Republic of the Philippines

HOUSE OF REPRESENTATIVES > RECE IveD
Quezon City 3
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NINETEENTH CONGRESS
First Regular Session
4247

HOUSE BILL no. "f 4!

Introduced by: Hon. Keith Micah “Atty. Mike” D.L. Tan

AN ACT

AUTHORIZING THE DIRECTOR GENERAL OF THE FOOD AND DRUG ADMINISTRATION TO ISSUE
EMERGENCY USE AUTHORIZATION, FURTHER AMENDING REPUBLIC ACT NO. 3720,
OTHERWISE KNOWN AS THE “FOOD, DRUG, AND COSMETIC ACT,” AS AMENDED BY REPUBLIC
ACT NO. 9711, OTHERWISE KNOWN AS THE “FOOD AND DRUG ADMINISTRATION (FDA) ACT
OF 2009”

EXPLANATORY NOTE

The 1987 Constitution mandates the State to protect and promote the health of the
people and instill health consciousness among them (Article Il, Section 15). The State is further
mandated to adopt an integrated and comprehensive approach to health development which
shall endeavor to make essential goods, health and other social service available to all the
people at affordable cost (Article XIII, Section 11).

Pursuant to Proclamation Nos. 922 (s. 2020) and 1021 (s.2020), the Philippines was
declared under a State of Public Health Emergency, as a State of Calamity due to the COVID-19
pandemic. Subsequently, Republic Act No. 11494 or the “Bayanihan to Recover as One Act,”
was enacted authorizing the President to suppress the COVID-19 pandemic through the
procurement of drugs and vaccines.

Republic Act No. 3720, otherwise known as the “Food, Drug and Cosmetic Act,” as
amended by the Executive Order No. 175., s. 1987, and the Republic Act No. 9711, otherwise
known as the “Food and Drug Administration Act of 2009,” mandate the Food and Drug
Administration (FDA) to establish and maintain a drug regulatory system to ensure the purity,
safety, efficacy and quality of drugs and vaccines in the country. Thus, the FDA is the sole
agency authorized to regulate health products and issue authorization.

Section 21 of R.A 3720, as amended, provided that any new drug should have an
authorization from the FDA based on an application containing full report of investigations to
show whether or not such drug is safe, efficacious and of good quality for use, based on clinical
studies, prior to manufacture, sale importation, exportation, distribution or transfer thereof.

Inasmuch as no registered drug and vaccine exist for COVID-19 in the country, President
Rodrigo Roa Duterte issued Executive Order No. 121 on 01 December 2020 entitled “Granting
Authority to the Director General of the Food and Drug Administration to Issue Emergency Use
Authorization (EUA) for COVID-19 Drugs and Vaccines, Prescribing Conditions therefore and for
other purposes.” E.0 121 gave authority to the Director General of the FDA to issue an EUA and
established the conditions under which said authorization may be issued. On such basis, FDA
has granted EUA for the COVID-19 vaccine from Pfizer on 14 January 2021, among others.


£O 121 provides that an EUA for a COVID-19 drug or vaccine shall only be issued when
all three circumstances are present: (1) It is reasonable to believe that the drug or vaccine may
be effective to prevent, diagnose or treat COVID-19; (2) the known and potential benefits of the
drug or vaccine when used to diagnose, prevent or treat COVID-19 outweigh the known and
potential risks of the drug or vaccine if any; and (3) there is no adequate, approved ad available
alternative to the drug or vaccine for diagnosing, preventing or treating COVID-19.

Considering that existing laws do not provide for the grant of EUA by the FDA, albeit EO
121 granted the Director General of the FDA the authority to issue EUA for COVID-19 drugs and
vaccines, such is a stopgap solution to the current inadequacy of our laws to address the
necessity of authorizing the FDA to issue EUA.

Thus, this bill seeks to authorize the Director General of the Food and Drug
‘Administration to issue an EUA to allow unapproved health products to be used during a public
health emergency or a threat, to diagnose, treat, or prevent serious or life-threatening diseases
or conditions when there are no adequate, approved and available alternative health products,
in order to enhance our pandemic preparedness and response.

It is hoped to expedite the availability of vaccines and therapeutics to people affected by
any public health emergency and is based on essential set of available quality, safety, and
efficacy performance data and ensure accelerated and smoother procurement and distribution
of vaccines to the Filipino people during a public health emergency.

In view of the foregoing, the immediate passage of this measure is earnestly sought.

poe
Keith Micah “Atty. Mike” D.L. Tan
4th District, Quezon


Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

NINETEENTH CONGRESS
First Regular Session

wo, 4247

HOUSE BILL NO.

Introduced by: Hon. Keith Micah “Atty. Mike” D.L. Tan

AN ACT
AUTHORIZING THE DIRECTOR GENERAL OF THE FOOD AND DRUG ADMINISTRATION TO ISSUE
EMERGENCY USE AUTHORIZATION, FURTHER AMENDING REPUBLIC ACT NO. 3720,
OTHERWISE KNOWN AS THE “FOOD, DRUG, AND COSMETIC ACT,” AS AMENDED BY REPUBLIC
ACT NO. 9711, OTHERWISE KNOWN AS THE “FOOD AND DRUG ADMINISTRATION (FDA) ACT
OF 2009”

Be it enacted by the Senate and the House of Representatives of the Philippines in Congress
assembled:

SECTION 1. Section 10 of the Republic Act. No. 3720, as amended is hereby further
amended to include new subsections (nn), (00), (qq), and (rr) to read as follows:

“SEC. 10. For the purposes of this Act, the term:
29K

“(NN) ‘EMERGENCY USE AUTHORIZATION’ MEANS THE AUTHORITY ISSUED BY THE
FDA DIRECTOR GENERAL, ALLOWING UNAPPROVED HEALTH PRODUCTS TO BE USED DURING
‘A PUBLIC HEALTH EMERGENCY OR THREAT, TO DIAGNOSE, TREAT, OR PREVENT SERIOUS OR
LIFE-THREATENING DISEASES OR CONDITIONS WHEN THERE ARE NO ADEQUATE, APPROVED
AND AVAILABLE ALTERNATIVE HEALTH PRODUCTS. THE EMERGENCY USE MAY EITHER BE FOR
AN UNAPPROVED HEALTH PRODUCT OR UNAPPROVED USE OF AN APPROVED HEALTH
PRODUCT.

“(O0). ‘UNAPPROVED HEALTH PRODUCT’ MEANS A HEALTH PRODUCT THAT IS NOT
APPROVED BY, LICENSED, OR REGISTERED WITH THE FDA AND, THEREFORE, NOT COVERED BY
ANY PERMIT, LICENSE, CERTIFICATION, OR ACCREDITATION ISSUED BY THE SAID AGENCY FOR
ITS MANUFACTURE, IMPORTATION, EXPORTATION, SALE, OFFER FOR SALE, DISTRIBUTION,
TRANSFER, AND/OR WHERE APPROPRIATE, THE USE, TESTING, PROMOTION, ADVERTISING,
AND SPONSORSHIP THEREOF.

“(PP) ‘UNAPPROVED USE OF AN APPROVED HEALTH PRODUCT’ MEANS A HEALTH
PRODUCT THAT IS APPROVED BY, LICENSED, OR REGISTERED WITH THE FDA BUT WHICH
INTENDED EMERGENCY USE IS NOT AMONG THOSE APPROVED UNDER ITS CERTIFICATE OF
PRODUCT REGISTRATION, MARKET AUTHORIZATIONM OR ANY OFFICIAL LICENSE ISSUED BY
THE FDA.

“(QQ) ‘PUBLIC HEALTH EMERGENCY’ MEANS, PURSUANT TO REPUBLIC ACT NO. 11332,
OTHERWISE KNOWN AS THE “MANDATORY REPORTING OF NOTIFIABLE DISEASES AND


HEALTH EVENTS OF PUBLIC HEALTH CONCERN ACT,” AN OCCURRENCE OR IMMINENT THREAT
OF AN ILLNESS OR HEALTH CONDITION THAT:

“(1) IS CAUSED BY ANY OF THE FOLLOWING:
“(l) BIO TERRORISM;

“(ll) APPEARANCE OF A NOVEL OR PREVIOUSLY CONTROLLED OR ERADICATED
INFECTIOUS AGENT OR BIOLOGICAL TOXIN:

“(IN) ANATURAL DISASTER;

“(IV)_ A CHEMICAL ATTACK OR ACCIDENTAL RELEASE;

“(V) ANUCLEAR ATTACK OR ACCIDENT; OR

“(VI)_ AN ATTACK OR ACCIDENTAL RELEASE OF RADIOACTIVE MATERIALS; AND
“(2) POSES A HIGH PROBABILITY OF ANY OF THE FOLLOWING:

(1) ALARGE NUMBER OF DEATHS IN THE AFFECTED POPULATION;

(ll) A LARGE NUMBER OF SERIOUS INJURIES OR LONG-TERM DISABILITIES IN THE
AFFECTED POPULATION;

(Ill) WIDESPREAD EXPOSURE TO AN INFECTIOUS OR TOXIC AGENT THAT POSES A
SIGNIFICANT RISK OF SUBSTANTIAL HARM TO A LARGE NUMBER OF PEOPLE IN
THE AFFECTED POPULATION;

(IV) INTERNATIONAL EXPOSURE TO AN INFECTIOUS OR TOXIC AGENT THAT POSES
A SIGNIFICANT RISK TO THE HEALTH OF CITIZENS OF OTHER COUNTRIES; OR

(V) TRADE AND TRAVEL RESTRICTIONS;

“(RR) ‘PUBLIC HEALTH THREAT’ MEANS, PURSUANT TO R.A NO. 11332, ANY SITUATION
OR FACTOR THAT MAY REPRESENT A DANGER TO THE HEALTH OF THE PEOPLE.”

SEC. 2. A new Chapter XV and eight (8) new sections, Sections 38, 39, 40, 41, 42,
43, 44 and 45 shall be included to R.A No. 3720, as amended, which shall read as follows:

“CHAPTER XV EMERGENCY USE AUTHORIZATION

“SEC. 38. CRITERIA FOR THE ISSUANCE OF AN EUA. ~ THE ISSUANCE OF AN EUA
UNDER THIS ACT BY THE FDA DIRECTOR GENERAL IS JUSTIFIED, ONLY IF, AFTER
CONSULTATION WITH THE DEPARTMENT OF HEALTH, THE DEPARTMENT OF SCIENCE
AND TECHNOLOGY, AND OTHER CONCERNED GOVERNMENT AGENCIES, THE FDA
DIRECTOR GENERAL CONCLUDES THAT:

“(1) A BIOLOGICAL, CHEMICAL, RADIOLOGICAL, OR NUCLEAR AGENT OR ANY
AGENT THAT MAY CAUSE A SERIOUS OR LIFE-THREATENING DISEASE OR CONDITIONS
EXISTS;


“(2) BASED ON THE TOTALITY OF SCIENTIFIC EVIDENCE AVAILABLE TO THE FDA
DIRECTOR GENERAL, INCLUDING DATA FROM ADEQUATE AND WELL-CONTROLLED
CLINICAL TRIALS, IF AVAILABLE, IT IS REASONABLE TO BELIEVE THAT:

“j, THE HEALTH PRODUCT, FOR WHICH AN EUA WILL BE ISSUED, MAY BE
EFFECTIVE IN DIAGNOSING, TREATING, OR PREVENTING SERIOUS OR LIFE-THREATENING
DISEASE OR CONDITION DURING A PUBLIC HEALTH EMERGENCY OR THREAT; AND

“ji. THE KNOWN AND POTENTIAL BENEFITS OF THE SAID HEALTH
PRODUCT, WHEN USED TO DIAGNOSE, PREVENT, OR TREAT SUCH DISEASE OR
CONDITION, OUTWEIGH THE KNOWN AND POTENTIAL RISKS OF THE PRODUCT;

“(3) THERE IS NO ADEQUATE, APPROVED, AND AVAILABLE ALTERNATIVE TO
THE HEALTH PRODUCT FOR DIAGNOSING, PREVENTING, OR TREATING A DISEASE OR
CONDITION DURING THE EXISTENCE OF A PUBLIC HEALTH EMERGENCY OR THREAT,
AND

(4) ALL REQUIREMENTS FOR THE ISSUANCE OF AN EUA UNDER THIS ACT AND
OTHER PERTINENT REGULATIONS AND ISSUANCES ARE SATISFIED.

“SEC. 39. REPORT OF THE DIRECTOR GENERAL OF THE FDA. - THE FDA
DIRECTOR GENERAL SHALL CONDUCT A SEPARATE AND INDEPENDENT
DETERMINATION OF THE SAFETY AND POTENTIAL EFFECTIVENESS OF THE HEALTH
PRODUCT AND THEREAFTER, ISSUE A REPORT ON SAID FINDINGS, PRIOR TO THE
GRANT OF AN EUA.

“SEC. 40. CONTENTS OF THE AUTHORIZATION. — AN EUA ISSUED PURSUANT TO
THIS ACT SHALL STATE:

“(1) EACH DISEASE OR CONDITION THAT THE HEALTH PRODUCT MAY BE USED
TO DIAGNOSE, PREVENT, OR TREAT WITHIN THE SCOPE OF THE AUTHORIZATION;

“(2) THE FDA DIRECTOR GENERAL'S FINDINGS THAT THE KNOWN AND
POTENTIAL BENEFITS OF THE HEALTH PRODUCT, WHEN USED TO DIAGNOSE, PREVENT,
OR TREAT SUCH DISEASE OR CONDITION, OUTWEIGH THE KNOWN AND POTENTIAL
RISKS OF THE PRODUCT; AND

“(3) THE FDA DIRECTOR GENERAL'S FINDINGS, CONCERNING THE SAFETY AND
POTENTIAL EFFECTIVENESS OF THE HEALTH PRODUCT IN DIAGNOSING, PREVENTING,
OR TREATING SUCH DISEASES OR CONDITIONS, INCLUDING, TO THE EXTENT
PRACTICABLE, GIVEN THE CIRCUMSTANCES OF THE EMERGENCY, AN ASSESSMENT OF
THE AVAILABLE SCIENTIFIC EVIDENCE.

“SEC. 41. APPLICATION FOR EUA. - AN APPLICATION FOR THE ISSUANCE OF AN
EUA SHALL BE SUBMITTED BY THE INDUSTRY OR GOVERNMENT AGENCY CONCERNED,
SUCH AS THE NATIONAL PROCURER OR THE PUBLIC HEALTH EMERGENCY
IMPLEMENTER.

THE APPLICATION SHOULD DEMONSTRATE COMPLIANCE WITH CURENT GOOD
MANUFACTURING PRACTICES AND ACCOMPANIED BY AN UNDERTAKING BY THE
MANUFACTURER TO COMPLETE THE DEVELOPMENT OF THE DRUG AND VACCINE,
AMONG OTHERS.


“SEC. 42. DURATION OF AUTHORIZATION. — AN EUA UNDER THIS SECTION
SHALL BE EFFECTIVE UNTIL THE TERMINATION OF THE DECLARATION OF PUBLIC HEALTH
EMERGENCY ISSUED PURSUANT TO THE PRECEDING SECTION OR A REVOCATION AS
PROVIDED FOR UNDER THE SUCCEEDING SECTION.

“SEC. 43. REVIEW AND REVOCATION OF AUTHORIZATION. — THE FDA DIRECTOR
GENERAL MAY, WHEN NECESSARY, REVISE OR REVOKE AN EUA UPON THE
OCCURRENCE OF ANY OF THE FOLLOWING CIRCUMSTANCES:

“THE FDA DIRECTOR GENERAL MAY, WHEN NECESSARY, REVISE OR REVOKE AN
EUA UPON THE OCCURRENCE OF ANY OF THE FOLLOWING CIRCUMSTANCES:

“(a) THE PUBLIC HEALTH EMERGENCY OR THREAT, AS MAY BE DETERMINED BY
THE NATIONAL GOVERNMENT, NO LONGER EXISTS;

“(b) THE CRITERIA UNDER SECTION 39 OF THIS ACT FOR THE ISSUANCE OF AN
EUA ARE NO LONGER SATISFIED; OR

“(c) OTHER CIRCUMSTANCES MAKE SUCH REVISION OR REVOCATION
APPROPRIATE TO PROTECT PUBLIC HEALTH OR SAFETY.

“SEC. 44. EMERGENCY USE INSTRUCTIONS. - THE FDA SHALL, IN
CONSULTATION AND COORDINATION WITH THE DOH, THE DOST, AND OTHER RELEVANT
AGENCIES, ISSUE EMERGENCY USE INSTRUCTIONS TO INFORM HEALTH CARE PROVIDERS AND
INDIVIDUALS, TO WHOM AN ELIGIBLE HEALTH PRODUCT UNDER THIS ACT IS TO BE
ADMINISTERED, CONCERNING SUCH PRODUCT'S EUA.”

“SEC. 45. POST-AUTHORIZATION MONITORING. — THE FDA, TOGETHER WITH
OTHER CONCERNED OFFICES OF THE DOH, SHALL CONDUCT POST-AUTHORIZATION
MONITORING TO TRACK PRODUCT DEVELOPMENT, ADDITIONAL RELEVANT INFORMATION,
AND THE STATUS FROM THE MANUFACTURER CONCERNING FULL-PRODUCT LIFE-CYCLE. THE
HOLDER OF AN EUA SHALL BE REQUIRED TO COMPLETE SPECIFIC PHARMACOVIGILANCE
OBLIGATIONS, WITH A VIEW TO PROVIDING COMPREHENSIVE DATA CONFIRMING A POSITIVE
BENEFIT-RISK BALANCE.

SEC. 3. Implementing Guidelines. The FDA shall formulate and issue guidelines, as may
be necessary, for the effective implementation of this Act.

SEC. 4. Separability Clause. — If any provision of this Act is declared unconstitutional or
invalid, other sections or parts thereof not affected thereby shall remain in full force and effect.

SEC. 5. Repealing Clause. - Except as otherwise expressly provided in this Act, all other
laws, decrees, executive orders, proclamations and administrative regulations or parts thereof
inconsistent herewith are hereby repealed or modified accordingly.

SEC. 6. Effectivity Clause. ~ This Act shall take effect fifteen (15) days after its publication

in two (2) newspapers of general circulation.

Approved,