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AmendED:

RA 8293 - Intellectual Property


Code of the Philippines

RA 6675 - Generics Act of


1998
RA 5921- Pharmacy Law

Access to Effective
affordable competition
quality
(PRIMARY)
drugs and
medicines Price regulation
for all

Intellectual
Property Office
(IPO)

Patentability of drugs and medicines


Compulsory licensing
Special compulsory licensing
Infringement

Safety, quality and efficacy of drugs and


medicines and procedures on parallel
Food and Drug importation

Administration
(FDA)

Innovator or Comparator Drug


drug with an active pharmaceutical
ingredient or molecule that was first or
originally marketed anywhere in the world
on the basis of documentation of quality,
safety and efficacy by a specific company or
an entity which is expressed in its international
non-proprietary name and usually carries a
brand name.

Pharmaceutical alternative
refers to products that contain the same
molar amount of the same active
pharmaceutical moiety(s) but differ in dosage
form, and/or chemical form
deliver the same active moiety by the same
route of administration but are otherwise not
pharmaceutically equivalent.
may or may not be bioequivalent or
therapeutically equivalent to the comparator
product

Pharmaceutical equivalence
refers to drug products that contain the
same molar amount of the same active
pharmaceutical ingredient(s) in the same dosage
form, if they meet comparable standards, and if they
are intended to be administered by the same route.
does not necessarily imply therapeutic
equivalence, as differences in the excipients and/or
the manufacturing process and some other
variables can lead to differences in product
performance.

Therapeutically equivalent
refers to two pharmaceutical products that
are pharmaceutically equivalent or
pharmaceutical alternatives and after
administration in the same molar dose, their
effects, with respect to both efficacy and
safety, are essentially the same when
administered to patients by the same route.

Interchangeable pharmaceutical
product
drug which is therapeutically equivalent
to an innovator drug and can be
interchanged with the innovator drug in clinical
practice.
It does not necessarily refer to
Bioavailability/Bioequivalence (BA/BE),
which is not applicable to all drug products.

Non-traditional outlets
refers to supermarkets, convenience
stores, other retail establishments duly
licensed by the BFAD to sell over-the-counter
drugs

AmendED:
RA 8293 - Intellectual Property
Code of the Philippines

RA 6675 - Generics Act of


1998
RA 5921- Pharmacy Law

Access to Effective
affordable competition
quality
(PRIMARY)
drugs and
medicines Price regulation
for all

COMPULSORY
LICENSE

USE BY
GOVERNMENT

EFFETIVE
COMPETITION

SPECIAL
COMPULSORY
LICENSE

PARALLEL
IMPORTATION

right of the patent owner to


prevent unauthorized persons
from using the patented process
and making, using, offering for sale,
or importing the patented product or
a product obtained directly by the
patented process

RA 8293 - "Intellectual Property Code of the


Philippines

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;

1. Introduction in
the Philippines or
Anywhere Else in
the World

2. Private and
Non-commercial
scale or purpose

3. Experimental Use
for Scientific or
Educational
Purposes

4. Regulatory Evaluation
and Approval
a) Use of Data by BFAD
b) Data Protection from
Unfair Commercial
Use

5. Preparation in a
Pharmacy or by a
Medical Professional

6. Ship, Vessel,
Aircraft or Land
Vehicle Use

(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 of exploitation by the
owner of the patent or his licensee, is
anticompetitive;

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


national emergency or other circumstances of
extreme urgency requiring the use of the invention

(d) In the case of drugs or medicines, there is


public noncommercial use of the patent by the
patentee, without satisfactory reason

(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

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

(a) National emergency or


other circumstances of
extreme urgency;

(b) 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;

(c) Where a judicial or administrative


body has determined that the manner of
exploitation by the owner of the patent or
his licensee is anticompetitive;

(d) In case of public non-commercial


use of the patent by the patentee, without
satisfactory reason;

(e) 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;

(f) 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.

FIRST
PATENT

PATENT
SECOND
PATENT

A compulsory license 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 (TradeRelated Aspect of Intellectual Property Rights)
Agreement

Imports of a patented or
trademarked product from a country
where it is already marketed. (WHO)

Civil Action
Patent Infringement
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

Access to Effective
affordable competition
quality
(PRIMARY)
drugs and
medicines Price regulation
for all

e-EDPMS

COSTCONTAINMENT
MEASURES

PRICE
REGULATION

AGAINST
ILLEGAL PRICE
MANIPULATION

MDRP

Determination of Maximum Retail Prices of Drugs and Medicines

Inclusion Drugs and Medicines in the List Subject to Price Regulation.

Implementation of Fair Price of Drugs and Medicine

Implementation of Cost Containment Measures

Imposition of Administrative Fines and Penalties

Deputization of Government Entities

Inquiries, Studies, Hearings, Investigations, and Proceedings

AO 2008-0014 - Guidelines on the Pilot


Implementation of Electronic Essential Drug
Price Monitoring System
AO 2011-0012 Implementing Guidelines
on the Electronic Drug Price Monitoring
System (EDPMS) version 2.0

National Center for Pharmaceutical Access


and Management (NCPAM)
of the Department of Health
was mandated to ensure universal access to Essential
Medicines for all Filipinos
established Electronic Essential Drug Price Monitoring
System (e-EDPMS)
System-owner and over-all lead office in managing the
implementation of e-EDPMS

a) Establish policies, procedures and guideline in data collection,


reporting, processing, analysis and dissemination of information.
b) Issue orders or issuances requiring pharmaceutical outlets and
establishments to use the Electronic Drug Price Monitoring System
software in reporting data to the DOH
c) Check or validate the data being reported to the DOH.
d) Review reports or information, and provide analysis or
interpretation.
e) Prepare factsheets and annual medicines price bulletin.

f) Monitor and evaluate the implementation of the system.


g) Provide funds necessary to maintain and implement the
h) Provide orientation and training on matters related to the use or
operation of the system and other relevant trainings.

i) Grant user names and passwords to users who are authorized to


use the e-EDPMS.

FDA Circular No. 2010-017 and


Department Circular No. 2010-0200
FDA Circular No. 2010-017 - dated 04 October 2010
Department Circular No. 2010-0200 - dated 16 July 2010
Requires all drug manufacturers and traders to upload
their data in the e-EDPMS website on or before 15 October
2010.

FDA Implementation
FDA Circular No. 2010-017 - dated 04 October 2010
Department Circular No. 2010-0200 - dated 16 July 2010
Include in the inspection parameters of the Drug
Establishments during the initial and renewal application of their
LTO:
Has the Pharmacist or staff attended e-EDPMS Seminar
Has the pricelist been uploaded and updated regularly?

http://uhmis2.doh.gov.ph/eedpms

List of Drugs Subject to Price Regulations


Criteria:
Included in the current edition of the PNDF essential drug
list
Indicated for the treatment of chronic illnesses and life
threatening conditions
Indicated for prevention of diseases
Indicated for prevention of pregnancies
Anesthetic agents
Intravenous fluids
As determined by Secretary of DOH

Factors Used by DOH in Determining


Products Under MRP
Address public health authorities especially those that
account for the leading causes of morbidity and
mortality
Drugs that have high price differentials/ arbitrage
compared to international prices
Drugs that have limited competition in terms of lacking
of generic counterparts or lack of market access to
these products
Drugs where innovator product is most expensive and
most prescribed and/or dispensed in the market

Factors to Consider in Recommending MRP


Cost to the manufacturer, importer, trader, distributor, wholesaler, or
retailer of the following but not limited to:
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
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 machinery was brought through
credit facilities
Any change in the cost of labor brought about by a change in
minimum wage
Any change in the cost of transporting or distributing the
medicines to the area of destination

Factors to Consider in Recommending MRP


Retail prices of drugs and medicines that are subject to regulation
in the Philippines and other countries
Supply available in the market
Others:
Marketing costs (per drug and total global cost)
Research costs (local and global/per drug)
Promotion costs
Advertising costs
Incentives and discounts
Taxes and other fees, imposts, duties, and other charges
imposed by competent authorities
Other analogous cases

GMAP and MDRP


GMAP
- Government Mediated Access Price
- voluntary price reduction by 50%

MDRP
- Maximum Drug Retail Price
- mandatory price reduction by EO 821 s 2009

Products under GMAP


1st batch
- Of the 21 products in the DOH list, 16 molecules were
voluntarily reduced by 50% on August 2009

2nd batch
- 93 more medicines and five medical devices were brought
down up to 70% off current retail prices
- For majority of products, the new price rate took effect on
March 31, 2010
- The new price rate for other products took effect on
August 1, 2010

1st batch of Products


under GMAP
(16 molecules)

ACTIVE
INGREDIENT/
MOLECULE

DOSAGE STRENGTH AND FORM

COMPANY

OLD
RETAIL
PRICE

GMAP

40mg tablet

Boehringer

51.50

25.75

Telmisartan 40mg +
Hydrochlorothiazide 12.5mg tablet

Boehringer

50.00

25.00

80mg tablet

Boehringer

89.00

44.50

Telmisartan 80mg +
Hydrochlorothiazide 12.5mg tablet

Boehringer

89.00

44.50

150mg tablet

Sanofi-Aventis
via Winthrop

48.76

24.38

Irbesartan 150mg +
Hydrochlorothiazide 12.5mg tablet

Sanofi-Aventis
via Winthrop

50.26

25.13

300mg tablet

Sanofi-Aventis
via Winthrop

80.00

40.00

Irbesartan 300mg +
Hydrochlorothiazide 12.5mg tablet

Sanofi-Aventis
via Winthrop

83.00

41.50

ANTIHYPERTENSIVE
1. Telmisartan

2. Irbesartan

ACTIVE
INGREDIENT/
MOLECULE

DOSAGE STRENGTH AND FORM

COMPANY

OLD
RETAIL
PRICE

GMAP

75mg Film-coated tablet

Sanofi-Aventis

123.50

61.75

30mg Modified Release tablet

Servier

15.00

7.50

80mg tablet

Servier

15.00

7.50

Piperacillin 2g + Tazobactam 250mg


vial

Wyeth

2175.46

730.20

4g + Tazobactam 500mg vial

Wyeth

4614.00

1270.06

ANTI-THROMBOTIC

3. Clopidogrel

ANTI-DIABETIC/ ANTIHYPOGLYCEMIC
4. Gliclazide

ANTIBIOTIC/ ANTIBACTERIAL
5. Piperacillin +
Tazobactam an
all its salt form

ACTIVE
INGREDIENT/
MOLECULE

DOSAGE STRENGTH AND FORM

COMPANY

OLD
RETAIL
PRICE

GMAP

500mg tablet

Bayer

83.83

41.91

500mg tablet (Extended Release)

Bayer

99.23

49.62

1g tablet

Bayer

145.10

72.55

250mg tablet

Bayer

65.13

32.57

2mg/ml (100ml) for injection

Bayer

1884.17

942.00

2mg/ml (50ml) or 100mg IV infusion


(50ml)

Bayer

1440.87

720.43

400mg (200ml) for injection

Bayer

3207.17

1603.59

125mg/5ml (60ml) suspension

Sanofi-Aventis

131.00

65.50

500mg tablet

Sanofi-Aventis
via Winthrop

23.50

11.75

500mg (100ml) IV infusion

Sanofi-Aventis

379.50

189.75

ANTIBIOTIC/ ANTIBACTERIAL
6. Ciprofloxacin
and all its salt
form

7. Metronidazole
and all its salt
form

ACTIVE
INGREDIENT/
MOLECULE

DOSAGE STRENGTH AND FORM

COMPANY

OLD
RETAIL
PRICE

GMAP

625mg tablet

GSK

97.75

48.90

375mg tablet

GSK

79.50

39.75

1g tablet

GSK

142.25

71.15

600mg vial for injection

GSK

687.50

343.75

1.2g vial for injection

GSK

1156.75

578.40

Amoxicillin 200mg +Clavulanic Acid


28.5mg/5ml (70ml) suspension

GSK

555.50

277.75

Amoxicillin 125mg +Clavulanic Acid


31.25mg/5ml (60ml) suspension

GSK

378.00

189.00

Amoxicillin 250mg +Clavulanic Acid


62.5mg/5ml (60ml) suspension

GSK

648.50

324.25

Amoxicillin 400mg +Clavulanic Acid


57mg/5ml (70ml) suspension

GSK

940.50

470.25

Amoxicillin 400mg +Clavulanic Acid


57mg/5ml (35ml) suspension

GSK

523.75

261.90

ANTIBIOTIC/ ANTIBACTERIAL

8. Co-Amoxiclav
(Amoxicillin +
Clavulanic
Acid)

ACTIVE INGREDIENT/
MOLECULE

DOSAGE
STRENGTH AND
FORM

COMPANY

OLD RETAIL
PRICE

GMAP

15mg vial/ampul for


injection

Bristol-Meyer
Squibb via Zuellig

9750.00

3520.00

10. Carboplatin

10mg/vial (15ml) vial


or 150mg for injection

Bristol-Meyer
Squibb via Zuellig

3610.00

1805.00

11. Cisplatin

50mg powder vial for


injection

Bristol-Meyer
Squibb via Zuellig

2804.00

1125.00

50mg tablet

Bristol-Meyer
Squibb via Zuellig

33.50

17.50

200mg vial for


injection

Baxter

698.95

175.00

500mg vial for


injection

Bristol-Meyer
Squibb via Zuellig

649.00

324.50

1g or 1000mg vial for


injection (no innovator
locally)

Qualimed

1155.00
(most
expensive
brand)

577.50

ANTI-NEOPLASTICS/ ANTI-CANCER

9. Bleomycin and all its


salt form

12. Cyclophosphamide

ACTIVE INGREDIENT/
MOLECULE

DOSAGE
STRENGTH AND
FORM

COMPANY

OLD RETAIL
PRICE

GMAP

ANTI-NEOPLASTICS/ ANTI-CANCER

13. Etoposide (no


innovator locally)

100mg tablet

Qualimed

1130.00
(most
expensive in
the market)

565.00

14. Mercaptopurine

50mg tablet

GSK

79.00

39.50

15. Methotrexate
Sodium (No
innovator locally)

2.5mg tablet

Qualimed

23.00 (most
expensive
brand)

11.00

50mg/2ml vial for


injection

Qualimed

612.00 (most
expensive
brand)

306.00

400mgampul for
injection

Baxter

369.00

166.67

16. Mesna

Source: Advisory Council for Price Regulation Resolution No. 2009-001

2nd batch of Products


under GMAP
- March 2010

TRADE NAME

INTERNATIONAL NONPROPRIETARY NAME

MANUFACTURER

1. Ezetrol

Ezetimibe

Schering-Plough

2. Vytorin

Ezetimibe + Simvastatin

MSD/Schering-Plough

Losartan +
Hydrochlorothiazide

MSD

4. Seroxat

Paroxetine

GlaxoSmithKline

5. Leponex

Clozapine

Novartis

6. Tykerb

Lapatinib

GlaxoSmithKline

7. Zoladex

Goserelin

AstraZeneca

3. Cozaar/ Hyzaar

TRADE NAME

INTERNATIONAL NONPROPRIETARY NAME

MANUFACTURER

Goserelin

AstraZeneca

Asparaginase

Sanofi-Aventis

Salbutamol

GlaxoSmithKline

11. Coumadin

Warfarin

Bristol-Myers Squibb

12. Fraxiparine

Nadroparin

Sanofi-Aventis

13. Betopic

Betaxolol

Alcon Laboratories

14. Ciloxan

Ciprofloxacin

Alcon Laboratories

8. Zoladex LA
9. Leunase

10. Ventolin Rotacaps

TRADE NAME

INTERNATIONAL NONPROPRIETARY NAME

MANUFACTURER

Pilocarpine

Alcon Laboratories

16. Quinax

Dihydroazapentacene
polysulfonate

Alcon Laboratories

17. Avodart

Dutasteride

GlaxoSmithKline

18. Revovir

Clevudine

Hi-Elsai
Pharmaceutical

Levofloxacin

Winthrop
Pharmaceuticals

Meloxicam

Winthrop
Pharmaceuticals

Fluticasone Propionate +
Salmeterol

GlaxoSmithKline

15. IsoptoCarpine

19. Levofloxacin Winthrop


20. Meloxicam Winthrop
21. Seretide

Source: Philippines Pharmaceutical & Healthcare Report Q3 2010, p.25

E.O. 821 s 2009


Prescribing the Maximum Retail Prices for
selected drugs and medicines that address
diseases that account for the Leading causes
of Morbidity and Mortality
- Signed on July 27, 2009

Products under MDRP


The remaining 5 molecules which did not
voluntarily comply with 50% price cut on August
2009 were placed under mandatory price reduction
through Executive Order No. 821 s 2009
Implemented on August 2009

ACTIVE INGREDIENT/
MOLECULE

DOSAGE STRENGHT AND FORM

MDRP
(Php)

2.5mg tablet

9.60

5mg tablet

22.85

10mg tablet

38.50

10mg Film-coated tablet

34.45

ANTIHYPERTENSIVE
1. Amlodipine (includng
its S-isomer and salt
form)
ANTI-CHOLESTEROL

2. Atorvastatin

20mg Film-coated tablet

40mg Film-coated tablet

50.50

80mg Film-coated tablet

50.63

Amlodipine besilate 5mg +


Atorvastatin calcium 10mg tablet

45.75

Amlodipine besilate 5mg +


Atorvastatin calcium 20mg tablet

66.25

ACTIVE INGREDIENT/
MOLECULE

DOSAGE STRENGHT AND FORM

MDRP
(Php)

Amlodipine besilate 5mg +


Atorvastatin calcium 40mg tablet

84.42

Amlodipine besilate 5mg +


Atorvastatin calcium 80mg tablet

89.99

Amlodipine besilate 10mg +


Atorvastatin calcium 10mg tablet

51.13

Amlodipine besilate 10mg +


Atorvastatin calcium 20mg tablet

73.25

Amlodipine besilate 10mg +


Atorvastatin calcium 40mg tablet

91.79

Amlodipine besilate 10mg +


Atorvastatin calcium 80mg tablet

91.79

ANTI-CHOLESTEROL
2. Atorvastatin

ACTIVE INGREDIENT/
MOLECULE

DOSAGE STRENGHT AND FORM

MDRP
(Php)

ANTIBIOTIC/ ANTIBACTERIAL
3. Azithromycin and all
its Salt Form

250mg tablet

108.50

200mg/5ml powder for suspension


(15ml)

427.50

200mg/5ml powder for suspension


(22.5ml)

638.00

500mg tablet

151.43

500mg vial for injection

992.50

2g granules

468.00

ACTIVE INGREDIENT/
MOLECULE

DOSAGE STRENGHT AND FORM

MDRP
(Php)

ANTI-NEOPLASTICS/ ANTI-CANCER
4. Cytarabine

5. Doxorubicin and all


its Salt Form

100mg/ml ampul/vial (IV/SC)

240.00

100mg/ml ampul/vial (IV/SC) (5ml) or


500mg vial

900.00

100mg/ml ampul/vial (IV/SC) (10ml) or


1g vial

1800.00

20mg/ml (5ml) ampul/vial for injection

1980.00

10mg powder vial for injection

1465.75

50mg powder vial for injection

2265.74

Source: EO 821 s 2009

No retailer shall sell drugs and medicines at a


retail price exceeding the MRP approved by
the President of the Philippines

The MRP 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.

All drug outlets are required to post in a


conspicuous area within their premises a clear
copy of the MRP order.
They shall always maintain a copy of the said order to
be easily accessible and readable to the consuming
public and shall update it regularly as the situation may
warrant.

to reduce, if not, eliminate out-ofpocket expenses on the part of the


patients who should be the primary
beneficiaries of social health welfare

a. Intensify and accelerate the Outpatient Drug Benefit


Packages

b. Accreditation of all health-related units such as hospital


pharmacies, commercial pharmacies, and other DOH recognized
drug outlets
c. Imposition of penalties through a penalty structure for erring
accredited professionals that would not prescribe quality, generic
medicine within the MRP or PhilHealth List for reimbursements
d. Reimbursements must be based on the current edition of
the PNDF and limited to drug products covered by prescriptions
containing the corresponding generic names of the drug products

e. Drug products that may be covered by the


reimbursements shall be purchased only from hospital
pharmacies. In case of unavailability of drug products in the
hospital pharmacies, reimbursements may be made directly
to the patients but shall be charged to the reimbursements
earmarked for the hospital or the medical doctor for the
same service provided
f. Reimbursement of drug products and services related to
rational, quality drug access including, but not limited to,
setting fixed reimbursement prices/drug price reference
index to selected drugs and medicines,

All government agencies, including local government


units, shall procure drugs and medicines within the
Philippine National Drug Formulary

stocks of any basic necessity or prime


commodity 50% higher than his usual
inventory
unreasonably limits, refuses or fails to
sell the same to the general public at the
time of discovery of the stocks

has no price tag


is misrepresented as to its weight or
measurement
is adulterated or diluted; or
whenever a person raises the price by more
than 10% of its price in the immediately
preceding month

competitors for the same market and dealing in the


same basic necessity or prime commodity, perform
uniform or complementary acts among themselves
which tend to bring about artificial and unreasonable
increase in the price of any basic necessity or prime
commodity or when they simultaneously and
unreasonably increase prices on their competing
products thereby lessening competition among
themselves

AmendED:
RA 8293 - Intellectual Property
Code of the Philippines

RA 6675 - Generics Act of


1998
RA 5921- Pharmacy Law

a. Government All government health agencies and


their personnel as well as other government
agencies, including government owned and
controlled corporations shall use generic names in
all transactions related to purchasing,
prescribing, dispensing, reimbursing and
administering of drugs and medicines.

b. Private All private medical, dental and veterinary


practitioners shall prescribe using the generic
name. The brand name may be included, if so
desired

c. Health workers in government and all employed by the


government practicing or working in private institutions
shall use generic terminology only all transactions related to
purchasing, prescribing, dispensing, reimbursing and
administering of drugs and medicines such as but not limited
to:
1. All those employed by government, whether full or part time,
while in government facilities.
2. Medical and other Consultants, whether for free or otherwise
working in government institutions/facilities
3. Medical Doctors having private practice in government
facilities,
4. And all other government public health workers.

d. 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 branded 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.

e. Drug outlets, including drugstores, hospital


and non-hospital pharmacies and nontraditional outlets such as supermarkets,
convenience stores and other retail establishments,
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 be informed to exercise his
option.

Consumers shall have the right to demand for


information on all generic equivalents
available.

All drug outlets are obligated to provide their


clients all generic equivalents offered for sale
in their establishment.

The drug outlets referred to herein shall post in


conspicuous places as determined by the BFAD in
their establishments a list of drug products with the
same generic names and their corresponding
prices and shall form part of the licensing requirements
for such outlets.
hard copies, printed materials, or through
programmed computers accessible to the public

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 or,
THIS PRODUCT HAS THE SAME THERAPEUTIC
EFFICACY AS THE INNOVATOR PRODUCT OF THE
SAME GENERIC NAME.

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.

In the event that an essential drug becomes off-patent in


the Philippines and there are no generic versions applied
for or registered with the BFAD, or sold commercially in the
Philippines, the Secretary of Health shall require such
manufacturing companies to manufacture or cause to
manufacture generic counterparts.

AmendED:
RA 8293 - Intellectual Property
Code of the Philippines

RA 6675 - Generics Act of


1998
RA 5921- Pharmacy Law

Sale of Prescription Medicines,


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.

Packaging of Over-the-Counter Drugs


Non-prescription or over the-counter drugs may be sold in their
original packages, bottles and containers to the consuming public
through supermarkets, convenience stores and other retail
establishments.
Only solid dosage forms with individual original and primary
packaging as, approved by BFAD, like blisters packs, foils packs, and
other similar individual packaging, may be sold in smaller
quantities.
No other repackaging shall be allowed. Any new packaging shall
require BFAD approval. BFAD shall issue appropriate guidelines on
proper packaging of OTC drugs

Sale of Over-the-Counter Pharmaceutical


Products in Nontraditional Outlets
Pharmaceutical, drug or biological manufacturing
establishments, importers and wholesalers of drugs,
medicines, or biological products shall not sell their
products for re-sale except to retail drug outlets,
hospital pharmacies or other drug wholesalers under
the supervision of a registered pharmacist, and
supermarkets, convenience stores, other retail
establishments only for over-the-counter drugs, duly
licensed by the BFAD.

drug outlets with special licenses to operate issued in


compliance with the DOH and BFAD guidelines that serve
to improve access to essential drugs and the general
healthcare of the population, especially the poor. In
support of this intent
-shall be allowed to carry a selected list of prescription,
over-the-counter, and other such drugs and medicines as
deemed necessary to address the pressing health
needs of an area.

a. 1st violation Warning


b. 2nd violation Administrative fine of a minimum of
P10, 000.00 to P50,000.00 depending on the gravity and
extent of the violation, including the recall of the offending
product when applicable;

c. 3rd violation Administrative fine of minimum of P60,


000.00 P150, 000.00 Pesos, depending on the gravity
and extent of the violation, and in addition thereto, the
recall of them offending product, and suspension of the
Certificate of Product Registration (CPR) when
applicable;

d. 4th violation Administrative fine of a minimum P 200,


000.00 P500, 000.00, depending on the gravity
and extent of the violation, and in addition thereto, the recall of
the offending product, revocation of the CPR, suspension of the
License to Operate (LTO) and or License to Import and
Distribute, when applicable, for a period of one year;
e. 5th and succeeding repeated violations Administrative
fine of P1,000,000.00, and, when applicable, the recall of the
offending product, revocation of the CPR, revocation of the
License to Operate (LTO) and or License to Import and
Distribute of the company concerned, including the blacklisting
of the company to be furnished the Government Procurement
Policy Board (GPPB) and the Department of Trade and
Industry (DTI);

f. An additional penalty of 2,500. 00 per day shall be


made for every day the violation continues after having
received the order from the DOH