Over the past 50 years, the donation of organs, tissues and cells and their use in transplantation has made rapid progress[1]. This activity was, of course, one of the great medical breakthroughs. Thanks to it, medical science has been able to multiply the extension of human life. However, its development throughout history has always presented the world with controversies of all kinds, including religious and spiritual, moral and ethical, legal and economic. These controversies persist to this day. The purpose of this point is to analyse the legal criteria for organ donation, since transplantation is a matter of enormous importance, touching on fundamental issues of the human condition, such as dignity, freedom, property and the defence of essential legal goods, such as life or health, which deserve to be protected. Herein lies the competence of the governments of all countries to promote the common good by assuming their role in the functions of directing, financing, insuring, providing, controlling and supervising the activity related to the donation and transplantation of organs, tissues and cells of human origin . [2]
In fact, in response to the diverse and complex needs associated with organ donation and transplantation, several international bodies have adopted international laws enshrining the principle of voluntary, non-commercial and unpaid organ donation in all countries, which have become a standard development in medical and surgical practice both nationally and globally and have encouraged all countries around the world to do the same. For example, in 1991, the World Health Organisation (WHO) adopted the Guiding Principles on Human Organ Transplantation. These principles have influenced legislation in over 50 countries and have been revised over time to adapt to medical and scientific developments[3]. According to these principles, the purchase and sale of human organs for transplantation is prohibited. Therefore, donation must be voluntary and with the consent of the donor or his family. They also promote an equitable distribution of organs, giving priority to medical need. They also encourage regularisation and supervision of transplantation procedures. Thus, these recommendations and resolutions demonstrate the concerns and positions of each on the need to regulate organ donation to avoid possible abuses.
But how are these principles applied in different countries? According to several reports by international organisations dealing with the main challenges of organ donation, the implementation of these principles varies from country to country, depending on legislation, medical infrastructure and public health policies. Many countries have adopted laws prohibiting organ trading and have established oversight systems to ensure transparency in transplantation[4]. Others have implemented awareness campaigns to encourage altruistic organ donation[5]. They have also developed databases to manage organ allocation and prevent illegal practices[6]. They have established penalties for violations of these laws and have also provided the necessary funds for their implementation and operation. Finally, agreements have been established between countries to share information and improve the safety and effectiveness of transplantation[7]. However, while many countries have adopted these principles, there are some that, for a variety of reasons, have not developed clear transplant laws[8].
Indeed, the failure of some countries to enact clear laws on organ donation and transplantation can have a number of negative consequences, both for patients and for the healthcare system as a whole. Without clear legislation, illegal organ-trading networks can emerge, putting the safety of donors and recipients at risk. Their absence can also lead to unequal distribution of organs, favouring those with greater financial resources. The lack of awareness campaigns and a legal framework facilitating donation can lead many people to feel insecure and fearful about becoming donors. Finally, a lack of supervision can lead to unsafe procedures, endangering the lives of patients and compromising the quality of transplants[9]. Organ donation and transplantation is one of the most challenging branches of medical science, as it involves a number of legitimate interests that must be scrupulously respected, both for the living and the cadaveric donor. It is therefore important that all countries enact clear laws that promote education, care of the organs removed, regulation, protection and monitoring of the rights of all those involved in organ and tissue donation.
Indeed, taking into account international conventions, resolutions and declarations, it is up to the government of each country to determine through its legislation who can be a living or cadaveric donor. With this provision, the government would give everyone who freely wishes to be a living or cadaveric donor the opportunity to do so, giving another chance at life to many people on the waiting list for an organ. It is also up to the government to determine who can receive an organ and tissue donation. All this confirms once again that the process of organ donation for transplantation is not so simple. It is a very complex and serious matter that requires the organisation of serious and competent teams. It is therefore essential that from the outset the law in each country defines who can receive a donation and for what purpose. In several countries, no one has the right to receive a donation without prior authorisation in the law. Institutions authorised to receive organ donations cannot even dispose of the organs received according to their own criteria. They may only receive organs for the purposes already provided for in the law of each country.
Therefore, the “Organ Donation and Transplantation Law” of each country is the local government’s effort to safeguard at all times the respect of the will of citizens to decide to be donors and to express their consent to the mechanisms provided. No one is obliged to be a donor or a recipient. For this reason, the principle of autonomy is always present in the various legislations on organ donation and transplantation. Free organ donation is also guaranteed in all legislations. Therefore, the sale or purchase of organs and tissues is prohibited worldwide. This is crucial in the fight against organ trafficking and trading, a reality that is unfortunately present in some countries and which led the World Health Organisation, in 1987, to express its concern about the trade in human organs for the first time and to call for appropriate measures to prevent the buying and selling of organs[10].
As I have already mentioned, organ donation can take place during life or after death. But for each case, the law of each country lays down the criteria to be taken into account, because what is at stake is the inviolability of the person’s dignity. Certainly, organ donation is a valuable activity, so it is up to each government to ensure its smooth operation for the good of patients and society, ensuring transparency in access to information on the processes involved in organ, tissue and cell donation and transplantation.
With the legal criteria, the government of each country aims to organise, monitor and control organ and tissue donation in its territory. The primary objective is to ensure the health and well-being not only of the person wishing to donate, but also of the healthcare personnel involved and the recipient. The legal criteria also aim to promote cooperation and health safety and to prevent the commercialisation of organs. Violation of these criteria is punishable by sanctions.
P. Jean Rolex, CM
[1] Pan American Health Organisation. (2013). Legislation on organ, tissue and cell donation and transplantation: compilation and comparative analysis. Washington, D.C. Retrieved from https://www3.paho.org/hq/index.php.
[2] Baquero, A., Alberú, J. (2011). Ethical challenges in transplantation practice in Latin America: Aguascalientes paper. Nefrología 31(3), 275-285.
[3] World Health Organization (2009). Human organ and tissue transplantation. Retrieved from https://apps.who.int/gb.
[4] Ibid,
[5] World Health Organisation (2010). WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation. Retrieved from https://www.indt.gub.uy/.
[6] World Health Organization (2009). Human organ and tissue transplantation. Retrieved from https://apps.who.int/gb.
[7] World Health Organization (2010). WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation. Retrieved from https://www.indt.gub.uy/.
[8] World Health Organization (2009). Human organ and tissue transplantation. Retrieved from https://apps.who.int/gb.
[9] Rosselló De Miguel, C., Bordei, L., Juárez Serrano, A.J., Salas Ferrer, M., López Macarro, U.S. & Esteban Marco, P. (2024). Legal and ethical aspects of organ donation. Ocronos Journal, 7(9), 1647.
[10] World Health Organization. (2019). Strategy and action plan on organ, tissue and cell donation and equitable access to organ, tissue and cell transplantation 2019-2030. Retrieved from https://www.paho.org/es/documentos/cd5711.
