SIXTEENTH CONGRESS OF THE REPUBLIC 
OF THE PHILIPPINES 
Second Regular Session 
SENATE 
S.No. 
2382 
) 
) 
) 
Introduced by Senator Miriam Defensor Santiago 
AN ACT 
'14 
AUG 27 P 3 :.46 
TO LAUNCH A NATIONAL STRATEGY TO SUPPORT REGENERATIVE 
MEDICINE THROUGH FUNDING FOR RESEARCH AND COMMERCIAL 
DEVELOPMENT OF REGENERATIVE MEDICINE PRODUCTS AND 
DEVELOPMENT OF A REGULATORY ENVIRONMENT THAT ENABLES RAPID 
APPROVAL OF SAFE AND EFFECTIVE PRODUCTS 
EXPLANATORY NOTE 
The Constitution, Article 2, Section 15 provides: 
SEC. 15. The State shall protect and promote the right to health of 
the people and instill health consciousness among them. 
According to the U.S. Department of Health and Human Services, the potential 
benefits of regenerative medicine in improved health care and economic savings are 
enormous. 'Regenerative medicine products reportedly have been effective in the 
treatment of numerous diseases such as diabetes, spinal cord injury, heart disease, stroke, 
and various forms of cancer. 
The Alliance for Regenerative Medicine in the U.S. said "Regenerative medicine 
represents the single most promising new approach to mitigating the human and 
economic costs of disease, and changing the course of human health." 
I-Ience, this bill seeks to establish a national strategy to support regenerative 
medicines and a Regenerative Medicine Coordinating Council within the Department of 
Health, Office of the Secretary.l 
~~~;~ 
p' MIRlAM DEiE~SOR SANTI/GO 
1 This bill was originally filed by Ms. Degette and Mr. Paulsen in the U.S. House of 
Representatives (I-I.R. 4494; 113'h Congress, Second Session). 
1 


SIXTEENTH CONGRESS OF THE REPUBLIC 
OF THE PHILIPPINES 
Second Regular Session 
SEN~'I.E 
S.No. 
~a82 
) 
) 
) 
Introduced by Senator Miriam Defensor Santiago 
·14 
AUG 27 P 3 :46 
Be it enacted by the Senate and the House of Representatives of the Philippines in 
Congress assembled: 
1 
AN ACT 
2 
LAUNCHING A NATIONAL STRATEGY TO SUPPORT REGENERATIVE 
3 
MEDICINE THROUGH FUNDING FOR RESEARCH AND COMMERCIAL 
4 
DEVELOPMENT OF REGENERATIVE MEDICINE PRODUCTS AND 
5 
DEVELOPMENT OF A REGULATORY ENVIRONMENT THAT ENABLES RAPID 
6 
APPROVAL OF SAFE AND EFFECTIVE PRODUCTS 
7 
SECTION 1. Short Title. ~ This Act shall be known as the "Regenerative 
8 
Medicine Promotion Act." 
9 
SECTION 2. Report on Ongoing Government Programs and Activities Regarding 
10 
Regenerative Medicine. ~ Not later than six months after the date of effectivity of this 
11 
Act, the Secretary of Health (referred to as the "Secretary") shall provide for the" 
12 
completion, and submission to the Congress, of a report identifying all ongoing 
13 
government programs and activities regarding regenerative medicine. 
14 
SECTION 3. Establishment of Regenerative Medicine Coordinating Council. ~ 
15 
(a) Establishment. ~ The Secretary shall establish, within six months of the 
16 
enactment of this Act, in the Office of the Secretary, a Regenerative Medicine 
17 
Coordinating Council (referred to as the "Council"). 
18 
(b) Composition. ~ The Council shall be composed of the following: 
19 
(1) The Secretary of Trade and Industry 
20 
(2) The Secretary of Defense. 
21 
(3) The Secretary of Health. 
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1 
(4) The Secretary of Budget and Management. 
2 
(5) The Administrator of Philippine Veterans Affairs Office 
3 
(6) The Administrator of Food and Drugs. 
4 
(7) The Director of the National Institutes of Health. 
5 
(8) The members appointed by the Secretary under subsection (d). 
6 
(c) Chair. - The Secretary of Health shall be the Chair of the Council. 
7 
(d) Members Appointed by Secretary. - The Secretary shall appoint at least five 
8 
persons to serve as members of the Council under paragraph (b )(8). The members of the 
9 
Council appointed shall include persons with expertise in third-party payment, 
10 
regenerative medicine researchers from academic institutions, patient advocates, persons 
11 
with expertise in drug discovery, persons with expertise in drug development, persons 
12 
with expertise in basic research, persons with expertise in translational research, persons 
13 
with expertise in medical device development, persons with expertise in biomaterials, 
14 
clinicians, and persons with expertise in clinical research. 
15 
(e) Functions. - The Council shall consult with, and provide information to, the 
16 
Secretary of Health for purposes of implementing any recommendations in the report 
17 
required by Section 2; 
18 
(I) consult with, and provide information to, the Secretary of Health for 
19 
purposes of implementing any recommendations in the report required by Section 
20 
2' , 
21 
(2) prepare, and keep up-to-date, a national strategy to support research into 
22 
regenerative medicine and the development of drugs, biological products, medical 
23 
devices, and biomaterials for use in regenerative medicine; 
24 
(3) prepare a plan specifying priorities for research into regenerative 
25 
medicine; 
2 


, 
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1 
(4) not later than one year after the date of effectivity of this Act, establish 
2 
priorities for the award of grants under Sections 4 and 5 (relating to grants for 
3 
basic or preclinical research into regenerative medicine and for development of 
4 
drugs, biological products, medical devices, and biomaterials for use in 
5 
regenerative medicine, respectively); 
5 
(5) identifY sources of funding for research into regenerative medicine; 
7 
(6) identifY areas where such funding is inadequate; 
8 
(7) 
make 
recommendations 
regarding policies 
that will 
support 
9 
development and marketing of regenerative medicine products; 
10 
(8) facilitate development of consensus standards regarding scientific issues 
11 
critical to regulatory approval of regenerative medicine products; and 
12 
(9) determine the need for establishing centers of excellence or consortia to 
13 
further advance regenerative medicine. 
14 
(f) Transparency; Reporting Requirements. -
.15 
(1) Transparency. - The Council shall adopt procedures to ensure the 
15 
receipt of public input, such as holding public stakeholder meetings or creating 
17 
advisory boards. 
18 
(2) Annual Reports. - The Council shall submit an annual report on its 
19 
activities to the Congress, the Director of the National Institutes of Health, and the 
20 
Administrator of Food and Drugs. Each such report shall: 
21 
(A) provide details on progress in meeting goals identified by the 
22 
Council for regenerative medicine; 
23 
(B) make recommendations regarding funding, regulatory, or other 
24 
policies to achieve regenerative medicine goals identified by the Council; 
25 
(C) identify all regenerative medicine products currently on the 
25 
market and those in development; 
3 


1 
(D) identify regenerative medicine research and technological 
2 
advances and discoveries that occurred in the previous year; and 
3 
(E) assess the impact of regenerative medicine on the country's 
4 
economy, including with respect to: 
. 5 
(i) the number of people employed in companies or research 
6 
institutions working in regenerative medicine; 
7 
(ii) the number of companies pursuing regenerative medicine 
8 
products; 
9 
(iii) increases in tax revenues; and 
10 
(iv) the impact on national health spending. 
11 
SECTION 4. Grants for Basic or Preclinical Research into Regenerative 
12 
Medicine. -
13 
(a) Grants For Basic or Preclinical Research. - The Secretary may make grants to 
14 
eligible entities for the purpose of funding basic or preclinical research into regenerative 
15 
medicine. 
16 
(b) Conditions. - The Secretary may make a grant under this section for research 
17 
only if: 
18 
(1) the research is carried out directly by the grant recipient; 
19 
(2) the research is partly funded by one or more private entities; and 
20 
(3) the amount of the grant does not exceed the total amount provided for 
21 
the research by private entities (other than the grant recipient itself). 
22 
(c) Terms and Conditions. - A grant may be made on such terms and conditions as 
23 
the Secretary determines appropriate. 
24 
(d) Priority. - In awarding grants, the Secretary shall take into consideration the 
25 
priorities established by the Regenerative Medicine Coordinating Council under Section 
26 
3(e). 
4 


" 
, " 
1 
SECTION 5. Grants for Development of Drugs. Biological Products, Medical 
2 
Devices, and Biomaterials for Use in Regenerative Medicine. -
3 
(a) Grants For Drug Development. - The Secretary may make grants to eligible 
4 
entities for the purpose of funding projects that have as their aim -
5 
(1) the research and development of drugs, biological products, medical 
6 
devices, and biomaterials for use in regenerative medicine; and 
7 
(2) the making of an investigational new drug application with respect to 
8 
such drugs or biological products, or the making of an investigational device 
9 
exemption application with respect to such devices, by not later than the end of the 
10 
4-year period beginning on the date on which such grant is made. 
11 
"Eligible entity" means a collaborative partnership including a qualified non-profit . 
12 
entity or an institution of higher education; and a for-profit entity. 
13 
(b) Terms and Conditions. - A grant under this Section may be made on such 
14 
terms and conditions as the Secretary determines appropriate. 
15 
(c) Priority. - In awarding grants nnder this Section, the Secretary shall take into 
16 
consideration the priorities established by the Regenerative Medicine Coordinating 
17 
Council under Section 3(e). 
18 
SECTION 6. Authorization of Appropriations. - To carry out the provisions of 
19 
this Act, there are authorized to be appropriated such sums as may be necessary for each 
20 
fiscal year. 
21 
SECTION 7. Separability Clause. - If any provision or part hereof, is held invalid 
22 
or unconstitutional, the remainder of the law or the provision not otherwise affected shall 
23 
remain valid and subsisting. 
24 
SECTION 8. Repealing Clause. - Any law, presidential decree or issuance, 
25 
executive order, letter of instruction, administrative order, rule or regulation contrary to 
5 


, ' 
, , ' 
1 
or is inconsistent with the provision of this Act is hereby repealed, modified, or amended 
2 
accordingly. 
3 
SECTION 9. Effectivity Clause. - This Act shall take effect fifteen (15) days after 
4 
its publication in at least two (2) newspapers of general circulation. 
Approved, 
/fldp20aug20 14 
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