EIGHTEENTH CONGRESS OF THE
REPUBLIC OF THE PHILIPPINES
Third Regular Session

HOUSE OF REPRESENTATIVES

House Bill No. OY

Introduced by BHW Partylist Rep. Angelica Natasha Co
pe

AN ACT
ESTABLISHING THE GOVERNMENT VACCINE INDEMNIFICATION
PROGRAM, PROVIDING FUNDS THEREFOR, AND FOR OTHER
PURPOSES

EXPLANATORY NOTE

No less than the Constitution states that it is the policy of the State to protect
and promote the right to health of the people and instill health consciousness among
them. Further in Articles XIII, Section 12, on Social Justice and Human Rights on
Health, declares that it is the responsibility of the State to “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”.

With these Constitutional mandate in mind, this measure proposes to
institutionalize a government vaccine-related injury indemnification program to
balance the need for social justice while recognizing the government's obligation to
ensure a sustainable supply of safe and cost-effective vaccines within a predictable

regulatory environment.

1 1987 Constitution. Article 2, Section 15.
‘The State shall protect and promote the right to health of the people and instill health consciousness among
them,


This scheme is not without precedence. Prior to the US Congress’ enactment of
the National Childhood Vaccine Injury Act of 19862 that established the National
Vaccine Injury Compensation Program, claimants for vaccines-related injuries’ only
course of action was through the court system. Without a clear and predictable system
of indemnification, vaccine manufacturers are constantly in a difficult predicament
with ever-present potential exposure to lawsuits. Accordingly, the market had to
contend with high prices, shortages and reduced investment in vaccine research.
Furthermore, several small vaccine manufacturers left the market. 3

In view of the societal benefits of having in place such a vaccine compensation
scheme, several countries have implemented a variety of approaches as to the
administration and funding, eligibility, process and decision-making, standard of
proof, elements of compensation and litigation rights to this scheme. These countries
include China, Japan, Taiwan and South Korea, as well as those in the European
Union, notably Austria, Denmark, Sweden. Italy, Hungary, Iceland and Slovenia. +

To ensure the effective implementation of this Act, the bill proposes to create
the Vaccines Compensation Board whose composition shall come from both the
government and key players in the private healthcare sector. This is in recognition of
the Constitutional principle of promoting greater public-private collaboration by
encouraging the participation of non-governmental, community-based, or sectoral
organizations that promote the welfare of the nation.5

‘The warnings and lessons from the current pandemic must be heeded. Putting
in place a vaccine-related injury indemnification system that will be embedded in the
public immunization program will help protect and compensate the most

? Cf. httpsi//www federalregister.gov/documents/2020/07/20/2020-15673/national-vaccine-injury-
‘compensation-program-revisions-to-the-vaccine-injury-table

3 Cf. Damage Payments Unit [Internet
site] http://www.direct.gov.uk/en/MoneyTaxAndBenefits/BenefitsTaxCreditsAndOtherSupport/Disabledpeop!
e/06_10018714

4 Cf. https://www.who int/bulletin/volumes/89/5/10-081901/en/
5 1987 Constitution. Article 2, Section 23.

The State shall encourage non-governmental, community-based, or sectoral organizations that promote the
welfare of the nation.


marginalized and vulnerable sectors of society from any unanticipated adverse events
resulting from vaccination, Such a system will build mutual trust and foster closer
collaboration among the relevant stakeholders within the healthcare ecosystem.

Finally, having this vaccine-injury compensation scheme will remove
apprehension and reluctance on the part of manufacturers and suppliers of ensuring
adequate supply of vaccines over threats of possible court cases for liability and the
associated negative media coverage. On the other hand, this system will provide a fair,
efficient and predictable remedy for the injured parties.

With the prospects of the availability and the eventual supply of essential
vaccines in the country in response to the current pandemic by various pharmaceutical
companies and the likely occurrence of similar public health crises in the future, there
is an urgent necessity for government to anticipate valid concerns over the

introduction and use of new vaccines. We must be prepared now.

Hence, approval of this proposed measure is earnestly sought.

Rep. Angeli, fasha Co
BHW list


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EIGHTEENTH CONGRESS OF THE
REPUBLIC OF THE PHILIPPINES
Third Regular Session

HOUSE OF REPRESENTATIVES

House Bill No. _/480

Introduced by BHW Partylist Rep. Angelica Natasha Co
piste in) essed ee el ee

AN ACT
ESTABLISHING THE GOVERNMENT VACCINE INDEMNIFICATION
PROGRAM, PROVIDING FUNDS THEREFOR, AND FOR OTHER
PURPOSES
Beit enacted by the Senate and House of Representatives of the Philippines in Congress

assembled:

Sec. 1. Short Title. — This Act shall be known as the “Vaccine Indemnification
Fund Act of 2020”.

Sec. 2. Declaration of Policy. — It is the policy of the State to protect and
promote the right to health of the people and instill health consciousness among them.
Likewise, it is the State’s responsibility to establish and maintain an effective drug
regulatory system and undertake appropriate policies that are responsive to the
country's health needs and problems.

Consistent with this Constitutional mandate, the State shall implement a
system for vaccine-related injury indemnification to serve as a fair, efficient and stable
mechanism for individuals to obtain compensation upon the occurrence of verified
vaccine-related adverse events without need to attribute fault or negligence on vaccine
manufacturers or supplier. This shall be the primary mode of compensation and as an
alternative to long-drawn, expensive court litigations that constrain vaccine recipients

from pursuing bona fide claims for vaccine-related injuries.

Sec. 3. Sources of the Fund — The Government Vaccine Indemnification
Fund (the “Fund”) shall be subsidized by pharmaceutical companies that supply


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government with vaccines for public immunization programs. Pharmaceutical
companies participating in public tenders and are awarded government contracts for
the supply of such vaccines shall reserve least one percent (1%) of the contract price
which shall form part of the Fund. The reserved amount shall be deposited with the
Bureau of the Treasury of the Department of Budget and Management.

See. 4. Use of the Fund. — The Fund shall be earmarked exclusively to
compensate and indemnify identified vaccine recipients who sustain injury in
connection with the use of the vaccines and where the adverse effects are attributable

to the vaccination.

Sec. 5. Management of the Fund. — The Fund shall be managed by the
Vaccines Compensation Board (the “Board”) composed of the following:

1, Secretary of Justice - Chairperson

.. Secretary of Health — Vice-Chairperson

. Secretary of Budget and Management ~ Member

. Secretary of Finance ~ Member

. Sectoral representative from the healthcare industry - Member

. Sectoral representative from the patient advocacy groups - Member

Yageown

. Sectorial representative from the medical societies - Member

The sectoral representatives shall have a term of office of three (3) years. The
President of the Philippines shall appoint from among a list of three (3) candidates
upon the favorable recommendation by the organizations of their respective sectors.
Upon approval of this Act, the sectoral representative from the healthcare industry
shall have an initial term of one (1) year and the sectoral representative from patient
advocacy groups shall have an initial term of two (2) years. Thereafter, the three-year
term shall apply to all subsequent appointments. No sectoral representative who has
served a full term shall be eligible for reappointment to the Board.

Sec. 6. Powers and Functions of the Board. — The Board shall have the
following powers and functions:

(a) Provide overall strategic direction and guidance in the implementation of

this Act including but not limited to the administration and utilization of

the Fund, eligibility requirements, rules on filing claims for injury or death


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and the decision-making process, standard of proof required, elements of
compensation and litigation rights of the parties involved;

(b) Exercise original and exclusive jurisdiction on verified bona fide claims for
compensation or indemnification on vaccine-related injuries or death;

(©) Establish an efficient system for reporting and periodic reviews on the use
and management of the Fund through stringent internal controls and
information systems; and,

(d) Such other powers as may be proper and necessary to perform their duties
and responsibilities effectively and with full transparency taking into
consideration the best interests of all relevant stakeholders.

Sec. 7. Appropriations. — The amount needed for the initial
implementation of this Act shall be charged against the appropriations of the
Department of Health (DOH) in the current and subsequent General Appropriations
Act. Thereafter, the amount needed for the continued implementation of this Act shall
be taken from the Fund. In case the Fund, after careful assessment and projected
utilization, shall be insufficient to answer for potential claims, the DOH shall subsidize
such amount in the supplemental budget to be included in the annual General
Appropriations.

Sec. 5. Implementing Rules and Regulations. — Within six (6) months
from the approval of this Act, the Department of Justice (DOJ), the Department of
Health (DOH), the Department of Budget and Management (DBM) and the
Department of Finance (DOF) in coordination with other implementing agencies, shall
formulate rules and guidelines as may be necessary for the proper implementation and
enforcement of this Act.

Sec. 6. Repealing Clause. — All laws, decrees, letters of instruction,
resolutions, orders or parts thereof which are inconsistent with the provisions of this
Act are hereby repealed, modified or amended accordingly.

Sec. 7. Effectivity Clause. — This Act shall take effect fifteen (15) days after
its publication in the Official Gazette or in two (2) newspapers of general circulation.

Approved,