THJRTEENTH CONGRESS OF THE REPUBLIC ) 
OF THE PHILIPPINES 
1 
First Regular Session 
1 
S E N  
f
a
 
t.) 
S. B. 
Introduced by Senator Miriam Defensor Santiago 
EXPLANATORY NOTE 
The Constitution, Article 2, Section 13 provides that: 
The State shall establish and maintain an effective food and drug regulatory 
system and undertake appropriate health manpower development and research, 
respoxsive to he<&ntry’s health needs and problems. 
Republic Act No. 6675 a k a .  the “Generics Act of 1998” requires the use of generic 
terminologies in prescription of drugs. However, such requirement is not sufficient as drugs, 
having the same generic tenn, may have different active ingredients. 
This bill aims to establish therapeutic equivalence requirements for the 
order to ensure that the drug products with similar generic name also contain 
components responsible for the claimed therapeutic effect. 


THIRTEENTH CONGESS OF THE REPUBLIC 
) 
OF THE PHILIPPNES 
) 
First Regular Session 
1 
I *  
SEN 
S. B. 
“I 
Introduced by Senator Miriam Defensor Santiago 
AN ACT 
TO ESTABLISH THERAPEUTIC EQUIVALENCE REQUIREMENTS FOR GENERIC 
DRUGS 
Be it enacted by the Senate and House of Representatives of the Philippines in Congress 
assembled: 
SECTION 1. Short Title. - This Act shall be known as the “Generic Drug Uniformity 
Act.” 
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.- - 
SECTION 2 
Declaration 
of 
Policy 
- It is the policy of the State to 
ensure safe and good quality of drugs, and regulate their production, in order to protect the health 
of the consumer 
(1) “Generic Drugs” are drugs not covered by patent protection and which 
SECTION 3. DejXtion ofTevms. - For purposes of this Act, the term: 
e labeled 
1. . 
solely by their international non-proprietary or generic name. 
(2) “Generic Name or Generic Terminology” is the identification of drugs and medicines 
by their scientifically and internationally recognized active ingredients or by their official generic 
name as determined by the Bureau of Food and Drugs of the Department of Health. 
(3) “Active Ingredient” is the chemical component responsible for the claimed 
therapeutic effect of the pharmaceutical product. 
(4) “Essential Drugs List” or “National Drug Formulary” is a list of drugs prepared and 
periodically updated by the Department of Health on the basis of health conditions obtaining in 
the Philippines, as well as on internationally accepted criteria. It shall consist of a core list and a 
complementary list. 


(5) “Core List” is a list of drugs that meets the health care needs 
.
.
 . 
population. 
(6) “Complementary List’’ is a list of alternative drugs used when 
the core essential drug or when there is a hypersensitivity reaction to the core essential drug 01 
when, for one reason or another, the core essential drug cannot be given 
(7) “Drug Establishment” means any organization or company involved in the 
manufacture, importation, repacking and/or distribution of drugs or medicines 
SECTION 4. Therapeutic Equivalence. - A drug i s  the therapeutic equivalent of a drug 
listed in the essential drugs list or National Drug Formulary when, with respect to the listed 
drug- 
(1) all of its active ingredients are the same, it is of the same dosage form, it has the same 
route of administration, it is identical in strength or concentration, and it meets the same 
compendia1 or other applicable standard, except that it may differ in shape, scoring, 
configuration, packaging, expiration time or labeling; and 
7.- 
1- 
(2) it is expected to have the same clinical effect and safety profile when administered to 
patients under conditions specified in the labeling; and 
(3) it either does not present a known or potential bioequivalence problem and meets an 
acceptable in vitro standard or if it does present such a problem, is shown to meet an appropriate 
bioequivalence standard. 
If a drug meets the requirements of subsections (l), (2) and (3), with res ect to an 
essential drugs list, the Department’ of Health Secretary shall include in the appr Val ‘of the 
application for the drug that it is the therapeutic equivalent the listed drug involved. (I 
SECTION 5. Licensing of Drug Establishment. - When the Secretary approves an 
application for the licensing of drug establishments, he shall include in such approval a finding 
that the drug for which the application is approved is or is not the therapentic equivalent of the 
listed drug involved. 


SECTION 6. Sepavability Clause. - If any provision or part hereof, is held invalid or 
unconstitutional, the remainder of the Ad or the provision not otherwise affected shall remain 
valid and subsisting. 
SECTION 7. Repealing Clause. - Any law, presidential decree or i ssuanc 1, executive 
order, letter of i nstruction, administrative order, rule o r  r egulation contrary t 0, or inconsistent 
with the provisions of this Act is hereby repealed, modified or amended accordingly. 
SECTION 8. Effeecthdjp Clause. - This Act shall take effect fifteen (15) days after its 
publication in at least two (2) newspapers of general circulation. 
Approved. 
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