the registry does not record.



(6) the transit provided for in paragraph 5 may take a maximum of 3 days.



(7) the Exported embryos is prohibited.



TITLE IV



MANAGEMENT OF RESEARCH ON HUMAN EMBRYONIC STEM CELLS



§ 12



The Ministry of



The Ministry is exercised in the management of research on human embryonic

stem cells:



and) issues, changes or cancels a permit to conduct research on human embryonic

stem cells and to import human embryonic stem cells

under this Act,



(b) the role and Manager) for the registry operator,



(c)) performs a scan of research workplaces; within this activity,

monitors that does not conduct research on human embryonic

stem cells in violation of the law, and imposes penalties for administrative

offences under section 15 to 17 and



(d)) maintains a registry of lines; the register is a public information system

Administration ^ 8).



section 13 of the



Register lines



(1) research on human embryonic stem cells can be made

only on the lines of registered Ministry. The registration shall be subject to and

lines resulting from the separation from already registered lines.



(2) the register lines contains the following data



and the designation and address of the workplace), where the line was created, the



(b) designation and address) of the site where the lines used to research,



(c) the trade name or name), registered office and identification number of the legal

the person who uses the line,



(d) the name of the country of origin),



e) authorisation number research



f) identification or other registration numbers lines in foreign

If registrations have been allocated, or other unique

identification of the line,



g) imported lines date of import,



h) for lines that were created in the Czech Republic the business name or name and

the seat of the Centre of assisted reproduction, which has provided an embryo, from which it was

the line created,



I) date of issue of certificate of registration,



j) in the case of insolvent lines sunset date of the line.



(3) the information referred to in the registry of the Ministry of each public

accessible, even by remote access; upon request, issue a

the Ministry statement from the registry.



(4) an application for registration shall submit to the Ministry of the line of the legal entity that

is authorized to conduct research on human embryonic stem cells

under this Act, and these lines has created or will be on the following lines

to carry out research, within 30 working days from the date of their creation. In

the request shall indicate the particulars referred to in paragraph 2 (a). a) to (h)). The Ministry of

shall decide on the registration of the line within 4 weeks from the date of receipt of the request;

If the applicant complies with the conditions for registration lines under this Act;

the Ministry performs registration.



(5) If a registration is incomplete or contains a false

the information Ministry of it returns to the applicant within 4 weeks from the date of its

delivery together with an indication of the defects of administration and challenge and the deadline for their

the deletion. In the absence of defects in the application deadline,

the Department of management of the stops.



(6) in the case of imported lines provides to the registry the information referred to in paragraph 2

(a). a) to (g)) legal person authorized to conduct research on human

embryonic stem cells, whose research with these lines

import, within 10 working days from the date on which these lines.



(7) changes in the data lines and data lines that are

registered in accordance with paragraph 1, it shall notify the legal person conducting

research on human embryonic stem cells to the Ministry within 10

working days of the date on which the change occurred.



§ 14



Review of research on human embryonic stem cells and

related activities



(1) the Ministry is authorised to carry out, even without reporting, control

researching on research work in the field of biology and medicine

in order to check compliance with the conditions under which research is conducted,

in particular, whether the research was permitted, and in order to control the use of embryos to

human embryonic stem cells and preventing the execution of unauthorized

research on human embryonic stem cells.



(2) the Inspection referred to in paragraph 1 shall be exercised by the Ministry through the

responsible for employees (hereinafter referred to as "enforcement officers"). Control

workers demonstrate a written mandate. Pattern written credentials

the Ministry shall determine by Decree. Enforcement officers are outside the rights and

obligations stipulated by special legislation ^ 9) entitled to

access to containers and other storage facilities, which are used

or may be used for the storage of the embryos for use on human

embryonic stem cells, for the storage of lines, and they are entitled to

remove from them the samples.



(3) statutory authority or the members of the statutory body of the legal person,

who carries out the research on human embryonic stem cells, are

required to ensure inspection personnel carrying out checks in accordance with

paragraph 1 required documentation relating to this research and more

the documents control staff find as needed for

the clarification of the circumstances in which the research is carried out.



(4) the Protocol on the outcome of the checks, the Ministry shall issue within 20 working days

from the date of completion of the inspection.



(5) control activities the Ministry is governed by a special legal

regulation ^ 9), unless this Act provides otherwise.



(6) on the control activities related to research under section 2 (b). (f))

the provisions of paragraphs 1 to 5 shall apply mutatis mutandis.



TITLE V OF THE



ADMINISTRATIVE OFFENCES



§ 15



Misdemeanors



(1) a natural person has committed the offence by



and) conducts research on human embryonic stem cells in violation of

with section 3 (2). 1 or 2, or



(b)) takes human embryonic stem cells in contrary to section 10, or is

export or propel in violation of § 11.



(2) for the offence referred to in paragraph 1 can be used to impose a fine of up to $ 2,000.



section 16 of the



Administrative offences of legal persons



(1) a legal person commits an administrative offense, by



and) conducts research on human embryonic stem cells in violation of

with section 3 (2). 1 or 2 or violates any of the conditions laid down in the authorisation issued

under sections 4 to 7,



(b)) takes human embryonic stem cells in contrary to section 10, or is

export or propel in violation of § 11,



(c)) shall indicate the incorrect information in the application for permit to import human

embryonic stem cells under section 10 or in the notice of their exports

or transit under section 11, or when you register the lines pursuant to section 13 or section 19,



(d)) as a person entitled to conduct research on human embryonic stem

the cells, for which research is these lines import, has notified the Ministry of

changes in registered information according to § 13 para. 7,



(e)) as a person entitled to under this Act does not give

application for authorisation to the Ministry changes the focus of the research or its

early termination pursuant to section 6 (1). 4, or



f) conducts research on lines that have not been registered under this

the law.



(2) a legal person entitled to activity center of assisted reproduction

committing an administrative offense, by



and) provide human embryo to obtain human embryonic stem

cells for research purposes without the written consent under section 8 (2). 1 (b).

and)



b) provide human embryo to obtain human embryonic stem

cells for research purposes, contrary to section 8 (2). 3,



c) provide human embryo to obtain human embryonic stem

cells for other than the permitted research



(d)) provide remuneration for the written consent to the use of human embryonic

stem cells,



e) learn the persons mentioned in § 8 paragraph. 1 (b). and) on the use of the surplus

the embryos according to § 9 para. 1 and 2, or



(f)) will not keep written consent under section 8 (2). 1 (b). and) for at least

30 years from the date of its grant.



(3) for the administrative offence referred to in paragraph 1 (b). a) and b) and paragraph 2 (a).

) to c) saves the fine to $ 2 000 000 for the administrative offence pursuant to

paragraph 2 (a). (d) a fine of up to Czk 1 000 000) and for the administrative offence pursuant to

paragraph 1 (b). c) to (f)) and paragraph 2 (a). e) and (f) a fine of up to 500 000)

CZK.



§ 17



Provisions common to administrative offences



(1) a legal person for an administrative offence is not liable if he proves that

made every effort, that it was possible to require that the infringement of the

a legal obligation is prevented.



(2) in determining the amount of the fine on a legal person shall take account of the seriousness of the

the administrative offense, in particular, the way a criminal offence and its consequences, and

the circumstances under which it was committed.



(3) the liability of a legal person for an administrative offense shall cease, if the

administrative authority about him has not initiated proceedings within 1 year from the date on which it

learned, but not later than within 3 years from the date on which it was committed.



(4) administrative offences under this law are heard at first instance

by the Ministry.




(5) the Fines collected and enforced by the Ministry. Fines are receiving State

the budget.



TITLE VI OF THE



COMMON AND TRANSITIONAL PROVISIONS



section 18



(1) in proceedings under this Act shall proceed according to the code of administrative procedure,

unless otherwise provided by this Act.



(2) an application for a permit may be submitted for research and importation at the earliest 2 months after

entry into force of this Act.



(3) in the case of a woman, and if married, whether or not her husband, and the giver

do not or are not known, the excess embryos can be used for

How to obtain human embryonic stem cells for research, if there are

fulfil the other requirements of the law. Consent under section 8 (2). 1 (b).

a) is not required.



§ 19



Registration lines arising before the effective date of this Act,



(1) line created or imported before the date of entry into force of this

the law shall be deemed to have been imported or created in accordance with this

by law, if they are registered until 31 December 2006. December 2008. On these lines

You can do already started research under this Act without the permission of

ministries to 31. December 2008, if the research is carried out in the

part of the research plan, project or grant project according to

special legal regulation ^ 10).



(2) in the application for registration of the line referred to in paragraph 1 shall specify



and the business name or name), registered office and identification number of the legal

people in the Czech Republic, where are the lines used,



(b) the country of origin) and address of the authorized providers of health

the service, which was carried out,



(c) the purpose of the carried out research,)



(d)) the identification or registration number in international registrations,

If this number is allocated, or other unique identification

the embryos.



(3) an application for registration shall submit to the Ministry of the line of the legal entity that

is authorized to conduct research on human embryonic stem cells

under this Act. The request shall specify the information referred to in paragraph 2.

The Ministry shall decide on the registration of the line within 4 weeks from the date of delivery of the

the request; If the applicant complies with the conditions for registration under this line

the law, the Ministry performs registration.



(4) If a registration is incomplete or contains a false

the information Ministry of it returns to the applicant within 4 weeks from the date of its

delivery together with an indication of the defects of administration and challenge and the deadline for their

the deletion. In the absence of defects in the application deadline,

the Department of management of the stops.



PART TWO



cancelled



section 20



cancelled



PART THREE



cancelled



section 21



cancelled



PART FOUR



Amendment of the Act on administrative fees



section 22



In the annex to the Act No 634/2004 Coll., on administrative fees, for

item following item 102, 102A, including footnote

No. 61a is inserted:

"Entry 102A



Receipt of the request

and) ^ 61a) research on human

embryonic stem cells-$ 500

(b)) ^ 61a) imports a line of human

embryonic stem cells-$ 500

c) registration ^ 61a) line of human

embryonic stem cells-$ 500



61A) Act No. 227/2006 Coll., on research on human embryonic

stem cells and related activities and amending certain

related laws. ".



PART FIVE



Amendment of the Act No. 130/2002 Sb.



Article 23 of the



Act No. 131/2002 Coll., on research and development support from the public

resources and amending some related laws (Act on the promotion of

research and development), as amended by law No. 41/2004 Coll., Act No. 215/2004

Coll., Act No. 340/2005 Coll., Act No. 413/2005 Coll. and Act No. 81/2006

Coll., is amended as follows:



1. In section 35 is at the end of paragraph 2, the period is replaced by a comma and the following

the letter i), which read as follows:



"i) processing of opinions on applications for authorisation of research on human

embryonic stem cells or the application for amendment of the authorisation,

where appropriate, the request for authorisation to import human embryonic stem

cells, and this on the basis of the design of its advisory body, which is

Bioetická the Commission. ".



2. In article 35, the following paragraph 7 and 8 are added:



"(7) the Council for research and development shall establish the Commission as their professional Bioetickou

and advisory body that handles documents for solution of tasks of the Council for

research and development related to the bioetickými aspects of research and development,

in particular, the proposals of the expert advice of the Council for research and development applications

about how to enable research on human embryonic stem cells, or to

change requests this authorization, or applications for authorisation

importation of human embryonic stem cells. The Chairman Of The Bio-Ethical

the Commission is a member of the Council for research and development.



(8) the membership of the advisory bodies of the Council for research and development will not constitute a

the employment ratio for the Czech Republic. The rewards for the work in the outlined

bodies provides for the President of the Council for research and development. ".



section 24



The transitional provisions of Act No. 130/2002 Sb.



The Council shall establish Bioetickou as its advisory body to the Commission and shall be approved by the

Statute and rules of procedure within 2 months from the date of entry into force of this

the law. In the Statute of the Council in particular modifies the way to deal with conflicts of interest,

so, in order to ensure independence in the processing of the draft opinion to the

requests for permission to conduct research on human embryonic stem

cells or to change requests this authorization.



PART SIX



cancelled



§ 25



cancelled



PART SEVEN



cancelled



section 26



cancelled



PART EIGHT



The EFFECTIVENESS of the



section 27 of the



This Act shall take effect on 1 January 2000. June 2006.



in z. H K in r.



Klaus r.



Paroubek in r.



1) section 27 and following of Act No. 20/1966 Coll., on the health care of the people, in

amended by Act No 227/2006 Sb.



2) Act No 227/2000 Coll. on electronic signature and amending certain

other laws (the law on electronic signature), as amended

regulations.



3) article 48 of the Treaty establishing the European Community.



4) section 35 of Act No. 130/2002 Coll., on research and development support from the public

resources and amending some related laws (Act on the promotion of

research and development), as amended by Act No 227/2006 Sb.



5) section 11 of Act No. 266/1994 Coll., on criminal records, as amended by Act No.

126/2003 Coll.



6) § 6 para. 1 (b). c) of Act No. 455/1991 Coll., on trades

business (Trade Act).



7) Act No. 101/2000 Coll., on the protection of personal data and on amendments to certain

laws, as amended.



8) Act No. 365/2000 Coll., on public administration and information systems of the

amendments to certain other laws, as amended by Act No. 517/2002 Sb.



9) Act No. 553/1991 Coll. on State control, as amended

regulations.



10) Act No. 131/2002 Coll., as amended.