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This page features the full text of
Republic
Act No. 6675
Generics 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."
Sec.
2. Statement of Policy. - 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;
1. "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 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 drugs and medicine and serves as the complete identification of the
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,
pharmacist, and any other
business
establishment which sell drugs or medicines.
7. "Essential Drug 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 in the internationally accepted criteria. It shall consist of a core
list or a complimentary list.
8. "Core List" is the list of drugs that
meet the health care
needs
hundred eighty days upon the approval of this Act.
9. "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.
10. "Brand Name" is the proprietary name
given by the manufacture
to
distinguish its product from those of competitors.
11. "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 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 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.
(b)
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 jointly 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 and 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. Who shall use generic Terminology. - (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.
(b)
All medical, dental and veterinary practitioners, including private
practitioners,
shall write prescriptions using generic name. The brand name maybe
included
if so desired.
(c)
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.
(d)
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 Quality, Manufacturer’s Identity and Responsibility.
- 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. 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
drug.
Sec.
9. Rules and 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. 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 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. 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 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. 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)
The second conviction, the penalty of fine in the amount of not less
than
two thousand pesos (P2,000).
(c)
For 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)
For 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.
Any
juridical person which 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: 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 practice
profession
to the Professional Regulation Commission, as the case may be, for the
violation of the Act.
Sec.
13. Separability 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.
Sec.
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.
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, respectively.
Approved:
September 13, 1988.
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