Kidney transplantation has taken place in Colombia since 1963.¹ The country has faced and overcome great challenges regarding the legislation of donation and transplantation, such as its regulation and the prohibition of transplant tourism.²

During the 2010-2015 period there was a significant decline in the rate of deceased organ donors and the number of transplant procedures done with deceased-donor grafts. There was also a progressive increase in family refusal of organ donation in addition to a climb in the number of patients on the waiting list for solid organ transplant. Since 2016, organ donation and transplantation policies in Colombia have shifted to an opt-out model.³

We present the results obtained in Colombia after the implementation of the opt-out model and a brief comparative analysis of donation and transplant statistics, using the Mann-Whitney test (among variables of interest), between the years 2010-2016 and 2017-2020 (before and after legislative changes were established).

In 2016, Colombia changed its policy on donation of organs and tissues, eliminating the need for an explicit written consent for donation (opt-in) and transitioning to a program with presumed consent (opt-out) with the aim to increase the national rates of deceased donation and transplantation, raising awareness of the reality of organ donation/transplantation and fulfilling the increasing demand for grafts in the country.

The analysis of official data from 2010-2016 and 2017-2019 shows that after the adjustment of policy there has not been a significant change in the rate of donors per million inhabitants (P = .90), the number of solid organ transplant procedures (P = .46), the number of kidney transplants (P = .64), or the number of kidney transplants from deceased donors performed per period (P = .99; Figures 1 and 2).⁴

Despite the results expected after the change in policy, there has been a significant rise in the number of patients included on the organ transplant waiting list (P = .01), especially patients waiting for a renal graft (P = .01), and the percentage of live-donor kidney transplants performed (P = .04; Figures 3 and 4).

It is not possible to evaluate the effect of family attitudes toward organ donation as, since the operation of the new framework, no official data have been published. The current analysis did not include data from 2020 considering the negative effect that the COVID-19 pandemic had on organ donation and transplant procedures. It is important to note that during that year there was a decline in the number of patients on the waiting list due to the high mortality within this population (251 deaths in total).

The dynamics of organ donation and transplantation arise from a complex interplay of clinical, logistic, financial, intersectoral, religious, social, cultural, and legislative factors.⁵ Colombia is an example of how changes in only 1 field (shift in legislation to declare organ donation as mandatory at the end of life) are insufficient to obtain a significant effect on organ donation and transplantation, or to increase graft access in patients with end-stage disease.

Multiple international experiences that demonstrate the limited effect of legislative policies related to presumed consent for organ donation over transplantation dynamics have been published to date.^6-8 In Colombia, an initial null effect had already been described after legislative changes were established;^9,10 however, our analysis until the beginning of the COVID-19 pandemic shows the lack of improvement in the number of organ transplants or donations from deceased donors since the start of the opt-out model (presumptive consent to donation) and the need for additional measures to improve access to organ donation in our country.

The shift in donation and transplant policy (opt-in to opt-out) has not increased the number of renal donors, the national deceased donor rate, or the number of kidney transplants performed. Additional measures are needed to improve national donation and transplantation indexes so that the increasing demand for renal grafts is met.