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<front>
<journal-meta>
<journal-id journal-id-type="publisher-id">Transpl. Int.</journal-id>
<journal-title-group>
<journal-title>Transplant International</journal-title>
<abbrev-journal-title abbrev-type="pubmed">Transpl. Int.</abbrev-journal-title>
</journal-title-group>
<issn pub-type="epub">1432-2277</issn>
<publisher>
<publisher-name>Frontiers Media S.A.</publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id pub-id-type="publisher-id">16664</article-id>
<article-id pub-id-type="doi">10.3389/ti.2026.16664</article-id>
<article-version article-version-type="Version of Record" vocab="NISO-RP-8-2008"/>
<article-categories>
<subj-group subj-group-type="heading">
<subject>Original Research</subject>
</subj-group>
</article-categories>
<title-group>
<article-title>Five years after introduction of an opt-out consent system for organ donation; lessons learned from England and the Netherlands</article-title>
<alt-title alt-title-type="left-running-head">Jansen et al.</alt-title>
<alt-title alt-title-type="right-running-head">
<ext-link ext-link-type="uri" xlink:href="https://doi.org/10.3389/ti.2026.16664">10.3389/ti.2026.16664</ext-link>
</alt-title>
</title-group>
<contrib-group>
<contrib contrib-type="author" corresp="yes">
<name>
<surname>Jansen</surname>
<given-names>Nichon Esther</given-names>
</name>
<xref ref-type="aff" rid="aff1">
<sup>1</sup>
</xref>
<xref ref-type="corresp" rid="c001">&#x2a;</xref>
<uri xlink:href="https://loop.frontiersin.org/people/1443678"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Wind</surname>
<given-names>Tineke Jentina</given-names>
</name>
<xref ref-type="aff" rid="aff2">
<sup>2</sup>
</xref>
<uri xlink:href="https://loop.frontiersin.org/people/1537251"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Heemskerk</surname>
<given-names>Martin B. A.</given-names>
</name>
<xref ref-type="aff" rid="aff1">
<sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Hemke</surname>
<given-names>Aline C.</given-names>
</name>
<xref ref-type="aff" rid="aff1">
<sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Williment</surname>
<given-names>Claire</given-names>
</name>
<xref ref-type="aff" rid="aff3">
<sup>3</sup>
</xref>
<uri xlink:href="https://loop.frontiersin.org/people/2333839"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Madden</surname>
<given-names>Sue</given-names>
</name>
<xref ref-type="aff" rid="aff3">
<sup>3</sup>
</xref>
<uri xlink:href="https://loop.frontiersin.org/people/1699188"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Gardiner</surname>
<given-names>Dale</given-names>
</name>
<xref ref-type="aff" rid="aff3">
<sup>3</sup>
</xref>
<uri xlink:href="https://loop.frontiersin.org/people/1797782"/>
</contrib>
</contrib-group>
<aff id="aff1">
<label>1</label>
<institution>Research Department, Dutch Transplant Foundation</institution>, <city>Leiden</city>, <country country="NL">Netherlands</country>
</aff>
<aff id="aff2">
<label>2</label>
<institution>Department of Organ Donation Coordination, Maastricht Universitair Medisch Centrum&#x2b;</institution>, <city>Maastricht</city>, <country country="NL">Netherlands</country>
</aff>
<aff id="aff3">
<label>3</label>
<institution>NHS Blood and Transplant Blood Donation</institution>, <city>Bristol</city>, <country country="GB">United Kingdom</country>
</aff>
<author-notes>
<corresp id="c001">
<label>&#x2a;</label>Correspondence: Nichon Esther Jansen, <email xlink:href="mailto:n.jansen@transplantatiestichting.nl">n.jansen@transplantatiestichting.nl</email>
</corresp>
</author-notes>
<pub-date publication-format="electronic" date-type="pub" iso-8601-date="2026-09-15">
<day>15</day>
<month>09</month>
<year>2026</year>
</pub-date>
<pub-date publication-format="electronic" date-type="collection">
<year>2026</year>
</pub-date>
<volume>39</volume>
<elocation-id>16664</elocation-id>
<history>
<date date-type="received">
<day>28</day>
<month>03</month>
<year>2026</year>
</date>
<date date-type="rev-recd">
<day>28</day>
<month>03</month>
<year>2026</year>
</date>
<date date-type="accepted">
<day>17</day>
<month>08</month>
<year>2026</year>
</date>
</history>
<permissions>
<copyright-statement>Copyright &#xa9; 2026 Jansen, Wind, Heemskerk, Hemke, Williment, Madden and Gardiner.</copyright-statement>
<copyright-year>2026</copyright-year>
<copyright-holder>Jansen, Wind, Heemskerk, Hemke, Williment, Madden and Gardiner</copyright-holder>
<license>
<ali:license_ref start_date="2026-09-15">https://creativecommons.org/licenses/by/4.0/</ali:license_ref>
<license-p>This is an open-access article distributed under the terms of the <ext-link ext-link-type="uri" xlink:href="https://creativecommons.org/licenses/by/4.0/">Creative Commons Attribution License (CC BY)</ext-link>. The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.</license-p>
</license>
</permissions>
<abstract>
<p>Five years after changing from opt-in to opt-out consent systems in England and the Netherlands, we examine the impact on donor registrations, consent rates, donor numbers, and reflect on lessons learned. Opt-out legislation was implemented in May 2020 in England and July 2020 in the Netherlands. In England, 44% of the population is now registered; 40% recording an opt-in decision and 4% an opt-out decision. In the Netherlands, mandated donor registration resulted in the entire adult population having their decision recorded: &#x201c;Yes, I want to be a donor&#x201d; (34%), &#x201c;No objection&#x201d; (24%), or &#x201c;No, I don&#x2019;t want to be a donor&#x201d; (31%), while 11% leave the &#x201c;Decision to next of kin&#x201d;. Despite these structural changes, the consent categories created by opt-out legislation (&#x201c;deemed&#x201d; consent in England and &#x201c;No objection&#x201d; in the Netherlands) remain challenging in practice, with fewer than 50% of families agreeing to donation. In England, the family consent rate declined from 69% to 57% between 2020 and 2025 and the donor numbers remain below pre-pandemic levels. In contrast, the Netherlands experienced a modest increase in family consent rates and donor numbers compared to the opt-in consent system. Opt-out legislation provides an important policy framework, but sustained system-level commitment remains essential.</p>
</abstract>
<abstract abstract-type="graphical">
<title>Graphical Abstract</title>
<p>
<fig>
<graphic mimetype="image" mime-subtype="tiff" xlink:href="ti-39-16664-abs.tif" position="anchor">
<alt-text content-type="machine-generated">Infographic compares organ donor consent in England and the Netherlands five years after opt-out system introduction, noting registration rates and consent rate changes, and emphasizes the need for infrastructure, training, digital systems, and stakeholder engagement for success.</alt-text>
</graphic>
</fig>
</p>
</abstract>
<kwd-group>
<kwd>donor register</kwd>
<kwd>England and Netherlands</kwd>
<kwd>lessons learned</kwd>
<kwd>opt-out consent system</kwd>
<kwd>organ donation policy</kwd>
</kwd-group>
<funding-group>
<funding-statement>The author(s) declared that financial support was not received for this work and/or its publication.</funding-statement>
</funding-group>
<counts>
<fig-count count="7"/>
<table-count count="4"/>
<equation-count count="0"/>
<ref-count count="14"/>
<page-count count="10"/>
</counts>
</article-meta>
</front>
<body>
<sec sec-type="intro" id="s1">
<title>Introduction</title>
<p>In May and July 2020, England and the Netherlands shifted their consent systems for organ donation from Opt-In to Opt-Out. The primary aim was to increase consent for organ donation and, ultimately, increase the number of organ donors.</p>
<p>In England, all adults aged 18 and over are considered potential organ and tissue donors unless they have made a decision not to donate or are part of a small number of protected groups. Under the legislation this is referred to as deemed consent. Within the United Kingdom, Wales commenced deemed consent in 2015, England 2020, Scotland in 2021 and Northern Ireland in 2023. The legislation across the four UK nations, and the UK&#x2019;s Crown Dependencies, is broadly similar [<xref ref-type="bibr" rid="B1">1</xref>].</p>
<p>While there is no legal requirement to record a donation decision, individuals may choose to register an opt-in or opt-out decision on the National Health Service (NHS) Organ Donor Register (ODR) or express their wishes verbally to family members, who can relay this information during donation discussions.</p>
<p>The primary route for opt-in registrations is through driving licence applications or renewals, accounting for approximately 89% of registrations [<xref ref-type="bibr" rid="B2">2</xref>]. In comparison, around 7% occur via the website and 4% via the NHS App. Opt-out decisions can only be recorded through the website or NHS App. In the Netherlands, an &#x201c;active donor registration&#x201d; process was implemented, fundamentally changing the structure of the Donor Register into a mandated choice system. By July 2021, the entire population aged 18 and older had a recorded decision. Individuals could register &#x201c;Yes,&#x201d; &#x201c;No,&#x201d; or delegate the decision to next of kin or a specific person. Those who did not respond were registered as having &#x201c;No objection,&#x201d; ensuring a recorded preference for all adults. Individuals can change their decision at any time. In 2022, several of the current authors (NEJ, CW, DG) published an early comparative analysis of the introduction of opt-out legislation in England and the Netherlands [<xref ref-type="bibr" rid="B3">3</xref>]. Full details of implementation and the consent systems are outlined in that paper. We concluded that legislation alone is unlikely to increase donation and that successful implementation requires established operational infrastructure, adoption of digital infrastructure, clinical codes of practice, professional training, sustained public awareness campaigns and engagement across society, including with faith and community groups.</p>
<p>We also observed that legislative reform can enable wider system investment, stimulating funding for donation infrastructure and public promotion, and opening dialogue with communities about organ donation. At the time of publication, however, it was too early to determine the impact of opt-out legislation on consent rates or donor numbers, and any early analysis would be confounded by the COVID-19 pandemic.</p>
<p>Now, 5&#xa0;years after the introduction of opt-out legislation, this study evaluates its impact on donor registrations, consent rates and donor numbers in England and the Netherlands, and provides further insights into the lessons learned.</p>
</sec>
<sec sec-type="materials|methods" id="s2">
<title>Materials and methods</title>
<sec id="s2-1">
<title>England</title>
<p>Data on donor registrations, consent rates and numbers of organ donors were obtained from NHS Blood and Transplant (NHSBT), which maintains the ODR, the Potential Donor Audit (PDA) and the UK Transplant Registry.</p>
<p>The PDA captures all deaths under the age of 81 occurring in UK intensive care units or emergency departments and identifies potential organ donors. Data are entered by Specialist Nurses in Organ Donation (SNODs). A key metric derived from the PDA is the organ donation consent rate, defined as the proportion of eligible families approached for a donation decision in whom consent for donation is obtained; in England this includes those donors who have registered an opt-out decision. For comparative purposes in this paper, this is referred to as family consent. Population estimates for England were obtained from the Office for National Statistics [<xref ref-type="bibr" rid="B4">4</xref>].</p>
</sec>
<sec id="s2-2">
<title>The Netherlands</title>
<p>In the Netherlands, donor registration data were obtained from the national Donor Register [<xref ref-type="bibr" rid="B5">5</xref>]. In addition, medical records of patients who died in intensive care units were reviewed retrospectively. Potential donors were defined as donors who are medically suitable for donation, regardless of their registration in the Donor Register, including those with a &#x201c;No&#x201d; registration. In the Netherlands the key measure of consent is the overall consent rate, defined as the proportion of all potential donors in whom consent for donation is obtained; this includes those who have registered a &#x201c;No&#x201d; decision.</p>
<p>These data are recorded in NovaNORD, a database maintained by the Dutch Transplant Foundation, and entered by (organ) donor coordinators [<xref ref-type="bibr" rid="B6">6</xref>].</p>
</sec>
<sec id="s2-3">
<title>Comparative analysis</title>
<p>For comparative purposes, donor register data for both countries were summarised for the period before and after the introduction of opt-out legislation (2019&#x2013;2025). Organ donation consent rates were analysed for 2017&#x2013;2025 and deceased donor numbers for 2010&#x2013;2025 to provide longer-term contextual trends.</p>
<p>Relative Risk and corresponding 95% confidence intervals (CI&#x2019;s) were calculated to test the hypothesis that opt-out legislation would increase the overall consent rate for organ donation. The &#x201c;Risk in exposed group&#x201d; is analysed for the years <italic>during</italic> the opt-out legislation (2022&#x2013;2025) and the &#x201c;Risk in unexposed group&#x201d; for the years <italic>before</italic> implementation of the legislation (2017&#x2013;2019). The years 2020 and 2021 were excluded due to potential confounding effects of the COVID-19 pandemic. Statistical significance was assessed using P-values corresponding to values of the standard normal distribution; a P-value &#x3c;0.05 was considered statistically significant. All Sankey diagrams created using SankeyMATIC.</p>
</sec>
<sec sec-type="ethics-statement" id="s2-4">
<title>Ethics statement</title>
<p>This study, using data from Dutch and English organ donation data registers, was conducted in accordance with the principles of the World Medical Association Declaration of Helsinki. Both the Netherlands and England operate under ethical frameworks consistent with the Declaration of Istanbul on Organ Donation and Transplantation. No interventions or procedures involving human participants were performed, and only anonymized, registry-based data were used.</p>
</sec>
</sec>
<sec sec-type="results" id="s3">
<title>Results</title>
<sec id="s3-1">
<title>Organ donor registrations</title>
<sec id="s3-1-1">
<title>England</title>
<p>In January 2026, 44% of the 57.7 million residents in England were registered on the ODR, comprising 40% with an opt-in decision and 4% with an opt-out decision. This compares to 35% opt-in and 2% opt-out of the population in January 2020, immediately prior to the implementation of deemed consent legislation. Only 136 individuals had nominated a representative to make a donation decision on their behalf. Trends in donor registration between 2019 and 2026 are shown in <xref ref-type="fig" rid="F1">Figure 1</xref>.</p>
<fig id="F1" position="float">
<label>FIGURE 1</label>
<caption>
<p>Number of donor registrations in England on the NHS Organ Donor Register 1<sup>st</sup> of January 2019&#x2013;2026&#x2a;. &#x2a; Only 136 individuals have nominated a representative to make a donation decision on their behalf, so this is not displayed in the figure.</p>
</caption>
<graphic mimetype="image" mime-subtype="tiff" xlink:href="ti-39-16664-g001.tif">
<alt-text content-type="machine-generated">Stacked area chart displaying changing proportions of three groups from January 2019 to January 2026: &#x22;ODR opt in&#x22; (green) increases steadily, &#x22;ODR opt out&#x22; (red) grows slightly, and &#x22;Not registered&#x22; (blue) gradually decreases. Chart illustrates registration choices over time.</alt-text>
</graphic>
</fig>
</sec>
<sec id="s3-1-2">
<title>The Netherlands</title>
<p>Following the active donor registration process, the entire Dutch population aged 18 years and older was recorded in the Donor Register by July 2021. In January 2026, 34% of residents had registered &#x201c;Yes, I want to be a donor,&#x201d; 24% &#x201c;No objection,&#x201d; and 31% &#x201c;No, I do not want to be a donor,&#x201d; while 11% delegated the &#x201c;Decision to next of kin&#x201d; or &#x201c;Specific person.&#x201d; Overall, 58% of the population had registrations permitting organ donation. Registration proportions have remained largely unchanged since July 2021 (<xref ref-type="fig" rid="F2">Figure 2</xref>).</p>
<fig id="F2" position="float">
<label>FIGURE 2</label>
<caption>
<p>Number of donor registrations in the Netherlands on the 1st of January 2019&#x2013;2026.</p>
</caption>
<graphic mimetype="image" mime-subtype="tiff" xlink:href="ti-39-16664-g002.tif">
<alt-text content-type="machine-generated">Stacked area chart showing annual counts from January 2019 to January 2026 of organ donor registration preferences in five categories. Green shows &#x201C;yes, I want to be a donor,&#x201D; blue indicates &#x201C;no objection,&#x201D; red is &#x201C;no, I do not want to be a donor,&#x201D; yellow represents &#x201C;decision next of kin,&#x201D; and gray is &#x201C;no registration.&#x201D; Category counts shift over time, with a notable decrease in &#x201C;no registration&#x201D; around January 2021, correlating with increased declarations in other categories.</alt-text>
</graphic>
</fig>
</sec>
</sec>
<sec id="s3-2">
<title>Family consent rates for organ donation</title>
<sec id="s3-2-1">
<title>England</title>
<p>The annual family consent rate for organ donation following approaches to donor families in England declined from 69% in 2020 to 57% in 2025, the lowest level recorded in more than a decade (<xref ref-type="table" rid="T1">Table 1</xref>). See <xref ref-type="sec" rid="s11">Supplementary Table 2</xref> for the distinction in family consent rates between donation after brain death (DBD) and donation after circulatory death (DCD) donors.</p>
<table-wrap id="T1" position="float">
<label>TABLE 1</label>
<caption>
<p>Annual consent rate for organ donation following approaches of donor families in England and the Netherlands January 2017 &#x2013; December 2025.</p>
</caption>
<table>
<thead valign="top">
<tr>
<th align="left">Calendar year</th>
<th colspan="2" align="center">England</th>
<th colspan="2" align="center">Netherlands</th>
</tr>
<tr>
<th align="left">&#x200b;</th>
<th colspan="2" align="center">Opt-out implemented May 20, 2020</th>
<th colspan="2" align="center">Opt-out implemented July 1, 2020</th>
</tr>
<tr>
<th align="left">&#x200b;</th>
<th align="center">Annual family consent rate (%)</th>
<th align="center">Monthly range (min %, max %)</th>
<th align="center">Annual family consent rate (%)</th>
<th align="center">Monthly range (min %, max %)</th>
</tr>
</thead>
<tbody valign="top">
<tr>
<td align="left" style="color:#201F1E">2017</td>
<td align="center" style="color:#201F1E">65</td>
<td align="center" style="color:#201F1E">(62, 69)</td>
<td align="center" style="color:#201F1E">45</td>
<td align="center" style="color:#201F1E">Not available</td>
</tr>
<tr>
<td align="left" style="color:#201F1E">2018</td>
<td align="center" style="color:#201F1E">67</td>
<td align="center" style="color:#201F1E">(61, 71)</td>
<td align="center" style="color:#201F1E">44</td>
<td align="center" style="color:#201F1E">Not available</td>
</tr>
<tr>
<td align="left" style="color:#201F1E">2019</td>
<td align="center" style="color:#201F1E">68</td>
<td align="center" style="color:#201F1E">(64, 74)</td>
<td align="center" style="color:#201F1E">42</td>
<td align="center" style="color:#201F1E">Not available</td>
</tr>
<tr>
<td align="left" style="color:#201F1E">2020</td>
<td align="center" style="color:#201F1E">69</td>
<td align="center" style="color:#201F1E">(65, 74)</td>
<td align="center" style="color:#201F1E">48</td>
<td align="center" style="color:#201F1E">Not available</td>
</tr>
<tr>
<td align="left" style="color:#201F1E">2021</td>
<td align="center" style="color:#201F1E">66</td>
<td align="center" style="color:#201F1E">(58, 72)</td>
<td align="center" style="color:#201F1E">60</td>
<td align="center" style="color:#201F1E">(52, 71)</td>
</tr>
<tr>
<td align="left" style="color:#201F1E">2022</td>
<td align="center" style="color:#201F1E">62</td>
<td align="center" style="color:#201F1E">(56, 70)</td>
<td align="center" style="color:#201F1E">60</td>
<td align="center" style="color:#201F1E">(51, 65)</td>
</tr>
<tr>
<td align="left" style="color:#201F1E">2023</td>
<td align="center" style="color:#201F1E">61</td>
<td align="center" style="color:#201F1E">(57, 70)</td>
<td align="center" style="color:#201F1E">61</td>
<td align="center" style="color:#201F1E">(49, 72)</td>
</tr>
<tr>
<td align="left" style="color:#201F1E">2024</td>
<td align="center" style="color:#201F1E">59</td>
<td align="center" style="color:#201F1E">(52, 62)</td>
<td align="center" style="color:#201F1E">59</td>
<td align="center" style="color:#201F1E">(48, 73)</td>
</tr>
<tr>
<td align="left" style="color:#201F1E">2025</td>
<td align="center">57</td>
<td align="center">(54, 61)</td>
<td align="center" style="color:#201F1E">56</td>
<td align="center" style="color:#201F1E">(48, 61)</td>
</tr>
</tbody>
</table>
<table-wrap-foot>
<fn>
<p>In the Netherlands, the family consent rate includes all potential donor families approached for donation. Following the implementation of the legislation, many individuals registered as &#x2018;No&#x27; were no longer approached because their donation decision was already known. In England, the family consent rate includes all eligible donor families approached for donation, including those of donors who had opted out.</p>
</fn>
</table-wrap-foot>
</table-wrap>
</sec>
<sec id="s3-2-2">
<title>The Netherlands</title>
<p>In the Netherlands, the annual family consent rate for organ donation following approaches to donor families declined from 60% in 2021 to 56% in 2025. However, this is still higher than the family consent rate under the opt-in system, which peaked at 48% in 2020 (<xref ref-type="table" rid="T1">Table 1</xref>).</p>
</sec>
</sec>
<sec id="s3-3">
<title>Donor registration, family approach, and overall consent rate</title>
<sec id="s3-3-1">
<title>England</title>
<p>Changes to the PDA data collection system in September 2020 enabled more accurate recording of donor registration status. Consequently, the proportion of unknown registrations declined from 71% in 2017 to 12% in 2025 (<xref ref-type="table" rid="T2">Table 2</xref>). Since September 2020, the potential donors with known registration status, the proportion registered as opt-in increased steadily to 37% by 2025, while opt-out registrations remained low at approximately 3%.</p>
<table-wrap id="T2" position="float">
<label>TABLE 2</label>
<caption>
<p>Registration on the Organ Donor Register (where known) of identified potential organ donors<xref ref-type="table-fn" rid="Tfn1">&#x2a;</xref> in England included in the Potential Donor Audit 2017&#x2013;2025.</p>
</caption>
<table>
<thead valign="top">
<tr>
<th align="left">Calendar year</th>
<th align="center">Total audited deaths number</th>
<th align="left">Total potential donors number</th>
<th align="center">Total number of potential donors where ODR registration known</th>
<th align="left">ODR opt-in registration number/Total where ODR registration known number (%)</th>
<th align="left">ODR opt-out registration number/Total where ODR registration known number (%)</th>
<th align="left">Not registered number/Total where ODR registration known number (%)</th>
<th align="left">
<xref ref-type="table-fn" rid="Tfn1">&#x2a;</xref>Register not consulted or outcome not documented number/Total potential donors number (%)</th>
</tr>
</thead>
<tbody valign="top">
<tr>
<td align="left">2017</td>
<td align="center">28,507</td>
<td align="center">6,226</td>
<td align="center">1,786</td>
<td align="center">1,564/1,786 (87.6)</td>
<td align="center">7/1,786 (0.4)</td>
<td align="center">215/1,786 (12.0)</td>
<td align="center">4,440/6,226 (71.3)</td>
</tr>
<tr>
<td align="left">2018</td>
<td align="center">27,926</td>
<td align="center">6,196</td>
<td align="center">1,772</td>
<td align="center">1,539/1,772 (86.9)</td>
<td align="center">24/1,772 (1.4)</td>
<td align="center">209/1,772 (11.8)</td>
<td align="center">4,424/6,196 (71.4)</td>
</tr>
<tr>
<td align="left">2019</td>
<td align="center">27,631</td>
<td align="center">6,331</td>
<td align="center">1,965</td>
<td align="center">1,720/1,965 (87.5)</td>
<td align="center">42/1,965 (2.1)</td>
<td align="center">203/1,965 (10.3)</td>
<td align="center">4,366/6,331 (69.0)</td>
</tr>
<tr>
<td align="left">2020</td>
<td align="center">30,960</td>
<td align="center">6,367</td>
<td align="center">2,743</td>
<td align="center">1,581/2,743 (57.6)</td>
<td align="center">100/2,743 (3.6)</td>
<td align="center">1,062/2,743 (38.7)</td>
<td align="center">3,624/6,367 (56.9)</td>
</tr>
<tr>
<td align="left">2021</td>
<td align="center">35,239</td>
<td align="center">6,255</td>
<td align="center">4,707</td>
<td align="center">1,615/4,707 (34.3)</td>
<td align="center">123/4,707 (2.6)</td>
<td align="center">2,969/4,707 (63.1)</td>
<td align="center">1,548/6,255 (24.7)</td>
</tr>
<tr>
<td align="left">2022</td>
<td align="center">31,195</td>
<td align="center">5,895</td>
<td align="center">5,035</td>
<td align="center">1,713/5,035 (34.0)</td>
<td align="center">148/5,035 (2.9)</td>
<td align="center">3,174/5,035 (63.0)</td>
<td align="center">860/5,895 (14.6)</td>
</tr>
<tr>
<td align="left">2023</td>
<td align="center">29,975</td>
<td align="center">5,937</td>
<td align="center">5,153</td>
<td align="center">1,887/5,153 (36.6)</td>
<td align="center">130/5,153 (2.5)</td>
<td align="center">3,136/5,153 (60.9)</td>
<td align="center">784/5,937 (13.2)</td>
</tr>
<tr>
<td align="left">2024</td>
<td align="center">29,888</td>
<td align="center">5,910</td>
<td align="center">5,123</td>
<td align="center">1,871/5,123 (36.5)</td>
<td align="center">139/5,123 (2.7)</td>
<td align="center">3,113/5,123 (60.8)</td>
<td align="center">787/5,910 (13.3)</td>
</tr>
<tr>
<td align="left">2025</td>
<td align="center">27,865</td>
<td align="center">5,714</td>
<td align="center">5,024</td>
<td align="center">1,878/5,024 (37.4)</td>
<td align="center">169/5,024 (3.4)</td>
<td align="center">2,977/5,024 (59.3)</td>
<td align="center">690/5,714 (12.1)</td>
</tr>
</tbody>
</table>
<table-wrap-foot>
<fn id="Tfn1">
<label>&#x2a;</label>
<p>The ODR, is not consulted for all potential donors; where potential donors are assessed to be medically unsuitable for organ donation prior to the family approach, the ODR, register may not be checked.</p>
</fn>
</table-wrap-foot>
</table-wrap>
<p>The consent group of identified eligible organ donors included in the PDA in England 2017 &#x2013; 2025 is provided in <xref ref-type="sec" rid="s11">Supplementary Table 1</xref>. The number of families approached for organ donation, based on the consent group, and family consent rate in England 2017 &#x2013; 2025 is given in <xref ref-type="sec" rid="s11">Supplementary Table 3</xref>. The Sankey visuals compare the period before and after implementation of opt-out legislation, see <xref ref-type="fig" rid="F3">Figure 3</xref>.</p>
<fig id="F3" position="float">
<label>FIGURE 3</label>
<caption>
<p>Number of eligible donors, family approaches and family consents by consent group in England, pre and post opt-out legislation. Around a third of eligible donors, in England, are deemed medically unsuitable through donor screening programs so families are not approached. Note: The family consent rate is presented in this diagram, the denominator differs from that used in <xref ref-type="fig" rid="F4">Figure 4</xref> for the Netherlands.</p>
</caption>
<graphic mimetype="image" mime-subtype="tiff" xlink:href="ti-39-16664-g003.tif">
<alt-text content-type="machine-generated">Sankey diagram comparing organ donor consent outcomes in England for 2017-2019 and 2022-2025. Flows from eligible donors split by expressed opt-in, opt-out, deemed consent, and other categories, showing those resulting in consent, no consent, or family not approached. Consent rate decreased from 66.7 percent to 59.7 percent.</alt-text>
</graphic>
</fig>
<p>The inferential statistical analysis, using Relative Risk, showed that the overall consent rate in England is significantly lower following the implementation of opt-out legislation compared to the period before, see <xref ref-type="table" rid="T3">Table 3</xref>.</p>
<table-wrap id="T3" position="float">
<label>TABLE 3</label>
<caption>
<p>Comparison of overall consent rates in England and the Netherlands before and after implementation of the Opt-Out Act.</p>
</caption>
<table>
<thead valign="top">
<tr>
<th align="left">Hypothesis</th>
<th align="left">Group</th>
<th align="center">Consent (n)</th>
<th align="center">Objection (n)</th>
<th align="center">Total</th>
<th align="right">Risk [95% CI]</th>
<th align="center">Relative risk (RR); [95%CI]</th>
<th align="center">Chi</th>
<th align="center">P-value</th>
</tr>
</thead>
<tbody valign="top">
<tr>
<th colspan="9" align="left">England</th>
</tr>
<tr>
<td rowspan="2" align="left">Overall consent rate</td>
<td align="left">Exposed (opt-out Act)</td>
<td align="right">6,063</td>
<td align="right">10,897</td>
<td align="right">16,933</td>
<td align="right">0.356 [0.349&#x2013;0.363]</td>
<td rowspan="2" align="right">0.961 [0.934&#x2013;0.989]</td>
<td rowspan="2" align="right">&#x2212;2.65</td>
<td rowspan="2" align="right">&#x3c;0.05&#x2a;</td>
</tr>
<tr>
<td align="left">Unexposed (before opt-out Act)</td>
<td align="right">5,650</td>
<td align="right">9,590</td>
<td align="right">15,240</td>
<td align="right">0.370 [0.363&#x2013;0.378]</td>
</tr>
<tr>
<th colspan="9" align="left">Netherlands</th>
</tr>
<tr>
<td rowspan="2" align="left">Overall consent rate</td>
<td align="left">Exposed (opt-out Act)</td>
<td align="right">1,022</td>
<td align="right">2,001</td>
<td align="right">3,023</td>
<td align="right">0.338 [0.321&#x2013;0.354]</td>
<td rowspan="2" align="right">1.060 [0.995&#x2013;1.128]</td>
<td rowspan="2" align="right">1.842</td>
<td rowspan="2" align="right">&#x3e;0.05</td>
</tr>
<tr>
<td align="left">Unexposed (before opt-out Act)</td>
<td align="right">1,679</td>
<td align="right">3,006</td>
<td align="right">4,685</td>
<td align="right">0.358 [0.344&#x2013;0.372]</td>
</tr>
</tbody>
</table>
<table-wrap-foot>
<fn>
<p>CI , confidence interval; &#x2a; &#x3d; p-value &#x3c;0.05.</p>
</fn>
</table-wrap-foot>
</table-wrap>
</sec>
<sec id="s3-3-2">
<title>The Netherlands</title>
<p>Analysis of potential organ donors between 2017 and 2025 shows an increase in &#x201c;Yes&#x201d; registrations from 24% to 29% and the emergence of the &#x201c;No objection&#x201d; category to approximately 20% of potential donors (<xref ref-type="table" rid="T4">Table 4</xref>). Over the same period, the proportion of potential donors registered as &#x201c;No, I do not want to be a donor&#x201d; increased from 16% to 39%. The proportion without a recorded registration declined from 52% to 6% following implementation of active donor registration.</p>
<table-wrap id="T4" position="float">
<label>TABLE 4</label>
<caption>
<p>Registration in the Donor Register of identified potential organ donors<xref ref-type="table-fn" rid="Tfn2">&#x2a;</xref> in the Netherlands in the intensive care unit 2017&#x2013;2025.</p>
</caption>
<table>
<thead valign="top">
<tr>
<th align="left">Calen-dar year</th>
<th align="center">Total deaths in ICUs number</th>
<th align="center">Total identified potential donors number</th>
<th align="center">Yes, I want to be a donor number/Total registered number (%)</th>
<th align="center">No objection number/<break/>Total registered number (%)</th>
<th align="center">No, I do not want to be a donor number/Total registered number (%)</th>
<th align="center">Decision by next of kin number/Total registered number (%)</th>
<th align="center">Not registered number/Total registered number (%)</th>
<th align="center">
<xref ref-type="table-fn" rid="Tfn2">&#x2a;</xref>Register not consulted number/Total potential donors number (%)</th>
</tr>
</thead>
<tbody valign="top">
<tr>
<td align="left">2017</td>
<td align="center">7,755</td>
<td align="center">951</td>
<td align="center">203/851 (23.6)</td>
<td align="center">NA</td>
<td align="center">137/851 (16.1)</td>
<td align="center">67/851 (7.9)</td>
<td align="center">444/851 (52.2)</td>
<td align="center">100/951 (10.5)</td>
</tr>
<tr>
<td align="left">2018</td>
<td align="center">7,990</td>
<td align="center">1,039</td>
<td align="center">229/921 (24.9)</td>
<td align="center">NA</td>
<td align="center">158/921 (17.2)</td>
<td align="center">64/921 (6.9)</td>
<td align="center">470/921 (51)</td>
<td align="center">118/1,039 (11.4)</td>
</tr>
<tr>
<td align="left">2019</td>
<td align="center">7,373</td>
<td align="center">1,033</td>
<td align="center">189/904 (20.9)</td>
<td align="center">NA</td>
<td align="center">184/904 (20.4)</td>
<td align="center">62/904 (6.6)</td>
<td align="center">469/904 (51.9)</td>
<td align="center">129/1,033 (12.5)</td>
</tr>
<tr>
<td align="left">2020</td>
<td align="center">7,618</td>
<td align="center">987</td>
<td align="center">205/876 (23.4)</td>
<td align="center">NA</td>
<td align="center">204/876 (22.8)</td>
<td align="center">52/876 (5.9)</td>
<td align="center">415/876 (47.4)</td>
<td align="center">111/987 (11.2)</td>
</tr>
<tr>
<td align="left">2021</td>
<td align="center">7,750</td>
<td align="center">915</td>
<td align="center">250/874 (28.6)</td>
<td align="center">158/874 (18.1)</td>
<td align="center">302/874 (34.6)</td>
<td align="center">80/874 (9.2)</td>
<td align="center">84/874 (9,6)</td>
<td align="center">41/915 (4,5)</td>
</tr>
<tr>
<td align="left">2022</td>
<td align="center">6,981</td>
<td align="center">1,102</td>
<td align="center">309/1,050 (29.4)</td>
<td align="center">214/1,050 (20.4)</td>
<td align="center">403/1,050 (38.4)</td>
<td align="center">79/1,050 (7.5)</td>
<td align="center">45/1,050 (4.3)</td>
<td align="center">52/1,102 (4.7)</td>
</tr>
<tr>
<td align="left">2023</td>
<td align="center">6,810</td>
<td align="center">1,147</td>
<td align="center">318/1,101 (28.9)</td>
<td align="center">218/1,101 (19.8)</td>
<td align="center">439/1,101 (39.9)</td>
<td align="center">77/1,101 (7)</td>
<td align="center">49/1,101 (4.5)</td>
<td align="center">46/1,147 (4)</td>
</tr>
<tr>
<td align="left">2024</td>
<td align="center">6,793</td>
<td align="center">1,244</td>
<td align="center">344/1,188 (29)</td>
<td align="center">237/1,188 (19.9)</td>
<td align="center">426/1,188 (35.9)</td>
<td align="center">110/1,188 (9.3)</td>
<td align="center">71/1,188 (6)</td>
<td align="center">56/1,244 (4.5)</td>
</tr>
<tr>
<td align="left">2025</td>
<td align="center" style="color:#201F1E">6,732</td>
<td align="center" style="color:#201F1E">1,192</td>
<td align="center" style="color:#201F1E">318/1,129 (28.2)</td>
<td align="center" style="color:#201F1E">222/1,129 (19.7)</td>
<td align="center" style="color:#201F1E">440/1,129 (39)</td>
<td align="center" style="color:#201F1E">78/1,129 (7)</td>
<td align="center">71/1,129 (6.3)</td>
<td align="center" style="color:#201F1E">63/1,192 (5.3)</td>
</tr>
</tbody>
</table>
<table-wrap-foot>
<fn>
<p>NA, not applicable.</p>
</fn>
<fn id="Tfn2">
<label>&#x2a;</label>
<p>The Donor Register was not consulted for all identified potential organ donors, such as in cases where donation had already been discussed with the family before consulting the register, the donor was from abroad, or the donor was a child.</p>
</fn>
</table-wrap-foot>
</table-wrap>
<p>Family support varied by registration category. Families generally supported donation when the donor had registered &#x201c;Yes,&#x201d; whereas in cases of &#x201c;No objection&#x201d; families declined donation in more than half of cases (<xref ref-type="sec" rid="s11">Supplementary Table 4</xref>). When the decision was delegated to next of kin, consent rates ranged between 28% and 52%. Considering both donor registration and family decision-making, the overall consent rate across all potential donors remained approximately 35% between 2017 and 2025.</p>
<p>The Sankey visuals compare the period before and after implementation of opt-out legislation, see <xref ref-type="fig" rid="F4">Figure 4</xref>.</p>
<fig id="F4" position="float">
<label>FIGURE 4</label>
<caption>
<p>Number of potential donors, family approaches and family consent per outcome in the Donor Register in the Netherlands, pre and post opt-out legislation. Note: This diagram presents the overall consent rate, the denominator differs from that in <xref ref-type="fig" rid="F3">Figure 3</xref> for England.</p>
</caption>
<graphic mimetype="image" mime-subtype="tiff" xlink:href="ti-39-16664-g004.tif">
<alt-text content-type="machine-generated">Sankey diagrams compare organ donor consent sources in the Netherlands between 2017 to 2019 and 2022 to 2025, showing increased potential donors, slightly higher overall consent rates, and categories like &#x201C;yes&#x201D; registration, &#x201C;no objection,&#x201D; decisions by next of kin, and registration status.</alt-text>
</graphic>
</fig>
<p>The inferential statistical analysis, using Relative Risk, showed that the overall consent rate in the Netherlands is not significantly higher following opt-out legislation compared to the period before, see <xref ref-type="table" rid="T3">Table 3</xref>.</p>
</sec>
</sec>
<sec id="s3-4">
<title>Organ donor numbers</title>
<sec id="s3-4-1">
<title>England</title>
<p>Deceased donor numbers declined sharply in 2020, coinciding with the introduction of opt-out legislation and the COVID-19 pandemic. Donor numbers fell from a peak of 1,432 in 2019 to 1,043 in 2020. Numbers have since increased gradually to 1,207 in 2025, although they remain below pre-pandemic levels (<xref ref-type="fig" rid="F5">Figure 5</xref>). In recent years, DCD has exceeded DBD, with 678 DCD and 529 DBD donors recorded in 2025.</p>
<fig id="F5" position="float">
<label>FIGURE 5</label>
<caption>
<p>Number of DBD, DCD organ donors in England 2010&#x2013;2025. Donation after brainstem death (DBD) &#x3d; deceased organ donation following diagnosis of death using neurological criteria; Donation after circulatory death (DCD) &#x3d; deceased organ donation following diagnosis of death using cardiorespiratory diagnosis.</p>
</caption>
<graphic mimetype="image" mime-subtype="tiff" xlink:href="ti-39-16664-g005.tif">
<alt-text content-type="machine-generated">Stacked bar chart showing the number of DBD (Donation after Brain Death) and DCD (Donation after Circulatory Death) donors from 2010 to 2025, with values increasing overall but DCD donors rising more notably in recent years.</alt-text>
</graphic>
</fig>
</sec>
<sec id="s3-4-2">
<title>The Netherlands</title>
<p>Between 2010 and 2025, the number of deceased donors in the Netherlands increased following implementation of the opt-out system, with the highest number recorded in 2024 (n &#x3d; 360). However, donor numbers in recent years remain broadly comparable with earlier peaks, such as 2014 (n &#x3d; 269). A notable trend is the increasing number of donors following euthanasia, rising from 13 in 2022 to 34 in 2025. In total, 189 organ donors following euthanasia have been realised since 2012 (<xref ref-type="fig" rid="F6">Figure 6</xref>).</p>
<fig id="F6" position="float">
<label>FIGURE 6</label>
<caption>
<p>Number of DBD, DCD, and donors following euthanasia in the Netherlands 2010&#x2013;2025. Donation after brain death (DBD) &#x3d; deceased organ donation following diagnosis of death using neurological criteria; Donation after circulatory death (DCD) &#x3d; deceased organ donation following diagnosis of death using cardiorespiratory diagnosis.</p>
</caption>
<graphic mimetype="image" mime-subtype="tiff" xlink:href="ti-39-16664-g006.tif">
<alt-text content-type="machine-generated">Stacked bar chart showing the annual numbers of organ donors in three categories from 2010 to 2025: DBD donors (blue), DCD donors (orange), and donors following euthanasia (green). The chart reveals fluctuations, with DCD donors rising significantly in 2024 and 2025, while DBD donor numbers generally decline.</alt-text>
</graphic>
</fig>
</sec>
</sec>
</sec>
<sec sec-type="discussion" id="s4">
<title>Discussion</title>
<sec id="s4-1">
<title>Reflections after 5&#xa0;years of implementation of the opt-out consent system</title>
<sec id="s4-1-1">
<title>England</title>
<p>A government-commissioned evaluation of deemed consent legislation in England examined the perspectives of families approached for organ donation and healthcare professionals involved in donation discussions [<xref ref-type="bibr" rid="B7">7</xref>, <xref ref-type="bibr" rid="B8">8</xref>]. Many families had limited understanding of deceased organ donation and perceived themselves as the principal decision-makers, rather than deemed consent as an expression of the deceased&#x2019;s choice. Families relied heavily on specialist nurses in organ donation for guidance and emotional support and reported high satisfaction with their care. Healthcare professionals reported that the legislation had not reduced the complexity of family discussions or end-of-life care, and most remained unconvinced that legislation alone would improve consent rates. The evaluation concluded that deemed consent was unlikely to have caused the observed decline in consent rates, suggesting other factors influenced the reduction in consent and donor numbers.</p>
<p>Public attitudes towards the NHS have shifted markedly since the COVID-19 pandemic. YouGov&#xae; polling indicated 70% of respondents rated the NHS as &#x201c;good&#x201d; in 2020, whereas since October 2022 more than 60% have consistently rated it as &#x201c;bad&#x201d; [<xref ref-type="bibr" rid="B9">9</xref>]. A preliminary analysis suggests a moderate positive correlation between positive public opinion of national NHS services and family consent rates (correlation coefficient &#x2b;0.73; <xref ref-type="sec" rid="s11">Supplementary Figure 1</xref>). Internal NHSBT surveys similarly show declining public awareness of the organ donation system and softening support for donation in principle.</p>
<p>In England, the coexistence of opt-in and opt-out pathways creates a complex dual consent system. Deemed consent may confuse the public, leading to misunderstanding or disengagement, where individuals neither opt-in nor opt-out. Registration patterns have remained relatively stable since implementation, suggesting limited sustained public engagement. On the other hand, the inferential analysis demonstrated significant lower overall consent rates.</p>
<p>England operates a &#x201c;soft&#x201d; opt-out model in which families are expected to support the deceased&#x2019;s decision. In practice, families may override both expressed opt-in decisions and deemed consent. In more than 50% of applicable deemed cases in recent years, families have not supported donation (<xref ref-type="table" rid="T3">Table 3</xref>). This highlights the continued centrality of the family at the bedside and raises important questions about the practical authority of individual decisions and &#x201c;soft&#x201d; opt-out legislation. Similar patterns across other UK nations suggest these challenges are systemic rather than purely legislative.</p>
<p>Together, these findings suggest that legislative reform alone is insufficient to create a supportive culture for deceased organ donation. Societal understanding, trust in healthcare institutions and effective professional practice remain central to donation discussions and family consent.</p>
</sec>
<sec id="s4-1-2">
<title>The Netherlands</title>
<p>Since implementation of the opt-out system in July 2020, active donor registration has doubled registrations in the Donor Register from 7 million to 14 million, covering the entire population aged 18 and older. Knowing the potential donor&#x2019;s wishes provides greater clarity during the family approach. The annual family consent rate rose to approximately 56%, compared with 48% under the opt-in system. However, the large number of &#x201c;No, I do not want to be a donor&#x201d; registrations has considerably reduced the donor pool. When the entire consent process, from donor registration to family approach, is considered, the increase in overall consent rate compared with the opt-in system is small, which was also the outcome of the inferential analysis.</p>
<p>The number of realised donors has nevertheless increased. This partly reflects increasing donation after euthanasia. In 2024, an exceptionally high number of potential donors, despite declining intensive care deaths, also contributed to a high number of realised donors. Greater opportunities for extended criteria donors, abdominal normothermic regional perfusion for DCD donors, machine preservation, and, since 2021, DCD heart donation have further expanded the potential donor pool. Given the limited increase in overall consent, the increase in realised donors cannot be attributed to the opt-out system alone.</p>
<p>A positive aspect of the Dutch system is that all 14 million adults are now registered, ensuring that family approaches are based on the potential donor&#x2019;s documented wishes. Under the opt-in system, families often faced donation decisions without knowing their loved one&#x2019;s preferences. The opt-out system has also prompted discussion within many families, with some now initiating donation conversations in intensive care.</p>
</sec>
<sec id="s4-1-3">
<title>England</title>
<p>Faced with falling donor numbers in 2024, the Organ Donation Joint Working Group (ODJWG), jointly chaired by the Department of Health and Social Care and NHS Blood and Transplant produced <italic>A Bolder, Braver Approach for Organ Donation in the UK</italic>. [<xref ref-type="bibr" rid="B10">10</xref>]. The Group brought together UK clinical leaders, donor family representatives and international experts. It concluded that deemed consent legislation is positive and permissive, does not require amendment and has helped signal support for donation and enable system improvements. However, it found no reliable evidence that opt-out legislation alone increases consent rates and noted persistent public confusion about deemed consent. The report advises against using legislation in public-facing marketing, unless legally required, or in discussions with grieving families. Deemed consent was considered too complex and potentially counterproductive in acute grief, with concern that referencing the law may provoke resistance or &#x201c;reactance.&#x201d; Instead, communication should focus on the individual&#x2019;s values, the positive impact of donation and supporting families. The Group recommends acting within the law but not leading with it, positioning legislation as a supportive framework rather than a tool of persuasion. Implementation of the Report is ongoing across the UK.</p>
<p>England&#x2019;s experience provides several lessons. We continue to consider the legislation valuable: it signalled societal and governmental support for donation while respecting individual autonomy through the mechanism of opt-out. It also enabled engagement with faith and community groups, broadening conversations beyond the clinical setting.</p>
<p>However, implementation could have been bolder. Campaigns emphasised choice and positioned opt-in and opt-out equally, rather than articulating a clear pro-donation societal norm. The law alone therefore did not generate a pro-donation culture, a factor that moderates policy effectiveness [<xref ref-type="bibr" rid="B11">11</xref>]. If opt-out legislation is intended as both a legal and cultural shift, it requires confident, sustained public messaging that supports pro-donation social norms while respecting individual autonomy. Low public acceptance may otherwise hinder successful implementation [<xref ref-type="bibr" rid="B12">12</xref>].</p>
</sec>
<sec id="s4-1-4">
<title>The Netherlands</title>
<p>The opt-out system was introduced during the COVID-19 pandemic, limiting opportunities to train intensivists on approaching families about the new &#x201c;No objection&#x201d; category. In-person training was not possible, and even trained intensivists might wait months or years before encountering their first case. Van Oosterhout et al. found that donor conversations involve a complex interplay between donor registration and clinician-family interactions [<xref ref-type="bibr" rid="B13">13</xref>]. Clinicians&#x2019; personal considerations, previous experiences with the family and professional context shaped four distinct approaches to discussing &#x201c;Yes&#x201d; or &#x201c;No objection&#x201d; registrations, each reflecting increasing family influence by the family on the outcome of the donation decision.</p>
<p>The family&#x2019;s role is also influenced by awareness and understanding of the opt-out system. Registration of 7 million previously unregistered residents occurred during the COVID-19 pandemic, a period of high mortality fear, that may not have been ideal for considering donation preferences. However, 31% registered &#x201c;No, I don&#x2019;t want to be an organ donor&#x201d; suggesting that those strongly opposed could still record their preference.</p>
<p>Similar findings emerged in Nova Scotia, Canada, where deemed consent was also introduced during the pandemic. Sarti et al. found variable family awareness of the new law and their role in decision-making [<xref ref-type="bibr" rid="B14">14</xref>]. Some were optimistic about deemed consent, while others felt that continued family consultation limited its potential impact.</p>
</sec>
</sec>
<sec id="s4-2">
<title>Limitations</title>
<p>Our study has several limitations. First, implementation of opt-out legislation in both England and the Netherlands coincided with the COVID-19 pandemic, making it difficult to separate the effects of legislative change from wider impacts on healthcare systems, public attitudes and organ donation activity. Second, this observational analysis of national registry and audit data cannot establish causality. Third, organ donation activity is influenced by multiple factors beyond legislation. Fourth, differences in registration systems, data collection methods and consent processes limit direct comparisons between countries. Finally, donor registrations and consent rates may not fully capture wider societal attitudes towards donation.</p>
</sec>
</sec>
<sec sec-type="conclusion" id="s5">
<title>Conclusion</title>
<p>Five years on, our earlier conclusions remain broadly valid. Legislation alone has not transformed donation rates. Operational infrastructure, professional training, digital systems and stakeholder engagement remain essential. In both England and the Netherlands, opt-out legislation functioned as an enabler, signalling governmental commitment, unlocking investment, and creating opportunities for engagement with faith and community groups.</p>
<p>We underestimated the extent to which legislative change is symbolic rather than transformative in itself. While opt-out legislation signals a pro-donation stance, it does not automatically create a pro-donation culture. The Dutch experience illustrates this clearly: the new category &#x201c;No objection&#x201d; remains challenging, with fewer than half of families supporting donation.</p>
<p>We also underestimated the importance of narrative clarity and cultural positioning. In both countries, public campaigns were deliberately neutral, emphasising individual choice and avoiding pressure to donate. While principled, this limited the opportunity to present donation as an expected and valued social contribution. Legislative reform that aspires to cultural change requires sustained, confident public messaging that supports donation as a shared societal good while respecting individual autonomy.</p>
<p>Taken together, the experiences of England and the Netherlands suggest that opt-out legislation should be understood not as a standalone solution, but as a structural platform from which supportive systems, public engagement and a pro-donation culture can be built.</p>
</sec>
</body>
<back>
<sec sec-type="data-availability" id="s6">
<title>Data availability statement</title>
<p>The original contributions presented in the study are included in the article/<xref ref-type="sec" rid="s11">Supplementary Material</xref>, further inquiries can be directed to the corresponding author.</p>
</sec>
<sec sec-type="author-contributions" id="s7">
<title>Author contributions</title>
<p>All authors participated in the study design, data analysis, and interpretation of the findings, as well as in the critical review and revision of the manuscript. NJ and DG drafted the manuscript; TW, MH, AH, CW, and SM contributed to data interpretation, provided expert input, and reviewed the final version. All authors contributed to the article and approved the submitted version.</p>
</sec>
<sec sec-type="COI-statement" id="s9">
<title>Conflict of interest</title>
<p>The author(s) declared that this work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.</p>
</sec>
<sec sec-type="ai-statement" id="s10">
<title>Generative AI statement</title>
<p>The author(s) declared that generative AI was not used in the creation of this manuscript.</p>
<p>Any alternative text (alt text) provided alongside figures in this article has been generated by Frontiers with the support of artificial intelligence and reasonable efforts have been made to ensure accuracy, including review by the authors wherever possible. If you identify any issues, please contact us.</p>
</sec>
<sec sec-type="supplementary-material" id="s11">
<title>Supplementary material</title>
<p>The Supplementary Material for this article can be found online at: <ext-link ext-link-type="uri" xlink:href="https://www.frontierspartnerships.org/articles/10.3389/ti.2026.16664/full#supplementary-material">https://www.frontierspartnerships.org/articles/10.3389/ti.2026.16664/full&#x23;supplementary-material</ext-link>
</p>
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<supplementary-material xlink:href="Image2.jpeg" id="SM3" mimetype="application/jpeg" xmlns:xlink="http://www.w3.org/1999/xlink"/>
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