Generics Act of 1988 (Republic Act 6675)

(Republic Act 6675) (September 13, 1988) (Corazon C. Aquino)

(________________)

AN ACT TO PROMOTE, REQUIRE AND

ENSURE THE PRODUCTION OF AN

ADEQUATE SUPPLY, DISTRIBUTION,

USE AND ACCEPTANCE OF DRUGS

AND MEDICINES IDENTIFIED BY THEIR

GENERIC NAMES

○ It was signed into a law on

(______________) by President

(________________)

(6675)

SECTION 1. Title.

Republic Act (_________)

(_________)

This Act shall be

known as the “Generics Act of

1988”.

SECTION 2.

Statement of Policy.

—

It is hereby declared the policy of

the State:

○ To promote, encourage and

require the use of generic

terminology in the importation,

manufacture, distribution,

marketing, advertising and

promotion, prescription and

dispensing of drugs;

Republic Act 6675

○ To ensure the adequate supply of

drugs with generic names at the

lowest possible cost and

endeavor to make them available

for free to indigent patients;

○ To encourage the extensive use

of drugs with generic names

through a rational system of

procurement and distribution;

Republic Act 6675

To promote drug safety by

minimizing duplication in

medications and/or use of drugs

with potentially adverse drug

interactions.

(Section 3.) (Definition of Terms)

(__________)

(__________________)

“Generic Name or Generic

Terminology” is the identification of

drugs and medicines by their

scientifically and internationally

recognized active ingredients or by

their official generic name as

determined by the Bureau of Food

and Drugs of the Department of

Health.

(SECTION 3 – DEFINITION OF TERMS) (GENERIC NAME) (Generic Terminology) () ()

(____________)

(____________)

A.K.A (_________) is the identification of

drugs & medicines by their scientifically and

internationally recognized active ingredients or

by their official generic name as determined by

the Bureau of Food and Drugs of the Department

of Health.

(SECTION 3 – DEFINITION OF TERMS) (CHEMICAL NAME)

(_____________)

(_________) is the description of the chemical

structure of the drug or medicine and serves as

the complete identification of a compound.

(SECTION 3 – DEFINITION OF TERMS) (DRUG PRODUCT)

(___________________)

(_______________) is the finished product form that

contains the active ingredients, generally but not

necessarily in association with inactive

ingredients.

(SECTION 3 – DEFINITION OF TERMS) (DRUG ESTABLISHMENT)

(______________________)

(_____________) is any organization or

company involved in the manufacture,

importation, repacking and/or distribution of drugs

or medicines.

(SECTION 3 – DEFINITION OF TERMS) (DRUG OUTLETS)

(_________________)

(_____________)

means drugstores, pharmacies,

and any other business establishments which sell

drugs or medicines.

(SECTION 3 – DEFINITION OF TERMS) (ESSENTIAL DRUG LIST)

(Department of Health) (core list) (complementary list)

(__________________________)

(____________________)

(____________) is a list of drugs

prepared and periodically updated by the

(_____________) on the basis of health

conditions obtaining in the Philippines as well as

on an internationally accepted criteria.

● It shall consist of a (________) and a

(_________________).

(SECTION 3 – DEFINITION OF TERMS) (CORE LIST)

(_________________)

(____________) is a list of drugs that meets the health

care needs of the majority of the population.

(SECTION 3 – DEFINITION OF TERMS) (COMPLIMENTARY LIST)

(___________________)

(_______________) is a list of alternative drugs

used when there is no response to the core

essential drug or when there is a hypersensitivity

reaction to the core essential drug or when, for

one reason or another, the core essential drug

cannot be given.

(SECTION 3 – DEFINITION OF TERMS) (BRAND NAME)

(________________)

(____________) is the proprietary name given by the

manufacturer to distinguish its product from those

of competitors.

(SECTION 3 – DEFINITION OF TERMS) (GENERIC DRUGS)

(______________)

(________) are drugs not covered by patent

protection and which are labeled solely by their

international non-proprietary or generic name.

SECTION 4

The Use of Generic Terminology for Essential

Drugs and Promotional Incentives

SECTION 5

● Posting and Publication

(SECTION 6 – WHO SHALL USE GENERIC

TERMINOLOGY) (government health agencies) (purchasing, prescribing, dispensing &

administering )

(_______________________)

All (_________________) and their

personnel as well as other government

agencies shall use generic terminology or

generic names in all transactions related to

(________, _______, _________, ________) of drugs and medicines.

(medical, dental & veterinary practitioners) (private

practitioners)

(_________________)

All (_____, _______ & _________), including (_____________), shall write prescriptions using

the generic name. The brand name may be

included if so desired.

(SECTION 6 – WHO SHALL USE GENERIC TERMINOLOGY) (organization or company) (appear prominently) (above the brand name) ()

(___________________)

Any (________/_______) involved in the

manufacture, importation, repacking,

marketing and/or distribution of drugs and

medicines shall indicate prominently the

generic name of the product. In the case of

brand name products, the generic name

shall (__________) and immediately

(____________) in all product labels

as well as in advertising and other

promotional materials.

(SECTION 6 – WHO SHALL USE GENERIC TERMINOLOGY)

(Drug outlets, including drugstores, hospital and non-hospital pharmacies and

nontraditional outlets) (post in conspicuous places)

(______________________)

(________, _________, ______, ________, ________) such as supermarkets

and stores, shall inform any buyer about

any and all other drug products having the

same generic name together with their

corresponding prices so that the buyer may

adequately exercise his option. Within one

(1) year after approval of this Act, the drug

outlets referred to herein, shall post in

conspicuous places in their establishments,

a list of drug products with the same generic

name and their corresponding prices.

SECTION 7

● Provision of Quality, Manufacturer’s Identity and

Responsibility

SECTION 8

Required Production

SECTION 9

Rules and Regulations

SECTION 10

Authority to Import

SECTION 11

Education Drive

SECTION 12

PENALTY

(SECTION 12 – A) (first conviction) (officially recorded)

(_________)

(a) for the (__________), he shall

suffer the penalty of reprimand which

shall be (__________) in the

appropriate books of the Professional

Regulation Commission.

(SECTION 12) (two thousand pesos (P2,000.00) (five thousand pesos

(P5,000.00))

(________________)

(b) for the second conviction, the

penalty of fine in the amount of not less

than (________________________)

but not exceeding (_________________) at the discretion of the

court.

(SECTION 12-A) (five thousand pesos (P5,000.00) (ten thousand pesos

(P10,000.00)) (thirty (30))

(c) for the third conviction, the penalty

of fine in the amount of not less than

(_____________________) but

not exceeding (_______________) and suspension of his

license to practice his profession, for

(________) days at the discretion of the

court.

(SECTION 12- A) (ten thousand pesos

(P10,000.00)) (one)

(____________________)

(d) for the fourth and subsequent

conviction, the penalty of fine not less

than (______________) and suspension of his

license to practice his profession for

(________) year or longer at the discretion of

the court.

(SECTION 12 – B) ( five thousand pesos

(P5,000.00)) (ten thousand pesos

(P10,000.00)) (suspension or revocation) (fine and

suspension or revocation) (six (6) months) ((1) year) ( ipso facto

deported)

● Any juridical person who violates Section

6(c), 6(d), 7 or 8 shall suffer the penalty of a fine

of not less than (_________________) nor more than

(___________) and (_______________) of

license to operate such drug establishment or

drug outlet at the discretion of the Court:

● Provided, That its officers directly responsible

for the violation shall suffer the penalty of

(_______&______/_____) of license to practice

profession, if applicable, and by imprisonment of

not less than (________) nor more than one

(_________) or both fine and imprisonment at the

discretion of the Court; and Provided, further, That

if the guilty party is an alien, he shall be (__________)

after service of sentence without need

of further proceedings.

(SECTION 12 - C) (Secretary of Health) (suspension or cancellation) () () () ()

(____________)

The (__________) shall have the

authority to impose administrative sanctions such as

(________________) of license to

operate or recommend suspension of license to

practice profession to the Professional Regulation

Commission as the case may be for the violation

of this Act.

SECTION 13

Separability Clause

SECTION 14

Repealing Clause

SECTION 15

Effectivity