CONGRESS OF THE PHILIPPINES
FIFTEENTH CONGRESS
First Regular Session

HOUSE OF REPRESENTATIVES

HOUSE BILL No.

Introduced by HONORABLE EUFRANIO C. ERIGUEL, M.D.

EXPLANATORY NOTE
‘The Philippines has become a hub for medical tourism. In the last two years,
an increasing number of foreigners come in solely for stem cell therapy that some
hospitals offer at a cheaper cost than when done outside the country. Stem cell
treatments, a type of regenerative medicine, introduce new cells into damaged

tissue in order to treat a disease or injury Prometheus like. Through rigorous
research on stem cell treatment which was first developed from the findings of
Canadian scientists Emest A. McCulloch and James E. Till in the 1960s,
thousands of patients around the globe have already benefitted from using stem
cell delivered safely by skilled and certified physicians. Diseases once considered
incurable are responding well to stem cell treatment and are restoring hope to

patients who thought they had lost their lives forever.

‘Though the benefits of stem cell treatment are a major breakthrough in the
field of biotechnology, the cost far outweighs its benefits. It is very expensive and
only few physicians are licensed to do the procedure, especially in the Philippines.
At this moment, the full promise of stem cell research remains unknown. There is
much to be learned about its benefits and application in the cure of some of the
most devastating diseases and conditions. It is potentially a cure for a severed
spinal cord, diabetes, Parkinson’s, cancer, heart disease and others.

_ In response, this bill establishes a Stem Cell Research and Storage Center
mandated to conduct stem cell research under established standards of open
scientific exchange, peer review, and public oversight. Aside from this, it seeks to

promote research and human clinical trials using stem cells that are ethically


obtained and show evidence of providing clinical benefit for human patients;
promote the derivation of pluripotent stem cell lines without the creation of human
embryos for research purposes and without the destruction or discarding of, or risk
of injury to, a human embryo.

Such an act will make the country a haven for open scientific inquiry and
technological innovation. The bill will promote investment and generate jobs citing
the experience of other countries. In California alone, the biomedical industry is a
critical component of the state’s economy providing employment in over 2,500
companies to over 225,000 Californians, and pays $12.8 billion in wages and
salaries, investing more than $2.1 billion in research, and reports nearly $7.8
billion in worldwide revenue.

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

* HON. C. ERIGUEL, M.D.



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CONGRESS OF THE PHILIPPINES
FIFTEENTH CONGRESS

First Regular Session

HOUSE OF REPRESENTATIVES

HOUSE BILL No.

Introduced by HONORABLE EUFRANIO C. ERIGUEL, M.D.

AN ACT TO INTENSIFY STEM CELL RESEARCH

AND FOR OTHER PURPOSES

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

Congress assembled:

SECTION 1. Short Title. - This Act may be cited as the “Stem Cell

Therapeutic and Research Act of 2010.”

SECTION 2. Declaration of Policy. - It is the policy of the State to protect
and promote the people's right to life and health. Toward this end, the State
aims to bolster evidence-based research on medicinal interventions and
technology to cure debilitating diseases. This policy is pursuant to
provisions of the 1987 Constitution as follows:

Article II, Section 15, [t]he State shall protect and promote the right

to health of the people and instill health consciousness among them;


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Article XIII, Section 12, {t]he state shall establish and maintain an
effective food and drug regulatory system and undertake appropriate health
manpower development and research responsive to the country's health
needs and problems.

Article XIV, Section 10, [slcience and technology are essential for
national development and progress. The State shall give priority to research
and development, invention, innovation and their utilization...

Article Il, Section 12, [ijt shall equally protect the life of the mother

and the life of the unborn from conception.

SECTION 3. Definition of Terms. For purposes of this Act, the following
terms are defined.

(1) HUMAN EMBRYO: refers to any organism, not protected as a human
subject that is derived by fertilization, parthenogenesis, cloning, or
any other means from one or more human gametes or human diploid
cells,

(2) STEM CELLS - refer to primary cells in the human body from which
all other tissues “stem” from, They are programmed in the laboratory
to potentially become any other kind of cell. As unspecialized cells, it
can self-renew indefinitely and also differentiate into more mature
cells with specialized functions and which could be used to repair
damaged tissues and replace diseased organs.

(3) EMBRYONIC STEM CELLS - refer to the primitive type of cell that can
be coaxed into developing into any of the 220 types of cells found in

the human body (e.g. blood cells, heart cells, brain cells, nerve cells,


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etc). They are derived from embryos that develop from eggs that have
been fertilized in vitro and not from a woman’s body.

(4)ADULT STEM CELLS - refer to undifferentiated cells found

throughout the body that divide to replenish dying cells and
regenerate damaged tissues. It is also known as somatic stem cells.

(5) INDUCED PLURIPOTENT STEM CELLS - refer to specially treated
ordinary cells -- e.g. skin cells -- that are specially processed to exhibit

some of the properties of embryonic stem cells.

Section 4. Stem Cell Research and Storage Center. - A Stem Cell
Research and Storage Center is hereby established under the direct
supervision of the Department of Health through the Secretary. It shall
conduct and support basic and applied research to develop techniques for
the isolation, derivation, production, testing, and human Clinical use of stem
cells that may result in improved understanding of or treatments for
diseases and other adverse health conditions, including pluripotent stem
cells that have the flexibility of embryonic stem cells, prioritizing research
with the greatest potential for near-term clinical benefit in human patients,
provided that such isolation, derivation, production, testing, or use will not
involve the following:

(1) the creation of a human embryo for research purposes;

(2) the destruction of or discarding of, or risk of injury to, a living

human embryo; or
(3) the use of any stem cell, the derivation or provision of which

would be inconsistent with the standards established.


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Section 5. Guidelines - Not later than 90 days after the date of the
enactment of this Act, the Secretary shall issue guidelines to carry out
Section 4. Such guidelines shall, as appropriate, take into consideration
guidelines on human stem cell research developed by nationally and

internationally recognized scientific organizations.

Section 6. Reporting Requirements - (a) The Secretary shall annually
prepare and submit to the appropriate committees of the Congress a report
describing the activities carried out under this law during the preceding
fiscal year, and including a description of whether and to what extent stem
cell research has been conducted.

(b) The Secretary shall also submit to the Congress a report outlining
the number of research proposals that were peer reviewed, a summary and
detailed list of all such research proposals that were not funded, and an
explanation of why the proposals did not merit funding. ;

(c) The Head of the Bureau of Food and Drugs should keep the head of
the Stem Cell Research and Storage Center informed of the types of human
stem cell and related research that would facilitate the evaluation of the

safety or effectiveness of drugs, devices, and biological products.

Section 7. Public Disclosure - The Director of the center created for this
purpose shall publish the guidelines issued and keep a public website which

shall be constantly updated to reflect the researches done.

Section 8. Appropriations. Such sums as may be necessary for the initial

implementation of this Act shall be taken from the current appropriations of


the DOH. Thereafter, the fund necessary to carry out the provisions of this

Act shall be included in the annual General Appropriations Act.

Section 9. Effectivity Clause. - This Act shall take effect fifteen (15) days

afler its publication in two (2) national newspapers of general circulation.

Approved,