APPENDIX R

Republic of the Philippines

Second Regular Session

Begun and held in Metro Manila, on Monday, the twenty‐fifth day of July,
nineteen hundred and eighty‐eight

[ Republic Act No. 6675 ]

AN ACT TO PROMOTE, REQUIRE AND ENSURE THE PRODUCTION OF AN ADEQUATE SUPPLY,

Be it enacted by the Senate and House of Representative of the Philippines in Congress assembled:

Sec. 1 Title. ‐ This Act shall be known as the Generics Act of 1988.
Sec. 2 Statement of Policy. ‐ It is hereby declared the policy of the State:
To promote, encourage and require the use of generic terminology in the importation,
manufacture, distribution, marketing, advertising and promotion, prescription and dispensing of
drugs;
To ensure the adequate supply of drugs with generic names at the lowest possible cost
and endeavor to make them available for free to indigent patients;
To encourage the extensive use of drugs with generic names through a rational system or
procurement and distribution;
To emphasize the scientific basis for the use of drugs, in order that health professionals
may become more aware and cognizant of their therapeutic effectiveness, and
To promote drug safety by minimizing duplication medications and/or use of drugs with
potentially adverse drug interactions.
Sec. 3 Definition of Terms. ‐ The following terms are herein defined for purposes of this Act.
1) "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.
2) "Active Ingredient" is the chemical component responsible for the claimed
therapeutic effect of the pharmaceutical product.
3) "Chemical Name" is the description of the chemical structure of the drug or medicine
and serve as the complete identification of a compound.

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4) "Drug Product" is the finished product form that contains the active ingredients,
generally but not necessarilly in association with inactive ingredients.
5) "Drug Establishment" is any organization or company involved in the manufacture,
importation, repacking and/or distribution of drugs or medicines.
6) "Drug Outlets" means drugstores, pharmacies, and any other business
establishments which sell drugs or medicines.
7) "Essential Drugs List" or "National Drug Formulary" is a list of drugs prepared and
periodically updated by the Department of Health on a 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.
8) "Core List" is a list of drugs that meets the health care needs of the majority of the
population.
9) "Complementary 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.
10) "Brand Name" is the proprietary name given by the manufacturer to distinguish its
product from those of competitors.
11) "Generic Drugs" are drugs not covered by patent protection and which are labeled
solely by their international non‐proprietary or generic name.
Sec. 4 The Use of Generic Terminology for Essential Drugs and Promotional Incentives.
(a) In the promotion of the generic names for pharmaceutical products, special
consideration shall be given to drugs and medicines which are included in the
Essential Drugs List to be prepared within one hundred eighty (180) days from
approval of this Act and updated quarterly by the Department of Health on the basis
of health conditions obtaining in the Philippines as well as on internationally
accepted criteria.
(b) The exclusive use of generic terminology for in the manufacture, marketing and sales
of drugs and medicines, particularly those in the Essential Drugs List, shall be
promoted through such a system of incentives as the Board of Investments jointly
with the Department of Health and other government agencies as may be authorized
by law, shall promulgate in accordance with existing laws, within one hundred eighty
(180) days after approval of this Act.

Sec. 5 Posting and Publication. ‐ The Department of Health shall publish annually in at least
two (2) newspapers of general circulation in the Philippines the generic names and the
corresponding brand names under which they are marketed, of all drugs and medicines
available in the Philippines.

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Sec. 6 Who Shall Use Generic Terminology. ‐

(a) All government health agencies and their personnel as well as other government
agencies shall use generic terminology or generic names in all transactions related to
purchasing, prescribing, dispensing, and administering of drugs and medicines.
(b) All medical, dental and veterinary practitioners, including private practitioners shall
write prescriptions using the generic name. The brand name may be included, if so
desired.
(c) Any organization or company involved in the manufacture, importation, repacking,
marketing and/or distribution of drugs and medicines shall indicate prominently the
generic name of the product. In any case of brand name products, the generic name
shall appear prominently and immediately above the brand name in all product
labels as well as in advertising and other promotional materials.
(d) Drug outlets, including drugstore, hospital and non‐hospital pharmacies and non‐
traditional outlets such as supermarkets and store, shall inform any buyer about any
and all other drug products having the same generic name, together with their
corresponding prices so that the buyer may adequately exercise his option.
Within one (1) year after approval of this Act, the drug outlets referred to herein, shall post
in conspicuous places in their establishments, a list of drug products with the same generic
name and their corresponding prices.
Sec. 7 Provision on Quality, Manufacturer's Identity and Responsibility. ‐ In order to assure
responsibility for drug quality in all instances, the label of all drugs and medicines shall
have the following: name and country of manufacture, dates of manufacture and
expiration. The quality of such generically labeled drugs and medicines shall be duly
certified by the Department of Health.

Sec. 8 Required Production. ‐ Subject to rules and regulations promulgated by the Secretary
of Health, every drug manufacturing company operating in the Philippines shall be
required to produce, distribute and make available to the general public the medicines it
produces, in the form of generic drugs.
Sec. 9 Rules and Regulations. ‐ The implementation of the provisions of this Act shall be in
accordance with the rules and regulations to be promulgated by the Department of
Health. Rules and regulations with penal sanctions shall be promulgated within one
hundred eighty (180) days after approval of this Act and shall take effect fifteen (15)
days after publication in the Official Gazette or in two (2) newspapers of general
circulation.

Sec. 10 Authority to Import. ‐ Within three (3) years from the effectivity of this Act, extendible
by the President for another two (2) years and during periods of critical shortage and
absolute necessity, the Department of Health is hereby authorized to import raw
materials of which there is a shortage for the use of Filipino‐owned or controlled drug
establishments to be marketed and sold exclusively under generic nomenclature. The

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President may authorize the importation of raw materials tax and duty‐free. The
Secretary of Health shall ensure that the imported raw materials are allocated fairly and
efficiently among Filipino‐owned or controlled drug establishments. He shall submit to
the Office of the President and to Congress a quarterly report on the quantity, kind and
value of the raw materials imported.
Sec. 11 Education Drive. ‐ The Department of Health jointly with the Department of Education,
Culture and Sports, Philippine Information Agency and the Department of Local
Government shall conduct a continuous information campaign for the public and a
continuing education and training for the medical and allied medical professions on
drugs with generic names as an alternative of equal efficacy to the more expensive
brand name drugs. Such educational campaign shall include information on the illnesses
or symptoms which each generically named drug is supposed to cure or alleviate, as
well as its contraindications. The Department of Health with the assistance of the
Department of Local Government and the Philippine Information Agency shall monitor
the progress of the education drive, and shall submit regular reports to Congress.
Sec. 12 Penalty. ‐
(A) Any person who shall violate Section 6(a) or 6(b) of this Act shall suffer the penalty
graduated hereunder, viz.:

(a) For the first conviction, he shall suffer the penalty of reprimand which shall be
officially recorded in the appropriate books of the Professional Regulation
Commission.

(b) For the second conviction, the penalty of fine in the amount of not less than two
thousand pesos (P 2,000.00) but not exceeding five thousand pesos (P 5,000.00) at
the discretion of the court.
(c) For the third conviction, the penalty of fine in the amount of not less than five
thousand pesos (P 5,000.00) but not exceeding ten thousand pesos (P 10,000.00)
and suspension of his license to practice his profession for thirty (30) days at the
discretion of the court.
(d) For the fourth and subsequent convictions, the penalty of fine of not less than ten
thousand pesos (P 10,000.00) and suspension of his license to practice his
processions for one year or no longer at the discretion of the court.
(B) Any juridical person who violates Section 6(c), 6(d), 7 and 8 shall suffer the penalty of a
fine of not less than five thousand pesos (P 5,000.00) nor more than ten thousand pesos
(P10,000.00) and suspension or revocation of license to operate such drug
establishment or drug outlet at the discretion of the Court: Provided, that its officers
directly responsible for the violation shall suffer the penalty of fine and suspension or
revocation of license to practice profession, if applicable, and by imprisonment of not
less than six (6) months nor more than one (1) year or both fine and imprisonment at

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the discretion of the Court: and Provided, further, that if the guilty party is an alien, he
shall be ipso facto deported after service of sentence without need of further
proceedings.
(C) The Secretary of Health shall have the authority to impose administrative sanctions such
as suspension or cancellation of license to operate or recommend suspension of license
to practice profession to the Professional Regulation Commission as the case may be for
the violation of this Act.

Sec. 13 Separability Clause. ‐ If any provision of this Act is declared invalid, the remainder or
any provision hereof not affected thereby shall remain in force and effect.
Sec. 14 Repealing Clause. ‐ The provision of any law, executive order, presidential decree or
other issuance's inconsistent with this Act are hereby repealed or modified accordingly.
Sec. 15 Effectivity. ‐ This shall take effect fifteen (15) days after its complete publication in the
official Gazette or two (2) newspapers of general circulation.

Approved.,

Signed Signed
RAMON V. MITRA JOVITO R. SALONGA
Speaker of the House of Representatives President of the Senate

This Act which is a consolidation of Senate Bill No. 453 and House Bill No. 10900 was
finally passed by the Senate and the House of Representatives on August 25, 1988 and August 31,
1988, respectively.

Signed Signed
QUIRINO D. ABAD SANTOS, JR. EDWIN P. ACOBA
Speaker of the House of Representatives Secretary of the Senate

Approved: September 13, 1988

Signed
CORAZON C. AQUINO
President of the Philippines

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