Republic of the Philippines 
HOUSE OF REPRESENTATIVES 
Quezon City, Metro Manila 
Eighteenth Congress 
Third Regular Session 
HOUSE BILL NO._________ 
Introduced by Representative Jocelyn Sy Limkaichong 
EXPLANATORY NOTE 
This bill seeks to improve the access to and delivery of safe and effective 
biologicals and vaccines to the Filipino people and support the creation of a 
local biologicals and vaccines development and manufacturing ecosystem in the 
country. 
Section 15, Article II of the 1987 Constitution provides: 
“Section 15. The State shall protect and promote the right to 
health of the people and instill health consciousness among them.” 
Vaccines underpin prevention and control of major infectious diseases 
across the world. Vaccines are biological medicines that prevent disease by 
showing the body how the disease-causing agent looks like and train the 
immune system to create antibodies. Over the past hundred years, together with 
antibiotics, vaccines have extended human lifespans and have led to eradication 
of disease like smallpox. Generations of children have been spared from 
lifetime disability due to polio, disfigurement from measles, and death from 
rabies, because of vaccination. 
Biologicals, including vaccines, antibodies, anti-toxins, anti-venoms, and 
sera, are highly sophisticated and resource-intensive products that can sustain 
entire economic sectors. Programs like the Expanded Program on Immunization 
(EPI) of the Department of Health have already influenced human development 
on a massive scale by ensuring survival of Filipino children to adulthood. By 
June 4, 2021
11:35 am
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these reasons alone, domestic biological research and production in the 
Philippines should have been initiated. A more recent and still evolving reason 
pushes further why local biological manufacturing is imperative to control 
pandemics. Biological products against the “severe acute respiratory syndrome 
coronavirus 2” or SARS-CoV 2 will help the restoration of social and economic 
activities disrupted by the pandemic. However, countries with local capacity to 
produce vaccines and other biologicals are expected to prioritize domestic 
demand over exporting to other countries like the Philippines. COVID-19 is 
upon us but this scourge will not be the last nor will it be the worst. It is thus 
vital that a domestic biological and vaccine production ecosystem is established 
in the Philippines not only for the current pandemic response but more 
importantly, to prepare for the next one.  
Yet for all the necessity of making biologicals for our own use here in the 
country, headwinds in the form of regulatory policy, market competition, and an 
anti-science culture have derailed past efforts and continue to pose risk to 
initiatives. Making biologicals here in the Philippines for Filipinos requires a 
community of researchers, engineers, health professionals, managers, and 
decision-makers. Great patience and persistence are needed through the long 
planning and execution period. Deep pockets are needed to finance the billions 
of pesos necessary to build just one manufacturing facility. The partnership of 
the public and private sectors is needed to make products that require complex 
technology, significant resources, and specialized safety and security measures.  
A State policy supporting biological manufacturing and research needs 
not only to provide incentives to innovation but also streamline regulations to 
ensure access by Filipinos to safe and effective goods.  By encouraging the 
industrial ecosystem and aligning public sector demand, biological and vaccine 
manufacturing can finally be established in the Philippines, thus, provide 
another pillar of economic activity.  This helps assure national security, and 
more importantly, provides Filipinos a better quality of life by protecting them 
from disease. 
In accordance with the State policy of protecting and promoting the right 
to health of the people, the approval of this measure is earnestly sought. 
JOCELYN SY LIMKAICHONG 


Republic of the Philippines 
HOUSE OF REPRESENTATIVES 
Quezon City, Metro Manila 
Eighteenth Congress 
Third Regular Session 
HOUSE BILL NO._________ 
Introduced by Representative Jocelyn Sy Limkaichong 
AN ACT 
PROVIDING FOR THE DEVELOPMENT OF LOCAL BIOLOGICALS 
MANUFACTURING 
CAPABILITY, 
ESTABLISHING 
FOR 
THE 
PURPOSE 
THE 
PHILIPPINE 
BIOLOGICALS 
AUTHORITY, 
DEFINING ITS POWERS AND FUNCTIONS, AND APPROPRIATING 
FUNDS THEREFOR  
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 “Biologicals 
Development Act.” 
SEC. 2.  Declaration of Policy. – It is the policy of the State to improve 
the access to and delivery of safe and effective biologicals and vaccines to the 
Filipino people.  Towards this end, the State shall adopt measures to support the 
development of a local biologicals and vaccines manufacturing ecosystem, 
streamline regulations, and ensure compliance with international safety 
standards of biologicals and vaccines. 
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SEC. 3. Objectives. – This Act has the following objectives: 
a) 
Support human resource development for biologicals and vaccines 
technology and related fields; 
b) 
Encourage and support local research on biologicals and vaccines; 
and 
c) 
Provide incentives for the local manufacture of biologicals and 
vaccines by Filipino companies. 
SEC. 4. Definition of Terms. – As used in this Act: 
a) 
Biological refers to a substance that is produced by or extracted 
from a biological source that needs for its characterization and the 
determination of its quality a combination of physical-chemical-biological 
testing together with the production process and its control; also refers to 
products or preparations containing the said substance as an active ingredient; 
b) 
Biosafety refers to containment principles, technologies, and 
practices that are implemented to prevent unintentional exposure to pathogens 
and toxins or their accidental release from a laboratory or similar facility; 
c) 
Biosecurity refers to institutional and personal security measures 
designed to prevent the loss, theft, misuse, diversion, or intentional release of 
pathogens and toxins from a laboratory or similar facility; 
d) 
Biotechnology refers to any technological application that uses 
biological systems, living organisms, or derivatives thereof, to make or modify 
products or processes for specific use; 


e) 
Vaccine refers to a biological preparation that improves immunity 
to a particular disease that contains an agent that resembles a disease-causing 
microorganism, and is often made from weakened or killed forms of the 
microbe, its toxins, its surface proteins, or its genetic material; and 
f) 
Vaccine technology refers to any technological application to make 
vaccines including genetic engineering, cell and tissue culture, chemical 
engineering, and packaging and materials technology. 
SEC. 5. Philippine Biologicals Authority. – There is hereby established a 
body to be known as the Philippine Biological Authority, hereinafter referred to 
as the Authority, that shall oversee an ecosystem conducive to the development 
of the Philippine biologicals industry.  The Authority shall be attached to the 
Department of Science and Technology (DOST) for policy and program 
coordination.  Its principal office shall be in Metro Manila, but it may establish 
other branches or offices elsewhere in the Philippines as may be necessary or 
proper for the accomplishment of its purposes and objectives. 
SEC. 6. Powers and Functions. – In furtherance of the objectives of this 
Act, the Authority shall exercise the following powers and functions: 
a) 
Create a long-term Philippine Biologicals Development Plan and 
update it accordingly; 
b) 
Create a research agenda for biologicals and vaccines; 


c) 
Develop and prescribe policies and standards for biologicals and 
vaccines research and manufacturing including biosecurity and biosafety, for 
recommendation to appropriate government implementing agencies; 
d) 
Coordinate and facilitate technology transfer from technology 
owners and research institutions to local institutions and manufacturers; 
e) 
Enter into, make and execute contracts and agreements of any kind 
or nature related to the implementation of this Act; 
f) 
Acquire or obtain from any governmental authority whether 
national or local, foreign or domestic, or from any person, corporation, 
partnership, association or other entity, such charters, franchises, licenses, 
rights, privileges, assistance, financial or otherwise, and concessions as are 
conducive to, and necessary or proper for the attainment of its purposes and 
objectives; 
g) 
Outsource services, activities, projects, and programs to capable 
third-party providers; and 
h) 
Exercise all the powers necessary to attain the objectives of this 
Act. 
SEC. 7. Board of Administrators. – The powers of the Authority shall be 
exercised, and all its activities and properties shall be controlled by a Board of 
Administrators, hereinafter referred to as the Board. 
The Board is composed of the following: 
a) 
Secretary of Science and Technology, as ex-officio chairperson; 


b) 
Secretary of Health, as ex-officio co-chairperson; 
c) 
Permanent representatives of the following government offices: 
1) 
Department of Trade and Industry; and 
2) 
Department of National Defense. 
d) 
Permanent representatives of the following industries or sectors: 
1) 
One (1) researcher from an academic or research institution 
engaged in biotechnology, vaccine technology, virology, or 
related fields;  
2) 
One (1) licensed clinician providing vaccination services; 
and  
3) 
One (1) members from the pharmaceutical industry 
belonging to Filipino companies. 
The members representing the sectors or industries shall be appointed by 
the President of the Philippines upon recommendation of the Secretary of 
Science and Technology. 
The appointive members of the Board shall have a term of four (4) years.  
The Board shall meet regularly at least once a month or more often as the 
exigencies of the service demand. The presence of at least four (4) members 
shall constitute a quorum, and the majority vote of the members present, there 
being a quorum, shall be necessary for the adoption of any resolution, decision, 
or any other act of the Board.  For expediency, virtual meetings may be held in 
lieu of face-to-face meetings. 


The members of the Board are entitled to receive a per diem for every 
meeting actually attended subject to the pertinent laws, rules and regulations on 
compensation, honoraria and allowances. 
SEC. 8. Powers and Functions of the Board. – The Board shall exercise 
the following powers and functions: 
a) 
Define and approve the policies, plans, strategies, programs, 
procedures and guidelines for the Authority in accordance with its purposes and 
objectives, and to control the management, operation and administration of the 
Authority; 
b) 
Approve the Authority’s organizational structure, staffing pattern, 
operating and capital expenditure, and financial budgets in accordance with 
pertinent laws; 
c) 
Appoint, transfer, promote, suspend, remove or otherwise 
discipline any subordinate officer or employee of the Authority, upon 
recommendation of the Director General; 
d) 
Create such committee or committees and appoint the members 
thereof, as may be necessary or proper for the management of the Authority or 
the attainment of its purposes and objectives; 
e) 
Determine the research priorities of the Authority consistent with 
the framework of its purposes and objectives and in coordination with other 
government agencies; and 


f) 
Exercise other powers and functions and perform other acts as may 
be necessary or proper for the attainment of the purposes and objectives of the 
Authority.  
SEC. 9. Director General and Other Officers. – The Authority is headed 
by a Director General who shall be appointed by the President of the Philippines 
upon recommendation of the Secretary of Science and Technology.  The 
Director General shall have a term of six (6) years. 
The Director General shall be assisted by such Deputy Director 
General(s), program managers, and coordinators as the Board may determine to 
carry out the purposes and objectives of this Act. 
SEC.  10. Powers, Functions and Duties of the Director General. – The 
Director General shall exercise the following powers, functions and duties: 
a) 
Supervise and direct the management, operation and administration 
of the Authority; 
b) 
Execute contracts, including the deeds that may incur obligations, 
acquire and dispose of assets, and deliver documents on behalf of the Authority; 
c) 
Implement and enforce policies, decisions, orders, rules and 
regulations adopted by the Board; 
d) 
Recommend to the Board the Authority’s organizational structure, 
staffing pattern, operating and capital expenditure in accordance with pertinent 
laws; 


e) 
Submit to the Board a quarterly report on the operations of the 
Authority; 
f) 
Submit to the Board an annual budget and such supplemental 
budget as may be necessary for its consideration and approval; and 
g) 
Exercise such other powers and functions and perform [such] other 
acts as may be necessary or proper for the attainment of the purposes and 
objectives of the Authority, or as may be delegated by the President of the 
Philippines. 
SEC. 11. Government Agency Support and Coordination. – The 
Authority may, for the purpose of its research and development activities, 
obtain and secure the services of scholars, scientists, and technical personnel of 
any unit of the DOST, Department of Health (DOH), and other agencies of the 
government. Such personnel may be paid honoraria as may be fixed and 
authorized by the Board following the usual government rules and regulations 
governing honoraria and allowances. The Authority shall also assist, cooperate 
and coordinate with other government agencies, such as the Food and Drug 
Administration and Research Institute for Tropical Medicine of the DOH, 
Philippine Council for Health Research and Development of the DOST, State 
universities and colleges, National Institutes of Health, and the Philippine 
Genome Center for the implementation of the purposes and objectives of this 
Act. 


SEC. 12. Human Resource Development. – The Authority, in pursuit of 
its objectives, shall:  
a) 
Provide for human resource development in the following fields: 
biotechnology and related areas including molecular biology, microbiology, 
virology, chemistry, biosecurity and biosafety, and vaccine technology;  
b) 
Provide funds for scholarships, study grants, training programs and 
short courses, both local and foreign; 
c) 
Support annual conventions and conferences of professionals in the 
field of biotechnology and related areas; 
d) 
Engage Balik scientists and foreign experts following the terms of 
reference and compensation structure of the Balik Scientist Program; and 
e) 
Provide for qualified employees of the Authority and its attached 
units the benefits of Republic Act No. 8439, also known as the “Magna Carta 
for Scientists, Engineers, Researchers and Other S & T Personnel in the 
Government,” or Republic Act No. 7305, also known as the “Magna Carta of 
Public Health Workers,” whichever is applicable. 
SEC. 13. Biologicals and Vaccines Research and Development. – The 
Authority, in pursuit of its objectives, shall:  
a) 
Provide funding for a spectrum of researches, from basic to 
clinical, towards the development of safe and effective biologicals and vaccines; 
b) 
Support research institutions, facilities, and laboratories, in the 
private or government sector, in terms of funding for operations, maintenance, 


research, capacity building, acquisition of equipment, buildings, and other 
capital assets; and 
c) 
Support venues for publication and dissemination of research 
output in the field of biotechnology and related areas. 
SEC. 14. Biotechnology Industrial Parks. – In coordination with the 
Philippine Economic Zone Authority, the Authority shall designate 
biotechnology industrial parks with applicable economic zone privileges, and 
with infrastructure adequate for biosafety and biosecurity global standards. 
SEC. 15. Support for Filipino Biologicals Manufacturers. – The 
following support shall be provided to Filipino biologicals and vaccines 
manufacturers:  
a) 
Financial Incentives – In coordination with the Department of 
Trade and Industry-Board of Investments and the Department of Finance, local 
biological and vaccine manufacturers shall be granted a tax holiday for the first 
five (5) years of their operations covering the following: 
1) 
Income; 
2) 
Import duties on equipment and modular units including 
bioreactors, related materials including active pharmaceutical ingredients, 
reagents, excipients, and preservatives, as well as vials, containers and other 
packaging materials; and  
3) 
Export sales of locally-manufactured biologicals and vaccines, 
whether in bulk or in finished form. 


b) 
Guaranteed Purchase (Filipino First) – Notwithstanding any law 
to the contrary, the DOH and Local Government Units, together with their 
health facilities, offices, and hospitals, shall preferentially purchase first from 
Filipino manufacturers all the vaccines and biologicals required for their 
programs including the Expanded Program on Immunization; Provided, That 
such vaccines and biologicals shall be procured in the most judicious, 
economical, and expeditious manner, and shall be exempted from the provisions 
on bidding process required under Republic Act No. 9184 or the “Government 
Procurement Reform Act” and other relevant laws; Provided further, That in 
case the forecasted demand exceeds the capacity of local production by Filipino 
manufacturers, the balance may be purchased by the DOH and local 
government units from foreign producers. 
c) 
Multi-year Supply Agreement – The DOH and local government 
units, together with their health facilities, offices, and hospitals, may procure 
biologicals and vaccines through negotiated multi-year supply agreements with 
Filipino manufacturers. 
d) 
Technology Transfer – The DOH and the Authority shall undertake 
initiatives to improve the capacity of Filipino manufacturers including acquiring 
biologicals and vaccines production know-how, and license these to Filipino 
manufacturers.  
 
SEC. 16. Biologicals Statistics Database. – In coordination with the 
DOH, the Authority shall: 


a)
Regularly collect and publish domestic vaccination information
including prevalence of vaccination, volume of vaccines purchased and sold, 
and volume of imported and exported vaccines;  
b)
Establish and regularly update a registry of biologicals and
vaccines research institutions, biologicals and vaccines manufacturers, and 
biotechnology industrial parks in the country, including production capacity and 
current status; and 
c)
Establish and regularly update a registry of individuals trained in
biotechnology and related fields including molecular biology, microbiology, 
virology, chemistry, biosecurity and biosafety, and vaccine technology. 
SEC. 17. International Cooperation. – The Authority may enter into a 
memorandum of agreement or memorandum of understanding with 
international partners, upon the approval of the Board. 
SEC. 18. Biologicals Development Fund. – The Biologicals 
Development Fund, hereinafter referred to as the Fund, is created and shall be 
used exclusively to finance activities to achieve the objectives of this Act.  The 
Authority shall administer the Fund following existing government budgeting, 
accounting, and auditing rules and regulations.  
The Fund shall be sourced from the following: 
a)
The amount of Two billion pesos (P 2,000,000,000.00) shall be
appropriated from available funds of the National Treasury not otherwise 
appropriated; 


b) 
Grants, license fees, bequests, and donations consisting of such 
properties, real or personal, including funds and valuable effects or things, as 
may be useful, whether from local or foreign sources: Provided, That 
acceptance of grants, license fees, bequests, and donations from foreign 
governments shall be subject to the approval of the President of the Philippines 
upon the recommendation of the Secretary of Science and Technology; 
c) 
Sub-allotments from other government entities; and 
d) 
A portion of the revenues from excise tax on alcohol, heated 
tobacco products, and vapor products as provided under Subsections B (3) and 
D(3), Section 288-A of Presidential Decree No. 1158, as amended by, among 
others, Republic Act No. 11346 and Republic Act No. 11467, otherwise known 
as the “National Internal Revenue Code of 1997,”  as determined by the 
Secretary of Health upon consultation with the Board.  This allocation is in 
furtherance of the attainment of one of the Sustainable Development Goals, 
specifically ensuring healthy lives and promoting well-being for all at all ages 
by supporting the research and development of vaccines and medicines for the 
communicable and non-communicable diseases.  
 
SEC. 19. Appropriations. – The amount necessary for the initial 
implementation of this Act shall be charged to the current year’s appropriations 
for the Department of Science and Technology and the Department of Health.  
Thereafter, such amount as may be necessary to fund the continued 


implementation of this Act shall be included in the annual General 
Appropriations Act. 
SEC. 20.  Appointment of Board Members. – Within thirty (30) days 
from the approval of this Act, the President of the Philippines shall appoint the 
members of the Board as well as the Director General and Deputy Director 
General(s) of the Authority. 
SEC.  21.  Annual Report. – The Authority shall submit to Congress an 
annual accomplishment report which shall include the status of its priority 
researches and operations, including the disbursements from the Fund. In the 
exercise of its oversight functions, Congress may inquire into the programs of 
the Authority and the disbursements from the Fund. 
SEC.  22. Implementing Rules and Regulations. – Within thirty (30) 
days from the completion of their appointments, the Board shall convene and, in 
collaboration with the Secretary of Science and Technology, formulate the rules 
and regulations necessary for the implementation of this Act.   The 
implementing rules and regulations shall be issued within one hundred twenty 
(120) days from the date of the Board’s initial meeting and shall take effect 
fifteen (15) days after its publication in a newspaper of general circulation. 
SEC.  23.  Separability Clause. – If any provision or part of this Act is 
declared unconstitutional or invalid, the remaining parts or provisions not 
affected shall remain in full force and effect. 


SEC. 24. Repealing Clause. – Subsections B(3) and D(3), Section 288-A 
of the National Internal Revenue Code of 1997, as amended by, among others, 
Republic Act No. 11346 and Republic Act No. 11467, are amended accordingly 
insofar as the Biologicals Development Fund shall be allocated a portion of the 
revenues from excise tax on alcohol, heated tobacco products, and vapor 
products.  
All other laws, decrees, executive orders, rules and regulations, and other 
issuances inconsistent with or contrary to the provisions of this Act are 
repealed, amended or modified accordingly. 
SEC. 25.  Effectivity. – This Act shall take effect fifteen (15) days 
following its publication in the Official Gazette or in a newspaper of general 
circulation. 
Approved,