Development of the Organ Donation and Transplantation System in China
The evolution of organ donation and transplantation in China represents a transformative journey marked by systematic reforms, legislative advancements, and international collaboration. Over six decades, China has transitioned from reliance on ethically contentious practices to establishing a voluntary, citizen-driven system aligned with global ethical standards. This progression is categorized into three distinct phases: the Initial Exploration Phase (1960–2005), the Development and Construction Phase (2005–2015), and the Scientific Standardization Phase (2015–2019). Each phase reflects critical milestones in policy, infrastructure, and clinical practice that collectively shaped China’s modern organ transplantation landscape.
Initial Exploration Phase (1960–2005)
China’s organ transplantation journey began with pioneering clinical achievements. The first kidney transplantation was performed in 1960 at Peking University First Hospital, followed by the first successful living-donor kidney transplant in 1972 at the First Affiliated Hospital of Sun Yat-Sen University. These early efforts laid the groundwork for transplant surgery in China. During this period, young surgeons traveled abroad to acquire expertise from European and American institutions, integrating advanced techniques into domestic practice. However, the absence of standardized regulations, ethical frameworks, or a national registry system characterized this era.
A significant challenge was the reliance on organs from executed prisoners, a practice that drew international criticism. Despite sporadic instances of civilian donations, the lack of a structured donation system necessitated alternative sources. This phase underscored the urgent need for legal and ethical guidelines to govern organ procurement and allocation, prompting subsequent reforms.
Development and Construction Phase (2005–2015)
In 2005, China committed to reforming its organ transplantation system at a World Health Organization (WHO) meeting, pledging to prioritize voluntary citizen donations and phase out the use of organs from executed prisoners. This pledge catalyzed a decade of legislative and institutional advancements.
Legal and Regulatory Frameworks
Key policies emerged to establish accountability and transparency. The Interim Provisions on the Administration of Clinical Application of Human Transplant Techniques (2006) introduced accreditation for transplant institutions, reducing qualified hospitals from over 600 to 164 by 2007. The Regulations on Human Organ Transplantation (2007) codified ethical principles, prohibiting organ trafficking, mandating donor consent, and ensuring equitable recipient selection. These regulations aligned China with WHO guidelines and international norms.
In 2011, the Amendment (VIII) to the Criminal Law criminalized organ trading, reinforcing legal deterrence against exploitation. Concurrently, the Ministry of Health collaborated with the Chinese Medical Association to publish The Clinical Guidelines for Organ Transplantation (2010) and Clinical Technique Norms of Organ Transplantation (2010), standardizing surgical practices and post-operative care.
Citizen-Driven Organ Donation System
A pilot program for deceased organ donation launched in 2010, spearheaded by the China Organ Donation Administrative Center (CODAC) under the Red Cross Society of China. This initiative introduced a three-tier donor classification:
- Category I: Donation after brain death.
- Category II: Donation after circulatory death.
- Category III: Donation after brain death followed by circulatory death.
To support this system, China developed the Criteria and Technical Specifications for Brain Death Determination (2013), training 3,643 certified professionals by 2019. A nationwide network of organ procurement organizations (OPOs) and donor coordinators was established, with 2,516 coordinators trained through 34 certification programs.
Technological Infrastructure
The China Organ Transplant Response System (COTRS), launched in 2011, automated organ allocation based on medical urgency, compatibility, and geographic proximity. The Provisions on the Administration of Human Organ Procurement and Allocation (2013) mandated COTRS use, ensuring transparency and traceability. By 2014, deceased donations surged to 1,702 cases, signaling growing public trust.
Scientific Standardization Phase (2015–2019)
On January 1, 2015, China ceased using organs from executed prisoners, relying exclusively on voluntary donations. This milestone, hailed as the “China Model,” emphasized ethical sourcing and operational transparency.
Growth in Donation and Transplantation
Deceased donations grew annually by 20%–34%, reaching 6,302 cases in 2018 (Figure 1). The per-million-population (PMP) donation rate rose from 0.03 in 2010 to 4.53 in 2018. Transplant volumes followed suit:
- Kidney transplants: 12,430 in 2018 (20% annual growth in deceased donations).
- Liver transplants: 5,219 in 2018 (18% annual growth).
- Heart transplants: 487 in 2018 (21% annual growth).
- Lung transplants: 403 in 2018 (20% annual growth) (Figure 2).
Quality Control and Innovation
Post-2015, China prioritized clinical quality. The National Health Commission established quality control centers to monitor outcomes and reduce regional disparities. The Clinical Guideline for Organ Transplantation (2017) updated 27 protocols, incorporating evidence-based practices and local data. Innovations such as non-ischemic liver preservation, ABO-incompatible kidney transplants, and pediatric liver transplantation achieved international recognition.
International Collaboration
China engaged globally through initiatives like the Knowledge Transfer and Leadership in Organ Donation (KeTLOD) program (2016–2019), training professionals and raising public awareness. The Kunming Consensus (2019), endorsed by 62 countries, highlighted China’s role in advancing ethical transplantation under WHO principles.
Conclusion
China’s organ donation and transplantation system has evolved into a comprehensive framework encompassing legal, technical, and ethical dimensions. From initial reliance on executed prisoners to a citizen-driven model, China’s reforms demonstrate commitment to global standards. With robust infrastructure, quality control, and international partnerships, China continues to refine its system, offering a replicable model for nations navigating similar challenges.
doi.org/10.1097/CM9.0000000000000779
Was this helpful?
0 / 0