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Republic of the Philippines © are. 13 DEC 2017
HOUSE OF REPRESENTATIVES TIME: ap

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Quezon City BY:
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SEVENTEENTH CONGRESS "e €
‘Second Regular Session
House BILL No889°

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 cloning, 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

+ http://www.explorestemcells.co.uk/historystemceliresearch.html
 http://www.philstar.com/headlines/2016/01/29/1547448/4-philippine-hospitals-can-perform-stem-cell-procedures


‘such as adult bone marrow, peripheral blood, umbilical cord, and, the most
controversial of all, embryos.?

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.

43
Luis fa \Y” F. VILLAFUERTE, JR.

3 Available URL: http://www.cancer.ca/en/cancer-information/diagnosis-and-treatment/stem-cell-transplant/harvesting-
stem-cells/2region=on

a fertilized egg grows into a blastula (~100 cells) which only survive for a short time before it must be implanted in a
womb. (https://www.eurostemcell.org/embryonic-stem-cell-research-ethical-dilemma)


Republic of the Philippines
HOUSE OF REPRESENTATIVES,
Queson City

SEVENTEENTH CONGRESS
Second Regular Session

6890

HOUSE BILL NO.

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 will 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 growth 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 of
the 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 shall 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 ceftified 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 detailed 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 Ethics Committee
(NTEC)

2. Vice-chairperson — Director of Phil.FDA

3. Members:
a. Representative from a government health facility or organization;
b. Representative from a private health facility or organization;
c. 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. —
a. 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.

b. 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.:

. Genetically altered human adult stem cells for human treatment;
Genetically altered human umbilical cord stem cells for human treatment;
Adipose (Fat) derived human stem cell;

. 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.

aONs


c. Registered and Permitted — the following stem cell preparations 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. Adult human 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
compatibility testing, if used allogeneically, 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 (PhP10,000,000.00) out of any appropriated funds in the National
Treasury for such initial requirements for the implementation of this Act.

SECTION 10. Repealing Clause. — All laws, 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,