DOH Policies on Living Non-Related Organ Donation

Policy intent and legal commitments

The DOH adopts rules to ensure living non-related donation and transplantation are conducted consistent with Republic Act No. 9208 (Anti-Human Trafficking Act) and its Implementing Rules and Regulations.
The DOH commits to abide by the Declaration of Istanbul on Organ Trafficking and Transplant Tourism.
The DOH commits to abide by the WHO Guiding Principles on Organ Transplantation.
The Order declares that Non-directed Living Non-Related Donation (LNRD) is not permitted.
The Order clarifies nomenclature changes by replacing the National Human Organ Preservation Effort (NHOPE) with Philippine Network for Organ Sharing (PHILNOS) and clarifying scope of function.
The Order provides for the transfer of the function of PhilNETDAT to the Philippine Organ Donation and Transplantation Program (PODTP) as part of abolishing non-directed LNRD and creating PHILNOS.

Coverage and covered actors

The Order covers kidney and other organ donors and recipients, whether working with living non-related donation.
The Order covers all health and health-related professionals and individuals engaged in or participating in transplantation and donation.
The Order covers all DOH offices/bureaus, including attached agencies and field offices.
The Order covers all health and health-related facilities such as hospitals and laboratories.
The Order covers other government and non-government agencies and organizations, including foundations and associations organized to promote and support transplantation and donation programs, and medical/specialty societies.
The Order governs transactions and activities related to living non-related kidney donation and transplantation that fall under these covered persons and institutions.

Definitions established

Living Related Donors (LRDs) are related to the recipient by blood within the fourth-degree of consanguinity, including parents, children, siblings, nephews/nieces, and first cousins.
Living Non Related Donors (LNRDs) are not related by blood to the recipient but have the willingness and intention to donate a kidney based on certain reasons.
LNRDs are classified into Voluntary Donors and Commercial Donors.
Voluntary Donors are those not related by blood to the recipient but bear close emotional ties with the recipient (including spouses, relatives by affinity, friends, employers/employees of long standing, colleagues, fiancés/fiancées, and adoptive parents or children).
Commercial Donors (kidney/organ vendors) offer their kidneys and other organs for sale, usually engaging a broker or agent, where payment or a promise of payment is a precondition and pre-requisite to the organ donation.
Directed Kidney/Organ Donor refers to a donor who has a specific recipient in mind and donates following the donor designation principle with due consideration of the donor’s wishes.
Non-Directed Kidney/Organ Donor refers to a donor who donates to whomever the donor matches on a list of waiting patients for organ transplant.
Board refers to the Philippine Board for Organ Donation and Transplantation (PBODT).

Guiding principles and general policies

The Order requires equity in allocation: non-directed donated organs belong to the community and must be allocated fairly among transplant centers and among recipients, with priority determined by medical need and probability of success.
The Order requires justice: allocation criteria must be objective and independent of gender, race, creed, culture, and socio-economic status.
The Order requires benevolence: only organs voluntarily donated with full informed consent by a competent adult may be subject for transplantation.
The Order prohibits trade/commerce of kidneys/organs: facilities must not allow the trade or commerce of kidneys/organs.
The Order requires non-maleficence: no harm should occur to the donor or recipient in the immediate and post-transplantation process.
The Order requires solidarity and altruism: stakeholders share safeguarding objectives, and organ donation must be done foremost out of selflessness and philanthropy.
The Order requires volunteerism and enumerates volunteerism requirements: donors must have competence (decision-making capacity), willingness to donate, freedom from coercion, medical and psychosocial suitability, and full information of risks/benefits and alternatives available to the donor and to the recipient.
The DOH adopts policy rules for kidney transplantation from LNRDs and provides that these policies cover transplantation of other organs where applicable.

Substantive prohibitions and participation rules

The DOH requires compliance with the WHO Guiding Principles, the Declaration of Istanbul, and Republic Act No. 9208 and its Implementing Rules and Regulations in the practice of kidney transplantation from LNRDs.
The DOH requires highest consideration for donor and recipient safety and requires pursuit of transparency regarding risks to both.
The Order strictly prohibits payment as precondition for kidney donation and the sale and purchase of kidneys by kidney vendors/commercial donors.
The Order states that kidney transplantation is not part of medical tourism.
The Order provides that foreigners are not eligible to receive organs from Filipino living non-related donors.
The Order prohibits health and health-related facilities and professionals from allowing trade of kidneys.
The Order permits directed LNRDs only when the donation is voluntary and truly altruistic, with no compensation or gratuity package attached.
The Order requires directed LNRDs to be screened and approved by the Hospital Ethics Committee (HEC).
The Order provides that Non-directed LNRD are not allowed to donate organs for transplantation.
The Order prohibits any hospital, foundation, organization, or agency (public or private) from keeping a list of potential non-directed LNRDs and from utilizing non-directed LNRDs for transplantation.
The Order requires transplant-related facilities to implement and adopt quality standards and practices in medical and organizational management of kidney transplantation.
The DOH and the Philippine Health Insurance Corporation (PHIC) enforce the Order and monitor facilities through licensing and accreditation rules to ensure accessibility, quality, and sustainability.
The Order requires professional societies related to organ donation and transplantation to ensure members comply with PODTP guidelines for organ transplantation practice.
The Order provides that members of professional societies are accredited by the PHIC for purposes of payment.
The Order prohibits, in no instance, transporting or exporting any kidney/organ for transplantation abroad.
The Order creates the PBODT to oversee implementation of policies related to organ transplantation.
The Order assigns the PODTP (under the Degenerative Disease Office (DDO) of the National Center for Disease Prevention and Control (NCDPC)) as the overall implementing body for organ donation and transplantation in the country.
The Order creates PHILNOS as the coordinating body responsible for allocating organs from deceased donors.

Operational structures and responsible bodies

The PBODT reviews and approves policies supporting a rational, ethical, accessible, and equitable organ transplantation program in the country.
The PBODT approves the issuance of the Certificate of Accreditation of transplant facilities.
The PBODT is chaired by the Secretary of Health.
The PBODT includes as members: the Undersecretary for Policy and Standard Development Team (PSDT) for Service Delivery as Vice Chairperson; the Chairman of National Transplant Ethics Committee (NTEC); and a PHIC representative designated by the PHIC President.
The PBODT includes a representative from a government transplant facility designated by the Secretary of Health and a representative from a private transplant facility designated on a rotational basis for a term of 2 years.
The PBODT includes representatives from professional societies involved in transplantation—PSTS, PSN, and PUA—designated by the societies on a rotational basis for a term of 2 years.
The PBODT includes a Professional Regulation Commission (PRC) representative designated by the Chair of the PRC, and a representative designated by the Secretary of Health per PBODT recommendation.
The Secretary of Health may appoint additional members based on PBODT and PODTP recommendations, including additional members to the NTEC and PHILNOS.
The DOH’s Executive Committee provides oversight of the Board, and the National Center for Disease Prevention and Control serves as the Secretariat of the Board.

Implementation, registries, accreditation, monitoring

The PODTP serves as the overall implementing body of the organ donation and transplantation system in the country.
The PODTP monitors transplant facilities’ compliance with this Order and with other operational guidelines it formulates.
The PODTP performs other functions ordered by the Secretary of Health related to its primary functions.
The NTEC formulates national ethical standards/guidelines for organ donation and transplantation for PBODT approval.
The NTEC assists the PBODT in resolving ethical issues and in monitoring transplant facilities for compliance with ethical standards/guidelines.
The PHILNOS acts as the central coordinating body for allocating donor kidneys/organs from deceased donors according to established criteria.
The PHILNOS implements policies on deceased donor allocation.
The PHILNOS maintains 3 national registries with data from each local transplant facility:
- a Registry of all kidney transplants performed in the country;
- a Registry of all placed living donors (including LRD and directed LNRD);
- a Registry of all patients seeking kidney transplantation (national waiting list).
The Bureau of Health Facilities and Services (BHFS) inspects and monitors transplant facilities.
The BHFS issues Certificate of Accreditation and implements sanctions to non-compliant transplant facilities.
The PHIC issues accreditation of health facilities and professional, implements sanctions to non-compliant transplant facilities, and serves as part of inspection and monitoring teams.
The HEC monitors and resolves ethical issues in hospital processes and recommends sanctions to the hospital administration.
The hospital administration determines the proper sanction for culpable persons and sanctions are reported to the PODTP.
The HEC reports to the NTEC and performs other functions ordered by NTEC related to ethical issues.
The Hospital Transplant Coordinating Office (HTCO) maintains the 3 registries at the transplant hospital level and reports to PHILNOS.
The Kidney Donor Monitoring Unit (KDMU) performs follow-up donor protection and long-term monitoring of donors after donation based on specific guidelines, and reports activities to PODTP.
Transplant facilities must comply with accreditation and operation rules and must develop and organize programs and services required by existing DOH standards and regulations.
Transplant facilities may be set up only in DOH-licensed hospitals and must be accredited to perform kidney/organ transplantation.
Each transplant facility must establish its own HEC, HTCO, and KDMU to comply with and operationalize the Order’s policies.

Funding, monitoring reports, and sanctions

The national government allocates PHP 20 million per year to support operations of the organ donation and transplantation program starting 2010.
Funds may be augmented from government or private sources to support the program.
The PODTP leads monitoring for compliance by all covered entities with the Order’s rules and regulations.
The PODTP reports regularly to the PBODT and provides recommendations related to organ donation and transplantation practice.
The PODTP calls on independent bodies and organizations to constitute a monitoring and evaluation team involving medical and specialty societies, non-government organizations, the private sector, other professionals, and civil society.
The PODTP continually develops and supports programs and projects toward achieving world-class status for the country in renal/organ care and transplantation.
Non-compliance with PODTP standards and policies is a ground for suspension or revocation of the license to operate of the hospital or its transplant facility.
Violations by erring professionals (doctors and members of the transplantation team) must be forwarded to the DOH and to the PRC, PSN, PSTS, and other appropriate professional organizations for appropriate sanctions.
The forwarding of violations does not prejudice the filing of appropriate civil or criminal charges whenever warranted.

Repeal, separability, and effectivity

Administrative Order No. 2008-0004 and other provisions or issuances inconsistent with DOH Administrative Order No. 2010-0018 are repealed and/or modified accordingly.
If any provision or part of the Order is declared unauthorized or invalid by a court of law or competent authority, the remaining provisions remain valid and effective.