THIRTEENTH CONGRESS OF THE REPUBLIC) 
OF THE! PHILIPPINES 
1 
5 
28 P232 
First Regular Session 
1 
. 
i
.
.
,
 
! .  
. 
Introduced by Senator Miriam Defensor Santiago 
EXPLANATORY NOTE 
The Constitution provides that: 
Article 2, Section 15. The State shall protect and promote the right to 
health of the people and instill health consciousness among them. 
Article 13, Section 11. The State shall adopt an integrated and 
comprehensive approach to health development -xxx- There shall be 
priority for the needs of the underprivileged sick, elderly, disabled, 
women, and children. 
Annually, at least 1 billion people worldwide contract one of eight sexually transmitted 
diseases (STDs) - chlamydia, gonorrhea, syphilis, trichomoniasis, hepatitis B, herpes, human 
immunodeficiency virus (HIV), and human papilloma virus. Of these, hepatitis B, herpes, HIV, 
and human papilloma virus are incurable and represent two-thirds of the new infections. 
STDs impose high human costs in pain, diminished quality of life, disability, and 
mortality. In women, STDs other than HIV can produce infertility, cancers, and numerous 
pregnancy-related complications including ectopic pregnancy, spontaneous abortion, and 
stillbirth Passed to a fetus or infant, these infections can cause low birthweight, pneumonia, 
neurologic damage, and congenital abnormalities. These infections also substantially enhance 
susceptibility to HIV infection. 
Biologically and socially, women are more vulnerable to STDs than men. Many STDs 
~ 
are transmitted more easily from 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 1990% topical microbicides have attracted scientific attention as a 
possible new technology for preventing STDs, including HIV. Like today's spermicides, 
microbicides would be used vaginally by women to help protect themselves, their partners, and 
their infants from the sexual transmission of HIV and other STD pathogens. These compounds 


could be formulated in a number of ways - as a gel, film, sponge or time-released capsule - and 
could he used in addition to condoms or as an alternative when condom use is not possible. 
The social, health, and economic bhdens of STDs are especially severe for developing 
countries such as the Philippines. Among women ages 15-49 in developing countries, STDs 
represent the second largest cause of mortality and disability. Only two maternal causes, that is, 
immediate complications of pregnancy and childbirth, rank higher. This hill seeks to facilitate 
the development of microbicides to prevent the transmission of STDs. 


THIRTEENTH CONGRESS OF THE REPUBLIC) 
OF THE PHILIPPINES 
First Regular Session 
Introduced by Senator Miriam Defensor Santiago 
AN ACT 
TO FACILITATE THE DEVELOPMENT OF MICROBICIDES 
TO PREVENT SEXUALLY TRANSMITTED DISEASES 
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 as the “Microbicides Development 
Act of 2005.” 
SECTlON 2. Definition of Terms. - As used in this Act, the term: 
(a) “Microbicides” -refers to agents that destroy microbes, such as antiseptic. 
(b) “STD” - refers to any sexually transmitted disease, and includes chlamydia, 
gonorrhea, syphilis, trichomoniasis, hepatitis B, herpes, human immunodeficiency 
virus (HIV) (which includes acquired immune deficiency syndrome or AIDS), and 
human papilloma virus. 
(c) “ D O H  - refers to the Department of Health. 
(e) “Secretary” - refers to the DOH Secretary 
SECTION 3. Microbicides For Preventing Transmission of Sexually Transmitted 
Diseases. - 
(1) Expansion of Activities. - The Secretary shall expand, intensify, and 
coordinate the activities of the DOH with respect to research on the development of 
microbicides to prevent the transmission of STDs, including HIV. 
(2) Coordination. - The Secretary shall coordinate the activities under subsection 
(1) as outlined in subparagraph (3)(a) among all appropriate government agencies and 
components of the DOH to the extent such government agencies and components have 
responsibilities that are related to the development of microbicides 


(3) Program for Microbicide Development. - In carrying out subsection (l), the 
DOH shall establish a program to support research to develop microhicides that can 
substantially reduce transmission of sexually transmitted infections. Activities under such 
subsection shall provide for an expansion and intensification of the conduct and support 
of - 
(a) basic research on the initial mechanisms of infection by sexually 
transmitted pathogens; 
(b) development of appropriate animal models for evaluating safety and 
efficacy of microhicides; 
(c) development of mucosal delivery systems; 
(d) research on approaches to the design of contraceptive and non- 
contraceptive microbicides; 
(e) clinical trials; and 
(0 behavioral research on use, acceptability and compliance with 
microbicides. 
(4) Implemeniafzon Plan. - The Secretary, in coordination with the Philippine 
Council for Health Research and Development as described in subsection (2), shall 
develop and implement a plan to ensure that the research programs described in 
paragraph (3)(a) are implemented in accordance with a plan for such programs. Such plan 
shall include the comments of the Secretary and shall include, hut not be limited to, the 
following information: 
(a) Description of plan and objectives with respect to microbicides 
research. 
(b) Description of the agencies involved and their role in microbicides 
research. 
(c) Capacity of such agencies to conduct microbicides research as 
described in (3)(a). 


(d) Description of grant and contract mechanisms available to facilitate 
microbicides research, including grant and contract mechanisms, support for 
preclinical product development and clinical trial capacity. 
(e) Description of the plan for increasing number of investigators in this 
area of research. 
(5) Public Comment. - The Secretary shall develop a mechanism to provide the 
public, including non-profit private entities concerned with microbicides research, 
opportunities to submit comments on the plan, including provisions relating to the 
selection of products for clinical evaluations. 
SECTION 4. Reports to Congress. -The 
Secretary shall submit, not later than one year 
after the date on enactment, and annually thereafter, a report that describes the activities of the 
DOH, under the research programs referred to in subsection (3), that shall include - 
(a) a description of the research plan with respect to microbicides research 
prepared under subsection (4); 
(b) an assessment of the development, revision, and implementation of such plan; 
(c) a description and evaluation of the progress made, during the period for which 
such report is prepared, in the research on microbicides; 
(d) a summary and analysis of expenditures made, during the period for which the 
report is made, for activities with respect to microbicides conducted and supported by the 
DOH; and 
(e) such comments and recommendations as the Secretary considers appropriate. 
SECTION 5. Coordination. - The Secretary, to the extent practicable, shall consult with 
the Director for the National Center for Disease Prevention and Control and Director for the 
Philippine Health Research and Development in developing the plan under subparagraph (4) for 
research on microbicides that takes into consideration research on STDs and microbicides carried 
out at the National Center for Disease Prevention and Control and Philippine Health Research 
and Development. 


. -  
SECTION 6. Implementing Agency. - The Secretaj is hereby authorized and directed to 
adopt a system to implement and carry out the provisions of this Act. The DOH shall, within 
sixty (60) days from the effectivity of this Act, promulgate rules and regulations, including those 
of disciplinary nature, to carry out and enforce the provisions of this Act. 
SECTION 7. Coordinating Agency. - The Philippine Council for Health Research and 
Development is hereby authorized to assist the DOH in conducting the research for microbicides. 
SECTION 8. Appropriations. - Such sums as may be necessary to carry out this program 
are hereby authorized to he appropriated from the National Treasury. 
SECTION 9. SeparubzZiiy Clause. - If any provision, or part hereof, is held invalid or 
unconstitutional, the remainder of the law or the provision shall remain valid and subsisting. 
SECTION 10. Repealing Clause. - Any law, presidential decree or issuance, executive 
order, letter of instruction, administrative order, rule or regulation contrary to or inconsistent 
with the provisions of this Act is hereby repealed, modified or amended accordingly. 
SECTION 11. Eflecfivity Clause. -This Act shall take effect fifteen (15) days after its 
publication in at least two (2) newspapers of general circulation. 
Approved,