REVISED NATIONAL POLICY ON LIVING NON-RELATED DONATION AND TRANSPLANTATION AND ITS IMPLEMENTING STRUCTURE AMENDING FOR THE PURPOSE ADMINISTRATIVE ORDER NO. 2008-0004-A

I. RATIONALE

Administrative Order 2008-0004-A is hereby amended to articulate the
commitment of the Department of Health (DOH) to abide by the rules set
forth by the RA 9208 (Anti-Human Trafficking Act), the Declaration of
Istanbul on Organ Trafficking and Transplant Tourism and the WHO Guiding
Principles on Organ Transplantation by not permitting the Non-directed
Living Non-Related Donation (LNRD). Furthermore, the amendments shall
include the changes in the nomenclature of National Human Organ
Preservation Effort (NHOPE) to Philippine Network for Organ Sharing
(PHILNOS) and a clarification of its scope of function. Also included is
the transfer of the function of PhilNETDAT to the existing Philippine
Organ Donation and Transplantation Program (PODTP) as a result of the
abolition of non-directed LNRD and the creation of the PHILNOS.

II. COVERAGE

The following, whether public or private, shall be governed by this
Order:

1. Kidney and other organ donors and recipients.

2. All health and health-related professionals and individuals
engaged or have any participation in the conduct of transplantation and
donation.

3. All Offices/Bureaus, including attached agencies and field offices
of the DOH.

4. All health and health-related facilities such as but not limited
to hospitals, laboratories.

5. Other government and non-government agencies and organizations,
such as but not limited to foundations organized to promote and support
transplantation and donation programs and associations such as medical
and specialty societies.

III. DEFINITION OF TERMS

1. Living Related Donors (LRDs) – related to the recipient by blood
within the fourth-degree of consanguinity (e.g. parents, children,
siblings, nephews/nieces, first cousins).

2. Living Non Related Donors (LNRDs) – not related to the recipient
by blood but have the willingness and intention to donate a kidney based
on certain reasons.

These donors are classified into:

a. Voluntary Donors – Those who are not related by blood to the
recipient but bear close emotional ties with him/her. (e.g., spouses,
relatives by affinity, friends, employers/employees of long standing,
colleagues, fiancé/fiancée and adoptive parents or children).

b. Commercial Donors – Also known as kidney/organ vendors who offer
their kidneys and other organs for sale. They usually engage the
services of a broker or agent. Payment or a promise of payment is a
precondition and pre-requisite to the organ donation.

2.a.1 Directed Kidney/Organ Donor – someone who has a specific
recipient in mind whom he would want to donate to. This follows the
principle known as donor designation wherein the donor’s wishes are
given due consideration.

2.a.2 Non-Directed Kidney/Organ Donor – a donor who would donate to
whoever he/she matches on a list of waiting patients for organ
transplant.

3. Board – refers to Philippine Board for Organ Donation and
Transplantation (PBODT)

IV. GUIDING PRINCIPLES

The Philippine Organ Donation and Transplantation Program (PODTP)
shall be guided by these principles:

1. Equity – Non-directed donated organs belong to the community. Such
organs must be allocated fairly among transplant centers and among
recipients. Determination of priority shall be based on medical need and
probability of success.

2. Justice – The criteria to be adopted in determining allocation of
organs must be objective and independent of gender, race, creed, culture
and socio-economic status.

3. Benevolence – Only organs that are voluntarily donated with full
informed consent by a competent adult shall be subject for
transplantation. All health and health related facilities shall not
allow the trade or commerce of kidneys/organs.

4. Non-maleficence – No harm should occur to the donor or recipient
in the process of transplantation whether immediate or post
transplantation.

5. Solidarity – All stakeholders shall have a common and shared
objective of safeguarding the health of both the recipient and the
donor.

6. Altruism – Organ donation must be done first and foremost out of
selflessness and philanthropy to save and ensure the quality of life of
the beneficiary.

7. Volunteerism – Organ donation must be done out of the donor’s:

• Competence (decision-making capacity)
• Willingness to donate
• Freedom from coercion
• Medical and psychosocial suitability
• Full information of the risks and benefits as a donor
• Full information of the risks, benefits and other alternative
  treatment available to the recipient

V. GENERAL POLICY STATEMENTS

As the mandated agency to promote and protect the health of the
Filipino people, the DOH adopts the following policies in the practice
of kidney transplantation from LNRDs. These policies shall cover the
transplantation of other organs where applicable.

1. The Department of Health is committed to abide by the WHO Guiding
Principles on Organ Transplantation, the Declaration of Istanbul on
Organ Trafficking and Transplant Tourism and RA 9208 (Anti-Human
Trafficking Act) and its Implementing Rules and Regulations.

2. The safety of both donor and recipient shall be given highest
consideration and transparency regarding the risks to both shall be
pursued rigorously.

3. Payment as precondition for kidney donation and sale and purchase
of kidneys by kidney vendors/commercial donors are strictly prohibited.

4. Kidney transplantation is not part of medical tourism.

5. Foreigners are not eligible to receive organs from Filipino living
non-related donors.

6. All health and health-related facilities and professionals shall
not allow the trade of kidneys.

7. Directed LNRDs are permitted only when it is voluntary and truly
altruistic, without any kind of compensation or gratuity package
attached to it. They must be screened and approved by the Hospital
Ethics Committee. Non-directed LNRD are not allowed to donate organs for
transplantation. No hospital, foundation, organization or agency,
public or private, are allowed to keep a list of potential non-directed
LNRDs and to utilize non directed LNRD’s for transplantation.

8. All health and health-related facilities shall implement and adopt
quality standards and practices in the medical and organizational
management of kidney transplantation. The DOH and The Philippine Health
Insurance Corporation (PHIC) shall enforce this Administrative Order and
monitor these facilities through their licensing and accreditation
rules and regulations to ensure accessibility, quality and
sustainability of the services.

9. All professional societies related to organ donation and
transplantation shall ensure that all their members comply with PODTP
guidelines relative to the practice of organ transplantation. The
members of professional societies related to this practice shall
likewise be accredited by the PHIC for purposes of payment.

10. In no instance shall any kidney/organ be transported or exported for
transplantation abroad.

11. A Philippine Board for Organ Donation and Transplantation (PBODT)
is hereby created for the purpose of overseeing the implementation of
policies related to organ transplantation. The Philippine Organ
Donation and Transplantation Program (PODTP) under the Degenerative
Disease Office (DDO) of the National Center for Disease Prevention and
Control (NCDPC) shall serve as the overall implementing body for organ
donation and transplantation in the country. A Philippine Network for
Organ Sharing (PHILNOS) is hereby created to serve as the coordinating
body in charge of allocating organs from Deceased donors.

VI. OPERATIONAL STRUCTURES (See Annex 1^*)

1. Philippine Board for Organ Donation and Transplantation
(PBODT)

a. Roles and Functions

i. Review and approve policies in support of a rational, ethical,
accessible and equitable organ transplantation program in the country.
ii. Approve the issuance of the Certificate of Accreditation of
transplant facilities.

b. Composition

i. Secretary of Health, who shall act as the Chairperson
ii. Undersecretary for Policy and Standard Development Team (PSDT)
for Service Delivery – Vice Chairperson
iii. Chairman of National Transplant Ethics Committee (NTEC)
iv. PHIC Representative designated by the PHIC President
v. Representative from a government transplant facility designated
by the Secretary of Health (DOH)
vi. Representative from a private transplant facility designated
by the private transplant facilities on a rotational basis to a term of 2
years
vii. Representative from the professional societies involved in
transplantation – Philippine Society of Transplant Surgeon (PSTS),
Philippine Society of Nephrology (PSN), Philippine Urology Association
(PUA) designated by the societies on a rotational basis to a term of 2
years
viii. Representative from Professional Regulation Commission (PRC)
designated by the Chair of the PRC
ix. Representative designated by the Secretary of Health per
recommendation of the PBODT

The Secretary of Health may appoint additional members based on the
recommendation of the PBODT and PODTP. He may also appoint additional
members to the National Transplant Ethics Committee (NTEC) and the
Philippine Network for Organ Sharing (PHILNOS) based on the
recommendation of the PODTP.

The Executive Committee of the Department of Health will serve as
oversight of the Board.
The National Center for Disease Prevention and Control shall serve as
the Secretariat of the Board.

2. Philippine Organ Donation and Transplantation Program
(PODTP)

Roles and Functions

i. Overall implementing body of the organ donation and
transplantation system in the country
ii. Monitor compliance of transplant facilities to policies set
forth by this order and other operational guidelines that may be
formulated.
iii. Perform such other function as may be ordered by the
Secretary of Health related to its primary functions.

3. National Transplant Ethics Committee (NTEC)

Roles and Functions

i. Formulate national ethical standards/guidelines on organ
donation and transplantation for approval by the PBODT.
ii. Assist the PBODT in the resolution of ethical issues
iii. Assist in the monitoring of transplant facilities to ensure
compliance with ethical standards/guidelines
iv. Perform such other functions as maybe ordered by the Secretary
of Health or PBODT for those related to ethical issues.

4. Philippine Network for Organ Sharing (PHILNOS)

Roles and Functions

i. Act as the central coordinating body to ensure that all donor
kidneys/organs from Deceased donor are allocated according to
established criteria.
ii. Implement the policies on deceased donor allocation.
iii. Maintain 3 national registries, with data coming from each
local transplant facility, to include:

a.Registry of all kidney transplants performed in the country.
b.Registry of all placed living donors – LRD and directed LNRD

c.Registry of all patients seeking kidney transplantation
(national waiting list)

iv. Perform such other functions as may be ordered by the Secretary
of Health and PBODT for those related to its primary functions.

5. Bureau of Health Facilities and Services (BHFS)

Roles and Functions

i. Inspect and monitor transplant facilities ii. Issue
Certificate of Accreditation
iii. Implement sanctions to non-compliant transplant facilities
iv. Perform such other functions as may be ordered by the
Secretary of Health and PBODT related to its primary functions.

6. Philippine Health Insurance Corporation (PHIC)

Roles and Functions

i. Issue accreditation of health facilities and professional
ii. Implement sanctions to non-compliant transplant facilities
iii. Serve as a member of inspection and monitoring team
iv. Perform such other functions as may be ordered by the
Secretary of Health and PBODT related to its primary functions.

7. Hospital Ethics Committee (HEC)

Roles and Functions

i. Monitor and resolve ethical issues that may arise in the
process of organ donation and transplantation in the hospital.
ii. Recommend sanctions for violation of the guidelines to the
hospital administration. The hospital shall determine the proper
sanction to be given to whoever is deemed culpable for the violation in
accordance with the Administrative Order on LNRD’s Violations and
corresponding sanctions shall be reported to PODTP.
iii. Report to the NTEC
iv. Perform such other functions as may be ordered by NTEC related
to its primary functions.

8. Hospital Transplant Coordinating Office (HTCO)

Roles and Functions

i. In charge of maintaining the 3 registries at the transplant
hospital level
ii. Report to the PHILNOS
iii. Perform such other functions as may be ordered by PHILNOS
related to
its primary functions

9. Kidney Donor Monitoring Unit (KDMU)

Roles and Functions

i. In-charge of follow-up donor protection and long-term
monitoring of donors after donation based on specific guidelines
ii. Report activities of the transplant facility to the PODTP
iii. Perform such other functions as may be ordered by PODTP
related to its primary functions

10. Transplant Facility

i. Comply with the rules and regulations governing the
accreditation and operation of kidney transplant facilities

ii. Develop and organize programs and services in support of its
transplantation program as required by existing DOH standards and
regulations.

Transplant facilities can only be set-up in DOH-licensed hospitals
and shall be accredited to perform kidney/organ transplantation. Each
transplant facility shall establish its own HEC, HTCO and KDMU to comply
with and operationalize the policies on organ transplantation herein
promulgated.

VII. FUNDING SUPPORT

The national government will allocate P20 million pesos per year in
support of the operations of the organ donation and transplantation
program starting 2010. Funds may be augmented from government or private
sources to support the program.

VIII. MONITORING AND EVALUATION

The Philippine Organ Donation and Transplantation Program (PODTP)
shall take the lead in the conduct of monitoring relative to compliance
to rules and regulations of all those covered in this Order. PODTP shall
report regularly to the PBODT and provide recommendations related to
the practice of organ donation and transplantation.

The PODTP shall call on the support of independent bodies and
organizations involved in kidney transplantation to constitute a
monitoring and evaluation team involving medical and specialty
societies, non-government organizations, the private sector, other
professionals and civil society. It shall continually develop and
support programs and projects towards achieving a world-class status for
the country in renal/organ care and transplantation.

IX. VIOLATIONS AND SANCTIONS

Non-compliance with the standards and policies of the PODTP shall be a
ground for suspension or revocation of the license to operate of the
hospital or its transplant facility subject to the implementing rules
and regulations to be established.

Furthermore, any violations by erring professionals (doctors and
members of transplantation team) shall be forwarded to the DOH and to
the PRC, PSN, and PSTS and other appropriate professional organizations
for appropriate sanctions without prejudice to the filing of appropriate
civil or criminal charges whenever warranted.

X. REPEALING CLAUSE

Administrative Order No. 2008-0004 and other provisions or issuance
found inconsistent with this Order are hereby repealed and/or modified
accordingly.

XI. SEPARABILITY CLAUSE

In the event that any provision or part of this Order be declared
unauthorized or rendered invalid by any court of law or competent
authority, those provisions not affected by such declaration shall
remain valid and effective.

XII. EFFECTIVITY

This Order shall take effect fifteen (15) days after publication in a
newspaper of general circulation.

Adopted: 23 June 2010

(SGD.) ESPERANZA I. CABRAL, M.D.
Secretary of Health

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^*Text
Available at Office of the National Administrative Register, U.P. Law
Complex, Diliman, Quezon City