Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

NINETEENTH CONGRESS
First Regular Session

HOUSE BILL No._ 7099

Introduced by: Hon. Keith Micah “Atty. Mike” D.L. Tan

AN ACT
PROVIDING FOR AN “OPT-OUT” SYSTEM OF ORGAN AND TISSUE DONATION,
PROMOTING THE RIGHT TO HEALTH, AND PROVIDING PENALTIES THEREFOR

EXPLANATORY NOTE

Article Il, Section 15 of the 1987 Constitution provides that, "the State shall protect
and promote the right to health of the people and instill health consciousness among them."

There is an increasing number of kidney disease which affect Filipinos. End Stage
Renal Disease (ESRD) which is a consequence of underlying diseases such as diabetes
mellitus and hypertension increased the demand for medications and treatments such as
the hemodialysis.

In the Philippines, the estimated cost of hemodialysis in P3,000 per session. If the
patient is on it three times a week, the total cost would be P468,000 a year. However, this
amount does not include other medications and laboratories that an average person would
need

To address this concern, government medical institutions offer free or low-cost
dialysis treatment to Filipinos. Just recently, the Philippine Red Cross extended its arms to
lessen the suffering of people afflicted with kidney failure by providing a modem state-of-the-
art dialysis center with quality healthcare.

Despite the availability of dialysis machines, kidney transplantation is still the
treatment of choice for ESRD because it offers a better-quality life and long-term survival
The estimated life expectancy post-transplant is 17.19 years compared to only 5.48 years, if
the patient remains on dialysis. Moreover, the difference in the total quality of life in terms of
physical, social, emotional, spiritual, and financial aspects between transplant vis-a-vis
patients was determined to be 18.12% greater in transplant patients.

Unlike in other developed countries, kidney donors in the Philippines come mostly
from living related donors (95%) and a mere 5% from deceased donors despite efforts made
by the government and non-governmental organizations to encourage organ donations.

The incentive for systematic reform of organ and tissue donation has arisen
internationally because of the increased incidence of end stage organ failure and the
corresponding growth in need for transplants. Several countries have responded to this
challenge by implementing strategies to increase organ and tissue donation, and now, have
established reform models. The "Opt-In" or "Opt-Out" donation models are the more known.
"Opt-In" donation system means that only those with explicit consent are considered donors


While, "Opt-Out" donation system means that everyone is treated as a donor unless
they specifically object to do so. Both strategies allow individuals (or their next of kin) power
to determine what happens to their cadaveric organs: the difference between them is the
"default" treatment of someone who has expressed no wish either way. Opt-Out strategies
are likely to increase donation rates because those who do not register a preference either
way will be treated as donors. Opt-Out organ donation systems are often called "presumed
consent.”

In recent years, technical, social, and public opinion in many countries has shifted
towards the view that Opt-Out provisions can help promote organ donation. Two
components of transplantation regulation- presumed consent and allocation priority- are
thought to increase the donor population by decreasing the ease of opting out and giving
registered donors priority among the pools of individuals in need of organ transplant.

The joint implementation of these components is believed to yield beneficial effects.
Explicit Opt-Out laws have long been among the major interventions used to increase the
pool of potential donors in countries such as Austria, Belgium, the Czech Republic, Finland,
France, Greece, Hungary, Israel, Italy, Luxembourg, Norway, Poland, Spain, Slovenia,
Sweden and Turkey.

There is evidence that supports the association between presumed consent and
increased donation rates and that countries with Opt-Out laws have rates 25 to 25% higher
than those in countries requiring explicit consent. However, presumed consent appears to
be only one of several factors. Other factors include potential donor availability,
transplantation infrastructure, health care spending, and public attitudes, as well as familial
consent and donor registries.

If a person can be an organ recipient, they should also be able to give an organ and
vice versa. This principle is consistent with the view that a fair concept of justice calls for
reciprocal altruism, because organs may be considered a scarce societal resource - ie. the
demand for donated organs is higher than the supply of such organs.

It also justifies the perceived unfair action of free-riders: those who are willing to
receive an organ but unwilling to donate one. Moral duty must be the foundation of our
organ donation laws. This duty places a legal obligation on any citizen to contribute to the
system they stand to benefit from.

It is this context that this Opt-Out system of organ donation is sought to be approved
in substitution of the voluntary organ donation system existing under the "Organ Donation
Act of 1991."

In view of the foregoing, the immediate approval of this bill hereby sought.

Keith Micah “Atty. Mike” D.L. Tan
4th District, Quezon


Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

NINETEENTH CONGRESS
First Regular Session

‘guLNo, 1099

HOUSE BILL NO.

Introduced by: Hon. Keith Micah “Atty. Mike” D.L. Tan

AN ACT
PROVIDING FOR AN “OPT-OUT” SYSTEM OF ORGAN AND TISSUE DONATION,
PROMOTING THE RIGHT TO HEALTH, AND PROVIDING PENALTIES THEREFOR

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

SECTION 1. Short Title. - This Act shall be known as the "Organ and Tissue
Donation Act."

SEC. 2. Coverage. - This Act shall cover all government and private hospitals, health
facilities, organ and tissue retrieval organizations, medical and allied medical practitioners or
professionals, foundations and non-government organizations that are involved in organ and
tissue donation from deceased donors for transplantation

SEC. 3. Definitions. - For purposes of this Act, the following terms shall be defined as
follows:

a. Allocation. - The assignment of human tissues and organs to a transplant
candidate, based on a set of rules.

b. Brain Death Criteria. - A set of standards, guidelines, or rules that determine and
diagnose brain death by neurological criteria as determined by the Philippine Neurological
Association (PNA)

¢. Clinical Donor Coordinator (CDC). - A healthcare professional who shall be
designated to coordinate with the donor family and hospital in order to facilitate a donation
and proper transport of donated organs or tissues. surgical, obstetrical or other medical and
nursing care. It shall also be construed as any institution, building or place where there are
facilities and personnel for the aforementioned purposes.

k. Medical Practitioner. - Any physician, dentist, nurse, pharmacist, or paramedical or
other supporting personnel (including medical and dental technicians, nursing assistants,
and therapists).

|. Organ. - A differentiated and vital part of the human body, formed by different
tissues, that maintains its structure, vascularization and capacity to develop physiological
functions with an important level of autonomy.

m. Organ and Tissue Retrieval Organization (OTRO). - A hospital-based organization
accredited by the DOH, created for the purpose of detecting, identifying, and evaluating
potential organ and tissue donors, and recovering such from deceased donors for


individuals needing transplantation. OTROs, in coordination with the CDC and CTC, shall
serve as the vital link between the donor and recipient. Their responsibilities include brain
death certification, donor maintenance, and retrieval, preservation, and transport of organs
and/or tissues for transplantation.

n. Organ and Tissue Retrieval Team (OTRT). - A group made up of highly-skilled
healthcare professionals led by a surgeon who is competent to safely lead the retrieval of
organs and/or tissues for transplantation.

0. Philippine Organ Donor and Recipient Registry System (PODRRS). - A national
computerized and strictly confidential database of all organ transplant candidates,
recipients, organ donors, and transplants performed in the Philippines. The System shall
also contain the list of individuals who chose and expressed to opt-out from donating organs
and/or tissue, as provided in this Act.

p. Physician. - A medical practitioner who is authorized to practice medicine under
the laws of the Republic of the Philippines.

q. Potential Multiple Organ Donor (PMOD). - Any patient who will imminently become
brain dead or who currently meets the criteria for brain death who may donate more than
one organ and/or issue(s).

r. Procurement. - A process that includes donor identification, evaluation, obtaining
consent for donation, donor maintenance, and retrieval of organs and/or tissues.

s. Recipient. - A patient to whom human organs and/or tissues are transplanted

t. Referring Hospital (RH). - A hospital that identifies and refers potential donors to
OTPOs; or to the appropriate Tissue Bank. RHs are required to refer and report potential
organ donors to the DOH-PhilNOS.

u. Tissue. - All constituent parts of the human body formed by cells.

v. Tissue Bank. - A hospital unit where activities of processing, preservation, storage,
or distribution of human tissues are undertaken. It may also be responsible for procurement
or testing of tissues.

w. Transplantation. - The transfer (engraftment) of human cells, tissues, or organs
from a donor to a recipient with the aim of restoring function/s in the body.

x. Transplant Candidate - A patient diagnosed to have end-stage organ disease that
is qualified to undergo an organ and/or tissue transplant procedure.

y. Transplant Facility (TF) - A hospital accredited by the DOH to perform organ and/or
tissue transplantation,

SEC. 4. Determination and Declaration of Death. - A person shall be determined and
declared dead if:

1) In the opinion of the consulting physician, in concurrence with the attending
physician, 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; or

2) In the opinion of the attending physician, based on the acceptable standards of
medical practice, there is an absence of natural respiratory and cardiac functions and,
attempts at resuscitation would not be successful in restoring those functions. In this case,
death shall be deemed to have occurred at the time these functions ceased.

Provided that, the death of the person in Sec. 3 hereof shall be determined in
accordance with the Brain Death Criteria provided by the PNA, by which brain death shall be
declared by two (2) different physicians who are both not part of the transplant team. The
physicians are preferably, but not limited to, a neurologist, neurosurgeon, internist, or
anesthesiologist who shall determine and establish brain death based on existing
guidelines. The death shall be recorded in the patient's medical record.

SEC. 5. Establishment of Organ and Tissue Retrieval Organizations (OTROs). - The
DOH, in coordination with the DOH-PhilNOS, shall accredit and ensure the establishment of
OTROs in tertiary hospitals, government and private, as part of the national organ and
tissue procurement network

The OTROs shall establish affiliations with facilities/institutions that provide
ancillary/support services such as, but not limited to, laboratory diagnostic capability in
virology, tissue typing, imaging facility, to include at least an ultrasound machine with
doppler capability, and ambulance services for donor/s, organ/s, and tissue/s transport.

Provided that, each OTRO shall have an Organ Retrieval Team whose members are
licensed and board-certified surgical and medical experts. Provided that, collaborations with
other retrieval teams of other transplant facilities without an OTRO can be entertained on a
case-by-case basis.

Each OTRO shall be mandated to serve its designated Donor Service Area (DSA)
which shall be determined by DOH and DOH-PhilNOS, through population-based
designation, in coordination with the Philippine Statistics Authority (PSA)

All Tertiary Hospitals and Trauma Centers, with or without OTROs, shall be required
to have CDC and CTC in order to optimize the identification and referral of donors and/or
PMODs.

SEC. 6. Retrieval of Organs and Tissue After Death. - The designated medical
practitioner of a hospital may, subject to and in accordance with this Act, authorize, in
writing, the removal of any organ and/or tissue of a dead person unless he/she has opted-
out to organ and tissue donation, as confirmed by DOH-PhilNOS through the PODRRS.

Organ procurement may be performed in any hospital provided that is well- equipped
and capable of performing such operation while tissue procurement shall be performed by
the appropriate Tissue Bank, as accredited by the DOH

Provided that, for possible medicolegal cases and unidentified dead individuals, no
procurement of organ and/or tissue shall be performed and the OTRO shall immediately
communicate and inform the Medicolegal Division and Crime Laboratory of the Philippine
National Police (PNP) and/or National Bureau of Investigation (NBI).

Moreover, no authority shall be given for the removal of organs and/or tissues from
the body of the deceased if:


1) During his/her lifetime, he/she has registered an objection to organ and/or tissue
donation, as provided in this Act, after his/her death;

2) Helshe is not a citizen of the Philippines. Provided that, Filipinos who have lost
their citizenship and obtained citizenship in another country, and are residents in the
Philippines, may also be given authority to donate their organs to a living related transplant
recipient, in accordance with the Opt-In System provided in Section 8 hereof, unless with
explicit consent to donate;

3) He/she is below eighteen (18) years of age unless both living parent(s) or legal
next-of-kin or legal guardian has consented to such removal, or

4) He/she is an incompetent person, unless the living parent(s) or legal next-of- kin or
legal guardian has consented to such removal.

SEC. 7. Opt-Out System. - Upon the effectivity of this Act, any person who objects to
the removal of his/her organ and/or tissue after his death may register his objection, in
respect of that organ and/or tissue, with the DOH-PhilNOS at any time or with the following
agencies:

a. Land Transportation Office (LTO) upon driver's license renewal;
b. Government Services Insurance System (GSIS);

c. Social Security System (SSS);

d. Philippine Health Insurance Corporation (PhilHealth);

e. Commission on Elections (COMELEC); or

f, Such other department or agency assigned by the PSA.

Such objection shall be registered and recorded real-time in the PODRRS. Upon the
receipt of the duly-signed written objection, the concerned agency shall thereafter issue a
certification and an opt-out card to the person which shall serve as a proof that his objection
was duly registered and recorded

Provided that, any person who has registered his/her opt-out may cancel his/her
registration at any time in the prescribed form, as may be determined by the DOH-PhilNOS,
in coordination with the abovementioned agencies. Such cancellation shall be recorded real-
time in the PODRRS.

SEC. 8. Opt-in System. - Upon the effectivity of this Act, any person who desires to
donate his/her organs and/or tissues, may register, in respect of such organ and/or tissue,
with the DOH-PhilNOS.

Upon receipt of the duly-signed written opt-in form, DOH-PhiINOS shall issue a
certification and an opt-in card to the person, which shall serve as proof of such registration
Such registration shall be recorded and maintained in the PODRRS

Provided that, any person who has registered his/her opt-in may cancel his/her
registration at any time in the prescribed form, as may be determined by the DOH-PhilNOS.
Such cancellation shall be recorded real-time in the PODRRS.


SEC. 9. Allocation of Organs and Tissues. - In the allocation of any organ and/or
tissues retrieved pursuant to this Act, matching and other circumstances, as may be
determined by DOH and DOH-PhilNOS shall be considered.

SEC. 10. Roles and Functions of DOH-PhilNOS. - In addition to the roles and
functions of the DOH-PhilNOS, as provided by official DOH issuances, policies, laws, rules
and/or regulations, it shall act as the central coordinating body to ensure that all deceased
donors of organs and/or tissues are allocated according to established criteria and such
other roles and functions, as may be deemed necessary. Provided that, DOH-PhilNOS shall
operate in coordination with OTROs.

SEC. 11. Hospital Transplant Ethics Committees (HTECs). - All hospitals and
transplant facilities shall establish their own HTECs. HTECs shall monitor and resolve
ethical issues that may arise in the process of organ and tissue donation and
transplantation.

The functions of the HTECs shall be in accordance with DOH policies and guidelines
and shall have its own Standard Operating Procedures (SOPs) based on the
recommendations of the National Transplant Ethics Committee (NTEC).

The members of the HTEC shall ensure its independence from political, institutional,
professional, and market influence. HTEC members shall undergo basic and continuing
training on organ and tissue donation and transplantation

SEC. 12. National Transplant Ethics Committee (NTEC). - The NTEC shall be
established under DOH and shall serve as the national oversight of the HTECs on ethical
issues regarding organ and tissue donation and transplantation. In addition, the NTEC is
tasked to

a. Assist in the formulation of national ethical standards and guidelines on organ and
tissue transplantation;

b. Assist in the development of legislation, rules, and regulations regarding organ and
tissue donation and transplantation;

c. Provide opinions, recommendations, and final resolution of cases referred by
HTECs;

d. Assist in the monitoring of hospitals to ensure compliance with ethical standards or
guidelines in relation to organ and tissue donation and transplantation;

e. Foster awareness on ethical health care issues on organ and tissue donation and
transplantation;

f. Participate in international discussions and collaborations with similar committees
and organizations in the field; and

g. Perform such other functions as may be deemed necessary by the Secretary of
Health.

SEC. 13. Persons Authorized to Perform the Retrieval and Transplantation of Organs
and Tissues. - The retrieval and transplantation of organ and tissues shall only be performed
by transplant surgeons duly accredited and certified by the Philippine Society of Transplant
Surgeons. Provided that, the removal of the eye and eye tissues shall be performed only by


Eye Bank Technicians who undergo training in the science of eye banking conducted by an
organization duly-accredited by the DOH. Such trainings shall be in accordance with the
accepted international standards of eye banking and shall include, but not limited to,
retrieval, processing, storage, and distribution of eye tissue.

SEC. 14. Transport of Donated Organs and Tissues. - In order to maintain the quality
and integrity of organs and tissues for transplantation, to ensure traceability, and to minimize
any potential risk, it is vital that donor organs and tissues and their accompanying blood and
tissue samples are packaged, labeled, and transported to the Transplant Facility
appropriately, and in a speedy and timely manner.

SEC. 15. PhilHealth Assistance. - Organ and tissue transplantation and deceased
organ and tissue procurement, under this Act, shall be covered, partially or in full, by the
Philippine Health Insurance Corporation (PhilHealth). Provided that, the assistance given by
PhilHealth shall be determined through fair and transparent assessment process.

SEC. 16. Prohibited Acts. - The following acts shall be prohibited:

a. Selling of Organs and/or Tissues. To enter into a contract or arrangement under
which a person agrees, for valuable consideration, whether given or to be given to
himself/herself or to another person, the sale or supply of any organ or tissue, whether
before or after his or her death or the death of another person, as the case may be:

b. Buying of Organs and/or Tissues. To give or offer to give valuable consideration for
the sale or supply of, or for an offer to sell or supply, any organ from the body of another
person;

c. Performing organ and/or tissue removal and/or transplantation of an unauthorized
person. To remove and / or transplant any organ and/or tissue of a person without an
authorized physician;

d. Advertising and promoting the buying and selling of organs and/or tissues. No
person shall issue or cause to be issued any advertisement relating to the buying or selling
of any organ and/or tissue in the Philippines; and

e. Destroying, forging, mutilating, and altering the PODRRS or any related
documentation. To willfully destroy, forge, mutilate, or make any unauthorized alteration in
the PODRRS or any related documentation

SEC. 17. Penalties. - The following penalties are hereby provided:

a. Any person found guilty of committing any of the acts enumerated in Section 12
(a), (b) and (c) shall suffer the penalty of imprisonment of twenty (20) years and a fine of not
less than One million pesos (PI,000,000.00) but not more than Two million pesos
(P2,000,000.00);

b. Any person found guilty of committing any of the acts under Section 12 (d) and (e)
shall suffer the penalty of imprisonment of two (2) years and a fine not less than One
hundred thousand pesos (P100,000.00) but not more than Five hundred thousand pesos
(P500,000.00).

SEC. 18. Education and Information Campaign. - To ensure public awareness of the
maximum benefits of organ and tissue donation provided in this Act, the DOH, in
cooperation with institutions such as the National Kidney and Transplantation Institute


(NKTI), civic and non-government health organizations, and other health- related agencies
involved in the donation and transplantation of human organs and tissues, as well as the
Department of Education (DepEd) and the Commission on Higher Education (CHED) shall
undertake public information and education program for this purpose.

The DOH shall ensure that all health professionals, both in government and private
sectors, as well as media organizations from print, radio, and television are encouraged to
undertake massive public information campaign to emphasize the importance of organ and
tissue donation in relation to the opt-out system.

DepEd and CHED shall mandate the inclusion of organ and tissue donation and the
opt-out system, for increased awareness, in the school curriculum and in all medical and
paramedical related courses, respectively. Moreover, the importance of organ and tissue
donation and the opt-out system shall be included in the Health and Sciences subjects in the
curriculum of both the elementary and secondary levels as well as in the general education
curriculum in the collegiate level. The Secretary of Health shall coordinate with the Secretary
of Education and the Chairperson of CHED for the effective and efficient implementation of
this Act.

The DOH shall further endeavor to disseminate massive public information campaign
on organ and tissue donation through other means, such as, but not limited to, the internet,
social media, and print ads. The DOH shall also provide annual professional training
programs and seminars for clinical staff in the management and implementation of this Act,
particularly on the deceased organ and/or tissue donation process.

SEC. 19. Phased Implementation. - The DOH and DOH-PhilNOS, in coordination
with concerned agencies, shall develop strategies and approaches for the phased
implementation of this Act which shall initially consist of massive public information
campaign through national and local consultations, surveys, impact assessments, trainings
and seminars, print and online advertisements, television and radio advertisements, among
others, for the first six (6) months following the effectivity of this Act.

Immediately after the effectivity of this Act, any individual who decides to opt-out from
organ and/or tissue donation may do so in accordance to Sec. 7 of this Act. Provided that,
six (6) months following the effectivity of this Act, the opt-out system of organ and/or tissue
donation shall be fully implemented.

SEC. 20. Data Management. - The DOH and DOH-PhiINOS, in coordination with the
National Privacy Commission (NPC) and other concerned agencies, shall ensure that all
data compiled under this Act shall be strictly confidential through the implementation of
appropriate organizational, physical, and technical security measures in accordance to
existing laws, rules, and regulations.

SEC. 21. Appropriation. - The amount of One Billion Pesos (P1,000,000,000.00) shall
be appropriated for the management and implementation of this Act which shall be included
in the General Appropriations Act (GAA).

SEC. 22. Repealing Clause. - All laws, decrees, orders, rules and regulations or other
issuances or parts thereof inconsistent with the provisions of this Act are hereby repealed or
modified accordingly.

SEC. 23. Separability Clause. - If any portion or provision of this Act is declared
unconstitutional, the remainder of this Act or any provision not affected thereby shall remain
in force and effect.


SEC. 24. Effectivity. - This Act shall take effect after fifteen (15) days following the
completion of its publication either in the Official Gazette or in a newspaper of general
circulation in the Philippines.

Approved,