EIGHTEENTH CONGRESS OF THE 
REPUBLIC OF THE PHILIPPINES 
Second Regular Session
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Feb 01 2021 ml
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SENATE 
S. No. 2029
INDEX.
Introduced by SENATORS VICENTE C. SOTTO III and PIA S. CAYETANO
AN ACT
EXEMPTING MEDICATIONS AND VACCINES FROM CERTAIN PROVISIONS OF 
REPUBLIC ACT NO. 11223, OTHERWISE KNOWN AS THE UNIVERSAL 
HEALTHCARE ACT, DURING PUBLIC HEALTH EMERGENCIES
EXPLANATORY NOTE
Republic Act No. 11223, or the Universal Healthcare Act, provides for the health 
technology assessment (HTA) process, a priority setting mechanism that shall be 
recommendatory to the Department of Health (DOH) and Philippine Health Insurance 
Corporation (PhilHealth) for the development of policies and programs, regulation, and 
the determination of a range of entitiements such as drugs, medicines, pharmaceuticai 
products, and other devices, procedures and services.1 The iaw further provides that a 
positive recommendation from the Health Technology Assessment Council (HTAC) is 
needed before the DOH and PhilHealth can invest in any health technology or develop 
any benefit package.2 One of the criteria that the HTAC must observe prior to making 
recommendations is that such a pharmaceutical product must have undergone Phase IV 
clinical trial, and systematic review and meta-analysis must be readily available.3
However, public health emergencies such as the COVID-19 pandemic require the 
State to act faster than what regular procedures allow in order to expedite the
1 Section 34 (a), Republic Act No. 11223.
2 Section 34 (a), Republic Act No. 11223.
3 Section 34 (b) (2), Republic Act No. 11223.


procurement of life-saving medications and vaccines. Currently, all available COVID-19 
vaccines have not reached Phase IV clinical trials. It will take another two (2) to (5) years 
of further data gathering before reaching Phase IV. At present, some COVID-19 vaccine 
manufacturers have released preliminary data based on Phase III clinical trials. 
Emergency Use Authorizations have been issued around the world, based on the Phase 
III preliminary data. Republic Act No. 11223, which only allows HTAC to commence its 
review process based on data from Phase IV clinical trials, effectively limits the 
recommendatory power of the HTAC, and hinders the country's procurement efforts.
To this end, this bill seeks to authorize the HTAC to make recommendations on 
medications and vaccines to the DOH and the PhilHealth based on preliminary data from 
Phase III clinical trials and World Health Organization recommendations for a limited 
period, in the absence of completed Phase III and Phase IV clinical trials, during public 
health emergencies.
In view of the foregoing, the immediate passage of this bill is earnestly sought.
PIA S. CAYEyANO


EIGHTEENTH CONGRESS OF THE 
REPUBLIC OF THE PHILIPPINES 
Second Regular Session
SENATE 
S. No. 2029
r<rr received
e-filed
IS n.T.r..Feb 01 2021 fTT
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t k.5e;
8:00 a.m.
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Introduced by SENATORS VICENTE C. SOTTO III and PIA S. CAYETANO
AN ACT
EXEMPTING MEDICATIONS AND VACCINES FROM CERTAIN PROVISIONS OF 
REPUBLIC ACT NO. 11223, OTHERWISE KNOWN AS THE UNIVERSAL 
HEALTHCARE ACT, DURING PUBLIC HEALTH EMERGENCIES
Be it enacted by the Senate and House of Representatives of the Philippines in the 
Congress assembled:
1 
Section 1. Short Title. - This Act shall be known as the "Agarang Lunas Laban sa
2 
Krisis Pangkaiusugan Act".
3 
Sec. 2. Declaration of Policy. -It is the policy of the State to protect and promote
4 
the right to health of the people and instill health consciousness among them.
5 
Pursuant to this and the objectives of universal healthcare as provided in Republic
6 
Act No. 11223 or the Universal Healthcare Act, the State recognizes the importance of
7 
the heaith assessment technology process as a fair and transparent priority setting
8 
mechanism, adhering to the principles of ethical soundness, inclusiveness and preferential
9 
regard for the underserved, evidence-based and scientific defensibiiity, transparency and
10 
accountabiiity, efficiency, enforceability and avaiiability of remedies, and due process.
11 
The State acknowledges that public health emergencies such as the COVID-19
12 
pandemic necessitate the need for emergency processes in order to expedite the
13 
procurement of life-saving medications and vaccines. To this end, the State shail take
14 
proactive measures to fast-track the acquisition of medication and vaccines during public


1 
health emergencies, while maintaining due regard for scientific evidence and consensus,
2 
quality healthcare, and the safety of all Filipinos.
3 
Sec. 3. Authority to Make Recommendations Based on Preliminary Data from Phase
4 
III Clinical Trials. - Notwithstanding any law to the contrary, and upon the declaration of
5 
the President of a State of Public Health Emergency as provided in Republic Act No. 11332
6 
or the "Mandatory Reporting of Notifiable Diseases and Health Events of Public Health
7 
Concern Act", the Health Technology Assessment Council (HTAC) shall have the authority
8 
to make recommendations to the Department of Health (DOH) and the Philippine Health
9 
Insurance Corporation (PhilHealth) on medications and vaccines based on preliminary
10 
data from Phase III clinical trials and World Health Organization recommendations, in the
11 
absence of completed Phase III and Phase IV clinical trials, during times of public health
12 
emergencies: Provided, That the medication or vaccine manufacturer has been issued an
13 
Emergency Use Authorization (EUA) by the Philippine Food and Drug Administration
14 
(FDA): Provided, further. That the HTA process shall only be valid for as long as the EUA
15 
issued by the FDA is in effect, such that in the event of revocation or cancellation thereof
16 
by the FDA Director General, the HTA process shall be terminated regardless of stage,
17 
and if it has been completed, the results shall be set aside: Provided, finally. That this
18 
authority shall expire five (5) years from the declaration of State of Public Health
19 
Emergency, or until such time that the President, upon recommendation of the DOH,
20 
declares the Public Health Emergency to be over.
21 
Sec. 4. Separability Clause. - If any provision of this Act is declared
22 
unconstitutional or otherwise invalid, the validity of the other provisions shall not be
23 
affected thereby.
24 
Sec. 5. Repealing Clause. - All other laws, decrees, orders, rules and regulations,
25 
other issuances, or parts thereof inconsistent with the provisions of this Act are hereby
26 
repealed or modified accordingly.
27 
Sec. 6. Effectivity. - This Act shall take effect immediately upon its publication in
28 
a newspaper of general circulation or in the Official Gazette.
Approved,