EIGHTEENTH CONGRESS OF THE 
REPUBLIC OF THE PHILIPPINES 
Second Regular Session
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■ •’
21 
JM126 P3--42
SENATE
Introduced by Senator Francis "Tol" N. Tolentino
AN ACT
INSTITUTIONALIZING THE GRANT OF 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"; AND FOR OTHER PURPOSES
Explanatory Note
The Philippine government has announced its own vaccine deployment program, with 
the procurement of vaccines as the initial and crucial step. Negotiations to secure at least 148 
million doses of COVID-19 vaccines from approximately seven companies are being discussed 
with the end goal of inoculating around 50 to 70 million Filipinos by the end of 2021.1
In its Press Statement dated 14 January 2021, the Philippine Food and Drug 
Administration (FDA) announced that it has granted an Emergency Use Authorization (EUA) 
to Pfizer-BioNtech's COVID-19 vaccine.2 An EUA would allow procurement and use of an 
unregistered drug during the existence of a public health crisis.3 To date, various COVID-19 
vaccine candidates have already applied for and were granted EUAs by different countries. 
Several pharmaceutical companies, such as the UK firm AstraZeneca, Russian company
1 https://cnnnhllinnines.eom/news/2021/l/6/WHO-on-PH-COVID-19-vacdnatlon-Droaram.html 
2httPs://www.fda.aov.Dh/fda-DhlliDPine«;-arants-emeraencv-use-authorl2atlon-to-pfizer-blontech-covldjg^
vaedne/
3 Section 564 of the United States Code: Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-392, as 
amended by the Pandemic and All-Hazards Preparedness Reauthorizab'on Act of 2013 (PAHPRA).


Gamaleya Research Institute, Chinese drug maker Sinovac Biotech, and India-based firm 
Bharat Biotech,4 have iikewise sought the issuance of an EUA from the Phiiippine FDA.
Apparent from the foregoing is that a key requirement to any vaccine procurement 
pian and suppiy agreement is the grant of an authorization to use unregistered vaccines by 
the procuring government. In the Phiiippines, the FDA is the soie agency authorized to 
reguiate health products and issue authorization under Section 4 of Republic Act (R.A.) No. 
3720, otherwise known as "Food, Drug, and Cosmetic Act," as amended by R.A. No. 9711, 
otherwise known as the "FDA Act of 2009."
However, a reading of R.A. No. 3720, as amended, and Its Implementing Rules and 
Regulations (IRR), do not provide for or contemplate the grant of EUA by the FDA. Despite 
the lack of authority, the FDA in recent months issued at least four (4) circulars, allowing for 
an EUA for COVID-19 drugs, to wit: (!) FDA Qrcular No. 2020-036, dated 14 December 2020; 
(ii)?Dl\, Circular No. 2020-012-A, dated July 27,2020; (iii)?Dk Circular No. 2020-012-B, dated 
26 August 2020; and ^/V;fDA Circular 2020-012, dated 2 April 2020.
Although Executive Order (E.O.) No. 121, dated 1 December 2020, granted the 
Director General of the FDA the authority to issue EUA for COVID-19 drugs and vaccines, it 
could be argued that this is insufficient to clothe the said agency with the authority to do so. 
Under the Administrative Code of the Philippines, executive orders refer to acts of the 
President providing for rules of a general or permanent character In the implementation or 
execution of constitutional or statutory powers.5 They cannot amend, revise, repeal, or in any 
way, alter what is stated under a law passed by Congress. As provided under Article 7 of the 
Civil Code of the Philippines, "[l]aws are repealed only by subsequent ones, and their violation 
or non-observance shall not be excused by disuse, or custom or practice to the contrary."6
Moreover, the provision on procurement of COVID-19 drugs and vaccines under 
Section 12 of Republic Act No. 11494, otherwise known as the "Bayanihan to Recover as One 
Act," neither authorizes the FDA Director General to grant EUA to pharmaceutical companies. 
Although the FDA and the Health Technology Assessment Council (HTAC) are empowered to
4httDs://newsinfo.lnaulrer.npt/1386482/indian-firm-seeks-eua-ln-ph-for-lts-cx)vid-19-vacdne;
covaxln#lxzz6kBXTlV6N
5 Section 2, Chapter 2, Book III of Executive Order No. 292, otherwise known as the "Administrative Code 
of 1987."
6 Article 7, Republic Act No. 386, otherwise known as the "Civii Code of the Philippines."


determine the minimum standards for the distribution of medications and vaccines,7 the said 
Act did not contemplate granting the FDA the authority to issue EUA for the procurement of 
COVID-19 vaccines.
This glaring void in the law deems the FDA's issuances on EUA and the grant thereof 
to COVID-19 vaccine manufacturers subject to stricter legal scrutiny. They may be declared 
void if found to be in excess of the authority conferred or in conflict with the governing statute. 
Invalidating the EUA issuances and grants, however, in time of a public health crisis would be 
an impractical thing to do. It would result in unnecessary delays in the deployment of the 
much-needed COVID-19 vaccines for the Filipinos.
Hence, in order to address the lack of authority to grant EUA under the existing FDA 
law, this Bill seeks to further amend R.A. No. 3720 in order to define EUA and provide the 
parameters for its issuance. The proposed measure not only gives legitimacy to the circulars 
issued by the FDA on EUA but also ensures the faster and smoother procurement and 
distribution of vaccines to the Filipino people during a public health emergency.
In light of the foregoing, the passage of this bill is earnestly sought.
'TOL" N. TOLENTINO
Senator
' Section 12 of Republic Act No. 11494, otherwise known as the "Bayanihan to Recover as One Act."


EIGHTEENTH CONGRESS OF THE 
)
REPUBLIC OF THE PHILIPPINES 
)
Second Regular Session 
)
Igjii
of tljc S'l'tritf' rp
SENATE
s. No. 2024
21 JAN 26 P3 -42
Introduced by Senator Francis "To!" N. Tolentino
AN ACT
INSTITUTIONALIZING THE GRANT OF 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"; AND FOR OTHER PURPOSES
Be It enacted by the Senate and the House of Representatives of the Philippines in 
Congress assembled: 
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Section 1. Section 10 of Republic Act (R.A.) No. 3720, as amended, is hereby 
further amended to include new subsections (nn), (oo), (pp), (qq), and (rr) to read as 
follows:
"SEC. 10. For the purposes of this Act, the term:
XXX
(NN) EMERGENCY USE AUTHORIZATION (EUA) REFERS TO 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


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AVAILABLE ALTERNATIVE HEALTH PRODUCTS. THE EMERGENCY 
USE MAY EITHER BE FOR AN UNAPPROVED HEALTH PRODUCT OR 
UNAPPROVED USE OF AN APPROVED HEALTH PRODUCT.
(00) 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 AUTHORIZATION, OR ANY 
OFFICIAL LICENSE ISSUED BY THE FDA.
(QQ) PUBLIC HEALTH EMERGENCY MEANS, PURSUANT TO REPUBLIC 
ACT (R.A.) 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:
(I) BIO TERRORISM;
(II) 
APPEARANCE OF A NOVEL OR PREVIOUSLY 
CONTROLLED OR ERADICATED INFECTIOUS AGENT 
OR BIOLOGICAL TOXIN;
(III) A NATURAL DISASTER;


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(IV) A CHEMICAL ATTACK OR ACCIDENTAL RELEASE;
(V) A NUCLEAR ATTACK OR ACCIDENT; OR
(VI) 
AN ATTACK OR ACCIDENTAL RELEASE OF 
RADIOACTIVE MATERIALS; AND
(2) POSES A HIGH PROBABILITY OF ANY OF THE FOLLOWING:
(I) A LARGE NUMBER OF DEATHS IN THE AFFECTED 
POPULATION;
(II) A LARGE NUMBER OF SERIOUS INJURIES OR LONG­
TERM DISABILITIES IN THE AFFECTED POPULATION;
(III) 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."
Section 2. A new Chapter XV and six (6) new sections, Sections 38, 39, 40, 41, 
42, and 43 shaii be introduced to R.A. No. 3720, as amended, which shail read as 
foiiows:
"CHAPTER XV
EMERGENCY USE AUTHORIZATION


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SEC. 38. SCOPE OF 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. 39. CRITERIA FOR 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 CONDITION EXISTS;


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(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:
i. 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
ii. 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. 40. DECLARATION BY THE DIRECTOR GENERAL OF THE FDA. 
- THE FDA DIRECTOR GENERAL SHALL CONDUCT A SEPARATE AND 
INDEPENDENT DETERMINATION AND, THEREAFTER, ISSUE A 
DECLARATION ON SAID FINDINGS, PRIOR TO THE GRANT OF AN EUA. 
THE DETERMINATION AND DECLARATION SHALL BE SEPARATE FROM 
THE DECLARATION OF A PUBLIC HEALTH EMERGENCY BY THE


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NATIONAL GOVERNMENT. LIKEWISE, THEY SHOULD SATISFY THE 
CRITERIA ENUMERATED UNDER THE IMMEDIATELY PRECEDING 
SECTION AND ALL OTHER REQUIREMENTS PROVIDED FOR BY THIS 
ACT.
SEC. 41. DURATION OF AUTHORIZATION. - AN EUA UNDER THIS 
SECTION SHALL BE EFFECTIVE UNTIL THE TERMINATION OF THE 
DECLARATION ISSUED PURSUANT TO THE PRECEDING SECTION ORA 
REVOCATION AS PROVIDED FOR UNDER THE SUCCEEDING SECTION.
SEC. 42. REVIEW AND REVOCATION OF AUTHORIZATION. - THE 
FDA DIRECTOR GENERAL SHALL PERIODICALLY REVIEW THE 
CIRCUMSTANCES AND THE APPROPRIATENESS OF ALL EUA ISSUED 
PURSUANT TO THIS ACT.
THE FDA DIRECTOR GENERAL MAY, WHEN NECESSARY, REVISE 
OR REVOKE AN EUA UPON THE OCCURRENCE 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. 43. 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


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AN ELIGIBLE HEALTH PRODUCT UNDER THIS ACT IS TO BE 
ADMINISTERED, CONCERNING SUCH PRODUCT'S EUA."
Section 3. Separability Clause. - If any provision of this Act is deciared 
unconstitutional or invalid, other sections or parts thereof not affected thereby shall 
remain in full force and effect.
Section 4. Repealing Clause. - All laws, decrees, executive orders, rules, and 
regulations, or parts thereof, inconsistent with the provisions of this Act are hereby 
repealed or modified accordingly.
Section 5. Effectivity Clause. - This Act shall take effect fifteen (15) days after 
its complete publication in the Official Gazette or in at least one (1) newspaper of 
general circulation.
Approved,