R.A.

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

Nelson T. Tubon, 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. Tubon, 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. Tubon, R.A. 9502

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

Nelson T. Tubon, 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. Tubon, 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. Tubon, 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. Tubon, 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. Tubon, 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. Tubon, 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. Tubon, 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. Tubon, 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. Tubon, 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. Tubon, R.A. 9502

 Drugs and Medicines

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

Nelson T. Tubon, 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. Tubon, 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. Tubon, 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. Tubon, 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. Tubon, 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. Tubon, 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. Tubon, 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. Tubon, 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. Tubon, 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. Tubon, 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. Tubon, 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. Tubon, 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. Tubon, 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. Tubon, R.A. 9502

 Refusal to Sell Drugs and
Medicines
PENALT
Y(Php100,000.00) but NMT (Php500,000.00), at
□ fine of NLT
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. Tubon, 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. Tubon, 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. Tubon, 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. Tubon, 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. Tubon, 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. Tubon, 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. Tubon, 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
supermarkets, convenience stores
public through
and other retail establishments.

Nelson T. Tubon, 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. Tubon, R.A. 9502