Republic of the Philippines 
HOUSE OF REPRESENTATIVES 
Quezon City 
NINETEENTH CONGRESS 
First Regular Session 
HOUSE BILL NO. ____ 
Introduced by HON. LUIS RAYMUND “LRAY” F. VILLAFUERTE, JR.,  
HON. MIGUEL LUIS R. VILLAFUERTE, HON. TSUYOSHI ANTHONY G. 
HORIBATA AND HON. NICOLAS “NICK” C. ENCISO VIII 
EXPLANATORY NOTE 
Despite the controversies marring the earlier development of stem cells that include 
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,1 and some forms of cancer. 
The past decade has seen this science as effective in treating stroke, autism, 
Parkinson's disease, third-degree burns, spinal injuries, and other ailments both 
common and rare. Stem cell research has become a major breakthrough in the field of 
biotechnology and its applications remain inexhaustible. 
Stem cell treatment is offered in very few hospitals in the Philippines. Moreover, the 
cost of the treatment is staggering. There is much to be learned from its benefits, 
including the manner by which it may be applied as viable treatment. It would need 
more intensive research, including clinical trials, and funding to grow. With the proper 
government intervention, stem cell may be enhanced and made accessible to the 
public. 
The Philippine country also needs to address the proliferation of clinics and 
establishments falsely offering stem cell products and procedures. There is also the 
question of retaining ethical integrity since 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. Hence, there is a need for the government to regulate 
stem cell research and those involved in its practice. 
In view of the foregoing, this bill seeks to intensify stem cell research and therapy in the 
Philippines. It 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 
1 http://www.explorestemcells.co.uk/historystemcellresearch.html 
August 23, 2022
2:00 pm
4022


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 RAYMUND “LRAY” F. VILLAFUERTE, JR.  
MIGUEL LUIS R. VILLAFUERTE   
 
 
 
 
TSUYOSHI ANTHONY G. HORIBATA 
 
 
 
NICOLAS “NICK” C. ENCISO VIII
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Republic of the Philippines 
HOUSE OF REPRESENTATIVES 
Quezon City 
NINETEENTH CONGRESS 
First Regular Session 
HOUSE BILL NO. ____ 
Introduced by HON. LUIS RAYMUND “LRAY” F. VILLAFUERTE, JR.,  
HON. MIGUEL LUIS R. VILLAFUERTE, HON. TSUYOSHI ANTHONY G. 
HORIBATA AND HON. NICOLAS “NICK” C. ENCISO VIII 
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". 
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. 
4022


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, 
immunohematology, 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. 
11. 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. 
12. 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. 
13. 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. 
14. 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. 
15. 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. 
16. 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. 


17. Standard Operating Procedures (SOP) — refers to a compilation of written 
policies and detailed instructions required to perform the defined activities of the 
accredited facilities. 
18. 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; and 
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.: 
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. 
c. 
Registered and Permitted — the following stem cell preparations and therapies 
may be performed only in health facilities accredited by DOH: 
d. 
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. 
e. 
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. 
f. 
Human umbilical cord stem cells — Includes stem cells derived from 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 (Php 10,000,000) 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,