Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

EIGHTEENTH CONGRESS
Second Regular Session

8816

House Bill No.

Introduced by Representative PABLO JOHN F. GARCIA

EXPLANATORY NOTE

Article Il, Section 15 of the Constitution provides that “The State shall protect and
promote the right to health of the people and instill health consciousness among them.” It also
states in Article XIII, Section 11 that “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. [x x x]"

In 2006, then United States Health and Human Services Secretary Michael Leavitt
said, “Pandemics happen. Anything we say in advance of a pandemic happening is alarmist;
anything we say afterwards is inadequate.”’ Indeed, in hindsight—after more than a year since
Covid-19 started grabbing headlines and ravaging the world—we could have done more. As
the government is currently all-out in addressing the present concerns brought about by this,
disease, we should also take stock of what we can improve upon for future pandemics so that
lives and livelihoods nationwide may be saved. This is not being alarmist; it is preparing for
the inevitable.

Mass vaccination is part of any sound pandemic preparedness and response policy.”
It creates herd immunity for the benefit of the vulnerable aside from preventing the spread of
the contagion. However, Covid-19's novelty has made high-income nations scramble for
vaccine stocks—leaving poorer nations with what little remains. But even rich nations such
as Canada have experienced supply issues due to export restrictions and supply chain
shortfalls.‘ Local vaccine production is thus a matter of necessity especially for less capable
nations such as ours.

‘ Ball University, Influenza Pandemic Operations and Response Plan, available at
https:/;www_bsu.edu/about/administrativeoffices/emergency-
preparedness/pandemicfluprep/operresponseplan/influpanoperrespondplan.

? See World Health Organization, Pandemic Influenza Preparedness and Response: A WHO Guidance
Document available at: https://www.ncbi.nim.nih.gov/books/NBK143067/.

3 Megan Twohey et al., New York Times, With First Dibs on Vaccines, Rich Countries Have ‘Cleared
the Shelves’, available at _hitps:/www.nytimes.com/2020/12/15/us/coronavirus-vaccine-doses-
reserved.html.

4 Paula Newton, CNN, Shutout by allies, Canada will produce its own vaccines by the end of 2021,
https://edition.cnn.com/2021 /02/02/americas/canada-coronavius-vaccines/index.html.

® See notes 3 and 4.


This bill aims to incentivize the rapid partnering of local manufacturers and vaccine
creators or inventors to speed up mass vaccination efforts in the event of another novel
contagion. This bill empowers the Department of Health, through the Food and Drug
Administration, to approve certain vaccines or drugs for emergency and/or right-to-try use, and
incentivizes their local production by providing tax incentives to participating local and foreign
firms.

It is hoped that this measure, in conjunction with regular vaccine procurement,
importation, research and development, and other auxiliary efforts, will lead to a strong

response should another pandemic spread.

In view of the foregoing, the urgent passage of this bill is earnestly sought.

Rep. PABKOSOHN F. GARCIA.
3rd District, Province of Cebu


Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

EIGHTEENTH CONGRESS
Second Regular Session

8816

House Bill No.

Introduced by Representative PABLO JOHN F. GARCIA

AN ACT
AUTHORIZING THE FOOD AND DRUG ADMINISTRATION TO GRANT EMERGENCY
USE AND RIGHT-TO-TRY AUTHORIZATION FOR VACCINES OR DRUGS TO ADDRESS
NOVEL PANDEMICS, PRESCRIBING CONDITIONS THEREFOR, INCENTIVIZING THEIR
LOCAL PRODUCTION, AND FOR OTHER PURPOSES

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

Section 1. Short Title. This Act shall be known as the “Emergency Use and Right-
to-Try Authorization Act of 2021”.

Section 2. Declaration of Policy. - It is the policy of the State to protect and
promote the right to health of the Filipino people. Furthermore, 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 at affordable cost. Finally, it is the
policy of the State to exert all measures possible such as the authorization of the emergency
and right-to-try use of drugs and vaccines and the incentivization of their local manufacture, to
save the lives and livelihoods of Filipinos from novel pandemics.

Section 3. Definition of Terms. - For purposes of this Act, the following terms shall
be defined as follows:

(a) A drug or vaccine shall mean a pharmaceutical product, whether
registered with the Food and Drug Administration (FDA) or given emergency use or
right-to-try authorization, and which pertains to chemical compounds or biological
substances, other than food, intended for use in the diagnosis, treatment, or prevention
of a disease involved in a novel pandemic; and

(b) Anovel pandemic is a new life-threatening infectious disease that has
not been previously identified in humans and which is quickly spreading across
countries or continents.


(©) Foreign entity shall mean the foreign patent-holders or creators of a
novel pandemic drug or vaccine;

(4) Recognition shall refer to the acceptance of the regulatory decision of
another trusted institution concerning a drug or vaccine. It shall be based on evidence
of conformity that the requirements of the reference regulatory authority are sufficient
to meet the regulatory requirements of the FDA as provided for in this Act.

(e) Reliance shalll refer to the act whereby the national regulatory authority
(NRA) in one jurisdiction may take into account and give significant weight to
assessments performed by another NRA or trusted institution, or to any other
authoritative information in reaching its own decision.

Section 4. Emergency Use Authorization for drugs and vaccines for novel
pandemics. - The Director General of the FDA is hereby authorized to issue an Emergency
Use Authorization (EUA) for drugs and/or vaccines for use against novel pandemics subject
to the conditions in the succeeding Section.

Outside clinical trials and except in cases where a right-to-try authorization is issued,
no unregistered novel pandemic drug or vaccine may be manufactured, sold, imported,
exported, distributed or transferred without an EUA.

Section 5. Conditions for the Issuance of Emergency Use Authorization. - An
EUA on a drug or vaccine for a novel pandemic shall be issued and remain valid only when all
of the following circumstances are present

(2) Based on the totality of evidence available, including data from
adequate and well-known controlled trials, it is reasonable to believe that the drug or
vaccine may be effective to prevent, diagnose or treat the novel pandemic;

(b) The known and potential benefits of the drug or vaccine when used to
diagnose, prevent or treat the novel pandemic disease outweigh the known and
potential risks of + the += drugs or_~—svaccine, if’ «any; and

() There is no adequate, approved and available alternative to the drug or
vaccine for diagnosing, preventing or treating the novel pandemic disease.

Section 6. Applications for Emergency Use Authorization. - An application for
the issuance of an EUA shall be submitted by the local or foreign drug or vaccine manufacturer,
the drug or vaccine creator, or government agency concemed, such as the national procurer
or the public health program implementer.

The application should demonstrate compliance with current good manufacturing
practices, as may be determined in the implementing rules and regulations consistent with the
objectives and policies of this Act, and be accompanied by an undertaking by the manufacturer
to complete the development of the drug and vaccine, among others.


Section 7. Reliance and Recognition. - In evaluating applications for EUA, the
FDA Director General shall have the power to implement reliance and recognition processes
for emergency use of novel pandemic drugs and vaccines. For this purpose, the FDA Director
General may accept the regulatory decisions of institutions such as the World Health
Organization, the Centers for Disease Control and Prevention of the United States, or other
internationally recognized and established regulatory authorities.

Section 8. _ Expert Panel. - The FDA shall convene a panel composed of experts
on drug and vaccine development, which shall conduct a review of available data on the safety
and effectiveness of a novel pandemic drug or vaccine applied for an EUA. After review, the
panel shall submit to the FDA Director General its report and recommendations.

Section 9. Validity of the Emergency Use Authorization. - An EUA issued
pursuant to this Act shall be valid only within the duration of the declared public health
emergency due to the novel pandemic, without prejudice to the discretion of the FDA Director
General to revisit or revoke the same, as may be appropriate, to protect the general public
health and safety.

Section 10. Post-Authorization Monitoring. - The FDA, together with other
concemed offices of the DOH, shall conduct post-authorization monitoring to track product
deployment, additional relevant information, and the status from the manufacturer conceming
the full life-cycle of the product drug or vaccine. 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.

Section 11. Right-to-Try Authorization. - Eligible patients may be permitted by the
FDA to have access to eligible investigational drugs or vaccines for novel pandemics.

An eligible patient is a patient who has:

(a) Been diagnosed with a life-threatening disease due to a novel
pandemic;

(b) Exhausted approved treatment options and is unable to participate in a
clinical trial involving the eligible investigational drug or vaccine, the fact of which must
be certified by a licensed physician in good standing; and

(c) Has provided, or their legally authorized representative has provided,
written informed consent regarding the eligible investigational drug or vaccine.

An eligible investigational drug or vaccine is an investigational drug or vaccine:
(a) For which a Phase 1 clinical trial has been completed;
(b) That has not been approved or licensed by the FDA for any use;

(ce) Forwhich an application has been filed with the FDA, oris eligible under
a reliance and recognition process as described herein, or is under investigation in a


clinical trial that is intended to form the primary basis of a claim of effectiveness in
support of FDA approval and is the subject of an active investigational new drug
application submitted to the FDA; and

(d) Whose active development or production is ongoing, and that has not
been discontinued by the manufacturer or placed on clinical hold by the FDA.

The FDA shall act on Right-to-Try Authorization applications within three (3) days from
date of application.

Section 12, Tax Incentives for the Local Manufacture of Drugs and Vaccines. -
Local manufacturers and foreign entities, which have entered into agreements for the
production of drugs or vaccines, whether registered with the Food and Drug Administration
(FDA) or given emergency use or right-to-try authorization, to expedite mass treatment and
immunization efforts following a novel pandemic, shall both enjoy the following tax benefits,
when applicable:

(2) Full tax exemption, whether from income tax, sales tax, excise tax,
transfer tax, value-added tax, percentage tax, or otherwise, for any revenue, income,
profit, and the like conceming the agreement, manufacturing, and subsequent sale of
the novel pandemic drug or vaccine;

(b) Exemption from all kinds of local taxes, fees, or charges imposed by a
local government unit on the agreement, manufacturing, and subsequent sale of the
novel pandemic drug or vaccine, including real property taxes for two (2) years after
on the machineries and equipment directly used for the manufacturing process; and

(c) Tax and customs duty-free importation of equipment, supplies,
ingredients, components, raw materials, and the like used solely for the local
manufacture of the drug or vaccine and which are not locally available.

Section 13, Intellectual Property Protection. - Nothing in this Act shall be
construed to mean a diminution or elimination of any Intellectual Property Rights enjoyed by
any person, natural or juridical, by virtue of any law, rule, regulation, treaty, and/or international
agreement.

Section 14. Revenue Issuances. - The Department of Finance, through the Bureau
of Internal Revenue and the Bureau of Customs, shall issue the corresponding Revenue
Regulations and/or Revenue Memorandum Circulars related to the grant of the incentives
mentioned in the preceding section within thirty (30) days from the effectivity of this Act.

Section 15. Implementing Rules and Regulations. - The Department of Health
shall issue within ninety (90) days from the effectivity of this Act the necessary rules and
regulations for the effective implementation of this Act.

Section 16. Repealing Clause. - All laws, executive orders, proclamations, rules,
regulations and other issuances or parts thereof which are inconsistent with the provisions of
this Act are hereby repealed, amended, or modified accordingly.


Section 17. Separability Clause. - If any part or provision of this Act is held
unconstitutional or invalid, other parts or provisions thereof which are not affected shall
continue to remain in full force and effect.

Section 18. Effectivity. - This Act shall take effect fifteen (15) days following
completion of its publication in at least two (2) newspapers of general circulation,

Approved,