MALACAÑANG
MANILA
EXECUTIVE
ORDER NO. 821
PRESCRIBING
THE MAXIMUM DRUG RETAIL PRICES FOR SELECTED DRUGS AND MEDICINES THAT
ADDRESS DISEASES THAT ACCOUNT FOR THE LEADING CAUSES OF MORBIDITY AND
MORTALITY
WHEREAS,
access to affordable medicines for diseases that account for the
leading causes of morbidity and mortality is critical to improve the
health and productivity of Filipinos, prevent impoverishment of
families due to high cost of health care and thereby achieve the
Millennium Development Goals and National Objectives for Health;
WHEREAS,
Chapter 3, Section 17, of Republic Act 9502, otherwise known as “The
Universally Accessible Cheaper and Quality Medicines Act of 2008,”
and its implementing rules and regulations provide that 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 and provided
for within the law;
WHEREAS,
in an effort to make medicines affordable and accessible to the
majority of Filipinos, and acting on the conviction that health is a
basic human right, the President ordered the Department of Health and
the Department of Trade and Industry to determine and recommend
Maximum Drug Retail Prices (MDRP);
WHEREAS,
the determination of the MDRP is premised on the following criteria:
(a) conditions that address public health priorities especially those
that account for the leading causes of morbidity and mortality; (b)
drugs that have high price differentials/arbitrage compared to
international prices; (c) drugs that have limited competition in
terms of lack of generic counterparts or lack of market access to
these products; (d) drugs where the innovator product is the most
expensive yet most prescribed and/or dispensed in the market; and (e)
the conditions as stated in Sections 19 (2) of Republic Act No. 9502,
among others;
WHEREAS,
various stakeholders, academic institutions, including the Advisory
Council for Medicine Price Regulation created pursuant to Section 18
of RA 9502, were involved in the process of consultation in the
selection of the initial twenty-one (21) drugs and medicines for the
imposition of MDRP;
WHEREAS,
as a consequence of the President’s appeal to pharmaceutical
companies during the process of consultation, many of these companies
voluntarily undertook to reduce by at least fifty per cent (50%) the
prices of sixteen (16) drugs that address diseases of public health
concern originally included in the MDRP, such as hypertension,
diabetes, common bacterial infections, amoebiasis (a leading cause of
diarrhea), cancers (like leukemia, the number one pediatric cancer
killer) and the like. In addition, these pharmaceutical companies
also undertook to reduce by about ten to fifty per cent (10%-50%) the
prices of twenty-two (22) other drugs and medicines not included in
the initial list recommended by the DOH and DTI. The reduction of the
prices of these drugs and medicines shall commence on August 15, 2009
and shall be fully implemented by September 15, 2009;
WHEREAS,
of the
original drugs and medicines recommended for MDRP, only five (5) are
not compliant with the rates proposed by DOH and DTI;
NOW
THEREFORE, I, GLORIA MACAPAGAL-ARROYO, President
of the Republic of the Philippines, by the powers vested in me by
law, do hereby impose the Maximum Drug Retail Prices over the
following active ingredients, including the indicated specific
preparations registered and available in the market:
ACTIVE
INGREDIENT/ MOLECULE |
DOSAGE
STRENGTH AND FORM
|
MDRP
(PhP)
|
||
ANTI-HYPERTENSIVE | ||||
1. Amlodipine (including its S-isomer and all salt form) | 2.5 mg tablet | 9.60 | ||
5 mg tablet | 22.85 | |||
10 mg tablet | 38.50 | |||
ANTI-CHOLESTEROL | ||||
2. Atorvastatin | 10 mg film-coated tablet | 34.45 | ||
20 mg film-coated tablet | 39.13 | |||
40 mg film-coated tablet | 50.50 | |||
80 mg film-coated tablet | 50.63 | |||
Amlodipine besilate 5 mg + Atorvastatin calcium 10 mg tablet | 45.75 | |||
Amlodipine besilate 5 mg + Atorvastatin calcium 20 mg tablet | 66.25 | |||
Amlodipine besilate 5 mg + Atorvastatin calcium 40 mg tablet | 84.42 | |||
Amlodipine besilate 5 mg + Atorvastatin calcium 80 mg tablet | 89.99 | |||
Amlodipine besilate 10 mg + Atorvastatin calcium 10 mg tablet | 51.13 | |||
Amlodipine besilate 10 mg + Atorvastatin calcium 20 mg tablet | 73.25 | |||
Amlodipine besilate 10 mg + Atorvastatin calcium 40 mg tablet | 91.79 | |||
Amlodipine besilate 10 mg + Atorvastatin calcium 80 mg tablet | 91.79 | |||
ANTIBIOTIC/ ANTIBACTERIAL | ||||
3. Azithromycin and all its Salt form | 250 mg tablet | 108.50 | ||
200 mg/5 ml_ powder for suspension (15 mL) | 427.50 | |||
200 mg/5 mL powder for suspension (22.50 mL) | 638.00 | |||
500 mg tablet | 151.43 | |||
500 mg vial for injection | 992.50 | |||
2 g granules | 468.00 | |||
ANTI-NEOPLASTICS/ ANTI-CANCER | ||||
4. Cytarabine | 100 mg/ mL ampul/vial (IV/SC) | 240.00 | ||
100 mg/ mL ampul/vial (IV/SC) (5mL) or 500 mg vial | 900.00 | |||
100 mg/ mL ampul/vial (IV/SC) (10mL) or 1g vial | 1800.00 | |||
20 mg/mL (5mL) ampul/vial for injection | 1980.00 | |||
5. Doxorubicin and all its Salt form | 10 mg powder vial for injection | 1465.75 | ||
50 mg powder vial for injection | 2265.74 |
Section
2. APPLICABILITY.
a. This Order
shall apply to all medicines covered under Section 1 which are
currently BFAD-registered and are available in the market.
b. The MDRP of
all drugs and medicines stated herein shall be imposed in all retail
outlets, public or private, including drugstores, hospitals and
hospital pharmacies, health maintenance organizations (HMOs),
convenience stores and supermarkets and the like.
b.1.
Price differentials as an effect of this Order shall be shouldered by
the corresponding manufacturer/trader/importer.
b.2.
No public or private entity or person shall be allowed to sell,
reimburse, or demand from the public or patients payment or
compensation higher than the MDRP.
c. This Order
shall also apply to government agencies, offices and
instrumentalities procuring, acquiring and reimbursing drugs and
medicines covered in Section 1 hereof.
c.1.
The prescribed MDRP shall serve as the ceiling for the procurement of
the herein enumerated list of drugs by the national agencies, local
government units, and all other government entities including but not
limited to the Philippine Charity Sweepstakes Office (PCSO) and the
Philippine Amusement and Gaming Corporation (PAGCOR).
c.2.
The prescribed MDRP shall serve as the ceiling for the procurement of
the said enumerated list of drugs by government hospitals including
the Philippine General Hospital, hospitals managed by the Department
of Health including specialty centers, hospitals under the auspices
of the Department of National Defense and the Philippine National
Police, government-owned and controlled hospital corporations, local
government hospitals, and all other types of government hospitals.
c.3.
The prescribed MDRP shall serve as the ceiling for the retail price
of the said enumerated list of drugs of all drug consignment
arrangements entered into by government hospitals including
government-owned and controlled hospital corporations and local
government units, and all other government entities.
c.4.
The prescribed MDRP shall serve as the ceiling for the reimbursement
of the said enumerated list of drugs by the Philippine Health
Insurance Corporation, the Social Security System and the Government
Services Insurance System and all government entities reimbursing
drugs and medicines including the PCSO.
Section
3. IMPLEMENTATION.
a. The Department
of Health is hereby ordered to put in place all the necessary
policies and systems to fully implement this Order.
b. The Bureau of
Food and Drugs (BFAD) shall immediately act upon any application for
registration of drugs and medicines listed above within fifteen (15)
days upon its filing; thereafter, the approval or disapproval of the
Certificate of Product Registration should be released within ninety
(90) days.
c. Ail
government-owned and controlled television and radio stations are
hereby ordered to provide all necessary support to DOH in
disseminating the list of drugs, their MDRPs, and such other
information as required.
d. All other
agencies of government, national and local, including
Government-Owned Controlled Corporations (GOCCs) and Government
Funding Institutions (GFIs) are hereby ordered to provide all
necessary support to DOH for the enforcement and implementation of,
including the dissemination of information, as well as monitoring
compliance with this Order.
Section
4. VIOLATIONS AND CIRCUMVENTION OF THE MDRP. Any
actions construed as circumventing or violating the intent of this
Order shall be dealt with accordingly.
Section
5. REVIEW. The
list of medicines and their corresponding MDRPs shall be subject for
review after three (3) to six (6) months by the DOH and as may be
recommended thereafter upon the effectivity of this Order or as often
as necessary as determined by the Secretary of Health.
Section
6. TRANSITION. The
period from the issuance of this Order up to August 15, 2009 shall
constitute the transition period in which appropriate packaging,
labeling, and disposition of existing inventory should be
accomplished.
Thereafter,
regardless of extent of existing inventory and compliance with
packaging and labeling requirements, strict implementation of the
MDRP and this Order shall be enforced.
Section
7. REPEALING CLAUSE. All
executive issuances, orders, rules and regulations or parts thereof
inconsistent with this Executive Order are hereby revoked or modified
accordingly.
Section
8. EFFECTIVITY. This
Order shall immediately be published in at least two (2) newspapers
of general circulation and shall take effect on August 15, 2009.
DONE on this 27th
day of July
in the Year of Our Lord Two Thousand and Nine.
(Sgd.) GLORIA
MACAPAGAL-ARROYO
By the President:(Sgd.) EDUARDO R. ERMITA
Executive
Secretary