Republic of the Philippines =
HOUSE OF REPRESENTATIVES | LATEsyUL 16 028:
Quezon City TIME:SI 2b)
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EIGHTEENTH CONGRESS ig sgl 6
First Regular Session ‘Se mnperd

HOUSE BILL NO. 7110

Introduced by: Hon. Angelina “Helen” D.L. Tan, M.D

AN ACT AMENDING SECTION 34 (b) OF R.A NO. 11223, OTHERWISE KNOWN AS
AN ACT INSTITUTING UNIVERSAL HEALTH CARE FOR ALL FILIPINOS,
PRESCRIBING REFORMS IN THE HEALTH CARE SYSTEM, AND APPROPRIATING
FUNDS THEREFOR

EXPLANATORY NOTE

Republic Act No. 11223 or the Universal Health Care Law was primarily enacted
to enroll all Filipinos to the National Health Insurance Program and to prescribe
complementary reforms in the health system.

Among the reforms under this law, the Department of Health as the steward for
the whole health system was tasked to ensure the availability, affordability and
acceptability of safe and quality health services. In particular, the Health Technology
Assessment (HTA) was institutionalized as a fair and transparent mechanism for the
determination of range of entitlements such as drugs, medicines, pharmaceutical
products, and other devices procedures and services provided under the law.

For safety and effectiveness of such interventions, the law provides that “Each
intervention must have undergone Phase IV clinical trial and systematic review and
meta-analysis must be readily available. The interventions must also not pose any harm
to the users and health care providers.” (emphasis supplied). Hence, only vaccines
including drugs and medicines which have undergone such Phase IV clinical trial may
be used for any population-based intervention by the Department of Health.

However, in light of the recent events particularly our experience with the COVID-
19 Pandemic, such requirement poses as a limit to our country’s immediate access to
any breakthrough drugs and medicines, which are critical in the promotion of public
health especially in times of pandemic. Considering that time is of essence in the fight
against any disease outbreak, immediate procurement of vaccines including drugs and
medicines has become a top priority in order to save lives and pre-empt debilitating
effects of a pandemic.

This bill therefor seeks to amend Section 34 (b) of the Universal Health Care Law
in order to relax the stringent requirements for a Phase IV clinical trial, and systematic
review and meta-analysis in times of public health emergencies.

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


Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

EIGHTEENTH CONGRESS
First Regular Session

HOUSE BILL NO. vee)

Introduced by: Hon. Angelina “Helen” D.L. Tan, M.D

AN ACT AMENDING SECTION 34 (b) OF R.A 11223, OTHERWISE KNOWN AS AN
ACT INSTITUTING UNIVERSAL HEALTH CARE FOR ALL FILIPINOS,
PRESCRIBING REFORMS IN THE HEALTH CARE SYSTEM, AND APPROPRIATING
FUNDS THEREFOR

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

SECTION 1. Section 34(b)(2) of Republic Act No. 11223, otherwise known as the
“Universal Health Care Act, is hereby amended to read as follows:

“SEC. 34 .Health Technology Assessment (HTA). —
10
“(b) The following criteria must be observed in the conduct of HTA:

“(1) Responsiveness to Magnitude, Severity, and Equity. - The health
interventions must address the top medical conditions that place the
heaviest burden on the population, including dimensions of magnitude or
the number of people affected by a health problem, and severity or health
loss by an individual as a result of disease, such as death, handicap,
disability or pain, and conditions of the poorest and most vulnerable
population;

*(2) Safety and Effectiveness. - Each intervention must have undergone
Phase IV clinical trial, and systematic review and meta-analysis must be
readily available. The interventions must also not pose any harm to the
users and health care providers; PROVIDED THAT, IN CASE OF A
PANDEMIC OR UPON THE DECLARATION OF A STATE OF PUBLIC
HEALTH EMERGENCY, SUCH REQUIREMENTS MAY BE DISPENSED
WITH;”

xxx

SEC.5. - This Act shall take effect fifteen (15) days after its publication in the Official
Gazette or in a newspaper of general circulation.

Approved,