Republic of the Philippines

REPRESS
HOUSE OF REPRESENTATIVES of ys

“a
Searcy RECEIVED
OB JUL 213
SIXTEENTH CONGRESS oat:
First Regular Session Tales si
; >=
2
RS
House sino, 1178 e

Introduced by HON. PHILIP A. PICHAY

EXPLANATORY NOTE

Republic Act No. 6675, otherwise known as the Generic Drugs Act of 1988, was passed
into law in 1988, After nearly two decades of effectivity, the noble objectives of the law
remain, well, objectives. Except for the record high of 80 percent compliance in 1988, shortly
after it became effective, observance of the law has since been dismal.

This miserable state of affairs ultimately adversely affects our people who are long
deprived of affordable medicines, and renders nugatory the constitutional right to health
granted to them.

This bill removes the discretion given to physicians, dentists and veterinarians in the
manner of prescribing medicines. The existing law allows them to include in the prescription
the brand name “if so desired.” This seemingly harmless phrase has actually afforded doctors
‘the opportunity to circumvent the law by not following the guidelines set by the Department of
Health on this matter. It is not uncommon to hear reports of the audacity of some who
prescribe only branded products. Equally unfortunate are accounts of failure, if not utter
refusal, by some drug outlets, to dispense medicines in accordance with established rules, in
open defiance of the law granting consumers better choice or affordable alternatives [Section 6
(d), RA 6675]

Also, this measure requires manufacturers, traders and importers of medicines to
produce and make available to the market the generic label or counterparts of their patented
products at costs lower by at least 20% to 25%.

The proposal has a two-fold purpose. First, to effect a paradigm shift in the minds of
the Filipino consumer that generic drugs are of the same quality as their branded counterparts.
As part of the defective education of Juan de la Cruz, majority of Filipinos erroneously believe
that generic medicines are inferior to the branded ones. In fact, the former have the same
active ingredients, undergo identical manufacturing process, and pass through equally strict
regulation and monitoring by the Bureau of Food and Drugs (BFAD).


Corollary to the first point, this bill seeks to make medicines affordable to the people as
far as the generic counterparts are concerned. The resulting change in the people’s
Perspective, that is, that generic drugs are as potent and effective, and are of the same quality
as the branded products, would impact significantly on the health needs of the people. The
reduced rates of generic labeled products by at least 20% to 25% would benefit the public
immediately, instead of waiting for 20 years for the patent to expire before such product would
be availed of by the people, And since the generic equivalents would no longer require
aggressive promotional or marketing efforts, manufacturers, traders and importer, it is hoped,
would embrace this proposal

Simply put, this bill endeavors to strengthen the Generic Drugs Act of 1988, and make
medicines truly affordable to the public. It is prayed that the government agencies tasked to
implement the law, like the BFAD, shall strictly monitor compliance therewith and firmly enforce
the same,

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

AM

PHILIP A. PICHAY

wT Ma



Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

SIXTEENTH CONGRESS
First Regular Session

House ano, 1178

Introduced by HON. PHILIP A. PICHAY

AN ACT
AMENDING CERTAIN PROVISIONS OF REPUBLIC ACT NO. 6675, OTHERWISE
KNOWN AS THE GENERIC DRUGS ACT OF 1988 AND FOR OTHER PURPOSES

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

SECTION 1. Section 6 (b) of Republic Act No. 6675, otherwise known as the “Generics
Act of 1988” is hereby amended to read as follows:

“Sec. 6 Who Shall Use Generic Terminology. —

(a) xxx

(b) All medical, dental and veterinary practitioners, including private
practitioners, shall write prescriptions using generic name, [The
brand name maybe included if so desired.]”

(©) xxx

(d) xxx"

SEC. 2. Every drug importer, trader and manufacturer operating in the Philippines,
which will introduce a new patented product, shall be required to manufacture its generic
labeled or equivalent and make available the same to the market: Provided, That the price of
the latter shall be at least 20% to 25% lower than the former.

SEC. 3. The penal sanctions provided in Sec. 12 of Republic Act No. 6675 shall likewise
apply to violations of Section 2 of this Act.


SEC. 4. The implementation of the provisions of this Act shall be in accordance with the
rules and regulations to be promulgated by the Department of Health. Rules and regulations
with penal sanctions shall be promulgated within one hundred eighty (180) days after approval
of this Act and shall take effect (15) days after publication in the Official Gazette or in two (2)
newspapers of general circulation.

SEC. 5. Any laws, decrees, ordinances or rules and regulations which are inconsistent
with or contrary to the provisions of this Act is hereby amended or repealed.

SEC. 6. This Act shall take effect fifteen (15) days after its complete publication in the
Official Gazette or in at least two (2) national newspapers of general circulation.

Approved,