Key Benefits:
16 March 2007 (State 1 Er January 2014)
The Swiss Federal Council,
Having regard to art. 2, para. 3, 8, para. 8, 9, para. 2, 10, para. 3, 14, para. 4, 15, 24, para. 2, 25, para. 4, 26, 29, para. 2, 30, para. 3, 31, para. 2 and 3, 36, para. 3, 42, 50, para. 2, 54, 59, para. 6, and 60, para. 1, of the Act of 8 October 2004 on Transplantation (Transplantation Act) 1 ,
Stops:
1 This order shall rule:
2 The use of organs, tissues or cells for autogenous transplantation is governed by:
3 This order does not apply to the use of standardized transplants. The use of organs, tissues or cells used in the manufacture of autogenous standardized transplants is regulated by art. 48 and 49; the use of organs, tissues or cells used in the manufacture of standardized allogeneic transplants is also regulated by art. 3 to 12.
1 Repealed by c. 1 of Annex 6 to the O of 20 seven. 2013 on clinical trials, with effect from 1 Er Jan 2014 ( RO 2013 3407 ).
2 New content according to the c. 1 of Annex 6 to the O of 20 seven. 2013 on clinical trials, effective from 1 Er Jan 2014 ( RO 2013 3407 ).
3 New content according to the c. I of the O of 10 seven. 2008, effective since October 15. 2008 ( RO 2008 4461 ).
For the purposes of this order:
2 In addition, the definitions given to s. 2 of the Clinical Trials Order of September 20, 2013 2 Are applicable.
1 New content according to the c. 1 of Annex 6 to the O of 20 seven. 2013 on clinical trials, effective from 1 Er Jan 2014 ( RO 2013 3407 ).
2 RS 810.305
Are deemed to be close by s. 8, para. 8, of the Transplantation Act:
1 In the absence of documents attesting to the consent or refusal of the deceased person, at least one of the relatives shall be asked if he or she is aware of a declaration of gift made by the deceased person or if he or she may designate another person who has Knowledge of such a declaration.
2 If several relatives are consulted and the statements they are aware of are divergent, the most recent declaration is considered to be decisive.
3 Persons less than 16 years of age may also report a declaration of gift made by the deceased.
1 Has the authority to make the decision the closest to the 16-year-old who had the closest ties to the deceased. The applicant establishes this by questioning the relatives.
2 The applicant may admit, provided that there is no evidence to the contrary, that the persons in the following order were most closely related to the deceased if they had maintained regular personal contact With her until her death:
3 If there are several relatives within the meaning of para. 1, the levy is allowed if:
1 Any person over the age of 16 is entitled to appoint a person of trust under s. 8, para. 6, of the Transplantation Act.
2 If the deceased has designated several persons of trust, the levy is authorized if:
Death shall be found in accordance with the guidelines set out in Annex 1, c. 1.
Preliminary medical measures taken under s. 10, para. 3, the Transplantation Act must not last more than 72 hours after the patient's death.
1 Physicians responsible for the collection of organs, tissues or cells must provide the potential donor with complete and understandable information, both orally and in writing, prior to sampling.
2 They shall inform in particular:
3 They give him a reasonable period of reflection to decide whether or not he gives his consent.
4 They document the information process and keep records for ten years.
1 Organs, tissues or cells may be removed from a living person only if an independent specialist, with the necessary experience for this type of verification, has ensured that the donor has freely consented to the donation and that This one is free.
2 The specialist must document the audit and keep records for ten years, separately from the medical record.
3 If a living potential donor is excluded from the donation, he or she has the right to request a second opinion.
1 Any person who collects organs, tissues or cells on a living person shall ensure that an insurance contract within the meaning of the Act of 2 April 1908 on the insurance contract 1 Has been entered into for that person for the risk of death and disability related to the levy and for a period of at least 12 months from the date of collection.
2 In the event of death, the provision of insurance amounts to 250 000 francs. The right to benefit rests with the survivors.
3 The amount to be provided for a possible disability is 250 000 francs. The insurance benefit is calculated on the basis of the provisions for the evaluation of the damage awards provided for in Schedule 3 of the Accident Insurance Order of December 20, 1982 2 .
Other costs to be reimbursed under s. 14, para. 2, let. B, of the Transplantation Act all costs certified that the removal of organs, tissues or cells causes the donor, in particular:
Every person who uses organs, tissues or cells shall have a quality assurance system in accordance with Annex 2, c. 1.
1 All activities carried out between the moment the organ is removed and the moment before the Registry are governed by Annex 2, c. 2.
2 All activities related to the collection, preparation and storage of tissues or cells, except for haematopoietic stem cells, shall be governed by Annex 2, c. 3, and the Good Manufacturing Practices (GMP) rules set out in Schedule 3.
3 The use of hematopoietic stem cells is governed by Annex 4; the procedure to be followed in the event of reactivity to tests is governed by Annex 5, c. 6.
The declaration concerning the removal of organs, tissues or cells or the transplantation of tissues or cells shall be filed no later than the end of April for the preceding calendar year and shall indicate:
1 Introduced by ch. I of the O of 10 seven. 2008, effective since October 15. 2008 ( RO 2008 4461 ).
Anyone wishing to store hematopoietic stem cells derived from umbilical cord blood for an autogenous transplant must report it to the Federal Office of Public Health (OFSP) before the start of the activity.
1 Introduced by ch. I of the O of 10 seven. 2008, effective since October 15. 2008 ( RO 2008 4461 ).
Authorisation to transplant organs shall be issued if:
Authorization to store tissues or cells is issued if:
Authorisation to import or export tissues or cells, as well as organs whose allocation is not defined according to Art. 16 to 23 of the Transplant Act is issued if:
1 Any person who wishes to transplant, within the framework of standard treatment, genetically modified organs, tissues or cells, or deliver them to third parties, must be authorised by the FOPH. 1
2 The authorisation shall be issued if:
1 New content according to the c. I of the O of 10 seven. 2008, effective since October 15. 2008 ( RO 2008 4461 ).
1 Transplantation centres must publish and transmit to the FOPH at the latest by the end of June the results of transplants carried out during the past calendar year.
2 In particular, the results should indicate:
3 The Federal Department of the Interior may:
4 Any transplant centre that temporarily or permanently interrupts a transplant program must:
1 New content according to the c. I of the O of 10 seven. 2008, effective since October 15. 2008 ( RO 2008 4461 ).
1 The holder of a tissue or cell storage authorization shall maintain a sufficient quantity of appropriate biological samples taken from the donors so that they can be subjected to the tests required during the two Years following the transplantation of tissues or cells.
2 It is required to report to the OFSP no later than the end of April the following data for the past calendar year:
1 The holder of an authorization to import or export may import or export organs, tissues or cells only from or to foreign services that possess an authorization to use tissue, Cells or organs in accordance with the laws of their country.
2 It is required to report to the OFSP no later than the end of April the following data for the past calendar year:
1 The ability to donate is assessed by a physician with the required experience or by a person trained in this activity who is placed under the supervision of a physician.
2 The assessment of the suitability of the donation, the exclusion of the donation, the obligation to carry out tests, the tests to be carried out, the requirements to be met by tests carried out on tissues or cells, as well as the procedure to be followed in case of Reactivity to tests, are governed by Annex 5.
1 The reactivity to a test can only be communicated to the donor if it has been previously confirmed by appropriate methods.
2 This communication must be accompanied by a proposal for appropriate advice and follow-up.
3 The donor may not give up the communication of reactivity to a test only if there is no risk of infection for others.
Genetically modified organs, tissues or cells must be labelled "genetically modified".
The Clinical Trials Order of September 20, 2013 1 Applies to clinical trials for the transplantation of organs, tissues or cells of human origin.
Repealed
The authorization to transplant tissues or cells from embryos or fetuses is issued if:
1 The donor of embryonic or fetal tissue or cells obtained as a result of voluntary termination of pregnancy or spontaneous abortion shall be provided by a specialist doctor with comprehensive and comprehensible information, Including:
2 It must have a reasonable period of reflection in deciding whether or not to give consent.
1 The couple concerned referred to in Art. 40 of the Transplantation Act should receive comprehensive and comprehensible information from a specialist doctor, including:
2 It must have a reasonable period of reflection to decide whether or not to consent.
1 The application for authorization must be addressed to the FOPH.
3 The application for authorisation for transplantation, in the context of standard treatment, of genetically modified organs, tissues or cells, or for their release to third parties must include:
5 The application for authorization for transplantation, as part of standard treatment, for tissues or cells derived from embryos or fetuses, must include:
1 Repealed by c. 1 of Annex 6 to the O of 20 seven. 2013 on clinical trials, with effect from 1 Er Jan 2014 ( RO 2013 3407 ).
2 RS 814.912
3 New content according to the c. 1 of Annex 6 to the O of 20 seven. 2013 on clinical trials, effective from 1 Er Jan 2014 ( RO 2013 3407 ).
4 Repealed by c. 1 of Annex 6 to the O of 20 seven. 2013 on clinical trials, with effect from 1 Er Jan 2014 ( RO 2013 3407 ).
1 The FOPH may call upon independent experts or organizations for the scientific evaluation of the application for authorization.
2 It shall inform the relevant Ethics Commission of the expert opinions on applications for the authorisation of clinical trials.
1 The FOPH decides on applications for the transplantation and delivery of genetically modified organs, tissues or cells to third parties, having received the opinion of the Federal Commission of Experts on Biological Safety (CFSB) and the Federal Ethics Commission for Biotechnology in the Non-Human Domain (CENH).
2 It communicates its decision to the OFEV, the CFSB, the CENH and, in addition, to the competent ethics committee when it comes to clinical trials.
1 The FOPH conducts an inspection to verify that the conditions for granting the authorization are met. It may renounce an inspection if it is established in another way that the conditions for granting the authorisation are fulfilled.
2 It may, at any time, carry out additional inspections. It may instruct the cantons or third parties to carry out inspections.
1 The authorization is issued in the name of the applicant; it is not transferable.
2 Its period of validity shall be no more than five years.
1 Repealed by c. 1 of Annex 6 to the O of 20 seven. 2013 on clinical trials, with effect from 1 Er Jan 2014 ( RO 2013 3407 ).
The OFSP may suspend or withdraw the authorization when:
The OFSP publishes:
The Federal Department of the Interior may issue technical requirements relating to the authorisation and reporting regime and records; it takes into account relevant international standards.
1 The cantons shall ensure that hospitals with intensive care services define, inter alia, the following procedures and ensure that they are carried out 24 hours a day:
2 They shall ensure that hospitals with an intensive care unit communicate the names of the local coordinators to the national remit service.
1 The local coordinator shall ensure that the following procedures are properly engaged and coordinated within the transplant centre:
2 It is responsible for the quality assurance and control of the procedures defined in para. 1.
3 It collaborates with the national remit service, other transplant centres, hospitals and tissue and cell banks.
1 The local coordinator shall ensure that the following procedures are properly committed and coordinated within the hospital:
2 It is responsible for the quality assurance and control of the procedures defined in para. 1.
3 It collaborates with the national authorities, transplant centres and tissue and cell banks.
1 The bodies responsible for the enforcement of the legislation are authorised to process the personal data necessary for carrying out the tasks assigned to them by the Transplantation Act.
2 They may transmit non-confidential data to foreign authorities or institutions and to international organizations.
3 Data processing and the rights of data-processing persons are governed by the Federal Law of 19 June 1992 on Data Protection 1 .
The implementing bodies of the legislation shall take the technical and organisational measures provided for in the data protection legislation to prevent personal data being lost, processed or consulted without any Authorization, or stolen by third parties. In particular, they set out the processing regulations laid down in the Federal Data Protection Act of 14 June 1993. 1 .
1 The maintenance of the stem cell registry referred to in s. 62 of the Transfusion Act is entrusted to Transfusion CRS Switzerland SA (Transfusion CRS) 1 .
2 To this end, the OFSP concludes with Transfusion CRS an agreement which, inter alia, regulates the remuneration, by the Confederation, of delegated tasks.
1 Transfusion CRS processes all requests for the research of hematopoietic stem cells histocompatible with a given patient coming from Switzerland or from abroad.
2 It coordinates the collection, tissue typing and transplantation of hematopoietic stem cells and monitors the health of the donor.
3 It shall carry out the tasks assigned to it in accordance with the directives referred to in Annex 1, c. 3.
1 Anyone who processes the data necessary for the establishment of the compatibility of the tissues shall communicate this data to Transfusion CRS.
2 The communication shall be in a pseudonymous form and shall include in particular:
The Federal Department of the Interior may update Annexes 1 to 6 in order to adapt them to international developments or technical developments. It shall carry out updates which may constitute technical barriers to trade in agreement with the Federal Department of Economics, Training and Research 1 .
The order of 26 June 1996 on the control of transplants 1 Is repealed.
1 [RO 1996 2309, 1999 1403, 2001 1508 3294 hp. II 10, 2002 82]
The amendment to the existing law is set out in Schedule 7.
1 Clinical trials for the transplantation of organs, tissues or cells begun before the entry into force of this order may be continued until the next essential modification to the protocol or until expiry From authorization, but up to 1 Er July 2012 at the latest, in accordance with the provisions of the order of 26 June 1996 on the control of transplants 1 .
1 [RO 1996 2309, 1999 1403, 2001 1508 3294 hp. II 10, 2002 82]
2 Repealed by c. I of the O of 10 seven. 2008, with effect from October 15. 2008 ( RO 2008 4461 ).
Anyone who already stores, at the time of the entry into force of the amendment of 10 September 2008 of this order, haematopoietic stem cells derived from umbilical cord blood for the purpose of an autogenous transplant, must communicate it To the OFSP until 15 April 2009.
1 Introduced by ch. I of the O of 10 seven. 2008, effective since October 15. 2008 ( RO 2008 4461 ).
This order shall enter into force on 1 Er July 2007.
(art. 7, 27, 29, para. 1, let. A, and 51, para. 3)
1 Update as per c. I al. 1 of the DFI O of 12 Jan 2010 ( RO 2010 373 ), c. I of the DFI O of 15 August 2011 (RO 2011 3797) and c. 1 of Annex 6 to the O of 20 seven. 2013 on clinical trials, effective from 1 Er Jan 2014 (RO) 2013 3407).
2 This text is available free of charge from the Federal Office of Public Health, Biomedecine Division, 3003 Berne. It can be obtained from the Swiss Academy of Medical Sciences, Petersplatz 13, 4051 Basel or downloaded from the Internet address www.samw.ch > Ethics > Directives.
3 This text can be ordered against payment, consulted free of charge from the Federal Office of Public Health, Division Biomedecine, 3003 Berne or downloaded from the Internet address www.bag.admin.ch/transplantation/.
(art. 13, 14, para. 1 and 2, 16, let. D, 17, let. B, 18, let. B, and 34, let. (b)
The Guide to the Safety and Quality Assurance of Council of Europe Organs, Tissues and Cells, in its 2009 version 2 , is applicable as follows:
1 Update as per c. I al. 1 of the DFI O of 12 Jan 2010, in force since 1 Er Feb 2010 ( RO 2010 373 ).
2 The Safety and Quality Assurance Guide for Organs, Tissues and Cells (3 E Edition and addendum 2009) may be ordered against payment or consulted free of charge from the Federal Office of Public Health, Division Biomedicine, 3003 Berne.
(art. 14, para. 2)
The provisions applicable under the Good Manufacturing Practices (GMP) rules are as follows:
1 Update as per c. II al. 1 of the O of 10 seven. 2008 ( RO 2008 4461 ) And c. I al. 1 of the DFI O of 12 Jan 2010, in force since 1 Er Feb 2010 (RO 2010 373).
2 OJ L 262, 14.10.2003, p. 22. This directive can be ordered against payment, consulted free of charge from the Federal Office of Public Health, Division Biomedecine, 3003 Berne or downloaded from the Internet address www.bag.admin.ch/transplantation/.
3 The text of the guide " Rules Governing Medicinal Products in the European Union, Volume 4: Medicinal Products for Human and Veterinary Use-Good Manufacturing Pract I These (2009) " Can be ordered against payment, consulted free of charge from the Federal Office of Public Health, Division Biomedecine, 3003 Berne or downloaded from the Internet address www.bag.admin.ch/transplantation/.
4 RS 0.812.101 . This text can be ordered against payment, consulted free of charge from the Federal Office of Public Health, Division Biomedecine, 3003 Berne or downloaded from the Internet address www.bag.admin.ch/transplantation.
(art. 14, para. 3)
The provisions for the use of hematopoietic stem cells are as follows:
1 New content according to the c. I al. 2 of the DFI O of 12 Jan 2010, in force since 1 Er Feb 2010 ( RO 2010 373 ).
2 The text entitled "FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration" Can be ordered against payment, consulted free of charge from the Federal Office of Public Health, Division Biomedecine, 3003 Berne or downloaded from the Internet address www.bag.admin.ch/transplantation/.
3 The text entitled "NetCord FACT International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection, and Release" Can be ordered against payment, consulted free of charge from the Federal Office of Public Health, Division Biomedecine, 3003 Berne or downloaded from the Internet address www.bag.admin.ch/transplantation/.
(art. 14, para. 3, and 23, para. 2)
1 |
Aptitude Assessment |
2 |
Exclusion of donation |
3 |
Obligation to perform tests |
4 |
Tests to be performed |
5 |
Requirements to be met by tests performed on tissues or cells |
6 |
Procedure for HIV, HBV and HCV Tests |
1 Update as per c. II al. 1 of the O of 10 seven. 2008 ( RO 2008 4461 ) And c. I al. 1 of the DFI O of 12 Jan 2010, in force since 1 Er Feb 2010 (RO 2010 373).
(art. 16, let. B and c)
1 |
Medical Specialties Required |
2 |
Required operating conditions |