SIXTEENTH CONGRESS )
REPUBLIC OF THE PHILIPPINES )
FIRST REGULAR SESSION )

HOUSE OF REPRESENTATIVES

Introduced by Representative Rufus B. Rodriguez and
Representative Maximo B. Rodriguez, Jr.

1790

EXPLANATORY NOTE

House Bill No.

This bill was originally introduced as House Bill No. 5390 by the undersigned Rufus
B. Rodriguez during the 15” Congress where it was approved by the Committee on Health

Transplantation has prolonged and improved the quality of life of patients in need of
organ replacement. The traditional source of organ grafts has always been the deceased
donors, i.e. individuals who suffer severe irreversible brain injury with the rest of the body
remaining practically intact and “healthy.” However, the perennial lack of deceased organ
donors has continually hampered the widespread application of transplantation. The
imbalance of supply and demand has created the need to resort to other sources of grafts,
such as living donors. Organ donation from living donors, albeit, a noble act of charity, has
been beset by numerous ethical issues, it has unfortunately lent itself to abuse and has been
tainted with commercialism in many areas of the world and oftentimes has been associated
with human trafficking.

‘On June 23, 2010 the Department of Health (DOH) attempted to address the
situation by establishing mechanisms to curtail organ sale and protect the living kidney donor
through AO No. 2002-0124 and AO No. 2008-0004-A. Despite the enactment of the Organ
Donation Act in 1991 and the subsequent issuance of Administrative Orders, the potential of
the use of deceased donors has yet to be fully utilized

The 2008 Declaration of Istanbul on Organ Trafficking and Transplant Tourism
strongly encouraged governments, in collaboration with health care institutions, professional
and non-governmental organizations to take appropriate action to increase deceased organ
donation, remove obstacles and disincentives to deceased organ donation, enact legislation
and create transplantation infrastructure so as to fulfill each country’s deceased donor
potential (Istanbul Declaration 2008). Tackling the issue of human organ and tissue
transplantation in the 63 World Health Assembly, it was reported that “experience in
countries with the most successful deceased donor programs has shown the advantage of
having strong national organizations that can stimulate, coordinate and regulate donation
and transplantation. Such organizations can inform the public about the importance of
sustaining a community resource that is built on voluntary, unpaid donation of organs,
tissues and cells rather than on the exploitation inherent in organ purchases and that
provides equitable access to all.” (63% World Health Assembly provisional agenda item
11.21),

‘The potential of deceased donor organs is yet to be maximized in our country where
the estimated number of deaths due to accidents is about 8,000 per year (ADB-ASEAN
Regional Road Safety Program Accident Costing AC7 Report: Philippines). This bill is


necessary to institutionalize the development of a national system of promoting organ
donation from deceased donors and sharing of grafts through the Philippine Network for
Organ Sharing (PHILNOS) that shall implement a system of timely referral and processing of
potential multiple organ donors, uphold equitable allocation, efficient procurement and
transplantation of organs from deceased donors.

The state also recognizes that the source of organs should not be restricted only to
deceased donors but should include living donors who are willing to donate out of altruism,
The state needs to strictly supervise and regulate the practice of living donation in order to
protect the rights of the donor thus preventing the act of exploitation and selling of organs,

In view of the foregoing, immediate passage of this bill is earnestly requested,

S
RUFUS B. RODRIG)

VE
MAXIMO B/ RODRIGUEZ, JR.


‘SIXTEENTH CONGRESS )
REPUBLIC OF THE PHILIPPINES )
FIRST REGULAR SESSION )

HOUSE OF REPRESENTATIVES,

Introduced by Representative Rufus B. Rodriguez and
Representative Maximo B. Rodriguez, Jr.

House Bill No__ 1790

AN ACT
ESTABLISHING A NATIONAL PROGRAM FOR SHARING OF ORGANS FROM
DECEASED DONORS AND REGULATION OF HUMAN ORGANS FOR DONATION AND
TRANSPLANTATION FROM LIVING DONORS

Be it enacted by the Senate and House of Representatives of the Philippines in Congress
assembled.

CHAPTER |
GENERAL PROVISIONS

SECTION 1. Short Title. - This Act shall be known as the “Organ Donation Act of 2013”

SEC. 2, Policy. - The State shall protect and promote the right to health of the people and
instil health consciousness among them. It recognizes the importance of an active deceased
donor program in providing valuable treatment to those with kidney failure as well as in
protecting the vulnerable sectors of society from the potential for abuse of living organ
donors. It maintains that the human body or parts thereof, is beyond the commerce of man
and shall prohibit any commercialization in the handling of organs for transplantation. The
State shall respect the desire of citizens who want to donate organs and shall ensure that
the consent process is informed and purely voluntary. It recognizes the family's right to make
a choice by having access to complete information, including the positive impact that the act
of organ donation will have on fellow Filipinos.

SEC. 3. Definition of Terms. - The following terms shall be defined as follows:

a) Advertisement shall refer to the inclusion of any form of advertising or the
promotion of goods, services or ideas through paid announcements in the print,
broadcast or electronic media whether to the public generally or to any section
of the public or individually selected persons for the purpose of promoting
‘commercial dealings in human organs, tissues and/or parts.

b) Attending Physician (AP) shall refer to the primary physician responsible for both
the care and management of the potential multiple organ donor.

©) Grain Death (BD) shall refer to the irreversible cessation of all functions of the
entire brain.


Co)

e)

9

h)

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k)

Clinical Transplant Coordinator (CTC) shall refer to the TC who shall have the
responsibilty of coordinating the transplant candidate's evaluation, management,
and follow-up care.

Commercial Dealings shalll refer to the sale, barter or any transaction of human
organs, tissues and/or parts which involves valuable consideration in whatever
form and any transaction involving the illegal trafficking of human organs and/or
tissues through whatever means and acting as a broker for such transactions
whether for money or any other consideration in violation of this Act.

Commercial Donors shall refer to those who are known to be kidneylorgan 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.

Death shall refer to the irreversible cessation of circulatory and respiratory
functions or the irreversible cessation of all functions of the entire brain. A
Person shall be medically and legally dead if either: (1) In the opinion of the
attending physician, based on the acceptable standards of medical practice,
there is an absence of natural respiratory and cardiac function and, attempts
resuscitation would not be successful in restoring those functions. In this case,
death shall be deemed to have occurred at the time these function ceased; or
(2) n the opinion of the consulting physician, concurred in by the attending
physician, that on the basis of acceptable standards of medical practice, there is
an irreversible cessation of all brain functions; and considering the absence of
such functions, further attempts at resuscitation or continued supportive
maintenance would not be successful in restoring such natural functions. In this
case, death shall be deemed to have occurred at the time when these conditions
first appeared.

Decedent shall refer to a deceased individual, and includes a still-born infant or
fetus.

Donation of an organ or tissue shall refer to a voluntary act of a person to give
his organs or tissues gratuitously in favor of another, who accepts it. In this case,
the recipient shall have no demandable or enforceable right over the organ or
tissue donated

Donor shall refer to an individual authorized under this Act to donate all or part of
the body or decedent.

Donor Service Area (DSA) shall refer to the territorial jurisdiction of an organ
procurement organization as may be designated by the Philippine Network of
(Organ Sharing

Gift or Incentives shall refer to money in any form (ie. cash, check or its
equivalent in kind) that is given to the donor from the recipient and considered
unduly beneficial to the donor.


m)

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x)

Hospital shall refer to a hospital licensed, accredited or approved under the
law, and includes a hospital operated by the government.

Host OPO shall refer to the particular OPO which, having received an organ
donor call from a referring hospital, assumes responsibility for organ
Procurement.

Human Organ shall refer to the kidney, liver, heart, lung, pancreas, skin and any
other human organ that may be transplanted to another living person.

Human Tissue shall refer to bone marrow, bone, muscle tissue and any other
human tissue that may be transplanted to another living person.

Indigent shall refer to an individual who has been certified by the local branch of
the Department of Social Welfare and Development of the area in which he/she
is @ resident to be belonging to that sector living or earning below the poverty
threshold as determined from time to time by the National Economic and
Development Authority.

‘Medical care shall refer to medicines and laboratory examinations necessary to
be made for purposes of, and pursuant to, transplantation. It however does not
include expenses for the treatment of unrelated medical illness that is
discovered during evaluation procedures.

Organ Procurement shall refer to the administrative procedure involved with
acquiring organs for transplantation through various programs, systems, or
organizations. it includes obtaining consent, donor management, and arranging
for transportation of donor organs to the hospital for processing and transplant.

Organ Procurement Organization (OPO) shall refer to a Philippine Network of
Organ Sharing accredited non-profit organization, independent or hospital-
based, licensed and authorized by DOH to procure organs for transplantation.
‘An OPO is responsible for the procurement of organ donations from deceased
donors from hospitals, including preservation and transportation of such organs.

Organ-Specific Allocation Scoring System (OSASS) shall refer to the national
scoring system by which allocation of organs/grafts from deceased donors shall
be based.

Organtissue Bank Storage Facility shall refer to a facility licensed, accredited or
approved under the law for storage of human bodies or parts thereof

Organ Transplant Candidate (OTC) shall refer to a patient diagnosed to have
end-stage-organ-disease and is medically suitable to receive an organ graft.

Philippine Organ Donor and Recipient Registry System (PODRRS) shall refer to
the web-based electronic utility used by the Philippine Network of Organ Sharing
contractor to conduct its business. The PODRRS comprises of the national
database of all organ trensplant candidates, organ transplant recipients, and
organ donors, and all other software, applications and security architecture


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Needed for the collection, modification, validation, reporting, management and
redundancy of data associated with the tasks and activities of the Philippine
Network of Organ Sharing,

Potential Muttiple Organ Donor (PMOD) shall refer to any patient who will
imminently become brain dead or who currently meets the criteria for brain
death.

Procurement Transplant Coordinator (PTC) shall refer to the Transplant Coordinator
who shall have the responsibilty of coordinating the donors evaluation,
management, and recovery of organs for transplantation.

Referring Hospital (RH) shall refer to any hospital that identifies and refers
potential deceased organ donors to Philippine Network of Organ Sharing,

Testator shall refer to an individual who makes a legacy of all or part of his body

Transplant Center (TxC) shall refer to any hospital which is duly accredited by
the Department of Health (DOH) to perform organ transplantation

Transplant Coordinator (TC) shall refer to the designated trained health care
professional who takes the central role and acts as liaison among the referring
hospital, and the retrieval and transplant team members in processing a potential
‘organ donor.

Transplant Doctor shall refer to a licensed physician who is involved in the care
and/or management of a transplant candidate or recipient.

Transplant Facility shall refer to facility or hospital in which the transplant shall
be performed.

Valuable consideration means financial gain or advantage, but does not include the
reasonable costs associated with the removal, storage, transportation, and
transplantation of a human organ, tissue and/or part, or reimbursement for those
services, or the expenses of travel, housing, and lost wages incurred by the donor.

Living Related Donors (LRDs) shall refer to those who are related to the
recipient by blood within the fourth degree of consanguinity (i.e. parents,
children, siblings, nephews/nieces, first cousins)

Living Non- Related Donors (LNRDs) shall refer to those who are not related to
the recipient by blood but have the willingness and intention to donate a
kidney/organ based on certain reasons

‘These donors are classified into:

(@) Directed Kidney/Organ Donor shall refer to 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
con:



(b) Non-Directed Kidney/Organ Donor shalll refer to someone who would donate
to whoever he/she matches on a list of waiting patients for organ transplant.

SEC. 4. Coverage. - This Act shall cover all government and private hospitals, health
facilities, organ procurement organizations, medical and allied medical professionals,
foundations, non-government organizations and other government units that are involved or
have relevant roles in organ transplantation in the Philippines.

This Act shall cover deceased and living organ donations for transplantation
purposes.

CHAPTER II
PHILIPPINE NETWORK FOR ORGAN SHARING COMMISSION

‘SEC. 5. Creation of the Philippine Network for Organ Sharing Commission. - To carry out the
policy in Section 2 of this Act, there is hereby created the Philippine Network for Organ
Sharing Commission (PHILNOS), hereafter referred to as the Commission, which shall be
under the administrative supervision of the Office of the President. It shall facilitate and
‘oversee organ donation and organ transplantation involving living and deceased donors in
the Philippines and it shall serve as the central coordinating body of all living and deceased
organitissue donation and transplantation activities.

SEC. 6. Powers and Functions of the PHILNOS. The Commission shall exercise the
following powers and functions:

a. To formulate a program for living and deceased organ donation that will
ensure a rationalized harvest and distribution of human organs for the
purpose of providing valuable treatment to those in need of such organs;

b. To manage the national living and deceased donor program, ensuring
effectiveness, efficiency, equity and transparency especially in the national
system of allocation of deceased organs;

¢. To initiate and implement programs that will increase awareness and
acceptance of deceased organ donation and transplantation and that will
increase the number of organs from deceased donors for transplantation

d. To formulate and implement policies that will promote the ethical practice of
living and deceased organ donation and transplantation,

. To maintain a national waiting list of transplant candidates and a national
registry of transplant recipients.

f To make policy recommendations to the President of the Philippines for
legistation and other related matters pertaining to the living and deceased
donor programs.

g. Tollicense and supervise organ procurement organizations.

h. To issue subpoena in the course of any fact-finding investigation it may
undertake.

i. To create its own staffing pattern subject to the approval by the Department of
Budget and Management.

SEC. 7. Composition of the Commission. - The Commission shall be composed of a
Chairman and four Commissioners who shall all be citizens of the Philippines, the holder of a
degree in the field of medicine and its allied professions, law, public administration, or
management, and at the time of their appointment shall at least be forty years of age. At


least three of the members of the Commission, including the Chairman, shall be licensed
Physicians who have been jn the practice of the medical profession for at least ten
consecutive years.

) Appointment and Tenure. The Chairman and the Commissioners shall be
appointed by the President of the Philippines for a term of five years and they
shall serve as such until their successors shall have been appointed and
qualified

4) Salaries. Unless otherwise provided by law, the salary of the Chairman and the
Commissioners shall be equivalent to the salary of a Department Undersecretary
and Assistant Secretary, respectively.

©) Prohibition. No member of the Commission shall hold any other office or
employment during his tenure. Neither shall he engage in the practice of any
profession or in the active management or control of any business which in any
way may be affected by the functions of his office, nor shall he be financially
interested, directly or indirectly, in any contract with the Government, any of its
Subdivisions, agencies, or instrumentalities, including government-owned or
controlled corporations or their subsidiaries.

SEC. 8. The Executive Director. - The Commission shall have an Executive Director who
shall be appointed by the Chairman and who shall be a Career Executive Officer. He shall
possess the qualifications, hold the rank, and receive the salary of a Bureau Director. He
shall not be removed from office unless for cause provided by law.

a) Duties and Functions. The Executive Director shall have the duty of advising the
Commission and effecting the policies and decisions. His functions are as follows:

i. To act as the Chief Executive Officer of the Commission;
li, To be responsible for the general conduct of the operations and
management functions of the Commission; and
ii, To execute any other duties assigned to him by the Commission.

) Qualifications. The Executive Director must be a Filipino citizen and must possess
‘adequate and appropriate training with at least (3) years of experience in the field of
healthcare management.

©) Prohibition. To avoid conflict of interest, the Executive Director must not be a
physician in active medical practice during his term. Neither shall he be involved in
any OPO and/or health care institution,

In the event that the Executive Director is a transplant doctor, he shall only
be allowed to retum to active medical practice twelve (12) months from date of
termination of his term.

SEC. 9. Commission Structure. - The Commission shall be composed of the following
departments:

a) Accreditation and Training Department shall handle the accreditation of the OPO,
including its quality assurance and standardization. It shall also provide training and
certification of TCs.

b) Ethics and Legal Affairs Department shall handle ethical and legal matters.

¢) Finance Department shall handle standardization of organ acquisition costs
including system of reimbursement for the OPO members and auditing of
financial statements in relation with OPO transactions.

d) Information and Advocacy Department shall handle lay education, information
dissemination and media concerns,

€) Registry Department shall handle registry and research.


f) External Audit Department conducts a periodic review and audit of the Commission's
‘operations, with special emphasis on organ allocation procedures. it shall submit its
annual audit report to the Commission and Office of the President of the Philippines,
‘and make these reports available to the general public.

The External Audit Department shall be composed of designated representatives
from Philippine Health Insurance Corporation (PhilHealth), OPO, Transplant Hospital, Public
Sector, and from professional organizations related to transplantation, including but not
limited to the Philippine Society of Nephrology and the Philippine Society of Transplant
‘Surgeons.

Other departments may be formed upon the discretion of the Commission.

CHAPTER III
NATIONAL PROGRAM FOR SHARING OF ORGANS
FROM DECEASED DONORS

SEC.10. Organ Procurement Organization (OPO). -

1. Main Function and Requirement. An OPO is responsible for the procurement of
organs from deceased donors from hospitals including preservation and
transportation of such organs. All OPOs must secure licensing from the Commission.

2. Duties and Responsibilities. OPOs are required to fuffil the following duties and
responsibltes:

a. To respond to calls from RH within his DSA and subsequent evaluation of the
PMOD for eligibility:
b. To discuss organ donation with the potential donor's family;
¢. To obtain consent for donation and for removal of the organs;
d. To manage organ procurement within its DSA;
. To report to the Commission the availabilty of a PMOD immediately after
‘consent for donation is obtained:
To fuffil ofall medico legal requirements;
To ensure appropriate preservation and packaging of the organs;
To guarantee adequate tissue typing material is procured, divided and
Packaged:

i To guarantee written documentation of donor evaluation, donor maintenance,
‘consent for donation, death pronouncement, and organ procurement quality
‘accompanies the organ;

j. Toensure cooperation and coordination with other OPOs;

k. To promote deceased organ donation through education and information
dissemination; and

|__ To adhere to all DOH and the Commission's rules and regulations

3) Licensing of Organ Procurement Organizations. No OPO shall be allowed to engage
jn organ retrieval and transplantation activities without being licensed by the
Commission and subject to the rules and regulations that the Commission may
promulgate and implement.

4) Temporary Suspension of License. An OPO's license to operate can be suspended
by the Commission for failure to:

1) Respond to calls from Referring Hospitals (RH);

2) Procure an available organ;

3) Fulfil reportorial requirements; or

4) Comply with the Commission's rules and regulations.

ze>


5) Permanent Revocation of License. An OPO's license can be revoked by the
‘Commission for any of the following reasons:
1) Repeated violations of the Commission's rules and regulations;
2) Violation of Republic Act (RA.) No. 9208, otherwise known as Anti-Trafficking
Law, or
3) Violation of Section 16 of this Act.
The Commission, after consultation with professional _ medical
organizations, may provide for additional grounds for the revocation of an OPO's
license

6) Designation of DSA. The designation of the DSA shall be guided by the following
1) Geographical proximit
2) Technical capacity: and
3) Quality of service

‘SEC.11. Reporting of Brain Death. - All patients with brain death in a tertiary hospital within the
DSA of an OPO are to be considered potential multiple organ donors (PMOD) and as such,
should be reported by the hospital to the designated OPO.

Allltertiary hospitals, be it government or private, in the country are required to include the
number of brain death cases in their annual report. The Commission shall conduct a monthly
audit to all hospitals to ensure compliance.

SEC. 12. Brain Death (BD) Certification. - The following procedures shall be observed in
securing brain death certifications:
a) Organs may be procured only from patients who have been declared to have
suffered brain death and have a prior written intention to donate their organs
(such as an organ donor card or will) or whose next of kin have given
consent for organ donation
b) The Commission, in consultation with an appropriate professional
organization shall establish and promulgate the acceptable parameters for
declaring the occurrence of brain death (BD). Such criteria may be reviewed
and/or modified as deemed appropriate after such consultation.
) Certification of BD shall be done separately by two (2) physicians, both of whom
must be appropriately qualified and suitably experienced in neurological
‘assessment for the diagnosis of brain death and not a member of the transplant
team
4) Once the Certificate of BD has already been signed and issued, the time of death
shall consequently be noted in the chart which shall be signed by the Attending
Physician,

SEC. 13. Consent for Deceased Organ Donation. - The following procedures are to be observed
in obtaining consent for deceased organ donor.
a) Securing the family consent shall be the sole responsibility of the PTC and shall
‘commence only after the issuance of the Certificate of BD. Laboratory
examinations shall commence only after consent for donation is secured.
b) Consent for deceased organ donation must be obtained from the legal next-
‘of-kin of the PMOD in the following order of priority:
1. Spouse:
2. Son or daughter of legal age:


3. Either parent:
4. Brother or sister of legal age; or
5. Guardian over the deceased person at the time of death

¢) In the absence of any of the foregoing next of kin and any document of organ
donation, the physician in charge of the patient, the head of the hospital or a
designated officer of the hospital who has custody of the body of the
deceased classified as accident, trauma, or other medico-legal cases, may
authorize in a public document the removal from such body for the purpose of
transplantation of the organ to the body of a living person; Provided, that the
physician, head of hospital or officer designated by the hospital for this
purpose has exerted reasonable efforts, within forty-eight (48) hours, to
locate the nearest relative listed in Section 13b hereof as stipulated in R.A.
No. 7170.

d) To guarantee the priority of a decedent's wishes over the decedent's family
members with respect to their objections to organ donation, all hospitals and
emergency personnel shall be mandated to develop procedures of “routine
inquiry/required request” that will elicit from the patient, upon admittance to
the hospital, or their families, at patient's death, about their advance directive
‘on organ donation. If the patient expresses the intent to donate his or her
organs, that information is added to the patient's record.

e) Any of the following documents shall be recognized and honored as
expressions of the potential donor's desire to donate his organs upon his
death:

1. Organ Donor Card (ODC) which shall have the following elements:

i. Signature and/or fingerprint mark of testator,
ii Signature and/or fingerprint mark of one witness; and
ii, Date the ODC wes signed.

‘The Commission shall release a universal ODC that shall bear the Commission's
logo and a provisional space for the logo of the TxC or OPO where the ODC was
obtained.

2. Driver's License — The Land Transportation Office is mandated to provide
information on organ donation to all applicants for a license to operate a
motor vehicle. It is required to include a query regarding consent for
‘organitissue donation in case of brain death in all drivers’ licenses.

3. Living Wills. Living wills provide instructions for someone's medical care if
that person becomes incapacitated or otherwise unable to make decisions
for himself or herself. State statutes regulate living wills. In most cases, a
LIVING WILL can direct that one’s organs or tissues be taken and donated
if medically appropriate. If individuals execute a living will, it is advisable
for them to inform their physicians and their families of its existence.

4. Durable Powers of Attorney for Health Care. A durable POWER OF
ATTORNEY for health care names someone, the individual's “agent,” to
make important decisions regarding that person's health care should the


person become incapacitated. These documents can instruct the person's
agent to donate the person’s organs or tissues upon the person's death.
As with living wills, the durable power of attorney for medical care is only
effective if, in addition to the agent, the family and the person's physician
know of its existence.

5. Advance Care Medical Directive. An advance care medical directive
(ACMD) combines some features of the living will and the durable power of
attomey for health care. An ACMD allows individuals to provide
instructions for the type of care they do or do not want in a number of
medical scenarios. These documents need to be created in consultation
with their physician.

6. Video-tape of oral attestation.

SEC. 14. Removal of Organ after Death. - No authority shall be given for the removal of
the organ from the body of any deceased person:

(a)who has during his lifetime registered his objection with the Commission to the
removal of the organ from his body after his death;

(b)who is neither a citizen nor a permanent resident of the Philippines;

(c)who is below 21 years of age unless the parent or guardian has consented to
such removal;

(d)whom the authorized medical practitioners, after making such inquiries as are
reasonable in the circumstances, has reason to believe was not of sound mind,
unless the parent or guardian has consented to such removal ; or

(c)immediate relatives at time of death object to organ donation

SEC. 15. Examination of Human Body or Part Thereof. - A legacy or donation of all or part
of a human body authorizes any examination necessary to assure medical acceptability of
the legacy or donation for the purpose(s) intended.

In order to maximize the number of transplantable organs from the PMOD, the
necessary laboratory examinations, i.e. blood typing, tissue typing and/or crossmatching,
shall commence as soon as possible, ideally pre-procurement but not prior to obtaining
family consent for donation.

SEC. 16. Enlistment of the Organ Transplant Candidate. - All OTCs shall be enlisted
according to established criteria per organ. They shall be registered in the Philippine Organ
Donor and Recipient Registry System (PODRRS) through their respective TxCs.

SEC. 17. Organ Allocation. — The following shall be observed in the allocation of organs:

1) Only the OTC enlisted with PODRRS shall be eligible to receive an organ
retrieved from the deceased donor.

2) The Commission shall have the exclusive authority to allocate all retrieved
organs in the country. Organ allocation shall be in accordance with the
following rules:

a) Donated organs from deceased donors 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.


b) The criteria to be adopted in determining allocation of organs must be
objective and independent of gender, race, creed, culture and socio-
economic status,

©) Filipino recipients shall be given priority in the donor allocation. Inability to
pay should not be a deterrent for their prioritization and delivery of
services.

d) In no instance shall organs be transported or exported abroad.

3) The Commission shall formulate an allocation scoring system for each organ
procured. It shall oversee the formulation and implementation of each and
every allocation scoring system for each graft that shall form the basis for the
allocation of individual organs or grafts. Such a scoring system shall be
formulated through broad-based consultation and should be consistent with
current international and national ethical and scientific standards

4)The Commission shall ensure the transparency of the implementation of the
Organ-Specific Allocation Scoring System (OSASS) through daily electronic
monitoring and audit

5)All OSASS are subject to periodic review and revision as deemed appropriate
by the Commission

CHAPTER IV
REGULATION OF HUMAN ORGANS FOR DONATION
AND TRANSPLANTATION FROM LIVING DONORS,

SEC. 18. Acceptable Living Donations. ~ Donations are hereby considered acceptable upon
compliance with all of the following requisites:

a) Any individual, at least twenty one (21) years of age, of sound mind, who
underwent screening and counseling procedures and has been found suitable
as living donor based on the physical and psychological evaluation and
assessments made by physicians of the transplant facility who are not in any
way directly connected with the transplant team, and thus fully understands
the risks, benefits and consequences of removal of organs from his/her body
for the purpose of transplantation,

b) Informed written consent obtained for the removal of organs and tissues from
the donor's body for the purpose of transplanting the same to another living
human body. Such informed consent shall be in a document witnessed by a
relative of the donor and two (2) physicians neither of whom shall be a
member of the team of medical practitioners who will effect the removal of the
organ from the donor's body nor the physician or transplant team attending to
the recipient of the organ to be transplanted,

©) 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, and

) Living donors (LRDs and Voluntary Directed LNRDs) need not go through the
organ allocation system of PODRRS. They must however register themselves
to the Commission for documentation purposes

SEC. 19. Grounds for Rejecting Living Donation and Transplantation. - The following are
hereby considered grounds for rejecting living donation and transptantation:


a) Donor is a minor (less than 21 years of age).
'b) Donor is found to be ill (ie. cancer, kidney disease, sepsis, rabies, hepatitis
‘and HIV/STDs).
¢) Donor is a previous organ donor.
d) Donation will result in a physical and/or psychological harm to the donor.
e) Foreigners are not eligible to receive any organ from Filipino LNRD; Unless,
That heishe is a former Filipino citizen and that the potential donor is related to
foreigner by consanguinity within the fourth degree.
irected LNRD are not allowed to donate organs for transplantation,
No hospital, foundation, organization or agency, public or private, is
allowed to keep a list of potential non-directed LNRDs and to utilize
non-directed LNRDs for transplantation.
ji, PHILNOS js likewise prohibited to keep a list of potential non-directed
LNRDs in PODRRS and to utilize non-directed LNRDs for organ
allocation for the purposes of transplantation.

SEC. 20. Rights of Living Donors. Living donors under this Act shall be accorded the
following rights:

a) The costs for all medical and psychiatric work ups to determine the living
donor's fitness to donate shall be borne by the intended recipient: Provided
That when such recipient is an indigent as defined in this Act, such costs shall
be borne by the government transplant facility performing the transplant,

b) Living Donors shall be entitled to a leave of absence with pay for the period of
his confinement for purposes of actual transplantation and post-transplant
recovery for a period not to exceed fifteen (15) working days.

©) Should the living donor develop a disability, as defined under the Social
Security and Government Service Insurance System charters, resulting from
the donation procedure, he/she shall be entitled to a disability pay, as therein
defined and computed

d) Should the living donor eventually develop a disease or illness necessitating a
transplant, the said donor shall be given priority in PODRRS.

SEC. 21. Benefits for Donors. - Tissue and/or organ donors are entitled to following
benefits:

a) Airline companies are to provide at least 10% discount on airfare of potential
donors, on their way to and from the actual transplant operation, who have
been found suitable, mentally and physically to make the donation.

b) Pharmaceutical companies and their distributors are directed to ensure that at
least a 10% discount is likewise provided for post-donation related medicines
personally consumable by the donors.

SEC 22. Duty of Non-Indigent Recipients. - in all cases of living donation and
notwithstanding any agreement to the contrary, it shall be the responsibility of the non-
indigent recipient to shoulder the cost of the transplantation procedure and pre and post-
operation medical care of the donor, who has been found suitable mentally and physically to
make the donation.

Further, the recipient shall cause the name of the donor to be registered in the
registry of the PODRRS. Furthermore, the recipient is obliged to shoulder the expenses of
travel and housing, if any, and lost wages, if applicable and other related expenses in
connection with the donation. Finally, the recipient shall be made to answer financially,



wholly or partly depending on their agreement, for any subsequent disease that may be
developed by the donor in connection with the organ or tissue donated for a period of one
year after donation.

Nothing in this Act however shall proscribe the voluntary act of the recipient in
Providing additional assistance to the family of the donor either through livelihood projects
andior educational support to the family of the donor.

CHAPTER V
ORGAN/TISSUE BANK STORAGE AND TRANSPLANT FACILITIES,
TRANSPORT OF ORGANS AND PROHIBITION OF COMMERCIALIZATION OF HUMAN
ORGANS AND/OR TISSUES

SEC. 23. Duty of Hospitals and Organ/Tissue Bank Storage Facility. - It shall be the duty of
all hospitals to ensure that all removal and transplantation of human organs, tissues and/or
arts do not contravene the provisions of this Act and to report to the proper authorities any
contravention of this Act. Likewise, it shall be the duty of Organ/Tissue Bank Storage Facility
to ensure that all organs, tissues or parts stored in the facility were not acquired or received
for consideration in whatever form in contravention of this Act and to report to the proper
authorities any contravention of this Act.

All hospitals and medical institutions shall create a Hospital Ethics Committee whose
Purpose is to improve health care delivery and outcomes by helping to identify, analyze and
resolve ethical dilemmas as they emerge predominantly through consultation, education and
policy development. The Ethics Committee shall make recommendations in determining the
ethical principles and policies on organ, tissue and part transplantation in order to prevent
and avoid participation of the hospital, whether directly or indirectly, in commercial dealings
in human organs, tissues and/or parts.

All hospitals, medical institutions, organ or tissue bank storage facility shall record all
organs, tissues and/or parts received, the source of the donation, the purpose for the
donation, the names of the persons concerned, the date of the donation, storage, removal or
transplant of the organ, tissue and/or part and other relevant information necessary. The
records and documents containing such information shall be made available and transparent
to the public, whenever necessary.

All hospitals, medical institutions, organ or tissue bank storage facility shall submit
periodic reports which shall include relevant records and documents to the Oversight
Committee against Commercial Dealings in Human Organs andior Tissues as defined under
the next section on their compliance with the provisions of this Act.

SEC. 24. Organ Transplant Facilities -

a) Organ transplantation can be performed only in accredited and licensed TxC.

b) The Commission shall formulate and implement the accreditation
requirements for TxC, define their functions, monitor their operations and
ensure their compliance with all government regulations.

¢) Organ transplantation can be carried out only by medical professionals
accredited by the appropriate professional medical organizations

d) The Commission shall ensure that all medical and paramedical personnel
involved in transplantation shall comply with pertinent government
regulations.

@) No TxC may perform a transplant procedure using an organ from a deceased
donor that has not been allocated through the Commission.


f) Organ transplantation with deceased donor shall be carried out at the TxC of
choice of the OTC. The organ transplantation shall also be performed by the
transplant team of choice of the OTC.

‘SEC. 25. Air Transport. - The Civil Aviation Authority of the Philippines (CAAP) under the
Department of Transportation and Communication (DOTC) and the Commission shall jointly
formulate guidelines that shall govern the transport of procured organs through commercial
airlines. The CAAP shall ensure the compliance of all registered commercial airlines with the
regulations allowing transport of procured organs.

SEC. 26. Non-Commercialization of Donated Organs, Incentives and Recognitions. -
Organs should only be donated freely, without any monetary payment. Purchasing, or
offering to purchase organs for transplantation is prohibited. The Commission shall
formulate guidelines to ensure that any gifts or rewards are not, in fact, disguised forms of
payment for donated organs.
a) All OPOs have the option to give recognition to the family or next-of-kin of the
deceased organ donor and/or to the deceased organ donor through a
commemorative token or ceremony that has a monetary value not greater
than the amount that shall be stipulated by the Commission.
b) All OPOs shall not offer or give any gift to the family or next-of-kin of the
PMOD in anticipation or in exchange for organ donation.
©) No entity can offer gifts or incentives that can be construed as payment for a
donated organ

The Commission shall take measures, including the design, development, and
dissemination of information and education materials, to promote, protect and support the
dissent approach in cadaveric organ donation.

It shall also ensure that information materials produced by all government agencies
and private entities and persons are not inconsistent with the provisions of this Act.

SEC. 27. Acts that Promote or Facilitate Commercial Dealings in Human Organs andlor
Tissues. - The following acts which promote or facilitate commercial dealings in human
organs, tissues and/or parts shall be unlawful:

a) To knowingly lease or sublease, use or allow to be used any house, building or
establishment for the purpose of promoting commercial dealings in human
organs, tissues and/or parts;

b) To produce, print and issue or distribute publications which include
advertisements of the sale, barter, or other transactions on human organs,
tissues and/or parts for consideration in whatever form;

c) To knowingly benefit from, financial or otherwise, from commercial dealings in
human organs, tissues and/or parts;

d) To maintain a data bank of prospective commercial donors.

SEC. 28. Qualified Commercial Dealings in Human Organs and/or Tissues.-
The following are considered as qualified commercial dealings in human organs and/or
tissues:
a) When the crime is committed by a syndicate, or in large scale. Commercial
dealing in human organs, tissues and/or parts is deemed committed by a
syndicate if carried by a group of three (3) or more persons conspiring or


confederating with one another. It is deemed committed in large scale if
‘committed against three (3) or more persons, individually or as a group,

b) When the offender is a medical practitioner, doctor or physician or when the
offense is committed by a public officer or employee:

¢) When the crime is committed by a corporation, association or a group;

d) When the victim of the crime is a minor or those already of age but are unable
to fully take care of themselves or protect themselves from abuse, neglect,
cruelty, exploitation or discrimination because of a physical or mental disability
‘or condition;

) When the victim was forced to enter into the commercial dealing of his/her
organs tissues and/or parts due to force, violence, intimidation, threat,
fraudulent machinations, grave abuse of authority and other similar means
which vitiate free will and consent; and

f) When the donor suffered severe complications as a result of organ removal
and died as a consequence thereof.

CHAPTER VI
PROHIBITED ACTS AND
SANCTIONS/PENALTIES FOR NON-COMPLIANCE

SEC. 29. Sanctions/Penalties for Non-Compliance. -

(A) Non-compliance to the policy guidelines stated in this Act shall be ground for
suspension or revocation of license of the Hospital or Transplant Center, or
organ procurement organization subject to the implementing rules and
regulations to be established. Any violations by erring professionals — doctors,
nurses, transplant coordinators — shall be investigated by the Department of
Health and the Professional Regulations Commission, for appropriate
administrative sanctions

(B) A non-indigent recipient who fails to perform any of the mandatory duties
mentioned in Section 22 hereof as well as the local chief executive and
responsible officers of the local government unit concerned, the officials and
‘employees of hospitals and companies failing to comply with Sections 21 and
23 hereof shall be held individually liable and suffer the following penalties:

1. Fine of not less than One Hundred Thousand Pesos (P100,000.00) but not
exceeding Five Hundred Thousand Pesos (P500,000.00) or imprisonment
of not less than one year but not more than five years, or both, at the
discretion of the Court

2. For any subsequent violation in case of public and private corporations, a
fine of not less than Two Hundred Thousand Pesos (P200,000.00) but not
exceeding Six Hundred Thousand Pesos (P600,000.00) or imprisonment
for not less than two years but not more than six years, or both, at the
discretion of the court

Upon filing of an appropriate complaint, and after due notice and
hearing, the proper authorities may also cause the cancellation or
revocation of the business permit, permit to operate, franchise and other
similar privileges granted to any business entity that fails to abide by the
provisions of this Act.

Sec. 30. Prohibited Acts. - It shall be unlawful for any person, natural or juridical, to commit
any of the following acts


a) To advertise in any manner, whether formally through print or broadcast media
or informally, an offer to sell, barter or transact in human organs, tissues and/or
Parts or an offer to acquire, buy or to receive human organs, tissues and/or
Parts for consideration in whatever form:

b) To advertise, publish, print, broadcast or distribute, or cause the advertisement,
Publication, printing, broadcasting or distribution by any means, including the
Use of information technology and the internet, or any brochure, flyer, or any
Propaganda material that promotes commercial dealings in human organs,
tissues and/or parts;

©) To recruit, transport, transfer, harbor, provide, or receive a person by any
means, for the sale, barter, or any transaction of human organs, tissues and/or
parts which involves consideration in whatever form:

d) To offer consideration in money, kind or services for the purpose of acquiring,
buying, offering, selling, or trading human organs, tissues andlor parts;

e) To act as a facilitator, middleman, broker or other similar role in the sale, barter
or other transaction of human organs, tissues and/or parts for consideration in
whatever form:

f) To engage in the sale, barter or other transaction of human organs, tissues
andlor parts for consideration in whatever form;

g) To store and/or handle parts with the knowledge that the human organs, tissues
and/or parts has been acquired or transferred or sold for consideration in
whatever form;

h) To deliver, transport, transfer and/or distribute human organs, tissues and/or
parts with the knowledge that the human organs, tissues and/or parts has been
acquired or transferred or sold for consideration in whatever form;

i) To remove or transplant human organs, tissues and/or parts with the
knowledge that the human organs, tissues and/or parts has been acquired or
transferred or sold for consideration in whatever form;

i) To consent to the transplantation of human organs, tissues and/or parts and be
transplanted with the same with the knowledge that the human organs, tissues
and/or parts has been acquired or transferred or sold for consideration in
whatever form:

k) To offer to supply human organs, tissues and/or parts for consideration or
initiates or negotiates any argument for the supply thereof or for an offer to
supply human organs, tissues andlor parts.

1) To engage in the trading of human organs, tissues and/or parts for
consideration in whatever form:

m)To recruit or invite persons to supply human organs, tissues and/or parts for

consideration;

n) To make or receive payment for the supply of or for an offer to supply human
‘organs, tissues and/or parts.

SEC. 31. Penalties. - The following penalties and sanctions are hereby established for the
offenses enumerated in Sections 30, 31 and 32 of this Act:

a) Any person found guilty of committing any of the acts enumerated in Section 29
shall suffer the penalty of imprisonment of twenty (20) years and a fine of not
less than One million pesos (P1,000,000.00) but not more than Two million
pesos (P 2,000,000.00)


b) Any person found guilty of committing any of the acts enumerated in Section 30
shall suffer the penalty of imprisonment of fifteen (15) years and a fine of not
less than Five hundred thousand pesos (P 500,000.00) but not more than One
million pesos (P 1,000,000.00);

¢) Any person found guilty of qualified commercial dealing in human organs and/or
tissues under Section 28 shall suffer a penalty of life imprisonment and a fine of
not less than Two million pesos (P 2,000,000.00) but not more than Five million
pesos (P 5,000,000.00);

d) If the offender is a corporation, partnership, association, club, establishment or
any juridical person, the penalty shall be imposed upon the owner, president,
partner, manager, and/or any responsible officer who participated in the
commission of the crime or who shall have knowingly permitted or failed to
prevent its commission;

e) The registration with the Securities and Exchange Commission (SEC) and
license to operate of the erring corporation, association, or group shall be
cancelled and revoked permanently. The owner, president, partner or manager
thereof shall not be allowed to operate similar establishments in a different
name;

f) If the offender is a hospital, clinic or other similar licensed medical institution,
the penalty shall be imposed upon its owner, president, director, members of
the board, officials, doctors with knowledge of the illegal acts and participates
therein including the medical staff;

4) The license of the hospital, clinic or medical institution with the Department of
Health and other regulatory institutions shall be cancelled and revoked and the
license to practice of medical professionals found guilty of the illegal acts shall
be cancelled and revoked;

h) If the offender is a foreigner, he shall be immediately deported after serving his
sentence and be barred permanently from entering the country;

i) Any employee or official of government agencies who shall commit the
prohibited acts enumerated under Section 29 and Section 30 shall be held
administratively liable, without prejudice to criminal liability under this Act. The
concerned government official or employee shall, upon conviction, be
dismissed from the service and be barred permanently to hold public office.
His/her retirement and other benefits shall be likewise be forfeited.

SEC. 32. Confiscation and Forfeiture of the Proceeds and instruments Derived from
Commercial Dealings in Human Organs and Tissues. - In addition to the penalty imposed for
the violation of this Act, the court shall order the confiscation and forfeiture, in favor of the
government, of all the proceeds and properties derived from the commission of the crime,
unless they are the property of a third person not liable for the unlawful act: Provided,
however, that all awards for damages shall be taken from the personal and separate
properties of the offender: Provided, further, that if such properties are insufficient, the
balance shall be taken from the confiscated and forfeited properties.

When the proceeds, properties and instruments of the offense have been destroyed,
diminished in value or otherwise rendered worthless by any act or omission, directly or
indirectly, of the offender, or it has been concealed, removed, converted or transferred to
prevent the same from being found or to avoid forfeiture or confiscation, the offender shalll be
ordered to pay the amount equal to the value of the proceeds, property or instruments of the
offense,


‘SEC. 33. Prescriptive Period. - Commercial dealing in human organs, tissues and/or parts
cases under this Act shall prescribe in ten (10) years; provided however, that cases under
Section 30 of this Act shall prescribe in twenty (20) years. The prescriptive period shall
‘commence to run from the day on which the organ, tissue and/or part subject of the
commercial dealings has been removed for the purpose of transplantation or when the crime
was discovered by authorities and shall be interrupted by the filing of the complaint or
information and shall commence to run again when the proceedings terminate without the
accused being convicted or acquitted or unjustifiably stopped for any reason not imputable to
the accused

SEC. 34. Prosecution of Cases. - Any person who has personal knowledge of the
‘commission of any offense under this Act may file a complaint for commercial dealings in
human organs, tissues and/or parts.

‘SEC. 35. Venue. - A criminal action arising from violation of this Act shall be filed where the
offense was committed, or where any of its elements occurred: Provided, that the court
where the criminal action is first filed shall acquire jurisdiction to the exclusion of other
courts.

Sec. 36. Preferential Option to be State Witnesses and Entitlement under the Witness
Protection Program. - Any person who allowed the removal of his/her organ/s tissue/s and/or
part/s for consideration in whatever form shall have the option to be a state witness and shall
be entitled to the witness protection program under Republic Act No. 6981

CHAPTER VII
MISCELLANEOUS PROVISIONS

‘SEC. 37. Education. - The Department of Education, Culture and Sports shall include organ
donation awareness in the national high school curriculum. The Commission on Higher
Education (CHED) shall include organ donation awareness in all medical and paramedical
courses including, but not limited to, Medicine, Nursing, Physical Therapy, Occupational
Therapy, Respiratory Therapy, Radiation Technology and Medical Technology.

SEC. 38. National Organ Donation Awareness Week. - To further increase awareness on
deceased organ donation, a nominated week during the calendar year shall be declared as
National Organ Donation Awareness Week when the Commission, OPOs and/or hospitals
will be holding activities pertaining to organ donation

SEC. 39. Appropriation. ~

a) Initial Appropriations — There is hereby appropriated the sum of Forty Million
Pesos (Php 40,000,000) to be taken from the budget of the Office of the
President for the current year to finance the initial implementation of this Act.

b) Subsequent Appropriations - The annual budget of the Commission shall
thereafter be included in the General Appropriations Act.

¢) Other Funding Source. An amount not exceeding Forty Million Pesos (Php
40,000,000) annually is hereby set aside from the charity funds of the Philippine
Charity Sweepstakes Office to cover the financial requirements of this Act.


‘SEC. 40. implementing Rules and Regulations. - The Commission shall promulgate the rules
and regulations to effectively carry out the provisions of this Act not later than sixty days from
their assumption into office.

SEC. 41. Separability Clause. - If for any part or provision of this Act is held unconstitutional
or invalid, other parts or provisions hereof which are not be affected shall continue to remain
in full force and effect

‘SEC. 42. Repealing Clause. — All provisions of laws, presidential decrees, executive and
administrative orders, rules and regulations, or parts thereof, inconsistent with this Act are
hereby repealed amended or modified accordingly.

‘SEC. 43. Effectivity- This Act shall take effect fifteen (15) days from the date of its
publication in at least two (2) newspapers of general circulation.

Approved,