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Republic of the Philippines
CONGRESS OF THE PHILIPPINES
Metro Manila
Second Regular Session
Begun and held in Metro Manila, on Monday,
the twenty-fifth day of July, nineteen hundred and eighty-eight.
REPUBLIC ACT NO. 6675
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.
Be it enacted by the Senate and House Representatives of the
Philippines in Congress
assembled:
SECTION 1. Title – 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;
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;
To emphasize the scientific basis for the use of drugs, in order
that health professionals may
become more aware and cognizant of their therapeutic effectiveness;
and
To promote drug safety by minimizing duplication in medications
and/or use of drugs with
potentially adverse drug interactions.
SECTION 3. Definition of Terms – The following terms are herein
defined for purposes of this
Act:
(1) "Generic Name or Generic Terminology" is the identification of
drugs and medicines by their
scientifically and internationally recognize active ingredients or
by their official generic name as
determined by the Bureau of Food and Drugs of the Department of
Health.
(2) "Active Ingredient" is the chemical component responsible for
the claimed therapeutic effect
of the pharmaceutical product.
(3) "Chemical Name" is the description of the chemical structure of
the drug or medicine and
serves as the complete identification of a compound.
(4) "Drug Product" is the finished product form that contains the
active ingredients, generally but not necessarily in association
with inactive ingredients.
(5) "Drug Establishment" is any organization or company involved in
the manufacture,
importation, repacking and/or distribution of drugs or medicines.
(6) "Drug Outlets" means drugstores, pharmacies, and any other
business establishments which
sell drugs or medicines.
(7) "Essential Drugs List" or "National Drug Formulary" is a list of
drugs prepared and
periodically updated by the Department of Health on the basis of
health conditions obtaining in the
Philippines as well as on internationally accepted criteria. It
shall consist of a core list and a
complementary list.
(8) "Core List" is a list of drugs that meets the health care needs
of the majority of the population.
(9) "Complementary List" is a list of alternative drugs used when
there is no response to the core
essential drug or when there is hypersensitivity reaction to the
core essential drug or when for one
reason or another, the core essential drug cannot be given
(10) "Brand Name" is the proprietary name given by the manufacturer
to distinguish its product
from those of competitors.
(11) "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. –
(a) In the promotion of the generic names for
pharmaceutical products, special
consideration shall be given to drugs and medicines which are
included in the Essential Drugs List
to be prepared within one hundred eighty (180) days from approval of
this Act and updated
quarterly by the Department of Health on the basis of health
conditions obtaining in the Philippines
as well as on internationally accepted criteria.
(b) The exclusive use of generic terminology in the manufacture,
marketing and sales of drugs and
medicines, particularly those in the Essential Drugs List, shall be
promoted through such a system
of incentives as the Board of Investments jointly with the Department of Health and other
government agencies as may be authorized by law, shall promulgate in
accordance with existing
laws, within one hundred eighty (180) days after approval of this
Act.
SECTION 5. Posting and Publication – The Department of Health shall
publish annually in at
least two (2) newspapers of general circulation in the Philippines
the generic names, and the
corresponding brand names under which they are marketed, of all
drugs and medicines available
in the Philippines.
SECTION 6. Who Shall Use Generic Terminology - (a) All government
health agencies and their
personnel as well as other government agencies shall use generic
terminology or generic names in
all transactions related to purchasing, prescribing, dispensing and
administering of drugs and
medicines.
(b) All medical, dental and veterinary practitioners, including
private practitioners, shall write
prescriptions using the generic name. The brand name may be included
if so desired.
(c) Any organization or company 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
appear prominently and
immediately above the brand name in all product labels as well as in
advertising and other
promotional materials.
(d) Drug outlets, including drugstores, hospital and non-hospital
pharmacies and non-traditional
outlets 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.
CONTINUE
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