illmnti' 
I~H\;< "I H!.;;""I",~ l 
SIXTEENTH CONGRESS OF THE REPUBLIC 
) 
OF THE PHILIPPINES 
) 
First Regular Session 
) 
'13 
OCl -2 Al1 :31 
SENATE 
S. No. 
1764 
Introduced by Senator Miriam Defensor Santiago 
EXPLANATORY NOTE 
The Constitution, Article 2, Section 15 provides: 
The State shall protect and promote the right to health of the people, and instill 
health consciousness among them. 
It is absolutely imperative that consumers be made aware of the effects of pharmaceutical 
products, prescribed or bought over the counter. With greater importance are pharmaceutical 
products that cause impairment of certain cognitive functions of those who take them and affect 
their abilities to perform certain activities. 
This bill seeks to require pharmaceutical companies to properly label drugs that cause 
impairment of certain cognitive functions.' 
Lw,-
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MIRIAM DEF 
SOR S~TIrrO 
1t' 
. 
• This bill was originally filed in the Thirteenth Congress, Third Regular Session. 
1 


;S.el1l.ltl.> 
(~H.;. of tit. ji.f\'"hJr~ 
SIXTEENTH CONGRESS OF THE REPUBLIC 
) 
OF THE PHILIPPINES 
) 
First Regular Session 
) 
'13 
OCT -2 A11 :37 
SENATE 
, 
S. No. 
1764 
RECEiV U) II 'I···r· 
Introduced by Senator Miriam Defensor Santiago 
1 
AN ACT 
2 
PRESCRlBING THE PROPER LABELING OF PHARMACEUTICAL PRODUCTS 
3 
WHICH ACT ON THE BRAIN AND CENTRAL NERVOUS SYSTEM 
Be it enacted by the Senate and the House of Representatives of the Philippines in 
Congress assembled: 
4 
SECTION 1. Short Title. - This Act shall be known as the "Pharmaceutical Labeling 
5 
Act." 
6 
SECTION 2. Definition of Terms. - In this Act, the term: 
7 
(A) 
"Consumer" means a person who takes a psychoactive pharmaceutical whether in 
8 
the recommended or prescribed dose or otherwise; 
9 
(B) 
"Over-the-counter" means available without prescription from a pharmacy or 
10 
other retail outlet; 
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(C) 
"Packaging" means such of the external packaging as IS clearly on view on 
, 
12 
purchase or receipt of the product; 
13 
(D) 
"Prescription only" means available only by a prescription from a registered 
14 
medical practitioner; 
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(E) 
"Psychoactive pharmaceutical" means a pharmaceutical product which has a 
16 
clinical effect on the brain and central nervous system, and it is immaterial whether the 
17 
psychoactive pharmaceutical is available through prescription only or over the counter; 
18 
(F) 
"Specified psychoactive pharmaceutical" means a psychoactive pharmaceutical 
19 
specified by the Secretary of Health by order under Section 3; and 
20 
(G) 
"Warning symbol" means a prominent symbol the size, color and design of which 
21 
shall be prescribed by the Secretary of Health by regulations. 
I 


· , 
I 
SECTION 3. Pharmaceuticals with Psychoactive Side Effects. - The Secretary of Health 
2 
shall make a determination of which psychoactive pharmaceuticals can lead to impairment of the 
3 
consumer's ability to drive a motor vehicle or operate machinery such that the consumer is a 
4 
danger to himself or others. The Secretary of Health shall promulgate this order within twelve 
5 
(12) months from the effectivity of this Act. 
6 
SECTION 4. Regulations. - Not later than twelve (12) months from the effectivity of this 
7 
Act, the Secretary of Health shall promulgate final regulations to carry out the provisions of this 
8 
Act. 
9 
SECTION 5. Warning Label. - Drugs containing specified psychoactive pharmaceuticals, 
10 
as determined by the Secretary of Health, shall include on their packaging a warning stating the 
11 
following: "Warning: This drug may cause cognitive function impairment" 
12 
SECTION 6. Penalty Clause. - Any person who shall violate the provisions of this Act 
13 
shall, upon conviction, be subject to a fine of not less than Ten Thousand Pesos (PIO,OOO.OO) but 
14 
not more than One Hundred Thousand Pesos (PIOO,OOO.OO), or imprisomnent of not less than 
15 
two (2) months but not more than one (1) year, or both, upon the discretion of the court. 
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SECTION 7. Separability Clause. - If any provision or part of this Act is declared invalid 
17 
or unconstitutional, the same shall not affect the validity and effectivity of the other provisions 
18 
not affected thereby. 
19 
SECTION 8. Repealing Clause. - All laws, decrees, executive orders, rules and 
20 
regulations, and other issuances or parts thereof which are inconsistent with this Act are hereby 
21 
repealed, amended, or modified accordingly. 
22 
SECTION 9. Effectivity Clause. - This Act shall take effect fifteen (15) days following its 
23 
publication in at least two (2) national newspapers of general circulation. 
Approved, 
2