FOURTEENTH CONGRESS OF THE REPUBLIC) 
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OF THE PHILIPPINES 
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First Regular Session 
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Introduced by Senator Miriam Defensor Santiago 
EXPLANATORY NOTE 
The Constitution, Article 2, Section 13 provides that: 
"The State shall establish and maintain an effective fdod and drug 
regulatory system and undertake appropriate health manpower development and 
research, responsive to the country's health needs and problems." 
Republic Act No. 6675, also known as 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 term, may have different active ingredients. 
This bill aims to establish therapeutic equivalence requirements for the generic drugs, in 
order to ensure that the drug products with similar generic name also contain the same chemical 
components responsible for the claimed therapeutic effect.* 
' This bill was re-filed during the Thirteenth Congress, First Regular Session 


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FOURTEENTH CONGRESS OF THE REPUBLIC) 
OF THE PHILIPPINES 
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First Regular Session 
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S. No. 
Introduced by Senator Miriam Defensor Santiago 
AN ACT 
TO ESTABLISH THERAPEUTIC EQUIVALENCE REQUIREMENTS 
FOR GENERIC DRUGS 
Be it enacted by the Senate and House OfRepresentatives ofthe Philippines in Congress 
assembled: 
SECTION 1. Short Title. -This Act shall be known as the “Generic Drug Uniformity Act 
of 2007.’’ 
SECTION 2. Declaration of Policy. - It is the policy of the State to ensure safe and good 
quality of dnigs, and regulate their production, in order to protect the health of the consumer. 
SECTION 3. De)nitioi? of Terms. - For purposes of this Act, the term: 
(A) “Generic Drugs’’ means drugs not covered by patent protection and which are labeled 
solely by their international non-proprietary or generic name. 
(B) “Generic Name or Generic Terminology” means 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. 
(C) “Active Ingredient” means the chemical component responsible for the claimed 
therapeutic effect of the pharmaceutical product. 
(D) “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. 
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(E) “Core List” is a list of drugs that meets the health care needs of the majority of the 
population. 
(F) “Coinplementary List” is a list of alternative drugs used when there is no response to 
the core essential drug or when there is a hypersensitivity reaction to the core 
essential drug or when, for one reason or another, the core essential drug cannot be 
given. 
(G) “Drug Establishment” means any organization or company involved in the 
manufacture, importation, repacking andor distribution of drugs or medicines. 
SECTION 4. Therapeutic Equivalence. - A drug is the therapeutic equivalent of a drug 
listed in the essential drugs list or National Drug Formulary when, with respect to the listed 
drug- 
(A) 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 cornpendial or other applicable standard, except that it may differ in shape, 
scoring, configuration, packaging, expiration time or labeling; 
(B) It is expected to have the same clinical effect and safety profile when administered to 
patients under conditions specified in the labeling; and 
(C) 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 paragraphs (A), (B) and (C), with respect to an 
essential drugs list, the Department of Health Secretary shall include in the approval of the 
application for the drug that it is the therapeutic equivalent the listed drug involved. 
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 therapeutic equivalent of the 
listed drug involved. 
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SECTION 6. Separability Clause. - If any provision or part hereof, is held invalid or 
unconstitutional, the remainder of the Act or the provision not otherwise affected shall remain 
valid and subsisting. 
SECTION 7. Repeuling 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 8. Effectivity Clause. - This Act shall take effect fifteen (15) days after its 
publication in at least two (2) newspapers of general circulation. 
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Approved, 
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