Generic-Act-Group-8

GENERIC ACT
OF 1988
(REPUBLIC ACT
NO.6675)
 GENERIC ACT OF 1988 [REPUBLIC ACT NO.
6675]
● AN ACT TO PROMOTE, REQUIRE AND ENSURE
THE PRODUCTION OF AN ADEQUATE SUPPLY,
DISTRIBUTION, USE AND ACCEPTANCE OF
DRUGS AND MEDICINES IDENTIFIED BY THEIR
GENERIC NAMES.
 SECTION 1. Title - This Act shall be known as the Generics Act of 1988
 SECTION 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 endeavour to make them available for free to indigent patients;
• To encourage the extensive use of drugs with generic names through a rational
system of 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 in medications and/or use of drugs
with potentially adverse drug interactions.
 SECTION 3. Definition of Terms - The following terms are herein defined for purposes of
this Act:
a) "Generic Name or Generic Terminology" is the identification of drugs and medicines by their
scientifically and internationally recognize active ingredients or by their official generic name as
determined by the Bureau of Food and Drugs of the Department of Health.
b) "Active Ingredient" is the chemical component responsible for the claimed therapeutic effect of the
pharmaceutical product.
c) "Chemical Name" is the description of the chemical structure of the drug or medicine and serves as
the complete identification of a compound
d) "Drug Product" is the finished product form that contains the active ingredients, generally but not
necessarily in association with inactive ingredients
e) "Drug Establishment" is any organization or company involved in the manufacture, importation,
repacking and/or distribution of drugs or medicines.
f) "Drug Outlets" means drugstores, pharmacies, and any other business establishments which sell
drugs or medicines "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
 SECTION 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 in the basis of health conditions obtaining in the Philippines as well as on internationally
accepted criteria.
b) The exclusive use of generic terminology 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.
 SECTION 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.
 SECTION 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 the 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 drugstores, hospital and non-hospital pharmacies and non-traditional
outlets such as supermarkets and stores, 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.
 SECTION 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.
 SECTION 8. Required Production

 Subject to the 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 medicine it produces, in the form
of generic drugs.
 SECTION 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.
 SECTION 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 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.
 SECTION 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.
 SECTION 12. Penalty
• 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 (P2,000.00) but not exceeding five thousand pesos (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
(P5,000.00) but not exceeding then thousand pesos (P10,000.00) 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 (P10,000.00) and suspension of his license to practice his profession for one year or
longer at the discretion of the court.
 SECTION 12. Penalty (cont’)
● A) Any juridical person who violates Section 6(c), 6(d), 7 or 8 shall suffer the
penalty of a fine of not less than five thousand pesos (P5,000.00) 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 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.
● B) 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.
 SECTION 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
 SECTION 14. Repealing Clause

• The provisions of any law, executive order, presidential decree or other
issuances inconsistent with this Act are hereby repealed or modified
accordingly.
 SECTION 15. Effectivity

• This Act shall take effect fifteen (15) days after its complete publication in
the Official Gazette or two (2) newspapers of general circulation.
THANK
YOU!
GROUP 8

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GENERIC ACT

 SECTION 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

 SECTION 8. Required Production

 SECTION 9. Rules and Regulations

 SECTION 14. Repealing Clause

 SECTION 15. Effectivity

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