Republic Act no.

9502

UNIVERSALLY ACCESSIBLE CHEAPER

AND QUALITY MEDICINES ACT OF
2008
Definition

An act of providing 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 of extreme urgency
so require it shall :

Adopt appropriate measures to promote and

ensure access to affordable quality drugs and
medicine for all
Purpose
Establishment of effective competition policy in the
supply and demand of quality affordable drugs and
medicines

Regulations of price and medicines

Promote and ensure access to affordable quality

drugs and medicines for all
Sec 3

Construction in favor of protecting public health

 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

Drug outlet refers to drugstores, pharmacies, and any other business

establishments which sell drugs and medicines

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
 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 as well as on internationally
accepted criteria

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
 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

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
Chapter 3
DRUGS AND MEDICINES PRICE REGULATIONS

President of the Philippines

DOH

Drugs and medicines price regulation authority

Drugs and medicines price monitoring and

regulation authority
Chapter 3
DRUGS AND MEDICINES PRICE
REGULATIONS

Sec 17

Drugs and Medicines Price regulations

Authority of the President of the Philippines
Chapter 3
DRUGS AND MEDICINES PRICE REGULATIONS

Sec 18: DRUGS AND MEDICINES PRICE MONITORING AND

REGULATION AUTHORITY OF THE SECRETARY OF THE DOH

establish and initiate a system in price monitoring and regulation

within 120 days after enactment of this act

May create bodies or council from which advice maybe sought in

the implementation of a drugs or medicines price monitoring and
regulation policy
Sec.19: FUNCTIONS RESPONSIBILITIES OF THE
SECRETARY OF DOH

Recommend the maximum retail price of drugs and medicines

subject to price regulations

Include other drugs and medicines in the list subject to price

regulations

Power to cost containment and other measures

Other powers necessary to implement provisions of this act

Sec 23: LIST OF DRUGS AND MEDICINES SUBJECT
TO PRICE REGULATIONS

All drugs and medicines indicated in the treatment of chronic illness

and life threatening conditions
Drugs and medicines indicated for prevention of disease
Drugs and medicines indicated to prevent pregnancy
Anesthetic Agents
Intravenous fluids
Drugs and medicines include in the PNDF essential drug list
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

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, as defined under Section
5 of Republic Act No. 7581, otherwise known as the Price Act,
and all other acts committed in restraint of trade.
 Sec 25: PENALTY FOR ILLEGAL ACTS OF PRICE
MANIPULATION

Any person or entity who commits any act of illegal price manipulation
of any drug and medicine subject to price regulation shall suffer the
penalty of imprisonment for a period of not less than five (5) years nor
more than fifteen (15) years shall be imposed a fine of not less than
One hundred thousand pesos (Php100,000.00) or more than Ten million
pesos (Php10,000,000.00), at the discretion of the court.

The court may also order the suspension or revocation of its license to
operate (LTO), professional or business license
Chapter 4

STRENGTHENING OF THE
BUREAU OF FOOD AND DRUGS
Section 31:
STRENGTHENING OF THE BUREAU OF FOOD AND
DRUGS

For a more effective and expeditious implementation of this

Act, the Director or head of the Bureau of Food and Drugs
shall be authorized to retain, without need of a separate
approval from any government agency, and subject only to
existing accounting and auditing rules and regulations, all
the fees, fines, royalties and other charges, collected by the
Bureau of Food and Drugs under this Act and other laws that
it is mandated to administer based on the immediately prior
year of operations, for use in its operations
 After five (5) years from the coming into force of this Act, the
Director or head of the Bureau of Food and Drugs shall, subject
to the approval of the Secretary of the Department of Health,
determine if the fees and charges, mentioned in Subsection
hereof, are sufficient to meet its budgetary requirements

The Bureau of Food and Drugs shall submit a yearly

performance report to the Quality Affordable Medicines
Oversight Committee, as provided in Section 45 of this Act. The
report shall itemize the use of such retained funds in the past
year up to the present and the budgeted use of the same in
the succeeding periods
SEC. 32. Quality Assurance of
Drugs
The Bureau of Food and Drugs shall take the 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 provided that:

imported products in finished dosage forms, should be certified under the World
Health Organization (WHO) certification scheme on the quality of
pharmaceutical products moving in international commerce the registration for
multisource pharmaceutical products

should conform to the WHO guidelines on registration requirements to establish

interchangeability
CHAPTER 6: AMENDMENTS TO REPUBLIC ACT
NO. 6675, OTHERWISE KNOWN AS THE
GENERICS ACT OF 1988
SEC. 37. Section 5 of Republic Act No. 6675,
Posting and Publication
The Department of Health shall publish annually in
acceptable means of public dissemination in at least two
(2) newspapers of general circulation in the Philippines the
generic names, and the corresponding brand names
under which they are marketed, of all drugs and medicines
available in the Philippines.
SEC. 38. Section 6 of Republic Act No. 6675

SEC. 6. Who Shall Use Generic Terminology

All government health agencies and their personnel as well as
other government agencies shall use generic terminology or generic
names in all transactions related to purchasing, prescribing, dispensing
and administering of drugs and medicines.

All medical, dental and veterinary practitioners, including private

practitioners, shall write prescriptions using the generic name. The
brand name may be included if so desired.
 Any organization or company involved in the manufacture, importation,
repacking, marketing and/or distribution of drugs and medicines shall
indicate prominently the generic name of the product.

In the case of brand name products, the generic name shall appear
prominently and immediately above the brand name in all product labels as
well as in advertising and other promotional materials

Drug outlets, including drugstores, hospital and non-hospital pharmacies and

nontraditional outlets such as supermarkets and stores, shall inform any buyer
about any and all other drug products having the same generic name,
together with their corresponding prices so that the buyer may adequately
exercise his option
 Within one (1) year after the approval of this Act, the drug
outlets referred to herein shall post in conspicuous places in their
establishments a list of drug products with the same generic
name and their corresponding prices

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.
SEC. 39. Section 8 of Republic Act No. 6675

SEC. 8. Required Production.

Subject to the rules and regulations promulgated by
the Secretary of Health, 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
SEC. 40. Section 11 of Republic Act No. 6675

SEC. 11. Education 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. Such educational campaign shall include information on
the illnesses or symptoms which each generically named drug is supposed to
cure or alleviate, as well as in contraindications

The Department of Health with the assistance of the Department of the

Interior and Local Government and the Philippine Information Agency shall
monitor the progress of the education drive, and shall submit regular reports to
Congress
 CHAPTER 7

AMENDMENTS TO REPUBLIC ACT NO. 5921,

AS AMENDED, OTHERWISE KNOWN AS THE
PHARMACY LAW
SEC. 43. Section 25 of Republic Act No. 5921
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.

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."
SEC. 44. Implementing Rules and Regulations
to the Amendments to the Pharmacy Law

The Department of Health, in consultation with the appropriate

government agencies, within one hundred twenty (120) days
from the effectivity of this Act, shall promulgate the rules and
regulations necessary to effectively implement the provisions of
this Chapter.
 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, to be
composed of five (5) members from the Senate, which shall include
the Chairpersons of the Senate Committees on Trade and
Commerce and Health and Demography, and, five (5) members
from the House of Representatives, which shall include the
Chairpersons of the House of Representatives Committees on Trade
and Industry and Health.
The Quality Affordable Medicines Oversight Committee shall be
jointly chaired by the Chairpersons of the Senate Committee on
Trade and Commerce and the House of Representatives Committee
on Trade and Industry. The Vice-Chair of the oversight committee
shall be jointly held by the Chairpersons of the Senate Committee on
Health and Demography and the House of Representatives
Committee on Health.
SEC. 46. Appropriations

For the initial implementation of this Act, the amount of

Twenty-five million pesos (Php25,000,000.00), in addition to the
budget of the Department of Health, shall be provided for the
operations of the Office of the Secretary of the Department of
Health. The Quality Affordable Medicines Oversight
Committee shall be provided an initial budget of Five million
pesos (Php5,000,000.00) to perform its functions as mandated
under this Act. Thereafter, such sum as may be necessary for
its continued implementation shall be included in the annual
General Appropriations Act.
SEC. 47. Separability Clause

Any portion or provision of this Act that may be

declared unconstitutional or invalid shall not have
the effect of nullifying other portions and
provisions hereof as long as such remaining
portion or provision can still subsist and be given
effect in their entirety.
SEC. 48. Repealing Clause
All laws, decrees, executive orders, proclamations and
administrative regulations or parts thereof inconsistent
herewith are hereby repealed or modified accordingly.

SEC. 49. Effectivity Clause

This Act shall take effect fifteen (15) days after its publication
in at least two (2) national papers of general circulation