G.R. No. 88265. December 21, 1989
SANTIAGO A. DEL ROSARIO, GEORGE G. GACULA, EDGARDO G. SANTOS, ALBANO S. SIBAL, ALBERTO C. REYES, NONITO P. ARROYO, EMMANUEL F. TERENCIO, DOMINGO S. DE LEON, MODESTO O. LLAMAS, F…
GRIÑO-AQUINO, J.:
This is a class suit filed by officers of the Philippine Medical
Association, the national organization of
medical doctors in the Philippines, on behalf of their professional brethren
who are of kindred persuasion, wherein this Court is asked to declare as unconstitutional, hence,
null and void, some provisions of the Generics Act of 1988 (Rep. Act No. 6675), and of the implementing
Administrative Order No. 62 issued pursuant
thereto, specifically:
(a) Section 6, Pars. (a) and (b) of the Generics Act which provide:
“(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.” (p. 6, Rollo.)
(b) Section 12, Pars. (b), (c) and (d) of the same law which provide:
“b) For the second conviction, the penalty of fine in the amount of
not less than two thousand pesos (P2,000.00) but not exceeding five thousand
pesos (P5,000.00) at the discretion of the court.
“c) For the third conviction, the penalty of fine in the amount of
not less than five thousand pesos (P5,000.00) but not exceeding ten thousand
pesos (P10,000.00) and suspension of his license to practice his profession for
thirty (30) days at the discretion of the court.
“d) For the fourth and subsequent convictions, the penalty of fine
of not less than ten thousand pesos (P10,000.00) and suspension of his license
to practice his profession for one year or longer at the discretion of the
court.” (pp. 6-7, Rollo.)
and
(c) Sections 4 and 7, Phase 3 of Administrative Order No. 62,
Series of 1989 dated March 9, 1989,
of the respondent Secretary of Health, which read as follows:
“Section 4. Violate,
Erroneous and Impossible Prescriptions.
“4.1. Violative
Prescriptions:
“4.1.1
Where the generic name is not written;
“4.1.2
Where the generic name is not legible and a brand name which is
legible is written;
“4.1.3
Where the brand name is indicated and instructions added, such as
the phase ‘No Substitution’ which tend to obstruct, hinder or prevent proper
generic dispensing.
“4.2 What to do with Violative Prescriptions.
“Violative Prescriptions shall not be
filled. They shall be kept and reported
by the pharmacist of the drug outlet or any other interested party to the
nearest DOH Officer for appropriate action.
The pharmacist shall advise the prescriber of
the problem and/or instruct the customer to get the proper prescription.
“4.3
Erroneous Prescriptions:
“4.3.1
When the brand name precedes the generic name.
“4.3.2
Where the generic name is the one in parenthesis.
“4.3.3
Where the brand name in (sic) not in parenthesis.
“4.3.4
Where more than one drug product is prescribed in one
prescription form.
“4.4 What
to do with erroneous prescriptions.
“Erroneous prescriptions shall be filled. Such prescriptions shall also be kept and
reported by the pharmacist of the drug outlet or any other interested party to
the nearest DOH Office for appropriate action.
x x x x
x x x x x
“Section 7. Timetable of
Implementation.
“In order to give all affected parties adequate time for learning
and adjustment, the implementation of these Rules and Regulations shall in three phases, as follows:
“Phase 1 Education Drive x x x
“Phase 2 Monitoring of Compliance x x
x
“Phase 3 Implementation.
“Beginning September 1, 1989 the DOH and the other relevant
agencies of government shall monitor compliance with these Rules and Regulations and all violations shall be
subject to the appropriate sanctions and penalties provided for under these
Rules and Regulations and the Generics Act of 1988.” (pp.
7-9, Rollo.)
On March 15, 1989,
the full text of Republic Act No. 6675 was published in two newspapers of
general circulation in the Philippines. The law took effect on March 30, 1989, fifteen (15) days after its
publication, as provided in Section 15 thereof.
Section 7, Phase 3 of Administrative Order No. 62 was amended by Administrative Order No. 76 dated August 28, 1989 by postponing to January 1, 1990 the effectivity of the sanctions and penalties for violations
of the law, provided in Sections 6 and 12 of the Generics Act and Sections 4
and 7 of
the Administrative Order.
The petitioners allege that “as of this date, there is no
breach or violation yet” of the law (p.
9, Rollo), which took effect on March 30, 1989. However, as the penal provisions will only
take effect on January
1, 1990, it would
have been more accurate to state that “as of this date, no breaches or
violations of the law have been punished yet” (p. 9, Rollo).
The petition is captioned as an action for declaratory relief,
over which this Court does not exercise
jurisdiction. Nevertheless, in
view of the public interest involved, we decided to treat it as a petition for prohibition instead.
The petitioners’ main argument against paragraphs (a) and (b),
Section 6 of the law, is the alleged unequal treatment of government
physicians, dentists, and veterinarians, on one hand, and those in private
practice on the other hand, in the manner of prescribing generic drugs, for,
while the former are allegedly required to use only generic
terminology in their prescriptions, the latter may write the brand name of the drug in parenthesis below the
generic name. The favored treatment of
private doctors, dentists and veterinarians under the law is allegedly a specie of invalid class legislation.
There is no merit in that argument for it proceeds from a misreading and misinterpretation of the letter
and intent of paragraphs (a) and (b), Section 6 of the Generics Act. Indeed, as
explained by the public respondent:
“x x x while paragraph (a) enumerates the government
transactions (‘purchasing, prescribing, dispensing and administering of drugs
and medicines’) where the sole use of generic terminology has
been required, the ‘prescription’ of drugs is further governed by paragraph (b). And the use of the word ‘all’ in the latter provision emphasizes
the absence of any distinction between government and private physicians. In other words, in prescribing
drugs, physicians, whether in government service or in private practice, are both governed by
exactly the same rules, and thus, are both authorized to include the brand name
in their respective prescriptions.” (p. 44, Rollo.)
Furthermore, it may be observed that while paragraph (a) refers
to “all government health agencies, and their personnel as well as other
government agencies” (not necessarily physicians, dentists and veterinarians), paragraph
(b) refers to “all medical, dental and veterinary practitioners,
including private practitioners.”
Petitioners concede that the requirement for doctors, dentists,
and veterinarians to use the
generic terminology in writing their prescriptions, followed by the brand name
in parenthesis, is “well and good” (p. 12, Rollo). However, they complain that under paragraph
(d) of the law which reads:
“(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.” (Annex A, p. 23, Rollo.)
the salesgirl at
the drugstore counter is authorized to “substitute the prescribed medicine
with another medicine belonging to the same generic group.” Since doctors
are not allowed to instruct the
druggist not to substitute the prescription, or to “Dispense only as
Prescribed” (per Sec. 4, Adm. Order No. 62), the petitioners argue that
“the act of prescribing the correct medicine for the patient becomes the
act of the salesgirl at the drugstore counter, no longer the act of the
physician, dentist, or veterinarian” (p. 12, Rollo).
Here again, the petitioners have distorted the clear provisions
of the law and the implementing administrative order. For it is plain to see that neither paragraph
(d) of Section 6 of the Generics Act, nor Section 4 of Administrative Order No.
62, gives the salesgirl and/or druggist the discretion to substitute the doctor’s prescription.
On the contrary, Section 4, par. 4.1, of Administrative Order No.
62 directs the pharmacist not to fill “violative
prescriptions” (where the generic name is not written, or illegibly
written, and the prescription of a brand name is accompanied by the doctor’s
instruction not to substitute it), as well as “impossible prescriptions” (par. 4.5).
Even a doctor’s “erroneous” prescriptions “shall be
filled,” not substituted (par. 4.3, Adm. Order No. 62). And, Sections 3 and 5 of Adm. Order No. 63
enjoin the drug outlets “not (to) favor or suggest” or
“impose” a particular brand or product on the customer. The administrative order provides:
“In order to
ensure the informed choice and use of drugs by the patient/buyer, the
drug outlet is required to:
“3.1.1 Inform the
patient/buyer of all available drug products generically equivalent to the one prescribed with their corresponding
prices. In so doing, the drug outlet
shall not favor or suggest any particular product so that the
patient/buyer may fully and adequately
exercise his option to choose (Sec. 3, Adm.
Order No. 63 s. 1989).
x x
x x
x x x x x
“The following acts or omissions are considered violations of these rules
and regulations:
“5. 1 Imposing a particualar brand
or product on the buyer. x x x.”
(pp. 46-47, Rollo.)
The salesgirl at the drugstore counter merely informs the customer, but does not determine (for she is incompetent to
do so), all the other drug products or brands that have the same generic name,
and their corresponding prices. That
information she may obtain from the list of drug products determined by the
Bureau of Food and Drugs to have the same generic name, or which are the
chemical, biological, and therapeutic equivalent of the generic drug. All drugstores or drug outlets are required
by the law to post such list in a conspicuous place in their premises for the
information of the customers, for the choice of whether to buy the expensive brand-name
drug, or the less expensive generic, should be exercised by the customer alone.
The purpose of the Generics Act is to carry out 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.” (pp. 38-39, Rollo.)
or, as stated by
the public respondent, “to promote and require the use of generic drug
products that are therapeutically equivalent to their brand-name counterparts” (p. 39, Rollo) for “the therapeutic effect of a drug does not depend on its ‘brand’ but on the ‘active ingredients’ which it contains.” The medicine that
cures is the “active ingredient” of the drug, and not the brand name
by which it has been baptized by the manufacturer.
The public respondent points out that the institution of generics
in the Philippines
will compel physicians to prescribe drugs based on their therapeutic or
“active ingredient,” instead of their well-known brand names. Multiple
medications which may produce potentially adverse, even lethal, chemical reactions
in the patient will thereby be avoided.
Patients with limited means will be able to buy generic drugs that cost
less but possess the same active ingredients, dosage form, and strength as
brand names, many of which are priced beyond the reach of the common tao because the high costs of advertising, packaging, royalties,
and other inputs of production determine their pricing for the market.
The Court has been unable to find any constitutional infirmity in the
Generics Act. It, on the contrary,
implements the constitutional mandate for the State “to protect and
promote the right to health of the people” and “to make essential
goods, health and other social services available to all the people at affordable cost” (Section 15, Art. II and Section 11, Art. XIII, 1987 Constitution).
The prohibition against the use by doctors of “no
substitution” and/or words of similar import in their prescription, is a
valid regulation to prevent the circumvention of the law. It secures to the patient the right to choose between the brand name and its
generic equivalent since his doctor is allowed to write both the generic and
the brand name in his prescription form.
If a doctor is allowed to prescribe a brand-name drug with “no
substitution,” the patient’s option to buy a lower-priced, but equally
effective, generic equivalent would thereby be curtailed. The law aims to benefit the impoverished (and often
sickly) majority of the population in a still developing country like ours, not
the affluent and generally healthy minority.
There is no merit in the petitioners’ theory that the Generics
Act impairs the obligation of contract between a physician and his patient, for
no contract ever results from a consultation between patient and
physician. A doctor may take in or refuse a patient, just as the patient may
take or refuse the doctor’s advice or prescription. As aptly observed by the public respondent, no doctor has ever filed an action for
breach of contract against a patient who refused to take prescribed medication, undergo surgery, or
follow a recommended course treatment by his doctor
(p. 53, Rollo).
In any event, no private contract between doctor and patient may be
allowed to override the power of the State to enact laws that are reasonably
necessary to secure the health, safety, good order, comfort, or general welfare
of the community. This power can neither
be abdicated nor bargained away. All
contractual and property rights
are held subject to its fair exercise (Anglo-Fil
Trading Corporation vs. Lazaro, 124 SCRA 495).
Petitioners have also
assailed Section 12, paragraphs b, c and d, of the Generics Act
prescribing graduated penalties
(ranging from a reprimand to a fine of not less that P10,000 and the
suspension of the physician’s license to practice his profession for one [1] year or longer, at the discretion of
the court) for violations of its provisions.
Petitioners’ allegation that these penalties violate the constitutional
guarantee against excessive fines and cruel and degrading punishment,
has no merit. Penal sanctions are
indispensable if the law is to be obeyed. They are the “teeth” of the
law. Without them, the law would be
toothless, not worth the paper it is printed on, for physicians, dentists and
veterinarians may freely ignore its prescriptions and prohibitions. The penalty of suspension or cancellation of
the physician’s license is neither cruel, inhuman, or
degrading. It is no different from the
penalty of suspension or disbarment that this Court inflicts on lawyers and
judges who misbehave or violate the laws and the Codes of Professional and
Judicial Conduct.
We hold that the Generics Act and the implementing administrative
orders of the Secretary of Health are constitutional. In light of its beneficial provisions, we
cannot heed the petitioners’ plea to kill it aborning,
i.e., before it has had a chance to prove its value to our people as envisioned
by its makers.
WHEREFORE, the petition is dismissed for lack of
merit. Costs against
the petitioners.
SO ORDERED.
Fernan, C.J., Narvasa,
Cruz, Paras, Feliciano, Gancayco,
Padilla, Bidin, Sarmiento,
Cortes, Medialdea, and
Regalado, JJ., concur.
Melencio-Hererra, J., in the result.
Gutierrez, Jr., J., concurs in
the result only because of the failure to overcome the presumption of the constitutionality
and not because the respondent’s arguments are valid.