If an embryo cannot be used to induce a pregnancy, the physician explains to the couple that they are treated as part of a medically assisted reproduction procedure:

A.

The said embryo is supernumerary;

B.

Why it is, and

C.

That it must be destroyed if it is not used, in accordance with the conditions laid down by law, for the production of embryonic stem cells for the purpose of carrying out a research project (production of stem cells) or for a project of Research to improve processes for the production of embryonic stem cells.

¹ If a project for the production of embryonic stem cells or a research project aimed at improving the processes for the production of embryonic stem cells has been authorised, the doctor shall inform the couple orally and in an understandable way:

A.

The nature and purpose of the proposed research project and the expected date for the start of the project;

B.

Of his or her rights under s. 5, para. 3, the law and paras. 3 and 4 of this article;

C.

Free of charge under s. 4 of the Act;

D.

Measures provided for in s. 27 to protect the personal data of the couple;

E.

That third parties may acquire rights in embryonic stem cells or products obtained from embryonic stem cells, in accordance, for example, with the provisions of the Law of 25 June 1954 on patents ¹ , without the couple being able to claim any right;

F.

Embryonic stem cells or products derived from embryonic stem cells can be used in clinical research and practice without the couple being able to avail themselves of any right;

G.

Embryonic stem cells, in accordance with art. 9, para. 1, let. C, of the Act, may be transferred to other research projects; and

H.

The content of the consent form referred to in s. 3.

² The physician provides the couple with an information sheet and consent form provided by the person responsible for the research project (project direction).

³ The couple have the right to ask or have questions put to the project management.

⁴ A reasonable period of reflection must be given to the couple advising that the decision is not taken.

By signing the consent form, the couple stated that they had been informed in accordance with s. 2 and authorizes the use of the supernumerary embryo for the production of stem cells or for a research project aimed at improving the processes for the production of embryonic stem cells.

The refusal or withdrawal of consent by the couple or by one of the two partners shall not be prejudicial to the couple as a result of the treatment.

Anyone who wishes to obtain authorisation to produce embryonic stem cells for the purpose of carrying out a research project (Art. 7 of the Act) shall submit to the Federal Office of Public Health (Office) the following documents for consideration:

A.

The complete file of the embryonic stem cell production project, including an attestation of the suitability of the laboratory facilities;

B.

The complete dossier of the research project for which embryonic stem cells will be used, as submitted to the relevant Ethics Commission pursuant to Art. 17;

C.

The favourable opinion of the competent ethics committee on the research project;

D.

A note, based on an extract from the register referred to in Art. 18 of the law, explaining why the embryonic stem cells available in Switzerland are unsuitable for the research project in question;

E.

Indication of the number of supernumerary embryos likely to be required.

¹ The Office checks:

A. The record provided is complete;

B. The conditions for authorisation laid down by the law are fulfilled.

² He or she may request additional documentation from the project management.

¹ The Office shall decide within 60 days.

² If the Office requests the management of the draft additional documents, the time limit shall begin to run from the date of receipt of the required documents; the Office shall indicate to the project management the date on which the time limit begins to run.

Anyone who wishes to obtain authorisation to carry out a research project aimed at improving the processes for the production of embryonic stem cells (Art. 8 of the Act) shall submit to the Office the following documents for consideration:

A.

The complete record of the research project, including certification of the suitability of the laboratory facilities;

B.

A note explaining how the research project could provide essential knowledge for the improvement of production processes;

C.

A note explaining why it is not possible to obtain in another way knowledge of equal value, in particular through experiments on animal embryos;

D.

Indication of the number of supernumerary embryos likely to be required;

E.

The information sheet and consent form.

¹ The Office checks:

A. The record provided is complete;

B. The information sheet and consent form are understandable and complete;

C. The conditions for authorisation laid down by the law are fulfilled.

² He or she may request additional documentation from the project management.

¹ The Office shall decide within 60 days.

² If the Office requests the management of the draft additional documents, the time limit shall begin to run from the date of receipt of the required documents; the Office shall indicate to the project management the date on which the time limit begins to run.

Anyone who wishes to obtain permission to keep supernumerary embryos (art. 10 of the Act) shall submit to the Office the following documents for consideration:

A.

An authorization issued pursuant to s. 7 or 8 of the Act;

B.

A note explaining why the conservation of supernumerary embryos is absolutely essential;

C.

Certification of staff qualifications;

D.

Proof of the suitability of the laboratory facilities.

The Office checks:

A.

The file provided is complete;

B.

The conditions for authorisation laid down by the law are fulfilled.

Anyone who wishes to obtain authorisation to import embryonic stem cells (Art. 15 of the Act) shall provide the Office with the following documents for consideration:

A.

The complete dossier of the research project for which embryonic stem cells will be used, as submitted to the relevant Ethics Commission pursuant to Art. 17;

B.

The favourable opinion of the competent ethics committee on the research project;

C.

Indication of the number of embryonic stem cells and embryonic stem cell lines necessary, and their characterization, in accordance with Art. 29, para. 1, let. B;

D.

The certificate, provided by the competent body under the law in force in the country concerned or by another body recognised by that country, that:

1.

Embryonic stem cells were obtained from supernumerary embryos,

2.

The couple concerned, having been informed, freely consented to the use of the embryo for research purposes,

3.

The couple receives no remuneration.

The Office checks:

A.

The file provided is complete;

B.

The conditions for authorisation laid down by the law are fulfilled.

Anyone who wishes to obtain authorisation to export embryonic stem cells (Art. 15 of the Act) shall provide the Office with the following documents for consideration:

A.

The title, purpose and location of the research project for which embryonic stem cells will be used;

B.

The name and address of the project management;

C.

An indication of the number of embryonic stem cells and embryonic stem cell lines to be exported, and their characterization, in accordance with Art. 29, para. 1, let. B;

D.

The certificate, provided by the competent body under the law in force in the country concerned or by another body recognised by that country, that:

1.

The project provides essential knowledge on the diagnosis, treatment or prevention of serious diseases or the biology of human development,

2.

The project was ethically approved by an independent body of the project management.

The Office checks:

A.

The file provided is complete;

B.

The conditions for authorisation laid down by the law are fulfilled.

Anyone who needs an opinion from the Ethics Commission to carry out a research project for which embryonic stem cells will be used (art. 11 of the Act) must submit the following documents for consideration:

A.

A complete research project file;

B.

A note explaining why knowledge of equal value cannot be obtained in any other way;

C.

The information sheet and consent form, if it is necessary to produce embryonic stem cells for the research project concerned.

¹ The Ethics Commission shall verify:

A.

The file provided is complete;

B.

That the conditions laid down by law for the conduct of the research project for which stem cells will be used are fulfilled.

² If the research project is carried out at several sites, it is sufficient that the ethics committee responsible for the first site has given a favourable opinion in the framework of an ordinary procedure; the other relevant ethics committees will be able to Take their decision in a simplified procedure. The project management must present the favourable opinion of the competent ethics committee on the first site.

³ The Ethics Commission may, in order to evaluate the research project, use experts and request additional documentation from the project management.

¹ The Ethics Commission shall deliver its opinion within 30 days.

² If it relies on experts or requests the project management to provide it with additional documents, the time limit shall begin to run from the date of receipt of the opinion of the experts or documents required; it shall indicate to the Project direction the date on which the delay begins to run.

¹ Before launching the research project, the project management announces the project to the Office and communicates to it:

A.

The title of the research project, if the Office has already received the file relating to the research project in the context of the authorisation procedure referred to in Art. 5 or 13;

B.

The complete file of the research project, as submitted to the relevant Ethics Commission pursuant to s. 17, and the favourable opinion of the Ethics Commission, if it is a project for which embryonic stem cells are to be used in Switzerland.

² The Office may request additional documentation from the project management.

³ If there is no objection on the part of the Office, the Office shall assign a reference number to the research project within 15 days from the date of receipt of the advertisement or documents required. He communicates this number to the project management.

⁴ The research project can start as soon as the reference number has been communicated.

¹ The Ethics Commission may proceed with the re-evaluation of a research project and, if necessary, withdraw its favourable opinion if new scientific facts and the resulting ethical reassessment require it.

² It shall without delay notify the withdrawal of its favourable opinion to the management of the project and to the Office.

³ If it suspects irregularities in the implementation of the project, it shall inform the Office without delay.

¹ Anyone who produces embryonic stem cells, carries out a research project aimed at improving the processes for the production of embryonic stem cells, preserving surplus embryos, or importing or exporting stem cells Embryo, shall inform the Office of any significant changes that it intends to make to the project concerned.

² Anyone who carries out a research project for which embryonic stem cells are used must inform the Ethics Commission and the Office of any significant changes that it intends to make to the research protocol.

³ The Office or the Ethics Commission and the Office shall decide within 30 days from the date of receipt of the announcement of the amendments.

⁴ A project within the meaning of para. 1 may be continued in accordance with the announced amendments only if the Office issues a new authorisation.

⁵ A research project within the meaning of para. 2 may be continued in accordance with the announced amendments only if the Ethics Commission issues a new favourable opinion and the Office allows the project to be restarted.

¹ Any person producing embryonic stem cells or carrying out a research project aimed at improving the processes for the production of embryonic stem cells shall notify the Office within 15 days of the interruption or completion of the project Concerned.

² Anyone who carries out a research project for which embryonic stem cells are used must announce to the Office and the Ethics Commission within 15 days the interruption or completion of the project.

³ The reasons for the interruption must be specified in the advertisement.

¹ Any person producing embryonic stem cells or carrying out a research project aimed at improving the processes for the production of embryonic stem cells shall submit a report to the Office within six months of the interruption or Completion of the project concerned.

² Anyone who carries out a research project for which embryonic stem cells are used must submit a report to the Office and the Ethics Commission within six months of the interruption or completion of the project.

³ The Office may shorten this period if there are significant grounds for it; it may extend it in exceptional cases duly justified by the project management.

¹ Any final report must document the progress and results of the embryonic stem cell production project, the research project aimed at improving the processes for the production of embryonic stem cells or the project Research for which stem cells were used.

² The final report on a project for the production of embryonic stem cells must also specify:

A.

The number of embryos used;

B.

The number of embryonic stem cells that have been produced and the number of embryonic stem cell lines and their characterization, in accordance with art. 29, para. 1, let. B.

³ The final report on a research project to improve stem cell production processes must also:

A.

Specify the number of embryos used;

B.

Specify the number of embryonic stem cells that have been produced and the number of embryonic stem cell lines and their characterization, in accordance with art. 29, para. 1, let. B, if such stem cells were produced in connection with the project;

C.

Contain a summary of both positive and negative results.

⁴ The final report on a research project for which embryonic stem cells have been used must also contain a summary of the positive and negative results.

Any person who maintains embryonic stem cells shall indicate to the Office, at 1 ^Er July of each year, the number of stem cells entered and released, the number of stem cell lines stored and their characterization, in accordance with art. 29, para. 1, let. B.

¹ Data allowing the identification of the couple concerned shall not be communicated to persons involved in the production of embryonic stem cells or research projects.

² Before placing a supernumerary embryo at the disposal of a project for the production of stem cells or of a research project aimed at improving the processes of production of stem cells, the clinic where in vitro fertilization has been Makes anonymous the data relating to the supernumerary embryo by assigning them a code.

³ For 10 years, it retains the data relating to the couple concerned, the information sheet, the original signed consent form and the code key. Data security measures should correspond to the current state of the art.

The register referred to in Art. 18 of the Act shall include:

A.

To be used for the delivery of embryonic stem cells for research projects in Switzerland within the meaning of Art. 9, para. 1, let. C, of the Act;

B.

To assess whether appropriate embryonic stem cells are available in Switzerland for a given research project;

C.

Provide an overview of current or completed research projects in Switzerland.

¹ Anyone who produces embryonic stem cells, carries out a research project aimed at improving the processes for the production of embryonic stem cells or a project for which embryonic stem cells are used, or Embryonic stem cells should be communicated to the Office:

A.

Description of the project under which embryonic stem cells are produced or used, specifying:

1.

The title of the project

2.

Its purpose,

3.

The name and address of the project management,

4.

The expected start date of the project and its probable duration;

B.

The characterization of embryonic stem cells produced or used in the project as well as that of embryonic stem cell lines used; by embryonic stem cell lines, pluripotent cells are defined Obtained from cells of an early embryo, which can be cultured and reproduced in vitro for several generations and characterized by a stable genotype and phenotype.

² The Office shall record the particulars required in the Register in the Register. 1, let. A, when granting authorizations under s. 5, 8 or 13 or when he receives the announcement under s. 20.

³ It shall publish in the register the summaries provided for in Art. 25, para. 3, para. c, et al. 4.

⁴ It may request clarification on the indications provided.

¹ The emoluments are set within the limits of the ranges defined in Art. 31 They are a function of the time invested and the necessary technical knowledge.

² For benefits that are not explicitly referred to in s. 31, the amount of the fees is calculated on the basis of the time invested. The hourly amount varies, depending on the technical knowledge required and the function of the staff running, from 90 to 200 francs.

The Office shall, inter alia, collect the following fees:

The Office may require a supplement of up to 50 % of the fees if the benefit:

A.

Is, on request, provided as a matter of urgency or outside regular schedules;

B.

Is of unusual magnitude or presents particular difficulties.

In addition to the emoluments, the Office charges disbursements in the present case. In particular, the following are considered disbursements:

A.

Fees of members of commissions, experts and agents;

B.

Costs related to the search for evidence, scientific analysis, special examinations or the need to obtain documents;

C.

Travel and transportation costs;

D.

Costs of analysis performed in its laboratories or other laboratories;

E.

Costs of the work it entrusters to third parties.

The Office may prescribe forms:

A.

For the authorization procedures referred to in s. 5, 8, 11, 13 and 15;

B.

For advertisements or reports referred to in s. 20, 23 and 24;

C.

For indications which must be entered in the register of embryonic stem cells.

This order shall enter into force on 1 ^Er March 2005.