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Cheaper Medicines Act of 2008
Cheaper Medicines Act of 2008
June 6, 2008
CHAPTER 1
General Provisions
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protecting public health. DETcAH
(b) "Drug outlet" refers to drugstores, pharmacies, and any other business
establishments which sell drugs and medicines; 2ndrellaws08
(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;
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Formulary;
(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;
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(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;
CHAPTER 2
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"22.2. . . .;
"22.3. . . .;
"22.4. . . .;
"22.5. . . .; and
"22.6. . . . ."
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"(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;
"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.
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SECTION 9. Section 76.1 of Republic Act No. 8293, otherwise known as
the Intellectual Property Code of the Philippines, is hereby amended to read as
follows:
"76.2. . . .;
"76.3. . . .;
"76.4. . . .;
"76.5. . . .; and
"76.6. . . . ."
"No court, except the Supreme Court of the Philippines, shall issue any
temporary restraining order or preliminary injunction or such other provisional
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remedies that will prevent the grant of the special compulsory license. IDcAHT
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successful within a reasonable period of time. HIAcCD
"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
SECTION 14. Section 147 of Republic Act No. 8293, otherwise known as
the Intellectual Property Code of the Philippines, is hereby amended to read as
follows:
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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.
"147.2. . . . ."
SECTION 15. Section 159 of Republic Act No. 8293, otherwise known as
the Intellectual Property Code of the Philippines, is hereby amended to read as
follows:
"159.1. . . .;
"159.2 . . .;
"159.3 . . .; and
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CHAPTER 3
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.
(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
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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
(a) Retail prices of drugs and medicines that are subject to regulation in the
Philippines and in other countries;
(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;
(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
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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.
(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.
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
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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;
(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
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 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.
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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
(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
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warrant.
CHAPTER 4
(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.
CHAPTER 5
Non-Discriminatory Clause
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
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CHAPTER 6
Amendments to Republic Act No. 6675, Otherwise known as the Generics Act of 1988
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"(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. 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
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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.
CHAPTER 7
CHAPTER 8
Miscellaneous Provisions
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.
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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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