}REPUBLIC ACT NO.

6675]

AN ACT TO PROMOTE. REQUIRE AND ENSURE THE PRODUCTION OI AN
ADEQUATE SUPPLY. DISTRIBUTION. USE AND ACCEPTANCE OI
DRUGS AND MEDICINES IDENTIIIED BY THEIR GENERIC NAMES

Section. 1. Title. - This Act shall be known as the Generics Act of 1988.

Sec. 2. Statement of Policv - It 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 free for indigent patients:

To encourage the extensive use of drugs with generic names through a national
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 cognisant of the therapeutic effectiveness:
and:

To promote drug safety by minimizing duplication in 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:

Generic Name or Generic Terminology is the identification of drugs and
medicines by their scientifically and internationally recognized active ingredients or by
their generic names as determined by the Bureau of Iood and Drugs of the Department of
Health.

1. Active Ingredient is the chemical component responsible for the claimed
therapeutic effect of the pharmaceutical product.

2. Chemical Name is the description of the chemical structure of the drugs and
medicine and serves as the complete identification of the compound.

3. Drug Product is the finished product form that contains the active
ingredients. generally but not necessarily in association with inactive ingredients.
Republic Act No. 6675 page 2
4. Drug Establishment is any organization or company involved in the
manufacture. importation. repacking and/or distribution of drugs or medicines.

5. Drug Outlets means drugstores. pharmacist. and any other business
establishment which sell drugs or medicines.

6. Essential Drug List or National Drug Iormulary 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 in the internationally accepted criteria. It shall
consist of a core list or a complimentary list.

7. Core List is the list of drugs that meet the health care needs hundred eighty
days upon the approval of this Act.

8. Complimentary List is a list of alternative drugs used wherein no response to
the core essential drug or where there is hypersensitivity reaction to the core essential
drug or when. for one reason or another. the core essential drugs cannot be given.

9. Brand Name is the proprietary name given by the manufacture to distinguish
its product from those of competitors.

10. Generic Drugs are not covered by the patent protection and which are
labelled solely by their international non-proprietary or generic name.

Sec. 4. The se of Generic Terminologv for Essential Drugs ana 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 Drug List to be prepared within one hundred eighty (180) days from approval of
this Act and updated quarterly by the Department of Health conditions obtaining in the
Philippines as well as in the internationally accepted criteria.

a. The exclusive use of generic terminology in the manufacture. marketing and
sales of drugs and medicines. particularly those in the Essential Drug List. shall be
promoted through such a system of Incentive as the Board of Investments iointly with the
Department of Health and other government agencies as maybe authorized by laws.
within one hundred eighty (180) days after approval of this Act.

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

Sec. 6 hho shall use generic Terminologv - (a) All government 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 all drugs and medicines.
Republic Act No. 6675 page 3
a. All medical. dental and veterinary practitioners. including private practitioners.
shall write prescriptions using generic name. The brand name maybe included if so
desired.

b. Any organization or company involved in the manufacture. importation.
repacking. marketing and/or distribution of drugs and medicine shall indicate
prominently the generic name of the product labels as well as in advertising and other
promotional materials.

c. Drug Outlets. including drugstores. hospital and non-hospital pharmacies and
non-traditional outlets such as supermarkets and stores shall inform any buyer about 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 establishment. a list of drug products with the same generic name and their
corresponding prices.

Sec. 7. Provision on Oualitv Manufacturers Iaentitv ana Responsibilitv. - In
order to assure responsibility of drug quality in all instances. the label of drugs and
medicine shall have the following: name and country of manufacture. dates of
manufacture and expiration. The quality of such generically labelled drugs and medicines
shall be duly certified by the Department of Health.

Sec. 8. Requirea Proauction. - Subiect 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 drug.

Sec. 9. Rules ana Regulation - The implementation of the provision 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 hundred eighty (180) days after approval of this Act.

Sec. 10. Authoritv 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 Iilipino-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 Iilipino-owned or controlled drug establishment. He shall submit to the
office of the President and to the Congress a quarterly report of the quantity. kind and
value of the raw materials imported.

Sec. 11. Eaucation Drive - The Department of Health iointly with the
Department of Education. Culture and Sports. Philippine Information Agency and the
Republic Act No. 6675 page 4
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 drug. Such educational campaign shall include information on the
illnesses or symptoms which each generically named drug is suppose to cure or alleviate.
as well as its contradiction. The Department of Health with 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. Penaltv - A) Any person who shall violate Section 6(a). or 6(b) of this
Act shall suffer the penalty graduated hereunder. viz:

a. Ior 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. The second conviction. the penalty of fine in the amount of not less than two
thousand pesos (P2.000).

c. Ior the third conviction. the penalty of fine in the amount of not less than five
thousand pesos (P5.000) but not exceeding ten thousand pesos (P10. 000) and suspension
of his license to practice his profession for thirty days at the discretion of the court.

d. Ior the fourth subsequent convictions. the penalty of fine not less than ten
thousand pesos (P10. 000) and suspension of his license to practice his profession one
year or longer at the discretion of the court.

A. Any iuridical person 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) nor more than ten thousand pesos
(P10.000) and suspension or revocation of license to operate such drug establishment or
drug outlet at the discretion of the Court : Provide. 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
Proviaea 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 practice profession to the
Professional Regulation Commission as the case may be for the violation of the Act.

Sec. 13. Separabilitv Clause - If any provision of this Act is declared invalid. the
remainder of any provision hereof not affected thereby shall remain in force and effect.

Sec. 14. Repealing Clause - The provisions of any law. executive order.
presidential decree or other issuance inconsistent with this Act are hereby repealed or
modified accordingly.
Republic Act No. 6675 page 5
Sec. 15. Effectivitv - This Act shall effect fifteen (15) days after its complete
publication in the Official Gazette or two (2) newspapers of general circulation.

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 Representative on August 25.
1988. respectively.

Approved: September 13. 1988.