Republic of the
Philippines
Congress of the Philippines
Metro Manila
Congress of the Philippines
Metro Manila
Eighth
Congress
Second Regular Session
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 September 13, 1988
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
Be it enacted by the Senate
and House of Representatives of the Philippines in Congress
assembled::
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 endeavor 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:
(1) "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.
(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 serves as the complete identification of a
compound.
(4) "Drug
Product" is the finished product form that contains the
active ingredients, generally but not necessarily 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 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.
(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 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.
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 on 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 – 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 (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.
B) 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. 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. 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.
Approved,|
(Sgd.) RAMON
V. MITRA
Speaker of the House of Representatives |
(Sgd.) JOVITO
R. SALONGA
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.
|
(Sgd.) QUIRINO
D. ABAD SANTOS, JR.
Secretary General House of Represenatives |
(Sgd.) EDWIN
P. ACOBA
Secretary of Senate |
(Sgd.) CORAZON
C. AQUINO
President of the Philippines
President of the Philippines
