Transplantation Act
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Section 1 Non-Commercialism and Prohibition of Tra
Art. 6 Non-commercialism of donation
1 It is prohibited to offer, grant, request or accept a financial gain or a comparable advantage for a donation of human organs, tissues or cells. 2 The following are not regarded as a financial gain or a comparable advantage: a. reimbursement of loss of earnings and expenses incurred directly by the donor; b. compensation for damage incurred by the donor as a result of organs, tissues or cells being removed; c. a subsequent symbolic gesture of gratitude; d. a crossover living donation.
Para. 1 — Amended by Annex No 1 of the FD of 19 June 2020 on the Approval of the Council of Europe Convention against Trafficking in Human Organs and on its Implementation, in force since 1 Feb. 2021 (AS 2020 6567; BBl 2019 5971).
Art. 7 Prohibition of trade
1 It is prohibited: a. to trade in human organs, tissues or cells; b. to remove organs, tissues or cells from a living or deceased person or to transplant such human organs, tissues or cells if a financial gain or a comparable advantage has been offered, granted, requested or accepted for such organs, tissues or cells. 2 This prohibition does not apply to: a. the reimbursement of expenses incurred in the context of transplantation, and in particular costs for removal, transport, preparation, storage and transplantation; b. transplant products in accordance with Article 49.
Para. 1 let. b — Amended by Annex No 1 of the FD of 19 June 2020 on the Approval of the Council of Europe Convention against Trafficking in Human Organs and on its Implementation, in force since 1 Feb. 2021 (AS 2020 6567; BBl 2019 5971).
Section 2 Removal of Organs, Tissues or Cells from
Art. 8 Preconditions for removal
1 Organs, tissues or cells may be removed from a deceased person if: a. the person has consented before their death to the removal; b. death has been determined. 2 If no documented consent or refusal by the deceased person is available, the next of kin must be asked whether they are aware of the person having declared an intention to donate. 3 If the next of kin are not aware of any such declaration, organs, tissues or cells may be removed if the next of kin give consent. The decision of the next of kin shall be guided by what they believe the deceased person would have wanted. 3bis The request to the next of kin may be made and their consent obtained only once it has been decided to discontinue life support measures. 4 If there are no next of kin, or they cannot be contacted, removal is not permitted. 5 The wishes of the deceased person take priority over those of the next of kin. 6 If the deceased person has demonstrably delegated the decision on the removal of organs, tissues or cel
Para. 3bis — Inserted by No I of the FA of 19 June 2015, in force since 15 Nov. 2017 (AS 2016 1163, 2017 5629; BBl 2013 2317).
Art. 9 Criteria for death and determination of death
1 A person is dead if the functions of their brain, including the brain stem, have ceased irreversibly. 2 The Federal Council shall issue regulations on the determination of death. In particular, it shall specify: a. which clinical signs must be present so that it can be concluded that the functions of the brain, including the brain stem, have ceased irreversibly; b. the requirements which must be fulfilled by the doctors who determine death.
Art. 10 Preparatory medical measures
1 Medical measures intended solely to preserve organs, tissues or cells may only be undertaken prior to the death of the donor if the donor has been informed comprehensively and has freely given their consent. 2 If the donor is incapable of judgement and has not given their consent, measures in terms of paragraph 1 may only be carried out if the next of kin consent, and the measures meet the requirements of paragraph 3 letters a and b. The decision of the next of kin shall be guided by what they believe the deceased person would have wanted. 3 If they are uncertain as to what the donor would have wanted, the next of kin may consent to measures under paragraph 1 if these: a. are essential for the successful transplantation of organs, tissue or cells; and b. any risk or harm to the donor is minimal. 4 The Federal Council shall specify which measures do not meet the requirements of paragraph 3 letters a and b. It shall consult interested groups beforehand. 5 The next of kin may consent to
Art. 10 — Amended by No I of the FA of 19 June 2015, in force since 15 Nov. 2017 (AS 2016 1163, 2017 5629; BBl 2013 2317).
Art. 11 Independence of persons involved
1 Doctors who determine the death of a person may not: a. participate either in the removal or the transplantation of organs, tissues or cells; b. be subject to orders from a medical professional who is involved in such activities. 2 Doctors who remove or transplant organs, tissues or cells and associated medical personnel must not pressurise individuals who are caring for the dying person or who determine death or attempt to influence them in any other way.
Section 3 Removal of Organs, Tissues and Cells fro
Art. 12 Preconditions for removal
Organs, tissues and cells may be removed from a living person if: a. that person is capable of judgement and has reached the age of majority; b. that person has been informed comprehensively and has freely given their consent in writing; c. there is no serious risk to their life or health; d. the recipient cannot be treated with any other therapeutic method with comparable benefit.
let. a — Expression in accordance with Annex No 21 para. 1 of the FA of 18 Dec. 2008 (Adult Protection, Law of Persons and Law of Children), in force since 1 Jan. 2013 (AS 2011 725; BBl 2006 7001). This amendment has been made throughout the text.
Art. 13 Protection of persons incapable of judgement and minors
1 Organs, tissues and cells may not be removed from persons who are incapable of judgement or who are minors. 2 Exceptions may be permitted for the removal of tissues or cells capable of regeneration if: a. removal involves only a minimal risk and harm to the person who are incapable of judgement or minor; b. the recipient cannot be treated with any other therapeutic method with comparable benefit; c. no suitable adult donor who is capable of judgement is available; d. the recipient is a parent, child or sibling of the donor; e. the donation is likely to save the recipient's life; f. the legal representative has been informed comprehensively and has freely given their consent in writing; g. the donor who is a minor capable of judgement has been informed comprehensively and has freely given their consent in writing; h. there is no indication that the person incapable of judgement would object to removal; i. an independent authority has given permission. 3 A person incapable of judgement
Art. 13 — Expression in accordance with Annex No 21 para. 2 of the FA of 18 Dec. 2008 (Adult Protection, Law of Persons and Law of Children), in force since 1 Jan. 2013 (AS 2011 725; BBl 2006 7001). This amendment has been made throughout the text.
Art. 14 Reimbursement of expenses and insurance
1 Any person who removes organs, tissues or cells from a living person must ensure that this person is adequately insured against possible serious consequences of removal. 2 The insurer that would be responsible for the costs of treating the recipient's health condition if no living donation were available shall be responsible for: a. the cost of this insurance; b. compensation for loss of earnings and other expenses incurred by the donor in connection with removal. 2bis If the insurance contract is terminated for reasons other than a change of insurer, the insurer responsible prior to termination of the insurance contract remains liable for the costs. 3 The duty to bear costs stipulated in paragraph 2 shall also apply if the removal or transplantation cannot be carried out. If the recipient's insurer is not known, the Confederation shall bear the costs. 4 The Federal Council shall specify in particular: a. the serious consequences against which the donor must be insured; b. the conten
Para. 2 — Amended by No I of the FA of 19 June 2015, in force since 15 Nov. 2017 (AS 2016 1163, 2017 5629; BBl 2013 2317). Para. 2 let. b — Amended by No I of the FA of 19 June 2015, in force since 15 Nov. 2017 (AS 2016 1163, 2017 5629; BBl 2013 2317). Para. 2bis — Inserted by No I of the FA of 19 June 2015, in force since 15 Nov. 2017 (AS 2016 1163, 2017 5629; BBl 2013 2317).
Art. 15 Regulations of the Federal Council
1 The Federal Council shall specify the requirements which information must fulfil under the terms of Articles 12 letter b and 13 paragraph 2 letters f and g. 2 It may specify which other therapeutic methods have no comparable benefit for the recipient.
Section 3a Monitoring the Health of Living Donors
Inserted by No I of the FA of 19 June 2015, in force since 15 Nov. 2017 (AS 2016 1163, 2017 5629; BBl 2013 2317).
Art. 15a Liability for costs in connection with monitoring health
1 The insurers in terms of Article 14 paragraph 2 shall be liable for the medical costs incurred in connection with monitoring the health of organ or blood stem cell donors. 2 They shall make a non-recurring flat-rate payment to the living donor aftercare fund in accordance with Article 15b. 3 The Confederation shall pay the administrative costs of keeping the register unless these are covered elsewhere. It shall pay annual contributions to the living donor aftercare service in accordance with Article 15c based on the costs anticipated in the year concerned. 4 The Federal Council shall specify: a. the amount of the flat-rate payment; b. the due date for the flat-rate payment and the federal contribution. 5 When specifying the flat-rate payment, it shall take account of: a. the costs of medical tests; b. the costs of laboratory tests; c. the cost of the services provided by the living donor aftercare agency; d. the life expectancy of the donors; e. the frequency of the medical tests; f.
Art. 15b Living donor aftercare fund
1 The joint institution in terms of Article 18 of the Federal Act of 18 March 1994 on Health Insurance shall maintain a living donor aftercare fund, the purpose of which is to administer the flat-rate payment made by insurers in terms of Article 15a paragraph 2. 2 The living donor aftercare fund will be financed by the flat-rate payments made by the insurers in terms of Article 15a paragraph 2. It may also be financed by donations from third parties. The joint institution shall collect the flat-rate payment and shall charge interest on late payments. The rate of interest is set in accordance with the regulations of the joint institution. 3 The joint institution shall make an annual disbursement to the living donor aftercare agency in terms of Article 15c based on the anticipated costs of monitoring the health of donors. 4 The fund’s administrative costs are included in the costs of monitoring the health of the donors. They shall be limited to an amount appropriate for managing the fund
Para. 1 — SR 832.10
Art. 15c Living donor aftercare agency
1 The living donor aftercare agency is responsible for monitoring the health of organ and blood stem cell donors; it shall maintain a register in an appropriate and cost-effective manner. 2 It shall use the financial resources exclusively to cover the proven costs of monitoring the health of donors. It shall provide the Federal Office of Public Health (FOPH) with annual accounts in respect of the costs.
Section 4 Allocation of Organs
Art. 16 Scope
1 This section concerns the allocation of organs which the donor has not donated for a specific person. 2 The Federal Council: a. shall specify which organs shall be allocated in accordance with this section; b. may also declare this section to be applicable to the allocation of tissues and cells.
Art. 17 Non-discrimination
1 No-one may be discriminated against with respect to the allocation of organs. 2 The following persons must be treated equally with respect to allocation: a. persons resident in Switzerland; b. persons resident in a member state of the European Union, in Iceland or Norway and who in accordance with the Agreement of 21 June 1999 between the European Community and its Member States, of the one part, and the Swiss Confederation, of the other, on the free movement of persons or the Convention of 4 January 1960 establishing the European Free Trade Association: 1. are required to have mandatory health insurance in Switzerland, or 2. are entitled to international benefits assistance during a stay of limited duration in Switzerland; c. cross-border commuters under Article 25 of the Foreign Nationals and Integration Act of 16 December 2005 who at their own request are subject to mandatory health insurance in Switzerland, as well as their family members who are required to have mandatory health
Para. 2 let. b — SR 0.142.112.681 Para. 2 let. b — SR 0.632.31 Para. 2 let. c — SR 142.20. The title was amended on 1 Jan. 2019 pursuant to Art. 12 para. 2 of the Publications Act of 18 June 2004 (SR 170.512). Para. 2 let. c — Amended by No I of the FA of 19 June 2015, in force since 1 May 2016 (AS 2016 1163; BBl 2013 2317). Para. 3 — Amended by No I of the FA of 19 June 2015, in force since 1 May 2016 (AS 2016 1163; BBl 2013 2317).
Art. 18 Decisive criteria
1 The following criteria in particular shall be observed when allocating organs: a. the medical urgency of a transplantation; b. the medical benefit of a transplantation; c. the waiting time. 2 When allocating organs, an effort must be made to ensure that patients who, because of their physiological characteristics, are likely to have to wait a very long time have the same probability of being allocated an organ as patients without these characteristics. 3 The Federal Council shall specify the order in which the criteria are to be applied, or shall give them a weighting.
Art. 19 National organ allocation office
1 The Confederation shall create a national organ allocation office. 2 The national organ allocation office: a. keeps a list of individuals waiting to receive an organ (waiting list); b. allocates available organs to recipients after consultation with the transplant centres; c. organises and coordinates at national level all activities relating to allocation; d. collaborates with allocation organisations in other countries. 3 The national organ allocation office shall document each decision and retain this documentation for ten years. 4 The Federal Council shall regulate the allocation procedure.
Art. 20 Registration of patients
The attending doctor shall register patients for whom transplantation is medically indicated and who have given their written consent at a transplant centre without delay. Patients must also be registered if they are receiving replacement therapy.
Art. 21 Waiting list
1 Persons are placed on the waiting list in accordance with Article 17 paragraph 2. The Federal Council shall determine which persons who do not meet the requirements of Article 17 paragraph 2 are also placed on the waiting list. 2 The transplant centres shall decide whom to place on or remove from the waiting list. They may take only medical reasons into account. Article 17 paragraph 1 applies mutatis mutandis. 3 The transplant centres shall communicate their decisions with the necessary data to the national organ allocation office. 4 The Federal Council shall specify in more detail: a. the medical reasons according to paragraph 2; b. the necessary data according to paragraph 3.
Para. 1 — Amended by No I of the FA of 19 June 2015, in force since 1 May 2016 (AS 2016 1163; BBl 2013 2317).
Art. 22 Registration of donors
1 Hospitals and transplant centres shall inform the national organ allocation office, sending the necessary data, of all deceased persons who meet the criteria for organ removal. The Federal Council shall specify in more detail the necessary data. 2 Doctors, hospitals and transplant centres to whom a person has declared while alive their willingness to donate an organ have a duty to register this person with the national organ allocation office.
Art. 23 International exchange of organs
1 If no recipient can be found for an organ in Switzerland, the national organ allocation office shall offer the organ to a foreign organ allocation organisation. The right to exchange an organ under an international patients' programme in accordance with Article 18 paragraph 2 is reserved. 2 Offers or organs from other countries may only be accepted by the national organ allocation office. 3 The national organ allocation office may conclude agreements governing reciprocal organ exchange with foreign organ allocation offices. This shall require the approval of the FOPH.
Para. 3 — Second sentence amended by No I of the FA of 19 June 2015, in force since 15 Nov. 2017 (AS 2016 1163, 2017 5629; BBl 2013 2317).
Section 5 Removal, Storage, Import and Export, and
Art. 24 Mandatory notification of removal
1 Any person who removes organs, tissues or cells must notify the FOPH. 2 The Federal Council shall specify the content of the notification and the duties of the notifier.
Para. 1 — Term in accordance with No I of the FA of 19 June 2015, in force since 15 Nov. 2017 (AS 2016 1163, 2017 5629; BBl 2013 2317). This amendment has been made throughout the text.
Art. 25 Mandatory authorisation for storage, import and export
1 Authorisation from the FOPH is required by any person who: a. stores tissues or cells; b. imports or exports organs which are not allocated in accordance with Articles 16–23, tissues or cells. 2 Storage in a bonded warehouse shall be considered as importation. 3 Authorisation shall be granted if: a. the necessary technical and operative requirements have been fulfilled; b. a suitable quality assurance system is in place. 4 The Federal Council shall regulate the preconditions for authorisation and the authorisation procedure and shall specify the duties of persons who require approval.
Art. 26 Preparation
The Federal Council may issue regulations governing the preparation of organs, tissues and cells. In doing so, it shall take internationally accepted guidelines and standards into account.
Section 6 Transplantation
Art. 27 Mandatory authorisation
1 Organs may only be transplanted in transplant centres which have been granted the appropriate authorisation by the FOPH. 2 Authorisation shall be granted if: a. the necessary technical and operative requirements have been fulfilled; b. a suitable quality assurance system is in place; c. the quality of the transplantations is ensured. 3 Transplant centres must record, evaluate and regularly publish the outcome of transplantations using standardised criteria. 4 The Federal Council may make the transplantation of tissues or cells contingent on approval from the FOPH.
Para. 2 let. b — Amended by No I of the FA of 19 June 2015, in force since 15 Nov. 2017 (AS 2016 1163, 2017 5629; BBl 2013 2317).
Art. 28 Restriction of the number of transplant centres
The Federal Council may restrict the number of transplant centres in consultation with the cantons and taking developments in transplantation medicine into account.
Art. 29 Mandatory notification
1 Any person who transplants tissues or cells must notify the FOPH of this. 2 The Federal Council shall specify the content of the notification and the duties of the notifier.
Section 7 Duty of Due Diligence
Art. 30 Suitability of donors
1 Any person who removes or transplants organs, tissues or cells must verify the suitability of donors. 2 The following must be excluded as donors: a. any person who has received a transplant of organs, tissues or cells of animal origin or transplant products obtained therefrom; b. any person other than those mentioned under letter a whose organs, tissues or cells could transmit pathogenic agents or otherwise harm the health of the recipient; Article 31 paragraph 2 letter c applies notwithstanding. 3 The Federal Council shall regulate the requirements regarding donor suitability, responsibility for verifying suitability and the data that shall be recorded in the process.
Art. 31 Mandatory testing
1 Any person who removes or transplants organs, tissues or cells must make certain that these have been tested for pathogenic agents or markers thereof. 2 The Federal Council shall specify in particular: a. which tests for pathogenic agents or markers thereof must be carried out; b. which tests may be used; c. the cases in which organs, tissues or cells may be transplanted in spite of the test results being reactive. 3 It may provide for exemptions from mandatory testing if it can be ensured by other means that infection with pathogenic agents is excluded.
Art. 32 Removal and inactivation of pathogenic agents
The Federal Council may make provision for procedures to remove or inactivate pathogenic agents not to be used until they have received regulatory approval by the FOPH.
Art. 33 Mandatory labelling
Organs, tissues and cells and associated samples must be labelled in such a way that they can be identified unequivocally.
Art. 34 Mandatory documentation and traceability
1 Any person who handles organs, tissues or cells must: a. record all procedures and transactions of significance for the protection of health; b. keep these records in such a way that the data can be traced back as far as the donor and the recipient. 2 In particular, for each instance of removal or transplantation of organs, tissues or cells, the surname, first name and date of birth of both donor and recipient must be recorded.
Art. 35 Mandatory archiving
1 The records specified in Article 34 and all important documents shall be kept for 20 years. 2 If the business activity ends before this period expires, the complete documentation shall be stored safely or, if this is not possible, handed over to the FOPH.
Section 8 Clinical Trials
Art. 36
1 Clinical trials involving the transplantation of human organs, tissues or cells require authorisation from the FOPH in advance. For certain trials, the Federal Council may grant an exemption from mandatory authorisation or specify mandatory notification. 2 The FOPH shall determine whether the organs, tissues or cells used in a clinical trial meet the requirements specified in this Act. It may inspect clinical trials at any time. 3 The Federal Council shall issue regulations concerning the procedure. It may specify mandatory authorisation for changes to clinical trials. 4 It may specify notification or information requirements, in particular with regard to: a. the completion or discontinuation of a clinical trial; b. adverse events observed in connection with a clinical trial; c. the occurrence of circumstances during the conduct of a clinical trial which could affect the safety or health of the participants. 5 In issuing regulations in accordance with paragraphs 3 and 4, the Federal
Art. 36 — Amended by Annex No 4 of the Human Research Act of 30 Sept. 2011, in force since 1 Jan. 2014 (AS 2013 3215; BBl 2009 8045). Para. 6 — SR 810.30
Section 9 Handling Embryonic or Foetal Human Tissu
Art. 37 Principles and prohibitions
1 The time and method of a termination of pregnancy must be selected independently of subsequent transplantation of embryonic or foetal human tissues or cells. 2 It is prohibited: a. to keep superfluous embryos alive artificially after the seventh day of development or to keep aborted embryos or intact foetuses alive artificially for the purpose of remove tissues or cells from them for transplantation; b. to transplant embryonic or foetal tissues or cells into a person designated for this purpose by the donor; c. to use embryonic or foetal tissues or cells from women who are incapable of judgement for transplantation purposes.
Art. 38 Mandatory authorisation
1 Any person who wishes to transplant embryonic or foetal human tissues or cells into humans shall require authorisation by the FOPH. 2 Authorisation shall be granted for a clinical trial if: a. a therapeutic benefit can be expected; b. the necessary technical and operative requirements have been fulfilled; c. a suitable quality assurance system is in place. 3 Authorisation shall be granted for standard treatment if: a. a therapeutic benefit has been demonstrated; b. the recipient cannot be treated with another therapeutic method with comparable benefit; c. the conditions stated in paragraph 2b and c have been fulfilled.
Art. 39 Information and consent of donor
1 A woman may not be asked to donate embryonic or foetal human tissues or cells for transplantation purposes before she has taken the decision to terminate the pregnancy. 2 Embryonic or foetal human tissues or cells may only be transplanted if the donor has been informed comprehensively and has consented freely and in writing to the intended use.
Art. 40 Information and consent of the affected couple
1 A couple may not be asked to donate tissues or cells from a superfluous embryo for transplantation purposes until it has been established that the embryo is superfluous. 2 Tissues or cells from superfluous embryos may only be transplanted if the affected couple has been informed comprehensively and has consented freely and in writing to the intended use.
Art. 41 Independence of medical personnel
The individuals involved in the transplantation must not influence the medical personnel who carry out the termination of the pregnancy or are involved in the reproductive procedure. They may not be involved in either the termination or the reproductive procedure and may not have the authority to give instructions to those involved.
Art. 42 Regulations of the Federal Council
The Federal Council shall specify: a. the requirements that information provided under the terms of Articles 39 and 40 must fulfil; b. the duties of the persons requiring authorisation; c. the preconditions for granting authorisation and the authorisation procedure.