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SIXTEENTH CONGRESS OF THE REPUI3LIC 
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(~1\hf t,i oj! ;~--FHf',lf\t 
OF THE PI-IlLlPI'INES 
) 
First Regular Session 
) 
SENATE 
S. No. --7--2G-
RE,-' 
-------------------------------------
Introduced by Senator Miriam Defensor Santiago 
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EXPLANATOR Y NOTE 
The Constitution provides: 
Article II, Section 15. The State shall protect and promote 
the right to health of the people and instill health consciousness 
among them. 
Article XIII, Section 11. The Statc shall adopt an integrated 
and comprehensive approach to health development... There shall 
be priority for the needs of the underprivileged sick, elderly, 
disabled, women, and childrcn. 
Annually, at least I billion people worldwide contract one 0(' eight sexuaJJy transmitted 
diseases (STDs) - chlamydia, gonorrhea, syphilis, trichomoniasis, hepatitis B, herpes, human 
immunodeficiency virus (HlV), and human papilloma virus. Of these, hepatitis B, herpes, I-IIV, 
and human papilloma virus are incurable and represent two-thirds of the new infections. 
STDs Impose high human costs in pam, diminished quality of life, disability, and 
mortality. In women, STDs other than IIIV can produce infertility, cancers, and numerous 
pregnancy-related complications including ectopic pregnancy, spontaneolls abortion, and 
stillbirth. Passed to a fetns or infant, these infections can cause low birth weight, pneumonia, 
neurologic damage, and congenital abnormalities. These infections also substantially enhance 
susceptibility to HIV inrection. 
Biologically and socially, women are more vulnerable to STDs than men. Many STDs 
are transmitted more easily ii-om a man to a woman and are more likely to remain undetected in 
women, resulting in delayed diagnosis and treatment, and more severe complications. 


Since the early 1990s, topical microbicidcs have attracted scientific attention as a 
possible new technology for preventing STDs, including mv, Like today's spermicides, 
microbicides would bc used vaginally by women to help protect themselves, their partners, and 
their infants from the sexual transmission of HlV and other STD palhogens. These compounds 
could be formulated in a nUl11ber of ways - as a gel, film, sponge or time-released capsule - and 
COllid be used in mldition to condoms or as an alternative when condom lise is not possible. 
The social, health, and economic blll'dens of STDs are especially severe for developing 
countries such as (he Philippines. Among women ages 15-49 in developing countries, STDs 
represcnt the second largest cause of mortality and disability. Only two maternal causes, that is, 
immediate complications of pregnancy and childbirth, rank higher. This bill seeks to facilitate 
the development of microbicides to prevent the transmission of STDs.! 
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MIRIAM DEFE~OR SANTIAI/;' 
[foIi' 
1 This bill was origimdly filed during the Thirteenth Congress, rirst Regular Session. 
2 


1 
2 
3 
P1'l;ltr 
SIXTEENTH CONGRESS OF THE REPUBLIC 
) 
lrgtf1i"f ~~r tip' :: .... !'f,"'iJ.1r~ 
OF TI-IE PHILIPPINES 
) 
First Regular Session 
) 
'13 
JlIL 1"i f'/i:1 'j 
SENATE 
S.No.-----'l
t 2[i_ 
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Introduced by Senator Miriam Defensor Santiago 
J 
AN ACT 
TO FACILITATE THE DEVELOPMENT OF MICROBlCIDES 
TO PREVENT SEXUALLY TRANSMITTED DISEASES 
Be it enacted by the Senate and the House of Representatives of the Philippines in 
Congress assembled: 
4 
SECTION 1. Short Title. - This Act shall be known as the "Microbicides Development 
5 
Act." 
6 
SECTION 2. D~finition (!fTerl11s. -As used in this Act, the term: 
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(A) 
"Microbicides" mean agents that destroy microbes, slleh as antiseptic. 
8 
(8) 
"STD" means any sexually transmitted disease, and includes chlamydia, 
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gonorrhea, syphilis, trichomoniasis, hepatitis 13, herpes, human immunodeficiency virns (mV) 
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(which includes acquired immuno defIciency syndrome or AIDS), and human papilloma virus. 
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(C) 
"DOl-I" means the Department of Heaith. 
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(D) 
"Secretary" means the Secretary of Health. 
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SECTION 3. Microbicides for Prevenling 7/'ansmission of ,)'exually Transmilled 
14 
Diseases. -
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(A) 
Expansion of Activities. - The Secretary shall expand, intensify, and coordinate 
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the activities of the DOH with respect to research on the development of'microbicides to prevent 
17 
the transmission or STDs, including ]-IIV. 


1 
(B) 
Coordination. - The Secretary shall coordinate the activities under subsection (1\) 
2 
as outlined in subparagraph (C)(I) among all appropriate government agencies ancl components 
3 
of the DOH to thc extent such government agencies and components have responsibilities that 
4 
are related to the development of microbicides. 
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(C) 
Program for Microbicide Development. - In carrying out subsection (I), the DOH 
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shall establish a program to support research to develop microbicicles that can substantially 
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reduce transmission of sexually transmittecl infections. Activities under such subsection shall 
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provide for an expansion and intensification ofthe conduct and support of--
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(1) Basic research on the initial mechanisms of infection hy sexually transmitted 
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pathogcns; 
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(2) Development of appropriatc animal models for evaluating safety and emcacy 
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of mierobicidcs; 
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(3) Development of mucosal delivery systems; 
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(4) Research on approaches to the design of contraceptive and non-contraceptive 
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l1licrobicidcs; 
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(5) Clinical trials; and 
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(6) Behavioral research on use, acceptability and compliance with microbicides. 
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(D) 
Implementation Plan. - The Secretary, in coordination with the Philippine Council 
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for Health Research and Development as described in subsection (B), shall develop and 
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implement a plan to cnsure that the research programs described in paragraph (C) (I) are 
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implemented in accordance with a plan for such programs. Such plan shall include the comments 
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of the Secretary and shall include, but not be limited to, the following information: 
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(1) Description of plan and objectives with respect to microbicides research. 
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(2) Description of the agencies involved and their role in microbieides research. 
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(3) Capacity of such agencies to conduct microbicides research as described in 
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(CN). 
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(4) Description of grant and contract mechanisms available to facilitate 
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microbicides research, including grant and contract mechanisms, support for 
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preclinical product development and clinical trial capacity. 
2 


2 
3 
(E) 
(5) Description of the plan for increasing number of investigators in this area of 
research. 
Public COillmcnt. - The Secretary shall develop a mechanism to provide the 
4 
public, including non-profit private entities concerned with microbic ides research, opportunities 
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to submit comments on the plan, including provisions relating to the selection of products for 
6 
clinical evaluations. 
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SECTION 4. Reports to Congress. -The Secretary shall submit, not later than one year 
8 
aftcr the date of enactment of this Act, and annually thereafter, a report that describes the 
9 
activities of the DOH, under the research programs referred to in Section (3)(C), that shall 
10 
include-
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(A) 
A description of the research plan with respect to microbicides research prepared 
12 
under Section (3)(D); 
13 
14 
(8) 
(C) 
An assessment of the development, revision, and implementation of such plan; 
Description and evaluation of the progress made, during the period for which such 
15 
report is prepared, in the research on microbicides; 
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(D) 
A summary and analysis of expenditures made, during the period for which the 
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report is made, [or activities with respect to microbicides conducted anel supported by the DOH; 
18 
ami 
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(E) 
Such comments anel recommendations as the Secretary considers appropriate. 
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SECTION 5. Coordinatiol1. - The Secretary shall consult with the Director for the 
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National Center for Disease Prevention and Control and Director for the Philippine Health 
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Research and Development in developing the plan under Section 4 for research on microbicides 
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that takes into consideration research on STDs and microbicides carried out at the National 
24 
Center for Disease Prevention and Control and Philippine Health Research and Development. 
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SECTION 6. Implementing Agency. - The Secretary is hereby authorized and directed to 
26 
adopt a system to implement and carry out the provisions of this Act. The Secretary shall, within 
3 


sixty (60) days from the effectivity of this Act, promulgate rules and regulations, including those 
2 
of disciplinary nature, to carry out ancl enforce the provisions ofthis Act. 
3 
SECTION 7. Coordinating Agency. - The Philippine Council for Hcalth Research and 
4 
Development is hereby authorized to assist the DOH in conducting the research for microbicides. 
5 
SECTION 8. Appropriations. - Such sums as may be necessary to carry out this program 
G 
are hereby authorized to be appropriated ii'om the National Treasury. 
7 
SECTION 9. Separability Clause. - If any provision or parl hereof is held invalid or 
8 
unconstitutional, the remainder of the law or the provision shall remain valid and subsisting. 
9 
SECTION 10. Repealing Clause. - Any law, presidential decree or issuance, executive 
10 
order, letter of instruction, aciministrative order, rule, or regulatioll contrary to or inconsistent 
11 
with the provisions of this Act is hereby repealed, modified or amended accordingly. 
12 
SECTION II. Effectivity Clause. - This Act shall take effect fifteen (15) clays after its 
13 
publication in at least two (2) newspapers of general circulation. 
A pprovecl, 
4