WHO Guiding Principles on Human Cell, Tissue, and Organ Transplantation: Detailed Notes

WHO Guiding Principles on Human Cell, Tissue, and Organ Transplantation

Preamble

Historical Context

Human organ transplantation began with experimental studies in the early 20th century.
Alexis Carrel received the Nobel Prize in 1912 for his work.
Surgical transplantation from deceased and living donors started after World War II.
Over the past 50 years, transplantation has become a worldwide practice, enhancing many lives.
Continuous improvements in medical technology have increased the demand for organs and tissues, exceeding supply.

The Problem of Organ Shortage

The shortage of available organs has led to:
- Development of procedures to increase supply.
- Commercial traffic in human organs, especially from unrelated living donors.
- Traffic in human beings.
International communication and travel have facilitated patients traveling abroad for transplants for a single charge.

WHO Initiatives

Resolutions WHA40.13 and WHA42.5 expressed concern over commercial trade in organs and the need for global standards.
Resolution WHA44.25 endorsed the WHO Guiding Principles on Human Organ Transplantation.
The Guiding Principles have influenced professional codes, practices, and legislation worldwide.
Resolution WHA57.18 requested the Director-General to update the Guiding Principles based on global data.

Purpose and Scope of the Guiding Principles

The Guiding Principles provide an ethical and acceptable framework for acquiring and transplanting human cells, tissues, and organs for therapeutic purposes.
Each jurisdiction will determine the means of implementation.
The Principles preserve the essential points of the 1991 version and incorporate new provisions in response to current trends.
The Guiding Principles do not apply to:
- Transplantation of gametes, ovarian or testicular tissue, or embryos for reproductive purposes.
- Blood or blood constituents collected for transfusion purposes.

General Principles

Cells, tissues, and organs may be removed from deceased and living persons for transplantation in accordance with the following Guiding Principles.

Guiding Principle 1: Consent

Cells, tissues, and organs may be removed from the bodies of deceased persons for transplantation if:
- Any consent required by law is obtained.
- There is no reason to believe that the deceased person objected to such removal.

Commentary on Guiding Principle 1

Consent is the ethical cornerstone of all medical interventions.
National authorities are responsible for defining the process of obtaining and recording consent.
Consent can be:
- Explicit (“opting in”): Requires express consent during the person's lifetime, which can be oral or recorded on a donor card, driver’s license, identity card, medical record, or donor registry. When the deceased has neither consented nor clearly expressed opposition to organ removal, permission should be obtained from a legally specified surrogate, usually a family member.
- Presumed (“opting out”): Permits removal unless the person expressed opposition before death by filing an objection or an informed party reports an objection. People should be fully informed about the policy and have an easy means to opt out.
Procurement programs may be reluctant to proceed if relatives oppose the donation, even with explicit or presumed consent.
Donor programs need to review the deceased’s medical and behavioral history with family members.
For tissue donation, it is recommended to seek approval from the next of kin, ensuring the appearance of the deceased’s body is restored after tissue removal.

Guiding Principle 2: Separation of Responsibilities

Physicians determining that a potential donor has died should not be directly involved in cell, tissue, or organ removal or subsequent transplantation procedures, nor should they be responsible for the care of any intended recipient.

Commentary on Guiding Principle 2

This Principle avoids conflicts of interest.
National authorities will set legal standards for determining death and specify the criteria and process for determining death.

Guiding Principle 3: Deceased vs. Living Donors

Donation from deceased persons should be developed to its maximum therapeutic potential, but adult living persons may donate organs as permitted by domestic regulations.
Living donors should generally be genetically, legally, or emotionally related to their recipients.
Live donations are acceptable when:
- The donor’s informed and voluntary consent is obtained.
- Professional care of donors is ensured and follow-up is well organized.
- Selection criteria for donors are scrupulously applied and monitored.
Living donors should be informed of the probable risks, benefits, and consequences of donation; they should be legally competent and capable of weighing the information; and they should be acting willingly, free of any undue influence or coercion.

Commentary on Guiding Principle 3

The Principle emphasizes developing deceased donor programs and making existing programs more effective.
It sets basic conditions for live donation.
A genetic relationship between donor and recipient may be therapeutically advantageous.
Altruistic donations often originate from emotionally related donors.
Unrelated donors are a source of concern, except in cases such as hematopoietic stem cell transplantation or kidney exchanges.
Psychosocial evaluation is needed to guard against coercion or commercialism, especially with unrelated donors.
The evaluation should be carried out by an appropriately qualified, independent party.
Genuine and well-informed choice requires full, objective, and locally relevant information.
Voluntary consent implies the possibility of withdrawing consent until medical interventions on the recipient reach a point where the recipient would be in acute danger if the transplant did not proceed.
The health of living donors should be protected during selection, donation, and aftercare.
Care for the donor should match care for the recipient.

Guiding Principle 4: Minors and Legally Incompetent Persons

No cells, tissues, or organs should be removed from the body of a living minor for transplantation other than narrow exceptions allowed under national law.
Specific measures should be in place to protect the minor, and the minor’s assent should be obtained before donation.
What is applicable to minors also applies to any legally incompetent person.

Commentary on Guiding Principle 4

This Principle states a general prohibition on the removal of cells, tissues, or organs from legal minors for transplantation.
Major exceptions include familial donation of regenerative cells and kidney transplants between identical twins.
Review and approval by an independent body should be required if the parent(s) or legal guardian have a conflict of interest.
A minor’s objection to making a donation should prevail over the permission provided by any other party.
Professional counseling is especially important for minor donors.

Guiding Principle 5: Prohibition of Commercialization

Cells, tissues, and organs should only be donated freely, without any monetary payment or other reward of monetary value.
Purchasing, or offering to purchase, cells, tissues, or organs for transplantation, or their sale by living persons or by the next of kin for deceased persons, should be banned.
The prohibition on sale or purchase does not preclude reimbursing reasonable and verifiable expenses incurred by the donor, including loss of income, or paying the costs of recovering, processing, preserving, and supplying human cells, tissues, or organs for transplantation.

Commentary on Guiding Principle 5

Payment for cells, tissues, and organs is likely to take unfair advantage of the poorest and most vulnerable groups, undermines altruistic donation, and leads to profiteering and human trafficking.
It conveys the idea that some persons lack dignity and are mere objects.
The Principle aims to affirm the special merit of donating human materials to save and enhance life.
National law should ensure that any gifts or rewards are not disguised forms of payment.
Incentives with monetary value that can be transferred to third parties are not different from monetary payments.
Dangers also arise when payments are made to next of kin of deceased persons, vendors or brokers, or institutions having charge of dead bodies.
Compensation for the costs of making donations (including medical expenses and lost earnings for live donors) is permitted.
The need to cover legitimate costs of procurement and of ensuring the safety, quality, and efficacy of human cell and tissue products and organs for transplantation is also accepted.
Incentives that encompass essential items which donors would otherwise be unable to afford raise concerns.
Access to the highest attainable standard of health is a fundamental right, not something to be purchased in exchange for body parts.
Free periodic medical assessments related to the donation and insurance for death or complications that arise from the donation may legitimately be provided to living donors.
Health authorities should promote donation motivated by the need of the recipient and the benefit for the community.
All practices to encourage the procurement of cells, tissues, and organs for transplantation should be defined explicitly by health authorities in a transparent fashion.
National legal frameworks should address each country’s particular circumstances because the risks to donors and recipients vary.
The ban on paying for cells, tissues, and organs should apply to all individuals, including transplant recipients who attempt to circumvent domestic regulations by traveling to locales where prohibitions on commercialization are not enforced.

Guiding Principle 6: Promotion of Altruistic Donation

Promotion of altruistic donation of human cells, tissues, or organs by means of advertisement or public appeal may be undertaken in accordance with domestic regulation.
Advertising the need for or availability of cells, tissues, or organs, with a view to offering or seeking payment to individuals for their cells, tissues, or organs, or, to the next of kin, where the individual is deceased, should be prohibited.
Brokering that involves payment to such individuals or to third parties should also be prohibited.

Commentary on Guiding Principle 6

This Principle does not affect general advertisements or public appeals to encourage altruistic donation, provided that they do not subvert legally established systems of organ allocation.
Instead, it aims to prohibit commercial solicitations, which include offering to pay individuals, the next of kin of deceased persons, or other parties in possession (such as undertakers), for cells, tissues, or organs; it targets brokers and other intermediaries as well as direct purchasers.

Guiding Principle 7: Professional Responsibility

Physicians and other health professionals should not engage in transplantation procedures, and health insurers and other payers should not cover such procedures, if the cells, tissues, or organs concerned have been obtained through exploitation or coercion of, or payment to, the donor or the next of kin of a deceased donor.

Commentary on Guiding Principle 7

Health care professionals should only proceed with the removal, intermediate management, or implantation of cells, tissues, or organs when donations are unpaid and truly voluntary.
Failing to ensure that the person consenting to the donation has not been paid, coerced, or exploited breaches professional obligations and should be sanctioned by the relevant professional organizations and government licensing or regulatory authorities.
Physicians and health care facilities should also not refer patients to transplant facilities in their own or other countries that make use of cells, tissues, or organs obtained through payments to donors, their families, or other vendors or brokers; nor may they seek or accept payment for doing so.
Post-transplant care may be provided to patients who have undergone transplantation at such facilities, but physicians who decline to provide such care should not face professional sanctions for such refusals, provided that they refer such patients elsewhere.
Health insurers and other payers should reinforce adherence to high ethical standards by refusing to pay for transplants that violate the Guiding Principles.

Guiding Principle 8: Justifiable Fees

All health care facilities and professionals involved in cell, tissue, or organ procurement and transplantation procedures should be prohibited from receiving any payment that exceeds the justifiable fee for the services rendered.

Commentary on Guiding Principle 8

This provision reinforces Guiding Principles 5 and 7 by forbidding profiteering in cell, tissue, and organ recovery and implantation.
Health authorities should monitor the fees charged for transplantation services to ensure that they are not disguised charges for the cells, tissues, or organs themselves.
All persons and facilities involved should be accountable for all payments for transplantation services.
A medical or other health care practitioner uncertain whether a fee is justifiable should seek the opinion of an appropriate licensing or disciplinary authority before proposing or levying the fee.
Fees charged for similar services may be used as a reference.

Guiding Principle 9: Allocation Criteria

The allocation of organs, cells, and tissues should be guided by clinical criteria and ethical norms, not financial or other considerations.
Allocation rules, defined by appropriately constituted committees, should be equitable, externally justified, and transparent.

Commentary on Guiding Principle 9

Where donation rates do not meet clinical demand, allocation criteria should be defined at national or subregional level by a committee that includes experts in the relevant medical specialties, bioethics, and public health.
The criteria for distributing cells, tissues, and organs should accord with human rights and, in particular, should not be based on a recipient’s gender, race, religion, or economic condition.
The cost of transplantation and follow-up, including immunosuppressive treatment where applicable, should be affordable to all patients concerned.
The concept of transparency is central to all aspects of transplantation.

Guiding Principle 10: Quality, Safety, and Efficacy

High-quality, safe, and efficacious procedures are essential for donors and recipients alike.
The long-term outcomes of cell, tissue, and organ donation and transplantation should be assessed for the living donor as well as the recipient in order to document benefit and harm.
The level of safety, efficacy, and quality of human cells, tissues, and organs for transplantation must be maintained and optimized on an ongoing basis.
This requires implementation of quality systems including traceability and vigilance, with adverse events and reactions reported, both nationally and for exported human products.

Commentary on Guiding Principle 10

Optimizing the outcome of cell, tissue, and organ transplantation entails a rules-based process that encompasses clinical interventions and ex vivo procedures from donor selection through long-term follow-up.
Under the oversight of national health authorities, transplant programs should monitor both donors and recipients to ensure that they receive appropriate care.
Evaluation of information regarding the long-term risks and benefits is essential to the consent process.
Donors should not be permitted to donate in clinically hopeless situations.
Donation and transplant programs are encouraged to participate in national and/or international transplant registries.
All deviations from accepted processes that could elevate the risk to recipients or donors, as well as any untoward consequences of donation or transplantation, should be reported to and analyzed by responsible health authorities.
Transplantation of human material which does not involve maintenance treatment may not require active, long-term follow-up, though traceability should be ensured for the anticipated lifetime of the donor and the recipient.
Internationally agreed means of coding to identify tissues and cells used in transplantation are essential for full traceability.

Guiding Principle 11: Transparency and Privacy

The organization and execution of donation and transplantation activities, as well as their clinical results, must be transparent and open to scrutiny, while ensuring that the personal anonymity and privacy of donors and recipients are always protected.

Commentary on Guiding Principle 11

Transparency can be summarized as maintaining public access to regularly updated comprehensive data on processes, in particular allocation, transplant activities and outcomes for both recipients and living donors, as well as data on organization, budgets and funding.
Such transparency is not inconsistent with shielding from public access information that could identify individual donors or recipients while still respecting the necessity of traceability recognized in Principle 10.
The objective of the system should be not only to maximize the availability of data for scholarly study and governmental oversight but also to identify risks – and facilitate their correction – in order to minimize harm to donors or recipients.