R.A.

9502
June 6,
2008
Gloria Macapagal -
Arroyo
Nelson T. R.A. 9502
“Universally Accessible
Cheaper and Quality
Medicines Act of 2008”

Nelson T. R.A. 9502

 AN ACT  PROVIDING FOR CHEAPER AND
QUALITY MEDICINES, AMENDING FOR THE
PURPOSE REPUBLIC ACT NO. 8293 OR THE
INTELLECTUAL PROPERTY CODE, REPUBLIC
ACT NO. 6675 OR THE GENERICS ACT OF
1988, AND REPUBLIC ACT NO. 5921 OR THE
PHARMACY LAW, AND FOR OTHER
PURPOSES

Nelson T. R.A. 9502

 Amendments

□R.A. 8293
The Intellectual Property
Code
□R.A. 6675
The Generic Act of
1988
□R.A. 5921
The Pharmacy
Law R.A. 9502
 DEFINITION OF
TERMS
□“Compulsory License”
is a license issued by the Director
General of the Intellectual
Property Office to exploit a
patented invention without the
permission of the patent holder,
either by manufacture or through
parallel importation

Nelson T. R.A. 9502

 DEFINITION OF
TERMS
□“Drug outlet” refers
to drugstores, pharmacies, and
any other business
establishments which sell drugs
and medicines

Nelson T. R.A. 9502

 DEFINITION OF
TERMS
□“Essential drugs list or
national drug
formulary” refers to a list of
drugs prepared and periodically
updated by the DOH on the basis of
health conditions obtaining in the
Philippines as well as on internationally
accepted criteria

Nelson T. R.A. 9502

 DEFINITION OF
TERMS
□“Importer” refers to any
establishment that imports raw
materials, active ingredients and
finished products for its own use
or for distribution to other drug
establishments or outlets

Nelson T. R.A. 9502

 DEFINITION OF
TERMS
□“Manufacture” includes
any process or part of a process for
making, altering, finishing, packing,
labeling, breaking or otherwise
treating or adapting any drug with a
view to its sale and distribution, but
does not include the compounding or
dispensing of any drug in the ordinary
course of retail business

Nelson T. R.A. 9502

 DEFINITION OF
TERMS
□“Multisource
pharmaceutical products”
refers to pharmaceutically equivalent or
pharmaceutically alternative products that
may or may not be therapeutically
equivalent. Multisource pharmaceutical
products that are therapeutically equivalent
are interchangeable

Nelson T. R.A. 9502

 DEFINITION OF
TERMS
□“Retailer” refers to a
licensed establishment carrying
on the retail business of sale of
drugs and medicines to
customers

Nelson T. R.A. 9502

 DEFINITION OF
TERMS
□“Trader” refers to any licensed
establishment which is a registered
owner of a drug product that procures
the materials and packaging
components, and provides the
production monographs, quality
control standards and procedures, but
subcontracts the manufacture of such
products to a licensed manufacturer

Nelson T. R.A. 9502

 DEFINITION OF
TERMS
□“TRIPS Agreement”
or Agreement on Trade-Related
Aspects of Intellectual Property
Rights refers to the international
agreement administered by the WTO
that sets down minimum standards
for many forms of intellectual
property regulation

Nelson T. R.A. 9502

 DEFINITION OF
TERMS
□“Wholesaler” refers to a
licensed establishment or drug
outlet who acts as merchant,
broker or agent, who sells or
distributes for resale or
wholesale drugs and medicines

Nelson T. R.A. 9502

 Drugs and Medicines
Price Regulation:
 The President of the Philippines,
upon recommendation of the
Secretary of the DOH, shall have the
power to impose MRPs over any or all
drugs and medicines
 NO COURT, Except the SUPREME
COURT shall issue temporary
restraining order – prevent execution

Nelson T. R.A. 9502

 Drugs and Medicines

DO
□Price Monitoring and Regulation
Authority
H
□Can create such bodies,
consultative councils 
implementation of drug or medicine
PRICE MONITORING and
REGULATION POLICY

Nelson T. R.A. 9502

 Functions of DOH
□(A) Power to Recommend the MRP
of Drugs and Medicines
Subject to Price Regulation,
□(B) Power to Include Other Drugs
and Medicines in the List
Subject to Price Regulation,
□(C) Power to Implement Cost-
Containment and Other Measures,

Nelson T. R.A. 9502

 Functions of DOH
□(D) Power to Impose
Administrative Fines and
Penalties,
□(E) Power to Deputize Government
Entities, or
□(F) Other Powers Necessary to
Implement Provisions of this
Chapter, shall be immediately
operative.
Nelson T. R.A. 9502
 E.O. 821
□PRESCRIBING THE MAXIMUM
DRUG RETAIL PRICES FOR
SELECTED DRUGS AND
MEDICINES THAT ADDRESS
DISEASES THAT ACCOUNT FOR
THE LEADING CAUSES OF
MORBIDITY AND MORTALITY

Nelson T. R.A. 9502

 E.O. 821
□OUT of 22 - ONLY 5 ESSENTIAL
MEDICINES WERE APPROVED
□ anti-hypertensive - amlodipine (including its S-isomer
and all salt form)
□ anti-cholesterol - atorvastatin
□ antibiotic/antibacterial - azithromycin (and all its salt
form)
□ anti-neoplastics/anti-cancer - cytarabine (and all its salt
form)
□ anti-neoplastics/anti-cancer - doxorubicin (and all its
salt form)

Nelson T. R.A. 9502

 GMAP

ADVISORY COUNCIL
RESOLUTION 2009-001
ENTITLED IMPLEMENTING THE
VOLUNTARY PRICE REDUCTION
FOR ATLEAST 16 MOLECULES
OR (41 DRUG PREPARATIONS),
Also Known as GMAP
Government Mediated Access
Price
Nelson T. R.A. 9502
 List of Drugs & Medicines
that are subject to Price
Regulation
□All drugs and medicines indicated
for treatment of chronic illnesses
and life threatening conditions,
such as, but not limited to,
 endocrine disorders, e.g.,
diabetes mellitus;
 gastrointestinal disorders, e.g.,
peptic ulcer;

Nelson T. R.A. 9502

 List of Drugs and
Medicines
 urologic disorders, e.g., benign
prostatic hyperplasia (BPH);
 cardiovascular diseases, e.g.,
hypertension;
 pulmonary diseases, e.g., pulmonary
tuberculosis (PTB), asthma;
 auto-immune diseases, e.g.,
systemic lupus erythematosus (SLE);

Nelson T. R.A. 9502

 List of Drugs and
Medicines
 skin diseases, e.g., psoriasis;
 neuro-psychiatric disorders;
 other infectious diseases, e.g.,
human immunodeficiency virus-
acquired immune deficiency
syndrome (HIV-AIDS); and other
conditions such as organ
transplants and neoplasm

Nelson T. R.A. 9502

 List of Drugs and
Medicines
□Drugs and medicines indicated
for prevention of diseases, e.g.,
vaccines, immunoglobulin, anti-
sera;
□Drugs and medicines indicated
for prevention of pregnancy,
e.g., oral contraceptives;
□Anesthetic agents;

Nelson T. R.A. 9502

 List of Drugs and
Medicines
□Intravenous fluids;
□Drugs and medicines that are
included in the Philippine National
Drug Formulary (PNDF) Essential
Drug List; and
□All other drugs and medicines
which, from time to time, the
Secretary of the DOH determines
to be in need of price regulation.

Nelson T. R.A. 9502

 Illegal Acts of Price
Manipulation
PENALT
Y
imprisonment for a period of NLT (5)
years nor MT (15) years or shall be
imposed a fine of NLT (Php100,000.00)
nor MT (Php10,000,000.00), at the
discretion of the court. 
Suspension or revocation of
its LTO, professional or
business license
Nelson T. R.A. 9502
 Display of Maximum
Retail Price Fixed
□The MRP shall be printed on the
label of the immediate container
of the drug and medicine and the
minimum pack thereof offered
for retail sale with the words
“RETAIL PRICE NOT TO EXCEED”
preceding it, and “UNDER DRUG
PRICE REGULATION” on a red
strip.
Nelson T. R.A. 9502
 R.A. 6675
Amendments
□Who shall use Generic
Terminology
(e) There shall appear prominently
on the label of a generic drug the
following statement: this product
has the same therapeutic efficacy
as any other generic product of
the same name. Signed: BFAD.”

Nelson T. R.A. 9502

 Refusal to Sell Drugs
and Medicines
PENALT
Y (Php100,000.00) but NMT
□ fine of NLT
(Php500,000.00), at the discretion of the
court. 
□ For the succeeding offense, the penalties
shall not be less than (Php500,000.00) but
NMT (Php1,000,000.00), at the discretion of
the court,
□ and suspension or revocation of its LTO,
business or professional license, as the case
may be.

Nelson T. R.A. 9502

VIOLATIONS:
Provisions related to the Practice of Pharmacy
 
PENALTIES: SEC 12 Penalty as amended
First conviction:
shall suffer the penalty of reprimand – recorded in the
appropriate books of the PRC

Nelson T. R.A. 9502

Second conviction:
the penalty of fine in the amount of NLT
P2,000 (10,000) but not exceeding
P5,000 (25,000) at the discretion of the
court

Nelson T. R.A. 9502

 Third conviction:
Fine of NLT P 5,000 (25,000) to
P 10,000 (50,000) and suspension of
license to practice his profession for 30
(60) days at the discretion of the court.

Nelson T. R.A. 9502

Fourth and subsequent
convictions:
Fine of NLT P10,000 (100,000) and
suspension of his license to practice his
profession for 1 year or longer at the
discretion of the court

Nelson T. R.A. 9502

(Old Law) Officers responsible for the violation shall
suffer a penalty of fine and suspension or revocation of
license to practice & if applicable, imprisonment of not
less than 6 months but not to exceed 1 year or both
penalty and fine

(New Law) Any juridical person who violates Sec

6(c), 6(d), 7 or 8 shall suffer the penalty of a fine of NLT
(Php 100,000) and suspension or revocation of license to
operate such drug establishment or drug outlet at the
discretion of the court

Nelson T. R.A. 9502

□(New Law Sec 12 as amended)
□Provided, that its officers directly
responsible for the violation shall suffer
the penalty of fine of at least (Php
40,000) and suspension or revocation
of license to practice profession, if
applicable, and by imprisonment of NLT
6 months nor more than 1 year or both
fine and imprisonment at the discretion
of the court

Nelson T. R.A. 9502

 R.A. 5921 Amendments
□ SEC. 25. Sale of medicine, pharmaceuticals, drugs and
devices. – No medicine, pharmaceutical, or drug, except for
those which are non-prescription or over-the-counter, of
whatever nature and kind or device shall be compounded,
dispensed, sold or resold, or otherwise be made available
to the consuming public except through a prescription
drugstore or hospital pharmacy, duly established in
accordance with the provisions of this Act. Non-prescription
or over-the-counter drugs may be sold in their original
packages, bottles, containers or in small quantities, not in
their original containers to the consuming public through
supermarkets, convenience stores
and other retail establishments.

Nelson T. R.A. 9502

 R.A. 5921 Amendments
□ “Pharmaceutical, drug or biological
manufacturing establishments, importers and
wholesalers of drugs, medicines, or biologic
products, shall not sell their products for re-
sale except only to retail drug outlets, hospital
pharmacies or to other drug wholesalers under
the supervision of a registered
pharmacist, and supermarkets,
convenience stores, other retail
establishments for over-the-counter drugs,
duly licensed by the Bureau of Food and
Drugs.”

Nelson T. R.A. 9502