Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

SEVENTEENTH CONGRESS
Second Regular Session

HOUSE BILL NO. 7151

Introduced by Representative MICHAEL L. ROMERO

EXPLANATORY NOTE

A counterfeit drug is a pharmaceutically manufactured product which is
produced and sold with the intent to deceivingly represent its origin,
authenticity or effectiveness. It may contain unsuitable quantities of active
ingredients, or none, may be improperly processed within the body, may
contain ingredients that are not on the label (which may or may not be
harmful), or may be supplied with inaccurate or fake packaging and
labeling.

Counterfeit drugs are related to pharmaceutical fraud. Drug manufacturers
and distributors are increasingly investing in countermeasures, such as
traceability and authentication technologies, to try to minimize the impact of
counterfeit. drugs. Antibiotics with insufficient quantities of an active
ingredient add to the problem of antibiotic resistance.

If legitimate, correctly labeled, low-cost generic drugs are not considered as
counterfeit or fake, but can be caught up in anti-counterfeiting enforcement
measures. In that respect, c debate is raging as to whether counterfeit
products are first and foremost a threat to human health and safety or
whether provoking anxiety is just a clever way for wealthy nations to create
sympathy for increased protection of their intellectual property rights.

This House Bill seeks to safeguard, protect and promote the right to health of
the people and instill health consciousness among them, most especially
against counterfeit drugs.


Thus, the early pas; Of this bill is earnestly requested.

L. ROMERO Ph.D.


Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

SEVENTEENTH CONGRESS
Second Regular Session

HOUSE BILL NO. 7151

Introduced by Representative MICHAEL L. ROMERO

AN ACT

AMENDING REPUBLIC ACT 8203, OTHERWISE KNOWN AS THE
“SPECIAL LAW ON COUNTERFEIT DRUGS” TO FOSTER THE
IMPOSITION OF ALL EXISTING POLICIES AND GUIDELINES,
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.

Section 7 of Republic Act No. 8203 is hereby amended to read:

SECTION 7. Administrative Sanctions - Upon finding that the drugs
examined are counterfeit and the determination of the parties
liable thereof, the Bureau shall impose any or all of the following
sanctions:

a) permanent closure of the establishment concemed and the
revocation of its license to business;

b) a fine of not less than Three hundred thousand pesos
(P300,000.00) but not more than One million pesos
(P1,000,000.00);


cc) upon order of the Court, forfeiture, confiscation, and
destruction of products found to be counterfeited and the
equipment, instruments, and other articles used in violation of
this Act;

d) fling of an appropriate proceedings against the registered
pharmacist with the Professional Regulations Commission for
cancellation of professional license;

e) filing of criminal charges against the violator (s), which can
be instituted independently from the administrative case:
Provided, That the dismissal of the criminal case shall not lift
the closure order, except when it is a dismissal on the merits or
for lack of basis: Provided, further, That the withdrawal of the
private criminal complaint shall not be a ground for the
dismissal of the administrative proceedings; and

f) permanent disqualification of the person concerned, whether
natural or juridical, from owning or operating an
establishment engaged in any business activity under the
supervision of the Bureau.

SECTION 2.

Section 8 of Republic Act No. 8203 is hereby amended to read:

SECTION 8. Penalties. — The commission of any of the acts prohibited
under Sections 4 and 6 of this Act shall be punished by:

) imprisonment of not less than one (1) year and one (1) day;

but not more than six (6) years for more possession of counterfeit

drugs as provided for in Section 4(b) hereof; or

b) imprisonment of not less than six (6) years and one (1) day,
but not more than ten (10) years or a fine of not less than
Three hundred thousand pesos (P300,000.00) but not more
than One milion pesos (P1,000,000.00) or both such
imprisonment and fine at the discretion of the court in any
other case mentioned in Section 4 hereof; or

c) imprisonment of not less than one (1) year and one (1) day,

but not more than four (4) years and four (4) months if the

counterfeit drug is intended for animals; or


d) imprisonment of not less than six (6) years and one (1) day
but not more than ten (10) years for any manufacturer, seller or
distributor who shall conceal, substitute, dispose or destroy any
drug as may have been segregated and sealed by the Bureau
or who shall break, alter or tamper any mark or seal used by the
Bureau to identify those segregated drugs as provided for under
Section 6(a) of this Act. Any other person who breaks, alters or
tampers any mark or seal used by the Bureau to identify the
segregated drugs shall suffer the penalty of not less than one (1)
year and one (1) day, but not more than six (6) years
imprisonment; or
€) if, as a result of the use of the drug found to be counterfeit,
the illness sought to be cured is aggravated or physical injury
or suffering results therefore, a punishment of imprisonment
from twelve (12 years to fifteen (15) years and a fine ranging
from Three hundred thousand pesos (P300,000.00) to One
million pesos (P1,000,000.00) shall be meted out; or
f) should a counterfeit drug be the proximate cause of death of
@ victim, who unknowingly purchased and took a counterfeit
drug, the penalty of life imprisonment and a fine of not less than
One million pesos (P1,000,000.00) to Five million pesos
(P5,000,000.00) shall be imposed.

In case any act prohibited in Section 4 hereof is also punishable
under other laws, the offender shall, if warranted by the evidence,
be prosecuted under the law prescribing the highest penalty.

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 - If, 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,