Cheaper Medicine Law

1. R.A. 9502
August 6,
2022
Dumduma, Alvin
R.A. 9502

3. “Universally
Accessible Cheaper
and Quality
Medicines Act of
2008”
R.A. 9502

4. 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
R.A. 9502

5. Amendments
□R.A. 8293
□R.A. 6675
□R.A. 5921
The Intellectual Property Code
The Generic Act of 1988
The Pharmacy Law
R.A. 9502

6. 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
R.A. 9502

7. DEFINITION OF TERMS
□“Drug outlet” refers to
drugstores, pharmacies, and any other
business establishments which sell
drugs and medicines
R.A. 9502

8. 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
R.A. 9502

9. 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
R.A. 9502

10. 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
R.A. 9502

11. 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
R.A. 9502

12. DEFINITION OF TERMS
□“Retailer” refers to a licensed
establishment carrying on the retail
business of sale of drugs and
medicines to customers
R.A. 9502

13. 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
R.A. 9502

14. 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
R.A. 9502

15. 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
R.A. 9502

16. 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
R.A. 9502

17. Drugs and Medicines
□ Price Monitoring and Regulation
Authority
□ Can create such bodies, consultative
councils  implementation of drug or
medicine PRICE MONITORING and
REGULATION POLICY
DOH
R.A. 9502

18. 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,
R.A. 9502

19. 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.
R.A. 9502

20. 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
R.A. 9502

21. 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)
R.A. 9502

22. GMAP
R.A. 9502
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

23. 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;
R.A. 9502

24. 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);
R.A. 9502

25. 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
R.A. 9502

26. 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;
R.A. 9502

27. 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.
R.A. 9502

28. 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
R.A. 9502

29. 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.
R.A. 9502

30. 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.”
R.A. 9502

31. Refusal to Sell Drugs and
Medicines
□ fine of NLT (Php100,000.00) but NMT
(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.
PENALT
Y
R.A. 9502

32. 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
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33. 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
R.A. 9502

34. 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.
R.A. 9502

35. 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
R.A. 9502

36. (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
R.A. 9502

37. □ (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
R.A. 9502

38. 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.
R.A. 9502

39. 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.”
R.A. 9502

40. REFLECTION!