Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

Seventeenth Congress
Third Regular Session

HOUSE BILL No. 8613

Introduced by Rep. MARLYN B. ALONTE

AN ACT PROVIDING FOR AN “OPT-OUT” SYSTEM OF ORGAN DONATION AND
TRANSPLANTATION, AMENDING REPUBLIC ACT NO. 7170 OTHERWISE KNOWN
AS THE “ORGAN DONATION ACT OF 1991,” PROMOTING THE RIGHT TO HEALTH,
PROVIDING PENALTIES THEREFOR, AND FOR OTHER PURPOSES

EXPLANATORY NOTE

In recent years, the demand for donated organs is higher than the supply of such, that
human organs can already be considered a scarce societal resource. The surge in
demand is brought about by the increase in cases of kidney diseases.

More and more Filipinos are diagnosed with End Stage Renal Disease (ESRD), the last
stage of chronic kidney disease. At this point, the kidneys’ functions have reached an
advanced state and can no longer support one's body needs. The most common
treatment for ESRD is hemodialysis, which can cost a patient having the treatment three
times a week about P468,000 for a whole year. This does not include medications,
laboratories, and other treatment fees.

Although dialysis centers are abundant in the country, kidney transplantation is still the
treatment that offers better quality of life as well as longer survival for patients. A
transplant helps a patient live for an estimated 17 more years after the treatment, as
compared to just over 5 years for those who remain on dialysis treatment. Studies also
show that quality of life—physical, social, emotional, spiritual, and financial—post-kidney
transplant is 18.12% greater than those of dialysis patients.

But here's the sad truth: the Philippines needs to step up in its bid to increase organ
donation rates. Unlike in other developed countries, 95% of kidney donors in the
Philippines are from living donors, while only 5% are from deceased donors although
efforts are made by government and non-government organizations to encourage more
people to donate.

This Act provides an "Opt-Out" system in organ donation and transplantation. In this
donation system, everyone is treated as a donor unless they specifically object to being
one. It will allow individuals or their next of kin to determine what happens to their
cadaveric organs. Those who do not register a preference will still be treated as a donor,
often called "presumed consent". This process will likely increase the rate of donations,
as opposed to the "Opt-In" donation system which only counts those who explicitly gave
their consent to donate.


The "Opt-Out" donation system has been used by different countries—namely, Austria,
Belgium, the Czech Republic, Finland, France, Greece, Hungary, Israel,. Ifaly,
Luxembourg, Norway, Poland, Slovenia, Spain, Sweden and Turkey—to increase the
potential pool of organ donors. 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 35% higher than those in countries requiring explicit consent. But this is
not to say that presumed consent is the sole factor to the increase. Other factors include
potential donor availability, transplantation infrastructure, health care spending, and
public attitudes, as well as familial consent and donor registries.

The benefits mentioned above are the reasons this Act seeks to substitute the voluntary
organ donation system with the "Opt-Out" donation system under the “Organ Donation
Act of 1991.”

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

MARLYN B. ALONTE


Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

Seventeenth Congress
Third Regular Session

8613
HOUSE BILL No.

Introduced by Rep. MARLYN B. ALONTE

AN ACT PROVIDING FOR AN “OPT-OUT” SYSTEM OF ORGAN DONATION
AND TRANSPLANTATION, AMENDING REPUBLIC ACT NO. 7170
OTHERWISE KNOWN AS THE “ORGAN DONATION ACT OF 1991,”
PROMOTING THE RIGHT TO HEALTH, PROVIDING PENALTIES THEREFOR,
AND FOR OTHER PURPOSES

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

SECTION 1. Short Title. — This Act shall be known as the “Organ Donation Act
of 2018.”

Sec. 2. Definitions. -For purposes of this Act, the following terms shall be
defined as follows:

a. Death — The irreversible cessation of circulatory and respiratory functions or
the irreversible cessation of functions of the entire brain, including the brain stem. 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 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; or

2) In 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 resorting such


natural functions. In this case, death shall be deemed to have occurred at

the time when these conditions first appeared.

Provided that, the death of the person shall be determined in
accordance with the Brain Death Criteria, as provided by the Philippine
Neurological Association (PNA), which 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 shall determine and establish brain death based on existing
guidelines. The death shall be recorded in the patient’s medical record.

b. Department of Health-Philippine Network for Organ Sharing (DOH-
PhilINOS). — An attached organization of the DOH which facilitates and oversees
organ donation and transplantation involving deceased donors in the country. It
shall serve as the central coordinating body of all deceased organs, tissues, or
corneas donation and transplantation procedures.

c. Donor. — An individual authorized under this Act to donate organs, tissues,
and corneas to a decedent.

d. Hospital — A licensed, accredited, and approved hospital under the law,
which includes, a hospital operated by the Government.

e. Organ Bank Storage Facility — A facility licensed, accredited, or approved
under the law for storage of human bodies or parts thereof.

f. Organ Procurement Organization. - A non-profit, independent or hospital-
based, organization that is duly accredited by the Department of Health (DOH),
composed primarily of transplant coordinators and transplant specialists (internists
and surgeons), who can identify, evaluate, and maintain potential organ donors and
retrieve organs therefrom.

g. Part — Includes transplantable organs, tissues, eyes, bones, arteries, blood,
other fluids and other portions of the human body.

h. Physician or Surgeon — Amedical practitioner who isauthorized to practice
medicine under the laws of the Republic of the Philippines.

i, Portable Organ Perfusion. - A machine in which one donor organ is
connected to receives perfusion and cooling from a special machine perfusion fluid.
The organ is perfused continuously during transport with an oxygenated perfusion


fluid by a membrane pump that pumps perfusion fluid from the container, into the
organ’s artery and/or portal vein.

j. Transplant Center. — A medical institution with complete transplant facilities
and duly accredited by the Department of Health (DOH).

Sec. 3. Removal of Organ After Death. - The designated physician or surgeon
of a hospital or Transplant Center may, subject to and in accordance with this
section, authorize, in writing, the removal of any part of the body of a person who
has died in the hospital or Center for the purpose of transplantation of the organ to
the body of a living person.

No authority shall be given for the removal of the organ from the body of any
deceased person if:

a) During his lifetime, he has registered an objection to the removal of the

organ from his body after his death, in accordance to Section 4 of this Act;

b) He/she 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 person in need of the same, in accordance with the Opt-In

System provided in Section 5 hereof;

) He/she is below eighteen (18) years of age unless the parent or guardian

has consented to such removal; or

d) He/she is mentally ill, therefore, could not have given a valid consent

during his/her lifetime, unless the parent or guardian has consented to such

removal.

Sec. 4. Opt-Out System—Upon the effectivity of this Act, any person who
objects to the removal of any part or organ from his body after his death may
register his objection, in respect of that organ, with the Department of Health -
Philippine Network for Organ Sharing (PhiINOS), which may be done through the
National Registry or local registries which shall thereafter be established in each
region. Upon the receipt of DOH-PhiINOS of the duly signed written objection, it shall
issue a certification and an opt-out card to the person which shall serve as a proof
that his objection was duly recorded and registered.


The DOH-PhiINOS shall establish and maintain a National Register which shall
contain all Filipino citizens and all Filipinos who opted-out not to donate any organ,
tissue, or cornea after their death. Such register shall be updated real-time.

Any person who has registered his objection with the DOH-PhilNOS in respect
of any organ may withdraw his objection anytime in the prescribed form, as may be
determined by the DOH-PhiINOS. Upon receipt of the withdrawal of a person, the
DOH-PhiINOS shall issue the person an acknowledgement in the prescribed form and
shall immediately remove the objection from the National Register.

Section 5. Opt-In System. —Upon the effectivity of this Act, any natural-born
Filipino who has lost his or her citizenship and obtained citizenship in another
country, but who is a resident of the Philippines, and who desires to donate his or
her organ, may register such desire, in respect of that organ, with the Department
of Health - Philippine Network for Organ Sharing (PhiINOS), which may be done
through the National Registry or local registries which shall thereafter be established
in each region. Upon the receipt of DOH-PhiINOS of the duly signed written opt-in, it
shall issue a certification and an opt-in card to the person which shall serve as a
proof that his or her desire was duly recorded and registered.

The DOH-PhiINOS shall establish and maintain a National Register which shall
contain all such persons who opted-in to donate any organ, tissue, or cornea after
their death. Such register shall be updated real-time.

Any person covered by this Sectionwho has registered his or her opt-in with
the DOH-PhiINOS, in respect of any organ, may cancel his or her registration
anytime in the prescribed form, as may be determined by the DOH-PhiINOS. Upon
receipt of the cancellation of a person, the DOH-PhiINOS shall issue the person an
acknowledgement in the prescribed form and shall immediately remove his or her
name from the National Register.

Sec. 6. Proposed Recipients of Organs. - In the selection of a proposed
recipient of any organ removed pursuant to Section 4 of this Act, the following
circumstances shall be considered:

a. A person who has not registered any objection at any given time with the

DOH-PhilNOS in respect of any organ shall be prioritized;


b. A person who has registered his objection with the DOH-PhiINOS, in
respect of any organ, but who has withdrawn such objection shall have
priority over a person who has registered such objection; and

c. A person who has registered his objection with the DOH-PhilNOS shall be

given least priority.

Sec. 7. Roles and Functions of the DOH-PhiINOS. - In addition to the roles
and functions of the DOH-PhiINOS, as provided by DOH Administrative Order No.
2010-0018, DOH Administrative Order No. 2010-0019, and other laws, rules, and/or
regulations, it shall have the following roles and functions:

a. Act as the central coordinating body to ensure that all donor organs,

tissues, and cornea are allocated according to established criteria;

b. Implement the policies on deceased donor allocation;

c. Maintain a National Registry and local registries in each region, with

computer-based database and linked toTransplant Centers, to include:

(i) Registry of all kidney transplants performed in the country;

(ii) Registry of all Filipino citizens, in coordination with the Philippine
Statistics Authority (PSA) and Civil Registry Offices;

(iii) Registry of all Filipinos seeking organ, tissues, and corneas transplant;
and

(iv) Registry of all Filipinos who opt not to donate any organ, tissue, or
cornea, as prescribed in Section 5 of this Act; and

d. Such other roles and functions, as may be deemed necessary by the DOH.

Provided that, the DOH-PhilINOS shall operate in coordination with Organ
Procurement Organizations, duly accredited by the DOH.

Sec. 8. Organ Donation Ethics Committee Every Hospital and Transplant
Center,shall designate an organ donation ethics committee to ensure that the rights
and welfare of the organ donors and their families are protected.

Sec. 9. Persons Authorized to Perform the Removal and Transplant of Organs,
Tissues, and Corneas. — Only authorized physicians or surgeons in a hospital or
Transplant Center shall remove and/or transplant any organ which is authorized to
be removed and/or transplanted pursuant to this Act.Provided that, the removal of
corneal tissues shall be performed only by ophthalmic surgeons and ophthalmic


technicians trained in the methodology of such procedure and duly certified by the
accredited National Association of Ophthalmologists.

Sec. 10. Transport of Donated Organs, Tissues, and Corneas. — In order to
maintain the quality and integrity of an organ for transplantation, to ensure
traceability, and to minimize any potential risk, it is vital that donor organs and their
accompanying blood and tissue samples are packaged, labelled, and transported to
the Transplant Center appropriately, and in a timely manner through portable organ
perfusion machines.

Sec. 11. PhilHealth Assistance. — Organ transplantation, under this Act, shall
be covered by the Philippine Health Insurance Corporation (PhilHealth). Provided
that, the assistance given by Philhealth shall be determined through fair and
transparent assessment process.

Sec. 12. Prohibited Acts. - The following acts shall be prohibited:

a. Selling of Organs. To enter into a contract or arrangement under which a

person agrees, for valuable consideration, whether given or to be given to

himself or to another person, to the sale or supply of any organ, tissue or
cornea from his body or from the body of another person, whether before or
after his death or the death of the other person, as the case may be;

b. Buying of Organs. 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 removal and/or transplantation of an unauthorized

person. To remove and / or transplant any organ, tissue or cornea of a

person without an authorized physician or surgeon;

d. Advertising and promoting buying and selling of organs. No person shall

issue or cause to be issued any advertisement relating to the buying or selling

of any organ, tissue or cornea in the Philippines; and

e. Destroying, forging, mutilating, and altering registries. To willfully destroy,

forge, mutilate, or make any unauthorized alteration in any of the registries of

the DOH-PhilNOS.

Sec. 13. 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 (P1,000,000.00) 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. 14. Education and Information Campaign on Organ Donation. - In order
that the public shall obtain the maximum benefits from this Act, the DOH, in
cooperation with institutions, such as the National Kidney and Transplant Institute
(NKTI), civic and non-government health organizations and other health related
agencies, involved in the donation and transplantation of human organs, shall
undertake public education and information campaign program on organ donation
and transplantation.

Sec. 15. Implementing Rules and Regulation. — Within ninety (90) days after
the effectivity of this Act, the Secretary of Health, in coordination with the National
Kidney and Transplant Institute (NKTI) and other medical and healthcare
professionals, in government, private, and non-governmental health organizations
shall promulgate such rules and regulations as may be necessary and proper to
implement this Act.

Sec. 16. Appropriation. - The amount of Four Hundred Million Pesos
(P400,000, 000.00) shall be appropriated for the management and implementation of
this Act which shall be included in the General Appropriations Act (GAA).

Sec. 17. 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. 18. 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.


1 Sec. 19. Effectivity. — This Act shall take effect after fifteen (15) days

2 following the completion of its publication either in the Official Gazette or in a
3 newspaper of general circulation in the Philippines.
4 Approved,