Cheaper Medicines Act of 2008

(1)
June 6, 2008
REPUBLIC ACT NO. 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
CHAPTER 1
General Provisions
SECTION 1. Short Title. — This Act shall be known as the "Universally

Accessible Cheaper and Quality Medicines Act of 2008". ScTaEA
SECTION 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 medicines for all.
Pursuant to the attainment of this general policy, an effective competition

policy in the supply and demand of quality affordable drugs and medicines is
recognized by the State as a primary instrument. In the event that full competition is
not effective, the State recognizes as a reserve instrument the regulation of prices of
drugs and medicines, with clear accountability by the implementing authority as
mandated in this Act, as one of the means to also promote and ensure access to quality
affordable medicines.
SECTION 3. Construction in Favor of Protection of Public Health. —

All doubts in the implementation and interpretation of the provisions of this Act,
including its implementing rules and regulations, shall be resolved in favor of
Copyright 2015 CD Technologies Asia, Inc. and Accesslaw, Inc. Philippine Law Encyclopedia First Release 2015 1
protecting public health. DETcAH
SECTION 4. Definition of Terms. — For purposes of this Act, the

following terms are to mean as follows:
(a) "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;
(b) "Drug outlet" refers to drugstores, pharmacies, and any other business
establishments which sell drugs and medicines; 2ndrellaws08
(c) "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, including but not limited
to:
(1) any article recognized in the official United States

Pharmacopoeia-National Formulary (USP-NF), official
Homeopathic Pharmacopoeia of the United States, Philippine
Pharmacopoeia, Philippine National Drug Formulary, British
Pharmacopoeia, European Pharmacopoeia, Japanese
Pharmacopoeia, Indian Pharmacopoeia, any national
compendium or any supplement to any of them;
(2) any article intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in humans or animals;
(3) any article other than food intended to affect the structure or any
function of the human body or animals;
(4) any article intended for use as a component of any articles

specified in clauses (1), (2), and (3) not including devices or their
components, parts, or accessories; and
(5) herbal and/or traditional drugs which are articles of plant or

animal origin used in folk medicine which are: CacEID
(i) recognized in the Philippine National Drug
Formulary;
(ii) intended for use in the treatment or cure or mitigation

of disease symptoms, injury or body defects in
humans;
(iii) other than food, intended to affect the structure or

any function of the human body;
(iv) in finished or ready-to-use dosage form; and
(v) intended for use as a component of any of the articles

specified in clauses (i), (ii), (iii), and (iv);
(d) "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;
(e) "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;
(f) "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;
(g) "Manufacturer" refers to any establishment engaged in the operations

involved in the production of a drug with the end view of storage,
distribution, or sale of the product;
(h) "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; HITAEC
(i) "Retailer" refers to a licensed establishment carrying on the retail

business of sale of drugs and medicines to customers;
(j) "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;
(k) "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; and
(l) "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.
CHAPTER 2
Amendments to Republic Act No. 8293, Otherwise known as

the Intellectual Property Code of the Philippines
SECTION 5. Section 22 of Republic Act No. 8293, otherwise known as

the Intellectual Property Code of the Philippines, is hereby amended to read as
follows: EACIcH
"SEC. 22. Non-Patentable Inventions. — The following shall be

excluded from patent protection:
"22.1. Discoveries, scientific theories and mathematical

methods, and in the case of drugs and medicines, the mere discovery of a new
form or new property of a known substance which does not result in the
enhancement of the known efficacy of that substance, or the mere discovery of
any new property or new use for a known substance, or the mere use of a
known process unless such known process results in a new product that
employs at least one new reactant.
"For the purpose of this clause, salts, esters, ethers, polymorphs,

metabolites, pure form, particle size, isomers, mixtures of isomers,
complexes, combinations, and other derivatives of a known substance shall be
considered to be the same substance, unless they differ significantly in
properties with regard to efficacy; CEASaT
"22.2. . . .;
"22.3. . . .;
"22.4. . . .;
"22.5. . . .; and
"22.6. . . . ."

follows:
"SEC. 26. Inventive Step. — 26.1. An invention involves an

inventive step if, having regard to prior art, it is not obvious to a person skilled
in the art at the time of the filing date or priority date of the application
claiming the invention. (n)
"26.2. In the case of drugs and medicines, there is no inventive

step if the invention results from the mere discovery of a new form or new
property of a known substance which does not result in the enhancement of
the known efficacy of that substance, or the mere discovery of any new
property or new use for a known substance, or the mere use of a known
process unless such known process results in a new product that employs at
least one new reactant."

follows:
"SEC. 72. Limitations of Patent Rights. — The owner of a patent

has no right to prevent third parties from performing, without his
authorization, the acts referred to in Section 71 hereof in the following
circumstances:
"72.1. Using a patented product which has been

put on the market in the Philippines by the owner of the
product, or with his express consent, insofar as such use is
performed after that product has been so put on the said
market: Provided, That, with regard to drugs and medicines,
the limitation on patent rights shall apply after a drug or
medicine has been introduced in the Philippines or anywhere
else in the world by the patent owner, or by any party
authorized to use the invention: Provided, further, That the
right to import the drugs and medicines contemplated in this
section shall be available to any government agency or any
private third party;
"72.2. Where the act is done privately and on a

non-commercial scale or for a non-commercial purpose:
Provided, That it does not significantly prejudice the economic
interests of the owner of the patent;
"72.3. Where the act consists of making or using

exclusively for experimental use of the invention for scientific
purposes or educational purposes and such other activities
directly related to such scientific or educational experimental
use;
"72.4. In the case of drugs and medicines, where

the act includes testing, using, making or selling the invention
including any data related thereto, solely for purposes
reasonably related to the development and submission of
information and issuance of approvals by government
regulatory agencies required under any law of the Philippines
or of another country that regulates the manufacture,
construction, use or sale of any product: Provided, That, in
order to protect the data submitted by the original patent holder
from unfair commercial use provided in Article 39.3 of the
Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS Agreement), the Intellectual Property Office, in
consultation with the appropriate government agencies, shall
issue the appropriate rules and regulations necessary therein
not later than one hundred twenty (120) days after the
enactment of this law; cTSDAH
"72.5. Where the act consists of the preparation

for individual cases, in a pharmacy or by a medical
professional, of a medicine in accordance with a medical
prescription or acts concerning the medicine so prepared; and
"72.6 Where the invention is used in any ship,

vessel, aircraft, or land vehicle of any other country entering
the territory of the Philippines temporarily or accidentally:
Provided, That such invention is used exclusively for the needs
of the ship, vessel, aircraft, or land vehicle and not used for the
manufacturing of anything to be sold within the Philippines.
(Secs. 38 and 39, R.A. No. 165a)"

follows:
"SEC. 74. Use of Invention by Government. — 74.1. A Government

agency or third person authorized by the Government may exploit the
invention even without agreement of the patent owner where: HEITAD
"(a) The public interest, in particular, national security,

nutrition, health or the development of other sectors, as
determined by the appropriate agency of the government, so
requires; or
"(b) A judicial or administrative body has determined

that the manner or exploitation, by the owner of the patent or
his licensee, is anti-competitive; or
"(c) In the case of drugs and medicines, there is a

national emergency or other circumstance of extreme urgency
requiring the use of the invention; or
"(d) In the case of drugs and medicines, there is public

non-commercial use of the patent by the patentee, without
satisfactory reason; or
"(e) In the case of drugs and medicines, the demand

for the patented article in the Philippines is not being met to an
adequate extent and on reasonable terms, as determined by the
Secretary of the Department of Health." ITDSAE
"74.2. Unless otherwise provided herein, the use by the

Government, or third person authorized by the Government shall be subject,
where applicable, to the following provisions:
"(a) In situations of national emergency or other

circumstances of extreme urgency as provided under Section
74.1(c), the right holder shall be notified as soon as reasonably
practicable;
"(b) In the case of public non-commercial use of the
patent by the patentee, without satisfactory reason, as provided
under Section 74.1 (d), the right holder shall be informed
promptly: Provided, That, the Government or third person
authorized by the Government, without making a patent search,
knows or has demonstrable ground to know that a valid patent
is or will be used by or for the Government;
"(c) If the demand for the patented article in the

Philippines is not being met to an adequate extent and on
reasonable terms as provided under Section 74.1 (e), the right
holder shall be informed promptly; HEcTAI
"(d) The scope and duration of such use shall be

limited to the purpose for which it was authorized;
"(e) Such use shall be non-exclusive;
"(f) The right holder shall be paid adequate

remuneration in the circumstances of each case, taking into
account the economic value of the authorization; and
"(g) The existence of a national emergency or other

circumstances of extreme urgency, referred to under Section
74.1 (c), shall be subject to the determination of the President
of the Philippines for the purpose of determining the need for
such use or other exploitation, which shall be immediately
executory.
"74.3. All cases arising from the implementation of this

provision shall be cognizable by courts with appropriate jurisdiction provided
by law.
"No court, except the Supreme Court of the Philippines, shall issue any
temporary restraining order or preliminary injunction or such other provisional
remedies that will prevent its immediate execution.
"74.4. The Intellectual Property Office (IPO), in consultation

with the appropriate government agencies, shall issue the appropriate
implementing rules and regulations for the use or exploitation of patented
inventions as contemplated in this section within one hundred twenty (120)
days after the effectivity of this law." AcSCaI
SECTION 9. Section 76.1 of Republic Act No. 8293, otherwise known as
follows:
"SEC. 76. Civil Action for Infringement. — 76.1. The making,

using, offering for sale, selling, or importing a patented product or a product
obtained directly or indirectly from a patented process, or the use of a patented
process without the authorization of the patentee constitutes patent
infringement: Provided, That, this shall not apply to instances covered by
Sections 72.1 and 72.4 (Limitations of Patent Rights); Section 74 (Use of
Invention by Government); Section 93.6 (Compulsory Licensing); and Section
93-A (Procedures on Issuance of a Special Compulsory License under the
TRIPS Agreement) of this Code.
"76.2. . . .;
"76.3. . . .;
"76.4. . . .;
"76.5. . . .; and
"76.6. . . . ."

follows: EHTIDA
"SEC. 93. Grounds for Compulsory Licensing. — The Director

General of the Intellectual Property Office may grant a license to exploit a
patented invention, even without the agreement of the patent owner, in favor
of any person who has shown his capability to exploit the invention, under any
of the following circumstances:
"93.1. National emergency or other

circumstances of extreme urgency;
"93.2. Where the public interest, in particular,

national security, nutrition, health or the development of other
vital sectors of the national economy as determined by the
appropriate agency of the Government, so requires; or
"93.3. Where a judicial or administrative body

has determined that the manner of exploitation by the owner of
the patent or his licensee is anti-competitive; or
"93.4. In case of public non-commercial use of

the patent by the patentee, without satisfactory reason;
"93.5. If the patented invention is not being

worked in the Philippines on a commercial scale, although
capable of being worked, without satisfactory reason: Provided,
That the importation of the patented article shall constitute
working or using the patent; (Secs. 34, 34-A, 34-B, R.A. No.
165a) and HcSETI
"93.6. Where the demand for patented drugs and

medicines is not being met to an adequate extent and on
reasonable terms, as determined by the Secretary of the
Department of Health."
SECTION 11. A new Section 93-A is hereby inserted after Section 93 of

Republic Act No. 8293, otherwise known as the Intellectual Property Code of the
Philippines, to read as follows:
"SEC. 93-A. Procedures on Issuance of a Special Compulsory

License under the TRIPS Agreement. — 93-A.1. The Director General of the
Intellectual Property Office, upon the written recommendation of the
Secretary of the Department of Health, shall, upon filing of a petition, grant a
special compulsory license for the importation of patented drugs and
medicines. The special compulsory license for the importation contemplated
under this provision shall be an additional special alternative procedure to
ensure access to quality affordable medicines and shall be primarily for
domestic consumption: Provided, That adequate remuneration shall be paid to
the patent owner either by the exporting or importing country. The
compulsory license shall also contain a provision directing the grantee the
license to exercise reasonable measures to prevent the re-exportation of the
products imported under this provision.
"The grant of a special compulsory license under this provision shall

be an exception to Sections 100.4 and 100.6 of Republic Act No. 8293 and
shall be immediately executory.
"No court, except the Supreme Court of the Philippines, shall issue any
temporary restraining order or preliminary injunction or such other provisional
remedies that will prevent the grant of the special compulsory license. IDcAHT
"93-A.2. A compulsory license shall also be available for the

manufacture and export of drugs and medicines to any country having
insufficient or no manufacturing capacity in the pharmaceutical sector to
address public health problems: Provided, That, a compulsory license has
been granted by such country or such country has, by notification or
otherwise, allowed importation into its jurisdiction of the patented drugs and
medicines from the Philippines in compliance with the TRIPS Agreement.
HTASIa
"93-A.3. The right to grant a special compulsory license under this

section shall not limit or prejudice the rights, obligations and flexibilities
provided under the TRIPS Agreement and under Philippine laws, particularly
Section 72.1 and Section 74 of the Intellectual Property Code, as amended
under this Act. It is also without prejudice to the extent to which drugs and
medicines produced under a compulsory license can be exported as allowed in
the TRIPS Agreement and applicable laws."

follows:
"SEC. 94. Period for Filing a Petition for a Compulsory License. —

94.1. A compulsory license may not be applied for on the ground stated in
Subsection 93.5 before the expiration of a period of four (4) years from the
date of filing of the application or three (3) years from the date of the patent
whichever period expires last.
"94.2. A compulsory license which is applied for on any of the

grounds stated in Subsections 93.2, 93.3, 93.4, and 93.6 and Section 97 may
be applied for at any time after the grant of the patent. (Sec. 34(1), R.A. No.
165)"

follows:
"SEC. 95. Requirement to Obtain a License on Reasonable

Commercial Terms. — 95.1. The license will only be granted after the
petitioner has made efforts to obtain authorization from the patent owner on
reasonable commercial terms and conditions but such efforts have not been
successful within a reasonable period of time. HIAcCD
"95.2. The requirement under Subsection 95.1 shall not apply in

any of the following cases:
"(a) Where the petition for compulsory license seeks

to remedy a practice determined after judicial or administrative
process to be anti-competitive;
"(b) In situations of national emergency or other

circumstances of extreme urgency;
"(c) In cases of public non-commercial use; and
"(d) In cases where the demand for the patented drugs

and medicines in the Philippines is not being met to an
adequate extent and on reasonable terms, as determined by the
Secretary of the Department of Health. cCaDSA
"95.3. In situations of national emergency or other

circumstances of extreme urgency, the right holder shall be notified as soon as
reasonably practicable.
"95.4. In the case of public non-commercial use, where the

government or contractor, without making a patent search, knows or has
demonstrable grounds to know that a valid patent is or will be used by or for
the government, the right holder shall be informed promptly. (n)
"95.5. Where the demand for the patented drugs and medicines
in the Philippines is not being met to an adequate extent and on reasonable
terms, as determined by the Secretary of the Department of Health, the right
holder shall be informed promptly." HEISca
follows:
"SEC. 147. Rights Conferred. — 147.1. Except in cases of

importation of drugs and medicines allowed under Section 72.1 of this Act
and of off-patent drugs and medicines, the owner of a registered mark shall
have the exclusive right to prevent all third parties not having the owner's
consent from using in the course of trade identical or similar signs or
containers for goods or services which are identical or similar to those in
respect of which the trademark is registered where such use would result in a
likelihood of confusion. In case of the use of an identical sign for identical
goods or services, a likelihood of confusion shall be presumed.
"There shall be no infringement of trademarks or tradenames of

imported or sold patented drugs and medicines allowed under Section 72.1 of
this Act, as well as imported or sold off-patent drugs and medicines: Provided,
That, said drugs and medicines bear the registered marks that have not been
tampered, unlawfully modified, or infringed upon, under Section 155 of this
Code.
"147.2. . . . ."
follows:
"SEC. 159. Limitations to Actions for Infringement. —

Notwithstanding any other provision of this Act, the remedies given to the
owner of a right infringed under this Act shall be limited as follows: DHITcS
"159.1. . . .;
"159.2 . . .;
"159.3 . . .; and
"159.4 There shall be no infringement of trademarks or

tradenames of imported or sold drugs and medicines allowed under Section
72.1 of this Act, as well as imported or sold off-patent drugs and medicines:
Provided, That said drugs and medicines bear the registered marks that have
not been tampered, unlawfully modified, or infringed upon as defined under
Section 155 of this Code."
SECTION 16. Implementing Rules and Regulations on Amendments to

Republic Act No. 8293, otherwise known as the Intellectual Property Code of the
Philippines. — Unless otherwise provided herein, the Intellectual Property Office, in
coordination with the Department of Health and the Bureau of Food and Drugs, shall
issue and promulgate, within one hundred twenty (120) days after the enactment of
this Act, the implementing rules and regulations to effectively implement the
provisions of this Act that relate to Republic Act No. 8293, otherwise known as the
Intellectual Property Code of the Philippines. caAICE
CHAPTER 3
Drugs and Medicines Price Regulation
SECTION 17. Drugs and Medicines Price Regulation Authority of the

President of the Philippines. — The President of the Philippines, upon
recommendation of the Secretary of the Department of Health, shall have the power to
impose maximum retail prices over any or all drugs and medicines as enumerated in
Section 23. aDcHIC
The power to impose maximum retail prices over drugs and medicines shall be
exercised within such period of time as the situation may warrant as determined by the
President of the Philippines. No court, except the Supreme Court of the Philippines,
shall issue any temporary restraining order or preliminary injunction or preliminary
mandatory injunction that will prevent the immediate execution of the exercise of this
power of the President of the Philippines.
SECTION 18. Drugs and Medicines Price Monitoring and Regulation

Authority of the Secretary of the Department of Health. — To implement the policies
of this Act under this Chapter, the Secretary of the Department of Health is hereby
authorized to establish and initiate a price monitoring and regulation system for drugs
and medicines within one hundred twenty (120) days after the enactment of this Act.
The Secretary of the Department of Health may also create such bodies, consultative
councils, from which advice may be sought in the implementation of a drug or
medicine price monitoring and regulation policy. Such bodies or consultative councils
created by the Secretary of the Department of Health shall coordinate its efforts
together with other government agencies.
SECTION 19. Functions and Responsibilities of the Secretary of the

Department of Health. — Pursuant to Section 18 of this Act, the Secretary of the
Department of Health shall have the following powers:
(A) Power to Recommend the Maximum Retail Price of Drugs and Medicines
Subject to Price Regulation — (1) Upon application or motu proprio when the public
interest so requires, the Secretary of the Department of Health shall have the power to
determine the maximum retail prices of drugs and medicines which shall be
recommended to the President of the Philippines for approval. In order that affordable
prices of drugs and medicines from the different manufacturers, importers, traders,
distributors, wholesalers, or retailers shall be made available to the public, the
Secretary of the Department of Health, as he/she may deem fit and after a proper
determination, shall have such approved maximum retail prices of drugs and
medicines published; ECTIHa
(2) In recommending the maximum retail price, the Secretary of the

Department of Health shall consider the following factors:
(a) Retail prices of drugs and medicines that are subject to regulation in the
Philippines and in other countries;
(b) The supply available in the market;
(c) The cost to the manufacturer, importer, trader, distributor, wholesaler or

retailer of the following, but not limited to:
(i) The exchange rate of the peso to the foreign currency with which
the drug or any of its component, ingredient or raw material was
paid for;
(ii) Any change in the amortization cost of machinery brought about

by any change in the exchange rate of the peso to the foreign
currency with which the machinery was bought through credit
facilities; ScAHTI
(iii) Any change in the cost of labor brought about by a change in

minimum wage; or
(iv) Any change in the cost of transporting or distributing the

medicines to the area of destination;
(d) Such other factors or conditions which will aid in arriving at a just and
reasonable maximum price; and
(3) No retailer shall sell drugs and medicines at a retail price exceeding the
maximum retail price approved by the President of the Philippines as provided in
Section 17 of this Act: Provided, That, the Secretary of the Department of Health shall
immediately undertake a study on the prevailing prices of drugs and medicines subject
to price regulation and provide an initial list of drugs and medicines, which maximum
retail prices he/she shall recommend to the President of the Philippines. cCSTHA
(B) Power to Include Other Drugs and Medicines in the List Subject to Price
Regulation — Upon application or motu proprio when the public interest so requires
and after proper determination, the Secretary of the Department of Health may order
the inclusion of drugs and medicines to the list subject of price regulation under
Section 23 hereof.
(C) Power to Implement Cost-Containment and Other Measures — (1) The

Secretary of the Department of Health shall have the power to implement the fair
price of drugs and medicines for purposes of public health insurance and government
procurement based on the order of the President of the Philippines imposing
maximum retail prices; and
(2) The Secretary of the Department of Health shall have the power to
implement any other measures that the government may avail of to effectively reduce
the cost of drugs and medicines that shall include, but not limited to, competitive
bidding, price volume negotiations, and other appropriate mechanisms that influence
supply, demand and expenditures on drugs and medicines. SIaHDA
(D) Power to Impose Administrative Fines and Penalties — After due notice
and hearing, the Secretary of the Department of Health shall have the power to impose
administrative fines against any person, manufacturer, importer, trader, distributor,
wholesaler, retailer, or any other entity, in such amount as it may deem reasonable,
which in no case shall be less than Fifty thousand pesos (Php50,000.00) nor more than
Five million pesos (Php5,000,000.00) for violations of the maximum retail price
approved by the President of the Philippines pursuant to the provisions of this
Chapter.
(E) Power to Deputize Government Entities — The Secretary of the

Department of Health shall have the power to call upon and deputize any official,
agent, employee, agency, or instrumentality of the national and local government for
any assistance that it may deem necessary to carry out the purposes of this Chapter.
(F) Other Powers Necessary to Implement Provisions of this Chapter — The

Secretary of the Department of Health shall exercise such powers and functions as
may be necessary to implement and enforce the provisions of this Chapter of this Act,
including the power to require the production and submission of records, documents,
books of account, bills of lading, input documents, records of purchase and sale,
financial statements, and such other documents, information and papers as may be
necessary to enable the Secretary of the Department of Health to carry out its
functions, duties, and responsibilities. Accordingly, within thirty (30) days from the
effectivity of this Act and every December 31st of every year thereafter, every
manufacturer, importer, trader, distributor, wholesaler, and retailer of a drug and
medicine whether included in or excluded from the list of drugs and medicines that
are subject to price regulation shall furnish the Secretary of the Department of Health
a list, containing on the minimum the corresponding prices and inventory, of all drugs
and medicines it manufactures, imports, trades, distributes, wholesales, or retails, data
pertaining to the factors enumerated under Section 19 (A) (2), and any and all
necessary information that the Secretary of the Department of Health may require.
ECcDAH
SECTION 20. Procedures for Inquiries, Studies, Hearings, Investigations,

and Proceedings. — All inquiries, studies, hearings, investigations and proceedings
conducted by the Secretary of the Department of Health shall be governed by the rules
adopted by him/her, and in the conduct thereof shall not be bound by the technical
rules of evidence.
SECTION 21. Effectivity of the Decisions or Orders of the Secretary of the

Department of Health. — All decisions or orders of the Secretary of the Department
of Health pursuant to Section 19 Paragraphs (A) Power to Recommend the Maximum
Retail Price 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, (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.
SECTION 22. Review of the Decisions or Orders of the Secretary of the

Department of Health. — A party adversely affected by a decision, order or ruling of
the Secretary of the Department of Health may, within thirty (30) days from notice of
such decision, order or ruling, or in case of a denial of a motion for reconsideration
thereof, within fifteen (15) days after notice of such denial, file an appeal with the
Court of Appeals, which shall have jurisdiction to review such decision, order or
ruling. DAcSIC
The filing of a petition for a writ of certiorari or other special remedies in the
Supreme Court shall in no case supersede or stay any decision, order or ruling of the
Secretary of the Department of Health, unless the Supreme Court shall so direct, and
the petitioner may be required by the Supreme Court to give bond in such form and of
such amount as may be deemed proper.
SECTION 23. List of Drugs and Medicines that are Subject to Price
Regulation. — The list of drugs and medicines that are subject to price regulation
shall include, inter alia:
(a) 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; 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); 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;
(b) Drugs and medicines indicated for prevention of diseases, e.g., vaccines,
immunoglobulin, anti-sera;
(c) Drugs and medicines indicated for prevention of pregnancy, e.g., oral
contraceptives;
(d) Anesthetic agents;
(e) Intravenous fluids;
(f) Drugs and medicines that are included in the Philippine National Drug
Formulary (PNDF) Essential Drug List; and aAHTDS
(g) All other drugs and medicines which, from time to time, the Secretary of
the Department of Health determines to be in need of price regulation.
IESDCH
SECTION 24. Illegal Acts of Price Manipulation. — Without prejudice to

the provisions of existing laws on goods not covered by this Act, 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, 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.
SECTION 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 or shall be
imposed a fine of not less than One hundred thousand pesos (Php100,000.00) nor
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.
Whenever any act of illegal price manipulation of any drug and medicine
subject to price regulation is committed by a juridical person, its officials or
employees, or in case of a foreign corporation or association, its agent or
representative in the Philippines who are responsible for the violation, shall be held
liable therefor.
SECTION 26. Display of Maximum Retail Price Fixed and Approved by

Order of the President of the Philippines for Drugs and Medicines Subject to Price
Regulation. — (a) Within a reasonable period as may be determined by the Secretary
of the Department of Health, and: Provided, That it conforms to existing drug product
labeling requirements, every manufacturer, importer, distributor, wholesaler, trader, or
retailer of a drug and medicine intended for sale shall display the retail price which
shall not exceed the maximum retail price approved by order of the President of the
Philippines. The maximum retail price 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. CaESTA
(b) Within a period as may be determined by the Secretary of the Department

of Health from time to time, every manufacturer, importer, or trader shall issue a price
list to wholesalers, distributors, retailers and to the Secretary of the Department of
Health, indicating the retail price, the maximum retail price, and such other
information as may be required by the Secretary of the Department of Health.
SECTION 27. Reports from Local Government Units (LGUs) and the
Department of Trade and Industry (DTI). — All local government units and the
Department of Trade and Industry shall help ensure the implementation of pricing
policies provided under this Chapter by submitting quarterly price monitoring reports
to the Secretary of the Department of Health of drugs and medicines identified by the
latter, and any and all necessary information that the Secretary of the Department of
Health may require.
SECTION 28. Role of the Department of Health (DOH) and the
Department of Trade and Industry (DTI). — The Department of Health and the
Department of Trade and Industry shall conduct independent periodic surveys and
studies of the selling prices of all drugs and medicines referred to in Section 23 of this
Act all over the country as well as their share or effect on the family income of the
different economic groups in the country for purposes of serving as data base for
government efforts to promote access to more affordable medicines, as well as
evaluating the effectivity of the measures undertaken to promote access to more
affordable medicines. The DTI shall always officially provide the Secretary of the
Department of Health copies of these independent reports. HIACac
SECTION 29. Rules and Regulations. — The Secretary of the Department

of Health, in consultation with the Department of Trade and Industry, the
Congressional Oversight Committee and other appropriate government agencies,
shall, within one hundred twenty (120) days from the effectivity of this Act,
promulgate the rules and regulations necessary to effectively implement the provisions
of this Chapter.
SECTION 30. Reportorial and Public Notice Requirements. — (a) The

Secretary of the Department of Health shall submit a bi-annual Monitoring Report of
its performance on the implementation of this Act to the Office of the President. This
report submitted to the Office of the President shall be published in a newspaper of
general circulation within thirty (30) days upon submission.
(b) It shall also submit annually a report of its performance on the

implementation of this Act to both Houses of Congress, within fifteen (15) days from
the opening of the regular session. It shall also regularly report and comply
immediately to any order of the Congressional Oversight Committee.
(c) The order of the President of the Philippines imposing maximum retail
prices on drugs and medicines, including the conditions implementing it, shall be
published within fifteen (15) days from issuance in at least two (2) newspapers of
general circulation. All wholesalers, manufacturers, distributors, importers, or traders
shall have a copy of the order of the President of the Philippines and provide the same
to their clients and customers for every transaction. CTcSIA
(d) All drug outlets are required to post in a conspicuous area within its
premises a clear copy of the order of the President of the Philippines which shall be
easily accessible to the consuming public and updated regularly as the situation may
warrant.
CHAPTER 4
Strengthening of the Bureau of Food and Drugs
SECTION 31. Strengthening of the Bureau of Food and Drugs (BFAD).

— (a) 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, like upgrading of its facilities, equipment outlay,
human resource development and expansion, and the acquisition of the appropriate
office space, among others, to improve the delivery of its services to the public. This
amount, which shall be in addition to the annual budget of the Bureau of Food and
Drugs, shall be deposited and maintained in a separate account or fund, which may be
used or disbursed directly by the Director or head.
(b) 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 (a) hereof, are sufficient to meet its budgetary requirements. If so, it shall
retain all the fees and charges it shall collect under the same conditions indicated in
said Subsection (a) but shall forthwith, cease to receive any funds from the annual
budget of the National Government; if not, the provisions of Subsection (a) shall
continue to apply until such time when the Director or head of the Bureau of Food and
Drugs, subject to the approval of the Secretary of the Department of Health, certifies
that the abovestated fees and charges the Bureau of Food and Drugs shall collect are
enough to fund its operations. SaHcAC
(c) 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.
SECTION 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: Provided,
further, That the registration for multisource pharmaceutical products should conform
to the WHO guidelines on registration requirements to establish interchangeability.
AaECSH
CHAPTER 5
Non-Discriminatory Clause
SECTION 33. Non-Discriminatory Clause. — It shall be unlawful for any

retail drug outlet to refuse to carry either by sale or by consignment, or offer for sale
drugs and medicines brought into the country, as allowed under Section 7 of this Act
which amends Section 72.1 of the Intellectual Property Code of the Philippines or
Republic Act No. 8293, by the government or authorized third party which have been
previously approved for distribution or sale by the Bureau of Food and Drugs. For this
purpose, the said products shall be displayed with equal prominence as all other
products sold in the establishment.
SECTION 34. Refusal to Sell Drugs and Medicines. — No manufacturer,

importer, trader, distributor, wholesaler shall withhold from sale or refuse to sell to a
wholesaler or retailer any drug or medicine without good and sufficient reasons.
SECTION 35. Penalties. — Any person or entity who shall refuse to carry
or sell drugs and medicines pursuant to the provisions of this Chapter shall be
punished with a fine of not less than One hundred thousand pesos (Php100,000.00)
but not more than Five hundred thousand pesos (Php500,000.00), at the discretion of
the court. For the succeeding offense, the penalties shall not be less than Five hundred
thousand pesos (Php500,000.00) but not more than One million pesos
(Php1,000,000.00), at the discretion of the court, and suspension or revocation of its
license to operate (LTO), business or professional license, as the case may be. cDHAES
SECTION 36. Implementing Rules and Regulations on the

Non-Discriminatory Clause. — Within one hundred twenty (120) days from the
effectivity of this Act, the Department of Health, in consultation with the Department
of Trade and Industry, shall promulgate the rules and regulations necessary to
effectively implement the provisions of this Chapter. TaSEHD
CHAPTER 6
Amendments to Republic Act No. 6675, Otherwise known as the Generics Act of 1988

the Generics Act of 1988, is hereby amended to read as follows:
"SEC. 5. 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. 6. Who Shall Use Generic Terminology. — (a) 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. ECTIHa
"(b) 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.
"(c) 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.
"(d) 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. IASCTD
"(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."

"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. 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 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." DETcAH

"SEC. 12. Penalty. — (A) Any person who shall violate Section 6(a)
or 6(b) of this Act shall suffer the penalty graduated hereunder, viz: LLjur
"(a) for the first conviction, he shall suffer the penalty of reprimand
which shall be officially recorded in the appropriate books of the Professional
Regulation Commission.
"(b) for the second conviction, the penalty of fine in the amount of
not less than Ten thousand pesos (Php10,000.00) but not exceeding
Twenty-five thousand pesos (Php25,000.00), at the discretion of the court.
"(c) for the third conviction, the penalty of fine in the amount of not
less than Twenty-five thousand pesos (Php25,000.00) but not exceeding Fifty
thousand pesos (Php50,000.00) and suspension of his license to practice his
profession for sixty (60) days at the discretion of the court.
"(d) for the fourth and subsequent convictions, the penalty of fine of
not less than One hundred thousand pesos (Php100,000.00) and suspension of
his license to practice his profession for one (1) year or longer at the discretion
of the court. TaCDcE
"(B) Any juridical person who violates Sections 6(c), 6(d), 7 or 8 shall
suffer the penalty of a fine of not less than One hundred thousand pesos
(Php100,000.00) and suspension or revocation of license to operate such drug
establishment or drug outlet at the discretion of the court: Provided, That its
officers directly responsible for the violation shall suffer the penalty of fine of
at least Forty thousand pesos (Php40,000.00) and suspension or revocation of
license to practice profession, if applicable, and by imprisonment of not less
than six (6) months nor more than one (1) year or both fine and imprisonment
at the discretion of the court: and, 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.
"The administrative sanctions that shall be imposed by the Secretary of

the Department of Health shall be in a graduated manner in accordance with
Section 12.A.
"An administrative case may be instituted independently from the

criminal case: Provided, That, the dismissal of the criminal case or the
withdrawal of the same shall in no instance be a ground for the dismissal of
the administrative case." AcHCED
SECTION 42. Implementing Rules and Regulations to the Amendments to

the Generics Act of 1988. — The Department of Health, in consultation with the
appropriate government agencies, shall, within one hundred twenty (120) days from
the effectivity of this Act, promulgate the rules and regulations necessary to
effectively implement the provisions of this Act that relate to Republic Act No. 6675,
or the Generics Act of 1988.
CHAPTER 7
Amendments to Republic Act No. 5921, as Amended, Otherwise known as the

Pharmacy Law
SECTION 43. Section 25 of Republic Act No. 5921, as amended,

otherwise known as the Pharmacy Law, is hereby amended to read as follows:
"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. cTACIa
"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."
SECTION 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
SECTION 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. aHTDAc
SECTION 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.
SECTION 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.
SECTION 48. Repealing Clause. — All laws, decrees, executive orders,

proclamations and administrative regulations or parts thereof inconsistent herewith are
hereby repealed or modified accordingly. AIaDcH
SECTION 49. Effectivity Clause. — This Act shall take effect fifteen (15)
days after its publication in at least two (2) national papers of general circulation.
Approved: June 6, 2008
Endnotes
1 (Popup - Popup)
Implementing Rules and Regulations of RA 9502 (Universally Accessible, Cheaper and Quality Medicines
Act of 2008)
EO 54-2011
AO 268-2009
EO 821-2009
RA 165
RA 5921
RA 6675
RA 8293

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(1)

REPUBLIC ACT NO. 9502

AN ACT PROVIDING FOR CHEAPER AND QUALITY MEDICINES, AMENDING

SECTION 1. Short Title. — This Act shall be known as the "Universally

SECTION 2. Declaration of Policy. — It is the policy of the State to

Pursuant to the attainment of this general policy, an effective competition

SECTION 3. Construction in Favor of Protection of Public Health. —

SECTION 4. Definition of Terms. — For purposes of this Act, the

(a) "Compulsory License" is a license issued by the Director General of the

(c) "Drugs and medicines" refers to any chemical compound or biological

(1) any article recognized in the official United States

(4) any article intended for use as a component of any articles

(5) herbal and/or traditional drugs which are articles of plant or

(i) recognized in the Philippine National Drug

(ii) intended for use in the treatment or cure or mitigation

(iii) other than food, intended to affect the structure or

(iv) in finished or ready-to-use dosage form; and

(v) intended for use as a component of any of the articles

(f) "Manufacture" includes any process or part of a process for making,

(g) "Manufacturer" refers to any establishment engaged in the operations

(h) "Multisource pharmaceutical products" refers to pharmaceutically

(i) "Retailer" refers to a licensed establishment carrying on the retail

(k) "TRIPS Agreement" or Agreement on Trade-Related Aspects of

(l) "Wholesaler" refers to a licensed establishment or drug outlet who acts

Amendments to Republic Act No. 8293, Otherwise known as

SECTION 5. Section 22 of Republic Act No. 8293, otherwise known as

"SEC. 22. Non-Patentable Inventions. — The following shall be

"22.1. Discoveries, scientific theories and mathematical

"For the purpose of this clause, salts, esters, ethers, polymorphs,

SECTION 6. Section 26 of Republic Act No. 8293, otherwise known as

"SEC. 26. Inventive Step. — 26.1. An invention involves an

"26.2. In the case of drugs and medicines, there is no inventive

SECTION 7. Section 72 of Republic Act No. 8293, otherwise known as

"SEC. 72. Limitations of Patent Rights. — The owner of a patent

"72.1. Using a patented product which has been

"72.2. Where the act is done privately and on a

"72.3. Where the act consists of making or using

"72.4. In the case of drugs and medicines, where

"72.5. Where the act consists of the preparation

"72.6 Where the invention is used in any ship,

SECTION 8. Section 74 of Republic Act No. 8293, otherwise known as

"SEC. 74. Use of Invention by Government. — 74.1. A Government

"(a) The public interest, in particular, national security,

"(b) A judicial or administrative body has determined

"(c) In the case of drugs and medicines, there is a

"(d) In the case of drugs and medicines, there is public

"(e) In the case of drugs and medicines, the demand

"74.2. Unless otherwise provided herein, the use by the

"(a) In situations of national emergency or other

"(c) If the demand for the patented article in the

"(d) The scope and duration of such use shall be

"(e) Such use shall be non-exclusive;

"(f) The right holder shall be paid adequate

"(g) The existence of a national emergency or other

"74.3. All cases arising from the implementation of this

"74.4. The Intellectual Property Office (IPO), in consultation

"SEC. 76. Civil Action for Infringement. — 76.1. The making,

SECTION 10. Section 93 of Republic Act No. 8293, otherwise known as

"SEC. 93. Grounds for Compulsory Licensing. — The Director