Global Best Practices

Lessons from the World Leaders

Rishikesh Kumar*

You’re battling a severe illness and the only chance of survival is an organ transplant. Days turn into weeks as you wait, your hope dimming with each passing moment. Then, one night, a celestial figure appears in your dreams, offering you a miraculous choice:

“I will grant you a new citizenship in any country of your choice— where organ donation systems are the best in the world. Choose wisely, for your life depends on it.”

Would you pick Spain, the gold standard in organ donation? Or the United States, with its advanced technology and robust transplant networks? Maybe Singapore, with its cuttingedge policies and exceptional efficiency? Or would you stay in India, betting on the potential for reform?

Every eight minutes, someone in India dies awaiting an organ transplant, a silent crisis arising out of systemic inefficiencies and societal hesitations. Meanwhile, countries like Spain and Singapore lead a quiet revolution, achieving remarkable success in organ donations. How do their laws and practices differ? What lessons can India draw to save more lives?

This article explores global best practices in organ transplantation, compares them with India’s framework, and charts a roadmap for reform. Much like the Bhore Committee envisioned a transformative healthcare model, it’s time for India to reimagine its organ transplant ecosystem—where every life is given a fighting chance.

Spain: A Global Leader

Spain’s organ donation and transplantation system is recognised worldwide as a model of excellence.

In May 2024, Spain led a significant resolution at the World Health Assembly to enhance the availability, ethical access, and oversight of organ transplantation globally. Spain’s unparalleled success in the field is marked by the world’s highest deceased donor rate of 49.4 per million population in 2023.

Components of Spain’s success

A Strong Legislative Framework: Spain’s success in organ donation is underpinned by a robust legal framework established in 1979. The law ensures equitable allocation and transparency in organ distribution across the nation. Regular updates to the legislation have broadened donor criteria, now allowing the use of organs from individuals over 80 years old and non-standard risk donors. Spain excels in donation after circulatory death, an area often underutilised elsewhere, which constitutes 45 per cent of all donation activities in the country1.

The Soft Opt-Out System: Spain operates a ‘soft opt-out’ system, where all citizens are considered donors by default unless their families decide otherwise. This nuanced approach balances efficiency with sensitivity, earning public trust. Eight out of 10 families in Spain consent to organ donation—a figure significantly higher than countries like the United Kingdom, where only six in 10 families agree under a similar system. Spain’s example underscores that an opt-out policy alone is insufficient; it must be accompanied by cultural trust and institutional support.

Clinical Leadership: The role of hospital transplant coordinators—typically doctors from intensive care units—is pivotal to Spain’s transplantation success. These professionals identify potential donors, support grieving families, and manage complex logistics. Regional coordinators and the National Transplant Organisation (ONT) offer further guidance, ensuring smooth operations nationwide. Their training in family counselling and psychological support fosters empathetic communication, critical during such sensitive discussions.

The Role of ONT: Founded in 1989, the ONT has been instrumental in doubling Spain’s deceased donor rate in less than a decade. It oversees logistics, monitors ethical organ allocation, and leads public education initiatives. By collaborating with the media and sharing positive stories of organ donation, the ONT has significantly influenced public attitudes. Its transparency and emphasis on ethics have cemented public trust, a key factor in the program’s success.

Public Awareness and Cultural Acceptance: Organ donation often raises deep ethical, cultural and religious questions. The ONT addresses these challenges through transparent communication and awareness campaigns. People who discuss organ donation within their families are more likely to consent, and the ONT actively encourages such conversations. Patients’ associations further amplify the ONT’s message, building community trust and

Spain operates a ‘soft opt-out’ system, where all citizens are considered donors by default unless their families decide otherwise. This nuanced approach balances efficiency with sensitivity, earning public trust

promoting solidarity.

The US Policy Framework

The United States’ organ donation framework provides a robust example of how policies, laws and ethical considerations can work in tandem to create an effective organ transplantation system. Despite its reliance on an ‘opt-in’ model, the US has developed a nuanced system that ensures equitable organ allocation and ethical procurement, guided by federal laws, state-level adoption of model acts, and coordinated national oversight mechanisms.

Uniform Anatomical Gift Act

The UAGA was first promulgated in 1968, provides the foundation fororgan donation in the US. While not a federal law, its adoption across all states ensures consistency in regulations governing anatomical gifts. The UAGA allows individuals aged 18 or older to donate organs through a donor registry, driver’s license designation, or donor cards. Importantly, revisions in 1987 and 2006 clarified donor rights, explicitly stating that a decedent’s documented decision to donate cannot be overridden by next of kin, thus strengthening first-person authorisation.

The UAGA also delineates the hierarchy of relatives authorised to make decisions on organ donation in the absence of the decedent’s express intent, simplifying processes and reducing conflicts. It prohibits the sale of organs, aligning with ethical mandates established by the National Organ Transplant Act (NOTA).2

Equitable Allocation: Enacted in 1984, NOTA established the framework for equitable allocation of organs and addressed the growing demand for transplantation. It prohibits the sale of human organs and mandates “reasonable compensation” for procurement services to prevent exploitation.

NOTA also authorised the creation of the Organ Procurement and Transplantation Network (OPTN) and the United Network for Organ Sharing (UNOS). These entities ensure national coordination of organ allocation, develop policies, maintain waitlists, and standardise medical urgency criteria. Together, they aim to allocate organs to the sickest patients first while ensuring fair access across the US.

The OPT Network: The OPTN divides the US into 11 geographic regions, each managed by Organ Procurement Organisations (OPOs). These non-profit entities facilitate the recovery, preservation and transportation of organs, ensuring seamless logistics between donor hospitals and transplant centres.

A key feature of the US system is its data-driven allocation process, facilitated by OPTN’s algorithms. These consider medical urgency, waitlist time and compatibility to rank candidates, ensuring the ethical distribution of organs.

Research and Ethics: The US approach balances innovation with ethics. While deceased donors are not considered ‘human subjects’ under the Common Rule or FDA regulations, research involving transplant recipients is rigorously monitored. Additionally, entities like the Scientific Registry of Transplant Recipients (SRTR) collect and analyse data to inform policy decisions, improve outcomes, and guide future research.

The Singapore Story

Singapore’s organ donation framework is governed by three primary laws, each addressing distinct aspects of the process

A key feature of the US system is its data-driven allocation process, facilitated by OPTN’s algorithms. These consider medical urgency, waitlist time and compatibility to rank candidates, ensuring the ethical distribution of organs

to ensure clarity, fairness, and efficiency. Together, these laws create a robust and ethical system that maximises organ availability while safeguarding donor and recipient rights.3

Human Organ Transplant Act: The HOTA, introduced in 1987, forms the backbone of Singapore’s organ donation system. It operates on an ‘optout’ basis, automatically enrolling all Singaporean citizens and permanent residents aged 21 and above who are of sound mind. HOTA stands out for its balance of mandatory consent and ethical safeguards, making it a vital tool in addressing organ shortages.

The key highlights of HOTA are

Automatic Inclusion: All eligible individuals are presumed to consent to donate their kidneys, liver, heart, and corneas upon death unless they explicitly opt out.

Priority for Donors: Individuals who remain under HOTA receive higher priority on the transplant waiting list should they ever need an organ.

Regulation of Living Donations: HOTA prohibits the commercial trade of organs but allows regulated reimbursements for living donors to cover medical costs, income loss and insurance premiums. This ensures donors are not financially disadvantaged.

Amendments for Inclusion: Over the years, HOTA has been updated to expand its scope and refine its implementation, ensuring that more people benefit from transplants.

The MTERA: The HOTA focuses on life-saving organ transplants, MTERA caters to individuals who wish to contribute to medical advancements through their donations.

The key highlights of MTERA are

Opt-In Scheme: Unlike HOTA, individuals must voluntarily pledge to donate their organs, tissues, or even their entire body for research, education, or transplantation purposes.

Flexibility in Choice: Donors can specify which organs or tissues they wish to donate and for what purpose.

Posthumous Donations: Family members can authorise organ donations for a deceased individual under MTERA if the person had not made a prior pledge.

MTERA broadens the scope of donation, ensuring that organs and tissues not covered by HOTA (e.g., lungs, skin, bones) can contribute to medical progress.

Human Biomedical Research Act: The HBRA governs the use of human tissues and organs for biomedical research, ensuring that ethical practices are maintained in the pursuit of scientific innovation.

The key highlights of HBRA are

Consent Framework: Researchers must obtain explicit consent from donors or their families before using any organs or tissues.

Ethical Oversight: The act enforces strict guidelines to prevent exploitation or misuse of donated tissues.

HBRA complements HOTA and MTERA by ensuring that donations for research are handled responsibly and transparently.

Why Singapore’s Framework Excels

By combining these three laws, Singapore has created an all-encompassing system that addresses the needs of patients, respects donor rights, and promotes medical research. This integrated approach ensures

Singapore’s organ donation framework is governed by three primary laws, each addressing distinct aspects of the process to ensure clarity, fairness, and efficiency

that organ donation operates within an ethical and regulated environment, making Singapore’s policy a global benchmark.

Lessons for India

India stands at a pivotal moment to create a transformative organ donation system that is inclusive, transparent, and tailored to its unique challenges. By learning from global leaders in organ donation, India can design a framework that addresses its diverse needs while inspiring trust and participation.

Global Models as Inspiration: Spain’s opt-out model has shown how trust, strong legal frameworks and cultural sensitivity can significantly boost organ donation rates. Singapore’s integrated approach balances patient care, donor rights and medical research, while the US demonstrates the effectiveness of systems like the Organ Procurement and Transplantation Network (OPTN), which ensures fairness, transparency and prioritisation based on medical urgency.

India’s Progress and Potential: Indian states are beginning to lead the way in organ donation and transplantation. Gujarat stands out as a beacon of progress. It offers:

  • Affordable and Accessible Transplants: The state offers cardiac transplants in the public sector, a rare achievement, with government hospital services costing three times less than private facilities.
  • Pioneering Institutions: The Institute of Kidney Diseases and Research Centre (IKDRC) has performed over 640 liver transplants from deceased donors—the highest by a government hospital in India. Meanwhile, the UN Mehta Institute of Cardiology & Research Centre has successfully conducted around 30 heart transplants.
  • Educational Leadership: Gujarat established the Gujarat University of Transplantation Sciences (GUTS) in 2015, the world’s first university dedicated to transplantation and allied sciences,

By learning from global leaders in organ donation, India can design a framework that addresses its diverse needs while inspiring trust and participation emphasising research and training in this critical field.

Dr Pranjal Modi, Director of IKDRC and Vice-Chancellor of GUTS, has emphasised the importance of a national technology-driven program that seamlessly matches donors and recipients while addressing logistical challenges such as location.

Key Focus Areas:

  • Centralised and Accurate Databases: Developing robust state-level and national registries to streamline donor and recipient matching.
  • Standardised Waitlist Criteria: Prioritizing the sickest patients to ensure fairness in organ allocation.
  • Cost Recovery Models: Offering financial incentives or cost recovery for donors to address economic barriers and encourage participation.
  • Public Awareness and Trust: Building trust through education campaigns and culturally sensitive outreach to dispel myths about organ donation.
  • Leveraging Technology: Using AI and data analytics to enhance the efficiency and transparency of organ matching and allocation processes.

By blending these insights with innovative approaches and the successes of states like Gujarat, the country can create a compassionate, equitable and world-class organ donation framework.

Your Voice Counts: Let’s Discuss

Deceased organ donation can bridge the critical organ demand-supply gap and address ethical challenges. Brain-dead individuals, legally eligible donors, have the potential to save lives through timely organ donation.

The Common Cause vs. Union of India judgment (March 9, 2018) introduced the ’Living Will’, allowing individuals to record their medical preferences in advance, ensuring their autonomy in end-of-life care decisions.

Could this framework be expanded to include organ donation registration? Integrating organ donation preferences into the ‘Living Will’ process would simplify registration and ensure that individuals’ choices are respected.

We look forward to your thoughts on this proposal. The judgment link is attached for reference.

httpls://www.commoncause.in/uploadimage/case/185640911Living%20Will%20Judgment.pdf&embedded=true

References

  • Liverman, C. T., Domnitz, S., & Childress, J. F. (Eds.). (2018). Opportunities for organ donor intervention research: Saving lives by improving the quality and quantity of organs for transplantation. NCBI Bookshelf.National Academic Press. https://www.ncbi.nlm.nih.gov/books/NBK470922
  • Streit, S., Johnston-Webber, C., Mah, J., Prionas, A., Wharton, G., Casanova, D., Mossialos, E., & Papalois, V. (2023). Ten lessons from the Spanish model of organ donation and transplantation. Transplant International, 36. https://doi.org/10.3389/ti.2023.11009
  • Organ Donation | Singapore Hospice Council. (n.d.). Singapore Hospice Council. https://www.singaporehospice.org.sg/organdonation/

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October-December, 2024