[ G.R. No. 240764. November 18, 2021 ]
VENUS COMMERCIAL CO., INC., PETITIONER, VS. THE DEPARTMENT OF HEALTH AND THE FOOD AND DRUG ADMINISTRATION, RESPONDENT.
CONCURRING OPINION
CAGUIOA, J.:
I concur with the ponencia's declaration that Sections 12(a)1 and 30(4)2 of Republic Act (R.A.) No. 3720,3 as amended by R.A. No. 9711,4 and Section 2(b), paragraph 5,5 Article III of the Implementing Rules and Regulations of R.A. No. 97116 are not unconstitutional. I write this opinion only to expound on my view that the final sentence of Section 10(ff)7 of R.A. No. 3720, as amended, which grants respondent Food and Drug Administration (FDA) regulatory authority over health products, should be circumscribed by a holistic reading of the entire law.
Indeed, by virtue of the principle of subordinate legislation, Congress may delegate the authority to promulgate rules for the implementation of statutes.8 This is in recognition of the increasing complexity of the issues that must be addressed, as well as the expertise that administrative bodies possess in enforcing the broad policies of a legislation.9
Even so, the delegated authority to the administrative agency is not a legislative function — rather, it is a matter of law-execution. The delegating statute must therefore be complete in itself and provide adequate standards. When the nature of the delegated power is purely legislative in nature, the Court can strike down the statute as unconstitutional for violating the principle of separation of powers.10
In this case, I agree with the ponencia that R.A. No. 3720, as amended by R.A. No. 9711, satisfies both the completeness and sufficient standards test. There are adequate guidelines in the law within which respondent Department of Health (DOH) and the FDA must conform in the performance of their rule-making functions. This includes, to my mind, the limits to the FDA's exercise of discretion in determining whether a product is a health product under Section 10(ff) of R.A. No. 3720, as amended.
It is a well-settled principle that a law must not be read in truncated parts; each and every provision thereof must be considered in order to produce a harmonious whole.11 For this reason, Section 10(ff) of R.A. No. 3720, as amended, should not be read in isolation but rather, in conjunction with the other provisions of the law. In considering what other products could come within the purview of its regulatory jurisdiction, the FDA is bound not only by the standard that such product "may have an effect on health".12 If this were the case, practically any product would have an effect on health, whether intended or otherwise. Just to set an extreme example, a hammer can be considered to "have an effect on health" because in the hands of a murderer, it can be used as a weapon to cause death. As such, if this were the sole standard to which the FDA should conform, an absurd situation would result where the FDA can arrogate unto itself the authority to define its own regulatory jurisdiction. Surely, this goes beyond supplying the details within the scope of the statutory authority granted to it by the legislature.13
I maintain that a careful reading of R.A. No. 3720, as amended by R.A. No. 9711, provides the proper context in which products could be regulated by the FDA. In the declaration of policy of R.A. No. 9711, the express purpose of the amendatory statute is to institutionalize the FDA and enhance its regulatory capacity over health products.14 In line with this, the FDA's functions were expanded and its structure was organized to make room for "Centers" to effectively regulate health products, to wit:
SEC. 5. The FDA shall have the following centers and offices:
(a) The Centers shall be established per major product category that is regulated, namely:
(1) Center for Drug Regulation and Research (to include veterinary medicine, vaccines and biologicals);
(2) Center for Food Regulation and Research;
(3) Center for Cosmetics Regulation and Research (to include household hazardous/urban substances); and
(4) Center for Device Regulation, Radiation Health, and Research.
x x x x (Emphasis supplied)
These Centers significantly correspond to each category of health product in Section 10(ff), i.e., "food,15 drugs,16 cosmetics,17 devices,18 biologicals, vaccines, in-vitro diagnostic reagents19 and household/urban hazardous substances20 and/or a combination of and/or a derivative thereof." Clearly, in construing the boundaries of the FDA's discretion, the express legislative purpose of R.A. No. 9711 — that is, to regulate health products that are within the strengthened technical and administrative capacity of the FDA — is instructive. It may only regulate health products of the same class or kind as those comprising "health products" in Section 10(ff), as these are the only products that the legislature deemed to be within its administrative expertise.
In other words, Section 10(ff) does not grant the FDA a blanket license to extend its regulatory jurisdiction beyond what is necessary and allowed to implement the law. It cannot be used by the FDA as basis to assume jurisdiction over products simply by virtue of its perceived effect on health. Relatedly, Section 25 of R.A. No. 9711 excludes products within the jurisdiction of specialized agencies, even if these may have an effect on health:
SEC. 25. Coverage. — This Act shall govern all health products: Provided, That nothing in this Act shall be deemed to modify the sole and exclusive jurisdiction of other specialized agencies and special laws only insofar as the acts covered by these specialized agencies and laws, including, but not limited to, those covered by Republic Act No. 9211, Executive Order No. 245, Executive Order No. 18, and Presidential Decree No. 1468. (Emphasis supplied)
In all, the entire law, read as a whole, serves to limit the boundaries of the FDA's exercise of its power of subordinate legislation. Needless to state, as an agency created by Congress, the breadth and scope of its functions cannot be made to depend on its own determination of whether a certain product is a health product under. Section 10(ff) of R.A. No. 3720, as amended. If the Court were to rule otherwise, the FDA's unfettered exercise of its delegated rule-making power could dangerously venture into areas of policy.
Based on these premises, I concur with the ponencia in denying the Petition.
Footnotes
1 SEC. 12. (a) Any person who violates any of the provisions of Section eleven hereof shall, upon conviction, suffer the penalty of imprisonment ranging from one (1) year but not more than ten (10) years or a fine of not less than Fifty thousand pesos (P50,000.00) but not more than Five hundred thousand pesos (P500,000.00), or both, at the discretion of the court: Provided, That if the offender is a manufacturer, importer or distributor of any health product, the penalty of at least five (5) years imprisonment but not more than ten (10) years and a fine of at least Five hundred thousand pesos (P500,000.00) but not more than Five million pesos (P5,000,000.00) shall be imposed: Provided, further, That an additional fine of one percent (1%) of the economic value/cost of the violative product or violation, or One thousand pesos (P1,000.00), whichever is higher, shall be imposed for each day of continuing violation: Provided, finally, That health products found in violation of the provisions of this Act and other relevant laws, rules and regulations may be seized and held in custody pending proceedings, without hearing or court order, when the director-general has reasonable cause to believe from facts found by him/her or an authorized officer or employee of the FDA that such health products may cause injury or prejudice to the consuming public.
x x x x
Should the offense be committed by a juridical person, the Chairman of the Board of Directors, the president, general manager, or the partners and/or the persons directly responsible therefor shall be penalized.
Should the offense be committed by a foreign national, he/she shall, in addition to the penalties prescribed, be deported without further proceedings after service of sentence.
2 SEC. 30. The Director-General shall also exercise the following powers:
x x x x
(4) To issue orders of seizure, to seize and hold in custody any article or articles of food, device, cosmetics, household hazardous substances and health products that is adulterated, counterfeited, misbranded or unregistered, or drug, in-vitro diagnostic reagent, biologicals, and vaccine that is adulterated or misbranded, when introduced into domestic commerce pending the authorized hearing under Republic Act No. 3720, as amended, Executive Order No. 175 (1987), and Republic Act No. 7394, otherwise known as the Consumers Act of the Philippines[.]
3 AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS, DRUGS, AND COSMETICS BEING MADE AVAILABLE To THE PUBLIC BY CREATING THE FOOD AND DRUG ADMINISTRATION WHICH SHALL ADMINISTER AND ENFORCE THE LAWS PERTAINING THERETO, otherwise known as the "FOOD, DRUG, AND COSMETIC ACT," approved on June 22, 1963.
4 AN ACT STRENGTHENING AND RATIONALIZING THE REGULATORY CAPACITY OF THE BUREAU OF FOOD AND DRUGS (BFAD) BY ESTABLISHING ADEQUATE TESTING LABORATORIES AND FIELD OFFICES, UPGRADING ITS EQUIPMENT, AUGMENTING ITS HUMAN RESOURCE COMPLEMENT, GIVING AUTHORITY TO RETAIN ITS INCOME, RENAMING IT THE FOOD AND DRUG ADMINISTRATION (FDA), AMENDING CERTAIN SECTIONS OF REPUBLIC ACT No. 3720, As AMENDED, AND APPROPRIATING FUNDS THEREOF, otherwise known as the "FOOD AND DRUG ADMINISTRATION (FDA) ACT OF 2009," approved on August 18, 2009.
5 Sec. 2. Duties and Functions of the Director-General. As head of the FDA, the Director-General shall exercise the following powers and perform the following duties and functions:
x x x x
b. Quasi-Judicial Powers, Duties and Functions:
x x x x
(5) To issue orders of seizure, to seize and hold in custody any article or articles of food, device, cosmetics, household hazardous substances and health products that are adulterated, counterfeited, misbranded or unregistered; or any drug, in-vitro diagnostic reagents, biologicals, and vaccine that is adulterated or misbranded, when introduced into domestic commerce pending the authorized hearing under the FDA Act of 2009, these Rules and Regulations, and as far as applicable, other relevant laws[.]
6 THE RULES AND REGULATIONS IMPLEMENTING REPUBLIC ACT No. 9711 - THE FOOD AND DRUG ADMINISTRATION ACT OF 2009, approved on March 22, 2011.
7 SEC. 10. For the purposes of this Act, the term:
x x x x
(ff) 'Health products' means food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents and household/urban hazardous substances and/or a combination of and/or a derivative thereof. It shall also refer to products that may have an effect on health which require regulations as determined by the FDA.
8 See The Conference of Maritime Manning Agencies, Inc. v. Philippine Overseas Employment Administration, G.R. No. 114714, April 21, 1995, 243 SCRA 666, 675.
9 See Eastern Shipping Lines, Inc. v. POEA, No. L-76633, October 18, 1988, 166 SCRA 533, 544.
10 See ABAKADA Guro Party List v. Ermita, G.R. Nos. 168056, 168207, 168461, 168463 & 168730, September 1, 2005, 469 SCRA 14, 116-121.
11 Philippine International Trading Corporation v. Commission on Audit, G.R. No. 183517, June 22, 2010, 621 SCRA 461, 469.
12 R.A. No. 3720, as amended by R.A. No. 9711, Sec. 10(ff).
13 The Conference of Maritime Manning Agencies, Inc. v. Philippine Overseas Employment Administration, supra note 8.1a⍵⍴h!1
14 R.A. No. 9711, Sec. 3.
15 R.A. No. 3720, as amended by R.A. No. 9711, Sec. 10(e).1a⍵⍴h!1
16 Id., Sec. 10(f).
17 Id., Sec. 10(h).
18 Id., Sec. 10(g).
19 Id., Sec. 10(hh).
20 Id., Sec. 10(gg)
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