WHO Guiding Principles on transplantation

The WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation are a set of eleven principles providing an ethical framework for the donation and transplantation of human organs, tissues and cells.[1][2] Endorsed by the Sixty-third World Health Assembly on 21 May 2010 in Resolution WHA63.22, they updated an earlier 1991 set and articulate the international consensus that donation should be voluntary, altruistic and unpaid, that organs and tissues should be allocated equitably and transparently by medical criteria, and that the commercial trade in human body parts should be prohibited.[1][2][3] The Guiding Principles are not binding law, but they are the most widely cited global reference for transplantation ethics and have shaped national legislation and other instruments, including the Declaration of Istanbul.[2][3]

Background

The World Health Organization first adopted Guiding Principles on human organ transplantation in 1991 (Resolution WHA44.25).[2][3] Over the following two decades, transplantation expanded, the use of tissues and cells grew, and concerns intensified about transplant tourism, organ trafficking and the exploitation of poor and vulnerable donors.[2][3] In response, the World Health Assembly endorsed a revised and expanded set of eleven principles in 2010, extending their scope explicitly to cells and tissues as well as organs and strengthening provisions on the protection of living donors and on transparency and traceability.[1][2][3]

The eleven Guiding Principles

The principles, as endorsed in 2010, may be summarized as follows:[1][2]

• Consent for deceased donation. Cells, tissues and organs may be removed from deceased persons only if consent required by law is obtained and there is no reason to believe the deceased objected.
• Determination of death and conflict of interest. Physicians determining that a potential donor has died should not be directly involved in the removal of cells, tissues or organs, their subsequent transplantation, or the care of intended recipients.
• Priority for deceased donation; protection of living donors. Donation from deceased persons should be developed to its maximum therapeutic potential, but adult living persons may donate as permitted by domestic regulations, with the living donor genetically, legally or emotionally related to the recipient where required.
• Protection of minors and other vulnerable persons. No cells, tissues or organs should be removed from a living minor for transplantation except in narrow exceptions permitted by law; safeguards must protect minors and other legally incompetent persons.
• Voluntary, unpaid donation, prohibition of sale. Cells, tissues and organs should be donated freely, without monetary payment or reward of monetary value; the purchase, or offer to purchase, of body parts for transplantation, or their sale by living persons or the next of kin of deceased persons, should be prohibited. (Reimbursement of legitimate costs and reasonable expenses is permissible.)
• Prohibition of advertising and brokering. Advertising the need for, or availability of, cells, tissues or organs with a view to offering or seeking payment, and brokering for payment, should be prohibited.
• No profit for professionals and facilities. Physicians, health professionals and health facilities involved in procurement and transplantation should not receive payment exceeding the justifiable fee for services rendered.
• Prohibition of trade-derived material. Cells, tissues and organs obtained in violation of the principles (e.g., through trade) should not be accepted for transplantation.
• Equitable allocation. Allocation should follow clinical criteria and ethical norms, not financial or other considerations; rules should be equitable, externally justified and transparent.
• Quality, safety and traceability. High-quality, safe and efficacious procedures are essential; long-term outcomes should be assessed, and adverse events traced, donor and recipient should be identifiable while protecting confidentiality and privacy.
• Transparency and openness to scrutiny. The organization and execution of donation and transplantation activities, and their clinical results, must be transparent and open to scrutiny, while protecting personal anonymity and privacy.

(Numbering and exact wording follow the WHO text endorsed by WHA63.22.)[1][2]

Significance

The Guiding Principles establish the core international norms of transplantation ethics: consent, the separation of death-determination from procurement, the protection of living and vulnerable donors, financial neutrality and the prohibition of organ sale, equitable medical-criteria allocation, and safety, traceability and transparency.[1][2] They underpin national rules such as the United States' prohibition on the sale of organs in the National Organ Transplant Act, and they are reinforced by the transplant-community Declaration of Istanbul on organ trafficking and transplant tourism.[2][3] See financial neutrality and valuable consideration and organ trafficking and transplant tourism.

See also

• Declaration of Istanbul
• Financial neutrality and valuable consideration
• Organ trafficking and transplant tourism
• Consent models: opt-in vs opt-out · The dead donor rule

References

• World Health Organization. WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation (WHO/HTP/EHT/CPR/2010.01), as endorsed by Resolution WHA63.22, 21 May 2010. https://www.who.int/publications/i/item/WHO-HTP-EHT-CPR-2010.01
• WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation. Transplantation. 2010;90(3):229-233 (full text of the eleven principles with commentary). PMID 21235034. https://pubmed.ncbi.nlm.nih.gov/21235034/ ; https://journals.lww.com/transplantjournal/fulltext/2010/08150/who_guiding_principles_on_human_cell,_tissue_and.1.aspx
• Sixty-third World Health Assembly. Resolution WHA63.22, Human organ and tissue transplantation (21 May 2010). https://apps.who.int/gb/ebwha/pdf_files/WHA63/A63_R22-en.pdf