Quasi-Legislative Function - Fixing of Rates, Wages, Prices G.R. No. 190837 – Republic v. Drugmaker’s Laboratories !"c. Perlas-Bernabe, J. Petition for review on certiorari by FDA from an RTC ruling wic !eclare! Circulars "o. # an! $, s.#%%& null an! voi! 'tese circulars im(lemente! a testing re)uirement for !rug manufacturers*. +C grants te (etition an! rules tat te assaile! circulars are vali!.
D#$%R!N& A!ministrative A!ministrative agencies may eercise )uasi-legislative or rule-maing (owers only if tere eists a law wic !elegates tese (owers to tem. Te rules (romulgate! must be witin te confines of te granting statute an! must involve no !iscretion as to wat te law sall be, but merely te autority to fi te !etails in te eecution or enforcement of te (olicy set out in te law itself. •
An a!ministrative a!ministrative regulation may may be classifie! as a legislative rule, rule, an inter(retative inter(retative rule, or a contingent rule. Legislative rules are rules are in te nature of subor!inate legislation an! !esigne! to im(lement a (rimary legislation by (rovi!ing (rovi !ing te !etai !etails ls ter tereof. eof. Tey usually im(l im(lement ement eis eisting ting law law,, im(os im(osing ing gener general, al, etr etra-sta a-statutor tutory y obli obligatio gations ns (ursuant to autority (ro(erly !elegate! by Congress an! effect a cange in eisting law or (olicy wic affects in!ivi!ual rigts an! obligations. 'Tese re)uire notice, earing an! (ublication.* !"terpretative !"terpretativ e rules are inten!e! to inte inter(ret r(ret,, clari clarify fy or e(l e(lain ain eis eisting ting statutory statutory regul regulation ations s un!er wic te a!ministr a!min istrativ ative e bo!y o(erates. Teir (ur(ose or obec obective tive is mere merely ly to const construe rue te statute being a!min a!ministe istere! re! an! (ur(ort to !o no more tan inter(ret te statute. +im(ly, tey try to say wat te statute means an! refer to no single (erson or (arty in (articular but concern all tose belonging to te same class wic may be covere! by te sai! rules. 'Tese !on/t ave to meet te re)uirements of notice, earing an! (ublication.* $o"ti"ge"tt rules are tose issue! by an a!ministrativ $o"ti"ge" a!ministrative e auto autority rity base! on te eistence eistence of certai certain n facts or tin tings gs u(on wic te enforcement of te law !e(en!s. •
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!'(#R%)N% (&#(L& BFAD 'now FDA* 0 (etitioner Drugmaer/s 1aboratories, 2nc. an! Terrame!ic, Terrame!ic, 2nc. 0 res(on!ents *)$%+ #. Te FDA was create! (ursuant to RA 3&45 'Foo!, Drug, an! Cosmetic Act* to establis safety or efficacy stan!ar!s an! )uality measures for foo!s, !rugs an! !evices, an! cosmetic (ro!ucts. 4. Te D67 issue ssue! ! )# ,7 s. 1989 -Revise Rules a" Regulatio"s o" Registratio" o/ (armaceutical (roucts (roucts . Among oters, it re)uire! !rug manufacturers to register certain ce rtain !rug an! me!icine (ro!ucts wit te FDA before tey may release te same to te maret for sale. !t also re2uire a bioavailabilit4bioe2 bioavailabilit4bioe2uivale"ce uivale"ce -5)45& test /or a ma"u/acturer to secure a $erti/icate o/ (rouct Registratio" -$(R /or tese proucts . o 7owever, at te time te A6 was issue!, te im(lementation of te BA8B9 testing re)uirement was (ut on ol! because tere was no local facility ca(able of con!ucting it. 3. 1ater, BA8B9 testing facilities facilities were were establise! in in te country, country, an! an! FDA issue! te assaile! assaile! circulars. circulars. $ircular No. 1 s. 1997 resume! te im(lementation of te BA8B9 testing re)uirement wit te establisment of BA8B9 testing facilities in te country. $ircular No. 8 s. 1997 (rovi!e! 1997 (rovi!e! a!!itional im(lementation !etails concerning te BA8B9 testing re)uirement on !rug (ro!ucts. •
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:. Res( Res(on on!e !ent nts s ma manu nufa fact ctur ure! e! a !r !rug ug name! name! ri/ampici" ri/ampici" 0 0 bran!e! as ;Refam 455mg8en te CPR CPR e(ire! in 455#, res(on!ents res(on!ents a((lie! for an! were were grante! numerous yearly renewals of of teir CPR CPR for Refam, wic laste! until "ovember #<, 455=, albeit wit te con!ition tat tey submit satisfactory BA8B9 test results for sai! !rug.
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&. To com(ly wit te testing re)uirement, res(on!ents engage! te services of ?P @anila to con!uct BA8B9 testing on Refam, te results of wic were submitte! to te FDA. 2n turn, te FDA sent a letter !ate! July 3#, 455= to res(on!ents, basically saying te rug /aile te test. 7owever, te FDA still revali!ate! res(on!ents/ CPR for Refam two '4* more times, effective until "ovember #<, 455$, te secon! of wic came wit a warning tat no more furter revali!ations sall be grante! until res(on!ents submit satisfactory BA8B9 test results for Refam. $. 2nstea! of submitting satisfactory BA8B9 test results for Refam, res(on!ents file! a petitio" /or proibitio" a" a""ulme"t o/ $ircular Nos. 1 a" 8 s. 1997 before Br. 4<=, RTC @untinlu(a. Tey allege! tat it is te D67, an! not te FDA, wic was grante! te autority to issue an! im(lement rules concerning RA 3&45 'see #*. As suc, te issuance of te aforesai! circulars an! te manner of teir (romulgation contravene! te law an! te Constitution. Tey furter averre! tat tat te non-renewal of te CPR !ue to failure to submit satisfactory BA8B9 test results woul! not only affect Refam, but teir oter (ro!ucts as well. • •
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%. R%$ rule i" /avor o/ respo"e"ts an! !eclare! Circular "os. # an! $, s. #%%& null an! voi!, or!ere! te issuance of writs of (ermanent inunction an! (roibition against te FDA in im(lementing te aforesai! circulars, an! !irecte! te FDA to issue CPRs in favor of res(on!ents/ (ro!ucts. 2t el! tat tere is noting in RA 3&45 wic grante! eiter te FDA te autority to issue an! im(lement te subect circulars, or te +ecretary of 7ealt te autority to !elegate is (owers to te FDA. Tus, it conclu!e! tat te issuance of Circular "os. # an! $, s. #%%& constitute! an illegal eercise o/ legislative a" ami"istrative po6ers an!, ence, must be struc !own. #5. Petitioner FDA went straigt to te +C, filing a Rule petitio" wit an urgent (rayer for te imme!iate issuance of a TR6 an!8or a writ of (reliminary inunction against te im(lementation of te RTC/s 6r!er an! >rit of Permanent 2nunction. +C grante! FDA/s a((lication an! issue! a TR6 against te RTC/s or!ers. •
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!++:& 6it ;#LD!NG 1. <4N te *D) ma valil issue a" impleme"t $ircular Nos. 1 a" 8 s. 1997 – =es. •
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eneral rule An a!ministrative regulation nee!s to com(ly wit te re)uirements lai! !own by 96 4%4 on (rior notice, earing, an! (ublication in or!er to be vali! an! bin!ing. o 9ce(tion >en te same is merely an inter(retative rule, because ;wEen an a!ministrative rule is merely inter(retative in nature, its a((licability nee!s noting furter tan its bare issuance, for it gives no real conse)uence more tan wat te law itself as alrea!y (rescribe!G RA 3&45 (roibits te manufacture an! sale of (armaceutical (ro!ucts witout obtaining te (ro(er CPR from te FDA. o 2n tis regar!, te FDA as been !e(utiHe! by te same law to acce(t a((lications for registration of (armaceuticals an!, after !ue course, grant or reect suc a((lications. o Te same law actually autoriHes te +ec. of 7ealt, u(on te recommen!ation of te FDA Director, to issue rules an! regulations tat (ertain to te registration of (armaceutical (ro!ucts #. )# ,7 s. 1989 is actuall te rule tat i"trouce te 5)45& testi"g re2uireme"t /or te issua"ce o/ $(Rs coveri"g certai" parmaceutical proucts "ot te assaile circulars. o 2t is consi!ere! an a!ministrative regulation 0 a legislative rule to be eact 'see Doctrine* 0 issue! by te +ecretary of 7ealt in consonance wit te e(ress autority grante! to im by RA 3&45 to im(lement te statutory man!ate tat all !rugs an! !evices soul! first be registere! wit te FDA (rior to teir manufacture an! sale. o Consi!ering tat neiter (arty conteste! te vali!ity of its issuance, A6 =&, s. #%$% is !eeme! to ave com(lie! wit te re)uirements of (rior earing, notice, an! (ublication (ursuant to te (resum(tion of regularity accor!e! to te go vernment in te eercise of its official !uties.
# +ection :'a*, 'c*, an! 'e* of RA 3&45 (rovi!e+ection :. To carry out te (rovisions of tis Act, tere is ereby create! an office to be calle! te Foo! an! Drug A!ministration in te De(artment of 7ealt. +ai! A!ministration sall be un!er te 6ffice of te +ecretary an! sall ave te following functions, (owers, an! !uties 'a* To a!minister an! su(ervise te im(lementation of tis Act an! of te rules an! regulations issue! (ursuant to te same. 'c* To analyHe an! ins(ect foo!, !rug an! cosmetic in connection wit te im(lementation of tis Act. 'e* To issue certificate of com(liance wit tecnical re)uirements to serve as basis for te issuance of license an! s(ot-cec for com(liance wit regulations regar!ing o(eration of foo!, !rug an! cosmetic manufacturers an! establisments.
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$ircular Nos. 1 a" 8 s. 1997 are "ot ami"istrative regulatio"s because tey !o not 'a* im(lement a (rimary legislation by (rovi!ing te !etails tereofI 'b* inter(ret, clarify, or e(lain eisting statutory regulations un!er wic te FDA o(eratesI an!8or 'c* ascertain te eistence of certain facts or tings u(on wic te enforcement of RA 3&45 !e(en!s. o Teir only (ur(ose is for FDA to im(lement of te (rovisions of A6 =&, s. #%$%, inclu!ing tose covering te BA8B9 testing re)uirement, consistent wit an! (ursuant to RA 3&45. o Terefore, contrary to te res(on!ents/ assertion, te *D) as su//icie"t autorit to issue te sai circulars a" si"ce te 6oul "ot a//ect te substa"tive rigts o/ te parties tat te seek to gover", as tey are not a!ministrative regulations in te first (lace. As suc, no (rior earing, consultation, an! (ublication are nee!e! for teir vali!ity. As a final note, wile te (roliferation of generic !rugs an! me!icines is in!ee! a welcome !evelo(ment as it effectively ensures access to affor!able )uality !rugs an! me!icines for all troug teir lower (rices, te +tate, troug te FDA, must neverteless be vigilant in ensuring tat te generic !rugs an! me!icines release! to te maret are safe an! effective for use.
D!+(#+!%!>& (#R%!#N Petition grante!. RTC ruling set asi!e.
D!G&+%&R? Cristelle 9laine Collera
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