Rs 810.31 Act Of 19 December 2003 Relating To Research On Embryonic Stem Cells (Law On Research On Stem Cells, Lrcs)

Original Language Title: RS 810.31 Loi fédérale du 19 décembre 2003 relative à la recherche sur les cellules souches embryonnaires (Loi relative à la recherche sur les cellules souches, LRCS)

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$20 per month, or Get a Day Pass for only USD$4.99.
810.31 federal law on research on embryonic stem cells (law on research on stem cells, LRCS) of December 19, 2003 (State on January 1, 2014) the Federal Assembly of the Swiss Confederation, view of art. 119 of the Constitution, given the message of the federal Council of November 20, 2002, stop: Section 1 provisions general art. 1 object, purpose and field of application this Act sets the conditions governing the production of supernumerary human embryos from human embryonic stem cells and the use of these cells for research purposes.
It is intended to prevent misuse of supernumerary embryos and embryonic stem cells, and protect human dignity.
It does not apply to the use in the clinical trials of embryonic stem cells for transplantation purposes.

Art. 2 definitions for the purposes of this Act, means: a. embryo: the fruit of the fusion of the nuclei to the end of organogenesis; b. supernumerary embryo: all embryo from fertilization in vitro which cannot be used to induce pregnancy and has therefore no chance of survival; c. embryonic stem cell: any cell from an embryo vitro who is able to differentiate in any cell type , but who can not grow up to become a human being, and the cell line which is out; d. parthenote: from body of an egg is not fertilized.

Art. 3 prohibited practices shall: a. to produce an embryo for research purposes (art. 29, al. 1, of the Act of the Dec. 18, 1998 on medically assisted procreation), to produce stem cells from that embryo or use of such cells; b. changing the hereditary patrimony of germ cells (art. 35, al. 1, of the Act of the Dec. 18, 1998 on medically assisted procreation) to produce embryonic stem cells from an embryo whose germinal heritage has changed or use of such cells; c. to create a clone, a chimera or hybrid (art. 36, para. 1, of the Act of the Dec. 18, 1998 on medically assisted procreation), produce from a clone, a chimera or a hybrid embryonic stem cells , or use of such cells; d. develop a parthenote, produce from a parthenote stem cells, or use of such cells; (e) to import or export an embryo within the meaning of the let. a or b, a clone, a chimera, a hybrid or a parthenote.

It is also forbidden: a. use of supernumerary embryos for one purpose other than the production of cells embryonic stem; b. to import or export supernumerary embryos; c. to produce stem cells from an embryo supernumerary beyond its seventh day of development; d. to implant in a woman a supernumerary embryo used to produce stem cells.

RS 810.11 art. 4 free spare embryos and embryonic stem cells may not be transferred or acquired for a fee.
The use of supernumerary embryos or stem cells acquired for a fee is prohibited.
Are also considered as compensation the granting or acceptance of non-cash benefits.

May give rise to compensation costs: a. conservation or rehabilitation of supernumerary embryos; b. the production, treatment, conservation, or delivery of stem cells.

Section 2 Production of embryonic stem cells from supernumerary embryos art. 5 informed consent a supernumerary embryo cannot be used for the production of embryonic stem cells only if the couple concerned consented freely and in writing. Before giving his consent, the couple must be duly informed, understandably, orally and in writing, of the use that will be made of the embryo.
The consent of the couple may be requested only when the existence of supernumerary embryo is established.
The couple or one of the two partners may at any time withdraw his consent without having to justify its decision as long as the production of stem cells has not started.
If the couple or one of the two partners refuses or withdraws consent, the embryo must be destroyed immediately.
In case of death, the surviving partner decides to use the embryo to produce stem cells; It must take into account the will declared or presumed deceased.

Art. 6 independence of the persons participating in the research the people involved in the production of embryonic stem cells have not the right to participate in the process of reproductive medically assisted of the couple or to give instructions to the people involved in this procedure.

Art. 7 permission for the production of stem cells anyone who wants to produce embryonic stem cells from surplus embryos to carry out a research project must be in possession of an authorization issued by the federal Office of public health (office).
The license is granted on the following conditions: a. the research project received approval from the Ethics Committee under art. 11; b. There is not available in Switzerland adequate stem cells; c. the number of embryos used does not exceed the amount strictly necessary to the production of stem cells; d. scientific personnel and operation meet the requirements.

New content according to section 5 of the annex to the PMQS on Sept. 30. 2011 relating to research on the human being, in effect since Jan. 1. 2014 (2013 3215 RO; FF 2009 7259).

Art. 8 approval for a research project aimed at improving the production process of stem cells, in the framework of a research project to improve the production process, anyone who wants to produce the embryonic stem cells from supernumerary embryos must be in possession of an authorization issued by the Agency.
The license is granted on the following conditions: a. the project fills the scientific and ethical requirements set out in para. 3; (b) the number of embryos used does not exceed the number strictly necessary for the purpose of the research; c. scientific personnel and operation meet the requirements.

A research project can be achieved only if: a. the project aims to get the critical knowledge for the improvement of production processes; b. knowledge of equal value cannot be obtained in any other way; c. the project meets the requirements of scientific quality; d. project is ethically acceptable.

The Agency shall convene independent experts to evaluate the project scientific and ethical points of view.

Art. 9 obligations of the holder of the authorization, the holder of the authorization according to the art. 7 or 8 is required: a. destroy the embryo as soon as embryonic stem cells have been produced; (b) to submit to the office a report on the production of cells strains; c. of stem cells to provide against a possible compensation of costs within the meaning of art. 4 for the research projects in Switzerland and received approval from the commission of ethics in accordance with art. 11. the holder of the authorization for a project to improve the production process is also required: a. to report to the Agency the completion or the interruption of the research project; (b) to make available to the public a summary of these results within a reasonable time after the completion or discontinuance of the research project.

New content according to section 5 of the annex to the PMQS on Sept. 30. 2011 relating to research on the human being, in effect since Jan. 1. 2014 (2013 3215 RO; FF 2009 7259).

Art. 10 authorization to keep supernumerary embryos anyone who wants to keep supernumerary embryos must be in possession of an authorization issued by the Agency.
The license is granted on the following conditions: a. the production of stem cells referred to in art. 7 or 8 was allowed; b. conservation of supernumerary embryos is absolutely necessary to produce stem cells; c. scientific personnel and operations meet the requirements of conservation.

Section 3 use of embryonic stem cells art. 11Autorisation to perform a research project a research project for which cells embryonic stem are used can start only if the competent Ethics Committee gave its authorization.
The jurisdiction of the ethics commission and the authorisation procedure are based on research on the human act of September 30, 2011.

New content according to section 5 of the annex to the PMQS on Sept. 30. 2011 relating to research on the human being, in effect since Jan. 1. 2014 (2013 3215 RO; FF 2009 7259).
RS 810.30 art. 12 scientific requirements and ethics related to a research project a research project for which cells embryonic stem will be used cannot be achieved unless: a. the project is intended to obtain essential knowledge: 1. aiming to find, treat or prevent human disease graves, or2. bearing on the developmental biology of human being;


b. knowledge of equal value cannot be obtained in any other way; c. the project meets the scientific quality requirements; d. the project is acceptable at the ethical level.

Art. 13 obligations of project management project management is required to report to the office, before the project starts, any research project for which cells embryonic stem will be used.
It is also required: a. to declare the completion or the interruption of the research project to the Agency and to the competent ethics commission; b. within a reasonable time after the completion or discontinuance of the research project: 1 to report on the results of the research to the Agency and competent, 2. to make accessible to the public ethics commission summary of these results.

Art. 14 duties of the office the office may prohibit a research project for which cells embryonic stem will be used or impose charges if he does not fully meet the requirements of this Act.

Art. 15 approval of import and export of embryonic stem cells anyone who wants to import or export embryonic stem cells must hold an authorization issued by the office.
The storage in a customs warehouse is considered as an import.
The import authorisation is issued to the following conditions: a. stem cells are used for a research project accurate; b. the stem cells have been produced from embryos that were intended to induce pregnancy, but could not be used for this purpose; c. the concerned couple gave informed consent, freely and without receiving compensation for the use of the embryo for research purposes.

The export authorisation is issued if the conditions governing the use of stem cells in the destination country are equivalent to the requirements of this Act.

Art. 16 obligation to declare the conservation of embryonic stem cells anyone who maintains embryonic stem cells must declare it to the office.
The federal Council may provide for exceptions to this obligation if it is established that the Agency has been informed of another way that stem cells are kept.

Section 4 performance arts. 17. the federal Council implementing provisions: a. fixed the conditions in which consent is given and how and the extent of the information referred to in art. 5; (b) specify the conditions of the granting of the authorisations referred to in art. 7, 8, 10 and 15 and regulates the procedure; c. Specifies the obligations of holders of the authorization under art. 9 and people required to have permission under arts. 10 and 15; d. Specifies the content of the obligation to report and the rules imposed on those who are submitted and under the art project management. 13 and 16; e. clear the content of the register referred to in art. 18; (f) the amount of the fees referred to in art. 22 art. 18 registry office maintains a public register identifying the embryonic stem cells existing in Switzerland and involved research projects.

Art. 19 the office control verifies that the Act is respected. For this purpose, it shall including periodic inspections.
In the accomplishment of this task, he may: a. require that the information and documents necessary to control be provided free of charge; b. access to storage facilities and businesses; c. demand for free other assistance deemed necessary.

Art. 20 obligation to work anyone using surplus embryos or embryonic stem cells is required to attend free agency in the performance of its tasks; It must include: a. provide information; b. give access to the records; c. ensure access to companies and storage facilities.

Art. 21 measures the Board takes all measures necessary for the implementation of this Act.
There including quality for: a. intervene in the event of non-compliance and set a reasonable time limit for the restoration of a situation in conformity with the law; (b) suspend or withdraw an authorization; c. confiscate and destroy embryos and embryonic stem cells not comply with this Act, as well as the clones, chimeras, hybrids and parthenotes.

It has quality to take provisional measures that are necessary. In case of justified suspicion, it can including confine and keep on deposit, the embryonic stem cells, clones, chimeras, hybrids and embryos concerned parthenotes.
When they suspect that there is violation of this Act, customs services are entitled to detain at the border or in the warehouses of the embryos, embryonic stem cells, clones, chimeras, hybrids and parthenotes concerned Customs and seek the assistance of the office. It then proceeds to subsequent investigations and takes the steps that are necessary.

Art. 22 fees fees are charged for: a. the granting, suspension and withdrawal of permissions; (b) enforcement of controls; c. the prescription and enforcement of the measures provided for in art. 21 art. 23 Evaluation the Agency shall assess the effectiveness of this Act.
The federal Department of the Interior presents a report to the federal Council when the assessment is complete, but no later than five years after the entry into force of this Act, and submits proposals on the follow-up to this assessment.

Section 5 provisions criminal art. 24 crime is a punishable of imprisonment anyone intentionally: a. produced embryonic stem cells from an embryo created for research purposes, an embryo whose hereditary heritage has been changed or a clone, a chimera, a hybrid or a parthenote, has used such cells or imported or exported as an embryo, a clone, a chimera , a hybrid or a parthenote (art. 3, para. 1); b. has used a supernumerary embryo for purposes other that the production of embryonic stem cells, imported it or exported, produced embryonic stem cells from supernumerary embryo beyond its seventh day of development, or has implanted in a woman a supernumerary embryo used for the production of embryonic stem cells (art. 3 al. (2) is punishable by imprisonment or a fine of 200,000 francs at most, anyone, intentionally: a. has acquired or disposed of the surplus embryos or embryonic stem cells for a fee, or has used embryos or embryonic stem cells acquired against compensation (art. 4); b. has breached the requirements governing consent of the couple concerned (art. 5); c. engaged in acts subject to authorisation without authorization (art. 7 8, 10 and 15).

If the author has acted by profession, he is liable: a. to a term of imprisonment of more than five years and a fine of 500,000 francs at the most in the case referred to in the al. 1; (b) a sentence of imprisonment of more than five years or a fine of 500,000 francs at the most in the case referred to in para. 2. If the author has acted negligently, imprisonment is six months at the most or the fine of 100,000 francs at most.

Art. 25 contraventions punishable is stops or a fine of 50,000 francs to most anyone, intentionally or negligently, without having committed a crime within the meaning of art. 24: a. has breached the requirements governing the independence of individuals involved in research (art. 6); b. has not fulfilled the obligations that other matters in his capacity as holder of the authorization, has failed to meet expenses related to authorization, has not fulfilled the obligations which rested with the project management or has violated the obligation to report (art. 9, 10 13, 15 and 16); c. did a research project that this project has been banned by the agency or has failed to meet expenses related to this project (art. 14); d. has breached the obligation to cooperate (art. 20); (e) has contravened a prescription of execution whose failure is declared punishable by the federal Council or not complied with a decision which had been served on him under the threat of the penalty provided for in this section.

The attempt and complicity are punishable.
The contravention and the penalty prescribes five years.
In the case of very little gravity, may be dispensed to the criminal complaint, the criminal prosecution and punishment.

Art. 26 jurisdiction and administrative criminal law the prosecution and judgement of offences are the responsibility of the cantons.
The art. 6 and 7 (offences committed in a company) and 15 (false in securities, fraudulent obtaining a false statement) of the Federal Act of 22 March 1974 on administrative penal law shall apply.

RS 313.0 Section 6 provisions final art. 27 change of the law in force.

The mod. can be found at the RO 2005 947.

Art. 28 transitional provision anyone who has already begun a research project for which cells embryonic stem is used must inform the Board three months at the latest after the entry into force of this Act.

Art. 29 referendum and entry into force the present law is subject to the referendum.
The federal Council shall determine the date of entry into force.

Date of entry into force: 1 March 2005 RO 2005 947


RS 101 FF 2003 1065 ACF Feb 2. 2005 State on January 1, 2014

Related Laws