Extended consent regulation versus extended objection regulation – what is it actually about?

Referendum on the amendment of the Transplantation Act

by Ursula and Walter Knirsch*, board Hippocratic Society Switzerland

Transplantation medicine has become an indispensable part of modern medicine. Thanks to it, seriously ill people today may have the chance to live on with a donated organ. People who have received an organ donation are aware of the unique character of this gift to their lives. On 1 October 2021, the Transplantation Act was fundamentally revised by the Swiss Parliament. How did this come about? What has changed?

Since 2013, various measures have been taken in Switzerland with the action plan “More organs for transplants” to increase the willingness of the population to donate.1 Until now, the extended consent regulation was still valid in Switzerland. The person concerned decides during lifetime or the next relatives decide on the possibility of organ donation in accordance with the presumed will. 
  Once the Federal Council and Parliament had repeatedly rejected the presumed consent model, the popular initiative “Promote organ donation – save lives”, launched by a subgroup of an international non-profit organisation, Junior Chamber International Riviera JCI, was submitted in March 2019. It essentially involved a constitutional amendment to Article No. 119a by means of the addition of paragraph 4: “The donation of organs, tissues and cells of a deceased person for the purpose of transplantation shall be based on the principle of presumed consent, unless the person concerned expressed his or her refusal during his or her lifetime.” The initiative committee has now conditionally withdrawn the initiative in October in favour of the indirect counter-proposal, i.e., the withdrawal only applies if the counter-proposal becomes legally valid. We could have voted on the constitutional initiative, but the indirect counter-proposal is subject to an optional referendum. For this reason, a cross-party committee “No organ donation without explicit consent” has launched the referendum. In order for the referendum become successful, 50,000 certified signatures are needed by 20 January 2022.
  Why does it matter whether the Transplantation Act contains the explicit consent model or the presumed consent model? 
  The new extended explicit consent model introduced in the revised Transplantation Act removes the voluntary nature of organ donation as it was previously valid. The voluntary nature of organ donation is documented with an organ donor card.
  If there is no organ donor card or otherwise documented will to donate organs, up to now the relatives of a dying potential organ donor have been asked about the donor's presumed will and can consent to organ removal after brain death or death after cardiac arrest. The revised Transplantation Act would now ask whether the next relatives of the dying person are aware of any objection.
What’s the difference between explicit consent and presumed consent?
While the explicit “opt-in” consent model considers the dying person to be unimpeachable by the state, the presumed consent model puts him or her in the hands of the state. Consequently, there is a state-imposed disposability for organ removal. This implies a kind of “obligation to donate organs”, which can only be avoided by objecting. In other words, the difference between the explicit consent model and the presumed consent model is nothing less than a paradigm shift. Thus, the state intervenes in the physical integrity of its citizens in a new way. The dignity of the human being is infringed. This is not compatible with fundamental and personal rights contradicting the right to physical and mental integrity and to self-determination as laid down in article 10 para 2 of the Federal Constitution.
Is there a right to organs, is there an obligation to donate organs?
In our media it is often mentioned that people on waiting lists for organs die for lack of organs donated to them. This line of argument forgets that seriously ill people do not die from a “lack of organs”, but, unfortunately, from the consequences of their serious illness. At the same time, the term organ shortage suggests that there is a right for an organ and a certain obligation to donate as a possible organ donor. At this point, we should focus on the main idea of any donation. The term donation implies voluntariness and has the character of a gift. Accordingly, there can’t be any obligation to donate organs. Since the body of a person belongs only to that person, a potential recipient can’t claim the organs of that person. He or she can only accept what has been donated out of altruistic motives. Besides, in Switzerland it applies that the doctors involved in the processes of organ removal and transplantation must be independent of one another and may not be put under pressure, with this also meaning that organ donation may not being directly related to a need.2  
  We should assume that nobody would accept another person’s organ unless it was donated out of voluntary motives.
How can transplantation medicine be supported?
Transplant medicine is one of the great achievements of medicine. In principle, it deserves to be supported. Transplantation medicine is based on the trust of a potential donor in the guarantee provided by the state that his life, his death and his donated organs will be treated with dignity. Transplantation medicine is based on voluntariness, on the explicit consent of the donor during his or her lifetime or on the presumed consent expressed by his or her relatives after the best possible medical treatment has been completed. Transplantation medicine might also be supported according to the proposals of the National Advisory Commission on Biomedical Ethics (NCE) advocating a “third way” with a so-called declaration model. According to this, people should be regularly asked to consider the question of organ donation and to indicate whether they are willing to donate or not.3 The NCE rejects the presumed consent model.
  Solidarity and altruism are not enhanced by the state taking over and obliging us. Moreover, this would be a burden to the relationship of trust between doctor and patient, the basis of our medical practice. Instead, what is needed is a well-informed population educated in transplantation medicine, and their questions and concerns on this subject taken seriously in an honest way. This is the only way to support trustworthy transplantation medicine.
  These complex aspects of transplantation medicine must be discussed, and the new act should therefore be voted on by the people.•

Medical-ethical guidelines “Determination of Death with Regard to Organ Transplantation and Preparations for Organ Removal”, SAMW 2019
https://www.nek-cne.admin.ch/inhalte/Themen/Stellungnahmen/NEK-Stellungnahme_Organspende_DE.pdf (statement)

* Dr med. Ursula Knirsch, FMH Neurologist 
  Professor Dr med.Walter Knirsch, FMH Paediatrics/paediatric cardiology


Referendum: For a trustworthy Transplantation Medicine

Organ donation is a gift and must remain voluntary, therefore: No to organ donation without explicit consent!
  At the end of the autumn session 2021 of the Swiss Parliament a fundamental amendment of the Transplantation Act in the sense of an “extended opting-out solution” was adopted. In future, it would be allowed in principle to remove organs of all people at the end of their life, unless they expressly objected to organ donation during their lifetime or their relatives do not do so at the time of death.
  A non-party committee of physicians, nurses, theologians, lawyers, and ethicists have filed a referendum against this law. The board of the Hippocratic Society Switzerland supports this referendum. About such a paradigm shift, through which the state no longer would protect physical integrity in every case, the citizens must be able to decide!

Further information, arguments and signature forms can be found at: https://organspende-nur-mit-zustimmung.ch/



“Indirect counter proposal” bypasses the mandatory referendum

mw. According to the Federal Constitution, Swiss voters can demand an amendment to the Federal Constitution with 100,000 valid signatures collected within a period of 18 months (FC Art. 139 para. 1). The people and the cantons decide on this in a referendum (mandatory referendum, BV Art. 139 para. 5 and Art. 140 para. 1 a.). If the Federal Assembly draws up a counter proposal to the initiative at constitutional level, then the citizens vote on both at the same time (BV Art. 139 para. 5 and Art. 139b).
    At least, that is how it is provided for in the Federal Constitution. However, parliament can circumvent the mandatory referendum by adopting a so-called “indirect counter proposal” in the form of a law to persuade the initiators to withdraw their initiative. In order for citizens to be able to vote on the law, they must launch an optional referendum, this means submitting 50,000 signatures within 100 days of publication.
    In the past, the Federal Assembly occasionally used the trick of the “indirect counter-proposal”, but in recent decades it has done so more frequently. This was also the case with the popular initiative “Promote organ donation – save lives”. In fact, the amendment to the Transplantation Act adopted by the National Council and the Council of States (Art. 8a and 8b) corresponds in substance to the withdrawn popular initiative: If there is no explicit objection from a person to the removal of their organs (or part of their organs), their consent to organ donation is legally presumed, unless their next of kin can credibly demonstrate the deceased’s will to the contrary. This is a serious encroachment on the fundamental rights of the individual. Nevertheless, there will only be a referendum if we manage to deliver enough signatures in time.
    The parliament’s grip on the indirect counter proposal is a significant encroachment on the political rights of citizens and diminishes the trust between the population and the authorities – which is indispensable in direct democracy. After all, collecting 50,000 valid signatures (which is in fact about 60,000) is not a child’s play. In addition, this circumvents the requirement of the double majority (majority of the people and of the cantons) for constitutional amendments (which is disliked by some politicians), thanks to which a majority of the smaller cantons can overrule the majority of votes of the more populous cantons. And in concrete terms: We citizens do not get the two proposals (initiative text and counter proposal) openly and honestly placed side by side in the voting booklet. Is it not desirable that we can compare them exactly and then perhaps come across the fact that both say about the same thing? 
   Not a brilliant democratic achievement by our “servants of the people” in the Federal Parliament.



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