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Republic Vs Drugmaker'S Lab (GR No. 190837 March 5, 2014)
Republic Vs Drugmaker'S Lab (GR No. 190837 March 5, 2014)
190837 MARCH 5, 2014) nature its applicability needs nothing further than its bare issuance, for it gives no real
consequence more than what the law itself has already prescribed. When, on the other hand,
Republic of the Philippines vs Drugmaker’s Laboratories Inc. the administrative rule goes beyond merely providing for the means that ca facilitate or render
GR No. 190837 March 5, 2014 least cumbersome the implementation of the law but substantially increases the burden of
those governed, it behooves the agency to accord at least to those directly affected a chance to
be heard, and thereafter to be duly informed before that new issuance is given the force and
Facts: The FDA was created pursuant to RA 3720, otherwise known as the “Food, Drug and effect of law.
Cosmetics Act” primarily in order to establish safety or efficacy standards and quality measure
of foods, drugs and devices and cosmetics products. On March 15, 1989, the Department of
Health, thru then Secretary Alfredo RA Bengzon issued AO 67 s. 1989, entitled Revised Rules A careful scrutiny of the foregoing issuances would reveal that A0 67 is actually the rule that
and Regulations on Registration of Pharmaceutical products. Among others, it required drug originally introduced the BA/BE testing requirement as a component of applications for the
manufacturers to register certain drug and medicine products with FDA before they may issuamce of CPR covering certain pharmaceutical products as such, it is considered an
release the same to the market for sale. In this relation, a satisfactory administrative regulation – a legislative rule to be exact – issued by the Secretary of Health in
bioavailability/bioequivalence (BA/BE) test is needed for a manufacturer to secure a CPR for consonance with the express authority granted to him by RA 3720 to implement the statutory
these products. However, the implementation of the BA/BE testing requirement was put on mandate that all drugs and devices should first be registered with the FDA prior to their
hold because there was no local facility capable of conducting the same. The issuance of manufacture and sale. Considering that neither party contested the validity of its issuance, the
circulars no. 1 s. of 1997 resumed the FDA’s implementation of the BA/BE testing requirement court deems that AO 67 complied with the requirements of prior hearing, notice and
with the establishment of BA/BE testing facilities in the country. Thereafter, the FDA issued publication pursuant to the presumption of regularity accorded tl the govt in the exercise of its
circular no. 8 s. of 1997 which provided additional implementation details concerning the official duties.
BA/BE testing requirement on drug products.
On the other hand, circulars no. 1 and 8 s. of 1997 cannot be considered as administrative
Issue: Whether or not the circular issued by FDA are valid. regulations because they do not: a.) implement a primary legislation by providing the details
thereof; b.) Interpret, clarify or explain existing statutory regulation under which FDA operates
and/or; c.) Ascertain the existence of certain facts or things upon which the enforcement of RA
Held: Yes. Administrative agencies may exercise quasi-legislative or rule-making power only if 3720 depends. In fact, the only purpose of these is for FDA to administer and supervise the
there exist a law which delegates these powers to them. Accordingly, the rules so promulgated implementation of the provisions of AO 67 s. of 1989 including those covering the BA/BE
must be within the confines of the granting statutes and must not involve discretion as to what testing requirement consistent with and pursuant to RA 3720. Therefore, the FDA has sufficient
the law shall be, but merely the authority to fix the details in the execution or enforcement of authority to issue the said circulars and since theu would not affect the substantive rights of the
the policy set out in the law itself, so as to conform with the doctrine of separation of powers parties that they seek to govern – as they are not, strictly speaking, administrative regulations
and as an adjunct, the doctrine of non-delegability of legislative powers. in the first place – no prior hearing, consultation and publication are needed for their validity.
PASEI filed a petition for prohibition to annul the aforementioned DOLE and POEA circulars Covered by this rule are presidential decrees and executive orders
and to prohibit their implementation on the grounds that DOLE and POEA acted with grave promulgated by the President in the exercise of legislative powers whenever
abuse of discretion and/or in excess of their rule-making authority in issuing said circulars; the same are validly delegated by the legislature or, at present, directly
that the assailed DOLE and POEA circulars are contrary to the Constitution, are unreasonable, conferred by the Constitution: Administrative rules and regulations must also
unfair and oppressive; and that the requirements of publication and filing with the Office of the be published if their purpose is to enforce or implement existing law pursuant
National Administrative Register were not complied with. to a valid delegation.
HELD: Interpretative regulations and those merely internal in nature, that is,
The second and first grounds are unmeritorious. Article 36 of the Labor Code grants regulating only the personnel of the administrative agency and the public, need
the Labor Secretary the power to restrict and regulate recruitment and placement activities. It not be published. Neither is publication required of the so-called letter of
reads: “The Secretary of Labor shall have the power to restrict and regulate the recruitment instructions issued by the administrative superiors concerning the rules or
and placement activities of all agencies within the coverage of this title [Regulation of guidelines to be followed by their subordinates in the performance of their
Recruitment and Placement Activities] and is hereby authorized to issue orders and duties.”
promulgate rules and regulations to carry out the objectives and implement the provisions of
this title.” On the other hand, the scope of the regulatory authority of the POEA, which was
created by Executive Order No. 797 to take over the functions of the Overseas Employment
Actions; When a party has locus standi.—First, on the challenge of intervenors AMADER, VOL. 225, AUGUST 19, 1993 419
et al., that petitioners lack locus standi,we need only reiterate that the “proper-party”
requirement is satisfied if it is alleged that petitioners and intervenors have sustained or are in Philippine Association of Service Exporters, Inc. vs. Torres
danger of sustaining immediate injury resulting from the acts or measures complained of. in view of the complexity of the legal issue involved, the Court resolves not to grant
Petitioners PASEI and PEEPA allege that their member agencies, which enjoy protection against attorney’s fees.
competition by new licensees pursuant to LOI 1190, will suffer irreparable injury with the
repeal of LOI 1190 by EO 450, considering further that there is no additional demand for
Filipino workers abroad. Hence, any gain made by the new agencies on the supposed exclusive PESIGAN VS ANGELES
preserve of existing agencies necessarily results in the latter’s loss. FACTS:
_______________
Petitioners Anselmo and Marcelino Pesigan, carabao dealers, transported in a 10-wheeler truck
*EN BANC. in April 1982, 26 carabaos and a calf, from Camarines Sur to Batangas. Despite the health
418 certificate, permit to transport, and certificate of inspection issued to them by the provincial
veterinarian, provincial commander and constabulary command, respectively, while
4 SUPREME COURT REPORTS ANNOTATED petitioners were negotiating the town of Basud, Camarines Norte, the carabaos were
18 confiscated by private respondents, Police Station Commander Lt. Zanarosa, and provincial
Philippine Association of Service Exporters, Inc. vs. Torres veterinarian Dr. Miranda. The confiscation was based on Executive Order 626-A which
prohibited the transport of carabaos from one province to another. Pursuant to EO 626-A, Dr
Labor Law; Recruitment; Statutes; Letter of Instruction 1190 is a mere administrative
Miranda distributed the carabaos to 25 farmers of Basud. Petitioners filed for recovery of the
issuance. It is not a law for licensing of recruitment agencies.—As we view it, LOI 1190 simply
carabaos and damages, against private respondent Judge Angeles who heard the case in Daet
imposes a presidential review of the authority of the Minister of Labor and Employment to
and later transferred to Caloocan City, and dismissed the case for lack of cause of action.
grant licenses, hence, directed to him alone. Since this is undoubtedly an administrative action,
LOI 1190 should properly be treated as an administrative issuance. Unlike Presidential Decrees
ISSUE:
which by usage have gained acceptance as laws promulgated by the President, Letters of
Whether or not EO 626-A be enforced before its publication in the Official Gazette.
Instruction are presumed to be mere administrative issuances except when the conditions set
out in Garcia-Padilla v. Enrile exist. Consequently, to be considered part of the law of the land,
HELD:
petitioners must establish that LOI 1190 was issued in response to “a grave emergency or a
threat or imminence thereof, or whenever the interim Batasan Pambansa or the regular
Said executive order should not be enforced against the Pesigans on April 2, 1982 because, as
National Assembly fails or is unable to act adequately on any matter.” The conspicuous absence
already noted, it is a penal regulation published more than two months later in the Official
of any of these conditions fortifies the opinion that LOI 1190 cannot be any more than a mere
Gazette dated June 14, 1982. It became effective only fifteen days thereafter as provided in
administrative issuance.
article 2 of the Civil Code and section 11 of the Revised Administrative Code.
Same; Same; Same; Letter of Instruction 1190 did not amend or repeal Article 25 of the
Labor Code but merely added a tier for administrative review on licensing of recruitment
The word "laws" in article 2 (article 1 of the old Civil Code) includes circulars and regulations
agencies.—There is nothing in the LOI which repeals or runs counter to Art. 25 of the Labor
which prescribe penalties. Publication is necessary to apprise the public of the contents of the
Code, as amended. Instead, contrary to the perception of petitioners, LOI 1190 does not actually
regulations and make the said penalties binding on the persons affected thereby.
ban the grant of licenses nor bar the entry of new licensees since anybody could still apply for
license with the Minister of Labor and Employment, although the grant thereof is subject to the
ANSELMO L. PESIGAN and MARCELINO L. PESIGAN, petitioners, vs. JUDGE DOMINGO MEDINA
prior authority of the President. In fact, the LOI did not modify the rule-making power of the
ANGELES, Regional Trial Court, Caloocan City Branch 129, acting for REGIONAL TRIAL COURT
Minister of Labor and Employment under the Labor Code; it only added another tier of review.
of Camarines Norte, now presided over by JUDGE NICANOR ORIÑO, Daet Branch 40; DRA.
Same; Same; Same; Administrative Law; President Corazon Aquino’s E.O. 450 repealed
BELLA S. MIRANDA, ARNULFO V. ZENAROSA, ET AL., respondents.
Letter of Instruction 1190 of President Ferdinand Marcos both being mere administrative
Appeals; R.A. 5440 superseded Rule 42 of the Rules of Court.—The Pesigans appealed to
directives rather than statutes.—Petitioners also contend that EO 450 cannot repeal LOI 1190
this Court under Rule 45 of the Rules of Court and section 25 of the Interim Rules and pursuant
for Congress has not delegated that power to the President. We do not agree. There is no need
to Republic Act No. 5440, a 1968 law which superseded Rule 42 of the Rules of Court.
for legislative delegation of power to the President to revoke the LOI by way of an EO in view of
Statutes; Criminal Law; An Executive Order (Exec. Order No. 626-A dated Oct. 25, 1980),
our finding that LOI 1190 is a mere administrative directive, hence, may be repealed, altered or
prohibiting and penalizing transportation of carabaos from one province to another cannot be
modified by EO 450, and DO 9 must consequently be upheld.
enforced before its publication in the Official Gazette.—We hold that the said executive order
Attorneys; Award of attorney’s fee may be denied a winning party where issues are so
should not be enforced against the Pesigans on April 2, 1982 because, as already noted, it is
complex.—Of the three (3) groups of intervenors, only AMADER, et al., pray for attorney’s fees
a penal regulationpublished more than two months later in the Official Gazette dated June 14,
claiming that they were compelled to hire counsel to enforce and protect their rights. However,
419
1982. It became effective only fifteen days thereafter as provided in article 2 of the Civil Code ISSUES:
and section 11 of the Revised Administrative Code. [1] Is stemmed leaf tobacco subject to excise (specific) tax?
Same; Same; Same.—That ruling applies to a violation of Executive Order No. 626-A [2] Is purchase of stemmed leaf tobacco from manufacturers who are not classified as L-7
because its confiscation and forfeiture provision or sanction makes it a penal statute. Justice and permittees subject to tax?
fairness dictate that the public must be informed of that provision by means of publication in [3] Is the RR valid?
the Gazette before violators of the executive order can be bound thereby. [4] Is the possessor or owner, or importer or exporter, of stemmed leaf tobacco liable for the
payment of specific tax if such tobacco product is removed from the place of production
_______________ without payment of said tax?
[5] Does the imposition of excise tax on stemmed leaf tobacco under Section 141 of the 1986
*SECOND DIVISION. Tax Code constitute double taxation, considering they are paying the specific tax on the raw
175 material and on the finished product in which the raw material was a part?
VOL. 129, APRIL 30, 1984 175 HELD:
Pesigan vs. Angeles [1] Yes, excise taxes on domestic products shall be paid by the manufacturer or producer
Same; Same; Same.—Indeed, the practice has always been to publish executive orders in before[the] removal [of those products] from the place of production." "It does not matter to
the Gazette. Section 551 of the Revised Administrative Code provides that even bureau what use the article[s] subject to tax is put; the excise taxes are still due, even though the
“regulations and orders shall become effective only when approved by the Department Head articles are removed merely for storage in someother place and are not actually sold or
and published in the Official Gazette or otherwise publicly promulgated”. (See Commissioner of consumed.
Civil Service vs. Cruz, 122 Phil. 1015.)
Damages; Public Officers; The public officers who confiscated the carabaos acted in good When tobacco is harvested and processed either by hand or by machine, all itsproducts become
faith enforcing Exec. Order 626-A. The carabaos, however, have to be returned.—It results that subject to specific tax. Section 141 reveals the legislative policy to tax all forms of manufactured
they have a cause of action for the recovery of the carabaos. The summary confiscation was not tobacco — in contrast to raw tobacco leaves — including tobacco refuse or all other tobacco
in order. The recipients of the carabaos should return them to the Pesigans. However, they which has been cut, split, twisted, or pressed and is capable of being smoked without further
cannot transport the carabaos to Batangas because they are now bound by the said executive industrial processing.
order. Neither can they recover damages. Doctor Miranda and Zenarosa acted in good faith in
ordering the forfeiture and dispersal of the carabaos. Stemmed leaf tobacco is subject to the specific tax under Section 141(b). It is a partially
prepared tobacco. The removal of the stem or midrib from the leaf tobacco makes the resulting
stemmed leaf tobacco a prepared or partially prepared tobacco.
CASE DIGEST: LA SUERTE CIGAR & CIGARETTE FACTORY, Petitioner, vs. COURT OF
APPEALS and COMMISSIONER OF INTERNAL REVENUE, Respondents. (G.R. No. 125346; Despite the differing definitions for "stemmed leaf tobacco" under revenue regulations, the
November 11, 2014) onus of proving that stemmed leaf tobacco is not subject to the specific tax lies with the
cigarette manufacturers. Taxation is the rule, exemption is the exception.
FACTS:
These cases involve the taxability of stemmed leaf tobacco imported and locally purchased by [2] Stemmed leaf tobacco transferred in bulk between cigarette manufacturers are exempt
cigarette manufacturers for use as raw material in the manufacture of their cigarettes. Under from excise tax under the Tax Code vis-a-vis RRs.
the Tax Code, if it is to be exported or to be used in the manufacture of cigars, cigarettes, or
other tobacco products on which the excise tax will eventually be paid on the finished product. Section 137 authorizes a tax exemption subject to the following: (1) that the stemmed leaf
tobacco is sold in bulk as raw material by one manufacturer directly to another; and (2) that
La Suerte was assessed by the BIR for excise tax deficiency amounting to more than 34 million the sale or transfer has complied with the conditions prescribed by the Department of Finance.
pesos. La Suerte protested invoking the Tax Code which allows the sale of stemmed leaf tobacco
as raw material by one manufacturer directly to another without payment of the excise tax. The conditions under which stemmed leaf tobacco may be transferred from one factory to
However, the CIR insisted that stemmed leaf tobacco is subject to excise tax "unless there is an another without prepayment of specific tax are as follows: (a) The transfer shall be under an
express grant of exemption from [the] payment of tax." official L-7 invoice on which shall be entered the exact weight of the tobacco at the time of its
removal; (b) Entry shall be made in the L-7 register in the place provided on the page for
La Suerte petitioned for review before the CTA which cancelled the assessment. The CIR removals; and (c) Corresponding debit entry shall bemade in the L-7 register book of the
appealed to the CA which reversed the CTA. The CIR invoked a revenue regulation (RR) which factory receiving the tobacco under the heading, "Refuse, etc.,received from the other factory,"
limits the exemption from payment of specific tax on stemmed leaf tobacco to sales showing the date of receipt, assessment and invoice numbers, name and address of the
transactions between manufacturers classified as L-7 permittees. consignor, formin which received, and the weight of the tobacco.
[3] Yes, valid. Under Section 3(h) of RR No. 17-67, entities that were issued by the Bureau of and cigarettes for domestic sale and imported leaf and partially manufactured tobacco for
Internal Revenue with an L-7 permit refer to "manufacturers of tobacco products." Hence, the factory use were not collected for more than twenty (20) years. Such error was only discovered
transferor and transferee of the stemmed leaf tobacco must be an L-7 tobacco manufacturer. when an Assistant Chief of the Tobacco Inspection Service of the BIR appeared in a public
hearing of the Joint Legislative-Executive Tax Commission. As a result thereof, the Philippine
The reason behind the tax exemption of stemmed leaf tobacco transferred between two L-7 Tobacco Board, a policy making body of the National Government on Tobacco Authority,
manufacturers is that the same had already been previously-taxed when acquired by the L-7 adopted Resolution No. 2-67 interpreting the phrase “tobacco for domestic sale” as referring to
manufacturer from dealers of tobacco. There is no new product when stemmed leaf tobacco is wholesale disposal of tobacco products by cigar and cigarettes factories to its dealers while the
transferred between two L-7 permit holders. Thus, there can be no excise tax that will attach. phrase “tobacco for factory use” meant “imported leaf tobacco” intended for use by cigar and
The regulation, therefore, is reasonable and does not create a new statutory right. cigarette factories in the manufacture of tobacco products. The approval of this Resolution on
May 31, 1967 prompted respondent Commissioner to promulgate Memorandum Circular No.
Moreover, although delegation is not allowed as a rule, the power to fill in the details and 30-67 which was approved by then Secretary of Finance Eduardo Z. Romualdez and the
manner as to the enforcement and administration of a law may be delegated to various effectivity of which is specifically dated September 1, 1967 and not contingent on its
specialized administrative agencies. publication in the Official Gazette.
Same; Same; Same; Same.—Thus, the assailed Revenue Memorandum Circular was issued
[4] Importation of stemmed leaf tobacco not included in the exemption. The transaction to rectify the error in General Circular No. V-27 and to interpret the phrase “tobacco for
contemplated in Section 137 does not include importation of stemmed leaf tobacco for the domestic sale or factory use” with the view of arresting huge losses of tobacco inspection fees
reason that the law uses the word "sold" to describe the transaction of transferring the raw which were not collected and imposed since the said Circular (No. V-27) took effect.
materials from one manufacturer to another. Furthermore, the questioned Revenue Memorandum Circular was also issued to apprise those
concerned of the construction and interpretation which should be accorded to Act
[5] In this case, there is no double taxation in the prohibited sense because the specific tax is 31
imposed by explicit provisions of the Tax Code on two different articles or products: (1) on the VOL. 134, JANUARY 17, 1985 31
stemmed leaf tobacco; and (2) on cigar or cigarette.
La Suerte Cigar and Cigarette Factory vs. Court of Tax Appeals
Taxation; Words and Phrases; Statutes; The words “or to tobacco for domestic sale or No. 2613, as amended, and which respondent is duty bound to enforce. It is an opinion on
factory use” in Act. 2613 refer not merely to leaf tobacco but also to cigars and cigarettes as the how the law should be construed and there was no attempt whatsoever to enlarge or restrict
subjects of tobacco inspection fees.—Prior to the amendment of said Act, Sec. 6 and 7 thereof, the meaning of the law.
already covered the inspection of leaf tobacco, partially manufactured tobacco for local sale and Same; Same; Same; Same.—As admitted by counsel for petitioners, the latter were each
leaf tobacco and its products for export. If the intention of Congress was to apply the furnished with a copy of the Revenue Memorandum Circular in question and the purpose of the
amendment to those items already covered by Act 2613, then the word “leaf” should have been law, that is to inform or notify those who may be affected, has been substantially complied with.
easily included to modify the term “tobacco”. The omission of the word “leaf” is a clear Since it was further admitted by petitioners that said Memorandum is but a “Memorandum
indication that Congress intended to include within the purview of the law a new item; namely, Circular for purposes of the internal administration of the BIR and not a regulation within the
_______________ contemplation of Sections 4 and 338 of the NIRC and Section 79(b) of the Revised
Administrative Code”, said circular needs no publication in the Official Gazette as erroneously
*SECOND DIVISION. argued by the petitioners.
30 Same; Same; Same; Same.—When an administrative agency renders an opinion by means
of a circular or Memorandum, it merely interprets a pre-existing law, and no publication is
3 SUPREME COURT REPORTS ANNOTATED necessary for its validity. Construction by an executive branch of government of a particular
0 law although not binding upon courts must be given weight as the construction come from the
branch of the government called upon to implement the law. The promulgation of Revenue
La Suerte Cigar and Cigarette Factory vs. Court of Tax Appeals
Memorandum Circular No. 30-67 being in accordance with the Revised Administrative Code,
manufactured tobacco products for domestic sale and imported tobacco for factory use.
having been issued by the Commissioner of Internal Revenue with the approval of the Secretary
Same; Same; Same; An internal administrative memorandum or circular issued by the BIR
(now Minister) of Finance for the implementation of the Tobacco Inspection Law, has therefore
which constitutes a mere legal opinion on how the law (concerning collection of tobacco
the force and effect of law.
inspection fees) should be construed does not need to be published in the Official Gazette.—As
Same; Tobacco inspection fees are national taxes and may be collected without need of
herein earlier mentioned, the word “leaf”, although used to modify the term “tobacco” only in
prior inspection of the tobacco or cigarettes concerned.—Tobacco Inspection fees are
the Explanatory Note to then House Bill No. 735 was omitted when the Bill was signed into law
undoubtedly National Internal Revenue taxes, they being one of the miscellaneous taxes
(RA 31). However when General Circular No. V-27 dated October 29, 1946 was issued by then
provided for under the Tax Code. Section 228 (formerly Section 302) of Chapter VII of the Code
Collector of Internal Revenue Bibiano L. Meer to implement the provisions of Sections 6, 7 and
specifically provides for the collection and manner of payment of the said inspection fees. It is
14 of Act 2613 (Tobacco Inspection Law), the word “leaf” was erroneously included therein,
within the power and duty of the Commissioner to collect the same, even without inspection,
causing damage to the financial stability of the Government as the inspection fees due on cigars
should tobacco products be removed clandestinely or surreptitiously from the establishment of
the wholesaler, manufacturer or redrying plant and from the customs custody in case of
imported leaf tobacco. Errors, omissions or flaws committed by BIR inspectors and
representatives while in the performance of their duties
32
3 SUPREME COURT REPORTS ANNOTATED
2
La Suerte Cigar and Cigarette Factory vs. Court of Tax Appeals
cannot be set up as estoppel nor estop the Government from collecting a tax legally due.
Tobacco inspection fees are levied and collected for purposes of regulation and control and also
as a source of revenue since fifty percentum (50%) of said fees shall accrue to the Tobacco
Inspection Fee Fund created by Sec. 12 of Act No. 2613, as amended and the other fifty
percentum, to the Cultural Center of the Philippines. (Sec. 88, Chapter VII, NIRC).
Same; There is evidence found by the CTA that the tobacco and cigarettes in question were
in fact inspected prior to affixing of strip stamp.—The CTA held that the foregoing belie
petitioners’ assertions that no actual inspection was conducted to justify the collection of the
tobacco inspection fees. The findings of the Tax Court are duly supported by evidence. We find
no cogent reason to disturb the same. They are therefore binding on this Court.