Law to ensure the protection of embryos in connection with the importation and use of human embryonic stem cells (stem cell law-StZG)

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StZG

Date of completion: 28.06.2002

Full quote:

" Stem Cell Act of 28 June 2002 (BGBl. 2277), as last amended by Article 2 (29). Article 4 (16) of the Law of 7 August 2013 (BGBl. I p. 3154).

Status:

Last amended by Art. 2 (29) and Art. 4 (16) G v. 7.8.2013 I 3154

For more details, please refer to the menu under Notes

Footnote

(+ + + Text evidence from: 1.7.2002 + + +) 

  

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§ 1 Purpose of the Law

The purpose of this law is to respect and protect human dignity and the right to life and to ensure the freedom of research, in the light of the state's obligation to respect human dignity and the right to life,

1.

to prohibit in principle the importation and use of embryonic stem cells,

2.

to avoid the creation of embryonic stem cells or embryonic stem cell production from Germany, and to avoid the need for the creation of embryonic stem cells,

3.

determine the conditions under which, exceptionally, the importation and use of embryonic stem cells may be authorised for research purposes.

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§ 2 Scope

This law applies to the importation of embryonic stem cells and to the use of embryonic stem cells located in the country. Unofficial table of contents

§ 3 Definitions

For the purposes of this Act

1.

Stem cells are all human cells that have the ability to multiply themselves by cell division in a corresponding environment, and that themselves or their daughter cells become cells of different cells under suitable conditions. Specialisation, but not to develop an individual (pluripotent stem cells),

2.

Embryonic stem cells are all pluripotent derived from embryos which have been produced extracorporally and have not been used to bring a pregnancy or have been taken from a woman before the completion of their implantation in the uterus. Stem cells,

3.

Embryonic stem cell lines are all embryonic stem cells that are kept in culture or are subsequently stored cryoconserved,

4.

Embryo is already any human totipotent cell capable of sharing and developing into an individual in the presence of the necessary further conditions,

5.

Importation is the movement of embryonic stem cells within the scope of this Act.

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§ 4 Import and use of embryonic stem cells

(1) The importation and use of embryonic stem cells shall be prohibited. (2) By way of derogation from paragraph 1, the importation and use of embryonic stem cells for research purposes shall be permitted under the conditions set out in paragraph 6 above, where:

1.

to the conviction of the approval authority that:

a)

the embryonic stem cells, in accordance with the legal situation in the country of origin, have been obtained there before 1 May 2007 and are kept in culture or are subsequently stored in a cryoconserved manner (embryonic stem cell line),

b)

the embryos from which they have been obtained have been produced by medically assisted extracorporeal fertilisation for the purpose of achieving pregnancy, have been definitively no longer used for this purpose and have not been used for this purpose; and there is evidence that this has been done for reasons connected with the embryos themselves,

c)

for the transfer of embryos to the production of stem cells, no pay or other monetary advantage has been granted or promised, and

2.

the importation or use of the embryonic stem cells does not preclude other legal provisions, in particular those of the embryo protection act.

(3) The authorisation shall be refused if the extraction of the embryonic stem cells is manifestly contrary to the principles of the German legal order. Failure to do so cannot be justified by the fact that the stem cells have been obtained from human embryos. Unofficial table of contents

§ 5 Research on embryonic stem cells

Research on embryonic stem cells may only be carried out if it is scientifically substantiated that:

1.

They are responsible for high-ranking research objectives for scientific knowledge in the context of basic research or for the extension of medical knowledge in the development of diagnostic, preventive or therapeutic procedures for use in the field of medicine in humans, and

2.

according to the recognized state of science and technology

a)

the questions referred to in the research project have already been identified as far as possible in in-vitro models with animal cells or in animal experiments, and

b)

the scientific knowledge gained with the research project is likely to be achieved only with embryonic stem cells.

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§ 6 Approval

(1) Any importation and use of embryonic stem cells shall be subject to authorisation by the competent authority. (2) The application for authorisation shall require the written form. The applicant shall, in particular, provide the following information in the application documents:

1.

the name and professional address of the person responsible for the research project;

2.

a description of the research project, including a scientifically substantiated explanation that the research project meets the requirements of § 5,

3.

a documentation of the embryonic stem cells intended for importation or use that the conditions laid down in § 4 (2) (1) are met; the documentation shall be subject to proof that the conditions for the importation or use of the stem cells are:

a)

the embryonic stem cells provided for are identical to those registered in a scientifically recognised register which is open to the public and kept by public or state-authorised bodies; and

b)

This registration fulfils the conditions laid down in Article 4 (2) (1).

(3) The competent authority shall immediately confirm in writing to the applicant the receipt of the application and of the documents annexed thereto. It also brings together the opinion of the Central Ethics Commission for stem cell research. Upon receipt of the opinion, it shall inform the applicant of the opinion and the date of the decision of the Central Ethics Committee for stem-cell research. (4) The authorisation shall be granted if:

1.

the conditions laid down in section 4 (2) are met,

2.

the conditions laid down in § 5 are fulfilled and the research project is ethically justifiable in this sense; and

3.

an opinion of the Central Ethics Committee for stem cell research after participation by the competent authority.

(5) In the case of the complete application documents and an opinion of the Central Ethics Committee for stem cell research, the Authority shall make a written decision on the application within two months. In its decision, the Authority has to take into account the opinion of the Central Ethics Committee for stem cell research. If the competent authority departs from the opinion of the Central Ethics Committee for stem-cell research, the competent authority shall state the reasons for this in writing. (6) The authorisation may be granted subject to conditions and conditions. and shall be limited in time to the extent that this is necessary for the fulfilment or continuous compliance with the conditions of approval referred to in paragraph 4. If, after the granting of the authorisation, facts arise which preclude the approval, the authorisation may be revoked in whole or in part with effect for the future or may be made subject to the fulfilment of conditions or shall be limited to a limited period, to the extent that: this is necessary in order to comply with or continue to comply with the conditions of approval referred to in paragraph 4. Objection and action against the withdrawal or revocation of the authorisation shall not have suspensive effect. Unofficial table of contents

§ 7 Competent Authority

(1) The competent authority shall be a competent authority of the Federal Ministry of Health to be determined by the Federal Ministry of Health in accordance with the provisions of the law. It carries out the tasks assigned to it under this Act as administrative tasks of the Federal Government and is subject to the supervision of the Federal Ministry of Health. (2) For individually attributable public services according to this law are charges and expenses. Apart from the legal entities referred to in § 8 (1) and (2) of the Federal Law on Fees, the payment of fees exempts the research institutions recognized as charitable. (3) The Federal Ministry of Health is authorized to Agreement with the Federal Ministry of Education and Research to determine the chargeable facts and to provide fixed rates or framework rates by means of a legal regulation. In so doing, it is important to take due account of the economic value or the other benefits for the debtors. It may be determined in the regulation that a fee may also be levied on an individually attributable public service which has not been brought to an end if the reasons therefor are to be represented by the person who is responsible for the public service. individually attributable public service. (4) The applicant's own expenses incurred in the fulfilment of information obligations under the authorisation procedure are not to be reimbursed. Unofficial table of contents

§ 8 Central Ethics Commission for stem cell research

(1) An interdisciplinary, independent Central Ethics Commission for stem cell research, composed of nine experts from the fields of biology, ethics, medicine and theology, will be established at the competent authority. , Four of the experts will be appointed from the fields of ethics and theology, five of the experts from the fields of biology and medicine. The members of the Central Ethics Committee for stem cell research will be appointed by the Federal Government for a period of three years. The revocation shall be admissible. For each member, an alternate member is appointed as a rule. (3) The members and the alternates are independent and not bound to any instructions. They are committed to secrecy. § § 20 and 21 of the Administrative Procedure Act shall apply accordingly. (4) The Federal Government shall be authorized, by means of a legal regulation, to provide further information on the appointment and proceedings of the Central Ethics Commission for stem cell research, which shall: the use of external experts as well as cooperation with the competent authority, including the time limits. Unofficial table of contents

§ 9 Tasks of the Central Ethics Committee for stem cell research

The Central Ethics Committee for stem cell research examines and assesses, on the basis of the submitted documents, whether the requirements of § 5 are met and that the research project is ethically justifiable in this sense. Unofficial table of contents

§ 10 Confidentiality of information

(1) The application documents in accordance with § 6 shall be treated confidentially. (2) By way of derogation from paragraph 1, it may be used for inclusion in the register in accordance with § 11

1.

the information on embryonic stem cells according to § 4 para. 2 no. 1,

2.

the name and professional address of the person responsible for the research project;

3.

the basic data of the research project, in particular a summary presentation of the planned research, including the relevant reasons for its high-ranking, the institution in which it is to be carried out and its expected duration.

(3) If the application is withdrawn prior to the decision on the authorisation, the competent authority shall delete the data stored on the application documents and return the application documents. Unofficial table of contents

Section 11 Register

The information on embryonic stem cells and the basic data of the approved research projects shall be kept by the competent authority in a publicly accessible register. Unofficial table of contents

§ 12 Display obligation

The person responsible for the research project shall immediately notify the competent authority of any changes which have subsequently been made to the admissibility of the importation or the use of the embryonic stem cells. § 6 shall remain unaffected. Unofficial table of contents

Section 13 Criminal Code

(1) With a custodial sentence of up to three years or a fine, he shall be punished for who without authorization pursuant to Article 6 (1)

1.

to introduce embryonic stem cells, or

2.

embryonic stem cells that are located in the country.

Without authorisation within the meaning of sentence 1, the person concerned shall also be acting on the basis of an authorisation which has been deliberately misused. The trial is punishable. (2) Imprisonment of up to one year or a fine shall be punished, who shall be contrary to a fully-fledgable edition in accordance with § 6 (6) sentence 1 or 2. Unofficial table of contents

Section 14 Penal rules

(1) The offence is unlawful.

1.

Contrary to the second sentence of Article 6 (2), an indication referred to therein is not correct or not complete, or

2.

Contrary to § 12 sentence 1, an advertisement is not, not correct, not fully or not reimbursed in time.

(2) The administrative offence can be punished with a fine of up to fifty thousand euros. Unofficial table of contents

§ 15 Report

The Federal Government shall send the German Bundestag a report on the implementation of the law at a distance of two years, for the first time at the end of 2003. The report also presents the results of research on other forms of human stem cells. Unofficial table of contents

Section 16 Entry into force

This Act shall enter into force on the first day of the month following the date of delivery.