Switzerland: Voters Overwhelmingly Approve Opt-Out System for Organ Donations

Source: US Global Legal Monitor

On May 15, 2021, Swiss voters approved by a vote of 60.20%–39.80% an amendment to the Swiss Transplantation Act. The amendment replaced the current explicit opt-in rule for organ donations (consent solution) with an opt-out rule (presumed consent solution). The presumed consent solution assumes that a person wishes to donate unless they have made a statement of objection. Voter turnout was 40.26%. The new opt-out rule will enter into force in 2024 at the earliest.

Content of the Transplantation Act Amendment

The amendment provides that organs of a deceased person may be removed if the death has been declared and the person has not objected to the removal before their death. (Art. 8, para. 1.) Every person 16 years or older may record an objection, approval, or any other statement regarding organ donation in a newly established Organ and Tissue Donation Register. (Art. 8a; art. 10a, para. 1.) Such a statement may be revoked at any time. (Art. 8b.) The register may be consulted only after it has been decided to discontinue life support measures. (Art. 8c, para. 2.)

If no objection, approval, or other statement regarding organ donation has been recorded, the next of kin of the deceased person must be consulted as to whether they are aware of the person’s wishes. (Art. 8c, para. 3.) No organ removal may take place if the next of kin cannot be reached. (Art. 8, para. 3.) If they are not aware of any statement, they must be informed of their right to object to the organ removal, but must take into account the deceased’s presumed wishes. (Art. 8c, para. 4; art. 8, para. 2.) The wishes of the deceased take precedence over the wishes of the next of kin. (Art. 8, para. 6.)

The amendment requires the government to regularly provide the public with comprehensive information on transplantation medicine in general and on the new rules for organ donation. In particular, information must be provided on the possibilities for recording an objection, approval, or any other statement regarding organ donation and the option to revoke such a statement at any time; the consequences of not recording an objection — namely, that without an objection from the donating person or their next of kin organ, tissue, or cell removal will be permissible; and the risks and harms related to the preparatory medical procedures. The information must reach all communities and be accessible and comprehensible. (Art. 61.)

Recommendation from the Federal Council and Parliament

The Federal Council (the Swiss government) stated that even though a majority of Swiss people are in favor of organ donation, the actual numbers of donations are low because people do not record their consent. In the opinion of the Federal Council, the new rules satisfy ethical considerations by still involving the next of kin, who may object if they know the deceased’s opposition to organ donation. Furthermore, because of the comprehensive information duties with regard to registering an objection, one can assume that a person consented to an organ donation if no objection has been recorded, thereby relieving the next of kin of the duty to make such a difficult decision. (Popular Vote of May 15, 2022 — Explanations by the Federal Council at 34.)

Arguments from the Referendum Committee

The referendum committee contended that there will always be people who are not aware of their duty to object to an organ donation. In the committee’s opinion, the presumed consent solution violates a person’s constitutional rights to self-determination and physical integrity. In addition, the committee felt that not requiring explicit consent is unethical, as every medical procedure, even the smallest one, requires informed consent. Lastly, the committee contended that most people are not aware of what organ donation really entails and that organ removals are not performed on “cold bodies.” (Popular Vote of May 15, 2022 — Explanations by the Federal Council at 32, 33.)

Background to the Referendum

On March 22, 2019, the popular initiative “Promote Organ Donations – Save Lives” was officially submitted to the Federal Council. The initiative sought to replace the current consent solution with the presumed consent solution for organ donations. However, it did not regulate the role of the next of kin of the deceased. The Federal Council therefore endorsed an indirect counterproposal the amendment to the Transplantation Act discussed above — that had been submitted by the Federal Assembly (parliament). The popular initiative was withdrawn on the condition that the indirect counterproposal would be enacted. (Popular Vote of May 15, 2022 — Explanations by the Federal Council at 30.) However, the indirect counterproposal was challenged by an “optional referendum.” Optional referendums against federal acts are possible if valid signatures from 50,000 citizens are submitted within 100 days of the official publication of the enactment of the law. (Swiss Constitution art. 141.)