LEGISLATIVE HISTORY AND

STATUTORY BASIS
 LEGISLATIVE AND STATUTORY BASIS

1963 January 1982 December 1982

E.O. 851

E.O. 119
R.A. 3720
Created the Food and Drug
Administration within the The Freedom Constitution
Ministry of Health to FDA was abolished and
mandated the
implement the provisions of the Bureau of Food and reorganization of
the same law. Drugs assumed the government and this
The FDA had authority to functions of the FDA Executive Order
prescribe general standards except the functions of reorganized the Ministry of
and guidelines and impose the Narcotic Drug Health and its attached
sanctions in the Division which was agencies.
advertisement of food, transferred to the
drugs, and cosmetics in Dangerous Drugs Board
media Also affirmed that the
Ministry of Health is the
government’s main
instrumentality for
responding to health
concerns.
 LEGISLATIVE AND STATUTORY BASIS
1987 Constitution
R.A. 9711
Article 2, Section 15
The State shall protect and
promote the right to health of
the people and instill health
consciousness among them.
Article 13, Section 12
The State shall establish and
maintain an effective food and
drug regulatory system and
undertake appropriate health,
manpower development, and
research, responsive to the
country’s health needs and
problems.
July 2008
Changed the name of BFAD back to FDA.
In addition to the powers granted to FDA under
R.A. 3720, it was given the power to issue cease
and desist orders for health products whether or
not registered as well as to order the ban, recall,
and withdrawal of any health product found to be
dangerous.
It was also empowered to maintain bonded
warehouses to store confiscated goods at major
ports.
The Director General of the FDA was also given the
power to issue orders of seizure on any article of
food device, cosmetics, hazardous substances, or
health products which are adulterated,
counterfeited, misbranded, or unregistered.
 BRIEF HISTORY

The FDA Act created 4 Centers

Center for
Center for Drug
Cosmetics
Regulation and
Regulation and Center for Device
Research (to Center for Food
Research (to Regulation,
include veterinary Regulation and
include Radiation Health,
medicine, Research
household and Research
vaccines, and
hazardous/urban
biologicals
substances.
 OTHER LAWS THAT THE FDA IS MANDATED TO IMPLEMENT

▪ RA 8976, or The Food Fortification Law

▪ RA 9211, or The Tobacco Regulation

Act of 2003
▪ PD No. 881, or The Household Hazardous
▪ RA 7394, or The Consumer Act of the Act
Philippines
▪ EO No. 51, or The Milk Code of the
▪ RA 7581/10623, or The Price Act Philippines
▪ RA 10611, or The Food Safety Act of
2013
▪ RA 8172, or The ASIN Law,
▪ PD 856, or The Code of Sanitation of the
Philippines
 POLICY AND OBJECTIVES
POLICY
▪ R.A. 3720, SEC. 2. It is hereby declared
the policy of the State to insure safe and
good quality supply of food, drug and
cosmetic, and to regulate the production,
sale, and traffic of the same to protect the
health of the people.
▪ R.A. 9711, SEC. 3. It is hereby declared a
policy of the State to adopt, support,
establish, institutionalize, improve and
maintain structures, processes,
mechanisms and initiatives that are aimed, ▪ R.A. 9711, SEC. 4.This Act has the
directed and designed to: (a) protect and
promote the rightto health of the Filipino
people; and (b) help establish and maintain
an effective health products regulatory
system and undertake appropriate health
manpower development and research,
responsive to the country’s health needs
and problems. Pursuant to this policy, the
State must enhance its regulatory capacity:
and strengthen its capability with regard to
the inspection, licensing, and monitoring of
establishments and the registration and
monitoring of health products.
OBJECTIVES
▪ R.A. 3720, SEC. 3. In the
implementation of the foregoing
policy, the Government shall in
accordance with the provisions of this
Act:
▪ (a) Establish standards and quality measures for
food, drug, and cosmetic.
▪ (b) Adopt measures to insure pure and safe
supply of food, drug, and cosmetic in the country.
following objectives:
▪ (a) To enhance and strengthen the administrative
and technical capacity of the FDA in the
regulation of establishments and products under
its jurisdiction;
▪ (b) To ensure the FDA’s monitoring and regulatory
coverage over establishments and products
under its jurisdiction; and
▪ (c) To provide coherence in the FDA’s regulatory
system for establishments and products under its
jurisdiction.
REGULATORY FUNCTIONS AND
DELEGATED QUASI-JUDICIAL AND
QUASI-LEGISLATIVE POWERS
 REGULATORY FUNCTIONS
General:
▪ To require all manufacturers, processors, traders, sellers, distributors,
▪ To administer the effective implementation of the FDA Act of 2009, its importers, exporters, wholesalers, retailers, non-consumer users, and
IRR and other relevant Laws encourage consumers of health products to report to the FDA any
incident that reasonably indicates that said product has caused or
▪ To assume primary jurisdiction in the collection of samples of health contributed to the death, serious illness, or serious injury to a
products consumer, patient, or any person

▪ To analyze, test and/or inspect health products in connection with the ▪ To institute and strengthen the post marketing surveillance system in
implementation of the FDA Act, its IRR and other relevant laws and monitoring health products as defined in FDA Act, the IRR, and other
issuances laws, and the FDA issuances, and incidents of adverse events
involving such products
▪ To establish analytical data to serve as basis for the reparation of
health products standards, and to recommend standards of identity, ▪ To conduct, supervise, monitor, and audit research studies on health
purity, safety, efficacy, quality, and fill of container and safety issues of health products undertaken by entities duly
approved by the FDA
▪ To levy, assess, and collect appropriate fees in accordance with the
FDA Act, and other relevant laws as may be determined by the FDA ▪ To maintain bonded warehouses and/or establish the same whenever
necessary or appropriate, as determined by the Director General for
▪ To certify batches of antibiotic and antibiotic preparation, where confiscated goods in strategic areas of the country, especially at
applicable, in compliance with the provisions of the FDA Act, the IRR, major ports of entry
relevant laws and FDA issuances
▪ To accept grants, donations, and other endowments from local and
▪ To conduct appropriate tests on all applicable health products prior to external sources in accordance with pertinent laws, rules and
the issuance of appropriate authorizations, to ensure safety, efficacy, regulations
purity, and quality
▪ To call upon government and private testing laboratories, provided
▪ To require all concerned to implement the risk management plan that private testing laboratories are accredited by the Philippine
which is a requirement for the issuance of appropriate authorization Accreditation Office of the Department of Trade and Industry and the
DOH through the FDA

▪ To exercise such other powers and perform such other functions as

may be necessary to carry out its duties and responsibilities under
the FDA Act, the IRR, and other relevant laws as may be required by
the Secretary of Health
 FUNCTIONS AND POWERS
REGULATORY FUNCTIONS QUASI-LEGISLATIVE POWERS
Specific to the Director General of the FDA: General:

▪ To issue appropriate authorizations that would cover ▪ To periodically review its fees and propose any increase
establishments, facilities, and health products and promulgate rules and regulations governing the
collection of other related regulatory fees
▪ To determine the establishment and maintenance of
bonded warehouses, including the lease of ▪ To develop and issue policies, standards, regulations,
and guidelines that would cover establishments, facilities,
accreditation of bonded warehouses, whenever and health products
necessary or appropriate for confiscated goods in
the different regions of the country ▪ To develop and issue appropriate authorizations that
would cover establishments, facilities, and health
▪ To call on the assistance of any department, office, products
or agency and deputize members of the Philippine
National Police or any law enforcement agency for ▪ To prescribe policies, standards, regulations and
the effective implementation of the FDA Act, the guidelines with respect to information, advertisements,
promotions, sponsorship, and other marketing
IRR, and other relevant laws and issuances instruments or activities about the health products as
covered by the FDA Act, the IRR and other relevant laws
and issuances
▪ To conduct appropriate tests on all applicable health
products prior to the issuance of the appropriate
authorizations to ensure safety, efficacy, purity, and
quality
 QUASI-JUDICIAL POWERS
General:
Specific to the Director General of the FDA:
▪ To enter at reasonable hours, any factory, warehouse, or establishment in which
health products are manufactured, processed, packed, or held, for introduction ▪ To hold in direct or indirect contempt any person who disregards orders or writs
into domestic commerce, or are held, after such introduction, or to enter any issued by the FDA and impose the appropriate penalties following the same
vehicle used to transport or hold such health products in domestic commerce; procedures and penalties provided in the ROC
and to inspect in a reasonable manner, such factory, warehouse, establishment,
▪ To administer oaths and affirmations and issue subpoena duces tecum ad
or vehicle and all pertinent equipment, finished or unfinished materials,
testificandum requiring the production of such books, contracts, correspondence,
containers, and labeling therein
records, statement of accounts, and other documents and/or the attendance and
▪ To issue certificates of compliance with technical requirements to serve as basis testimony of parties and witnesses as may be material to any investigation
for the issuances of appropriate authorization and spot check for compliance with conducted by the FDA
regulations regarding operation of manufacturers, importers, exporters,
▪ To obtain information from any officer or office of the national or local
distributors, wholesalers, drug outlets, and other establishments and facilities of
governments, government agencies and its instrumentalities
health products as determined by the FDA
▪ To issue orders of seizure, to seize and hold in custody any article or articles of
▪ To impose administrative penalties/ sanctions in accordance with the FDA Act of
2009 and other relevant laws food, device, cosmetics, household hazardous substances, misbranded or
unregistered; or any drug, in-vitro diagnostic reagents, biological, and vaccine
▪ To issue cease and desist orders motu proprio or upon verified complaint in that are adulterated or misbranded, when introduced into domestic commerce,
accordance with the FDA Act of 2009, relevant laws and IRR pending the authorized hearing under the FDA Act, the IRR, as far as applicable,
and other relevant laws
▪ After due process, to order the ban, recall, withdrawal and/or destruction of any
health product found to have caused the death, serious illness or serious injury to ▪ To impose the following administrative sanctions for violations of the provisions of
a consumer or patient, or is found to be imminently injurious, unsafe, dangerous, the FDA Act, the IRR, and where applicable, other relevant laws, after
or grossly deceptive observance of and compliance with due process:
▪ Cancellation of any authorization which may have been granted by the FDA, or suspension of the
▪ To exercise such other powers and perform such other functions as may be validity thereof for such period of time as he/she may deem reasonable, which shall not exceed 1
necessary to carry out its duties and responsibilities under the FDA Act, the IRR, year
and other relevant laws as may be required by the Secretary of Health
▪ A fine of not less than PHP 50,000 but not more than PHP 500,000. An additional fine of not more
than PHP 1,000 shall be imposed for reach day of continuing violations.
Specific to the Director General of the FDA:
▪ Destruction and/or appropriate disposition of the subject health product and/or closure of the
▪ To render decisions on actions or complaints before the FDA, pursuant to the establishment for any violation of the FDA Act, the IRR and other relevant laws, and FDA issuances
FDA Act, the IRR, other existing laws, and FDA-promulgated issuances
 ADMINISTRATIVE FUNCTIONS
General:
▪ To create organizational units which are deemed
necessary to address emerging concerns and to
keep abreast with internationally acceptable
standards
▪ To review and recommend its staffing pattern and
position titles subject to the approval of the
Secretary of Health
▪ Subject to the approval of the SOH, to engage the
services of private lawyers/ firms to represent
officials and employees of the FDA, regardless of
their employment status, upon receipt by the FDA
officials or employees of the court notice that a legal
action, suit or proceeding is filed against them in
connection with the lawful exercise of their official
functions, duties, or responsibilities as FDA officials ▪ To call upon other govnerment and private testing
and employees. Any private lawyer/firm who/which
is connected or related to any regulated
establishment, including related foundations, shall
be disqualified from representing FDA officials and
employees to avoid impropriety and conflict of
interest. The costs incurred in connection with such
action, suit or proceeding, including attorney’s fees,
shall be paid from the Legal Fund
▪ To exercise such other powers and perform such
other functions as may be necessary to carry out its ▪ To create, subject to the approval of the SOH, any
duties and responsibilities under the FDA Act, the
IRR, and other relevant laws as may be required by
the Secretary of Health
Specific to the Director General:
▪ To determine the needed personnel of FDA and
appoint personnel below the Assistant-Director level
in accordance with the FDA Act, these IRR and the
civil service rules and regulations
▪ Upon the recommendation of the Deputy Director
General for Field Regulatory Operations Office, to
establish additional regional field/ satellite
laboratories in regions where the same is deemed
necessary
▪ Upon approval of the SOH, to establish additional
testing labs of the FDA as necessary
labs provided that private testing labs are
accredited by the Philippine Accreditation Office of
the DTI and the DOH through the FDA
▪ To recommend for the approval of the Secretary of
Health any proposed increase in licensing and
registration fees and charges and to promulgate
rules and regulations governing the collection of
other related regulatory fees;
organizational unit deemed necessary to address
emerging concerns and/or to keep abreast with
internationally acceptable standards
SYSTEMS AND PROCEDURES
APPLICATION PROCESS
 APPLICATION PROCESS
Download
• Application form is
downloaded from
www.fda.gov.ph
• The integrated application
form is in XLS or XLSX
format and is used for both
License and Registration
applications, as well as
amendments and other
certifications. Promos and
advertisements are also
now covered in the
application form.
Always remember that a
valid License to Operate
(LTO) license is required for
a Certificate of Product
Registration to be issued.
Fill Up Form
• Application form should be
filled up correctly.
• The app form has six parts,
namely:
• (1) General Info
• (2) Establishment Info
• (3) Product Info
• (4) Supporting Info
• (5) Sources and Clients
• (6) Applicant Info
• If the part is appropriately
filled, a green ‘PROCEED’ will
be indicated. Required
fields will appear
sequentially. If the form is
appropriately filled up, the
composed body text (in the
green box) will appear
Email
• Send an email to
pair@fda.gov.ph
• In the XLS app form, the
worksheet ‘Email’ composes
the subject and body of the
email that will be sent to the
email address above. Copy
and paste the appropriate
fields onto the email.
Include CCs if needed. The
XLS or XLSX file should not
be attached but it will be
require during submission.
Any attachment will lead to
a rejection of the schedule
request. Up to 10
applications per email are
accepted.

Scheduling
• Within 2 working days, a
Document Tracking Log (DTL)
is sent with a schedule for
submission
• The FDA will determine the
schedule of applications
according to the priority of
the Centers. A quota will be
set for the total number of
applications that can be
scheduled in a day. Multiple
applications sent in a single
email may be scheduled over
separate dates. Request for
specific schedules will not be
accommodated. Receiving
will be scheduled within 10
working days of receipt of
application email.
APPLICATION PROCESS
Payment Checklist Submission
• Fees are paid either at LBP • Check if all requirements are • Application is filed on
branches or at the FDA main in order schedule.
cashier • Be sure that you have a • Only apps scheduled for the
• Once a DTL is received, one checklist of requirements and day will be accommodated.
can pay immediately through that your documents are Hard copies will no longer be
any branch of the LBP. The complete. Don’t forget to required at submission. Don’t
main FDA cashier will only have the petition/ forget to get back the USB
accommodate those declaration form notarized. A given to transfer docs.
scheduled to be received softcopy of all requirement Remember the Routing Slip
during the day. A copy of the should be stored in a USB Number (RSN) number of
DTL provided by the FDA and device to facilitate transfer. each application. Use the
a copy of the app form are Include an XLS or XLSX copy RSN to follow-up by emailing
required to process payment. of the accomplished app pair@fda.gov.ph. Should you
Indicate in the app form the form. Please keep your USB fail to complete submission
tracking number provided. devices free from viruses. A on the set date, queue for
Check that the tracking copy of the payment slip is another schedule through
number indicated in the DTL also required at the point of pair@fda.gov.ph using the
is indicated in the proof of submission. RSN.
payment.
LIST OF CERTIFICATES AND
LICENSES
LIST OF CERTIFICATES AND LICENSES ISSUED BY FDA
▪ Issuance of License to Operate (LTO) ▪ 30 calendar days (per compliant
Initial/ Regular Renewal/ Automatic application)
Renewal/ Amendments or Variations
▪ Issuance of Certificate of Product ▪ 245 calendar days
Registration (CPR) of Pharmaceutical
Products (Initial)
▪ Issuance of Certificate of Product ▪ 68 calendar days
Registration (CPR) of Pharmaceutical
Products (Regular Renewal)
▪ Issuance of Certificate of Product ▪ 33 calendar days
Registration (CPR) of Pharmaceutical
Products (Automatic Renewal)
▪ Certificate of Product Registration (CPR)/ ▪ 52 calendar days
Certification/ Notification of
Pharmaceutical Products (Variations)
▪ Issuance of Certificate of Listing of ▪ 31 calendar days
Identical Drug Product (CLIDP)
PROCEDURE FOR ADMINISTRATIVE
COMPLAINTS
Procedure in Administrative Complaints

Temporary and/or
Commencement of Preliminary
Preventive
Action Conference
Measures

• Complaint by an • Cease and desist • Not applicable to

interested party, filed orders (30-60 days) cases motu proprio
before the FDA • Seizure of the subject filed by the FDA
Regional Office or products and/or • Simplification of the
FDA Central Office machines used in issues; matters to aid
• Action initiated by manufacturing in the speedy
any FDA officer, • Padlocking of disposition of the
commenced by filing warehouses/ case
a Report of Violation factories where the
• Anonymous subject products are
complaint, referred to stored
the proper FDA officer
for investigation
Procedure in Administrative Complaints

Submission of
Decision of the FDA
Position Papers and Appeal
Director General
Evidence

• Supporting affidavits • Seizure and • FDA decisions are

shall take the place of destruction of subject appealable to the
direct testimony health products Secretary of Health
• Administrative fines of • Decisions of the
P50,000 to P500,000 Secretary of Health
• Suspension/ are appealable to the
revocation of License Office of the
to Operate or President
Certificate of Product • Decisions of the
Registration Office of the President
• Closure of the subject are appealable to the
establishment Court of Appeals
FEEDBACK MECHANISM
 FEEDBACK MECHANISM

FDA survey
boxes

Public
Facebook
Assistance
Account
Desk

Email (General Email

Information) (Reports)
ILLUSTRATIVE CASES
Department of Health v. Phil Pharmawealth, Inc.
G.R. No. 182358 | February 20, 2013

FACTS:
▪ DOH Secretary Romualdez issued AO 10 and AO 66, S. 2000, which state that the
accreditation of government suppliers of pharmaceutical products may now be revoked
by the DOH Accreditation Committee after due deliberation, notice, and hearing.
▪ BFAD (now FDA) issued a “Report on Violative Products” which found that PPI’s
products were unfit for human consumption. DOH called PPI to a meeting and directed
it to submit a written explanation within 10 days, to which PPI belatedly replied that it
had referred the matter to its lawyers. DOH suspended PPI’s accreditation for 2 years.
▪ PPI filed this complaint to declare AO 10 and AO 66 null and void, averring that the
DOH Accreditation Committee, in suspending its accreditation, arrogated unto itself
powers that were expressly granted to BFAD under RA 3720, as amended:
▪ Sec. 25(d): When it appears to the Director [of the BFAD] that the report of the Bureau that any article
of food or any drug, device, or cosmetic secured pursuant to Section twenty-eight of this Act is
adulterated, misbranded, or not registered, he shall cause notice thereof to be given to the person or
persons concerned and such person or persons shall be given an opportunity to be heard before the
Bureau and to submit evidence impeaching the correctness of the finding or charge in question.

▪ On appeal, the CA granted the petition and ruled in favor of Phil Pharmawealth.
Department of Health v. Phil Pharmawealth, Inc.
G.R. No. 182358 | February 20, 2013
ISSUE: Whether AO 10 and AO 66 should be declared null and void for being issued ultra
vires

HELD: No. CA ruling reversed; complaint is dismissed.

▪ RA 3720 specifically provides that BFAD is an office under the office of the DOH Secretary, who
is authorized to supervise BFAD and issue rules and regulations as may be necessary to
effectively enforce the provisions of the same law.
▪ Sec. 4: To carry out the provisions of this Act, there is hereby created an office to be called the Food and Drug
Administration in the Department of Health. Said Administration shall be under the Office of the Secretary and shall
have the following functions, powers and duties…
▪ Sec. 26: Except as otherwise provided in this section, the Secretary of Health shall, upon recommendation of the Food
and Drug Administrator, issue rules and regulations as may be necessary to enforce effectively the provisions of this
Act.

▪ Thus, the issuance of AO 10 and AO 66 were well within the scope of the DOH Secretary’s
authority.

▪ PPI was afforded due process. Its accreditation was only suspended after it failed to submit its
explanation as directed by the DOH.

▪ The case must also be dismissed because the DOH, as a government agency, may not be sued
without its consent (doctrine of non-suability of the State).
Bengzon v. CA and Boie-Takeda Chemicals, Inc.
G.R. No. 82568 | May 31, 1988
FACTS:

▪ Respondent Boie-Takeda is a Philippine corporation engaged in the manufacture and sale of

“Danzen”, a tablet which contains serrapeptase, since 1970.

▪ The US FDA decided that serrapeptase, labelled for use in controlling edema and inflammation
caused by surgical procedures or trauma, was not actually effective.

▪ BFAD issued BFAD Regulations No. 1 and 1-A, s. 1987, which recalled the registration of all
drugs in the Philippines containing serrapeptase, including Danzen.

▪ Boie-Takeda filed a request for reconsideration with BFAD, claiming that serrapeptase was still
being used in 20 other countries, and that it had submitted voluminous data to BFAD regarding
the effectivity of the drug.

▪ BFAD summoned Boie-Takeda to a 15-minute hearing, after which it denied the latter’s request
for reconsideration. Boie-Takeda appealed to the DOH, which affirmed BFAD’s decision.

▪ Boie-Takeda filed with the Court of Appeals a petition for certiorari and prohibition with prayer for
preliminary injunction, averring that it was not accorded due process. The CA issued the writ.
The DOH now alleges grave abuse of discretion on the part of the CA in issuing the writ of
preliminary injunction.
Bengzon v. CA and Boie-Takeda Chemicals, Inc.
G.R. No. 82568 | May 31, 1988
ISSUE: Whether the CA committed grave abuse of discretion in issuing the writ of
preliminary injunction

HELD: No. CA resolution affirmed.

▪ The matter of whether Boie-Takeda was denied due process in the proceedings before BFAD
and DOH is still pending adjudication in the case before the CA.

▪ A writ of preliminary injunction may be granted to protect a litigant’s rights or interests during the
principal action.

▪ Here, the writ was issued to protect the right of Boie-Takeda to market Danzen in the
Philippines, which it has been doing for 17 years (at the time of this decision). The object of the
writ is to preserve the status quo pending the final determination of the CA case on the merits,
which is that Danzen was duly registered and sold in the Philippines under a valid license from
BFAD.

▪ The CA acted well within its power to issue the said writ, because it did so after a hearing where
both parties were allowed to present their arguments and memoranda.

▪ The issuance of the writ is a matter addressed to the sound discretion of the CA, which the SC
does not interfere in unless there has been manifest abuse. DOH failed to prove the same in its
petition.
Roma Drug v. Regional Trial Court of Guagua
G.R. No. 149907 | April 16, 2009
FACTS:

▪ BFAD inspectors, with the help of the NBI, conducted a raid on Roma Drug and 5 other
drugstores and seized several imported medicines, upon the request of SmithKline (now
Glaxo SmithKline), the only authorized Philippine distributor of the said medicines.
▪ SmithKline alleged that Roma Drug imported the medicines directly from abroad, which meant that the
medicines should be considered “counterfeit”, under Sec. 3(b)(3) of RA 8203, the Special Law on
Counterfeit Drugs (SLCD).

▪ The NBI filed a complaint against Roma Drug for violation of Sec. 4 of the SLCD with the RTC
of Guagua, Pampanga, which prohibits the sale of counterfeit drugs.

▪ Roma Drug challenged the constitutionality of the SLCD on the ground that it violated the
equal protection clause. It argued that the drugs, although imported directly from abroad, were
completely identical to those being sold by SmithKline, and thus should not be considered
counterfeit.
▪ Sec. 3(b)(3) of the SLCD defines “counterfeit” as including “unregistered drug product”.

▪ The RTC proceeded with the criminal case despite the challenge.

▪ Roma Drug then filed the instant petition for prohibition before the RTC of Guagua, assailing
the constitutionality of the SLCD.
Roma Drug v. Regional Trial Court of Guagua
G.R. No. 149907 | April 16, 2009

FACTS:
▪ In this petition, Roma Drug argues that the SLCD contravenes the ff. constitutional
provisions:
▪ Sec. 1, Art. III: No person shall be deprived of life, liberty, or property without due process of law, nor
shall any person be denied the equal protection of the laws.
▪ Sec. 11, Art. XIII: The State shall adopt an integrated and comprehensive approach to health
development which shall endeavor to make essential goods, health and other social services available
to all the people at affordable cost. There shall be priority for the needs of the underprivileged sick,
elderly, disabled, women, and children. The State shall endeavor to provide free medical care to
paupers.
▪ Sec. 15, Art. II: The State shall protect and promote the right to health of the people and instill health
consciousness among them.

▪ Glaxo SmithKline and BFAD opposed the petition. They assert that the above
provisions are not self-executing, and cannot be used to circumvent the property rights
of “legitimate drug importers, who take pains in having these imported drug products
registered before the BFAD”.
▪ The OSG, in its Comment, states that the question is one of policy wisdom of the law,
and thus beyond the interference of the judiciary.
Roma Drug v. Regional Trial Court of Guagua
G.R. No. 149907 | April 16, 2009

ISSUE: Whether the assailed provisions of the Special Law on Counterfeit Drugs (RA 8203)
are unconstitutional

HELD: Moot and academic.

▪ RA 8203 has been mooted by the passage of RA 9502, the Universally Accessible Cheaper and
Quality Medicines Act of 2008, which now grants the right to import drugs and medicines to any
government agency or any private third party.

▪ However, if the Court had to directly confront the constitutionality of the assailed provisions of
the SLCD, they would have been at least placed in doubt.

▪ As written, the assailed provisions of the SLCD make a criminal of any person who imports an
unregistered drug regardless of the purpose, even if the medicine can spell life or death for
someone in the Philippines.
▪ It does not allow for situations wherein the drug is out of stock in the Philippines, or when the ill person is too poor to
afford the medicines here or to travel abroad for treatment.
▪ It deprives Filipinos of the constitutionally-protected right to healthcare by denying them a plausible and safe means to
purchase medicines for lower prices.

▪ The assailed provisions of the SLCD also violate the equal protection clause for they equate the
importers of such drugs, regardless of altruistic intention, to those who would alter or counterfeit
drugs for profit at the expense of public safety.
BIBLIOGRAPHY
 BIBLIOGRAPHY OF CASE LAW AND RESEARCH MATERIALS
Case Law:
▪ G.R. No. 149907 Roma Drug v. RTC of Guagua
▪ G.R. No. 182358 DOH v. Pharmawealth
▪ G.R. No. L-82568 Bengzon v. CA
▪ A.C. No. 7199 Foodsphere v. Atty. Mauricio
▪ G.R. No. 190837 RP v. Drug Maker's Lab
▪ G.R. No. L-55230 Gordon v. Veridiano II
▪ G.R. No. 150877 Kho v. Lanzanas
▪ G.R. No. 156264 Allied Domecq Phil., Inc. v. Villon
▪ G.R. No. 209271 Biotech v. Green Peace
▪ G.R. No. L-34433 Oliveros-Torre v. Bayot
▪ S.V. More Pharma v. Drugmaker's Lab
PRIMARY SOURCES:
▪ Case Law
▪ R.A. 3720 (Food, Drug, and Cosmetic Act)
▪ R.A. 9711 (BFAD Strengthening Law)
▪ IRR of R.A. 9711
SECONDARY SOURCES:
▪ Research Article on Regulatory Issues on
Traditionally Used Herbal Products, Herbal
Medicines and Food Supplements in the
Philippines (Yolanda R. Robles et.al. Journal of
Asian Association of Schools of Pharmacy)
▪ Presentation of Ms. Agnette de Perio Peralta and
Ms. Maria Cecilia Credo Matienzo “The New Food
and Drug Administration (FDA) of the Republic of
the Philippines (Center for Device Regulation,
Radiation Health, and Research)
▪ FDA Citizens Charter
POTENTIAL REGULATORY PROBLEMS
 POTENTIAL REGULATORY PROBLEMS
GAPS
▪ Understaffing and overloading of products
that need to be tested
▪ There are inadequate provisions in the
Consumers Act that guarantee active
participation of regulatory agencies like the
FDA in the approval of commercial ads
▪ There is no patent protection on herbal
meds/ products and food supplements
▪ Documentation on healing effects/ claims
usually records only the negative effects
▪ “No approved therapeutic claims” is vague
▪ The phrase “FDA-approved” on the label
can be vague and misleading
▪ RA 8423 instituted the Philippine Institute
for Traditional and Alternative Health Care
but their mandate or role is not publicly
known
▪ There is currently a passive complaint
system for supplements
POSSIBLE SOLUTIONS
▪ Data of clinical trials should be made transparent
▪ FDA should have separate guidelines or requirements for
topical herbal products
▪ FDA should accredit institutions that will validate technical
data
▪ There should be a process patent for herbal products
▪ Documentation of effects should include positive feedback
▪ A product insert should be available. The language used
must be appropriate for the intended audience.
▪ “No approved therapeutic claims” should be translated to a
native dialect
▪ FDA should set labelling requirements for DS
▪ Label should instead state “Registered as Drug” or
“Registered as food supplement” so what level of
requirements the product has met
▪ Public feedback should start in the drugstore level
▪ There should be more extensive campaigns to empower
consumers to report adverse reactions
▪ Distributors or manufacturers should have own public
feedback to submit reports to FDA/ PITAHC
THANK YOU!