03 December 2021
GUIDELINES ON
ETHICAL ORGAN DONATION AND TRANSPLANTATION FROM LIVING DONORS
I. RATIONALE
Republic Act No. 7170, as amended,
otherwise known as the “Organ Donation Act of 1991” emphasizes the importance
of pursuing deceased organ donation. Further, this act states that the
“Secretary of Health shall endeavor to persuade all health professionals, both
government and private, to make an appeal for human organ donation.” The
Department of Health (DOH) strongly pushes to end the unethical and illegal
practices on organ donation by unscrupulous individuals, especially among
living non–related donations or from living donors not related by blood to the
recipients.
Organ transplantation when deemed appropriate has become the preferred option for patients with End Stage Organ Disease. Administrative Order 2010 – 0018 entitled Revised National Policy on Living Non–Related Donation and Transplantation and its Implementing Structure Amending for the Purpose of Administrative Order No. 2008 – 004 – A mandates the National Transplant Ethics Committee (NTEC) to formulate national ethical standards/guidelines on organ donation and transplantation for approval by the DOH. Both Living Related and Living Non–Related donors shall be covered by these ethical guidelines since they are healthy individuals and the surgical removal of a part or the whole organ is an invasive procedure that may have later effects on their health and physical, emotional, and social circumstance. The guidelines shall uphold the protection and best interests of any Living Donor and Recipient. These shall ensure the voluntariness of the donation and the protection of the rights, welfare, and safety of the organ donor.
II. OBJECTIVE
This Order establishes the principles,
policies and guidelines on ethical organ donation and transplantation from
living donors for the reference of health professionals and transplant
facilities performing organ donations and transplantation and other related
health facilities. Additionally, this order seeks to ensure the protection of
the rights, welfare, and safety of the organ donors and recipients.
III. SCOPE AND COVERAGE
This order shall apply to all government and private hospitals engaged in organ donation and transplantation, the National Transplant Ethics Committee (NTEC), Hospital Transplant Ethics Committee (HTEC), and all others concerned.
This shall also govern the conduct of practice of all those assigned in organ donation and transplantation from living donors.
IV. DEFINITION OF TERMS
A. Attending Physician – the doctor primarily attending to the recipient and his donor.
B. Donor Advocate – a Physician or a collegial body that has no relationship in any way with the recipient and the donor, who can assess and ascertain the medical and surgical suitability of the donor for the recipient.
C. Filipino Dual Citizen (FDC) – a natural–born Filipino who has become a citizen of another country by reason of naturalization and who retained or re–acquired his/her Philippine citizenship or who was granted recognition as a Filipino citizen by virtue of Republic Act No. 9225, otherwise known as the “Citizenship Retention and Reacquisition Act of 2003” and its implementing rules and regulation (IRR). Also, FDC is a foreign national, who has been acknowledge or recognized as a Filipino citizen, because his father and/or mother was/were Filipino citizen(s) at the time of the FDCs birth.
D. Foreigner – a person also referred to as an alien who does not fall in any of the categories as enunciated in Section I, Article IV of the 1987 Constitution of the Republic of the Philippines.
1. Those who are citizens of the Philippines at the adoption of this Constitution.
2. Those whose fathers or mothers are citizens of the Philippines.
3. Those born before 17 January 1973, of Filipino mothers, who elect Philippine citizenship upon reaching the age of majority, and
4. Those who are naturalized in accordance with the law.
E. Hospital Ethics Committee – a group of individuals trained in ethics from different disciplines, age groups, gender, and professions, established by a hospital or health care institution, whose main function is to address ethical issues involving patient care.
F. Hospital Transplant Ethics Committee – is a trained multi–sectoral committee that attends to ethical issues surrounding organ transplantation within the transplant facility.
G. Living Donors – persons of age 21 years of age and above who, and who are mentally competent:
1. Living Related Donors (LRD) – living donors who are 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 (LNRD) – living donors who are not related to the donors by blood. Relatives who are beyond the fourth degree of consanguinity are also considered to be LNRD.
LNRD are classified as:
a. “Emotionally Related” Donors – not related by blood to the recipient but bear close emotional ties with him/her that are proven beyond question (e.g., spouses, relatives by affinity, friends, colleagues, fiancé/fiancée and adoptive parents or children, employee – employer relationships).
b. Commercial Donors (organ vendors) – offer their organs with monetary or other payments as precondition and prerequisite to the organ donation. Commercial donors are prohibited.
LNRD can also be classified as:
a. Direct Organ Donor – a living donor who has a specific recipient in mind to whom he/she would like to donate. This follows the principle known as donor designation wherein the donor’s wishes are given due consideration.
b. Non–Directed Organ Donor – a living donor who does not have a specific recipient in mind but would donate to anyone in the list of waiting patients for organ transplant. This is not in conformity with ethical guidelines and protocol on organ donation and is therefore prohibited.
H. National Transplant Ethics Committee – is a collegial body created internally by the DOH and is an integral operational component of the PODTP that shall serve as the national oversight of the HTECs on ethical issues and dilemmas regarding organ donation and transplantation.
I. Organ – differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularization, and capacity to develop physiologic functions with an important level of autonomy (World Health Organization).
J. Organ Donation – an act of liberality, whereby one disposes gratuitously of one’s organ in favor of another, who accepts it.
K. Organ Sale – an act when a person (the seller) obligates himself/herself to give his/her organ to another (the buyer) for a monetary price or its equivalent.
L. Recipient – receiver of the organ directly from a donor; can also mean the transplant candidate or a donee. For this AO, recipients include Filipino citizens, Filipino dual citizens, and foreigners.
M. Transplant Team – group of healthcare providers responsible for the actual retrieval and transfer of the organ.
N. Vulnerable Person – any person who is susceptible to undue influence or other factors that may impair consent to the donation (e.g., elderly, persons with disabilities or mental health conditions, prisoners, members of the military, and indigenous peoples; or any person disadvantaged economically, professionally, or socially directly or indirectly in relation to the recipient). If the donor is a vulnerable person, extra measures shall be undertaken to guard against exploitation. These measures include ensuring that:
1. The donor can comply with all the requirements of an informed consent.
2. The
emotional relationship with the donor is established without question.
V. GENERAL GUIDELINES
A. Organ donation and transplantation shall be guided by the principles and values which aspire to manifest fidelity and achieve trustworthiness in organ donation and transplantation. (See Annex A) https://bit.ly/NTEC-AO
B. The National Transplant Ethics Committee shall serve as the national oversight of the HTEC on ethical issues and dilemmas regarding organ donation and transplantation.
C. The Hospital Transplant Ethics Committee shall be required for the accreditation of all transplant facilities. An existing Hospital Ethics Committee (HEC) may perform the functions of the HTEC. It shall abide by the norms and expectations required for HTEC which may be more than what HEC does in its usual work, processes, or procedures. There shall be a separate HTEC supported by a secretariat. The hospital administration shall provide administrative support and the honoraria of the HTEC members. (See Annex B)
VI. SPECIFIC GUIDELINES
A. National Transplant Ethics Committee (NTEC)
1. The NTEC shall be composed of a Chairperson, Co–chairperson, and seven (7) Cluster Expert Members to be designated by the Secretary of Health from representatives of the hospitals, academe, socio–civic organisations, government organizations and religious organizations and who shall serve for a term of 3 years. The members shall continue to serve on a holdover capacity at the end of their terms until such a time a replacement has been appointed. A Department Personnel Order (DPO) shall be issued for this purpose.
2. The NTEC shall report to the Secretary of Health
3. The Philippine Network for Organ Sharing (PhilNOS) under Philippine Organ Donation and Transplantation Program (PODTP) shall serve as the secretariat of the NTEC as mandated by DPO No. 2018 – 4821 “Reconstitution of the National Transplant Ethics Committee (NTEC) under the Department of Health” and its amendments DPO No. 2018 – 4821 – A and 2018 – 4821 – B.
4. The operating expenses for the NTEC shall come from the Department of Health Disease Prevention and Control Bureau in accordance with DPO 2018 – 4821 – B.
B. Organ Donors
1. A potential donor shall be 21 years old or above who voluntarily offers his/her organ. The potential donor must be ascertained to be an appropriate donor in accordance with standard medical practice and with the principles and provisions of this Order (see Annex D). He/she should be related to the recipient up to the 4th degree of consanguinity or at least have established emotional ties with the recipient. (See Annexes C.1 and C.2)
2. Potential LRDs shall be given priority over LNRDs. A document indicating the reason for the selection of the donor shall be submitted by the attending Physician of the recipient. If a recipient has several donors who do not have any distinct physical or compatibility advantage, the donor who is more emotionally and psychologically mature shall be selected. This shall be determined by the donor advocate or a person with the same qualifications designated by the transplant facility.
3. The potential donor and his/her spouse or if not married, a member of his/her family shall attend a Pre–Transplant Orientation in any DOH licensed and PhilHealth accredited transplant hospital. The orientation shall include among others an overview of the organ donation and transplantation procedure, importance of informed consent, benefits and risks to the donor and recipient, recognition and management of adverse effects, policies and guidelines related to the procedures, responsibilities of donors, recipients, transplant team and hospital, long term follow up requirements, previous outcomes, and alternatives to transplantation. A certificate of attendance shall be included in the evaluation of the donor by the HTEC.
4. The transplant facility/institution shall designate a donor advocate for the potential donor.
5. If the potential donor passes the initial matching tests, he/she shall be evaluated by a Psychiatrists or Clinical Pyschologist for competence in decision–making, motive for the donation, coercion or any limitation to free choice, and clarification of personal values. The Psychiatrist/Psychologist shall ensure that the donor is able to give free and informed consent. A corresponding report of this evaluation shall be submitted to the HTEC.
6. The potential donor shall be evaluated by a social worker to check the socio-economic status and for any financial inducement. The social worker shall make a home visit to ascertain the motivation for the donation, real living conditions, family situation and actual address of the donor. The written report of the social worker shall be included in the HTEC deliberation.
7. The eventual outcome of the evaluation and the decision to pursue or not to pursue the match and the basis for the decision shall be communicated to the transplant coordinator, attending Physician and to the potential donor. (See Annexes D, D.1)
8. If approved as a potential donor, informed consent shall be obtained by the Surgeon. His/her spouse or if not married, a member of his/her family shall again be given the same information as during the orientation. The patient shall be given time to reflect, discuss and ask questions. If he/she chooses to donate, consent forms and a Deed of Donation as required by the IRR of R.A. 9208 written in a dialect/language that is understandable to the donor are signed and witnessed. The informed consent process shall be documented and witnessed by persons unrelated to either the donor or the recipient and is not a member of the transplant team of the recipient. At any time before the donation, the potential donor is made to understand that he/she is free to change his/her mind and may withdraw his/her offer to donate. It shall also be made clear to the donor that he/she will not be charged for any procedure related to the donation.
9. The HTEC shall be provided with all the pertinent documentation during the time of their interview with the potential donor. The HTEC shall evaluate, then approve or disapprove the proposed donation based on this Administrative Order. The HTEC Certificate of Approval/Disapproval shall be given and included in the donor’s and recipient's charts. A total of seven copies shall be made and a copy be given to the donor, recipient, attending Physician, Transplant Surgeon, Transplant Coordinator, National Registry and HTEC. Additional copies may be submitted to fulfil other administrative requirements. (See Annex D, D.1 and E)
10. The donor shall be admitted and given the appropriate pre–operative, peri–operative and post–operative hospital care including treatment of any post–operative complications.
11. Upon discharge, the attending physician shall again explain to the donor and his/her spouse or a close relative or social relationship if not married, what was done, risks present, the importance of lifestyle conditions and follow up monitoring as required by good clinical practice. The follow up of the donor may be done by his/her attending Physician. He/she may also be referred to his/her original Physician for further follow up once the patient is completely stable. The HTEC shall ensure that there is a monitoring system within the institution that the donor is being followed up over his/her lifetime. Donor follow–up shall be done according to the DOH guidelines on donor monitoring.
12. All medical expenses related to the donation including donor care and follow up shall not be charged to the donor by the transplant facility.
13. Consistent with provisions of the R.A. 10173 or the Data Privacy Act of 2012, all personal information regarding the organ donor shall be kept confidential except when regulatory authorities request information regarding the donation.
C. Organ Recipient
1. A transplant candidate bearing a certificate form his/her attending Physician of the patient’s need and suitability for an organ transplant shall be submitted to the registry of recipients that is to be found in the Philippine Organ Donor and Recipient Registry (PODRRS).
2. If an enrolled PODDRRS, he/she shall be eligible to receive an organ from a deceased donor following the guidelines for organ allocation from deceased donors (A.O. 2010 – 0019 and A.O. 2010 – 0019 – A). However, if a Living Donor is willing and available, the recipient can opt for this instead and shall inform PhilNOS of their availment.
3. The potential recipient and his/her spouse or if not married, a member of his/her family shall attend a Pre–Transplant Seminar Orientation in any DOH licensed and PhilHealth accredited transplant hospital. The seminar shall include among others an overview of the organ donation and transplantation procedure, importance of informed consent, benefits and risks to the donor and recipient, recognition and management of adverse effects, policies and guidelines related to the procedures, responsibilities of donors, recipients, transplant team and hospital, long term follow–up requirements, previous outcomes, and alternatives to transplantation. A certificate of attendance shall be provided to the HTEC during the evaluation.
4. Records of the recipient shall be submitted to the HTEC along with other relevant documents for evaluation and approval or disapproval of the proposed donation based on this Order and the implementing guidelines of the Administrative Order on Living Donation (DOH A.O. 2010 – 0018). The HTEC Certificate of Approval shall be given to the recipient and to the national registry.
5. The recipient shall be admitted for the transplant and shall be given the appropriate pre–, peri–, and post–operative hospital care including treatment of any post–operative complications.
6. Upon discharge, the attending Physician shall again explain what was done, risks present and the importance of follow–up care. He/she shall also refer the recipient back to his/her original Physician.
7. The attending Physician shall submit to the HTEC an abstract of the patient's records as well as the name of his/her assigned attending Physician.
8. Consistent with the provisions of the R.A. 10173 or the Data Privacy Act of 2012, all personal information shall be kept confidential except when regulatory authorities request information regarding the transplantation.
D. Foreign Organ Donors and Recipients
1. Foreigners shall be eligible to receive professional medical care including organ transplantation in the Philippines. However, foreign patients cannot receive organs from living non–related Filipino donors as stipulated in the R.A. 9208, otherwise known as the Anti– Trafficking in Persons Act of 2003.
2. For foreign patients, the organ donor shall be a:
a. Related donor–up to 4th degree of consanguinity (parents, siblings, children, and first cousins of the recipient).
b. Spousal donor – at least (3) years legally married.
3. In addition, the following guidelines shall apply to foreign recipients and foreign related donors to ensure that human trafficking for organ donation does not occur.
a. The patient and/or patient’s doctor shall communicate with a Philippine hospital and accredited transplant surgeon regarding medical status of recipient and donor. The hospital or Surgeon shall inform them of the Philippine requirements.
b. Before going to the Philippines, the patient and donor shall be evaluated by a hospital ethics committee in their country.
c. Required documents to be submitted of the HTEC before surgery shall be authenticated by the Consular Office/Embassy of the appropriate Ministry of foreign country and should have an accompanying English translation. (See Annex C.2)
4. In addition to the requirements, the transplant candidate and donor upon coming to the Philippines shall be interviewed separately by the HTEC of the hospital where surgery will be performed. This interview shall be documented.
5. Based on the guidelines, the HTEC shall decide whether to approve or disapprove the case. If disapproved, the reasons shall be clearly stated and documented. (See Annex D, D.1 and E)
6. If HTEC approves the donation, it shall inform NTEC of the case within 24 working hours. The NTEC has the right to review and overrule the decision of the HTEC within 24 working hours from receipt of HTEC information. If NTEC does not respond within the time, it is presumed that the case has been approved and the transplant facility shall proceed with the surgery.
7. The HTEC shall consult with NTEC in cases where the HTEC has questions or unresolved issues related to this matter.
8. The NTEC shall conduct an audit of the HTEC about organ transplantation and donation cases involving foreign recipients and donors as deemed necessary.
9. The HTEC shall include required documents (together with the interview documentation) of foreign patients and donors when it submits its quarterly report to the NTEC.
VII. ROLES AND RESPONSIBILITIES
A. Department of Health – Central Office shall develop systems, policies and guidelines that will facilitate the implementation of organ donation and transplantation form living donors at all levels. As such, the following offices shall have the following responsibilities:
1. National Transplant Ethics Committee shall:
a. Formulate the national ethical standards and guidelines on organ donation and transplantation.
b. Assist in the development of legislation, rules and regulations regarding organ donation and transplantation.
c. Provide opinions, recommendations and final resolution of cases referred by HTECs.
d. Foster awareness on organ donation and transplantation ethical healthcare issues.
e. Participate in international discussions through interactions and collaboration with similar committees and organizations working in this field.
f. Provide technical assistance and monitor HTECs in the performance of their functions, helps in the accreditation of the transplant facility by the HFSRB by assessing the HTECs of the transplant facility to ensure compliance with ethical standards and guidelines.
g. Perform other functions assigned by the Secretary of Health.
2. Public Health Services Team (PHST) through
a. The Philippine Organ Donation and Transplantation Program (PODTP) shall:
(1) Oversee the organ donation and transplantation system in the country.
(2) Monitor compliance of the transplant facilities to policies set forth by this order and other operational guidelines that may be formulated.
(3) Perform other functions assigned by the Secretary of Health related to its primary function.
b. Philippine Network for Organ Sharing (PhilNOS) shall:
(1) Act as the central coordinating body to ensure that all donor kidneys/organ from deceased donors are allocated according to established criteria.
(2) Maintain the Philippine Organ Donor and Recipient Registry System (PODRRS).
(3) Shall serve as the Secretariat of the NTEC.
3. Health Facility Development Bureau (HFDB) shall:
a. Provide technical assistance to transplant facilities in alignment with the Philippine Health Facility Development Plan (PHFDP) 2020 – 2040.
b. Ensure the alignment to the requirements (human resource for health, equipment, and infrastructure) in organ donation and transplantation guidelines with Resource Stratified Framework for renal care and transplant.
4. Health Facilities and Services Regulatory Bureau (HFSRB) shall:
a. Ensure compliance of Accredited Kidney Transplant Unit’s HTEC to the guidelines of the NTEC.
b. Impose sanctions and penalties for ethical violations recommended by the NTEC.
B. The Transplant Hospitals shall establish a Hospital Transplant Ethics Committee in their respective hospitals and shall comply with the rules and regulations governing their accreditation and operation.
C. The HTEC shall fulfil the requirements for national and international assurances as it functions in accordance with the national laws and relevant rules and regulations. (Annex B)
VIII. VIOLATIONS AND SANCTIONS
1. Non–compliance of the transplant facilities with the standards and policies of this Administrative Order shall be investigated and sanctioned by the DOH in accordance with the existing relevant issuances.
2. Furthermore, any violations by erring professionals shall be forwarded to the DOH and to the Professional Regulatory Commission (PRC), as applicable, for appropriate sanctions. The referral of the said violations to the DOH and PRC shall be without prejudice to the filling of appropriate civil or criminal charges whenever warranted.
IX. REPEALING CLAUSE
The provisions in this Order shall
supersede any sections in existing provisions or administrative issuances that
are not consistent with the contents of this order.
X. SEPARABILITY CLAUSE
If any provision or part of this Order be declared unauthorized or rendered invalid by any court of law of competent authority, those provisions not affected by such declaration shall remain valid and effective.
XI. EFFECTIVITY
This order shall take effect fifteen (15) days following its publication in the Official Gazette or a newspaper of general circulation and upon filing with the University of the Philippines Law Center of three (3) certified copies of this Order.
FRANCISCO
T. DUQUE III, MD, MSc
Secretary of Health
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