Clicks South Africa

8/13/2019 Clicks South Africa

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CLICKS SOUTH AFRICA (PTY) LTD vTSHABALALA-MSIMANG ANDANOTHER NNO;PHARMACEUTICAL SOCIETY OF SOUTH AFRICA AND OTHERS vTSHABALALA-MSIMANG AND ANOTHER NNO 2005 (2) SA 530 (C)

2005 (2) SA p530

Ci!i"# 2005 (2) SA 530 (C)

C!$% N" 4128/04 and 4329/04

C"&' Cape Provincial Division

&*% Hlophe JP , Traverso DJP and Yekiso J

H%!' June 1, 2004 ; June 17, 2004 ; June 18, 2004

&*+%# August 2, 2004

C"$%, J J a!n"le"" SC #or "he applican" in "he $e% Clicks &a""er'

T oerane SC (%i"h hi& P Coppin and * +all) #or "he #irs" and second

responden"s in "he $e% Clicks &a""er'

- Tren.ove SC (%i"h hi& A Cockrell and d! Plessis) #or "he applican" in "he

Phar&ace!"ical Socie" &a""er'

+aleka SC (%i"h hi& +Soni, Sello and S Yacoo/) in "he Phar&ace!"ical

Socie" &a""er'

A##"!i"#$Link to Case Annotations

F

F,#"% . S,%&%,/""'%Administrative a! " #evie! " $% administrative a&tion " '(en &om)etent "#e&ommendation o% *ri&ing Committee set + u) in terms o% s 22+1- o% .edi&ines and#eated ustan&es A&t 101 o% 19 " '(et(er revie!ae " For &ondu&t o% *ri&ingCommittee to &onstitute administrative a&tion as intended in *romotion o%Administrative Justi&e A&t 3 o% 2000 *AJA-, not on5 s(oud it %a !it(in amit o% t(atde%inition, ut at ver5 east s(oud dire&t5 adverse5 a%%e&t rig(ts and (ave dire&te6terna ega e%%e&t " *rior to a&&e)tan&e o% re&ommendations 5 %irst res)ondent, t(e5

did not a%%e&t an5 one o% a))i&ants e6isting rig(ts or egitimate e6)e&tations dire&t5 "#e&ommendations a&king an5 %or&e or e%%e&t in res)e&t o% a))i&ants " ot )ossie to&onstrue reguations as (aving (ad an5 dire&t, e6terna ega e%%e&t " For a&tion to (ave

dire&t e%%e&t, it (as to a%%e&t )erson &on&erned dire&t5 rat(er t(an indire&t5; to eega5 inding determination o% individua rig(ts; and to eit(er estais(, &(ange or J

2005 (2) SA p53

!it(dra! e6isting rig(ts " #e&ommendations o% A Committee not (aving an5 o% t(eseattriutes " #e&ommendations not revie!ae under )rovisions o% *AJA " o!ever,re&ommendations revie!ae on asis o% &ommon a!, s 331- o% Constitution, and ot(er)rovisions o% Constitution

Administrative a! " #evie! " $% : administrative a&tion " '(en &om)etent " .aking o%

reguations in terms o% s 22+2- o% .edi&ines and #eated ustan&es A&t 101 o% 19 "'(et(er revie!ae " ot intention o% Legisature to in&ude rue"making in de%inition o%

and in amit o% administrative a&tion in s 1 o% *romotion o% Administrative Justi&e A&t 3o% 2000 " .aking o% reguations a&&ording5 not revie!ae on t(is asis C
http://jutastat.ukzn.ac.za/nxt/foliolinks.asp?f=xhitlist&xhitlist_x=Advanced&xhitlist_vpc=first&xhitlist_xsl=querylink.xsl&xhitlist_sel=title;path;content-type;home-title&xhitlist_d=%7BSalr%7D&xhitlist_q=%5Bfield%20folio-destination-name:%27a052530%27%5D&xhitlist_md=target-id=0-0-0-15275http://jutastat.ukzn.ac.za/nxt/foliolinks.asp?f=xhitlist&xhitlist_x=Advanced&xhitlist_vpc=first&xhitlist_xsl=querylink.xsl&xhitlist_sel=title;path;content-type;home-title&xhitlist_d=%7BSalr%7D&xhitlist_q=%5Bfield%20folio-destination-name:%27a052530%27%5D&xhitlist_md=target-id=0-0-0-15275http://jutastat.ukzn.ac.za/nxt/foliolinks.asp?f=xhitlist&xhitlist_x=Advanced&xhitlist_vpc=first&xhitlist_xsl=querylink.xsl&xhitlist_sel=title;path;content-type;home-title&xhitlist_d=%7BSalr%7D&xhitlist_q=%5Bfield%20folio-destination-name:%27a052530%27%5D&xhitlist_md=target-id=0-0-0-15275


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.edi&ine " .edi&ines " .edi&ines and #eated ustan&es Contro A&t 101 o% 19 "#eguations made in terms o% s 22+2- o% A&t in + #3 o% 30 A)ri 2004 " #eguation2- (c) ii-, )roviding %or determination o% )ri&e in res)e&t o% medi&ine !(ose saes&ommen&ed a%ter Januar5 2004 and )rovided t(at )ri&e o% t(at medi&ine (ad to edetermined !it( re%eren&e to )ri&e o% t(at medi&ine in ot(er &ountries in !(i&( )ri&e o%medi&ines and s&(edued sustan&es are reguated and )uis(ed " uent5 t(at )art o% reguations &om)ained o% neit(er vaguenor un&ertain

.edi&ine " .edi&ines " .edi&ines and #eated ustan&es Contro A&t 101 o% 19 "#eguations made in terms o% s 22+2- o% A&t in + #3 o% 30 A)ri 2004 " uiring ire&tor"+enera to determine and J

2005 (2) SA p532

)uis( re>uired met(odoog5 !it( !(i&( manu%a&turers or im)orters o% A medi&ine (adto &on%orm " ?(is no more t(an im)ementation o% reguations t(emseves " #eguation2- (e) not amounting to deegation to ire&tor"+enera o% )o!ers o% *ri&ing Committeenor o% .inisters )o!er to determine trans)arent )ri&ing s5stem or met(odoog5 %ordetermining singe e6it )ri&e " ?(is in ine !it( &onstitutiona dut5 o% .inister : to

)romote or )rote&t interests o% )ui& in e%%i&ient and e%%e&tive distriution o% medi&ines "ot(ing anomaous in )ro&ess o% e6e&ution o% t(is dut5 to &onsut !ide5, in&uding

memers o% *ri&ing Committee " ot &ontem)ated eit(er in enaing )rovision or inreguations t(emseves t(at, in e6e&ution o% dut5 to )romote e%%i&ient and e%%e&tive

distriution o% medi&ines, .inister C s(oud a&t on re&ommendation o% *ri&ing Committee" e&tion 22+ and reguations )romugated t(ereunder (ad to e inter)reted againsta&kground o% &onstitutiona rig(t to (eat( &are

.edi&ine " .edi&ines " .edi&ines and #eated ustan&es Contro A&t 101 o% 19 "

#eguations made in terms o% s 22+2- o% A&t in + #3 o% 30 A)ri 2004 "


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address " ?o e6tent t(at )rovisions o% s 22+2- (a) o% A&t &oud e &onstrued to e in&on%i&t !it( )rovisions o% s 491- (a) o% *(arma&5 A&t, atter )ie&e o% egisation &oud e&onstrued as (aving een amended 5 im)i&ation t(roug( suse>uent egisation

.edi&ine " .edi&ines " .edi&ines and #eated + ustan&es Contro A&t 101 o% 19 "#eguations made in terms o% s 22+2- o% A&t in + #3 o% 30 A)ri 2004 "


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a))i&ants &(aenged t(e vaidit5 o% t(e reguations on %ive road %ronts, viz (a) t(at t(ereguations )roviding %or &onstraints on t(e singe e6it )ri&e %or medi&ines !ere una!%uon t(e asis t(at t(e5 !ere void %or vagueness, t(at t(e5 !ere ultra vires and t(at t(e5&onstituted una!%u deegation o% )o!er; (b) t(at t(e reguations )roviding %or ana))ro)riate dis)ensing %ee !ere una!%u on t(e asis t(at t(e dis)ensing %ee )rovided%or t(erein !as not a))ro)riate, !as unreasonae and vioated ss 22 and 2 o% t(e

Constitution; (c) t(at reg 10, !(i&( )rovided %or a dis)ensing %ee, &onstituted una!%udeegation o% )o!er and !as aso void %or vagueness; (d) t(at t(e reguation deaing!it( J

2005 (2) SA p531

&(edue 0 medi&ines !as una!%u; and (e) t(at A t(ose as)e&ts o% t(e reguations)roviding %or in%ormation gat(ering !ere una!%u

As to t(e >uestion o% !(et(er t(e &ondu&t o% t(e *ri&ing Committee !as sue&t torevie!,

Held , t(at t(e mandate o% t(e *ri&ing Committee !as to : %ormuate re&ommendations

!(i&( !oud, i% a&&e)ted, enae t(e %irst res)ondent to make reguations reating to t(eintrodu&tion o% a trans)arent )ri&ing s5stem %or a medi&ines and s&(edued sustan&es

sod in t(e #e)ui& and, on an a))ro)riate dis)ensing %ee to e &(arged 5 a )(arma&istor 5 a )erson i&ensed in terms o% s 22+1- (a) o% t(e A&t n ine !it( its mandate t(e&ommittee did %ormuate t(e re>uired re&ommendations !(i&( it sumitted to t(e %irstres)ondent %or a&&e)tan&e t !as %or t(e %irst res)ondent to eit(er a&&e)t or ree&t t(ere&ommendations as %ormuated For t(e &ondu&t o% t(e *ri&ing Committee to &onstituteC administrative a&tion !it(in t(e meaning o% t(at term in *AJA, not on5 s(oud it %a

!it(in t(e amit o% t(at de%inition ut, at t(e ver5 east, s(oud dire&t5 adverse5 a%%e&trig(ts, and (ave a dire&t e6terna ega e%%e&t *aragra)(s B37 " B38 o% Dekiso Js

udgment at 1F " 2A-

Held , %urt(er, t(at t(e re&ommendations did not e%ore t(eir a&&e)tan&e 5 t(e %irstres)ondent dire&t5 a%%e&t an5 one o% t(e a))i&ants e6isting rig(ts or egitimatee6)e&tations ?(e5 !ere mere re&ommendations t(at !ere not inding on t(e a))i&ants,and t(e5 &oud not e &onstrued as (aving (ad an5 dire&t, e6terna ega e%%e&t*aragra)( B39 o% Dekiso Js udgment at 2: " C-

Held , %urt(er, t(at t(e re&ommendations did not e%ore t(eir = a&&e)tan&e 5 t(e %irstres)ondent im)ose an5 urden on t(e a))i&ants, nor did t(e5 at t(at stage remove

rig(ts %rom an5 one o% t(em =ven i% one !ere to a&&e)t t(at t(e *ri&ing Committee !asan organ o% tate, it &oud (ard5 e &on&eivae t(at t(e %ormuation o% t(ere&ommendations, !(i&( &oud on5 (ave a %ina e%%e&t on&e )romugated into reguation,&oud e said to &onstitute an e6er&ise o% )ui& )o!er ?(e dire&t, ega e%%e&t

&ontem)ated in t(e de%inition F o% administrative a&tion &oud not e &onditiona in t(esense o% )ending a&&e)tan&e 5 t(e %irst res)ondent ?(e &ondu&t and t(e a&tivities o%t(e *ri&ing Committee &oud not e &onstrued as &onstituting administrative a&tion, nordid t(e5 %a !it(in t(e amit o% t(e de%inition o% administrative a&tion as de%ined in s 1

o% *AJA *aragra)( B40 o% Dekiso Js udgment at 2 " F- +

Held , %urt(er, t(at %or t(e a&tivities o% t(e *ri&ing Committee to &onstituteadministrative a&tion su&( &ondu&t s(oud a&&ording to t(e de%inition o% administrativea&tion (ave (ad a dire&t ega e%%e&t on t(e a))i&ants For an5 a&tion to (ave a dire&te%%e&t it (ad to a%%e&t t(e )erson &on&erned dire&t5 rat(er t(an indire&t5, and t(eadministrative a&tion or de&ision (ad to e a ega5 inding determination o% individuarig(ts n ot(er !ords, t(e re&ommendations eit(er (ad to estais(, &(ange or !it(dra!

e6isting rig(ts %or t(em to &onstitute administrative a&tion ?(e re&ommendations o% t(e


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Committee did not (ave an5 o% t(ese attriutes *aragra)(s B41 " B42 o% Dekiso Jsudgment at 2+ " 3:-

Held, %urt(er, t(at t(e Committees re&ommendations !ere, (o!ever, revie!ae on t(easis o% &ommon a!, s 331- o% t(e Constitution, and ot(er )rovisions o% t(eConstitution *aragra)( B44 o% Dekiso Js udgment at 3= " F-

As to !(et(er t(e making o% reguations 5 t(e %irst res)ondent &onstituted

administrative a&tion as intended in *AJA,

Held , t(at it (ad not een t(e intention o% t(e Legisature to in&ude rue"making in t(ede%inition and amit o% administrative a&tion as intended in s 1 o% J

2005 (2) SA p535

*AJA ?o t(e e6tent t(at rue"making &oud e &onstrued as t(e im)ementation o%nationa egisation as A intended in s 82- (a) o% t(e Constitution, t(e atter se&tion o%t(e Constitution )rovided in im)ementing nationa egisation e6&e)t !(ere t(eConstitution or an A&t o% *ariament )rovides ot(er!ise n t(e &ase o% t(e )resent

matter *AJA, an A&t o% *ariament, )rovided ot(er!ise *aragra)( B49 o% Dekiso Jsudgment at A " C-

?(e a))i&ants aso argued t(at reg 2- (c) ii-, !(i&( made : )rovision %or t(edetermination o% t(e )ri&e o% a medi&ine t(at !ent on sae %or t(e %irst time a%ter Januar52004 5 re%eren&e to t(e )ri&e o% t(at medi&ine in ot(er &ountries in !(i&( t(e )ri&e o%

medi&ines and s&(edued sustan&es are reguated and )uis(ed, (ad no inteigiemeaning

Held , t(at t(e statutor5 res)onsiiit5 %or t(e determination o% a singe e6it )ri&e or t(e)ri&e o% a medi&ine or s&(edued sustan&e rested !it( t(e manu%a&turers or im)orterso% a C medi&ine or s&(edued sustan&e ?(e5 o)erated in a goa market and (ad to e

a!are o% ot(er &ountries in !(i&( )ri&es o% medi&ines and s&(edued sustan&es !erereguated and )uis(ed #eguation (c) &ontem)ated )ui&ation, 5 t(e ire&tor"+enera in t(e Government Gazette , o% a met(odoog5 %or &on%orming !it( internationaen&(marks ?(is met(odoog5 invoved taking into a&&ount t(e )ri&e and %a&tors t(at

in%uen&ed t(e )ri&e at !(i&( t(e medi&ine or s&(edued sustan&e deemed e>uivaent5 t(e ire&tor"+enera, !as sod in ot(er &ountries in !(i&( )ri&es o% medi&ines and

s&(edued sustan&es !ere reguated and )uis(ed ?(is sort o% in%ormation (ad to ereadi5 a&&essie to t(e manu%a&turers and im)orters, i% not 5 !a5 o% internationa

)ri&e ists, t(en t(roug( trade re)resentatives ?(ere !as no eviden&e to suggest t(att(e manu%a&turers and t(e = im)orters on !(om t(e reguations a))ied (ad (addi%%i&ut5 in &om)5ing !it( t(e reguation &om)ained o% ?(e a))i&ants &ontention t(att(e reguation in )oint !as vague and un&ertain !as a&&ording5 !it(out merit

*aragra)(s B7 " B7 o% Dekiso Js udgment at " F-

?(e a))i&ants argued t(at t(e reguations sometimes demonstrated F &onsiderae&on%usion aout t(e reations(i) et!een t(e )rodu&t )ri&e &om)onent o% t(e singe e6it

)ri&e and t(e ogisti& %ee, t(e atter eing t(e se&ond eement o% t(e singe e6it )ri&e, asde%ined, to !(i&( (ad to e added vaue added ta6


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&onsiderae &on%usion in t(e determination o% t(e )ri&e o% medi&ine and t(e ogisti& %eeas &ontended 5 t(e a))i&ants *aragra)( B78 o% Dekiso Js udgment at 7: " C-

?(e a))i&ants %urt(er &om)ained t(at t(e )rovisions o% t(e reguations deaing !it( anin&rease in t(e singe e6it )ri&e !ere os&ure ?(e5 argued in )arti&uar t(at t(einterreations(i) et!een reg 7 and reg 83- !as di%%i&ut to &om)re(end #eguation

1- )rovided t(at t(e )ri&e o% a medi&ine or s&(edued sustan&e (ad to e set 5 t(emanu%a&turer or im)orter o% t(e reevant medi&ine or s&(edued sustan&e ?(e )ri&e at

!(i&( su&( medi&ine or s&(edued sustan&e (ad to e sod (ad to e determined on t(easis o% t(e %ormua )rovided in reg 2- so as to arrive at a aseine singe e6it )ri&e

#eguation 7 in turn )rovided t(at t(e singe e6it )ri&e so determined &oud on5 ein&reased on&e a 5ear $n&e a singe e6it )ri&e (ad een set and determined, nomedi&ine or s&(edued sustan&e &oud e sod J

2005 (2) SA p53

at a )ri&e (ig(er t(an t(e singe e6it )ri&e so determined n ot(er !ords, t(e singe e6it)ri&e !as a ma6imum )ri&e A at !(i&( a medi&ine or s&(edued sustan&e &oud e sodin an5 one 5ear as determined in terms o% t(e reguations A medi&ine or s&(edued

sustan&e &oud e sod at a )ri&e o!er t(an t(e singe e6it )ri&e as ong as t(e o!er)ri&e !as marked on su&( medi&ine ?(ese %u&tuations : in )ri&es !ere intended to

)romote &om)etition amongst t(e manu%a&turers or im)orters o% medi&ines #eguation83- &ontem)ated an in&rease in t(e )ri&e o% su&( medi&ine )rovided t(at su&( anin&rease s(oud not e (ig(er t(an t(e singe e6it )ri&e in res)e&t o% t(at medi&ine and)rovided %urt(er t(at on5 one su&( in&rease !oud e )ermissie in an5 >uarter o% a5ear

Held , t(at reg 83-ii- )ro(iited an5 su&( in&rease !it(in C a )eriod o% si6 mont(s %romt(e &ommen&ement o% t(e reguations #eguation (e) &ontem)ated )ui&ation in t(eGovernment Gazette o% a met(odoog5 %or &on%orming to internationa en&(marks t&oud !e e t(at on&e su&( a met(odoog5 (ad een )uis(ed, t(e manu%a&turer or

im)orter !oud (ave to adust its singe e6it )ri&es to &on%orm !it( su&( met(odoog5,)rovided t(e adustment !as made !it(in t(ree mont(s o% )ui&ation o% su&(met(odoog5 ?(is )ui&ation did not entai t(e setting u) or t(e determination o% asinge e6it )ri&e t t(ere%ore %oo!ed t(at t(ere !as no sustan&e in a))i&ants&ontention t(at t(e reguations &om)ained o% !ere eit(er os&ure or in&om)re(ensie?(is !as e>ua5 a))i&ae to t(e a))i&ants &ontention t(at t(e reguations did notao! a manu%a&turer or an im)orter to de&rease t(e singe e6it )ri&e *aragra)( B79 o%Dekiso Js udgment at 7 " 8C- =

?(e a))i&ants %urt(er &ontended t(at t(ere !as no &arit5 in t(e reguations t(emseves

i% saes o% a medi&ine to t(e tate !ere to e in&uded in t(e &a&uation or determinationo% t(e singe e6it )ri&e

Held , t(at t(is reguation (ad to e &onstrued to )rovide t(at t(e singe e6it )ri&ea))ied to saes in res)e&t o% )ersons ot(er t(an t(e tate ?(is &onstru&tion !asrein%or&ed 5 t(e omission o% t(e F tate in t(e de%inition o% t(e su))5 &(ain in t(e

de%inition se&tion o% t(e reguations as !e as 5 t(e e6&usion o% t(e tate %rom t(ede%inition o% user in t(at se&tion aes o% a medi&ine to t(e tate !ere t(us not

in&uded in t(e &a&uation o% t(e singe e6it )ri&e and &onse>uent5 t(at )art o% t(ereguations &om)ained o% !as neit(er vague nor un&ertain as &ontended 5 t(ea))i&ants *aragra)( B80 o% Dekiso Js udgment at 8= " +- +

?(e a))i&ants aso &ontended %urt(er t(at t(e enaing )rovision, name5 s 22+ o% t(eA&t, did not aut(orise t(e deegation re%erred to in reg 2- (e) , !(i&( )rovided t(at t(e

ire&tor"+enera (ad to determine and )uis( in t(e Government Gazette amet(odoog5 %or &on%orming !it( internationa en&(marks, taking into a&&ount a


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numer o% %a&tors re%erred to in t(is su"reguation, sin&e t(is (ad t(e e%%e&t o% usur)ingt(e %un&tions o% t(e *ri&ing Committee

Held , t(at reg 2- (e) mere5 re>uired t(e ire&tor"+enera to determine and )uis(t(e re>uired met(odoog5 to !(i&( t(e manu%a&turers or im)orters o% a medi&ine ors&(edued sustan&e (ad to &on%orm ?(is !as no more t(an t(e im)ementation o% t(e

reguations t(emseves, and reg 2- (e) did not amount to a deegation to t(eire&tor"+enera o% t(e )o!ers o% t(e *ri&ing Committee nor o% t(e .inisters )o!er to

determine a trans)arent )ri&ing s5stem, or %or t(at matter a met(odoog5 %ordetermining a singe e6it )ri&e *aragra)( B82 o% Dekiso Js udgment at 8J " 9:-

Held , %urt(er, t(at t(e .inister (ad a dut5 to )romote or )rote&t t(e interests o% t(e)ui& in t(e e%%i&ient and e%%e&tive distriution o% medi&ines and s&(edued sustan&est(roug(out t(e #e)ui& o% out( A%ri&a ?(ere !as J

2005 (2) SA p53

a&&ording5 not(ing anomaous in t(e )ro&ess o% e6e&ution o% t(is dut5 to &onsut !ide5,in&uding !it( A t(e memers o% t(e *ri&ing Committee t never &oud (ave een

&ontem)ated eit(er in t(e enaing )rovision or in t(e reguations t(emseves t(at, int(e e6e&ution o% a dut5 to )romote e%%i&ient and e%%e&tive distriution o% medi&ines, t(e

.inister s(oud a&t on t(e re&ommendation o% t(e *ri&ing Committee *aragra)( B83 o%Dekiso Js udgment at 9= " F- :

Held , %urt(er, t(at t(e dis&ounting and t(e suse>uent marking"u) o% )(arma&euti&a)rodu&ts t(at &(ara&terised t(e sae o% su&( )rodu&ts in t(e )ast (ad (ad t(e e%%e&t o%negating t(e rig(t to (eat( &are ens(rined in s 271- o% t(e Constitution n terms o% s

272- o% t(e Constitution t(e tate (ad a &onstitutiona oigation to take reasonaeegisative and ot(er measures to a&(ieve t(e )rogressive reaisation o% t(e rig(ts

&ontained in s 27, !(i&( C in&uded t(e rig(t to (eat( &are and it !as against t(isa&kground t(at s 22+ and t(e reguations )romugated t(ereunder (ad to e

inter)reted *aragra)(s B88 " B89 o% Dekiso Js udgment at 70 " 71A-

Held , %urt(er, t(at t(e singe e6it )ri&e (ad not een im)osed on t(e manu%a&turers orim)orters ut !as &ontroed 5 t(e de%inition o% singe e6it )ri&e in reg 2; t(e )rovision%or )ui&ation o% t(e singe e6it )ri&e in terms o% reg 3; and t(e re>uirement t(at t(esinge e6it )ri&e (ad to e &ear5 and egi5 re%e&ted on )a&kages or a &ontainer in

!(i&( su&( medi&ine !as sod *aragra)( B92 o% Dekiso Js udgment at 71+ " -

Held , %urt(er, t(at t(e a))i&ants &ontention t(at t(ese measures !ere &onstraints ont(e singe e6it )ri&e (ad to e ree&ted in t(e ig(t o% t(e egisative )ur)ose o% ss 22+and 27 ?(e egisative regime !as to eiminate a&k o% trans)aren&5 in t(e )ri&ing = o%medi&ine, t(us making medi&ine more a%%ordae and &onsistent !it( a rig(t to (eat(

&are as &ontem)ated in s 27 o% t(e Constitution *aragra)( B93 o% Dekiso Js udgmentat 71 " 72A-

?(e a))i&ants atta&ked t(e vaidit5 o% reg 10, !(i&( )rovided %or t(e &a&uation o% t(e

a))ro)riate dis)ensing %ee &ontem)ated in s 22+2- (b) o% t(e A&t on t(e asis t(at it!as ultra vires , sin&e t(e dis)ensing %ee )rovided %or in t(is reguation F !as nota))ro)riate !it(in t(e meaning o% t(e em)o!ering )rovision, in )arti&uar s 22+2- (b) ?(e atta&k !as ased on a numer o% grounds, inter alia on t(e asis o% s 491- (b) o%t(e *(arma&5 A&t 3 o% 1974, !(i&( vested t(e .inister in &onsutation !it( t(e*(arma&5 Coun&i to determine t(e tari%% o% %ees )a5ae to a )(arma&ist in res)e&t o%)ro%essiona servi&es rendered, !(i&( !as aeged5 in &ontrast to t(e )rovisions o% + s22+2- (b) o% t(e A&t, !(i&( vested t(e .inister !it( )o!er to make reguations on an

a))ro)riate dis)ensing %ee to e &(arged 5 a )(arma&ist ?(e a))i&ants %urt(er&ontended t(at regs 10 and 11 !ere ultra vires e&ause t(e5 )ur)orted to determine t(e


8/74

ma6imum amount o% a dis)ensing %ee to e &(arged 5 a )(arma&ist !(en t(e sour&e o%su&( )o!er is s 491- (a) o% t(e *(arma&5 A&t and not s 22+2- (b) o% t(e A&t

Held , t(at t(is &ontention !as %a!ed as, %irst, t(e reguations &ontem)ated in s 22+2-(b) , in&usive o% regs 10 and 11, soug(t to introdu&e a trans)arent )ri&ing s5stem !(i&(s 491- (a) o% t(e *(arma&5 A&t did not &ontem)ate addressing and se&ond5, s 22+2-(b) soug(t to address t(e ver5 mis&(ie% !(i&( t(e *(arma&5 A&t, in its (istori&a &onte6t,%aied to address ?o t(e e6tent t(at t(e )rovisions o% s 22+2- (a) o% t(e A&t &oud e&onstrued to e in &on%i&t !it( t(e )rovisions o% s 491- (a) o% t(e *(arma&5 A&t, t(eatter )rovision &oud e &onstrued as (aving een amended 5 im)i&ation t(roug(

suse>uent egisation *aragra)( B9 o% Dekiso Js udgment at 72F " +-

As an aternative t(e a))i&ants &ontended t(at reg 10 !as, in an5 event, ultra virese&ause t(e dis)ensing %ee )rovided %or !as not a))ro)riate !it(in t(e J

2005 (2) SA p534

meaning o% s 22+2- (b) e&ause t(e dis)ensing %ee (ad een set at a time !(en t(esinge e6it A )ri&e (ad not as 5et een determined; t(e dis)ensing %ee )rovided %or in t(e

reguation !oud &ause t(e dis)ensing servi&es o% )(arma&ies to o)erate at a oss; t(edis)ensing %ee %aied to take into a&&ount t(e di%%erent t5)es o% )(arma&ies t(at e6isted

in )ra&ti&e; t(e dis)ensing %ee redu&ed a&&ess to )(arma&euti&a )rodu&ts in out(A%ri&a; and t(e dis)ensing %ee !oud resut in !ide"s&ae (arm !it(in t(e )(arma&5 :)ro%ession $n t(is asis it !as argued t(at reg 10 !as ultra vires sin&e t(e dis)ensing%ee so determined !as not a))ro)riate !it(in t(e meaning o% s 22+ o% t(e A&t

Held , t(at it !oud e s(eer s)e&uation to &ontend t(at t(ere !oud e signi%i&ant5%e!er )(arma&ies and !ide"s&ae (arm to t(e )ro%ession as a resut o% t(e )romugationo% t(e reguations As C at t(e date o% t(e (earing t(e reguations did not 5et a))5 to a

t(e a))i&ants, and t(e reguations &oud not e set aside )ure5 on asis o% s)e&uationas t(e a))i&ants soug(t to do ?(e dis)ensing %ee as )rovided %or in t(e reguation &oud

a&&ording5 not e (ed to e eit(er ina))ro)riate or unreasonae in an5 o% t(e %orms&ontended 5 t(e a))i&ants *aragra)(s B112 " B113 o% Dekiso Js udgment at 77+ "-

?(e a))i&ants in t(e Pharmaceutical Society a))i&ation %urt(er ased t(eir &aim %or t(ede&aration o% invaidit5 o% reg 10 on t(e asis t(at reg 10 vioated t(e a))i&ants rig(t to

%reedom o% trade under s 22 o% t(e Constitution e&ause t(e &a))ed dis)ensing %ee andt(e resutant e%%e&t o% )(arma&ies going out o% usiness, !as ike5 to (ave t(e e%%e&t o%

dis&ouraging )eo)e %rom remaining in t(e )(arma&5 )ro%ession or &(oosing to )ursuet(e )ro%ession in t(e %irst = )a&e ?(e a))i&ants aso ased t(eir &aim on t(e &ontentiont(at t(e &a))ed dis)ensing %ee and t(e &on&omitant )ressure on t(e )(arma&ies toremain viae !ere ike5 to %or&e )(arma&ists to turn to non")ro%essiona a&tivities su&(

as %ront s(o) saes in an attem)t to survive %inan&ia5

Held , t(at none o% t(e a))i&ants, eing entities, (ad F &aimed t(at t(e5 !ere &iti@ensentited to t(e rig(ts &on%erred u)on &iti@ens in terms o% s 22 o% t(e Constitution and it

%oo!ed t(at t(e a))i&ants reian&e on s 22 o% t(e Constitution !as mis)a&ed*aragra)( B118 o% Dekiso Js udgment at 79C " -

As regards dis)ensing %ees %or &(edue 0 medi&ines,

Held , t(at reg 13 )rovided t(at an a))ro)riate %ee to e + &(arged 5 a retaier inres)e&t o% &(edue 0 medi&ine !as a )er&entage mark"u) %or t(at medi&ine t(at !asa))ied at t(e date o% &ommen&ement o% t(e reguation ?(e retaiers !(o sod &(edue

0 medi&ines !oud kno! !(at t(eir mark"u) !as at t(e &ommen&ement o% t(ereguations ?(e reguation !as neit(er vague nor ultra vires t(e enaing )rovision as


9/74

suggested 5 t(e a))i&ants, and t(e a))i&ants &ontention !as atoget(er !it(outmerit *aragra)( B128 o% Dekiso Js udgment at 81C " =-

?raverso J*, dissenting, (ed t(at 1- t(e re&ommendations amounted to administrativea&tion )ara B41 o% ?raverso J*s udgment at 90=-; 2- t(e making o% t(e reguationsamounted to administrative a&tion )ara B4 o% ?raverso J*s udgment at 91:-;

and 3- t(e re&ommendations regarding a dis)ensing %ee !ere (a) )remised on a&on%used &on%ation et!een mark"u) and )ro%it; (b) &on%used in t(e sense t(at ado&umentation and deieration 5 t(e *ri&ing Committee )rior to t(e %iing o% t(eirans!ering )a)ers in t(is a))i&ation s(o!ed t(at t(e dis)ensing %ee !oud e an a"

in&usive one, and 5et in t(eir a%%idavits t(e5 said t(at it reated on5 to &ertain)ro&edures; and (c) &ontrar5 to t(e entire s&(eme o% t(e em)o!ering )rovision, name5to reguate t(e )ri&e o% medi&ine in a trans)arent and J

2005 (2) SA p53

&onsistent manner, suggested t(at )(arma&ists &oud e %or&ed to generate t(eir in&omenot %rom A t(eir &(osen )ro%ession ut rat(er %rom e&oming traders in ot(er&ommodities )ara B19 o% ?raverso J*s udgment at 1:/C " =- ?raverso J*

a&&ording5 %ound t(at t(e re&ommendation o% t(e *ri&ing Committee in res)e&t o% t(edis)ensing %ee !as aritrar5 and &a)ri&ious and took into a&&ount irreevant

&onsiderations !it(in t(e meaning o% s 2- (e) iii- and vi- o% t(e *romotion o%Administrative : Justi&e A&t 3 o% 2000 *aragra)( B170 o% ?raverso J*s udgment at1F-

C!$%$ C"#$i%'%A##"!i"#$

#e)orted &ases

Australian Broadcasting Tribunal vBond and Others 1990 AL# 11 CA-E re%erred to C

Bato Star ishing (Pty) !td v"inister o# $nvironmental A##airs and Others 2004 4- A490 CC- 2004 7- :CL# 87-E a))ied

Bel Porto School Governing Body and Others vPremier, %estern &a'e, and Another2002 3- A 2 CC- 2002 9- :CL# 891-E a))ied

&hairman, Board on Tari##s and Trade and Others vBrenco nc and Others 2001 4- A11 CA- E re%erred to

&ity o# &a'e Ton vA* Out'ost (Pty) !td and Others 2000 2- A 733 C- E re%erred to

*aood and Another v"inister o# Home A##airs and Others+ Shalabi and Another v"inister o# Home A##airs and Others+ Thomas and Another v"inister o# Home A##airs andOthers 2000 3- A 93 CC- 2000 8- :CL# 837-E a))ied =

*urban ent Board v$dgemont nvestments !td 194 A 92E re%erred to

$state Gee-ie v.nion Government 1948 2- A 494 - E re%erred to

edsure !i#e Assurance !td and Others vGreater /ohannesburg Transitional "etro'olitan&ouncil and Others 1999 1- A 374 CC- 1998 12- :CL# 148-E re%erred to F

erreira v!evin 0O and Others+ 1ryenhoe- and Others vPoell 0O and Others 199 1-A 984 CC- 199 1- :CL# 1-E a))ied
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10/74

irst 0ational Ban- o# SA !td t2a %esban- v&ommissioner, South A#rican evenueService and Another 2001 3- A 310 C- 2002 7- :CL# 702-E re%erred to

Har-sen v!ane 0O and Others 1998 1- A 300 CC- 1997 11- :CL# 1489-E re%erredto +

Helgesen vSouth A#rican "edical and *ental &ouncil 192 1- A 800 - E re%erred to

"inister o# Home A##airs v$isenberg 3 Associates4 n re $isenberg 3 Associates v"inister o# Home A##airs and Others 2003 - A 281 CC- 2003 8- :CL# 838-E a))ied

"istry vnterim "edical and *ental &ouncil o# South A#rica and Others 1998 4- A 1127CC- 1998 7- :CL# 880-E re%erred to

0ational *irector o# Public Prosecutions and Another v"ohamed 0O and Others 2002 4-A 843 CC- 2002 2- AC# 19; 2002 9- :CL# 970-E re%erred to

0e 0ational Party o# South A#rica vGovernment o# the e'ublic o# South A#rica andOthers 1999 3- A 191 CC- 1999 - :CL# 489-E re%erred to

Paola v/eeva 0O and Others 2004 1- A 39 CA- E re%erred to

Pharmaceutical "anu#acturers Association o# SA and Another4 n re $5 'arte President o#the e'ublic o# South A#rica and Others 2000 2- A 74 CC- 2000 3- :CL# 241-Ea))ied J

2005 (2) SA p510

vin- 191 1- A ?- E re%erred A to

vSu'ra 198 1- A 474 ?- E re%erred to

S v"a-anyane and Another 199 3- A 391 CC- 199 2- AC# 1; 199 - :CL#-E re%erred to

South A#rican Shore Angling Association and Another v"inister o# $nvironmental A##airs2002 - A 11 =- 2002 - :CL# 09-E re%erred to

The "aster v! Bac- 3 &o !td and Others : 1983 1- A 98 A- E re%erred to

The "aster v! Bac- and &o !td 1981 4- A 73 C- E re%erred to

1an ooyen and Others vThe State and Others (General &ouncil o# the Bar o# SouthA#rica ntervening) 2002 - A 24 CC- 2002 2- AC# 222; 2002 8- :CL# 810-Ere%erred to

S!&%$ C"#$i%'%

tatutes C

?(e Constitution o% t(e #e)ui& o% out( A%ri&a A&t 108 o% 199, ss 1 (c) , 22, 2, 27,331-, 82- (a) E see/uta6s Statutes o# South A#rica 7889 vo at 1"14, 1"148, 1"149and 1"19
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_sel=title;path;content-type;home-title&xhitlist_d=%7BSalr%7D&xhitlist_q=%5Bfield%20folio-destination-name:%27025246%27%5D&xhitlist_md=target-id=0-0-0-935http://jutastat.ukzn.ac.za/nxt/foliolinks.asp?f=xhitlist&xhitlist_x=Advanced&xhitlist_vpc=first&xhitlist_xsl=querylink.xsl&xhitlist_sel=title;path;content-type;home-title&xhitlist_d=%7BSalr%7D&xhitlist_q=%5Bfield%20folio-destination-name:%27013310%27%5D&xhitlist_md=target-id=0-0-0-15279http://jutastat.ukzn.ac.za/nxt/foliolinks.asp?f=xhitlist&xhitlist_x=Advanced&xhitlist_vpc=first&xhitlist_xsl=querylink.xsl&xhitlist_sel=title;path;content-type;home-title&xhitlist_d=%7BSalr%7D&xhitlist_q=%5Bfield%20folio-destination-name:%27981300%27%5D&xhitlist_md=target-id=0-0-0-1913http://jutastat.ukzn.ac.za/nxt/foliolinks.asp?f=xhitlist&xhitlist_x=Advanced&xhitlist_vpc=first&xhitlist_xsl=querylink.xsl&xhitlist_sel=title;path;content-type;home-title&xhitlist_d=%7BSalr%7D&xhitlist_q=%5Bfield%20folio-destination-name:%27621800%27%5D&xhitlist_md=target-id=0-0-0-14665http://jutastat.ukzn.ac.za/nxt/foliolinks.asp?f=xhitlist&xhitlist_x=Advanced&xhitlist_vpc=first&xhitlist_xsl=querylink.xsl&xhitlist_sel=title;path;content-type;home-title&xhitlist_d=%7BSalr%7D&xhitlist_q=%5Bfield%20folio-destination-name:%27035281%27%5D&xhitlist_md=target-id=0-0-0-12253http://jutastat.ukzn.ac.za/nxt/foliolinks.asp?f=xhitlist&xhitlist_x=Advanced&xhitlist_vpc=first&xhitlist_xsl=querylink.xsl&xhitlist_sel=title;path;content-type;home-title&xhitlist_d=%7BSalr%7D&xhitlist_q=%5Bfield%20folio-destination-name:%279841127%27%5D&xhitlist_md=target-id=0-0-0-1677http://jutastat.ukzn.ac.za/nxt/foliolinks.asp?f=xhitlist&xhitlist_x=Advanced&xhitlist_vpc=first&xhitlist_xsl=querylink.xsl&xhitlist_sel=title;path;content-type;home-title&xhitlist_d=%7BSalr%7D&xhitlist_q=%5Bfield%20folio-destination-name:%279841127%27%5D&xhitlist_md=target-id=0-0-0-1677http://jutastat.ukzn.ac.za/nxt/foliolinks.asp?f=xhitlist&xhitlist_x=Advanced&xhitlist_vpc=first&xhitlist_xsl=querylink.xsl&xhitlist_sel=title;path;content-type;home-title&xhitlist_d=%7BSalr%7D&xhitlist_q=%5Bfield%20folio-destination-name:%27024843%27%5D&xhitlist_md=target-id=0-0-0-8703http://jutastat.ukzn.ac.za/nxt/foliolinks.asp?f=xhitlist&xhitlist_x=Advanced&xhitlist_vpc=first&xhitlist_xsl=querylink.xsl&xhitlist_sel=title;path;content-type;home-title&xhitlist_d=%7BSalr%7D&xhitlist_q=%5Bfield%20folio-destination-name:%27024843%27%5D&xhitlist_md=target-id=0-0-0-8703http://jutastat.ukzn.ac.za/nxt/foliolinks.asp?f=xhitlist&xhitlist_x=Advanced&xhitlist_vpc=first&xhitlist_xsl=querylink.xsl&xhitlist_sel=title;path;content-type;home-title&xhitlist_d=%7BSalr%7D&xhitlist_q=%5Bfield%20folio-destination-name:%27993191%27%5D&xhitlist_md=target-id=0-0-0-3261http://jutastat.ukzn.ac.za/nxt/foliolinks.asp?f=xhitlist&xhitlist_x=Advanced&xhitlist_vpc=first&xhitlist_xsl=querylink.xsl&xhitlist_sel=title;path;content-type;home-title&xhitlist_d=%7BSalr%7D&xhitlist_q=%5Bfield%20folio-destination-name:%27041396%27%5D&xhitlist_md=target-id=0-0-0-1083http://jutastat.ukzn.ac.za/nxt/foliolinks.asp?f=xhitlist&xhitlist_x=Advanced&xhitlist_vpc=first&xhitlist_xsl=querylink.xsl&xhitlist_sel=title;path;content-type;home-title&xhitlist_d=%7BSalr%7D&xhitlist_q=%5Bfield%20folio-destination-name:%27002674%27%5D&xhitlist_md=target-id=0-0-0-1573http://jutastat.ukzn.ac.za/nxt/foliolinks.asp?f=xhitlist&xhitlist_x=Advanced&xhitlist_vpc=first&xhitlist_xsl=querylink.xsl&xhitlist_sel=title;path;content-type;home-title&xhitlist_d=%7BSalr%7D&xhitlist_q=%5Bfield%20folio-destination-name:%2761165%27%5D&xhitlist_md=target-id=0-0-0-15281http://jutastat.ukzn.ac.za/nxt/foliolinks.asp?f=xhitlist&xhitlist_x=Advanced&xhitlist_vpc=first&xhitlist_xsl=querylink.xsl&xhitlist_sel=title;path;content-type;home-title&xhitlist_d=%7BSalr%7D&xhitlist_q=%5Bfield%20folio-destination-name:%27581474%27%5D&xhitlist_md=target-id=0-0-0-15283http://jutastat.ukzn.ac.za/nxt/foliolinks.asp?f=xhitlist&xhitlist_x=Advanced&xhitlist_vpc=first&xhitlist_xsl=querylink.xsl&xhitlist_sel=title;path;content-type;home-title&xhitlist_d=%7BSalr%7D&xhitlist_q=%5Bfield%20folio-destination-name:%27953391%27%5D&xhitlist_md=target-id=0-0-0-1011http://jutastat.ukzn.ac.za/nxt/foliolinks.asp?f=xhitlist&xhitlist_x=Advanced&xhitlist_vpc=first&xhitlist_xsl=querylink.xsl&xhitlist_sel=title;path;content-type;home-title&xhitlist_d=%7BSalr%7D&xhitlist_q=%5Bfield%20folio-destination-name:%27025511%27%5D&xhitlist_md=target-id=0-0-0-15285http://jutastat.ukzn.ac.za/nxt/foliolinks.asp?f=xhitlist&xhitlist_x=Advanced&xhitlist_vpc=first&xhitlist_xsl=querylink.xsl&xhitlist_sel=title;path;content-type;home-title&xhitlist_d=%7BSalr%7D&xhitlist_q=%5Bfield%20folio-destination-name:%27831986%27%5D&xhitlist_md=target-id=0-0-0-1073http://jutastat.ukzn.ac.za/nxt/foliolinks.asp?f=xhitlist&xhitlist_x=Advanced&xhitlist_vpc=first&xhitlist_xsl=querylink.xsl&xhitlist_sel=title;path;content-type;home-title&xhitlist_d=%7BSalr%7D&xhitlist_q=%5Bfield%20folio-destination-name:%27814763%27%5D&xhitlist_md=target-id=0-0-0-6451http://jutastat.ukzn.ac.za/nxt/foliolinks.asp?f=xhitlist&xhitlist_x=Advanced&xhitlist_vpc=first&xhitlist_xsl=querylink.xsl&xhitlist_sel=title;path;content-type;home-title&xhitlist_d=%7BSalr%7D&xhitlist_q=%5Bfield%20folio-destination-name:%27025246%27%5D&xhitlist_md=target-id=0-0-0-935


11/74


12/74

o% t(e )arties invoved are on re&ord and it is t(us not ne&essar5 to : re)eat t(ese in t(isudgment e6&e)t to sa5 t(at a t(e a))i&ants are retaiers in medi&ine and reatedsustan&es in t(e )(arma&euti&a industr5 :ot( a))i&ations !ere (eard on 17 and 18June 2004 e%ore t(e Fu Court o% t(is ivision A%ter (earing argument 5 t(e )artiesinvoved, udgment !as reserved '(at %oo!s is m5 udgment on t(e issues in dis)uteC

?(e reie% soug(t

B3 ?(e reie% soug(t in ot( a))i&ations is an order revie!ing and setting aside t(ere&ommendation made 5 t(e *ri&ing Committee to t(e %irst res)ondent in terms o% s

22+2- o% t(e A&t and )ursuant to !(i&( t(e reguations, !(i&( are t(e sue&t o% a&(aenge in ot( a))i&ations, !ere )uis(ed t(e re&ommendations- ?(e se&ond ego% t(e reie% soug(t is t(e order de&aring some o% t(e )rovisions o% t(e reguations to einvaid and o% no %or&e and e%%e&t on various grounds !(i&( !i identi%5 in t(e &ourse o%t(is udgment

B4 As regards t(e %irst eg o% t(e reie% soug(t, name5, t(e revie! and t(e setting aside

o% t(e re&ommendation o% t(e *ri&ing = Committee, t(e a))i&ants seek to (ave t(eserevie!ed and set aside on t(e %oo!ing asis, name5 t(atE

B41 ?(e *ri&ing Committee !as not a!a5s )ro)er5 &onstituted during its deierations andde&isions made F

B42 ?(e *ri&ing Committee ao!ed )ersons outside t(e &ommittee to )arti&i)ate in itsdeierations

B43 ?(e *ri&ing Committee ao!ed its deierations to e materia5 in%uen&ed t(roug(

a&tive )arti&i)ation 5 su&( ot(er )ersons +

B44 ?(e *ri&ing Committee did not re&eive a materia re)resentations %rom t(estake(oders

B4 ?(e *ri&ing Committee took into a&&ount irreevant &onsiderations and %aied to take

reevant &onsiderations into a&&ount

B4 ?(e *ri&ing Committee a&ted aritrari5 in t(e determination o% !(at it &onsidered ana))ro)riate dis)ensing %ee

B47 ?(e *ri&ing Committee, in making re&ommendations to t(e %irst res)ondent as it did,)er%ormed an administrative a&t !it(in t(e meaning o% t(e de%inition o% t(eadministrative a&tion

1

B :e&ause o% t(e a%oregoing, so t(e a))i&ants &ontend in t(eir )a)ers andsumissions, t(e resutant re&ommendations made to t(e %irst res)ondent aremateria5 %a!ed and, %or t(is reason, t(e re&ommendation

2005 (2) SA p512

D=$ J

is sus&e)tie to revie! and s(oud e set aside ?(e a))i&ants %urt(er &ontend in t(eir)a)ers t(at t(e a&tivities o% t(e A *ri&ing Committee, in %u%iing its %un&tions, &uminating

in re&ommendations to t(e %irst res)ondent, &onstitute an administrative a&tion !it(int(e meaning o% t(e *romotion o% Administrative Justi&e A&t 3 o% 2000

B As regards t(e se&ond eg o% t(e reie% soug(t, name5, t(e : revie! and setting asideo% t(e reguations, t(e a))i&ants &ontend t(at an5 su&&ess%u atta&k on t(ere&ommendations inevita5 eads to t(e invaidit5 o% t(e reguations as !e ?(e vaidit5


13/74

o% t(e reguations is %urt(er atta&ked on t(e asis t(at, some o% t(e reguations, !(i&(t(e a))i&ants identi%5 in t(e *A a))i&ation, are C so vague and un&ertain as to rendert(ose as)e&ts o% t(e reguations identi%ied unen%or&eae and in&a)ae o% a))i&ation

?(e *ri&ing Committee

B7 ?(e *ri&ing Committee is a statutor5 &ommittee a))ointed 5 t(e %irst res)ondentin terms o% s 22+1- o% t(e A&t

2 n terms o% s 22+2- o% t(e A&t, t(e %irst res)ondent ma5, on t(e re&ommendation o%t(e *ri&ing Committee, make reguations on t(e introdu&tion o% a trans)arent )ri&ings5stem %or a medi&ines and s&(edued sustan&es sod in t(e #e)ui&; an a))ro)riatedis)ensing %ee to e &(arged 5 a )(arma&ist = and an a))ro)riate %ee to e &(arged 5!(oesaers or distriutors or an5 ot(er )erson seing &(edue 0 medi&ines(a)(b) (a)(c)

3 From t(e reading o% s 22+2- it is t(us &ear t(at t(e %irst res)ondent &annot makereguations ot(er t(an on t(e re&ommendation o% t(e *ri&ing Committee

?(e reguations F

B8 (ave aread5 made a )oint in )ara B3 t(at in terms o% s 22+2- o% t(e A&t t(e %irstres)ondent ma5, on t(e re&ommendation o% t(e *ri&ing Committee, make reguations ona t(ose as)e&ts s)e&i%ied in su)aras (a) , (b) and (c) t(ereo% ?(e reguations&ontem)ated in t(e a%orementioned se&tion !ere )romugated 5 t(e %irst res)ondenton + 30 A)ri 2004'er +overnment oti&e #3 )uis(ed in Government Gazette 2304dated 30 A)ri 2004

B9 ?(e a))i&ants &(aenge t(e vaidit5 o% &ertain )rovisions o% t(ese reguations on t(e

asis t(atE 2005 (2) SA p513

D=$ J

B91 ?(e reguations do not in&ude a singe e6it )ri&e A

B92 ?(e reguations give t(e ire&tor"+enera a dis&retion t(at is not )ermitted 5 t(e

em)o!ering )rovision

B93 ?(at &ertain )rovisions o% t(e reguations are vague and un&ertain

B94 ?(at t(e )ri&ing s5stem set u) 5 t(e reguations is not trans)arent :

B9 ?(at t(ose as)e&ts o% t(e reguations t(at )rovide %or an in&rease in t(e singe e6it

)ri&e are vague, un&ertain and ultra vires

:e%ore &onsidering t(e merits o% t(ese various ases o% atta&k, ot( on C t(e a&tivities o%t(e *ri&ing Committee and t(e vaidit5 o% t(e reguations t(emseves, it is ne&essar5 to&onsider a rie% (istor5 and t(e %a&tua a&kground !(i&( )re&eded t(e amendment tot(e A&t and t(e reguations )romugated t(ereunder

:rie% overvie! o% t(e various &ommissions, studies and re)orts on t(e saes and

trans)aren&5 in t(e %i6ing o% )ri&es o% medi&ine

The Steen-am' &ommission

B10 ?(e teenkam) Commission


14/74

4 !as estais(ed 5 t(e tate *resident in 197 to en>uire into, re)ort and makere&ommendations on as)e&ts reating to t(e manu%a&ture and = marketing o%)(arma&euti&a materias and )rodu&ts, !it( s)e&ia re%eren&e to, inter alia , t(e )ri&estru&ture o% )(arma&euti&a )rodu&ts, t(e in&rease in )ri&es and ot(er %a&tors, usagesand )ra&ti&es a%%e&ting t(e )ri&es o% su&( )rodu&ts !it( a vie! to &omating t(e trend o%in&reasing t(e )ri&es o% )(arma&euti&a )rodu&ts F

B11 ?(e Commission, %oo!ing its en>uir5, re&ommended t(at measures to redu&e or

&ontain t(e rise in &ost o% (eat( &are, as o))osed to t(e eve o% medi&ine )ri&es, on5s(oud e taken

The Brone &ommission o# $n=uiry +

B12 use>uent to t(e teenkam) #e)ort, t(e :ro!ne Commission

!as set u) to in>uire into t(e range and &osts stru&ture o% (eat( servi&es in t(e )ui&and )rivate se&tor in t(e #e)ui& o% out( A%ri&a !it( s)e&i%i& re%eren&e to, inter alia ,t(e &osts o% )(arma&ists in t(e &ondu&t o% t(eir )ra&ti&es and t(e )ro%it margins ondis)ensing and on &ommodities ?(e Commission %ound t(at t(ere (ad een a

&onsiderae in&rease in t(e &ost o% )(arma&euti&a )rodu&ts over t(e 5earsbid

?(ere (as aso een a stud5 into t(e e%%e&tiveness o% Finan&ing and eivering eat(Care in t(e #e)ui& o% out( A%ri&a undertaken 5 r ' J de


15/74

a%%ordaiit5 o% medi&ine and reated sustan&es ?(e &osts o% medi&ine and reatedsustan&es (ad rea&(ed a )oint !(ere a de&reased numer o% t(e memers o% t(e)o)uation &oud a&&ess (eat( &are + ?(ings (ad to &(ange %or t(e etter

2005 (2) SA p515

D=$ J

B1 ?(e %o&us on t(e rig(t to (eat( &are and, !it( it, a A &ommitted dut5 on t(e tate

to )rovide (eat( &are, %irst mani%ested itse% in s 21- (b) o% t(e Constitution o% t(e#e)ui& o% out( A%ri&a A&t 200 o% 1993,(a)(b) medical treatment at State e5'ense

13 &ommon5 re%erred to as t(e interim Constitution Gnike t(e %ina Constitution, t(einterim Constitution did not )rovide, as a matter o% a sustantive rig(t, a %undamentarig(t to (eat( &are, %ood, !ater and so&ia se&urit5 :

B1 $n&e t(e interim Constitution &ame into %or&e, a series o% measures aimed atmaking (eat( &are a%%ordae !ere taken and t(ese in&uded t(e signature 5 out(

A%ri&a o% t(e nternationa Convenant on =&onomi&, o&ia and Cutura #ig(ts, 19(a)14 on 3 $&toer 1994; t(e C estais(ment o% t(e ationa rug *oi&5 Committee in

e)temer 1994 and t(e suse>uent ado)tion o% t(e ationa rug *oi&5 %or out(A%ri&a

1 C(a)ter 4 o% t(e )oi&5 deas !it( t(e rationaisation o% t(e )ri&ing stru&ture o%medi&ines; envisages t(e a))ointment o% a *ri&ing Committee !it( &ear5 de%ined%un&tions to monitor and reguate drug )ri&es; tota trans)aren&5 in t(e )ri&ingstru&ture o% )(arma&euti&a manu%a&turers, !(oesaers, )roviders o% servi&es su&( asdis)ensers o% drugs as !e as )rivate &ini&s and (os)itas; introdu&tion o% non"dis&riminator5 )ri&ing s5stem, t(e aois(ment o% t(e t(en !(oesae and retai mark"u)s5stem and t(e re)a&ement t(ereo% !it( a )ri&ing s5stem ased on a %i6ed = )ro%essiona%ee ?(e ationa rug *oi&5 !as, amongst ot(er t(ings, in%ormed and guided 5 t(e

need not on5 to address and redressing t(e ega&5 o% t(e )ast, ut aso a need to)romote e>uit5, a&&essiiit5 and use o% (eat( &are servi&es 5 !a5 o% &ontro o% )ri&es

o% medi&ine and reated sustan&es F

B17 ?(e Constitution o% t(e #e)ui& o% out( A%ri&a1 !as ado)ted 5 t(e Constitutiona Assem5 on 8 .a5 199 ?(e amended te6t, du5&erti%ied 5 t(e Constitutiona Court, !as ado)ted on 11 $&toer 199 t is a matter o%)ui& kno!edge t(at t(e Constitution &ame into e%%e&t on 8 Feruar5 1997 ?(e&ommitment to making (eat( + &are avaiae, eit(er at t(e tate e6)ense or ata%%ordae )ri&es mani%ested itse% 5 !a5

2005 (2) SA p51

D=$ J

o% a guarantee to ever5one o% a rig(t o% a&&ess to (eat( &are servi&es as )rovided in s27 o% t(e A Constitution

B18 e&tion 27 o% t(e Constitution )rovidesE1- =ver5one (as t(e rig(t to (ave a&&ess to "

(a) (eat( &are servi&es, in&uding re)rodu&tive (eat( &are;

(b) su%%i&ient %ood and !ater; and :

(c) so&ia se&urit5, in&uding, i% t(e5 are unae to su))ort t(emseves and t(eir de)endants, a))ro)riate so&iaassistan&e

2- ?(e tate must take reasonae egisative and ot(er measures !it(in its avaiae resour&es, to a&(ieve

t(e )rogressive reaisation o% ea&( o% t(ese rig(ts


16/74

3- o one ma5 e re%used emergen&5 medi&a treatment C

?(e deveo)ment o% t(e ationa rug *oi&5 !as a )re&ursor to!ards t(e reaisation andentren&(ment o% a %undamenta rig(t to (eat( &are

B19 use>uent egisative measures, eing t(e .edi&ines and #eated ustan&es

Contro Amendment A&t17 !(i&( !i in t(e &ourse o% t(is udgment e re%erred to as t(e First Amendment A&t-

and t(e .edi&ines and #eated ustan&es Amendment A&t18 to !(i&( s(a re%er to as t(e e&ond Amendment A&t, s(oud a need arise to re%er

to t(is atter )ie&e o% egisation- !ere ado)ted ?(e egisative )rogramme (ave ustre%erred to mani%ests a &ear &ommitment on t(e )art o% t(e tate o% a need to takeste)s to make = medi&ine more a&&essie to ever5one t !as !it( a vie! to reaisingt(is oe&tive t(at t(e A&t !as amended, initia5 5 !a5 o% t(e First Amendment A&tand, suse>uent5, 5 !a5 o% t(e e&ond Amendment A&t t is !it( t(is a&kground inmind t(at !i seek to determine t(e issues in dis)ute amongst t(e )arties

B20 (ave aread5 made a )oint ese!(ere in t(is udgment t(at F t(e a))i&ants

)rimar5 areas o% atta&k are on t(e a&tivities o% t(e *ri&ing Committee in %u%iing its%un&tions; t(e vaidit5 o% t(e suse>uent re&ommendations made to t(e %irst res)ondent

and t(e reguations )romugated 5 t(e %irst res)ondent &onse>uent to a&&e)tan&e o%su&( re&ommendations +

?(e *ri&ing Committee

B21 *ursuant to t(e )rovisions o% s 22+1- o% t(e A&t t(e %irst res)ondent a))ointed

memers o% t(e *ri&ing Committee on nominations re&eived in res)onse to a )ui&noti&e &aing %or su&( nominations ?(e *ri&ing Committee does not (ave an5

stake(oder re)resentation and memers(i) is ased on ea&( memers e6)ertise

B22 $n&e a))ointed, t(e Committee ado)ted its )ro&edure %or t(e &ondu&t o% itsmeetings

19 ?(is )ro&edure, amongst ot(er t(ings, reated to times and )a&es !(ere t(e Committee !oud (od its meetings, t(e >uorum at su&( meetings, !(i&( t(e Committeedetermined !oud e a

2005 (2) SA p51

D=$ J

maorit5 o% memers )resent and t(at t(e de&isions o% t(e Committee !oud e taken 5&onsensus and t(at, A !(ere &onsensus &annot e attained, 5 resoution o% t(e maorit5o% memers )resent at t(e meeting

B23 $n&e a))ointed, t(e Committee &onsidered its maor task to e t(at o% )re)aring

re&ommendations 5 !a5 o% dra%t reguations ?(ese : re&ommendations !ere )re)ared5 t(e Committee and sumitted to t(e %irst res)ondent %or a&&e)tan&e $n&e t(e

re&ommendations !ere a&&e)ted 5 t(e %irst res)ondent, t(ese !ere )uis(ed %or&omment in t(e %orm o% dra%t reguations'er +overnment oti&e #37 )uis(ed inGovernment Gazette 2912 o% 1 Januar5 2004 ?(e dra%t reguations !ere )uis(edunder &over o% a noti&e C &aing on interested )ersons to sumit !ritten &omments andre)resentations on t(e dra%t reguations to t(e ire&tor"+enera o% t(e e)artment o%eat( Comments and re)resentations (ad to e sumitted !it(in t(ree mont(s o% t(edate o% )ui&ation o% t(e dra%t reguations nterested )ersons, as did t(e a))i&ants int(ese )ro&eedings, sumitted !ritten &omments and re)resentations as re>uired 5 t(e

invitation


17/74

?(e ora sumisssions

B24 $n&e t(e dra%t reguations !ere )uis(ed, an invitation !as sent to a stake(oders!(o !ere re>uested to sumit !ritten sumissions or re)resentations ?(e stake(oders!ere %urt(er re>uested = to make ora sumissions on t(eir !ritten sumissions or

re)resentations s(oud t(e5 desire to do so ?(is invitation !as sent 5 t(e o%%i&e o% t(eire&tor"+enera o% t(e e)artment o% eat(

20 ?(e se&ond )aragra)( o% t(e etter o% invitation reads as %oo!sE F?(e de)artment (as de&ided t(at it !oud e ene%i&ia to invite stake(oders to make ora re)resentations on

t(eir !ritten &omments on t(ese )ro)osed reguations ue to severe time &onstraints and in order to o)timise

t(e vaue o% t(e ora )resentations t(e %oo!ing &onditions !i e stri&t5 a))ied

?(e invitation t(en goes on to enumerate a numer o% &onditions !(i&( !oud e

a))i&ae in making su&( ora )resentations +

B2 ?(ere is a dis)ute as regards t(e nature o% t(e meetings (ed !(en su&( ora)resentations !ere made ?(e a))i&ants &ontend t(at su&( ora )resentations !ere

made at t(e meetings o% t(e *ri&ing Committee !(ist t(e atter maintains t(at su&()resentations !ere made at meetings arranged 5 t(e e)artment and not at t(e

meetings o% t(e *ri&ing Committee at(oug( some memers o% t(e *ri&ing Committee didattend su&( ora re)resentations ?(e a))i&ants go %urt(er to sa5 in t(eir )a)ers t(atE-uring t(e &ourse o% su&( meetings, t(e )ersons )ur)orting to re)resent t(e *ri&ing Committee !oud &ome

into t(e (earing and go out o% t(e (earing at !i; t(at t(ere !as no staiit5 at su&( meetings; t(at t(e

meetings !ere (ed

2005 (2) SA p514

D=$ Jin%orma5 as to suggest t(ere !as no )ro)er5 &onstituted &ommittee istening to t(e re)resentations; t(at A it

!as &ear at t(ese meetings t(at t(e *ri&ing Committee !as not a!a5s )ro)er5 &onstituted and t(at in vie!

t(ereo% !(atever re&ommendations !ere made 5 t(e )ri&ing Committee to t(e %irst res)ondent &an (ard5 e

said to (ave een a re&ommendation o% t(e *ri&ing Committee a&ting inde)endent5 as &ontem)ated in s

22+2- o% t(e e&ond Amendment A&t :

s(a return ater to t(is dis)ute in t(e &ourse o% t(is udgment

B2 $n&e t(e *ri&ing Committee (ad %u%ied its %un&tions, it made t(e re>uiredre&ommendations to t(e %irst res)ondent on a su&( matters as &ontem)ated in s22+2- (a) , (b) and (c) o% t(e A&t ?(e %irst res)ondent, a%ter C &onsidering t(ere&ommendations, reverted to t(e Committee on su&( as)e&ts o% t(e re&ommendations!(i&( reated to t(e issue o% an a))ro)riate dis)ensing %ee %or )(arma&ists and t(etiming o% t(e sumission o% in%ormation reating to t(e singe e6it )ri&e 5 t(emanu%a&turers and im)orters to t(e ire&tor"+enera $n&e t(e Committee addressedt(e issues raised 5 t(e %irst res)ondent, it t(e Committee- on&e again sumitted its

re&ommendations to t(e %irst res)ondent $n t(is o&&asion t(e %irst res)ondent a&&e)tedt(e re&ommendations, !(i&( !ere in t(e %orm o% dra%t reguations ?(e

re&ommendations, in t(e %orm in !(i&( t(e5 !ere, !ere )uis(ed in t(e GovernmentGazette o% 30 A)ri 2004 to &onstitute t(e reguations !(i&( are )art o% t(e sue&t o%atta&k 5 t(e a))i&ants = ?(e reguations !ere )uis(ed in Government Gazette 2304and took e%%e&t on 2 .a5 2004

B27 t is t(ese re&ommendations, !(i&( t(e *ri&ing Committee sumitted to t(e %irst

res)ondent and !(i&(, on a&&e)tan&e and suse>uent )ui&ation t(ereo% in t(eGovernment Gazette F &onstituted t(e reguations under atta&k, t(at t(e a))i&ants seekto (ave revie!ed and set aside

?(e atta&k on t(e re&ommendations o% t(e *ri&ing Committee


18/74

B28 (ave aread5 made a )oint ese!(ere in t(is udgment t(at t(e *ri&ing Committeeis a))ointed 5 t(e %irst res)ondent in terms o% s 22+1- o% t(e A&t #eguation 381- o%t(e +enera + #eguations, eing reguations )uis(ed in +overnment oti&e #10 o% 10A)ri 2003, )romugated in terms o% t(e A&t, )rovides %or t(e &om)osition o% t(e *ri&ingCommittee #eguation 381- o% t(e a%orementioned reguations )rovides as %oo!sE?(e *ri&ing Committee &ontem)ated in s 22+ o% t(e A&t s(a &onsist o% no more t(an 18 memers, ut s(ain&ude "

(a) one )erson nominated 5 t(e .inister o% Finan&e;

(b) one )erson nominated 5 t(e .inister o% ?rade and ndustr5;

(c) one or more )ersons re)resenting t(e e)artment o% eat(;

(d) at east one )erson !it( a&kground in )(arma&oog5;

(e) at east one )erson !it( a&kground in a!;

(#) at east one )erson !it( a&kground !it( a&ademi&a medi&a resear&(;

(g) at east t!o )ersons !it( e&onomi&s a&kground, one o% !(om must e a (eat( e&onomist; and

(h) at east one )erson re)resenting inde)endent )atient and &onsumer grou)s

B29 ?(e re&ommendations are atta&ked 5 t(e a))i&ants on t(e asis t(at t(e5 are

%a!ed in t(at, in t(e )ro&ess o% t(eir %ormuation, t(e J2005 (2) SA p51

D=$ J

*ri&ing Committee %aied to take reevant A &onsiderations into a&&ount; t(at t(e *ri&ingCommittee took irreevant &onsiderations into a&&ount; t(at t(e *ri&ing Committee, int(e determination o% su&( issues as t(e singe e6it )ri&e and an a))ro)riate dis)ensing

%ee, a&ted aritrari5 and &a)ri&ious5 and t(at t(e *ri&ing Committee did not re&eive amateria re)resentations ?(e a))i&ants t(en go on to &ontend t(at t(e &ondu&t o% t(e

*ri&ing : Committee, in a&ting in t(e manner it did, &onstitutes an administrative a&t!it(in t(e meaning o% t(e *romotion o% Administrative Justi&e A&t ?(e a))i&ants %urt(er

&ontend t(at i% t(e )rovision o% t(e *romotion o% Administrative Justi&e A&t do not a))5,t(en t(e re&ommendations &oud nevert(eess e &(aenged on t(e asis o% t(e &ommona!; t(e )rin&i)e o% egait5 &ontem)ated in s 1 (c) o% t(e Constitution and as !e as ont(e asis o% C s 331- o% t(e ust administrative a&tion &ause amongst ot(er reevant)rovisions o% t(e Constitution

oes t(e &ondu&t o% t(e *ri&ing Committee &onstitute administrative a&tionH

B30 For t(e &ondu&t o% t(e *ri&ing Committee to &onstitute an administrative a&tion asagainst t(e a))i&ants, t(ere oug(t to e6ist an administrative a! reations(i) ased on

aut(oritative )o!er ?(is reations(i) en&om)asses an eement o% suordination on t(eoe&t o% = su&( administrative a! reations(i) !(i&(, in t(e instan&e o% t(ese)ro&eedings, oug(t to e t(e a))i&ants Gse o% t(e aut(oritative )o!er )resu))oses t(eadministrative a! reations(i) et!een t(e organ o% tate, as t(e sue&t o% t(eadministrative a! reations(i) and t(e oe&t, !(i&( &oud eit(er e an individua or agrou) o% individuas as t(e oe&ts o% su&( reations(i)Administrative !a Administrative !a under the ?@@ &onstitution21 F

B31 ?(e aut(oritative od5 !oud e in a su)erior )osition visCvis t(e ot(er )art5 tot(is administrative a! reations(i), t(at is, t(e reations(i) o% suordination ?(ereations(i) is &(ara&terised 5 aut(oritative )o!er on t(e )art o% t(e organ o% tate and

t(e eement o% suordination on t(e )art o% t(e + individua or grou)s o% individuas ?(e


19/74

e%%e&ts o% t(e aut(oritative )o!er (ave to e %et 5 t(e individua or grou) o%individuas '(at (ave rie%5 stated in t(is and t(e )re&eding )aragra)(, is !(at usedto e t(e &ommon a! )osition )rior to t(e advent o% &onstitutiona su)rema&5 n t(easen&e o% su&( administrative a! reations(i), t(e &ondu&t o% t(e *ri&ing Committee&annot &onstitute an administrative a&tion as against t(e a))i&ants

B32 n t(e &urrent &onstitutiona order t(is administrative a! reations(i) is reguated5 s 33 o% t(e Constitution e&tion 33 o% t(e Constitution )rovides t(at udi&ia revie!

ies against administrative a&tion on5 ?(is se&tion, under (eading Just AdministrativeA&tion )rovides as %oo!sE

2005 (2) SA p550

D=$ J1- =ver5one (as t(e rig(t to administrative a&tion t(at is A a!%u, reasonae and )ro&edura5 %air

2- =ver5one !(ose rig(ts (ave een adverse5 a%%e&ted 5 administrative a&tion (as t(e rig(t to e given!ritten reasons

3- ationa egisation must e ena&ted to give e%%e&t to t(ese rig(ts and must "

(a) )rovide %or t(e revie! o% administrative a&tion 5 a : &ourt or, !(ere a))ro)riate, an inde)endent and im)artiatriuna;

(b) im)ose a dut5 on t(e state to give e%%e&t to t(e sig(ts in ss 1- and 2-; and

(c) )romote e%%i&ient administration

?(e &on&e)t administrative a&tion is not de%ined in t(e ust administrative a&tion &auseC

B33 n ine !it( t(e &onstitutiona im)erative in ss 3- o% t(e administrative usti&e&ause, *ariament ena&ted and )assed into a! t(e *romotion o% Administrative Justi&e

A&t 3 o% 2000 ?(e *romotion o% Administrative Justi&e A&t de%ines administrative a&tionin ss 1- t(ereo% as %oo!sE

administrative a&tion means an5 de&ision taken, or an5 %aiure to take a de&ision 5 "(a) an organ o% tate !(en "

i- e6er&ising a )o!er in terms o% t(e Constitution or a )rovin&ia &onstitution; or

ii- e6er&ising a )ui& )o!er or )er%orming a )ui& %un&tion in terms o% an5 egisation; or =

(b) natura or uristi& )erson, ot(er t(an an organ o% tate, !(en e6er&ising a )ui& )o!er o% )er%orming a )ui&%un&tion in terms o% an em)o!ering )rovision,

!(i&( adverse5 a%%e&ts t(e rig(ts o% an5 )erson and !(i&( (as a dire&t e6terna ega e%%e&t ut does not

in&ude " F

(aa) t(e e6e&utive )o!ers or %un&tions o% t(e ationa =6e&utive in&uding t(e )o!ers or %un&tions re%erred to in ss791- and 4-, 842- (a) , (b) , (c) , (d) , (#) , (g) , (h) , i-, and (-) , 82- (b) , (c) , (d) and (e) , 912-, 3-,4- and -, 923-, 93, 97, 98, 99 and 100 o% t(e Constitution;

(bb) t(e e6e&utive )o!ers or %un&tions o% t(e + *rovin&ia =6e&utive, in&uding t(e )o!ers re%erred to in ss 1211-and 2-, 122- (d) , (e) and (#) , 12, 1272-, 1322-, 1333- (b) , 137, 138, 139 and 141- o% t(eConstitution;

(cc) t(e e6e&utive )o!ers or %un&tions o% a muni&i)a &oun&i;

(dd) t(e egisative %un&tions o% *ariament, a )rovin&ia egisature or a muni&i)a &oun&i;

(ee) t(e udi&ia %un&tions o% a udi&ia o%%i&er o% a &ourt re%erred to in s 1 o% t(e Constitution or o% a )e&ia?riuna estais(ed under s 2 o% t(e )e&ia nvestigating Gnits and )e&ia ?riunas A&t 74 o% 199, and t(e

udi&ia %un&tions o% a traditiona eader under &ustomar5 a! or an5 ot(er a!;

(##) a de&ision to institute or &ontinue a )rose&ution;

(gg) a de&ision reating to an5 as)e&t regarding t(e a))ointment o% a udi&ia o%%i&er, 5 t(e Judi&ia ervi&e

Commission;


20/74

(hh) an5 de&ision taken or %aiure to take a de&ision in terms o% an5 )rovision o% t(e *romotion o% A&&ess ton%ormation A&t 2000; or

(ii) an5 de&ision taken or %aiure to take a de&ision in terms o% s 41-

B34 n terms o% t(is de%inition &ondu&t, in order to &onstitute administrative J

2005 (2) SA p55

D=$ J

a&tion as de%ined, (as to (ave a direct, e5ternal legal e##ect and (as to adversely A a##ectrights o% t(e individua or a grou) $n t(e %a&e o% it, it !oud a))ear t(at t(e de%inition o%administrative a&tion in s 1 o% t(e *romotion o% Administrative Justi&e A&t imits t(e

s&o)e o% administrative a&tion in s 33 o% t(e Constitution '(et(er su&( imitation&on%orms to t(e re>uirements o% t(e imitation &ause in s 3 o% t(e Constitution and t(us)asses muster, does not &a %or : determination in t(ese )ro&eedings

B3 From t(is de%inition, t(e %oo!ing eements o% t(e term administrative a&tion

emerge, name5EI a de&ision C

I t(at is o% an administrative nature

I made in terms o% t(e em)o!ering )rovision

I t(at is not s)e&i%i&a5 e6&uded 5 t(e A&t

I t(at adverse5 a%%e&ts rig(ts and

I t(at (as a dire&t, e6terna ega e%%e&t

B3 For t(e &ondu&t o% t(e *ri&ing Committee to e sue&t to revie! in terms o% s o%

t(e *romotion o% Administrative Justi&e A&t it (as to emod5 a t(e eementsenumerated in t(e )re&eding )aragra)( %aiing !(i&( t(e &ondu&t &om)ained o% &annot

e sue&t to revie! in terms o% t(e *romotion o% Administrative Justi&e A&t % t(e&ondu&t o% t(e *ri&ing Committee does not %a !it(in t(e amit o% t(e de%inition = o%administrative a&tion &ontained in s 1 o% t(e *romotion o% Administrative Justi&e A&t, t(eissue !(i&( !i t(en &a %or determination is !(et(er t(e &ondu&t o% t(e *ri&ingCommittee is e5ond udi&ia revie! A t(ese issues !i e determined in t(e &ourse o%t(is udgment

B37 ?o revert to t(e *ri&ing Committee, it !i e re&aed F t(at it is a &ommittee t(at

!as a))ointed and estais(ed in terms o% s 22+1- o% t(e A&t ts mandate !as to

%ormuate re&ommendations !(i&(, i% a&&e)ted, !oud enae t(e %irst res)ondent tomake reguations reating to t(e introdu&tion o% a trans)arent )ri&ing s5stem %or amedi&ines and s&(edued sustan&es sod in t(e #e)ui& and, on an a))ro)riatedis)ensing %ee to e &(arged 5 a )(arma&ist or + 5 a )erson i&ensed in terms o% s22+1- (a) o% t(e A&t n ine !it( its mandate t(e &ommittee did %ormuate t(e re>uiredre&ommendations !(i&( it sumitted to t(e %irst res)ondent %or a&&e)tan&e t !as %ort(e %irst res)ondent to eit(er a&&e)t or ree&t t(e re&ommendations as %ormuated t is

t(ese re&ommendations !(i&( are t(e sue&t o% a &(aenge 5 t(e a))i&ants on t(easis t(at t(e &ondu&t o% t(e *ri&ing Committee, in going aout %u%iing its %un&tions in

t(e %ormuation o% t(e re&ommendations, &onstitutes an administrative a&tion !it(in t(emeaning o% t(e term as &ontem)ated in s 1 o% t(e *romotion o% Administrative Justi&e

A&t

B38 For t(e &ondu&t o% t(e *ri&ing Committee to &onstitute an administrative a&tion


21/74

!it(in t(e meaning o% t(at term in terms o% t(e *romotion o% Administrative Justi&e A&t,not on5 s(oud it %a !it(in t(e amit o% t(at de%inition, ut, at t(e ver5 east, it !i(ave to &ontain t(ose eements (ave set out in )ara B3 o% t(is udgment ?(e most J

2005 (2) SA p552

D=$ J

im)ortant o% t(ese eements are, in m5 vie!, t(at t(e A re&ommendations s(oud

adverse5 a%%e&t rig(ts and s(oud (ave a dire&t e6terna ega e%%e&t venture tosuggest at t(is stage t(at su&( &ondu&t or a&tion s(oud a%%e&t t(e rig(ts o% t(e )erson

&on&erned dire&t5 rat(er t(an indire&t5

B39 $n&e t(e re&ommendations !ere %ormuated and sumitted to : t(e %irst res)ondent%or a&&e)tan&e, at t(at stage, t(at is )rior to a&&e)tan&e t(ereo% 5 t(e %irst res)ondent,t(e5 did not a%%e&t an5 one o% t(e a))i&ants e6isting rig(ts or egitimate e6)e&tationsdire&t5 u&( re&ommendations did not (ave an5 %or&e or e%%e&t on an5 one o% t(e

a))i&ants ?(ese !ere mere re&ommendations ?(e5 !ere not C inding on t(ea))i&ants and t(us &oud not e &onstrued as (aving (ad an5 dire&t, e6terna ega

e%%e&t ?(e a))i&ants did not %ee an5 e%%e&t o% t(e re&ommendations

B40 ?(e re&ommendations, )rior to t(e a&&e)tan&e t(ereo% 5 t(e %irst res)ondent, didnot im)ose an5 urden on t(e a))i&ants nor did t(e5, at t(at stage, remove rig(ts%rom an5 one o% t(e a))i&ants =ven i% one !ere to a&&e)t t(at t(e *ri&ing Committee isan organ o% state,(a)(b)

22 in m5 vie!, it &an (ard5 e &on&eivae t(at t(e %ormuation o% t(e re&ommendations!(i&( &an on5 (ave a %ina e%%e&t on&e )romugated into reguation &oud e said to

&onstitute e6er&ise o% )ui& )o!er ?(e dire&t, ega e%%e&t = &ontem)ated in t(ede%inition o% administrative a&tion &annot e &onditiona, in t(e sense o% )ending

a&&e)tan&e 5 t(e %irst res)ondent n m5 vie!, and on t(e grounds set out in t(is andt(e )re&eding )aragra)( aone, t(e &ondu&t and t(e a&tivities o% t(e *ri&ing Committee

&an (ard5 e &onstrued as &onstituting an administrative a&tion nor do su&( a&tivities%a !it(in t(e amit o% t(e de%inition o% administrative a&tion as de%ined in s 1 o% t(e F*romotion o% Administrative Justi&e A&t

B41 Furt(ermore, %or t(e a&tivities o% t(e *ri&ing Committee to &onstitute administrativea&tion, su&( &ondu&t, in terms o% t(e + de%inition o% administrative a&tion, s(oud (ave,

in as %ar as t(e a))i&ants are &on&erned, a dire&t ega e%%e&t For an5 a&tion to (ave adire&t e%%e&t, it ovious5 must a%%e&t t(e )erson &on&erned dire&t5 rat(er t(an indire&t5

ome !riters, in )arti&uar *e 1ille ,/udicial evie o# Administrative Action in South A#rica

23 are o% t(e vie! t(at dire&t e%%e&t re>uires %inait5 in t(e administration o% rig(ts, !(i&(

!oud e6&ude )reiminar5 ste)s in muti"staged de&isions ?(is !oud in&ude 2005 (2) SA p553

D=$ J

t(e making o% re)orts )rior to de&isions and an5 &ondu&t )re)arator5 to A t(e taking o% a

de&isionAdministrative /ustice Act Benchboo-*e 1ille o' cit24

B42 As regards t(e term ega e%%e&t, !(at t(is in m5 vie! !oud entai is t(at t(eadministrative a&tion or de&ision must e a ega5 inding determination o% individuarig(ts n ot(er !ords, t(e re&ommendations, to &onstitute an administrative a&tion,must eit(er : estais(, &(ange or !it(dra! e6isting rig(ts ?(e re&ommendations o% t(e


22/74

Committee do not (ave an5 o% t(ese attriutes ?(e )rin&i)es o% administrative usti&ea))5 to administrative a&tion on5 and t(e Committees re&ommendations %a s(ort o%t(is

B43 ?o t(e e6tent t(at t(e a))i&ants seek to (ave t(e C re&ommendations revie!ed andset aside in terms o% t(e *rovisions o% t(e *romotion o% Administrative Justi&e A&t, t(e

a))i&ants &(aenge on t(is ground &annot su&&eed %or t(e sim)e reason t(at t(e&ondu&t o% t(e Committee, &uminating in t(e re&ommendations, does not &onstitute an

administrative a&tion !it(in t(e meaning o% t(e *romotion o% Administrative Justi&e A&t

Are t(e %un&tions or t(e a&tivities o% t(e )ri&ing &ommittee revie!ae on ases ot(ert(an t(e )rovisions o% t(e Administrative Justi&e A&tH

B44 n t(e )re&eding )aragra)( determined t(at t(e %ormuation and = t(e sumissiono% t(e re&ommendations to t(e %irst res)ondent does not &onstitute an administrativea&tion in terms o% t(e )rovisions o% t(e *romotion o% Administrative Justi&e A&t ?(e

a))i&ants &ontend, as an aternative asis o% atta&k, t(at t(e Committees

re&ommendations are revie!ae on asis o% t(e &ommon a!, t(e administrative usti&e&ause and ot(er )rovisions o% t(e Constitution am in agreement !it( F t(is &ontention

B4 ?(e a&tivities and %un&tions o% t(e *ri&ing Committee are sue&t to t(e revie! ont(e )rin&i)es o% &ommon a!, t(e )rin&i)e o% egait5 as &ontem)ated in s 1 o% t(eConstitution, s 331- o% t(e Constitution and ot(er )rovisions o% t(e Constitution reatingto t(e + asi& vaues and )rin&i)es governing )ui& administration

2 ?(is is in ine !it( t(e )rin&i)es and t(e vision as set out in t(e '(ite *a)er onTrans#orming Public Service *elivery 1997- Batho Pele %hite Pa'er -2 As &orre&t5 )ointed out 5 .r "ale-a in (is sumissions and argument, t(e a))roa&(to e ado)ted in t(e revie! o% t(e Committees a&tivities, is to vie! t(e )ro&ess as an

integra s&(eme and not to treat it in a )ie&emea

2005 (2) SA p551

D=$ J

%as(ion ?(is a))roa&( !oud in&ude t(e revie! A o% t(e reguations t(emseves s(oud ite %ound t(at t(e5 too are revie!ae aving determined t(at t(e %un&tions and t(ea&tivities o% t(e *ri&ing Committee are not revie!ae in terms o% t(e )rovisions o% t(e

*romotion o% Administrative Justi&e A&t, ut t(at t(e5 are nevert(eess revie!ae interms o% t(e &ommon a! and ot(er reevant : )rovisions o% t(e Constitution, it is

)er(a)s a))ro)riate, at t(is stage, to make a determination !(et(er t(e reguationst(emseves are revie!ae in terms o% t(e )rovisions o% t(e *romotion o% AdministrativeJusti&e A&t, and, i% not, !(et(er t(e reguations are revie!ae on an5 ot(er asis

oes rue"making &onstitute an administrative a&t !it(in t(e C meaning o% t(e *romotiono% Administrative Justi&e A&tH

B4 ?(e a))i&ants &ontend in t(eir sumissions and aso vigorous5 did so in argument,

t(at t(e )romugation o% t(e reguations 5 t(e %irst res)ondent &onstitutes anadministrative a&tion !it(in t(e meaning o% t(e term in terms o% s 1 o% t(e *romotion o%

Administrative Justi&e A&t and t(at, in vie! t(ereo%, t(e reguations, as )romugated,are sue&t to revie! in terms o% t(e *romotion o% Administrative Justi&e A&tBato Star ishing (Pty) !td v "inister o# $nvironmental A##airs and Others

27 n advan&ing t(is argument, t(e a))i&ants &ontend t(at t(e de&ision 5 t(e *ri&ingCommittee to re&ommend t(e reguations, and t(e making o% t(e reguations 5 t(e %irstres)ondent &onstitutes an administrative a&tion as de%ined in t(e *romotion o%Administrative Justi&e A&t (ave aread5 determined t(at t(e &ondu&t o% t(e *ri&ing =

Committee, in )er%orming its %un&tions as it did, does not &onstitute an administrative


23/74

a&tion as de%ined in t(e *romotion o% Administrative Justi&e A&t and t(ere%ore t(e)er%orman&e o% its %un&tions and duties is not sue&t to revie! in terms o% t(e )rovisionso% t(e *romotion o% Administrative Justi&e A&t '(at remains to e determined t(oug( isF !(et(er t(e making o% t(e reguations 5 t(e %irst res)ondent &onstitutes anadministrative a&tion !it(in t(e meaning o% t(e *romotion o% Administrative Justi&e A&t

B47 ?o determine t(e >uestion !(et(er t(e making o% reguations &onstitutesadministrative a&tion as de%ined one (as

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