Act No. 227 / 2006 Coll.
Law on research on human embryonic stem cells and related activities and amending certain related laws
Valid
Effective from 01.06.2006
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227
THE LAW
of 26 April 2006
on research on human embryonic stem cells and related activities and amending certain related laws
Parliament has decided on this law of the Czech Republic:
PRINCIPLES OF LETTING WITH HUMAN EMBRYONALS
GENERAL PROVISIONS
Subject matter
This law governs
(a) conditions for research on human embryonic stem cells;
(b) authorising research on human embryonic stem cells;
(c) the conditions for carrying out research activities on human embryonic stem cells;
(d) the competence of the administrative and advisory bodies in the specified areas;
(e) control of research on human embryonic stem cells and related activities;
(f) the registration of human embryonic stem cell lines and the conditions for keeping their register;
(g) administrative penalties for infringement of this law.
Definition of terms
This law means:
(a) research on human embryonic stem cells systematic creative activity carried out in order to acquire new knowledge or use it on human embryonic stem cell lines;
(b) human embryonic stem cells, all pluripotent stem cells derived from human pre-implantation embryos created outside the body;
(c) human embryonic stem cell lines (hereinafter referred to as "lines") all human embryonic stem cells which are stored in or are stored in cryopreserved form,
(d) by the human embryo, a potent cell or a grouping of such cells which are capable of developing into a human individual;
(e) an excess human embryo of such a human embryo which has been produced by an extra-body fertilisation method for assisted reproduction purposes and has not been used for that purpose;
(f) the related activities of imports, exports, transit as well as the acquisition of human embryonic stem cells and their lines; these activities are not part of research;
(g) a list of the basic identification data established for the purpose of identifying and monitoring the origin of human embryonic stem cell lines;
(h) registration of entry into the line register;
(i) imports of human embryonic stem cells (hereinafter referred to as "imports") into the territory of the Czech Republic of human embryonic stem cells,
(j) by export of human embryonic stem cells (hereinafter referred to as "export"), the output of human embryonic stem cells from the Czech Republic.
CONDITIONS OF RESEARCH IN HUMAN EMBRYONAL CURRENT CURRENT AND AUTHORIZATION OF THIS RESEARCH
Conditions for research on human embryonic stem cells
(1) Research on human embryonic stem cells can only be carried out on the basis of an authorisation issued by the Ministry of Education, Youth and Sports (hereinafter referred to as the Ministry). This research may only be carried out at the workplaces listed in the permit for research on human embryonic stem cells.
(2) Research on human embryonic stem cells can only be conducted
(a) on imported lines, if they have been obtained from human embryos in a manner which does not contradict the legislation of the Czech Republic and the country of origin, their import has been authorised by the Ministry and the only reason for their introduction into the Czech Republic is to use them for research purposes under this law; or
(b) on lines derived from excess human embryos from health service providers in the Czech Republic in which assisted reproduction is carried out under special legislation (1) (hereinafter referred to as "assisted reproduction centre").
(3) In the course of research on human embryonic stem cells, tampering with these cells must not result in the creation of a new individual (reproductive cloning).
(4) Both lines and human embryos intended to obtain human embryonic stem cells must be protected from or used for activities which are illegal.
Conditions for issuing a research permit on human embryonic stem cells
(1) Research on human embryonic stem cells may only be carried out on the basis of an authorisation issued by the Ministry designated by the authorisation number.
(2) The Ministry will issue a permit for research on human embryonic stem cells only if it is demonstrated that:
(a) research is used to obtain essential scientific knowledge or to extend medical knowledge in the development of diagnostic, preventive or therapeutic procedures that can be applied to humans;
(b) according to current scientific and technical knowledge, research addresses issues which cannot be addressed only in vitro models with animal cells or in animal experiments;
(c) the expected scientific benefit cannot be achieved in any other way;
(d) the professional level of research, in particular the professional publishing activities, patents or patent applications and annual reports, is guaranteed;
(e) the research project is ethically acceptable; and
(f) the other conditions set out in Sections 3 and 5 are fulfilled.
Application for authorisation for research on human embryonic stem cells
(1) An application for a research permit may only be made in writing in paper form or in electronic form. The applicant may be only a legal person with its registered office in the Czech Republic or, where appropriate, a legal person having its registered office, central administration or principal place of business in the territory of another Member State of the European Union3) and having an organisational component which is listed as an object of activity in the Czech Republic, provided that such activity is included in the establishment or establishment list, the social contract, the statutes or other founding document of the applicant required by the law or provided for by a special law, provided that the applicant is established by it.
(2) The applicant shall indicate in the application for a research permit:
(a) the company or name, registered office and identification number of the person (hereinafter referred to as "identification number") of the applicant and the addresses of the places of work at which the research will be carried out;
(b) the name and, where applicable, the name and surname and address of the place of permanent residence, and, where applicable, the address of the place of residence of the persons exercising the function of the statutory authority of the applicant or his member;
(c) a detailed description of the research activity, indicating the research objectives and methods.
(3) The applicant shall support the application for a research permit:
(a) documentation of the applicant's previous research work in research and development areas available for human embryonic stem cells;
(b) a document proving the integrity of the persons exercising the function of statutory authority of the applicant or of his member in accordance with Article 7;
(c) documentation certifying compliance with the conditions set out in Article 4 (2).
(4) Upon receipt of the request, the Ministry shall, without undue delay, request the Research and Development Council 4 (hereinafter referred to as the Council) for an expert opinion which the Council shall draw up on the basis of an assessment of the request by the Bio-Ethics Commission. The Council shall forward this expert opinion to the Ministry within 8 weeks of the date of receipt of the request for such an opinion.
(5) In cases where the request for authorisation of a research or notification of changes to its focus pursuant to Article 6 (4) is directly related to treatment procedures, the Ministry shall also invite the Ministry of Health to draw up an expert opinion, which shall send it within 8 weeks of receipt of the request for such an opinion.
(6) The expert opinion of the Council or of the Ministry of Health shall clearly recommend or not recommend granting the authorisation and shall state the reasons for the recommendation or recommendation. The opinion shall also assess whether the application meets the conditions set out in Paragraph 4 (2) on a professional and ethical basis.
(7) If, in the decision, the Ministry deviates from or disagrees with the expert opinion of the Council or the Ministry of Health established in accordance with paragraph 5, the decision shall state the reasons for this.
Issue of permits for research on human embryonic stem cells
(1) The authorisation of research on human embryonic stem cells is issued for a period of 6 years only for specific and detailed research activities. The Ministry shall take a decision within 3 months of the date of receipt of the last expert opinion pursuant to Article 5 (4) to (6); if the Council's expert opinion and, where appropriate, the Ministry of Health makes a clear recommendation to grant the authorisation and the applicant fulfils the other conditions under this Act, the Ministry of Research shall issue the research permit.
(2) The Ministry shall indicate in the authorisation:
(a) the name, registered office and identification number of the applicant;
(b) the name and, where applicable, the name and surname and address of the place of permanent residence, and, where applicable, the address of the place of residence of the persons exercising the function of the statutory authority of the applicant or his member;
(c) the addresses of the places where this research can be carried out;
(d) a description or definition of the research activity authorised; and
(e) the date on which the research is authorised;
(f) the number of the research permit.
(3) A legal person authorised to research under this Act may request an extension of the research permit. The authorisation may be extended by a maximum of four years. The Ministry shall decide on the request for extension within 3 months of the date of receipt of the request. An application for an extension of an authorisation for research may not be submitted earlier than 18 months before the expiry of the period of validity but no later than 12 months before that date.
(4) The legal person authorised to research under this law shall, without undue delay, submit to the Ministry a request for authorisation to change the scope of the research, in particular changes to the research objectives and methods. On the basis of such information, the Ministry may amend or revoke the authorisation decision. To this end, the Ministry may request a new opinion from the Council, which shall send it to the Ministry within 8 weeks of the date of receipt of the request. The Ministry shall decide within 3 months of the date of receipt of the Council's expert opinion pursuant to Article 5 (4) and (5). An application for modification of the research permit may be submitted no later than 12 months before the expiry of the research permit.
(5) The legal person entitled to research under this Act shall notify the Ministry of Premature Termination of this Research without undue delay.
(6) The Ministry shall decide to revoke the research permit under this Act if the legal person authorised for research has ceased to comply with the conditions set out in Sections 3 to 6 or has committed an infringement pursuant to Section 16 (1) in the last two years. The decision to revoke the permit for research on human embryonic stem cells shall specify the date of termination of the research.
Proof of integrity
(1) For the purposes of this Act, a person who has not been legally convicted of an intentional offence or an act of negligence committed in connection with the performance of an activity under that law shall be deemed to be righteous if he is not looked at as if he had not been convicted.
(2) A citizen of the Czech Republic can prove integrity by listing from the register of criminal offences 5) not more than 3 months old.
(3) A national of a Member State of the European Union shall prove integrity by means of an extract of the criminal record or an equivalent document issued by the competent judicial or administrative authority of that State or the Member State of last residence. Where that State does not issue an extract from the criminal record or equivalent document, the person exercising the function of statutory authority of the applicant or his member shall submit a declaration of integrity within the meaning of the special legislation (6) made before the notary or authority of the Member State of which he is a citizen, or before the notary or authority of the Member State of last residence. These documents must not be more than 3 months old and must be accompanied by an officially certified translation into the Czech language. The document referred to in this paragraph may be replaced by a certificate of recognition provided that it also proves compliance with the conditions of integrity referred to in paragraphs 1 to 4.
(4) A citizen of a State other than those referred to in paragraph 2 or 3 shall prove integrity by means of an extract of the criminal record and corresponding documents issued by the State of which he is a citizen or by States in which he has remained continuously for more than 3 months in the last 3 years; such documents must not be more than 3 months old and must be accompanied by an officially certified translation into the Czech language.
RELATED ACTIVITIES
Collection of human embryonic stem cells for research purposes from superhuman embryos
(1) The collection of human embryonic stem cells for research purposes from excess embryos is possible if:
(a) the woman and the man from whom the excess embryo was obtained and the donor of germ cells (1) have given written consent in accordance with Article 9;
(b) the excess human embryo has been provided by a centre of assisted reproduction.
(2) Human embryos for the acquisition of human embryonic stem cells for research purposes can only be provided to a legal person carrying out authorised research under this law.
(3) Only superfluous human embryos that are not more than 7 days old may be used to obtain human embryonic stem cells for research purposes, provided that the duration of cryopreservation of the embryo is not included in the age of the embryo.
Written consent to use an excess human embryo to obtain human embryonic stem cells
(1) Written consent under Article 8 (1) (a) may be granted if it is obvious that it is an excess human embryo and at the same time before it is used to obtain human embryonic stem cells. Persons referred to in Article 8 (1) (a) shall be informed, both orally and in writing, of the purpose for which the excess human embryo is to be used before consent is granted in accordance with the first sentence, in an oral and written manner.
(2) The written consent referred to in Article 8 (1) (a) also contains explicit consent to the use of an excess human embryo to create human embryonic stem cells for research purposes and a declaration that they have been familiar with the purpose for which the excess embryo will be used. The written consent shall also include the name and / or surname, address of the place of permanent residence and the signature of the persons referred to in the first sentence, the date of the consent and the business or the name and address of the assisted reproduction centre in which the instruction took place. The written consent referred to in this paragraph shall be kept by the centre of assisted reproduction for at least 30 years from the date of its granting.
(3) The information referred to in the written consent referred to in Article 8 (1) (a) shall be subject to protection under special legislation (7).
(4) The written consent referred to in Article 8 (1) (a) may be withdrawn in writing, without giving any reason, within 3 months of the date of its granting, if the embryo has no longer been used to obtain human embryonic stem cells.
(5) A reward may not be granted for the use of an excess embryo to obtain human embryonic stem cells for research purposes.
(6) The costs of obtaining consent to the use of the embryo for human embryonic stem cells shall be borne by the assisted reproduction centre by a legal person authorised to research under this Act that intends to use these cells to obtain human embryonic stem cells.
Imports of human embryonic stem cells for research purposes
(1) Human embryonic stem cells can only be imported into the Czech Republic for research purposes in the form of a line. Imports of lines shall be subject to the Ministry's authorisation. Imported lines shall not be a source of infectious disease.
(2) The authorisation to import human embryonic stem cells shall be granted by the Ministry to a legal person who applies for a research permit on human embryonic stem cells or who has been granted a research permit under this Act and, at the same time, if the other conditions laid down in paragraphs 3 to 6 are met.
(3) The authorisation to import human embryonic stem cells may be requested no later than 9 months before the expiry of the research authorisation.
(4) Imports of human embryonic stem cells shall be authorised by the Ministry only if this is necessary to ensure the needs of research and development or international cooperation in research and development. The authorisation shall also specify a period of validity which shall not exceed 1 year and shall not exceed the period of validity of the permit for research on human embryonic stem cells.
(5) The applicant shall indicate in the application for import authorisation:
(a) the trading firm or the name, registered office and identification number of the legal person importing the lines;
(b) the names of the countries where the line is registered, including the registration numbers and the names of the registers and the name of the country of origin;
(c) for the import of lines for research in progress, the identification number of the research permit and the name and address of the legal person carrying out the research;
(d) a brief justification for the request.
(6) The applicant shall attach to the application for import authorisation:
(a) an officially certified certificate bearing an officially certified translation into the Czech language, issued by the competent authority of the country of origin, stating that the imported lines cannot be the source of an infectious disease;
(b) an officially certified certificate bearing an officially certified translation into the Czech language, issued by the competent authority of the country of origin, stating that the lines have been obtained in accordance with the legal order of the country of origin.
(7) The Ministry will decide on the application for import authorisation within 3 months of the date of its notification. In the case of an application made at a time when a legal person has yet to apply for the authorisation of a research operation referred to in paragraph 2, import authorisations may not be issued before the decision on the authorisation of a research operation is taken.
Exports and transit of human embryonic stem cells for research purposes
(1) Exports may only be carried out by a legal person who has a valid research permit under this Act.
(2) No later than 7 days before export, the person referred to in paragraph 1 shall notify the Ministry in writing:
(a) the registration number of the line assigned by the Ministry under this Act;
(b) the date when the line leaves the territory of the Czech Republic;
(c) the name and address of the consignee of the lines.
(3) Only lines registered in the Czech Republic that have already been subjected to research can be exported for further research purposes.
(4) The Ministry will include, without delay, data on the export of lines in the register.
(5) The transit of the lines must be notified to the Ministry in writing by the carrier no later than 7 days before the date on which the lines will be transported to the Czech Republic. In addition to the unambiguous identification of the carrier, the transit notification shall indicate the route on which the lines will move on the territory of the Czech Republic and the day on which the lines leave the territory of the Czech Republic. Line transit shall not be recorded in the register.
(6) The transit referred to in paragraph 5 may take no more than 3 days.
(7) Exports of embryos shall be prohibited.
MANAGEMENT OF RESEARCH ON HUMAN EMBRYONAL CABLES
Ministry
The Ministry shall carry out the following activities in the management of research on human embryonic stem cells:
(a) issue, amend or revoke authorisations for research on human embryonic stem cells and imports of human embryonic stem cells under this Act;
(b) ensures the role of the administrator and the operator of the registry of lines;
(c) carry out checks on research centres; in the framework of this activity, monitor whether research on human embryonic stem cells is being carried out in breach of the law and impose administrative penalties for offences pursuant to paragraphs 15 to 17; and
(d) keeps a register of lines; This register is a public administration information system8).
Register of lines
(1) Research on human embryonic stem cells can only be carried out on lines registered by the Ministry. The lines resulting from separation from already registered lines are also subject to registration.
(2) The register of lines contains the following information:
(a) the designation and address of the workplace where the line was created;
(b) the designation and address of the workplace where the line is used for research;
(c) the business name, registered office and identification number of the legal person using the line;
(d) the name of the country of origin;
(e) the number of the research permit;
(f) identification or other registration numbers of the lines in foreign registrations, if any, or other unambiguous identification of the line;
(g) for imported lines, the date of import;
(h) in the case of lines established in the Czech Republic, a commercial firm or the name and address of the assisted reproduction centre provided by the embryo from which the line was created;
(i) the date of issue of the registration certificate;
(j) in the case of the merging lines, the date of the end of the line.
(3) The data contained in the Ministry register are publicly available to everyone, including by remote access; on request, the Ministry shall issue an extract from the registry.
(4) The application for the registration of lines shall be submitted to the Ministry by a legal person who is entitled to research on human embryonic stem cells under this Act and has established or will carry out research on these lines within 30 working days of their creation. The application shall contain the particulars referred to in points (a) to (h) of paragraph 2. The Ministry shall decide on the registration of the lines within 4 weeks of the date of receipt of the application; If the applicant fulfils the conditions for the registration of lines under this Act, the Ministry of Registration shall carry out the registration.
(5) Where the application for a marketing authorisation is incomplete or contains false information, the Ministry shall return it to the applicant within 4 weeks of the date of its notification, indicating the defects in the submission and the request and the time limit for its removal. If the application is not remedied by the deadline, the Ministry shall terminate the proceedings.
(6) For imported lines, the data referred to in points (a) to (g) of paragraph 2 shall be provided in the register by a legal person authorised to research on human embryonic stem cells for which those lines are imported within 10 working days of the date on which they were obtained.
(7) Changes in line data and the addition of line data registered in accordance with paragraph 1 shall be notified by the legal person conducting research on human embryonic stem cells to the Ministry within 10 working days of the date of the change.
Control of research on human embryonic stem cells and related activities
(1) The Ministry is authorised to carry out, even without notification, an inspection at a research site carrying out research in the field of biology and medicine in order to check compliance with the conditions under which the research is carried out, in particular whether the research has been authorised and to check the use of embryos on human embryonic stem cells and to prevent the conduct of unauthorised research on human embryonic stem cells.
(2) The inspection referred to in paragraph 1 shall be carried out by the Ministry through authorised staff ("control staff"). Control officers shall be shown by written mandate. The model of the written mandate shall be laid down by the Ministry by decree. Control officers shall be entitled, outside the rights and obligations laid down by special legislation9) to access and take samples of containers and other storage facilities which serve or may serve to store embryos intended for use on human embryonic stem cells.
(3) The statutory authority or the members of the statutory body of a legal person carrying out research on human embryonic stem cells shall be required to provide the control staff carrying out the checks referred to in paragraph 1 with the required supporting documents concerning such research and other supporting documents which the control staff will find necessary to clarify the circumstances under which the research is carried out.
(4) The Protocol on the result of the inspection shall be issued by the Ministry within 20 working days of the date of completion of the check.
(5) The Ministry's audit activity is governed by special legislation9), unless otherwise provided for in this Act.
(6) The provisions of paragraphs 1 to 5 shall apply mutatis mutandis to the control of research activities referred to in Article 2 (f).
TRANSFERS
Transfers of a natural person
(1) A natural person commits an offence by:
(a) carry out research on human embryonic stem cells in breach of Article 3 (1) or (2); or
(b) it imports human embryonic stem cells in contravention of § 10, or it exports or executes them in breach of § 11.
(2) A fine of up to CZK 20,000 may be imposed for the offence referred to in paragraph 1.
Transfers of a legal entity
(1) A legal person commits an offence by:
(a) carry out research on human embryonic stem cells contrary to § 3 (1) or (2) or infringe the conditions laid down in the permit issued pursuant to § 4 to 7;
(b) imports human embryonic stem cells in contravention of § 10, or exports them or transmits them in breach of § 11;
(c) give incorrect information in the application for authorisation to import human embryonic stem cells pursuant to § 10 or in the notification of their export or transit pursuant to § 11 or in the registration of lines pursuant to § 13 or § 19;
(d) as a person authorised to research on human embryonic stem cells for whose research these lines are imported, they shall not notify the Ministry of Change of Registered Data pursuant to Paragraph 13 (7);
(e) as a person entitled to research under this Act, does not submit a request to the Ministry for authorisation to change the scope of the research or its early termination pursuant to Paragraph 6 (4); or
(f) carry out research on lines which have not been registered under this Act.
(2) The legal person authorised to operate the assisted reproduction centre shall commit an offence by:
(a) provide the human embryo to obtain human embryonic stem cells for research purposes without written consent pursuant to Article 8 (1) (a);
(b) provide the human embryo to obtain human embryonic stem cells for research purposes in breach of Article 8 (3);
(c) provide the human embryo to obtain human embryonic stem cells for research other than authorised;
(d) provide remuneration for written consent to the use of human embryonic stem cells;
(e) does not instruct the persons referred to in Article 8 (1) (a) about the use of the excess embryo referred to in Article 9 (1) and (2); or
(f) shall not maintain the written consent provided for in Article 8 (1) (a) for at least 30 years from the date of its granting.
(3) A fine of up to CZK 2 000 000 may be imposed for the offence referred to in paragraph 1 (a) and (b) and paragraphs 2 (a) to (c), 2 000 000 CZK for the offence referred to in paragraph 2 (d) and 1 000 000 CZK for the offence referred to in paragraph 1 (c) to (f) and 2 (e) and 2 (f) for the fine up to CZK 500 000.
Common provisions on infringements
(1) The Ministry is discussing the transfers under this Act.
(2) The fines are collected by the Ministry.
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Regulation Information
| Citation | Act No. 227 / 2006 Coll., on research on human embryonic stem cells and related activities and amending certain related laws |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 29.05.2006 |
|---|---|
| Effective from | 01.06.2006 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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