Machine Translation of "RS 810.211 Order of 16 March 2007 on the transplantation of organs, tissues and cells of human origin (Transplantation O..." (Switzerland)

Art. 1 Purpose and scope

¹ This order shall rule:

A.

The use of organs, tissues and cells of human origin, including:

1.: Their collection on deceased persons or on living persons,
2. ¹: ...
3.: Transplantation of tissues or cells from embryos or fetuses;

B.

The tasks of the cantons in terms of organisation and coordination;

C.

Tasks related to the maintenance of the stem cell registry.

² The use of organs, tissues or cells for autogenous transplantation is governed by:

A. ²: By art. 2, 19, 26, 37 to 44, 48, 49 and 56;
B. ³: In addition, by art. 13, 14, para. 2 and 3, and art. 15 A When organs, tissues or cells are prepared prior to transplantation.

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¹ Repealed by c. 1 of Annex 6 to the O of 20 seven. 2013 on clinical trials, with effect from 1 ^Er Jan 2014 ( RO 2013 3407 ).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 ).

Art. 2 ¹Definitions

For the purposes of this order:

A.: Usage: Any activity involving the use of organs, tissues or cells, including their removal, the fact that they are subjected to a test, their preparation, their import, their export, their storage and their transplantation;
B.: Preparation: Any activity consisting in the preparation of organs, tissues or cells for subsequent transplantation, without altering their physiological properties or functions; in preparation, in particular, culture.

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

Section 1 Involvement of relatives or persons of trust in decision-making

Art. 3 Pros

Are deemed to be close by s. 8, para. 8, of the Transplantation Act:

A.: The spouse, registered partner, or person who has made a life of a couple with the deceased;
B.: Children, parents, brothers and sisters
C.: Grandparents and grandchild;
D.: Other persons who had close ties to the deceased person.

Art. 4 Lack of evidence of consent or refusal

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.

Art. 5 Decision of the relatives

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:

A.: The spouse, registered partner, or person who has made a life of a couple with the deceased;
B.: Children;
C.: Parents, brothers and sisters;
D.: Grandparents and grandchild;
E.: Other persons who had close ties to the deceased person.

³ If there are several relatives within the meaning of para. 1, the levy is allowed if:

A.: All persons reachable within a reasonable period of time give their consent; and
B.: No opposition from non-reachable relatives is known.

Art. 6 Confidence Person

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:

A.: All persons reachable within a reasonable period of time give their consent; and
B.: No opposition from people of non-reachable trust is known.

Section 2 Death Recognition and Preliminary Medical Measures

Art. 7 Finding of death

Death shall be found in accordance with the guidelines set out in Annex 1, c. 1.

Art. 8 Duration of Preliminary Medical Measures

Preliminary medical measures taken under s. 10, para. 3, the Transplantation Act must not last more than 72 hours after the patient's death.

Art. Information of living donor

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:

A.: The purpose and conduct of preliminary examinations and intervention;
B.: The fact that the donation must be freely given and free and that it is punishable if it is made for consideration;
C.: The short-and long-term risks that the donation may pose to the donor's health;
D.: The probable duration of his hospitalization and the extent of incapacity for work or other constraints that may be imposed on him;
E.: The need for the donor to undergo regular health examinations;
F.: The obligation for the transplant centre to monitor the donor's state of health;
G.: Insurance provided for in s. 11 and compensation for costs under s. 12;
H.: General principles of data processing;
I.: The right to object to the donation without having to justify his refusal or to revoke his or her consent without any form of form;
J.: The psychological consequences that the donation by a living donor may have on the donor and the possibility that he or she has the benefit of psychological care;
K.: The expected benefits of transplantation, the harms it may present and any other therapeutic options available to the recipient.

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.

Art. 10 Verification of the freely consented character and free donation made by a living person

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.

Art. 11 Insurance

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.

¹ RS 221.229.1
² RS 832.202

Art. 12 Compensation for Costs

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:

A.: Travel expenses;
B.: Costs associated with verifying the suitability of the donor;
C.: Costs associated with the life follow-up of the donor's health status in accordance with s. 16, let. E, c. 2;
D.: The costs incurred for paid helpers to which the donor is to appeal, in particular the domestic helpers or the aids necessary for the care of persons.

Section 1 General provisions

Art. 13 Quality Assurance

Every person who uses organs, tissues or cells shall have a quality assurance system in accordance with Annex 2, c. 1.

Art. 14 International Regulations

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.

Section 2 Obligation to declare

Art. 15 Collection of organs, tissues and cells ¹

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:

A.: The nature and number of organs or tissues removed;
B.: The nature of the cells taken and the number of cell samples;
C.: The nature and number of tissues transplanted;
D.: The nature of the transplanted cells and the number of cell transplants.

¹ Introduced by ch. I of the O of 10 seven. 2008, effective since October 15. 2008 ( RO 2008 4461 ).

Art. 15 A ¹Storage of hematopoietic stem cells from umbilical blood for autogenous transplantation

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 ).

Section 3 Conditions and conditions for the granting of authorisation

Art. 16 Transplantation of organs

Authorisation to transplant organs shall be issued if:

A.

The company has a technical person with the necessary knowledge and experience, empowered to give instructions in its field of activity and responsible for quality;

B.

The medical specialties required in Annex 6, c. 1, are represented and required medical staff are available;

C.

The premises, apparatus and technical equipment shall be adapted to the intervention in question and to the state of science and technology (Annex 6, c. 2);

D.

The quality assurance system meets the requirements set out in Annex 2, c. 1;

E.

The quality assurance system also includes monitoring of the health of the living donor to ensure that:

1.: The medical and psychosocial data collected before and after the operation will be captured and documented with the consent of the living donor,
2.: The living donor will be offered health checks at appropriate intervals throughout his or her lifetime,
3.: The results of the reviews will be subject to regular scientific evaluation and will be made available to all transplant centres,
4.: The living donor will be informed and advised if the results of the reviews indicate the need for certain measures,
5.: The health impact findings will be incorporated into the information provided to future living donors.

Art. 17 Storage of tissues or cells

Authorization to store tissues or cells is issued if:

A.: The company has a technical person with the necessary knowledge and experience, empowered to give instructions in its field of activity and responsible for quality;
B.: The quality assurance system meets the requirements set out in Annex 2, c. 1.

Art. 18 Import and export of tissues or cells, as well as organs whose allocation is not defined according to Art. 16 to 23 of the Transplantation Act

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:

A.: The company has a technical person with the necessary knowledge and experience, empowered to give instructions in its field of activity and responsible for quality;
B.: The quality assurance system meets the requirements set out in Annex 2, c. 1.

Art. 19 Use of genetically modified organs, tissues or cells

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:

A.: The company has a technical person with the necessary knowledge and experience, empowered to give instructions in its field of activity and responsible for quality;
B.: The quality and biological safety of genetically modified organs, tissues or cells are guaranteed to patients and, in general, to humans, animals and the environment;
C.: The Federal Office for the Environment (OFEV) has, in consideration of the protection of the environment and the indirect protection of the human being, given its agreement for the standard treatment.

¹ New content according to the c. I of the O of 10 seven. 2008, effective since October 15. 2008 ( RO 2008 4461 ).

Section 4 Obligations of holders of an authorisation

Art. Obligations of transplant centres

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:

A.: The nature and number of transplants and transplants and the rate of retransplants;
B.: The survival rate of recipients after one, six and twelve months, and then annually;
C.: Organ survival after one, six and twelve months, and then annually;
D.: Important information about the effects and side effects of immunosuppressive therapy and the influence of the compatibility of tissue characteristics on the operation of the organ;
E.: The number of patients who have developed cancer after transplantation, the types of cancer involved and the time between transplantation and the development of cancer;
F.: Any other data that the transplant centres collect from national and international studies or registers, as well as the related evaluations. ¹

³ The Federal Department of the Interior may:

A.: Setting criteria for recording and evaluating transplant outcomes;
B.: Provide that transplant centres submit other data to the FOPH if they are needed to judge the quality of the transplants.

⁴ Any transplant centre that temporarily or permanently interrupts a transplant program must:

A.: Take immediate action to ensure that transplants can be carried out in another centre if the patients concerned wish to do so;
B.: Inform the patients concerned and the national remit service.

¹ New content according to the c. I of the O of 10 seven. 2008, effective since October 15. 2008 ( RO 2008 4461 ).

Art. Obligations of holders of storage authorization

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:

A.: The nature and number of the fabrics that it has stored;
B.: The nature of the cells it stored and their number in unit doses;
C.: The number of tissue inputs and outputs as well as cells in unit doses.

Art. Obligations of holders of an import or export authorization

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:

A.: The nature and number of the fabrics or organs that it imported or exported;
B.: The nature of the cells that it imported or exported and their number in unit doses;
C.: The country of origin, for imports, and the country of destination, for exports.

Section 5 Duty of care

Art. Aptitude to donation, obligation to perform tests and procedures to be followed in case of reactivity to tests

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.

Art. 24 Communication to the donor of reactivity to the test

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.

Art. 25 Designation of genetically modified organs, tissues or cells

Genetically modified organs, tissues or cells must be labelled "genetically modified".

Art. 26

The Clinical Trials Order of September 20, 2013 ¹ Applies to clinical trials for the transplantation of organs, tissues or cells of human origin.

¹ RS 810.305

Art. 27 To 33

Repealed

Art. 34 Conditions for the granting of authorisation relating to staff qualifications and exploitation

The authorization to transplant tissues or cells from embryos or fetuses is issued if:

A.: The company has a technical person with the necessary knowledge and experience, empowered to give instructions in its field of activity and responsible for quality;
B.: The quality assurance system meets the requirements set out in Annex 2, c. 1.

Art. 35 Information of the donor

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:

A.: The purpose and nature of the use of the tissues or cells;
B.: Diagnostic examinations to which it will be submitted for the purpose of protecting the recipient.

² It must have a reasonable period of reflection in deciding whether or not to give consent.

Art. 36 Information for the couple concerned

¹ The couple concerned referred to in Art. 40 of the Transplantation Act should receive comprehensive and comprehensible information from a specialist doctor, including:

A.: The purpose and nature of the use of the tissues or cells derived from the supernumerary embryo;
B.: Diagnostic examinations to which the couple or supernumerary embryo will be submitted for the purpose of protecting the recipient.

² It must have a reasonable period of reflection to decide whether or not to consent.

Art. Request

¹ The application for authorization must be addressed to the FOPH.

² ... ¹

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:

A.: Scientific literature outlining the results of clinical trials and pre-clinical reviews;
B.: Data on the risks posed by organs, tissues or cells to humans, animals and the environment, including risk analyses conducted under the Contained Use Order of August 25, 1999 ² Or under a procedure abroad relating to confined systems;
C.: A human, animal and environmental risk assessment of transplantation;
D.: A description of the safety measures necessary for the protection of humans, animals and the environment, in particular in order to prevent the release of microorganisms into the environment during and after transplantation, Transport, storage and treatment of waste. ³

⁴ ... ⁴

⁵ The application for authorization for transplantation, as part of standard treatment, for tissues or cells derived from embryos or fetuses, must include:

A.: Scientific literature outlining the results of clinical trials and pre-clinical reviews;
B.: Documents and forms that account for the information provided to the donor or couple concerned and their consent.

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 ).

Art. 38 Scientific evaluation of the application for authorisation

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.

Art. 39 Consultation procedure

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.

Art. 40 Inspection

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.

Art. Scope and duration of validity of authorization

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.

³ ... ¹

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 ).

Art. Suspension and withdrawal

The OFSP may suspend or withdraw the authorization when:

A.: The conditions for granting the authorisation are not or are no longer fulfilled;
B.: The holder of the authorisation does not comply with the obligations assigned to it;
C.: New safety information or scientific basis is required.

Art. 43 Publishing

The OFSP publishes:

A.: Once a year, the identity of the persons holding an authorization and the description of the authorized activity;
B.: Within 30 days, decisions to grant, withdraw or suspend an authorisation and notices of expiry of an authorisation.

Art. 44 Technical requirements for the authorization and reporting regime

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.

Section 1 Tasks of the cantons and local coordinators

Art. 45 Definition and Warranty of Procedures

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:

A.: Identification and management of potential organ, tissue or cell donors and communication of their names to the local coordinator;
B.: Death recognition;
C.: Information and care of relatives, including consent.

² They shall ensure that hospitals with an intensive care unit communicate the names of the local coordinators to the national remit service.

Art. Tasks in transplant centres

¹ The local coordinator shall ensure that the following procedures are properly engaged and coordinated within the transplant centre:

A.: Communication to the national service of the names of patients to be placed on the waiting list or to be removed from the list;
B.: Identification and management of potential donors of organs, tissues or cells;
C.: Death recognition;
D.: Information and care of relatives, including consent;
E.: Communication to the national service of the name of the donors;
F.: Communication to the national service of organ transplants assignments;
G.: Notification to tissue and cell banks of the existence of donors.

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.

Art. Tasks in hospitals

¹ The local coordinator shall ensure that the following procedures are properly committed and coordinated within the hospital:

A.: Identification and management of potential donors of organs, tissues or cells;
B.: Death recognition;
C.: Information and care of relatives, including consent;
D.: Communication to the national service of the name of the donors;
E.: Notification to tissue and cell banks of donor existence;
F.: Levy.

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.

Section 2 Data protection

Art. 48 Processing of personal data

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.

¹ RS 235.1

Art. Data security

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 RS 235.11

Section 3 Stem Cell Registry

Art. 50 Maintenance of the stem cell registry

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 The designation of the administrative unit has been adapted in accordance with Art. 16 al. 3 of the O of 17 Nov 2004 on Official Publications (RS 170.512.1 ). This mod has been taken into account. Throughout the text.

Art. 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.

Art. Obligation to communicate data

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:

A.: Donor code;
B.: Date of birth;
C.: Sex;
D.: Its infectious status with respect to cytomegalovirus;
E.: Tissue characteristics.

Art. Updating annexes

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.

¹ The designation of the administrative unit has been adapted to 1 ^Er Jan 2013 under Art. 16 al. 3 of the O of 17 Nov 2004 on Official Publications (RS 170.512.1 ).

Art. Repeal of the law in force

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]

Art. Amendment of the law in force

The amendment to the existing law is set out in Schedule 7.

Art. 56 Transitional provisions

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.

² ... ²

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 ).

Art. 56 A ¹Transitional provisions relating to the amendment of 10 September 2008

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 ).

Art. 57 Entry into force

This order shall enter into force on 1 ^Er July 2007.

(art. 7, 27, 29, para. 1, let. A, and 51, para. 3)

Guidelines

1.: Ch. II, chap. 1 and 2, and c. III, chap. A to C, the medical-ethical guidelines of the Swiss Academy of Medical Sciences concerning the diagnosis of death in the context of organ transplantation, in their version of 24 May 2011 ².
2.: ...
3.: Guidelines for the World Marrow Donor Associ A Tion (World Association of Cord Donors), in their version of 1 ^Er November 2008 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/.

State 1 ^Er January 2014

(art. 13, 14, para. 1 and 2, 16, let. D, 17, let. B, 18, let. B, and 34, let. (b)

International rules on safety and quality assurance applicable to the use of organs, tissues and cells

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.: Quality assurance referred to in s. 13 is governed by the provisions of chap. 2;
2.: Activities ranging from the removal of organs at the present time before their registry are governed by the provisions of the chap. 4;
3.: The collection, preparation and storage of tissues and cells, with the exception of haematopoietic stem cells, shall be governed by the provisions of chap. 5 (except for c. 7) and chap. 6.

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.

State 1 ^Er January 2014

(art. 14, para. 2)

International rules for Good Manufacturing Practices

The provisions applicable under the Good Manufacturing Practices (GMP) rules are as follows:

1.: Commission Directive 2003 /94/EC of 8 October 2003 laying down the principles and guidelines for good manufacturing practices concerning medicinal products for human use and experimental medicinal products for human use ²;
2.: A guide to good manufacturing practices established by the European Commission for medicinal products for human use and veterinary medicinal products (EudraLex, volume 4) ³.
3.: Principles and Guidelines for Good Manufacturing Practices established under the Convention of 8 October 1970 for the mutual recognition of inspections concerning the manufacture of pharmaceutical products ⁴, in their January 2009 version.

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.

State 1 ^Er January 2014

(art. 14, para. 3)

International rules on the use of hematopoietic stem cells

The provisions for the use of hematopoietic stem cells are as follows:

1.: International Standards for the Sampling, Preparation and Transplantation of Hematopoietic Stem Cells, Fourth Edition, October 2008 ².
2.: International standards for the collection, preparation, testing, storage, selection and delivery of umbilical cord blood, as of December 2008 ³.

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/.

State 1 ^Er January 2014

(art. 14, para. 3, and 23, para. 2)

Evaluation of the aptitude for donation, exclusion of donation, obligation to carry out tests, tests to be carried out, requirements to be met by tests and procedure to be followed in the event of reactivity to HIV, HBV and HCV tests

1	Aptitude Assessment

In the assessment of fitness for a gift referred to in s. 23, para. 1, it should be included:

A.

Medical and social history;

B.

Clinical status;

C.

Physical examination;

D.

Blood testing;

E.

The question of the donor or his or her relatives on:

1.: The risk of infection with the IH virus (HIV) and hepatitis B (HBV) or hepatitis C (HCV) viruses;
2.: The presence of signs of other serious systemic infections that are incurable or of unknown origin, or evidence of contamination by prion disease.

2	Exclusion of donation

The following are excluded from donations:

A.

Serious systemic or incurable systemic infection;

B.

Afflicted with a prion disease, presenting a risk of being infected by such a disease, suspected of being infected with rabies virus or suffering from another degenerative disease of unknown origin affecting the central nervous system;

C.

Malignant neoplasm, regardless of location, with the exception of some primary central nervous system tumours that do not form metastases, primary carcinoma of basal skin cells or in situ carcinoma of the cervix , however, are not excluded from the donation:

1.: Persons who have not developed a tumour for at least five years;
2.: Persons with a malignant disease for corneal donations, with the exception of individuals with retinoblastoma, haematological neoplasm or malignant tumours likely to affect the anterior pole of the eye.

3	Obligation to perform tests

3.1: Analyses adapted to the state of science and technology are carried out, by means of available tests, on organs, tissues, cells or the person who donated them to detect the presence of pathogens or indices Suggesting the presence of such agents.
3.2: The blood sample to be tested should be taken as far as possible before a transfusion or hemodilution. If the sample is taken later, this element must be taken into account when evaluating the results of serological tests.
3.3: If the tests are carried out abroad, it is necessary to prove that they are adapted to the state of science and technology.

4	Tests to be performed

4.1

The following tests should be performed in all cases: HIV-1 and VIH-2, HBV and HCV.

4.2

Testing should include detection of the following:

A.: Anti-HIV-1 and anti-HIV-2 antibody in organ, tissue or cell donors;
A ^Bis.: P24 antigen of HIV-1 in tissue or cell donors, with the exception of directly transplanted pancreatic islets;
B.: HIV-1 viral genome using an appropriate nucleic acid amplification technique in living organ donors;
C.: HBV surface antigen (Ag HBs) and anti-HBc antibodies in organ, tissue, or cell donors;
D.: Anti-HCV antibody in organ, tissue or cell donors;
E.: HCV viral genome using an appropriate nucleic acid amplification technique in tissue and cell donors, with the exception of directly transplanted pancreatic islets, and in living organ donors.

4.3

If the donor has been in high-prevalence areas, the test should focus on the detection of T-cell human leukemia virus (HTLV 1 and 2).

4.4

If the transplant is likely to result in infection, the tests should include the detection of the following pathogens:

A.: Cytomegalovirus;
B.: Pale trepone;
C.: Epstein-Barr; virus
D.: Toxoplasm gondii
E.: Herpes simplex virus;
F.: Herpes Zoster virus.

5	Requirements to be met by tests performed on tissues or cells

5.1

If the donor is deceased, samples for testing must be collected immediately before or immediately after tissue or cell removal.

5.2

If the donor is alive, the samples for testing shall be collected at the time of collection of the tissue or cells, or not more than seven days before or after the collection.

5.2.1

A new sample must be collected 180 days after the first sample and must be tested for serological tests. 4.2, let. A, c and d. Tissues and cells can only be transplanted if the test result on the second sample does not exclude a transplant.

5.2.2

It is possible to give up a second test according to the ch. 5.2.1, if:

A.: In addition to serological tests, the viral genomes VIH-1, HBV and HCV could be determined using an appropriate nucleic acid amplification technique, or
B.: A process for the extraction or inactivation of pathogens, validated for the viruses concerned, could be applied.

6	Procedure for HIV, HBV and HCV Tests

6.1

General A test result is reactive if, based on the state of the science and technology, it can be established that there is an infection or parameters indicating an infection. This may imply that different tests are combined or that the results of some tests are repeatedly reactive.

6.1.1

In case of reactivity to HIV, HBV or HCV tests or tests for the detection of other pathogens, transplantation is permitted if measures to reduce the risk of infection adapted to the state of science and technology are taken and If necessary, prophylaxis of infection or re-infection and post-operative monitoring are carried out.

6.1.2

The recipient must be fully informed about the risk of transplantation for his or her health. If it accepts this risk, it must confirm it in writing. If this information cannot be given before transplantation, it must be given after the intervention.

6.2

Procedure in case of reactivity of pancreatic organs and islets to tests.

6.2.1

In the case of reactivity to the HIV test, organs and pancreatic islets can be transplanted if the recipient is also reactive to the HIV test.

6.2.2

In the case of reactivity to the HBV test, the organs and pancreatic islets can be transplanted if:

A.: The HBV surface antigen (Ag HBs) test result is positive in both the donor and the recipient;
B.: The anti-HBc antibody test result is positive in the donor, or if
C.: The result of the HBV antibody test and HBV surface antigen (Ag HBs) is positive in the donor and the HBV surface antigen (Ag HBs) test result is positive in the recipient.

6.2.3

In the case of reactivity to the HCV test, the organs and pancreatic islets can be transplanted if:

A.

The HCV antibody test result is positive in the recipient and positive or negative in the recipient and the presence of HCV ribonucleic acid has been demonstrated in the recipient using an appropriate technique Nucleic acid amplification;

B.

The HCV antibody test result is positive or negative in both the living donor and the recipient, and the presence of HCV ribonucleic acid has been demonstrated in both the donor and the recipient. Appropriate nucleic acid amplification technology;

C.

The result of the HCV antibody test is positive in the living donor and no evidence of HCV ribonucleic acid has been identified in the living donor using an appropriate acid amplification technique Nucleic and, in the recipient:

1.: The HCV antibody test result is positive, or
2.: The result of the anti-HCV antibody test is negative and the presence of HCV ribonucleic acid has been demonstrated by an appropriate nucleic acid amplification technique.

6.3

Procedure for the reactivity of tissues and cells in tests.

6.3.1

In the case of reactivity to HIV testing, hematopoietic stem cells can be transplanted if the patient's life depends on it and the recipient is also reactive to the HIV test.

6.3.2

In the case of reactivity to HBV or HCV, hematopoietic stem cells can be transplanted if the patient's life depends on it.

6.3.3

In the case of reactivity to HIV, HBV or HCV testing, it is prohibited to transplant other tissues or cells, subject to c. 6.3.4.

6.3.4

If the HBV surface antigen (Ag HBs) test result is negative and that of anti-HBc antibodies is positive, other tissues or cells may be transplanted if it can be guaranteed that a HBV infection of the donor is Excluded.

6.3.5

The Chs. 6.3.3 and 6.3.4 do not apply to pancreatic islets.

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).

State 1 ^Er January 2014

(art. 16, let. B and c)

Transplantation of organs: medical specialties and required operating conditions

1	Medical Specialties Required

1.1

Transplants of the heart, liver, lung, kidney, small intestine, pancreas or pancreatic islets:

A.: Anaesthesiology (with experience in transplantation and external circulatory support);
B.: Angiology;
C.: Transplant surgery;
D.: Diabetology (with experience of acute transplantation and islet isolation, for the transplantation of the pancreas or islets);
E.: Immunology;
F.: Infectivity;
G.: Intensive medicine;
H.: Cardiology (with experience in the treatment of the most serious heart deficiencies, mechanical circulatory support and transplantation);
I.: Nephrology, including emergency dialysis (with experience of acute transplantation and emergency dialysis, for kidney transplantation);
J.: Pathology;
K.: Pneumology, including the possibility of emergency bronchoscopy (with experience of acute transplantation and emergency bronchoscopy for lung transplantation);
L.: Psychosomatic or psychological;
M.: Interventional radiology.

1.2

Transplants of the heart, lung, kidney, small intestine, pancreas or pancreatic islets:

-: Gastroenterology, including emergency endoscopy.

1.3

Liver Transplantation:

-: Hepatology (with experience in acute transplantation and emergency endoscopy).

2	Required operating conditions

2.1

Company-level requirements, operating 24 hours a day, 365 days a year:

A.: Emergency department with emergency response;
B.: Intensive care service;
C.: Operating rooms;
D.: Coordination of transplantation;
E.: Laboratory of Chemistry and Hematology with Emergency Determination Service;
F.: Laboratory with typing system.

2.2

Microbiology Laboratory.

2.3

Laboratory for the determination of serum concentrations for immunosuppressants.

State 1 ^Er January 2014

(art. 55)

Amendment of the law in force

... ¹

¹ The mod. Can be viewed at RO 2007 1961 .

State 1 ^Er January 2014

RS 810.211 Order of 16 March 2007 on the transplantation of organs, tissues and cells of human origin (Transplantation Ordinance)

Original Language Title: RS 810.211 Ordonnance du 16 mars 2007 sur la transplantation d’organes, de tissus et de cellules d’origine humaine (Ordonnance sur la transplantation)

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810.211

Organ, Tissue and Human Cell Transplantation Ordinance

(Transplantation Ordinance)

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