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FEDERAL CONSTITUTION
FEDERAL ACT ON DIRECT FEDERAL TAX
MEDICAL DEVICES ORDINANCE
CODE OF OBLIGATIONS
FEDERAL LAW ON PRIVATE INTERNATIONAL LAW
LUGANO CONVENTION
CODE OF CRIMINAL PROCEDURE
CIVIL PROCEDURE CODE
FEDERAL ACT ON POLITICAL RIGHTS
CIVIL CODE
FEDERAL ACT ON CARTELS AND OTHER RESTRAINTS OF COMPETITION
FEDERAL ACT ON INTERNATIONAL MUTUAL ASSISTANCE IN CRIMINAL MATTERS
DEBT ENFORCEMENT AND BANKRUPTCY ACT
FEDERAL ACT ON DATA PROTECTION
CRIMINAL CODE
CYBERCRIME CONVENTION
COMMERCIAL REGISTER ORDINANCE
FEDERAL ACT ON COMBATING MONEY LAUNDERING AND TERRORIST FINANCING
FREEDOM OF INFORMATION ACT
FEDERAL ACT ON THE INTERNATIONAL TRANSFER OF CULTURAL PROPERTY
FEDERAL ACT ON MEDICINAL PRODUCTS AND MEDICAL DEVICES
TAX HARMONISATION ACT
- I. History
- II. Context
- III. Commentary in the Strict Sense
- Recommended further reading
- Bibliography
- Materials
I. History
1 Beginning in the 1950s, transplant medicine evolved from an experimental form of therapy into a significant technique in human medicine. In 1952, the world’s first living-donor kidney transplant was performed. Eleven years later, both a liver and a lung transplant were performed, and in 1967, the first heart was transplanted. Starting in the mid-1960s, the first organ transplants also took place in Switzerland.
2 Due to the lack of federal authority to establish uniform regulations for transplant medicine, a confusing web of regulations emerged. Where cantonal regulations existed, they sometimes diverged significantly—both in terms of substantive value judgments and the prescribed procedures. At the time of the publication of the dispatch on a constitutional provision regarding transplant medicine in 1997, no canton yet had comprehensive regulations in place. In all cantons, the allocation of available organs remained unregulated. The incomplete and divergent cantonal regulations on transplantation, coupled with medical advancements, created a need for regulation and left room for private institutions to establish their own rules.
3 The Swiss Academy of Medical Sciences (SAMW) took on this task and, in 1969, initially issued medical-ethical guidelines for the definition and diagnosis of death, in which it also addressed the determination of death in the context of transplantation. In 1981, the SAMW issued a medical guideline on transplantation, which was replaced in 1995 by a new guideline for organ transplantation and withdrawn in 2007 following the entry into force of the Federal Act on the Transplantation of Organs, Tissues, and Cells.
4 Since 1992, the allocation of available organs has been centrally coordinated by Swisstransplant—a private foundation—in accordance with internally developed allocation rules. This allocation system was voluntary and could only be fair as long as all parties involved adhered to it. The aim of establishing a provision in the Federal Constitution and a federal law was therefore also to set uniform and binding rules for organ allocation.
5 From 1984 until the enactment of Art. 24decies of the Federal Constitution in 1999, seven parliamentary motions were submitted requesting that the Federal Council regulate transplant medicine—or at least parts of it—at the federal level; however, the Federal Council initially denied the need for such regulation. In 1994, the Federal Council accepted the Onken and Huber motions, which specifically called on it to ban organ trafficking and enact the necessary constitutional and statutory provisions. The Federal Office of Justice deemed existing federal powers insufficient, which is why a constitutional basis first had to be established to enable comprehensive regulation of transplant medicine.
6 In the referendum held on February 7, 1999, all cantons and a large majority of the electorate approved the new Article 24decies of the Federal Constitution. This was incorporated without amendment as Article 119a into the completely revised Federal Constitution.
7 The federal government considered it particularly urgent to protect recipients of blood products from infections, which is why it did not want to wait for the foreseeable length of time it would take to enact a transplantation law. Consequently, as early as 1996, it adopted the Federal Decree on the Control of Blood, Blood Products, and Transplants, which was partially repealed upon the entry into force of the Therapeutic Products Act in 2002 and completely repealed upon the entry into force of the Transplantation Act in 2007.
II. Context
8 With the inclusion of Art. 119a (initially as Art. 24decies of the former Federal Constitution) in the Federal Constitution, the federal government was authorized and obligated to enact uniform regulations in the field of transplant medicine (N. 13 ff.). Since 1999, the federal government has thus been responsible for comprehensively regulating the transplantation of organs, tissues, and cells, while ensuring the protection of human dignity, personal integrity, and health (N. 21 et seq.). In substance, para. 2 stipulates that the federal government must, in particular, establish criteria for the equitable allocation of organs. Para. 3 contains a constitutional prohibition on organ trafficking and a requirement that human organs, tissues, and cells be provided free of charge.
A. National Context
9 In 2004, based on Art. 119a of the FC, the Federal Government enacted the Federal Act on the Transplantation of Organs, Tissues, and Cells, which entered into force in 2007 along with the various associated ordinances. Since then, both the Transplantation Act and the associated regulations have been revised. Since the demand for available organs exceeds the supply, various attempts have been made to increase the latter. The “Organ Donation Initiative,” submitted on March 22, 2019, sought to shift from a consent-based system to an opt-out system. On June 14, 2019, the Federal Council decided to reject the initiative and submitted an indirect counterproposal in which it proposed the introduction of an expanded opt-out system. Parliament approved this and recommended rejecting the initiative, whereupon the initiative committee conditionally withdrew it. Due to the subsequent referendum against the legislative revision, the public voted on the adopted paradigm shift and approved the amendment to the Transplantation Act (TxG) by a margin of 60.2%, with a voter turnout of 40.3 percent.
B. International Context
10 The development of Swiss legislation on transplant medicine must be viewed within the international context. In 1978, the Committee of Ministers of the Council of Europe adopted its first resolution regulating transplant medicine. In regulating transplant medicine, particular attention should be paid to comprehensive information, the anonymity of the donor, the conditions for the donor’s consent, and the principle of non-remuneration. This was followed by numerous recommendations from the Committee of Ministers, which addressed, among other things, international cooperation regarding the exchange and transport of human substances, xenotransplantation, waiting lists, and organ trafficking.
11 Of great significance for transplant medicine is the Council of Europe’s Convention on Human Rights and Biomedicine, concluded in 1997 and ratified by Switzerland in 2008. Among other things, this convention stipulates that individuals must be informed prior to a medical intervention (informed consent, Art. 5), and contains provisions relevant to transplantation in Articles 19–22. Switzerland entered reservations stipulating that the principle of subsidiarity does not apply to living donation and that, in exceptional cases, the removal of regenerative tissue or cells may also be permitted for the benefit of a parent of a minor or a person lacking legal capacity. In 2009, Switzerland also ratified the Additional Protocol on the Transplantation of Human Organs and Tissues to the Convention on Human Rights and Biomedicine, which entered into force in 2010. In particular, this protocol establishes a ban on profit-making and sets forth the conditions for the removal of organs and tissues. Most recently, on February 1, 2021, the Council of Europe Convention against Trafficking in Human Organs entered into force, thereby committing Switzerland to combating organ trafficking.
12 European Union (EU) law is also of practical relevance. Among other things, it regulates quality and safety standards for the handling of transplanted organs, tissues, and cells. Furthermore, the World Health Organization (WHO) and the World Medical Association (WMA) have issued resolutions and guidelines on transplant medicine.
III. Commentary in the Strict Sense
A. Para. 1: Basis of Competence and Observance of Protective Obligations
13 Art. 119a of the FC grants the Confederation comprehensive authority to enact regulations in the field of organ, tissue, and cell transplantation (N. 14 ff.) and obligates it to ensure the protection of human dignity, personal integrity, and health (N. 21 ff.).
1. Federal Jurisdiction and Legislative Mandate (1st sentence)
14 Health care traditionally falls within the jurisdiction of the cantons due to the subsidiarity of federal jurisdiction pursuant to Art. 3 in conjunction with Art. 42, para. 1 of the FC.
It was only with the inclusion of Art. 24decies in the FC that jurisdiction over the regulation of transplant medicine was transferred from the cantons to the federal government. Art. 119a, para. 1 of the FC not only authorizes the federal government but also obligates it to legislate in the field of transplant medicine. The federal government’s jurisdiction has retroactive derogatory effect. Cantonal law therefore remains in effect as long as the federal government has not yet fulfilled its obligation or has not done so comprehensively. With the enactment of the Transplantation Act—which was adopted on October 4, 2004, and entered into force on July 1, 2007—and the associated regulations, the federal government has fulfilled its legislative mandate. The cantons are now responsible only for limited enforcement tasks. In particular, they are responsible for the prosecution and adjudication of criminal offenses (Art. 71 para. 1 TxG).
2. Material Scope of Application (1st sentence)
15 Art. 119a of the FC enables the Confederation to regulate transplant medicine comprehensively. The constitutional provision distinguishes between the transplantation of organs, tissues, and cells, thereby defining the material scope of application.
16 Transplantation within the meaning of Art. 119a of the FC refers to the transfer of organs, tissues, and cells to a human being for therapeutic purposes. A transplantation may take place within the same species (so-called allogeneic transplantation) or between different species (so-called xenogeneic transplantation). If the donor and recipient are the same individual, it is referred to as an autologous transplantation. A further distinction is made based on whether the organs, tissues, and cells to be used for the transplantation are obtained from a living person (so-called living donation) or a deceased person (so-called postmortem donation).
17 Organs are defined as parts of the body “whose cells and tissues together form a unit with a specific function” (e.g., heart, lungs, liver, kidneys, pancreas) . Also considered organs are, on the one hand, parts of an organ that are functionally equivalent to an organ (e.g., a lobe of the liver) and, on the other hand, body parts composed of various tissues that perform a specific function (e.g., a hand). Distinguishing between organs, tissues, and cells is particularly relevant because only organs are subject to the specific allocation procedure (N. 40 ff.). Tissues are structured groups of cells composed of either identical or different cell types that perform a common function in the body (e.g., skin, bone) . These must be distinguished from individual cells or unstructured cell masses and cell suspensions. These consist exclusively of identical cells. Cell transplantation can be used to repair tissue defects (e.g., transplantation of skin and cartilage cells) or to replace metabolic products that are not present in sufficient quantities in the body (e.g., insulin and serotonin). Article 119a of the FC grants the federal government regulatory authority over all organs, tissues, and cells usable in transplant medicine. This therefore also includes the transplantation of human fetal tissue. Pursuant to Article 38 of the Transplantation Act (TxG), the transplantation of embryonic and fetal tissues or cells requires authorization from the Federal Office of Public Health (FOPH).
18 The material scope of application of Art. 119a of the FC covers not only human but also animal organs, tissues, and cells, provided that a transfer to humans is intended (so-called xenotransplantation). The constitutional legislator thus explicitly did not take a position on xenotransplantation, but left it to the legislature to decide whether, and if so, how xenotransplantation should be permitted. Pursuant to Art. 43 of the Transplantation Act (TxG), xenotransplantations are permitted only with a case-by-case authorization from the Federal Office of Public Health.
19 Organs, tissues, and cells must be distinguished from implants. The former consist of living matter, and the latter of dead matter. The question of whether cases in which human or animal organs, tissues, or cells (e.g., human bones, cartilage, or tendons, as well as pig heart valves) are harvested, processed, and devitalized, and then implanted in humans in this devitalized state, should fall under the Transplantation Act or the Therapeutic Products Act was left open in the explanatory memorandum to the constitutional article. Under para. 2(a) of the Transplantation Act (TxG), devitalized transplants were excluded from the scope of the Transplantation Act.
20 However, the provision on jurisdiction in Art. 119a of the FC does not cover the handling of human and animal substances for purposes other than transplantation into humans (e.g., for the purpose of autopsies, assisted reproduction, or the manufacture of cosmetics).
3. Duties of Protection (2nd Sentence)
a. General Principles
21 Art. 119a, para. 1, sentence 2 of the FC (or Art. 24decies, para. 1 of the former FC) conferred upon the Federal Government the binding mandate to ensure the protection of human dignity, personality, and health in the regulation of transplantation medicine. The current catalog of fundamental rights did not yet exist in the aBV and thus did not exist at the time of the introduction of Art. 24decies aBV. These protective obligations are primarily based on the fundamental rights of the recipient and the donor. The fundamental rights of both individuals must be protected equally. In a broader context, the fundamental rights of the donor’s relatives and hospital staff may also be affected.
22 The list of protective duties in Art. 119a, para. 1 of the FC is exemplary in nature. The legislature must take all fundamental rights into account, with the principle of equality before the law and the prohibition of discrimination being of particular importance, especially with regard to organ allocation (N. 39 ff.). The protection of freedom of religion and conscience (Art. 15 of the FC) must also be considered. Although the constitutional article does not contain an explicit provision regarding the protection of animals required for xenotransplantation, the explanatory memorandum to Art. 24decies of the former FC already points out that the dignity of living beings (Art. 120, para. 2, of the FC) must be respected. Furthermore, Art. 80 of the FC on animal protection applies when organs, tissues, and cells are obtained from animals for use in transplant medicine.
23 The constitutional provision merely sets forth general principles that are binding on the authorities responsible for enacting and applying the law. The legislature retains considerable discretion in how it implements the constitutional requirements and resolves any conflicts of interest between the protective obligations; consequently, no specific rights can be derived from these protective obligations.
b. Determination of Death and the Time of Death
24 With improved technical capabilities in the field of resuscitation—which allow circulation to be maintained despite irreversible brain failure—people no longer die in a manner that is immediately apparent to others. The time of death determines whether a person is (still) a holder of fundamental rights or not. How death is defined and diagnosed is central insofar as a balancing of interests is absolutely impermissible when it comes to holders of fundamental rights. The Constitution contains no provision specifying how death is to be defined. However, the definition must satisfy the minimum constitutional guarantees and, in particular, be dignified and free from arbitrariness. The legislature defines death in Art. 9 para. 1 of the Transplantation Act (TxG) as the irreversible loss of brain function, including that of the brainstem, and thereby declares the so-called brain death to be applicable. Pursuant to para. 2, the legislature delegated the more detailed definition of brain death to the Federal Council, which in turn refers in Article 7 of the TxV to the medical-ethical guidelines of the Swiss Medical Association (SAMW) on “Determination of Death with Regard to Organ Transplants and Preparation for Organ Removal,” as amended on May 16, 2017. In addition to technical instructions for determining death and carrying out preparatory medical measures, these guidelines also include details on the procedure for ascertaining the patient’s wishes, conducting discussions with relatives, and dealing with the dying person and the body. The procedure for determining death establishes that death has occurred, but not the exact time of death. The official time of death is recorded as the time at which the physician has completed the diagnosis and documentation of death.
In the case of postmortem organ procurement, the procedure interferes with the dying process. A distinction must be made between primary and secondary brain death. In primary brain death, the irreversible loss of brain function is determined according to established criteria; it is only after the cessation of life-sustaining measures that cardiovascular function subsequently fails. Death following prolonged cardiac arrest or secondary brain death describes the situation in which circulation fails first—or unsuccessful resuscitation efforts are discontinued—and, after a certain period of time, brain death is determined due to a lack of blood flow to the brain. Uncertainties regarding, on the one hand, whether relatives may be consulted about a possible organ donation even before death is certified, and, on the other hand, whether relatives can consent to preparatory measures prior to death in the absence of a corresponding decision by the person who is still alive but incapable of making such a decision, led to organ donations following secondary brain death being temporarily suspended in Switzerland. These procedures have been performed again in Switzerland since 2011 and have increased since the revised Transplantation Act took effect in 2017, with the aim of increasing the number of organs available for transplantation.
25 The concept of brain death has also long been met with criticism. It is argued that the loss of brain function should not be equated with human death; rather, death should be determined by the cessation of circulation. According to the concept of brain death, death is an event that occurs at a specific point in time. Critics, however, view death as a process. Another criticism is that relying on the criterion of brain death serves only the interests of transplant medicine. Furthermore, because circulation is maintained, a brain-dead person cannot be identified as such without a complex determination of death, since the body continues to perform functions that make the person appear, from the outside, to be unconscious but alive (e.g., sweating, hair growth). Others advocate a so-called “partial brain death” concept, according to which it is sufficient for consciousness or the brainstem to have irreversibly ceased functioning. Swiss transplantation law (Art. 8, para. 1, let. b, in conjunction with Art. 9 of the Transplantation Act) is based on “total brain death,” i.e., the complete cessation of brain functions.
c. Protection of Human Dignity
26 Even before human dignity was introduced into the FC as an independent fundamental right with the 1999 total revision, Art. 24decies, para. 1 of the old FC (or Art. 119a, para. 1, sentence 2 of the FC) made its observance in the context of transplant medicine binding on the legislature. According to legal doctrine, respect for human dignity encompasses three elements: equality, integrity, and self-determination. It is considered a minimum guarantee that the state must observe. The government’s explanatory memorandum identifies three aspects of transplant medicine in which respect for human dignity is central: the determination of the time of death, organ procurement from the deceased, and the right to die with dignity. This list is not exhaustive.
27 As long as a person is alive, they are the bearer of fundamental rights. In the case of living persons, respect for and protection of human dignity are of absolute importance. Human dignity prohibits the removal of organs from a living person capable of making decisions without their free and informed consent, or the exploitation of such a person for the benefit of others. This implies a prohibition on commercialization. In the case of individuals who lack capacity or are minors, organ removal is compatible with human dignity only under very restrictive conditions.
28 It is only with death that the status as a holder of fundamental rights ends, and with it the resulting individual legal claims (N. 24). However, based on the objective legal content of the right, the state remains obligated even beyond death to uphold human dignity and to protect the deceased from inhumane treatment. There is no fundamental right belonging to the deceased person; rather, the fundamental right of the living person continues to apply beyond their death (N. 33). The body of a deceased person must be treated with respect. Even in the case of postmortem donation, the deceased must not be objectified, and their body parts must not be commercialized. The removal of body parts must be justified even in the case of postmortem donation, and any known wishes must be respected. This addresses the aspect of self-determination. Consent need not necessarily have been recorded by the deceased during their lifetime; other models of consent and objection may be compatible with the principle of human dignity, provided that the right to object does not become effectively meaningless due to a lack of information (N. 33).
29 With regard to the recipient of an organ, human dignity prohibits arbitrary allocation or a state-sanctioned weighing of the value of different human lives. Organs must therefore be allocated according to criteria that ensure equal treatment (N. 41 ff.).
d. Protection of Personality
30 The protection of personal freedom under Art. 10, para. 2 of the FC encompasses, in particular, physical and mental integrity and freedom of movement. With regard to physical integrity, the preparatory medical measures taken for the purpose of a donation while the potential donor is still alive deserve special attention. These preparatory measures have no direct benefit for the patient but are necessary to protect the organs from damage. They may only be performed if informed and free consent has been obtained, and they must not hasten death (Art. 10 of the Organ Transplantation Act).
31 Art. 10, para. 2, also specifically encompasses the protection of self-determination. Holders of fundamental rights have the right to independently determine essential aspects of their lives. The protection of self-determination within the meaning of Art. 10, para. 2 of the FC goes beyond the minimum guarantee protected by human dignity (see N. 28) and does not cease upon a person’s death. Organ procurement affects the donor’s right to self-determination. Therefore, organ procurement must be preceded by comprehensive information so that the donor can be informed and give legally valid, free consent (so-called “informed consent”).
32 In principle, the right to self-determination can be guaranteed not only through the donor’s explicit consent during their lifetime (consent model or “opt-in”), but opt-out models are also possible. It is essential here that potential donors (i.e., the entire population) be objectively, comprehensively, and regularly informed about the process of postmortem organ removal and the consequences of inaction, so that they can decide for or against organ removal on this basis. In the referendum held on May 15, 2022, Swiss voters approved the amendment to the Transplantation Act, which provides for a shift from the expanded consent model to the expanded opt-out model. The new regulation is expected to take effect in the third quarter of 2027. The actual implementation of this system change—including ensuring that the public receives the necessary information and establishing a functional registry that meets all technical and legal requirements—poses significant challenges.
33 The scope of protection of personal freedom encompasses not only the right of a person to effectively consent to or object to postmortem organ removal during their lifetime, but also enables individuals to issue binding instructions regarding key aspects of their own death. This is not a fundamental right of the deceased, but rather the fundamental right of the living that continues beyond death. Under both the currently applicable expanded consent model (Art. 8, para. 2 and 3, TxG) and the future expanded objection model (Art. 8, para. 2, revTxG), the next of kin must be consulted regarding the presumed will of the potential donor. The personal relationship with the deceased is generally relevant to the authority to make the decision (Art. 8, para. 8, TxG in conjunction with Art. 5, TxV). The minimum age for deciding on postmortem organ procurement is 16 years (Art. 8, para. 7, TxG in conjunction with Art. 5, para. 1, TxV) . For practical reasons, the legislature opted for a strict age limit rather than assessing the capacity to make decisions of a minor on a case-by-case basis, as is otherwise customary for medical procedures. This approach is maintained in the amendment to the Transplantation Act (Art. 8a revTxG). In the case of younger children and adolescents, as well as persons who are permanently or for an extended period of time incapable of making decisions, the next of kin decide on postmortem organ donation, taking into account the deceased person’s wishes.
34 In the case of living donation, the right to self-determination means that no transplants may be removed without informed, free consent. According to Art. 12(a) and (b) of the TxG, a person of sound mind and of legal age must give written consent to the living donation of organs, tissues, or cells after being informed of the risks. Living donation also falls within the scope of protection of physical and mental integrity. Art. 12(c) and (d) of the Transplantation Act (TxG) stipulate that there must be no serious risk to the life or health of the donor and that no other therapeutic method with comparable benefits is available to the recipient. Minors or persons lacking legal capacity may not, as a general rule, have transplants removed (Art. 13 para. 1 TxG). Under restrictive conditions, the removal of regenerative tissues and cells is permitted to save a parent, child, or sibling of the donor (Art. 13 para. 2 TxG). Since the donation of organs, tissues, and cells is not intended to cure the donor but rather the recipient, it constitutes an intervention for the benefit of another.
e. Protection of Health
35 The transplantation of organs, tissues, and cells involves risks that should not be underestimated, depending on the extent of the procedure and the health status of the donor and recipient. The protection of health that the legislature must ensure applies, on the one hand, to the donor and, on the other hand, to the recipient of transplants. In the case of the former, the protection of health must be taken into account, particularly in the case of living donation. The latter is permissible only if there is no serious risk to the life and health of the donor. Since the donor must not be exposed to any unnecessary risk, the principle of subsidiarity enshrined in Art. 12(d) of the Transplantation Act (TxG) applies, according to which a living donation may only be performed if no other therapeutic method promises a comparable benefit.
36 The recipient must be protected, in particular, from potential pathogens that could be transmitted during a transplant along with the organ, tissue, or cells. In principle, there is a legitimate interest in ensuring an adequate supply of organs. However, the protection of health under Article 119a(1), second sentence, of the FC does not give rise to either an individual’s right to an organ or an obligation on the part of the state to work toward increasing the organ supply. The constitutional provision does not, however, preclude measures such as information campaigns. These must inform the public not selectively, but comprehensively and as objectively as possible.
37 Furthermore, a broader duty of care may also encompass the mental health of both those directly affected and their relatives and medical professionals. The decision for or against organ donation is a matter of conscience that can be emotionally taxing for both the potential donor and their relatives. Preparatory measures are carried out on living individuals who lack the capacity to make decisions, and organ removals are performed on people whose brain death has just been determined and who still appear to be alive and show signs of reaction. Explantations can therefore also be emotionally taxing for medical professionals. This must be taken into account when dealing with all parties involved and in the regulation of transplant medicine.
B. Para. 2: Criteria for Organ Allocation
1. General Principles
38 Organs are a limited resource. In addition to the actual availability of organs, a successful transplant also requires compatibility (e.g., in terms of size and blood type). This shortage means that not everyone who needs an organ can receive one. As previously stated, there is no legal right to an organ (N. 37). However, the affected person has an enforceable right to ensure that the procedure is designed by the legislature in a fair manner (N 41 ff.). Establishing the criteria for fair organ allocation constitutes a binding legislative mandate.
39 The legislative mandate under para. 2 is limited to the allocation of human organs. This is because there was no chronic shortage of tissues and cells, and—due to the issue of tissue matching—only one recipient is typically eligible anyway, meaning there is no possibility of allocation. While at the time the message was issued, allocation problems arose only in the case of organ donations from deceased donors—since living donations at that time were still required to be directed to a specific person—“altruistic donations,” in which allocation is based on a waiting list, as well as cross-donations from living donors, are now also permitted. The explanatory memorandum to the constitutional article does not rule out the possibility that, in the event of a shortage of tissues or cells, their allocation could also be regulated, provided there is a chronic shortage. The federal government’s legislative authority thus extends beyond the allocation of human organs. The legislature has exercised this authority, for example, in the allocation of islet cells. Allocation regulations for the transplantation of animal organs would also be conceivable. As a result of new genetic engineering techniques (so-called genome editing), the first therapeutic trials have been conducted in the United States in which animal transplants were transferred to humans. In Switzerland, such procedures require authorization (Art. 43 TxG), and currently, no clinical studies on xenotransplantation in humans are taking place in Switzerland. It is still unclear whether there could be a shortage of animal organs in the future.
2. “Fair”
40 While the preliminary draft of Art. 24decies of the Federal Constitution (aBV) still provided that the federal government must ensure a fair allocation of organs, tissues, and cells, this high standard was scaled back during the drafting process; as a result, the legislature is now required to establish criteria for a fair allocation. Little can be inferred from the extremely vague term “fair” for the purpose of establishing a concrete allocation system: It can be interpreted differently depending on which theory of justice is applied and how the various values are weighted. The legislature must base the allocation criteria on fundamental rights. In addition to the aforementioned fundamental rights of human dignity (Art. 7 of the FC) and the protection of physical and mental integrity (Art. 10, para. 2 of the FC), particular attention must be paid to equality before the law (Art. 8, para. 1 of the FC), the prohibition of discrimination (Art. 8, para. 2 of the FC), the right to assistance in emergencies (Art. 12 of the FC), and relevant international law must be observed. This helps to define the concept of justice.
41 The allocation rule effectively determines who receives access to a potentially life-saving organ. Art. 119a of the FC does not prescribe a specific allocation model. However, a fair allocation must ensure equal and non-discriminatory treatment (Art. 8 of the FC) for all patients and therefore requires, at a minimum, that it be carried out without arbitrariness and based on “objective criteria.” It is doubtful whether objectivity is a feasible standard. Ultimately, value judgments are unavoidable. At the very least, allocation must not be based on irrelevant criteria but must pursue the actual purpose of organ transplantation and be guided by sound medical criteria.
42 Within the framework of national legislation, only a nationwide uniform allocation system based on binding guidelines can meet the requirements for fair organ allocation. Decentralized allocation systems could not guarantee that the most suitable person receives an organ, but might be justified if the country’s geographical size effectively precluded a national allocation system—which is not the case in Switzerland. Pursuant to Art. 19 in conjunction with Art. 54 para. 2 lit. abis of the Transplantation Act (TxG), the legislature is required to establish a national allocation agency for this purpose and may delegate the performance of this task to a public or private organization. The federal government opted for the private organization Swisstransplant, which had already been coordinating organ allocation in accordance with internal guidelines prior to the entry into force of the Transplantation Act (N. 4). The delegation of an administrative task to Swisstransplant means that, in performing its duties, it is bound by the Constitution and, in particular, by fundamental rights (Art. 35, para. 2 of the FC).
43 Allocation based on utilitarian models, in which collective overall benefit is the decisive factor, would be incompatible with the principle of equality before the law according to prevailing legal doctrine. Rather, allocation must be based on individual health with regard to the benefit and need for an organ transplant. Any criteria that pit the value of human life against one another (e.g., social status, fault, age, compliance—such as with regard to the medication and follow-up examinations that are absolutely necessary after an organ transplant) must be disregarded. The legislative message cites the prospect of success (benefit) and the urgency (need). The law currently designates the criteria of medical urgency, medical benefit, and waiting time (Art. 18 para. 1(a) through (c) of the Organ Transplantation Act) as decisive. Organ replacement can be vital to survival; therefore, the legislature must take Art. 12 of the FC (right to assistance in emergencies) into account when regulating organ allocation. It follows that the state must work to ensure that available organs are allocated to as many people as possible who need them to survive. However, no legal claim to an organ can be derived from this.
C. Para. 3: Principles: Requirement of Non-Commerciality and Prohibition of Organ Trafficking
44 Para. 3, of the Constitutional Provision stipulates that the donation of organs, tissues, and cells must be made without compensation and that no trade in organs may take place. The commercialization of human organs, tissues, and cells is to be counteracted by prohibiting their sale for profit. The two principles—the principle of non-remuneration and the prohibition on organ trafficking—are directly applicable due to their detailed formulation. The same applies to Art. 21 of the Biomedicine Convention, which prohibits the use of the human body or its parts for profit. Both principles also have direct horizontal effect (Art. 35, para. 3 of the FC). Art. 69 para. 1(a)-(c) of the Transplantation Act (TxG) criminalize the commercialization of transplants.
1. Non-remuneration
45 When drafting Art. 24decies aBV, the Federal Council assumed that it was already authorized, by virtue of existing federal powers, to regulate the non-remuneration of donations of organs, tissues, and cells; for this reason, the draft did not yet contain an explicit prohibition, but merely mandated the legislature to provide for non-remuneration.
46 The principle of non-remuneration prohibits only financial compensation for the donation of organs, tissues, or cells per se that is intended to generate a profit. The donor may receive financial compensation for expenses directly incurred as a result of the donation (e.g., travel costs and lost wages in the case of a living donation, as well as surgical costs and hospitalization) and for any damages caused thereby. In other words, the donation must not place a person in a better position than they would have been in had they not made the donation, nor must it place them in a worse position. Art. 6 para. 2 lit. a–d of the Tissue Act (TxG) specifies what is not to be considered a financial gain or other benefit. In addition to reimbursement of incurred costs, a subsequent symbolic gesture of gratitude (e.g., a thank-you card, a bouquet of flowers) (lit. c) and cross-donation between living donors (lit. d) are also excluded from the definition of financial benefit.
47 The donation must be made out of voluntary, altruistic motives. Financial incentives could undermine this goal, as individuals in more precarious economic circumstances might be inclined to consent to organ removal in exchange for monetary compensation. With regard to the interests of the recipient, the Federal Council argued in the message that the principle of non-remuneration enhances transplant quality, as it creates no incentive to donate low-quality transplants.
2. Donation
48 The use of the term “donation” in para. 3 has two consequences. First, the message on Art. 24decies of the FC states that only humans are capable of making a donation. Animal organs, tissues, and cells are therefore not covered by the principle of non-remuneration in Art. 119a, para. 3 of the FC. Second, the question of whether the criterion of voluntariness should be explicitly enshrined led to discussions in the National Council committees and in the Chambers. The majority in the Chambers argued that the term “donation” already implies voluntariness.
3. Prohibition of Organ Trafficking
49 The Federal Decree of March 22, 1996, on the Control of Blood, Blood Products, and Transplants had already prohibited the trafficking in transplants. The prohibition on trafficking in human organs was not yet provided for in the draft constitutional provision but was only incorporated into Art. 24decies aBV as a result of the parliamentary debate. The constitutional provision prohibits only the trade in human organs. Art. 22 of the Protocol to the Biomedicine Convention extends the prohibition to tissues. The legislature went beyond the constitutionally enshrined prohibition on organ trafficking and extended it to human tissues and cells (para. 7 of the Organ Transplantation Act) . As a result of the ratification of the Convention against Organ Trafficking, para. 69(1)(b) of the Transplantation Act (TxG) also prohibits and penalizes trafficking abroad, without requiring that the act or parts thereof take place in Switzerland or from Switzerland to a foreign country.
50 The term trade encompasses all exchange transactions (e.g., purchase, sale, exchange) aimed at personal gain, including advertising and brokerage activities. It thus refers to any form of distribution of human organs. Even the illegal removal of an organ falls under the definition of organ trafficking. Professional structures are not a prerequisite. However, compensation may be paid for the expenses incurred through removal, processing, and implantation. The exchange of organs between transplantation and allocation centers, without the intent to make a profit, does not fall under the definition of trafficking. The TxG defines and penalizes organ trafficking very comprehensively.
51 The prohibition on organ trafficking aims not only to protect those potentially directly affected, but also to safeguard trust in the transplantation system itself. This objective is also pursued at the international level (N. 10 et seq.).
About the Authors
Prof. Dr. iur. Franziska Sprecher, an attorney, is an associate professor of constitutional and administrative law with a special focus on health law at the Institute of Public Law and director of the Center for Health Law and Healthcare Management at the University of Bern.
Marina Rickenbacher is an attorney and studied at the Universities of Bern and British Columbia in Vancouver. Since March 2021, she has been writing her dissertation as part of the project “Governing by Values? On the History of Bioethics in Switzerland,” funded by the Swiss National Science Foundation.
The authors welcome suggestions and comments at franziska.sprecher@unibe.ch or marina.rickenbacher@unibe.ch.
Recommended further reading
Becchi Paolo/Bondolfi Alberto/Kostka Ulrike/Seelmann Kurt (Hrsg.), Organallokation, Ethische und rechtliche Fragen, Basel 2004.
Becchi Paolo/Bondolfi Alberto/Kostka Ulrike/Seelmann Kurt (Hrsg.), Die Zukunft der Transplantation von Zellen, Geweben und Organen, Basel 2007.
Borghi Marco/Sprumont Dominique, La transplantation d'organes, Repères pour une législation fédérale, Fribourg et al. 1995.
Dumoulin Jean-François, Transplantation d'organes en Suisse, Le droit au carrefour de la vie et de la mort, Neuchâtel 1997.
Guillod Olivier/Dumoulin Jean-François, Définition de la mort et prélèvement d’organes, Aspects constitutionnels, Neuchâtel 1999.
Hofer Pascal, Das Recht der Transplantationsmedizin in der Schweiz, Rechtsdogmatische, rechtspolitische und rechtsvergleichende Aspekte, Diss. Köln, Berlin et al. 2006.
Holliger Raphaela, Postmortale Organspende, Unter besonderer Berücksichtigung des Strafrechts, Diss., Zürich 2019.
Lachenmeier Pascal, Der Tod im liberalen Staat, Die Definitionsmacht des Rechts über den Todeszeitpunkt, Diss., Basel 2008.
Mader Mélanie, Le don d’organes entre gratuité et modèles de récompense, Quels instruments étatiques face à la pénurie d'organes?, Diss. Neuchâtel, Basel 2011.
Schmid Patrizia, Organentnahme an Verstorbenen, Rechtsgut und Rechtfertigung, Diss., Basel et al. 2003.
Schmidlin Cécile, Nudging durch den Staat, Die Standardvorgabe bei der Organspende im Lichte der Grundrechte, Diss., Zürich et al. 2025.
Schöning Rolf, Rechtliche Aspekte der Organtransplantation, Unter besonderer Berücksichtigung des Strafrechts, Diss., Zürich 1996.
Schott Markus, Patientenauswahl und Organallokation, Diss., Basel et al. 2001.
Sitter-Liver Beat, Gerechte Organallokation, Zur Verteilung knapper Güter in der Transplantationsmedizin, Fribourg 2003.
Tremp Dania, Lebendspende in der Schweiz, Insbesondere die finanzielle Absicherung des Spenders von Organen, Geweben und Zellen, Diss. Zürich, Basel 2010.
Tschumy Nicolas, Le corps humain après la mort, Le statut du cadavre en droit suisse, Diss. Lausanne, Bern 2022.
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Materials
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Botschaft zur Änderung des Transplantationsgesetzes vom 15.2.2023, BBl 2023 721 (zit. BBl 2023 721).
Bundesamt für Justiz, Gutachten vom 7.6.1995 über Bestand und Umfang von Gesetzgebungskompetenzen des Bundes im Bereich der Transplantationsmedizin, VPB 61.3 (1995), (zit. BJ Gutachten, VPB 61.3 (1995)).
Bundesamt für Justiz, Gutachten vom 22.6.2004 zur Auslegung von Art. 119 Abs. 2 Bst. e und Art. 119a Abs. 3 BV, VPB 68 (2004), Nr. 113 (zit. BJ Gutachten, VPB 68 (2004)).
Bundesgesetz über die Transplantation von Organen, Geweben und Zellen (Transplantationsgesetz), Änderung vom 1.10.2021, BBl 2021 2328 ff. (zit. BBl 2021 2328).
Bundesratsbeschluss über das Ergebnis der Volksabstimmung vom 7.2.1999 (Transplantationsmedizin; Raumplanungsgesetz; Initiative «Wohneigentum für alle») vom 23.3.1999, BBl 1999 III 2912 (zit. BBl 1999 III 2912).
Bundesbeschluss über die Genehmigung des Übereinkommens über Menschenrechte und Biomedizin vom 12.9.2001, BBl 2002 337 (zit. BBl 2002 337).
Bundesratsbeschluss über das Ergebnis der Volksabstimmung vom 15. Mai 2022 (Änderung des Bundesgesetzes über Filmproduktion und Filmkultur [Filmgesetz, FiG]; Änderung des Bundesgesetzes über die Transplantation von Organen, Geweben und Zellen [Transplantationsgesetz]; Bundesbeschluss über die Genehmigung und die Umsetzung des Notenaustausches zwischen der Schweiz und der EU betreffend die Übernahme der Verordnung [EU] 2019/1896 über die Europäische Grenz- und Küstenwache und zur Aufhebung der Verordnungen [EU] Nr. 1052/2013 und [EU] 2016/1624 [Weiterentwicklung des Schengen-Besitzstands]) vom 18.8.2022, BBl 2022 2010 (zit. BBl 2022 2010).
Motion Onken vom 7.12.1993, Verbot des Handels mit menschlichen Organen, angenommen vom Ständerat am 22.9.1994, vom Nationalrat am 23.3.1995 (93.3573) (zit. Motion Onken (93.3573)).
Motion Huber vom 28.2.1994, Gesetzgebung Transplantationsmedizin, angenommen vom Ständerat am 22.9.1994, vom Nationalrat am 23.3.1995 (94.3052) (zit. Motion Huber (94.3052)).
Protokoll der Sitzung der Kommission des Nationalrats für soziale Sicherheit und Gesundheit vom 11.9.1997.
Verfassungsbestimmung über die Transplantationsmedizin, Erläuternder Bericht und Entwurf zu Art. 24decies BV, Eidgenössisches Departement des Innern, August 1996 (zit. Erläuternder Bericht und Entwurf zu Art. 24decies BV).