FIFTEENTH CONGRESS: )
REPUBLIC OF THE PHILIPPINES )
First Regular Session )

HOUSE OF REPRESENTATIVES

introduced by Representative Rufus B, Rodriguez and
Representative Maximo 8, Rodriguez, Jr. __

5390

House Bill No.

EXPLANATORY NOTE.

Transplantation has prolonged and improved the quality of fife 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
jack 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 (OOH) 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-govemmental organizations to take appropriate
action to increase deceased organ donation, remove obstacles and disincentives to
deceased organ donation, enact legislation and create transplantation infrastructure
50 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 Warld 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 fiving 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 eamestly requested

RUFUS B, RODRIGPEZ

mM . RODRIGUEZ, JR.


FIFTEENTH CONGRESS }
REPUBLIC OF THE PHILIPPINES. )
First Regular Session )

HOUSE OF REPRESENTATIVES

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

5390

House Bill No.

An Act
Establishing a Nationat 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:

Sec. 1. Title, This Act shall be known as the "National Program for Sharing
Organs from Deceased Donors and Regulation of Human Organs for Donation and
Transplantation from Living Donors Act, " otherwise known as “Organ Donation Act
of 2011."

Sec. 2, Policy. The State shall protect and promote the right to health of the
people and instili 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 vuinerable 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. Creation and Nature of the Corporation. There is hereby created the
Philippine Network for Organ Sharing Corporation (PHILNOS), which shail have
the status of a tax-exempt government corporation attached to the Department of
Health for policy coordination and guidance. It shall facilitate a national system of
promoting organ donation from bath deceased and living donors and sharing of
organs in coordination with private organ procurement organizations. It is tasked to


serve as the central coordinating body for all deceased organ donation and
transplantation activities in the country.

Sec. 4, Records and Reports. The PHILNOS shall keep and cause to keep such
records as may be necessary for the purpose of making actuarial studies,
calculations and vatuations of the funds of the Corporation. The PHILNOS shall
maintain appropriate books of accounts to record its assets, liabilities, income,
expenses, receipts and disbursement of funds and other financial transactions and
operations.

Sec. §. Examination and Valuation of the Funds. The PHILNOS shall make a
Periodic actuarial examination and valuation of its funds in accordance with
accepted actuarial principles

Sec. 6, Exemptions from Taxes and Duties. It is hereby declared to be the
policy of the State that the actuarial solvency of the funds of the PHILNOS shall be
Preserved and maintained at all times. The PHILNOS, its assets, revenues
Including all accruals thereto, and any donation, contribution, bequest, subsidy or
financial aid which may be made to the Corporation shall be exempt from all taxes,
assessments, fees, charges, or duties of all kinds.

Moreover, said donation, contribution, bequest, subsidy or financial aid which may
be made to the Corporation shall constitute as allowable deduction from the
income of the donor for income tax purposes and shall be exempt from donor's tax,
subject to such conditions as provided for in the National Intemal Revenue Code,
as amended.

Sec. 7. Administration,

a. Implementing Body. The Philippine Network for Organ Shaving
{PHILNOS) shall implement the provisions of this Act

b, Powers and Functions of the PHILNOS. The PHILNOS shall exercise
the following powers and functions:

1) To administer and supervise the implementation of this Act;

2) To formulate, adopt, amend and/or rescind such rules and regulations
as may be necessary to carry out the provisions and purposes of this
Act, as well as the effective exercise of the powers and functions, and
the discharge of duties and responsibilities of the PHILNOS, Its officers
and employees;

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

4) To initiate and implement programs that will increase awareness and
acceptance of deceased organ danation and transplantation and that
will increase the number of organs from deceased donors for
transplantation;


5) To formulate and implement the policies that will promote the ethical
practice of living and deceased organ donation and transplantation

6) To supervise all functions of organ procurement organizations;

7) To serve as an advisory body to the President of the Philippines and to
relevant government agencies, in ali policies pertaining to organ
donation and transplantation,

8) To adopt and approve the annual and supplemental budget of receipts
and expenditures including salaries and allowances of the PHILNOS
personnel;

9) To: authorize such capital and operating expenditures and
disbursements of the PHILNOS as may be necessary and proper for
the effective management and operation of the Corporation;

10) To invest the funds of the PHILNOS, directly or indirectly in accordance
with the provisions of this Act, and all applicable laws and rules and
regulations.

11) To conduct continuing actuarial and statistical studies and valuations to
determine the financial condition of the PHILNOS, and taking into
consideration such studies and valuations and the limitations herein
provided, re-adjust the allocation or re-allocation of the funds to the
agency or organization covered;

12) To sue and be sued;

13) To enter into, make, perform and carry out contracts of every kind and

description with any person, firm or association or corporation,
domestic or foreign;

14) To carry on any other lawful business whatsoever in pursuance of, or in
connection with the provisions of this Act;

15) To have one or more offices in and outside of Metro Manila, and to
conduct its business and exercise its powers throughout and in any
part of the Republic of the Philippines;

16) To enter into agreements with the Philippine Health Insurance
Corporation ar any other entity, enterprise, corporation or partnership
for the benefit of Filipino patients needing organ transplantation;

17) To submit to the President of the Philippines and to both Houses of
Congress its Annual Report, and to make such report available to the
general public. The report shall contain the status of the PHILNOS
Fund, its total disbursements, reserves, average costing to Organ
Procurement Organizations (OPO) and any request for additional
appropriation. It should also contain data that ensures the
transparency of the allocation process for deceased organs and all
other data pertinent to the implementation of the national deceased
donor program.


18) To exercise such powers and perform such other acts as may be
deemed appropriate, useful, incidental or auxiliary to carry out the
provisions of this Act, or to attain the purposes and objectives of this
Act.

Sec. 8. QuasiJudicial Powers. The PHILNOS, in order to carry out its tasks
more effectively, shall be vested with the following powers:

a) Conduct investigations for the determination of a question, controversy,
complaint, or unresolved grievance brought ta its attention relating to living
and deceased organ donation or organ transplantation, and render decisions,
orders, or resolutions thereon, It shall proceed to hear and determine the
case even in the absence of any party who has been properly served with
Notice to appear. It shall conduct its proceedings or any part thereof in public
or in executive session; adjourn its hearings to any time and place, refer
technical matters or accounts to an expert and to accept his reports as
evidence, direct parties to be joined in or excluded from the proceedings, and
give all such directions as it may deem necessary or expedient in the
determination of the dispute before it,

) Issue summons and/or subpoenas requiring the attendance and/or testimony
of parties to a controversy or witnesses, or the production of documents and
other materials necessary to a just determination of the case under
investigation;

¢) Temporary suspension or permanent revocation of license, and/or imposition
of fines after due notice and hearing. The decision shall immediately be
executor, even pending appeal, when the public interest so requires, and as
may be provided for in the implementing rules and regulations,

The revocation of an OPO's accreditation shall disqualify it from
obtaining another accreditation in its own name, under a different name, or
through another entity, whether natural or juridicial.

In the exercise of its quasi-judicial powers, the Corporation shall not be bound by
the technical rules of evidence.

Sec.9. Coverage. This Act shail 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.

See. 10. Definition of Terms:

a) Attending Physician (AP) is the primary physician responsible for both the
care and management of the potential multiple organ donor.

b) Brain Death (BD) is the irreversible cessation of all functions of the entire
brain, including the brain stem.


°

aq)

e)

9)

h)

Death is the imeversible cessation of circulatory and respiratory functions or
the imeversible cessation of all functions of the entire brain, including the brain
stem, which is determined in accordance with the acceptable medical
practice and diagnosed separately by the attending physician and ancther
consulting physician, both of whom must be appropriately qualified and
suitably experienced in the care of such patients.

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

Donor Service Area (DSA) refers to the territorial jurisdiction of an organ
procurement organization as may be designated by the PHILNOS.

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

Organ Procurement is 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) is a PHILNOS 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 hosp tals,
including preservation and transportation of such organs,

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

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

Philippine Organ Donor and Recipient Registry System (PODRRS) is
the web-based electronic utility used by the PHILNOS contractor to conduct
its business, The PODRRS comprises of the natianal database of all organ
transplant candidates, organ transplant recipients, and organ donors, and
all other software, applications and security architecture needed for the
collection, modification, validation, reporting, management and redundancy
of data associated with the tasks and activities of the PHILNOS

Host OPO is the particular OPO which, having received an organ donor
call from a referring hospital, assumes responsibility for organ procurement.

Potential Multiple Organ Donor (PMOD) is any patient who will
imminently become brain dead, or who currently meets the criteria for brain
death,


9)
p)

q)

s)

y

4)

Referring Hospital (RH) refers to any hospital that identifies and refers
potential deceased organ danors to PHILNOS.

Testator is an individual who makes a legacy of all or part of his body

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

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

Procurement Transplant Coordinator (PTC) is the TC who shall have the
responsibility of coordinating the donor's evaluation, management, and
recovery of organs for transplantation,

Clinical Transplant Coordinator (CTC) is the TC who shail have the
responsibility of coordinating the transplant candidate's evaluation,
management, and follow-up care.

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

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

Living Non- Related Donors (LNRDs) 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:

(a) Voluntary Donors - Those who are not related by blood to the
recipient but bear close emotional ties with himher (ie. spouses,
relatives by affinity, fiends, employers/employees af long standing,
colleagues, fiancéfiancée and adoptive parents or children).

(b) Commercial Donors — It is 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,

i Directed Kidney/Organ Donor is someane who has a specific
recipient in mind whom he would want to donate to. This follows
the principle knawn as donor designation wherein the donor's
wishes are given due consideration.


ii Non-Directed_Kidney/Organ Donor is someone who would
donate to whoever he/she matches on a list of waiting patients for
organ transplant.

Sec. 11. The Board of Directors.

a)

b)

d)

Composition. The corporate powers and functions of the PHILNOS shall
be vested in and exercised by the Board of Directors hereinafter referred to
as the Board, and shall be composed of seven (7) members as follows:

4) The Secretary of Health;
2) The President of the Corporation;
3) The Chairman of the National Transplant Ethics Committee;

4) Two (2) representatives of professional organizations related to
transplantation, including but not limited to the Philippine Society of
Nephrology (PSN) and the Philippine Society of Transplant
Surgeons (PSTS);

5) A representative of the patient group; and
6) A representative of PhitHlealth,

The Secretary of Health shall be the ex officio Chairperson, while the
President of the Corporation shall be the Vice Chairperson of the Board

Appointment and Tenure. The President shall appoint all the Members of
the Board upon the recommendation of the Chairperson of the Board and in
consultation with the sectors concerned. Members of the Board shall have a
term of four (4) years each, renewable for a maximum of two (2) years,
except for members whose terms shall be co-terminus with their respective
positions in government. Any vacancy in the Board shall be filled in the
manner in which the original appointment was made and the appointee
shall serve only the unexpired term of his predecessor.

Meetings and Quorum. The Soard shall hold regular meetings at least once
a month, Special meetings may be convened at the call of the Chairperson or
by a majority of the members of the Board, The presence of four (4) voting
members shall constitute a quorum. In the absence of the Chairperson and
Vice Chairperson, a temporary presiding officer shall be designated by the
majority of the quorum,

Allowances and Per Diems. The members of the Board shall receive a
per diem for every meeting actually attended, subject to the pertinent
budgetary laws, and rules and regulations on compensation, honoraria and
allowances.


Sec. 12. The President of the Corporation.

a)

b)

)

d)

Duties and Functions. The President shall have the duty of advising the
Board and effecting the policies and decisions. His functions are as faltows:

1) To act as the chief executive officer of the PHILNOS

2) To be responsible for the general conduct of the operations and
management functions of the PHILNOS; and

3) To execute any other duties assigned to him by the Board.

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

Salary. The President shail receive a salary to be fixed by the Board, with the
approval of the President of the Philippines, payable from the funds of the
Corporation, subject to applicable laws and rules and regulations on
compensation of officers of government-owned of controlled corporations.
Prohibition. To avoid conflict of interest, the President 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 President 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. 13. Executive Department Composition. The Executive Department shall
be composed of the President of the Corporation and the Heads of the departments
which shail be the following:

@) 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 handie 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,

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

2) Registry Department shall handle registry and research.

Other departments may be formed upon the discretion of the Board of
PHILNOS.


Sec. 14, The External Audit Department. The Extemat Audit Department shall
conduct @ periodic review and audit of the operations of PHILNOS, with special
emphasis on organ allocation procedures. It shall submit its annual audit report to the
PHILNOS Board and Office of the President of the Philippines, and make these reports
available to the general public.

This department shall be composed of designated representatives from
PhilHeaith, OPO, Transplant Hospital, Public Sector, and from professional
organizations related to transplantation, including but not limited to the PSN and PSTS.

Sec. 15. Organ Procurement Organization (OPO).

a) 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
accreditation and licensing from PHILNOS,

b) Duties and Responsibilities. OPOs are required to fulfil the following duties
and responsibilities:

1) Respond to call from RH within his DSA and subsequent evaluation of the
PMOD for eligibility,

2) Discuss organ donation with the potential donor's family,
3) Obtain consent for donation and for removal of the organs;
4) Management of organ procurement within its DSA,

5) Reporting to PHILNOS the availability of a PMOD immediately after
consent for donation is obtained;

6) Fulfillment of all medicolegal requirements;
7) Appropriate preservation and packaging of the organs;

8) Assurance that adequate tissue typing material is procured, divided and
packaged

9) Assurance that written documentation of donor evaluation, donor
maintenance, consent for donation, death pronouncement, and organ
procurement quality accompanies the organ;

10) Cooperation and coordination with ather OPOs;

11) Promotion of deceased organ donation through education and
information dissemination; and

12) Adherence to alt DOH and PHILNOS rules and regulations

¢) Temporary Suspension of ticense. An OPO’s license to operate can be
suspended by PHILNOS for failure to:


1), Respond to calls fram Referring Hospitals (RH);
2) Procure an available organ;
3) Fulfil reportorial requirements; or
4) Non-compliance with the PHILNOS rules and regulations
d) Permanent Revocation of License. An OPO’s license can be revoked by
PHILNOS for any of the following reasons:
1) Repeated violations of PHILNOS rules and regulations;

2) Violation of Republic Act (RA) No. 9208, otherwise known as Anti
Trafficking Law; or

3) Violation of Section 22 of this Act.

The Corporation through its Board, after consultation with profess.onal
medical organizations, may provide for additional grounds for the revocation of
an OPO's license.

e) Designation of DSA. The designation of the DSA shall be guided by the
following:

1) Geographical proximity,
2) Technical capacity; and
3) Quality of service

Sec. 16. Reporting of Brain Death. Al patients with brain death in a tertiary
hospital within the OSA 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.

All tertiary hospitals, be it government or private, in the country are required to
include the number of brain death cases in their annual report.

Sec. 17. Brain Death Certification

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 argan donation.

b) The DOH, in consultation with an appropriate professional organization
such as the Philippine Neurological Association (PNA), shall establish and
promulgate the acceptable parameters for deciaring the occurrence of brain
death (BD). Such criteria may be reviewed and/or modified as deemed
appropriate by the members of the PNA or upon request by the PHILNOS


¢)

d)

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.

The death certificate should be signed at the time of death certification.

Sec. 18. Consent for Deceased Organ Donation.

a)

b)

c)

q)

e)

Consent for donation shall be obtained by the PTC and shall be done only after
the issuance of the BD certificate. Laboratory examinations shall commence
only after consent for donation is secured.

Consent for deceased organ donation must be obtained from the legal
next-of-kin of the PMD in the following order of priority, as stipulated in
R.A, No. 7170, otherwise known as the Organ Donation Act of 1991

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 the legal next-of-kin of the PMOD and in the absence of
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
18b hereof as stipulated in R.A. No. 7170.

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 personne! 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 organ
donation. If the patient expresses the intent to donate his or her organs,
that information is added to the patient's record

The following documents, or advance directives, shall be recognized and
honored as expressions of the testator's legacy or 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 was signed.

PHILNOS shall release a universal ODC that shall bear the PHILNOS logo
and a provisional space for the logo of the TxC or OPO where the ODC was
obtained

2) Driver's License;

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 fissues 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 Attomey 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. 19. Examination of Human Body or Part Thereof. A legacy or donation
of all of part of ¢ human body authorizes any examination necessary to assure
medical acceptability of the legacy ar donation for the purpose(s) intended

For purposes of this Act, all the necessary laboratory examinations, i.e. not
autopsy shall be conducted on the cadaver of accident, trauma, or other medico-
legal cases immediately after the pronouncement of death to determine viability
and/or quality of human organs that will be utilized for transplantation and/or in
furtherance of medical science.


Sec. 20. Enrollment of the Organ Transplant Candidate. All OTCs shall be
enrolled 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. 21. Organ Allocation.

a)
b)

c)

dq)

8)

Only the enrolled OTC shall be eligible to receive an organ retrieved from
the deceased donor.

Only PHILNOS shall have the authority to allocate all retrieved organs in
the country.

PHILNOS shail 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/grafts. Such a scoring system shail be
formulated through broad-based consultation and should be consistent with
current international and national ethicai and scientific standards.

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

All OSASS are subject to periodic review and revision as deemed
appropriate and as recommended by PHILNOS and/or by related
professional organizations such as the Philippine Society of Nephrology
and Philippine Society of Transplant Surgeons.

Sec. 22, Acceptable Living Donations.

a)

b)

Any individual, at least twenty ane (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 evatuation
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 bedy for the purpose of transplantation,

Informed written consent obtained for the removal of organs and tissues
from the donor's body for the purpose of transplanting the same to ancther
living human body. Such informed consent shall be in a document
witnessed by a relative of the donor and two (2) physicians neither of wnom
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 LNROs 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


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

Sec. 23. Grounds for Rejecting Living Donation and Transplantation.
a) Donor is a minor (less than 21 years of age)

b) Donor is found to be ill (i.e. 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 Filipina living non-
related donors; Uniess, That he/she is a former Filipino citizen and that the
potential donor is related to the said foreigner by consanguinity within the
fourth degree.

f) Non-directed LNRD are not allowed to donate organs for transplantation

i. 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 is 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. 24. Rights of Living Donors.

a) The costs for all medical and psychiatric work ups to determine the Inving
donor's fitness to donate shall be bome by the intended recipient.

b) Living Donors shalt 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 shal! be entitled to a disability pay, as
therein defined and computed.

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

Sec. 25. Organ Transplantation.

a) Organ transpiantation can be performed only in accredited and licensed
TxC,


b) The DOH, through the PHILNOS, shail formulate and implement the
accreditation requirements for TxC, define their functions, monitor heir
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)PHILNOS shall ensure that all medical and paramedical personne! involved
in transplantation shall camply with pertinent government regulations

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

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. 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. PHILNOS 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-k'n 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 PHILNOS.

») All OPOs shail not offer or give any gift to the family or next-of-kin of
the PMOD in anticipation or in exchange for organ donation
©) 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 PHILNOS, OPOs and/or hospitals
will be holding activities pertaining to organ donation

Sec. 27. Education. The Department of Education shall mandate the inclusion
of organ donation awareness in the national high school curriculum. The
Commission on Higher Education (CHED) shail mandate the inclusion of 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. 28. 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 organ
donation in case of brain death in alt drivers’ licenses.

Sec. 29. Air Transport

a) The Civil Aviation Authority of the Philippines (CAAP) under the
Department of Transportation and Communication (DOTC) and the OOH


shall jointly formulate guidelines that shail govern the transport of procured
‘organs through commercial airlines.

b) The CAAP shal! ensure the compliance of all registered commercial airlines
with the regulations allowing transport of procured organs

Sec. 30. Violations and Sanctions. 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 evting
professionals — doctors, nurses, transplant coordinators — shall be investigated by
the Department of Health and the Professional Regulations Commission for
appropriate administrative sanctions

Sec. 31. Appropriation.

a) Initial Appropriations - Congress shall appropriate the amount of Forty
Million Pesos (Php 40,000,000.00) for the initial implementation of this Act
b) Subsequent Appropriations - The following year after the amount
Necessary to implement the Program and thereafter, the appropriation shall
be included in the regular budgetary allocation for the Department of
Health, untii such time that the Corporation shall be self-sustaining through
its own funding
¢) Additional Appropriations - DOH may request Congress to appropriate
supplemental funding for PHILNOS in order to meet targeted milestones of
the Act as deemed necessary by the Corporation
Sec. 32. Financing

A standard Organ Acquisition Cost from organ retrievals coming from
deceased donors shall be determined by PHILNOS.

b) _PhilHealth shall develop a benefit package for the reimbursement o* the
‘organ acquisition cost to the Host OPO for every organ procurement event
that occurs

c) To be included in the PODRRS list, a potential transplant recipient of
PHILNOS shall pay a one-time, non-refundable registration fee.

d) PHILNOS shail be given authority to conduct tax-exempted fund-rasing
activities that will help augment the revolving fund for organ acquisition.

Sec. 33. Funds of the PHILNOS.

4) Funds. All income derived from registration fees or from fund-ra‘sing
activities shall be utilized solely for the continuous operations of PHILNOS.

The funds of the PH!LNOS shall not be used for purposes other than what
are provided for under this Act, Moreover, no portion of the funds of the
PHILNOS or income thereof shall accrue to the General Fund of the
National government and its political subdivisions, instrumentalities and


2)

3)

other agencies including government-owned and controlled corporations
except as may be allowed under this Act.

Deposits and Disbursements. All revenues collected and ali accruals
thereto shail be deposited, administered and disbursed in accordance with
the law. A maximum expense loading of seventy percent (70%) of the
yearly revenues from all sources may be disbursed for administrative and
‘Operational expenses except as may be otherwise approved by the
President of the Philippines on the basis of actuarial and management
studies.

Investment of Funds. The funds of the PHILNOS which are not needed to
meet its current obligations may be invested under such terms and
conditions and rules and regulations as may be prescribed by the Beard;
Provided, That investments shall satisfy the requirements of liquidity,
safety/security and yield in order to ensure the actuarial solvency of the
funds of the PHILNOS; Provided, further, That the PHILNOS shall submit
an annual report on all investments made to both Houses of Congress of
the Philippines, and to other agencies as may be required by law, as such
as:

(a) in interest-bearing bonds or securities or other evidence of
indebtedness of the Government of the Philippines;

(b) in interest-bearing deposits or securities in any domestic bank doing
business in the Philippines; Provided, That in the case of such
deposits, there shall not exceed at any time the unimpaired capita: and
surplus or total private deposits of the depository bank, whichever is
smaller, Provided, further, That the said bank has prior designation as
a depository for the purpose by the Monetary Board of the Central
Monetary Authority;

{c) in reai estate property including shares of stocks involving real estate
property and investments secured by first mortgages on real estate or
other collaterals acceptable to the PHILNOS; Provided, That, such
investment shall, in the determination of the Board, redound to the
benefit of the Corporation, its members as well as the general public;

(d} in toans te, or in bonds, debentures, promissory notes or cther
evidence of indebtedness of any solvent corporation created or existing
under the laws of the Philippines;

(e) in common and preferred stocks of any solvent corporation or financial
institution created or existing under the laws of the Philippines listed in
the stock exchange with proven track record of profitability over the last
three (3) years and payment of dividends at least once aver the same
Period; and


() in domestic mutual funds including investments related to the
operations of mutual funds.

Sec. 34. General Provisions.

a) Dispensation of PHILNOS funds. PHILNOS shall pay for the expenditures
of all Organ Donation Events that have been performed/processed by
authorized OPOs within their OSAs, provided, that all requirements are
submitted to PHILNOS within sixty (60) days from date of Organ
Procurement

Compensation for the staff and board members of PHILNOS shall be drawn
from the Corporation's own funds upon such time that it has been deemed
self-sustaining.

PHILNOS shall also provide for the funding of memorial gardens,
medallions, and similar tokens as recognition for the noble act of organ
donors.

b) Development and Disposition of Acquired Assets, PHiLNOS shall have
the right to develop and dispose of its acquired assets obtained in the
ordinary course of its business. To add value to, improve profitability of,
and/or enhance the marketability of an acquired asset, PHILNOS may
further develop/renovate the same either with its own capital or through a
joint venture arrangement with private companies or individuals.

PHILNOS may sell its acquired assets in accordance with existing
Commission on Audit (COA) rules and regulations for an amount not lower
than the current market value of the property. For this purpose, PHILNOS.
shall conduct an annual appraisal of its property or acquired assets to
determine its current market value. All notices of sale shall be published in
newspapers of general circulation.

No injunction or restraining order issued by any court, commission, tribunai
or office shalt bar, impede or delay the sale and disposition by PHILNOS of
its acquired assets, except on questions of ownership and national or public
interest.

Sec. 35. Implementing Rules and Regulations. PHILNOS, in consultation
with relevant medical societies and goverment agencies, shall promulgate the
necessary Implementing Rules and Regulations within three (3) months from the
Effectivity of this Act

Sec. 36. Separabitity Clause. If for any reason any section or provision of this
Act is held unconstitutional or invalid, the other sections or provisions hereof shall
not be affected thereby.


Sec. 37. Repealing Clause. All laws, presidential decrees, executive and
administrative orders, rules and regulations, or parts thereof, inconsistent with the
provisions of this Act are hereby repealed or modified accordingly.

Sec. 38. Effectivity. This Act shall take effect fifteen (15) days from the
date of its publication in at least three (3) national newspapers of general
circulation.

Approved,