Key Benefits:
8 October 2004 (State 1 Er January 2014)
1 This Act establishes the conditions under which organs, tissues or cells may be used for transplantation.
2 It must contribute to the availability of organs, tissues and cells for transplantation.
3 Its purpose is to prevent the abuse of organs, tissues or cells, in particular the trade in organs, in the application to the human being of transplantation medicine and to ensure the protection of human dignity, of the Personality and health.
1 This Law shall apply to the use of organs, tissues or cells of human or animal origin and of products derived from them (standardized transplants) intended to be transplanted to human beings.
2 It does not apply to use:
3 The use of organs, tissues or cells for autogenous transplants is regulated by art. 36 and 50 to 71. The Federal Council may, for organs, tissues and cells intended for a self-directed transplantation, which are treated before transplantation, make provisions to ensure the quality and safety of the operation. Standardized transplants for autogenous transplants are regulated by art. 4, 7, para. 2, let. B, 49 and 63 to 65.
For the purposes of this Law:
Any person who uses standardized organs, tissues, cells or transplants shall take all necessary measures according to the state of science and technique in order not to endanger the health of persons.
1 Where organs, tissues or cells have been removed for purposes other than transplantation, they may be stored or used for transplants or for the manufacture of standardized transplants only if s. 8, 12, let. B, 13, para. 2, let. F and g, 39, para. 2 and 40, para. 2, governing the information and consent of the donor were respected.
2 The provisions referred to in para. 1 also applies to the use of cord blood stem cells.
1 No person shall grant or collect any pecuniary benefit or other benefit for the donation of organs, tissues or cells of human origin.
2 Not considered to be a pecuniary benefit or other benefit:
1 It is prohibited:
2 This prohibition does not apply to:
1 Organs, tissues or cells may be removed from a deceased person if:
2 In the absence of any document attesting to the consent or refusal of the deceased, relatives are asked if they are aware of a donation declaration.
3 If the relatives are not aware of such a declaration, a removal of organs, tissues or cells may be made only if they consent to it. In making their decision, they must respect the presumed will of the deceased.
4 If the deceased does not have relatives or is not able to contact them, a levy is prohibited.
5 The will of the deceased takes precedence over that of the relatives.
6 If it is proved that the deceased has delegated to a person of trust the competence to make a decision concerning the removal of organs, tissues or cells, the latter shall act in place of the relatives.
7 A person who is 16 years of age is entitled to make a donation declaration.
8 The Federal Council defines the circle of relatives.
1 One person died when brain functions, including brain stem, were irreversible.
2 The Federal Council shall lay down provisions on the finding of death. In particular, it determines:
1 Medical measures exclusively aimed at the conservation of organs, tissues or cells may be taken, prior to the death of the donor, only with the free and informed consent of the donor.
2 Such measures are prohibited when they:
3 In the absence of a donation declaration, such measures may be taken after the death of the patient until the decision of the relatives is known. The Federal Council shall determine the maximum permitted duration of such measures.
1 A physician who reports the death of a person cannot:
2 Physicians who remove or transplant organs, tissues or cells, as well as medical personnel involved in such acts, must not exert any pressure related to urgency or any other influence on persons who Caring for the patient at the end of life or when he or she dies.
Organs, tissues or cells may be removed from a living person if:
1 It cannot be removed from organs, tissues or cells on minor or indiscriminant presnants.
2 Exceptionally, regenerating tissues or cells may be collected from underage or incompetent persons if:
3 Incompetent donors are involved to the greatest extent possible in the information process and in the process of seeking consent.
4 The cantons establish an independent authority within the meaning of para. 2, let. I, and settle the procedure.
1 Anyone who collects on a living person from organs, tissues or cells shall ensure that it is adequately insured against possible serious consequences of the levy.
2 An insurer who, in the absence of a gift by a living person, should bear the costs of the treatment of the recipient's disease, is responsible for:
3 The obligation to bear costs within the meaning of para. 2 exists even if retrieval or transplantation cannot be performed. If the insurer of the recipient is not known, the Confederation will bear the costs.
4 The Federal Council rules in particular:
1 This section governs the allocation of organs when donors have not designated a recipient.
2 The Federal Council:
1 When assigning a body, no one shall be discriminated against.
2 When allocating organs, persons domiciled in Switzerland must be treated equally.
3 An available organ is assigned to a non-resident person in Switzerland on the waiting list in accordance with Art. 21, para. 1:
4 No one shall have the right to the assignment of an organ.
1 In particular, the following criteria should be considered for the award:
2 At the time of allocation, efforts are being made to ensure that patients who, because of their physiological characteristics, have to expect a very long waiting period have the same probability of receiving a body as those who do not Not these characteristics.
3 The Federal Council shall determine the order in which the criteria shall be applied or the laying down.
1 The Confederation created a national remit service.
2 The national authority service:
3 The National Allocations Service establishes a record for each decision and retains it for 10 years.
4 The Federal Council shall rule on the procedure applicable to allocations.
The attending physician must notify a transplant centre as soon as possible of the name of the patient for whom a transplant is medically appropriate, with the written consent of that person being required. Communication must also take place if the patient is undergoing replacement therapy.
1 The waiting list is open to persons domiciled in Switzerland. The Federal Council lays down the conditions to which persons who are not domiciled in Switzerland may be registered.
2 Transplant Centres refer to persons who are on the waiting list and those who are deregistered. Their decisions are based solely on medical reasons. Art. 17, para. 1, shall apply mutatis mutandis.
3 Transplant centres shall communicate their decisions with the data necessary for the national authorities.
4 The Federal Council specifically describes:
1 Hospitals and transplant centres shall communicate to the national authority, with the necessary data, the names of the deceased persons who are amenable to organ removal. The Federal Council shall specify the necessary data.
2 Physicians, hospitals and transplant centres to which a person has declared his or her willingness to give his or her lifetime an organ to an unknown person are required to communicate the name of that potential donor to the national service of the Allotments.
1 Where there is no suitable recipient in Switzerland, the national authority service provides the body to a foreign allocation organisation. It is reserved for the exchange of a body within the framework of international programmes for patients within the meaning of Art. 18, para. 2.
2 Only the national authority service has the authority to accept an offer from abroad.
3 The national authority service may enter into agreements with foreign allocation organisations on the reciprocal exchange of organs. These conventions are subject to the approval of the Federal Office of Public Health (Office).
1 Any person who collects organs, tissues or cells on human beings shall announce it to the Office.
2 The Federal Council shall determine the data to be announced and the duties of the persons subject to the obligation to announce.
1 To be the holder of an authorisation issued by the Office any person:
2 Storage in a customs warehouse is considered to be imported.
3 The authorization is issued:
4 The Federal Council regulates the conditions for granting authorisation, as well as the procedure and lays down the obligations of persons subject to authorisation.
The Federal Council may make provisions for the preparation of organs, tissues and cells. In doing so, it takes into account recognized international guidelines and standards.
1 Only transplant centres for the benefit of an authorisation by the Office are authorised to transplant organs.
2 The authorization is issued:
3 Transplantation centres must regularly record, evaluate and publish the results of transplants according to uniform criteria.
4 The Federal Council may submit the grafts of tissues and cells to an authorisation issued by the Office.
The Federal Council may limit the number of transplant centres after consulting the cantons and taking into account developments in the field of transplantation medicine.
1 Any person who collects or transplants organs, tissues or cells shall examine the suitability of the donor for this purpose.
2 Are excluded from donors:
3 The Federal Council shall lay down the requirements relating to the suitability of the donor, the competence to establish such aptitude and the data to be identified on that occasion.
1 Anyone who collects or transplants organs, tissues or cells must ensure that they have been tested to detect the presence of pathogens or evidence of such presence.
2 In particular, the Federal Council determines:
3 It may provide for derogations from the obligation to carry out tests if it can be guaranteed in a different way than any infection by pathogens is excluded.
The Federal Council may provide that the use of processes for the removal or inactivation of pathogens is subject to authorisation by the Office.
The organs, tissues and cells, as well as the samples of analysis thereof, must be labelled in such a way as to be perfectly identifiable.
1 Anyone who uses organs, tissues or cells must:
2 At each organ, tissue or cell transplant or transplant, the donor's and recipient's name, first name, and date of birth are recorded.
1 Before being carried out, clinical trials for the transplantation of organs, tissues or cells of human origin require the authorisation of the Office. The Federal Council may exempt the regime from the authorization of specified clinical trials or plan to submit them to an obligation to advertise.
2 The Office shall verify that the organs, tissues or cells used in the clinical trial meet the requirements of this Law. It can control the execution of a clinical trial at any time.
3 The Federal Council shall issue procedural provisions. Any amendment to a clinical trial may be subject to authorization.
4 It may provide for an obligation to advertise and inform, in particular in the following cases:
5 The Federal Council shall issue the provisions required under paras. 3 and 4 taking into account recognized international regulations.
6 The Human Research Act of 30 September 2011 2 Also applies to clinical trials.
1 New content according to the c. 4 of the annex to the PMQ of 30 Sept. 2011 on human research, in force since 1 Er Jan 2014 ( RO 2013 3215 ; FF 2009 7259 )
2 RS 810.30
1 The date of termination of pregnancy and the method used must be chosen independently of a subsequent transplantation of tissues or cells from the embryo or fetus.
2 It is prohibited:
1 Any person who intends to graft tissue or cells from human embryos or fetuses on the human being must first obtain an authorization issued by the Office.
2 The authorization to conduct a clinical trial is issued:
3 The authorization to administer a standard treatment is issued if:
1 The consent of a pregnant woman for the use, for the purposes of transplantation, of tissues or cells derived from the embryo or foetus, can only be sought after the decision to interrupt the pregnancy has been made.
2 The tissue or cells derived from an embryo or foetus can only be transplanted with the free and informed consent of the donor, given in writing.
1 The consent of the couple concerned for the use in transplantation of tissues or cells derived from a supernumerary embryo may be sought only once the existence of such an embryo has been established.
2 Tissues and cells derived from supernumerary embryos may be transplanted only with the free and informed consent of the couple concerned, given in writing.
Persons involved in transplantation should not influence medical personnel who are engaged in termination of pregnancy or medically assisted procreation. They cannot participate or provide guidance to those involved in the intervention.
The Federal Council fixes:
1 Any person who intends to transplant organs, tissues or cells of animal origin or standardised transplants from such organs, tissues or cells must obtain prior authorisation from the Office.
2 The authorization to conduct a clinical trial is issued if:
3 The authorization to administer a standard treatment is issued if:
The holder of the authorisation shall be held:
Any person who collects or transplants organs, tissues or cells of animal origin or standardised transplants from them shall ensure that they have been tested in order to detect the presence of pathogens or indications of such Presence.
The Federal Council may, for the purposes of protecting injured persons:
The person causing the charge shall bear the cost of the measures taken by the competent authorities to:
1 The Federal Council lays down provisions governing the use of organs, tissues and cells of animal origin. In particular, it rules:
2 The Federal Council may:
1 In addition to the provisions of this Act, s. 3, 5 to 33, 58 to 67 and s. 84 to 90 of the Therapeutic Products Act of 15 December 2000 (LPTh) 1 Apply by analogy to the use of standardized transplants.
2 The Swiss Institute for Therapeutic Products is also responsible for conducting inspections of standardised transplants in accordance with Art. 60, para. 2, LPTh.
3 In addition, s. 36 to 41 and 53 to 57 LPTh apply by analogy to the use of standardized transplants derived from organs, tissues or cells of human origin.
4 Any person who collects organs, tissues or cells for the manufacture of standardized transplants shall verify the suitability of the donor for the purposes of s. 36 LPTh.
5 Art. 86, para. 1, let. D, LPTh also applies to the use of standardized human transplants.
1 The execution of this Law shall be the responsibility of the Confederation in so far as it is not expressly reserved for the cantons.
2 The Federal Council shall issue the implementing provisions.
1 The Confederation shall supervise the execution of this Law by the cantons.
2 It shall coordinate the implementing measures of the cantons where uniform execution is required at national level. For this purpose, it may in particular:
At the international level, the Confederation is taking measures to facilitate the exchange of information, to promote a rapid and safe exchange of organs, tissues and cells, and to actively combat organ trafficking.
The Confederation may organise or support professional development and continuing training programmes preparing medical staff to take appropriate care of the donors and their relatives.
1 The Federal Council may delegate implementation tasks to organisations and persons governed by public law or private law.
2 This jurisdiction applies in particular to:
3 The Federal Council provides for the remuneration of delegated tasks.
1 The Office shall conduct scientific assessments of the performance and effects of this Law.
2 These evaluations include:
3 The Federal Department of the Interior reports to the Federal Council on the outcome of the evaluations and submits proposals for further evaluation.
1 The cantons organise and coordinate the activities relating to transplants:
2 In particular, they provide that each hospital and transplant centre:
3 The local coordinator shall ensure that:
Every person responsible for the execution of this Law shall be obliged to keep the secret.
Any data collected under this Act, the disclosure of which is likely to affect a trustworthy interest, shall be treated as confidential.
1 Unless there is a overriding private interest, data may be disclosed in certain cases, upon written and substantiated request:
2 Unless there is overriding private interest, data may be provided:
3 Data of general interest relating to the application of this Law may be published. The data subjects must not be identifiable.
4 Moreover, they may be communicated to third parties:
5 Only the data necessary for the intended use can be communicated.
6 The Federal Council regulates the way in which data and information are communicated to the data subjects.
1 The Federal Council regulates the competences and the procedure for exchanging data with foreign authorities and institutions and with international organisations.
2 The disclosure of confidential data to foreign authorities and institutions or to international organizations shall be permitted only if:
1 The Office and the Cantons shall regularly inform the public on issues related to transplantation medicine. To this end, they may collaborate with organisations and persons of public or private law.
2 The information includes:
3 The Federal Council may provide for the possibility to include in a document or data medium appropriate the will of a person concerning the donation of organs, tissues or cells.
1 The Office maintains a register of stem cells.
2 The stem cell registry is used to identify cells that can be transplanted to a specified recipient. The data entered in the register can only be used for the purpose mentioned above.
3 The data necessary for the establishment of the compatibility of the tissues shall be entered in the Register, or the data concerning:
4 Anyone who deals with the data referred to in para. 3 transmits them to the authority holding the register. The data must be transmitted in a personalised manner only if the purpose mentioned in para. 2 requires it.
5 Any person who is registered in the Register may request, at any time, that the data concerning him be deleted.
6 The Federal Council specifies the type of stem cells managed in this register.
1 The Office shall ensure that the provisions of this Law are complied with. For this purpose, it shall conduct periodic inspections in particular.
2 It may take the necessary samples free of charge, require the relevant information and documents and request further assistance. It may instruct the customs authorities to take samples.
3 It has access to buildings, businesses, premises and vehicles for the performance of its tasks.
The person who uses standardized organs, tissues or cells or transplants shall be free to assist the Office in the performance of its tasks. It should include:
1 The Office may take any measures necessary for the implementation of this Law.
2 It may include:
3 The Office may take appropriate provisional measures. In the event of suspicion, it may, in particular, sequester or place in its custody organs, tissues, cells or standardised transplants contested.
4 When suspecting an offence under this Act, customs services shall be entitled to seize, at the border or in the customs warehouses, shipments of suspected standardized organs, tissues, cells or transplants and to request The competition of the Office. The Committee shall carry out the necessary further investigations and shall take the necessary measures.
The Confederation and the Cantons shall bear, each in their field of competence, the costs associated with the implementation of this Law.
1 Decisions taken pursuant to this Act and its implementing provisions may be appealed to the Federal Administrative Tribunal.
2 If the appeal against a decision on the allocation of organs is well founded, the Federal Administrative Court merely notes the extent to which the contested decision infringes federal law.
3 In addition, the legal remedies are governed by the general provisions of the federal procedure.
1 New content according to the c. I 11 of the Ass O. Fed. 20 Dec. 2006 on the adaptation of legislative acts to disp. Of the PMQ on the TF and the PMQ on the TAF, in force since 1 Er Jul. 2007 ( RO 2006 5599 ; FF 2006 7351 ).
1 The person shall be liable to imprisonment or a fine of up to 200 000 francs, unless he has committed a more serious offence within the meaning of the Penal Code 1 , anyone, intentionally:
2 If the author acts by profession, he shall be punished by imprisonment for not more than five years or a fine of not more than 500 000 francs.
3 If the author acts by negligence, he shall be punished by imprisonment for not more than six months or a fine of not more than 100 000 francs.
1 A person shall be liable to a judgment or a fine of 50 000 francs to the most anyone, wilfully or negligently, and provided that he has not committed an offence within the meaning of s. 69:
2 Attempt and complicity are punishable.
3 The contravention and sentence are prescribed by five years.
4 In cases of very little gravity, the criminal complaint, the criminal prosecution and the punishment can be renounced.
Federal Decree of 22 March 1996 on the control of transplants 1 Is repealed.
1 [RO 1996 2296, 2001 1505 2790 Annex c. 7, 2002 3335 art. 1, 2005 4779]
1 Every person who has an activity referred to in s. 24 and 29 shall notify the Office within six months after the coming into force of this Act.
2 Every person who has an activity referred to in s. 25 and 27 shall apply for leave to the Office within six months after the entry into force of this Law. It may continue to exercise this activity until the notification of the decision of the Office.
3 Authorizations within the meaning of s. 18 and 18 A The Federal Decree of 22 March 1996 on the control of transplants 1 Are valid until their expiration date.
4 The measures of the Office are reserved according to Art. 65.
1 [ RO 2001 1505 ]
1 This Law shall be subject to the referendum.
2 The Federal Council shall fix the date of entry into force.
Date of entry into force: 1 Er July 2007 4
1 RS 101
2 FF 2002 19
3 From 1 Er Jan 2007, the penalties and limitation periods must be adjusted according to the art conversion key. 333 al. 2 to 6 CP (RS 311.0 ), in the contents of the PMQ of Dec 13. 2002 ( RO 2006 3459 ; FF 1999 1787 ).
4 ACF of March 16, 2007