SEVENTEENTH CONGRESS
REPUBLIC OF THE PHILIPPINES —_)
Second Regular Session )

HOUSE OF REPRESENTATIVES

Introduced by Representative Maximo B. Rodriguez, Jr.

House Bill No. 7648
EXPLANATORY NOTE

Dengvaxia, a dengue vaccine produced by Sanofi Pasteur, despite having
successfully completed clinical studies which compare the safety and effectiveness
of the vaccines, studies where the Philippines was among the 10 countries that took
part in, is embroiled in a controversy on its efficacy.

Subsequently, Sanofi Pasteur applied for Denvaxia's inclusion in the
Philippine National Formulary pending approval by the Food and Drug Administration
(FDA). Then Health Secretary Janette Garin submitted a proposal to the Department
of Budget and Management (DBM) to buy three million doses of Dengvaxia. The
DBM issues a Php 3.5-billion Special Allotment Release Order to Garin's office to
purchase the vaccines. The Philippine Children's Medical Center (PCMC) makes a
Php 3-billion purchase order for the vaccines without approval from the Formulary
Executive Council (FEC). Garin then issued a Php 3-billion disbursement voucher to
the PCMC to fund the purchase of the vaccines. The government then kicked-off its
Php 3.5-billion, school-based dengue immunization program.

The World Health Organization (WHO), on the other hand, released papers
saying that Dengvaxia "may be ineffective or may even increase that risk in those
who are seronegative at the time of first vaccination" and that Dengvaxia "may act as
a silent natural infection that primes seronegative vaccines to experience a
secondary-like infection upon their first exposure to dengue virus"

Since then, there have been numerous deaths which are allegedly and
claimed to be related to the Dengvaxia vaccine. Sanofi Pasteur has agreed to refund
the unused doses of Dengvaxia amounting to around Php1.4 billion. However,
Sanofi has rejected the request of the Department of Health to refund the whole
amount of Php 3.5 billion and to set up an indemnification fund for children
administered the anti-dengue vaccine.

Now, the more than 800,000 children given Dengvaxia and their families are
at the mercy of Sanofi Pasteur in terms of receiving compensation for the damage
they have suffered. The controversy has eroded the public's trust in other similar
vaccination programs of the government. This is why there is a need to have a
survival/safeguard fund ready in all vaccination/immunization programs of the
government.

In view of the foregoing, immediate passage of this measure is requested

MAXIMO B. RODRIGUEZ, JR.


SEVENTEENTH CONGRESS )
REPUBLIC OF THE PHILIPPINES —_)
Second Regular Session )

HOUSE OF REPRESENTATIVES

Introduced by Representative Maximo B. Rodriguez, Jr.

House Bill No. 7648

AN ACT
ESTABLISHING THE GOVERNMENT VACCINATION PROGRAM
SURVIVALISAFEGUARD FUND

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

Section 1. Creation of Fund — There is hereby created a Government Vaccination
Program Survival/Safeguard Fund (Fund)

SEC 2. Sources of the Fund - The Government Vaccination Program
Survival/Safeguard Fund shall be funded by the different Pharmaceutical Companies
which produce/manufacture the vaccines that will be used by the government in their
vaccination program

The Pharmaceutical Companies shall be required to give an amount
equivalent to 20% of the contract price they entered into with the government to the
Government Vaccination Program Indemnification/Contingency Fund

SEC 3. The Government Vaccination Program Survival/Safeguard Fund will be used
to indemnify and compensate the people who received the vaccinations in cases
where there are issues in connection with the vaccines and/or when there resulted
negative effects brought about by the vaccinations.

SEC 4, The Fund shall be managed by a Board composed of
1. Secretary of Health - Chairman
2. Secretary of Budget and Management Vice Chairman
3. Chairman of the Senate Committee on Health
4. Chairman of the House of Representatives Committee on Health
5. A representative from the Philippine Medical Association

SEC 5. Powers and Functions of the Board. — The Board shall have the following
powers and functions:

(a) Promulgate policies that will maintain the fiduciary character of the Board;

(b) Provide overall strategic guidance in the management and use of the fund;

(c) Adopt a conflict of interest policy to ensure that board members will not vote on
matters if they have any stake therein;


SEC 6. The Fund does not in any way free or absolve the Pharmaceutical Company
and/or any other person from any liability whatsoever.

SEC 7. Separability Clause — Should any provision of this Act or any part hereof be
declared unconstitutional or invalid by a court, the other provisions hereof which are
not affected thereby, shall remain in force and effect.

SEC 8. Effectivity — This Act shall take effect fifteen (15) days after its complete
publication in the Official Gazette or in a newspaper of general circulation

Approved,