HOUSE °F REPRESENTATIVES

RECEIVED
—- 25 AUG 2016
Republic of the Philippines swe
HOUSE OF REPRESENTATIVES BY: [eau
ee cal ae

Quezon City

RECISTRATION UNIT

SEVENTEENTH CONGRESS BILLS aND INDEX SERVICE

First Regular Session

2
HOUSE BILL NO. 3821

Introduced by: HON. GUS S. TAMBUNTING

EXPLANATORY NOTE

This bill seeks to regulate the proliferation of supplemental medicines and other
related preparations in the market.

Most drug manufacturers of supplements and other dietary preparations using "NO
THERAPEUTIC CLAIM" on their packaging and promotion of their product capitalize on fine
print and disclaimers thus, unqualified substitution is allowed and the law cannot hold the
physician responsible for adverse consequences.

This legislation aims to put in place adequate safeguards for the purpose of protecting
consumers not to succumb to aggressive and exaggerated therapeutic claims of
unscrupulous manufacturers in their advertisement.

Therapeutic decisions reached by physicians are based on a complex body of medical
information relevant to a specific patient. It is not denied that therapeutic failure or toxicity
may result from improper substitution of a drug at the pharmacy counter.

More so, it is a policy of the State to protect and promote the right to health of the
people and instill health consciousness among them.

Hence the passage of this legislation is earnestly soygy


Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

‘SEVENTEENTH CONGRESS
First Regular Session
221
HOUSE BILL NO, 322

Introduced by: HON. GUS S. TAMBUNTING

AN ACT
REGULATING THE USE OF “NO THERAPEUTIC CLAIM” ON SUPPLEMENTAL
MEDICINES AND OTHER RELATED PREPARATIONS THEREBY MANDATING
PROPER PACKAGE LABELLING AND ESTABLISHING A STANDARD OF
PROTECTION AND PROMOTING THE WELFARE OF CONSUMERS AND FOR
OTHER PURPOSES.

Be it enacted by the Senate and House of Representatives of the Philippines in
Congress as assembled:

SECTION 1. Short Title. - This Act shall be known as "The Supplemental Medicines
Consumer Protection Act of 2016."

SECTION 2. Definition. — For purposes of this Act, the term ‘Supplemental Medicine’
means supplemental medicines, dietary preparations and other related supplements
including herbal preparations.

SECTION 3. The Department of Trade and Industry (DTI), Bureau of Food and Drugs
(BFAD) and other related agencies shall prescribe rules and regulations prohibiting deceptive
public advertisement including marketing activities and other exaggerated marketing
strategy of drug manufacturers and advertisers.

The DTI shall include in such rules deceptive public advertisement including
marketing activities and other exaggerated marketing strategy a definition of deceptive,
abusive and exaggerated advertising as well marketing of said supplemental medicines,
dietary preparations and other related supplements including herbal preparations and
including further, establishing a standard of protection in promoting the welfare of the
consumers.

The BFAD shall prescribe the rules on the proper mandatory package labeling as a
requirement that supplemental medicines, dietary preparations and other related


supplements including herbal preparations must adhere to and, comply with the required
mandatory testing and approval as to ensure dugs safety and efficacy.

The lead agencies, DTI and BFAD shall ensure and monitor the safety, therapeutic
and bioequivalence, and post-marketing surveillance of said supplemental medicines, dietary
Preparations and other related supplements including herbal preparations.

SECTION 4. Action by Private Persons. - Any person adversely affected by any
supplemental medicines, dietary preparations and other related supplements including
herbal preparation and manufacturers, or advertisers who shall violate any rule prescribed
under the provisions of this Act may, within one (1) year after the discovery of the violation,
bring a civil action against a person who has engaged or is engaging in prohibited acts so
stipulated. Such action may be brought to enjoin private parties, manufacturer or
advertisers, o enforce compliance with any rule under this Act to obtain damages or to
obtain such further and other relief as the court may deem appropriate.

SECTION 5. Separability Clause. — If any provision or part thereof is held invalid or
unconstitutional, the remainder provisions not otherwise affected shall remain valid and
subsisting.

SECTION 6. Repealing Clause. — Any law, presidential decree or issuance, executive
order, letter of instruction, administrative order, rule or regulation contrary to, or
inconsistent with, the provision of this Act is hereby repealed, modified, or amended
accordingly.

SECTION 7. Effectivity Clause, - This Act shall take effect fifteen (15) days after its
publication in at least two (2) newspapers of general circulation.

Approved,