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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
(SGD) JOVITO R. SALONGA
President of the Senate
Representatives
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 of the House of
Secretary of the Senate
(SGD) EDWIN P. ACOBA
Representatives
Approved:
September 13, 1988
(SGD.) CORAZON C. AQUINO
President of the Philippines
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