National Consensus on Contraindications for Corneal Donation for Transplantation in Switzerland.

PURPOSE: To establish a national consensus on contraindications for corneal donation for transplantation in Switzerland. METHODS: Swisstransplant (SWT), the Swiss national foundation coordinating tissue and organ donations, convened a working group consisting of six national corneal surgeons and eye bankers and donation experts to create a contraindication list for corneal donation. The group reviewed available national and international guidelines and recommendations, while adhering to Swiss law and transplant regulations. In cases of opposing opinions, the group held follow-up meetings until a consensus was reached. A consensus was defined as agreement among all parties present. RESULTS: From March 2021 to November 2021, the study group held six meetings and created a standardized minimal contraindication list for corneal donation in Switzerland. Thanks to this list, SWT has created a mandatory working and documentation file for donor coordinators to use when evaluating multiorgan donors for corneal harvesting. The authors agreed that while the national consensus list provides standardized minimal contraindication criteria, local eye banks may choose to introduce additional, more rigorous criteria. CONCLUSION: Given that corneal transplantation is the most commonly performed transplantation, establishing a consensus on contraindications is crucial for recipient safety. The creation of a consensus on contraindications for corneal donation in Switzerland is an essential contribution to fulfil the legal requirements concerning quality assurance and provides sufficient high-quality donor tissue within the country. Therefore, periodic review and revision of the consensus is considered critical.

Shared intent in third-party donation will underpin the success of new surrogacy laws.

The demands for surrogacy treatments continue to grow worldwide. However the legal guidance for non-commercial surrogacy treatments remains inadequate, and this commentary argues how the forthcoming guidance on surrogacy from the UK Law Commissions would benefit from a bold decision based on previous experience derived from similar developments in three other areas of assisted conception.

Regulations and Procurement Surgery in DCD Liver Transplantation: Expert Consensus Guidance From the International Liver Transplantation Society.

Donation after circulatory death (DCD) donors are an increasingly more common source of livers for transplantation in many parts of the world. Events that occur during DCD liver recovery have a significant impact on the success of subsequent transplantation. This working group of the International Liver Transplantation Society evaluated current evidence as well as combined experience and created this guidance on DCD liver procurement. Best practices for the recovery and transplantation of livers arising through DCD after euthanasia and organ procurement with super-rapid cold preservation and recovery as well as postmortem normothermic regional perfusion are described, as are the use of adjuncts during DCD liver procurement.

A NHS Foundation Trust v MC [2020] EWCOP 33: Revisiting Best Interests and 'Altruistic' Incapacitous Stem Cell Donation.

In A NHS Foundation Trust v MC, the Court of Protection revisits the question of whether adults should be allowed to act as bone marrow or peripheral blood stem cell donors if they lack decision-making capacity. This case note explores the positive and problematic implications of the case based on points that were raised in the judicial reasoning that specifically relate to i) practical implications concerning the key players in this environment, ii) the risk analysis within the best interest determination, iii) altruism and iv) the wider context as it relates to minor donors who lack capacity.

National survey on the opinions of French specialists in assisted reproductive technologies about social issues impacting the future revision of the French Bioethics laws.

INTRODUCTION: France is known for its conservative and unique position in assisted reproductive technologies (ARTs). At the eve of the future revision of French Bioethics laws, we decided to conduct a national survey to examine the opinions of French specialists in ARTs about social issues. MATERIAL AND METHODS: Descriptive study conducted in May 2017 in a university teaching hospital using an anonymous online questionnaire on current issues in ARTs. The questionnaire was sent by email to 650 French ARTs specialists, both clinicians and embryologists. RESULTS: After 3 reminders, 408 responses were collected resulting in a participation rate of 62.7% (408/650). Concerning pre-implantation genetic testing, 80% of the physicians were in favor of expanding the indications, which in France are presently limited to incurable genetic diseases. Authorizing elective Fertility Preservation was supported by 93.4% of the specialists, but without social coverage for 86.3% of them. Concerning gamete donation, 77.4% of the French ARTs specialists were in favor of giving a financial compensation to donors, 92% promoted preserving their anonymity and 80.9% were against a directed donation. ARTs for single heterosexual women were supported by 63.4% of the French specialists and by 72.5% for lesbian couples. The legalization of surrogacy was requested by 55.2%. DISCUSSION: Pending the revision of the French Bioethics laws, this survey provides an overview of the opinion of the specialists in ARTs on expanding ARTs for various social indications.Because of the evolution of social values, a more liberal and inclusive ART program is desired by the majority of ART specialists in France.

Effect of Opt-out System for Organ Donation After Brain Death on Ethical Legitimacy and Potential Efficacy in a Mathematical Model.

OBJECTIVES: We aimed to compare the possible outcomes of the current (opt-in) system and an opt-out system for organ donation in South Korea using a mathematical model. MATERIALS AND METHODS: A structured questionnaire was used to investigate the decision on organ donation and family consent after brain death under the current system and an opt-out system. The survey was conducted in August 2018 by means of a voluntary survey of 100 opposite-sex married couples. RESULTS: Sixty-three percent of participants wished to self-donate their organs after brain death: 69.5% were positive and 30.5% were negative regarding the implementation of the opt-out system. Among 200 participants, the total number of possible donors increased from 110 (55.0%) in the current system to 139 (69.5%) in the opt-out system. Positive autonomy was defined as obtainment of consent from the donor and the spouse, and negative autonomy was defined as concordaence of refusal between the donor and the spouse. Comparisons between the systems showed that the rate of autonomy increased from 57.0% in the current system to 61.5% in the opt-out system. Although the achievement of positive autonomy increased from 59.5% in the current system to 74.6% in the opt-out system, the achievement of negative autonomy decreased from 52.7% in the current system to 39.2% in the opt-out system. CONCLUSIONS: An opt-out system can increase the number of organ donors; however, achievement of negative autonomy can decrease.

[Evaluation of the Artificial Insemination Donor Data Act; data registration not yet in order]. / Evaluatie Wet donorgegevens kunstmatige bevruchting.

The Artificial Insemination Donor Data Act was first evaluated in 2012, and a second time in 2018. The aim of the most recent evaluation was to gain insight into the effectiveness and side effects of the law. The researchers did not only conduct a judicial analysis of the legislation and parliamentary history; they also visited fertility clinics, they undertook research at SDKB (Foundation for Artificial Insemination Donor Data), and interviewed stakeholders and key people involved in the process. From this, 17 recommendations were made, addressed to the Ministry of Health, Welfare and Sport, SDKB, fertility clinics and the Health and Youth Care Inspectorate. Some of these recommendations also affect the actions of fertility physicians and gynaecologists working in clinics and hospitals that perform donor treatments.

[Our new donation law: more autonomy?] / Onze nieuwe donorwet ­ meer autonomie?

On 1 July 2020, the registration of organ and tissue donors in the Netherlands changed from an opt-in to an opt-out system. This means that everyone in the Netherlands will be registered as an organ and tissue donor unless they have registered a different choice in the donor register. The hope is that this new method for donor registration will lead to more donors. Only a small majority of members of the Senate and the House of Representatives in the Netherlands voted for the legislative amendment that enabled this new system to come into effect. In the Senate the amendment was defended on the grounds that it would do more justice to the autonomy of the deceased; the new law will, however, have to be defended from the principles of justice and solidarity by a government that feels responsibility towards those needing a donor organ.

[The place of living-donor liver transplants in the Netherlands]. / De plaats van levertransplantatie met levende donor in Nederland.

There is a shortage of donor livers from deceased persons, which means there is a relatively high mortality rate among patients on the national liver-transplant waiting list in the Netherlands. This justifies expanding the current programme for liver transplants from living donors. The new law on donor organs law came into effect on 1 July 2020. The expectation is that this will lead to a greater supply of post-mortem donor livers. New methods for organ preservation could also lead to an increase in the number of available donor livers. An increase in the supply of donor livers could lead to changes in donor policy. These changes should take into consideration that a liver transplant from a living donor can take place earlier in the course of the disease and that the quality of the donor liver is better, which means that outcomes for the recipient are also better.

[The new Dutch Donor Act and Organ Donation]. / De nieuwe donorwet en orgaandonatie.

On 1 July 2020, the new Dutch Donor Act with an Active Donor Registration system will become effective. Consequent changes in clinical practice and matters related to dealing with a patient's family are described by means of an illustrative case history of a 53-year-old fictive female patient. Furthermore, the implications of an earlier change in the Dutch Donor Act in 2013 are discussed.

For Victims of Fatal Child Abuse, Who Has the Right to Consent to Organ Donation?

In rare circumstances, children who have suffered traumatic brain injury from child abuse are declared dead by neurologic criteria and are eligible to donate organs. When the parents are the suspected abusers, there can be confusion about who has the legal right to authorize organ donation. Furthermore, organ donation may interfere with the collection of forensic evidence that is necessary to evaluate the abuse. Under those circumstances, particularly in the context of a child homicide investigation, the goals of organ donation and collection and preservation of critical forensic evidence may seem mutually exclusive. In this Ethics Rounds, we discuss such a case and suggest ways to resolve the apparent conflicts between the desire to procure organs for donation and the need to thoroughly evaluate the evidence of abuse.

Deceased Organ Donation in Syria: Challenges and Solutions.

The first living-donor kidney transplant in Syria was performed 41 years ago; by 2019, 5407 renal transplants had been performed there. Three heart transplants from deceased donors were performed in the late 1980s; cardiac transplant activities have since discontinued. In 2003, a new, national Syrian legislation was enacted authorizing the use of organs from living unrelated donors and from deceased donors. This important law was preceded by another big stride in this regard: the acceptance by the higher Islamic religious authorities in Syria in 2001 of the principle of procurement of organs from deceased donors, provided that consent is given by a first- or second-degree relative. After the enactment of this law, kidney transplant rates increased from 7 per million population in 2002 to 17 per million population in 2007. Kidney transplants performed abroad for Syrian patients declined from 25% in 2002 to < 2% in 2007. Kidney transplants continued at comparable rates until 2010, before the beginning of the political crisis in 2011. Four decades after the first successful kidney transplant in Syria, however, patients needing an organ transplant must rely on living donors only. Moreover, 17 years after the law authorizing use of organs from deceased donors, a program is still not in place in Syria, and additional improvement of the legal framework is needed. The war, limited resources, and lack of public awareness about the importance of organ donation and transplant appear to be major factors inhibiting initiation of a deceased-donor program in Syria. A concerted and ongoing education campaign is needed to increase awareness of organ donation, change negative public attitudes, and gain societal acceptance. Every effort must be made to initiate a deceased-donor program to lessen the burden on living donors and to enable national self-sufficiency in organs for transplant.

Body donation in Italy: Lights and shadows of law No. 10/2020.

INTRODUCTION: Recently, law No. 10 of February 10, 2020, entitled "Rules regarding the disposition of one's body and post-mortem tissues for study, training, and scientific research purposes" was introduced in Italy. Although its provisions respond to a constructive subject, some practical issues are evident in the approved text. MATERIALS AND METHODS: A systematic review of the literature was performed by searching online medical and juridical databases to identify publications and Italian law provisions related to body donation programs. RESULTS: The updated regulatory framework was outlined and compared to that in force previously, and the following features are discussed: (a) matter of law; (b) donors' information and consent; (c) reference centers and funding, and (d) procedural regulatory details. Several critical issues were detected in the approved wording with respect to teaching/training recipients, the role of university anatomy institutes, family members' exclusion from participating in the donation process in any capacity, the duration of donation, the management of corpses, partial donations, and the compatibility with organ donation. Suggestions are provided to overcome certain operational limitations in implementing the regulation, which is still being drafted to date. CONCLUSIONS: This article shares with the international scientific community the principles and controversies underlying a regulatory innovation introduced in Italy to allow legislative amendments to inadequate provisions of body donation, as well as draw the attention of the entire anatomic community to critical issues if other countries undertake the same legislative reform.

Anonymity in EU Health Law: Not an Alternative to Information Governance.

Data sharing has long been a cornerstone of healthcare and research and is only due to become more important with the rise of Big Data analytics and advanced therapies. Cell therapies, for example, rely not only on donated cells but also essentially on donated information to make them traceable. Despite the associated importance of concepts such as 'donor anonymity', the concept of anonymisation remains contentious. The Article 29 Working Party's 2014 guidance on 'Anonymisation Techniques' has perhaps helped encourage a perception that anonymity is the result of data modification 'techniques', rather than a broader process involving management of information and context. In light of this enduring ambiguity, this article advocates a 'relative' understanding of anonymity and supports this interpretation with reference not only to the General Data Protection Regulation but also to European Union health-related legislation, which also alludes to the concept. Anonymity, I suggest, should be understood not as a 'technique' which removes the need for information governance but rather as a legal standard of reasonable risk-management, which can only be satisfied by effective data protection. As such, anonymity can be not so much an alternative to data protection as its mirror, requiring similar safeguards to maintain privacy and confidentiality.