Prescribing the Maximum Drug Retail Prices for Selected Drugs and Medicines

July 27, 2009

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); HCaDIS

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; DETcAH

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:

SECTION 1. List of Medicines and Corresponding Maximum Drug Retail Price (MDRP). —

	ACTIVE
	INGREDIENT/	DOSAGE STRENGTH	MDRP (PhP)
	MOLECULE	AND FORM
ANTI-HYPERTENSIVE
1.	Amlodipine	2.5 mg tablet	9.60
	(including its
	S-isomer and
	all salt form)
		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 +	45.75
		Atorvastatin calcium 10 mg
		tablet
		Amlodipine besilate 5 mg +
		Atorvastatin calcium 20 mg	66.25
		tablet
		Amlodipine besilate 5 mg +	84.42
		Atorvastatin calcium 40 mg
		tablet
		Amlodipine besilate 5 mg +	89.99
		Atorvastatin calcium 80 mg
		tablet
		Amlodipine besilate 10 mg +	51.13
		Atorvastatin calcium 10 mg
		tablet
		Amlodipine besilate 10 mg +	73.25
		Atorvastatin calcium 20 mg
		tablet
		Amlodipine besilate 10 mg +	91.79
		Atorvastatin calcium 40 mg
		tablet
		Amlodipine besilate 10 mg +	91.79
		Atorvastatin calcium 80 mg
		tablet
ANTIBIOTIC/ANTIBACTERIAL
3.	Azithromycin and all	250 mg tablet	108.50
	its Salt form
		200 mg/5 mL powder for	427.50
		suspension (15 mL)
		200 mg/5 mL powder for	638.00
		suspension (22.50 mL)
		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)	900.00
		(5mL) or 500 mg vial
		100 mg/mL ampul/vial (IV/SC)	1800.00
		(10mL) or 1g vial
		20 mg/mL (5mL) ampul/vial	1980.00
		for injection
5.	Doxorubicin and all	10 mg powder vial for injection	1465.75
	its Salt form
		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. aSITDC

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. STcDIE

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 Service Insurance System and all government entities reimbursing drugs and medicines including the PCSO. HDCAaS

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. All 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. aTcIAS

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. DCSTAH