Republic of the Philippines

HOUSE OF REPRESENTATIVES 2 DAT PHS_s 0 2022
Quezon City * TIME: SZ
3
NINETEENTH CONGRESS
First Regular Session

House Biitno. 4246

Introduced by: Hon. Keith Micah “Atty. Mike” D.L. Tan

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 the 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 therefore 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 systemic review and
meta-analysis in times of public health emergencies.

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

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Keith Micah “Atty. Mike” D.L. Tan
4th District, Quezon

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Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

NINETEENTH CONGRESS
First Regular Session

uno, 4246

HOUSE BILL NO.

Introduced by: Hon. Keith Micah “Atty. Mike” D.L. Tan

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

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) —
20K
“(b). The following criteria must be observed in the conduct of HTA:
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(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;”
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SEC. 2. Separability Clause. - If any provision or part of this Act is declared
unconstitutional, the remaining parts or provisions not affected shall remain in full force and
effect. :
SEC. 3. Repealing Clause. — All other laws, decrees, executive orders, proclamations, and
other executive issuances which are not consistent with or contrary to the provisions of this Act

are hereby repealed or amended accordingly.

SEC. 4. Effectivity. - This Act shall take effect fifteen (15) days after its publication in the
Official Gazette or in a newspaper of general circulation.

Approved,