Republic Act. No.

9502

“ Universally Accessible Cheaper

Sec 1. Title:

and Quality Medicines Act of 2008”

definition

 An act providing for cheaper and quality

medicines.

 Amending for the purpose of the following:

 R.A. 8293- intellectual property code
 R.A. 6675- generics act of 1978
 R.A. 5921- pharmacy law.
Sec. 2. Declaration of Policy

 It is the policy of the state to protect public

health and, when the public interest or
circumstances of extreme urgency so require,
it shall adopt appropriate measures to
promote and ensure access to affordable
quality drugs and medicine for all.
 Establishment of effective
competition policy in the supply and
demand of quality affordable drugs
and medicines Promote and
ensure access
to affordable
quality drugs
and medicines
for all
Regulation of prices of drugs and
medicines
Sec. 3

Construction in favor of protecting

public health
SEC 4: Definition of terms:

 Compulsory liscence- issued by the director

general of the intellectual Property office to
exploit a patented invention without permission
of the patent holder.

 Drugs and medicines- refers to any chemical

compound or biological substance, other than
food, intended for use in the treatment,
prevention, or diagnosis of disease in humans or
animals.
 Drug Outlet – refers to drug store, pharmacies,
and any other business establishments which
sells drugs and medicines.

 Essential drugs list or national drug

formulary. –refers to a list of drugs prepared
and periodically updated by the department of
health on the basis of health conditions
obtaining in the philippines.
Manufacture – includes any process or part of a
process of 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 ordinary course of retail bussiness.

Manufacturer- refers to any establishment engaged

in the production of a drug with the end view of
storage, distribution or sale of the product.
 Retailer- refers to any licensed establishment
carrying on the retail business of sale of drugs and
medicines to costumers.

 Trader- refers to any licenced 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 liscenced
manufacturer.
TRIPS Agreement- Trade related Aspects of
intellectual property rights.
- refers to international agreement
administered by WTO that sets down
minimum standards for many forms of
intellectual property regulation
 Chapter 3
Drugs and Medicine Price Regulation

President of the Philippines Drugs and Medicines Price regulation Authority

Drugs and Medicines Price Monitoring and

Secretary of DOH regulation Authority
 Chapter 3
Drugs and Medicine Price Regulation

Sec 17: Drugs and Medicine Price regulation Authority of the

President of the Philippines
 Chapter 3
Drugs and Medicine Price Regulation

Sec 18: Drugs and Medicine Price Monitoring and Regulation

Authority of the secretary of the Department of Health
Establish and initiate a system in price monitoring and regulation within
120 daysafter enactment of this act.

May create bodies or council from which advice maybe sought in the
implementation of a drug or medicine price monitoring and regulation
policy
Sec. 19: Functions Responsibilities of
the Secretary of DOH

a. Recommend the maximum retail price of drugs

and medicines subject to price regulation.
b. Include other drugs and medicine in the list
subject to price regulation.
c. Power to cost containment and other measures
d. Other powers necessary to implement provisions
of this chapter.
Sec 23: List of Drugs and Medicines
Subject to price regulation
a. All drugs and medicines indicated in the treatment
of chronic illnesses and life threatening conditions
b. Drugs and medicines indicated for prevention of
diseases
c. Drugs and medicine indicated to prevent pregnancy
d. Anesthetic agents
e. Intravenous fluids
f. Drugs and medicines included in the PNDF Essential
Drug list
g. Other drugs and medicines which from time to time
is added by the DOH secretary to be in need of price
regulation.
Sec. 24: illegal acts of price manipulation

It shall be unlawful for any manufacturer, importer, trader, distributor, wholesaler, retailer, or
any person engaged in any method of disposition of drugs and medicines to engage in acts of
price manipulation such as hoarding, profiteering, or illegal combination or forming cartel

Sec. 25: Penalty for illegal Acts of Price

Manipulation
Any person or entity who commits any act of illegal price manipulation of any drugs and
medicines subject to price regulation shall suffer the penalty of imprisonment for a period of
not less than 5 years nor more than 15 years or shall be imposed a fine of not less than 100,000
nor more than ten million pesos at the discretion of the court.

The court may also order the suspension or revocation of liscence to operate, proffesional or
bussiness liscence.
 Chapter 4

Strengthening of the
Bureau of Foods and Drugs
Section 31: Strengthening of the
Bureau of Food and Drugs
a) For more effective and expeditious implementation of this
act, the director of the BFAD shall be authorized to retain all
fees, fines, royalties and other charges collected under this
act and other laws it is mandated to administer for use in its
operation.
b) After 5 years from coming into the force of this act, the
director of BFAD determines if the fees and charges are
sufficient to meet its budgetary requirement.
c) BFAD shall submit a yearly performance report to the
Quality Affordable Medicine Oversight committee itemizing
the the use of retained funds .
Sec. 32: Quality Assurance of Drugs
 BFAD shall take necessary steps to ensure that all
drugs authorized for marketing in the country shall
conform to international standards for the content,
purity, and quality of pharmaceutical products as
established in the International Pharmacopoeia.
Chapter 6: Amendments to Republic Act 6675,
otherwise known as the Generics Act of 1988

Sec 37: Amendments of section 5 of R.A. 6675

sec5. Posting and Publication – the DOH shall
publish annually in at least 2 newspapers of
general circulation in the Philippines the generic
names and corresponding brand names under
which they are marketed, of all drugs and
medicines available in the philippines.
Chapter 6: Amendments to Republic Act 6675,
otherwise known as the Generics Act of 1988

Sec 38: Amendments of section 6 of R.A. 6675

sec6. who shall use Generic Terminology
a) All government health agencies and their personnel.
b) All medical, Dental and veterinary personnel.
c) Any organization involved in the manufacture,
importation, repacking, marketing and or
distribution of drugs and medicines.
d) Drug outlets, including drugstores, hospitals and
non hospital pharmacies, supermarket and store.
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.”
Chapter 6: Amendments to Republic Act 6675,
otherwise known as the Generics Act of 1988

Sec 39: Amendments of section 8 of R.A. 6675

sec 8. Required Production

every drug manufacturing company operating in the
Philippines shall be required to produce, distribute
and make widely available to the general public  an
unbranded generic counterpart of their branded
product.
Chapter 6: Amendments to Republic Act 6675,
otherwise known as the Generics Act of 1988

Sec 40: Amendments of section 11 of R.A. 6675

sec 11. Educational Drive

The Department of Health jointly with the Philippine
Information Agency and the Department of the Interior
and Local Government shall conduct a continuous
information campaign for the public and a continuing
education and training for the medical and allied medical
professions on drugs with generic names as an alternative
of equal efficacy to the more expensive brand name drugs
Sec. 12: Penalty

A) Violation of section 6a or 6b

a) All government health agencies and their

personnel.
b) All medical, Dental and veterinary personnel.
Frequency of Offence Monetary Penalty Non Monetary Penalty

First offence Reprimand and record in

PRC

second offence P10,000.00 - P25,000.00

Third offence P25,000.00 – P50,000.00 Suspension of

professional licence for 60
days

Fourth offence P 100,000 and above Suspension of

And subsequent professional licence for 1
conviction year or longer
Sec. 12: Penalty

B. Violation of section 6c, 6d, 7 or 8

-fine of Php100,000.00 or higher and

suspension or revocation of LTO such drug
establishment or drug outlet.
 Provided, that its officers directly responsible
for the violation:

 fine of P40,000.00 and above

and suspension or revocation of license to
practice profession,
 imprisonment of 6 months to 1 year
 or both fine and imprisonment
 Provided, further, That if the guilty party is an
alien, he shall be ipso facto deported after
service of sentence without need of further
proceedings.
C. The Secretary of Health shall have the
authority to impose administrative
sanctions such as suspension or cancellation
of license to operate or recommend
suspension of license to practice profession
to the Professional Regulation Commission
as the case may be for the violation of this
Act.
CHAPTER 7
 

AMENDMENTS TO REPUBLIC ACT NO. 5921, AS AMENDED,

OTHERWISE KNOWN AS THE PHARMACY LAW
CHAPTER 8
  MISCELLANEOUS PROVISIONS
 SEC. 45.  Congressional Oversight
Committee

For the effective implementation of this Act, there shall

be created a Congressional Oversight Committee,
hereinafter referred to as the

Quality Affordable Medicines Oversight Committee

Composition:Quality Affordable Medicines
Oversight Committee

 5 members from the Senate

(which includes the Chairperson of the Senate
Committees on Trade and Commerce and Health and
Demography)
 5 members from the House of Representatives,
(which includes the Chairperson of the House of
Representatives Committees on Trade and Industry and
Health)
SEC. 46. Appropriations

Department of Health
P25,000,000.00

Quality Affordable Medicines Oversight Committee

P5,000,000.00