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Republic of the Philippines
HOUSE OF REPRESENTATIVES,
Que3on City

EIGHTEENTH CONGRESS,
First Regular Session

HOUSE BILL No.2 754

Introduced by HON. LUIS RAYMUND “LRAY” F. VILLAFUERTE, JR.

EXPLANATORY NOTE

In the year 1978, stem cells were discovered. Despite the controversies
marring its earlier development including coining, embryo harvesting, and fabricated
research, stem cell science has become the standard of care in certain procedures
that require the natural creation of new cells such as bone marrow transplants and
spinal cord rehabilitation, *and some forms of cancer. The past decade has seen this
new branch of science effective in treating stroke, autism, Parkinson's disease,
disease, 3" degree burns, spinal injuries and other ailments both common and rare.
Diseases, like Parkinson's, once thought incurable, are now possible thanks to stem
cell treatment. Stem cell research has become a major breakthrough in the field of
biotechnology and its applications remain inexhaustible.

To date, stem cell treatment is offered only in four hospitals in the Philippines.
*Moreover, the cost of the treatment is staggering. Hence, promise of stem cell
treatment as a common procedure remains unknown. There is much to be learned
from its benefits, how it may be applied to other “incurable diseases" as viable
treatment and rehabilitation. It would need more intensive research, including clinical
trials, and funding for the fledgling practice to grow. With the proper government
intervention, stem cell practice may be enhanced and made accessible to the public.

However, Philippine society must also remain guarded against the rapid
proliferation of clinics, and establishments falsely offering stem cell products and
procedures. This can cause possible negative effects of untested and unregulated
Practice. There is also the question of retaining ethical integrity when practicing stem
cell treatment and harvesting. Stem cells can be harvested from a variety of sources
such as adult bone marrow, peripheral blood, umbilical cord, and, the most
controversial of all, embryos. ?

* http://www.explorestemcells.co.uk/historystemcellresearch.html
* http://www philstar.com/headlines/2016/01/29/1547448/4-pilippine-hospitals-can-perform -stem-cell-proced ures
{Available URL: http://www.cancer.ca/en/cancer-information/diagnosis-and-treatment/stem-cell-

transplant/harvestingstem-cells/?region=on a fertilized egg grows into a blastula (“100 cells) which only survive for a


Stem cells harvested from embryos have the capability of transforming
and multiplying into the most number of cell types known to man. The more
cell types a stem cell can transform into, the more viable it is in treating various
diseases. However, they are also harvested from the blastula, one of the
earliest stages of human life.* Because of where it is harvested from and the
controversy surrounding it, embryonic stem cells are discouraged and outright
banned in some countries but we do not have such regulations here. Hence,
there is a need for the government to regulate stem cell research and those
involved in its practice.

This bill seeks to intensify stem cell research and therapy in the
Philippines. The bill intends to establish a Bioethics Advisory Board (BAB) to
formulate the ethical standards that will guide the Institutional Review
Committee. The Board shall be responsible for addressing contentious ethical,
scientific, and legal issues in stem cell and cell-based research and therapies.
Under this bill, stem cell research and therapies shall undergo IRC approval in
accordance with the guidelines of the Department of Health (DOH) in the
manual of Standard Operating Procedures for Hospital Ethics Review
Committees.

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

LUIS JUNI RAY” F, VILLAFUERTE, JR.

short time before it must be implanted in @ womb. (https://www.eurastemecell.org/embryonic-stem-cell-research-
ethical-ilemma)


Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

EIGHTEENTH CONGRESS
First Regular Session

House BILL No. 1762

Introduced by HON. LUIS RAYMUND “LRAY” F. VILLAFUERTE, JR.

AN ACT
INTENSIFYING STEM CELL RESEARCH AND THERAPY IN THE PHILIPPINES
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 and cited as the "Stem Cell
Research and Therapy Act of 2017."

SECTION 2. Declaration of Policy. — It shall be the policy of the State to protect and
promote the people's right to life and health. For this purpose, the State shall intensify
human stem cell research on medical interventions that are evidence-based under an
effective food and drug regulatory system which wili undertake appropriate health
manpower for research and development responsive to the country's health needs and
problems essential for national development and progress. As such, priority will be
given to research and development, and invention, innovation and utilization without
Prejudice to the human embryo.

SECTION 3. Scope and Coverage. — The provisions of this Act shall apply to all
government and private facilities that are and will be involved in the use of human stem
Cell and cell-based therapies.

SECTION 4. Definition of Terms. — For the purpose of this Act, the following terms and
Phrases shall have the following definitions:

1. Adverse Event — a noxious and unintended response suspected or
demonstrated to be cause by the collection or infusion of a cellular therapy
product or by the product itself.

2. Allogeneic — refers to cells obtained from a donor and intended for infusion
into a genetically distinct recipient.


3. Autologous — refers to cells obtained from a patient and intended for
infusion into a patient.

4. Bioethics Advisory Board (BAB) — the national body to examined the
scientific, ethical, legal, and social issues arising from biomedical research
and development and recommends policies on stem cell and cell-based or
cellular research and therapies in the Philippines.

5. Cellular Therapy — the administration of products with the intent of providing
effector cells in the treatment of disease or support of other therapy.

6. Clinical Laboratory —a facility where tests are done on specimens from the
human body to obtain information about the health status of a patient for the
prevention, diagnosis and treatment of diseases. The tests include, but are
not limited to, the following disciplines: clinical chemistry, hematology,
immunohetamatology, molecular biology and cytogenetics. The total testing
process includes pre-analytical, analytical and post-analytical procedures.
Facilities that are involved in the pre-analytical processes such as collection,
handling or preparation of specimens or act as a mailing or distribution
center such as in a laboratory network or system are also considered to be
a part of a clinical laboratory.

7. Donor — a person who is the source of cells or tissue for a cellular therapy
product.

8. Expansion — refers to growih of one or more cell populations in an in vitro
culture system.

9, Facility — a location where activities covered by these Standards are
performed. Such activities include determination of donor eligibility
suitability, product collection, processing, storage, distribution, issue and
administration. A facility, under this Act may be any or all of the following:

a. Collection Facility — an entity providing the service of cellular therapy
product collection.

b. Processing Facility — a location where cellular therapy product
processing activities are performed in support of the Clinical Program.

C. Storage Area/Facility — an entity holding a cellular therapy product
for future processing, distribution or administration.

10.Genetic Manipulation — refers to an ex vivo procedure(s) that genetically
alters cell populations. A significant stem cell manipulation involves any
process that alters the biological and/or physiological characteristics of cells
or tissues including introduction of viral genes and other genetic processes
that Incorporate exogenous genetic material into the genome ofthe recipient
cells.

12.Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
— articles containing or consisting of human cells or tissues that are intended
for implantation, transplantation, infusion or transfer into a human recipient.

13. Institutional Reviews Committee (IRC) — a Committee established by an
institution in accordance with the regulations of the relevant governmental


agency to review biomedical and behavioral research that involves human
subjects and is conducted at or supported by that institution

14.Philippine Food and Drug Administration (Phil. FDA) — the agency of DOH
In the Philippines charged With the regulation of stem cell and cell-based or
cellular products,

15.Prohibited — refers to procedures, preparations or products that shall not be
allowed or permitted for development or commercial use without exemption.
These are banned or forbidden by law.

16.Restricted — refers to procedures, preparations or products that shail note
allowed unless a prior regulatory approval is obtained. These are controlled
by law or rules and limited to authorized activities. These are stem cell
products that have genetic manipulation.

17. Registered and Permitted — refers to procedures, preparations and products
allowed to be in trade by the Phil. FDA, and in facilities with prior DOH
accreditation. These are certified officially and legally by the government
office for specific activities. These are stem cell products that do not have a
genetic manipulation.

18.Standard Operating Procedures (SOP) — refers to a compilation of written
policies and detail instructions required to perform the defined activities of
the accredited facilities.

19.Stem Cell — undifferentiated cells from multicellular organisms that have the
capacity to divide and differentiate into different types of cells found in the
body.

SECTION 5. Bioethics Advisory Board. — Health facilities engaged in stem cell and
cell-based or cellular therapies shall comply with the guidelines set by BAB.
a. The Board Shall be comprised of, but not limited to, the following:

1. Chairperson — Secretary of Health / National Transplant
Fthics Committee (NTEC)

2 Vice-chairperson — Director of Phil. FDA

3. Members:
a. Representative from a goverment health facility or organization;
b. Representative from a private health facility or organization;
¢. Academicians, researchers, local and international experts.

b, The Board shall be responsible in formulating the ethical standards which shall
guide the IRC that shall be created in hospitals and other health facilities using
human stem cell and cell-based or cellular therapies.

c. The Board shall be responsible in addressing contentious ethical, scientific and
legal issues in stem cell and cell-based or cellular research and therapies.

SECTION 6. Institutional Review Committee (IRC). — Stem cell and cell-based or
cellular research and therapies shall undergo IRC approval in accordance with the
current guidelines set by DOH in the manual of "Standard Operating Procedures for


Hospital Ethics Review Committees". The Committee shall be responsible for reviewing
and verifying the following:

a. Ethical aspect of the research and therapy;

b. Scientific rationale, design and data collection on safety and efficacy of stem
cell and cell-based or cellular therapy programs;

c. Assurance and certification that the institution or clinical laboratory does not
carry out activities or programs involving the Prohibited Stem Cells specified in
Section 7 (a) of this Act;

d. Documentation and reporting of adverse events observed in patients receiving
stem cell and cell-based or cellular treatments.

SECTION 7. Prohibited Restricted and Permitted Activities for Stem Cell Preparation
and Therapy. —
b. Prohibited — The following stem cell preparations and therapies shall
be prohibited from creation, importation, promotion, marketing and
use.

1 Creation of human embryos for research purposes;

2 Human embryonic stem cells and their derivatives for human
treatment and research;

3 Aborted human fetal stem cells and their derivatives for human
treatment and research;

4. Plant parts labeled as stem cells.

c. Restricted — The following stem cell preparation and therapies shall
not be allowed for importation, promotion, marketing and use in
humans without prior regulatory application and approval from
Phil.FDA.:

1 Genetically altered human adult stem cells for human
treatment;

2 Genetically altered human umbilical cord stem cells for human
treatment;

3. Adipose (Fat) derived human stem cell;
4 Any human cells, tissues, and cellular and tissue-based
products
(HTC/Ps) that are subjected to genetic manipulation, as defined in Section
4 of this Act;
5 Live animal (xenobiotic) embryonic, fetal or adult stem cells in
parenteral form for human administration

d. Registered and Permitted — the following stem cell preoarations and
therapies may be performed only in health facilities accredited by
DOH.


1. Adult Human stem cells (autologous) — extracted from the
same patient. It may undergo basic processing (including
separation, fractionation, primary culture, expansion) but
without genetic modification

2 Adulthuman stem cells (allogeneic) — extracted from a human
donor. It may be followed by basic processing including
separation, fractionation, primary culture, expansion) but
without genetic modification. It requires Human Leukocyte
‘Antigen (HLA) compatibility testing and infectious screening as
is used with organ transplants or blood transfusions.

3. Human umbilical cord stem cells — Includes stem cells derived
trom umbilical cord blood and other stem cells derived from
umbilical cord, placenta and placental membrane extracted at
time of birth. It may be followed by basic processing (including
separation, fractionation, primary culture, expansion) but
without genetic modification. It requires HLA’ cotnpalibilily
testing, if used aliogeneically, and infectious screening as is
used with organ transplants or blood transfusions.

SECTION 8. Implementing Rules and Regulations. — Within ninety (90) days from
effectivity of this Act, the Department of Health shall formulate the Implementing Rules
and Regulations.

SECTION 9. Appropriations. — There is hereby appropriated the amount of Ten Million
Pesos (PhP 10,000,000.00) out of any appropriated funds in the National Treasury for
‘such initial requirements for the implementation of this Act.

SECTION 10. Repealing Clause. — Ali iaws, decrees, orders, rules and regulations
and other issuances, or parts thereof, which is inconsistent with the provisions of this
Act are hereby repealed or amended accordingly.

SECTION 11. Effectivity. — This Act shall take effect fifteen (15) days following its
publications in two (2) newspapers of general circulation.

Approved,