T~IRTEENTH CONGRESS OF THE 
) 
Firgt 
I kegular Session 
RE~YBLIC OF THE PHILIPPINES 
) 
'04 
.iUN 38 
%3 
) 
S E N A T E  
I 
EXPLANATORY 'NOTE 
' 
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In a policy review and program implementation of the Generics Law which was 
the national drug policy of the government conducted by policy experts and 
five (5) component pillars and strategies of implementing the Generics Law, were greatly 
affected because of the lack of administrative and technical capability of the Bureau of 
Food and Drugs (BFAD) to effectively perform its regulatory functions of licensing, 
registration and monitoring. 
to extend to our people safe, effective, affordable and accessible medicines, 
was disclosed that the quality assurance and rational drug use, two of the 
Considered as most crucial to this is its capability to perform bioavailability and 
bfoequivalence tests, which was often raised by multinational companies through the 
Phmaceuticul Healthcare Association of the Philippines (PHAP) and the Philippine Medical 
Association (PMA) as this aspect contributes to the perception of poor quality of generic 
products, The latter has been relentless in challenging BFAD to provide them with 
scientific data such as what these tests can yield to prove that generic drugs are as safe 
and as potent as the tested brand and products that they are using. 
As most of us know, BFAD is,the regulatory agency of the government tasked to 
ensure the quality of medicines and pharmaceuticals, among other products, that are 
made available to the public. Its two main divisions, namely, the Inspection and 
Licensing Division and Laboratory Division are tasked to ensure that before drugs are 
allowed to be circulated for sale to the market, they are cleared up for licensing and 
product registration. Once they are already in the market, monitoring is periodically 
conducted . 
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The critical points in drug quality assurance are the following: (a) Good 
Manufacturing Practices (GMP) as the basis for licensing; (b) Product registration or 
renewal wherein the safety, efficacy and quality of drugs are evaluated and tested; (c) 
Bioavailability and bioequivalence testing of drugs with reported bioavailability 
problems, and; (d) Quality monitoring of products on the market consisting of random 
sampling of drug supply in government facilities, at the drug outlets and on suspected 
drug products submitted by doctors, institutions and consumers. 
If these procedures are strictly and efficiently followed, then quality control by 
BFAD will be sufficient to ensure safety and efficacy. 
is, therefore, a need to transform BFAD into a more and credible 
one whose .integrity and credibility are above reproach and if 
reasonable doubt. To achieve this, it is vital, among other things, 
funding for the agency but more importantly to introduce 


major administrative reforms in BFAD to strengthen the capability of BFADs 
regulatory functions of licensing, registration and monitoring, and more specifically in 
the following aspects (I) Human resources in the field (2) Augmentation of existing 
laboratories and upgrading their equipment (3) Operational budget, and (4) Creation of 
a drug enforcement unit under its operational and administrative control which must 
be made separate and distinct from the Philippine National Police (PNP) whose 
enforcement powers will be strictly limited to the implementation of BFAD’s regulatory 
functions. 
This bill is intended to specifically address these ever-growing and urgent 
concerns and also to continue and conclude previous legislative initiatives to help 
government in its tasks of ensuring an effective drug regulatory system and 
undertaking the appropriate health manpower development and research, responsive 
to the country’s health needs and problems. 
Support for the passage and approval of this bill is thus earnestly sought. 
M A d A  CONSUELO A.S. MADRIGAL 
Senator 
reden/drafks 
bfadbildoc 


THIRTEENTH 
) 
REPUBLIC OF 
) 
’04 JUN 30 P!Q :04 
First Regular Session 
) 
S E N A T E  
S. B. No. 
.c: 1093 
I 
AN ACT 
STRENGTHENING AHE CAPABILITY OF THE BUREAU OF FOOD AND DRUGS 
(BFAD) BY ESTABLI~HING ADEQUATE TESTING LABORATORIES AND FIELD 
OFFICES IN ALL P~OVINCES AND CITIES, UPGRADING ITS EQUIPMENT, 
CREATING A 
UNIT (DEU) UNDER ITS OPERATIONAL 
AND 
AND 
APPROPRIATING 
FUNDS 
THEREFOR 
Be it enacted by the Senate and House of Representatives of the Philippines in Congress 
assembled: 
SECTION 1. Title. - This Act shall be known as the ”BFAD Empowerment Act of 
2004”. 
SEC. 2. Declarytion ofPoZicy. - It is hereby declared a policy of the State to adopt, 
support, establish, institutionalize, improve and maintain structures, processes, 
mechanisms and initiatives that are aimed, directed and designed to (a) protect and 
promote the right to health of the Filipino people, and (b) help 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, Pursuant to this policy, the State must enhance its regulatory capacity and 
strengthen its capability with regard to the licensing, registration and monitoring of 
drugs, food, cosmetics and hazardous substances. 
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SEC. 3. Increased Testing Facilities. - The Department of Health (DOH) is hereby 
mandated to improve, upgrade and increase the capability of the Bureau of Food and 
Drugs (BFAD), to test, assay and examine samples of pharmaceutical, cosmetics and 
food products being applied for registration, as well as monitor pharmaceutical, 
cosmetic and food products already in the market. 
For the purpose of achieving the above mandate, there shall be established at 
least one (1) testing laboratory each in Luzon, Visayas and Mindanao, which shall have 


all the necessary and appropriate state-of-the-art laboratory equipment and personnel 
complement. The main testing laboratory at the Bureau’s central office shall continue to 
be maintained. 
SEC. 4. BFAD’s Regulatory Field Oflces. - The BFAD shall establish field offices in 
all provinces and cities to effectively implement its regulatory functions. The present 
Regional Food and Drug Regulatory Oflce (RFDRO) in every regional office of the DOH 
shall now be put under the BFAD’s sole administrative control. All Regional Food and 
Drug Regulatory Officers (RFDRO’s) shall now be designated as Food and Drug Regulatory 
Officers (FDROs) at-large and shall likewise be under the BFAD’s administrative control. 
The DOH, in collaboration with the BFAD, shall seek the creation of additional plantilla 
positions as may be necessary to support the said BFAD Field Offices, subject to the 
rules and regulations of the Civil Service Commission. 
SEC. 5. Drug Enforcement Unit. - The BFAD shall establish a Drug Enforcement 
Unit (DEU) which will be composed of not less than ten (10) qualified personnel in 
every region and who will be directly under the supervision of the FDRO. They shall 
bear arms, wear official uniforms aqd insignias and shall be classified as law 
enforcement agents. Their authority and functions shall be strictly limited to the 
implementation of BFAD’s regulatory functions. 
SEC. 6. Work Program. - The DOH, the BFAD, the Department of Budget and 
Management and the Department of Finance shall prepare the necessary work 
programs to cover the staggered implementation of this Act for a period not exceeding 
five (5) years. 
SEC. 7. Appropriations. - The appropriations for the BFAD included in the DOH 
under the current General Appropriations Act shall be used to carry out the initial 
implementation of this Act. Thereafter, such sums as may be necessary for its staggered 
implementation shall be included in the annual General Appropriation Act. 
All receipts derived from registration and licensing fees, sale of publications and 
services, assessment, fees, fines, penalties and other fees and charges authorized and 
imposed under this Act are hereby constituted as a special account in the General Fund, 
for the implementation of this Act: Provided, That no amount shall be disbursed to cover 
personal services expenses and purchase of motor vehicles. 


The fund may be augmented by grants, donations and endowments from 
various sources, domestic or foreign, for purposes related to their functions. 
SEC. 8. Implementing Rules and Regulafions. - The DOH, in collaboration with the 
BFAD, shall promulgate the rules and regulations to implement this Act within ninety 
(90) days from the approval of this Act. 
SEC. 9. Separability Clause. - If, for any reasons, any provision or part of this Act 
is declared unconstitutional or invalid, such other parts not affected thereby shall 
remain in full force and effect. 
SEC. 10. Repealing Clause. - AI1 laws, presidential decrees, administrative orders 
and executive issuances or parts thereof inconsistent with the provisions of this Act are 
hereby repealed or modified accordingly. 
SEC. 11. 
Eflectivity. - This Act shall take effect fifteen (15) days after its 
publication in at least two (2) newspaper of general circulation. 
Approved,