Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

SEVENTEENTH CONGRESS
Second Regular Session

HOUSE BILL NO. 715 2

Introduced by Representative MICHAEL L. ROMERO

EXPLANATORY NOTE

A generic drug is equivalent to its brand name counterpart, but is usually less
expensive. A generic drug must have the same active ingredients, route of
administration, dosage form, strength, and indications as the original brand
product. Generic drugs are approved, and are deemed to be as safe and
effective as the brand name product.

Generics cannot be sold until after the drug patent expires on the original
brand name product. A drug manufacturer applies for a patent to protect
their drug from being copied and sold by another company and losing
profits.

During the period of patent protection, only the original manufacturer can
research, develop and sell the brand name drug. When the patent expires,
other manufacturers can submit an abbreviated new drug application for
approval to market the generic version.

Generics have lower research costs and higher market competition and
those substantial savings are passed on to the patient. However, generic
drugs still must meet strict FDA requirements with respect to quality,
performance, labeling, manufacturing, and bioequivalence.

This House Bill seeks to promote drug safety by minimizing duplication in
medications and/or use of drugs with potentially adverse drug interactions.




Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

SEVENTEENTH CONGRESS
Second Regular Session

HOUSE BILL NO. mee 52

Introduced by Representative MICHAEL L. ROMERO

AN ACT

AMENDING REPUBLIC ACT 6675, OTHERWISE KNOWN AS THE
“GENERICS ACT OF 1988” TO PROMOTE THE EXTENSIVE USE OF
GENERIC DRUGS THROUGH A RATIONAL SYSTEM OF
PROCUREMENT AND DISTRIBUTION, PROVIDING STIFFER
PENALTIES AND SANCTIONS, AND FOR OTHER PURPOSES

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 2018.”
SECTION 2.
Section 12 of Republic Act No. 6675 is hereby amended to read:

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 twenty thousand pesos
(P20,000.00) but not exceeding fifty thousand pesos
(P50,000.00) at the discretion of the court.

(c) for the third conviction, the penalty of fine in the
amount of not less than fifty thousand pesos (P50,000.00)
but not exceeding one hundred thousand pesos
(P100,000.00) and suspension of his license to practice his
profession for one (1) year at the discretion of the court.

(d) for the fourth and subsequent convictions, the penalty
of fine of not less than fifty thousand pesos (P50,000.00)
and the revocation of his license to practice his profession
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 One hundred
thousand pesos (P100,000.00) nor more than Five hundred
thousand pesos (P500,000.00) and 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 one (1) year nor more than six (6) years 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 3. TRANSITORY PROVISION - Existing industries, businesses and
offices affected by the implementation of this Act shall be given six (6)
months transitory period from the effectivity of the IRR or such other
period as may be determined, to comply with the requirements of this
Act.

SECTION 4. IMPLEMENTING RULES AND REGULATIONS - The departments
and agencies charged, to be led by the Department of Health (DOH)
with carrying out the provisions of this Act, shall within sixty (60) days
after the effectivity of this Act, formulate the necessary rules and

regulations for its effective implementation.

SECTION 5. REPEALING CLAUSE - All laws, decrees, executive orders,
rules and regulations, or parts thereof inconsistent with the provisions of
this Act are hereby repealed or modified accordingly.

SECTION 6. SEPARABILITY CLAUSE - [f, for any reason, any section or
provision of this Act is held unconstitutional or invalid, the other sections
‘or provisions hereof shall not be affected thereby.

SECTION 7. EFFECTIVITY CLAUSE — This Act shall take effect after fifteen
(15) days from its publication in the Official Gazette or in at least two
(2) national newspapers of general circulation whichever comes
earlier.

Approved,