data exclusivity and public health under the trips agreement

7/21/2019 Data Exclusivity and Public Health under the TRIPS Agreement

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2/28


3/28

DA] 1

@APA DRHLTXIÎPY AO@ ]TJLIH BDALPB TO@DZ PBDPZI]XACZDDGDOP

KLAXT]K AKSKDYD *

Ajstraht

Pbd Acrddgdot ko Pra`d Zdlatd` Aspdhts kn Iotdlldhtual ]rkpdrty Zicbts (tbd PZI]XAcrddgdot) is tbd nirst iotdroatikoal acrddgdot tk sdt hdrtaio gioigug staoàr`s nkr

tbd prktdhtiko kn tdst àta sujgittd` tk oatikoal `ruc rdculatkry autbkritids io kr`drtk kjtaio garfdtioc apprkval nkr pbargahdutihals.1Pbis prktdhtiko bas hrdatd` a suicdodris prkpridtary ricbt io uoìshlksd` ionkrgatiko, afio tk a patdot ricbt. PbdPZI]X rdcigd nkr tdst àta prktdhtiko is alsk pkpularly fokwo as àta dxhlusivity,altbkucb tbdrd is skgd hkotrkvdrsy as tk wbdtbdr tbd PZI]X àta prktdhtikoprkvisikos ahtually dstajlisb a àta dxhlusivity rdcigd kr okt. Pbdrd bas jddo guhbhkohdro as tk tbd dnndht tbat tbd PZI]X nragdwkrf nkr tdst àta prktdhtiko gay bavdko ahhdss tk gdìhiods, dvdo tbkucb tbis issud bas okt ydt attrahtd` tbd sagd ldvdl knaha`dgih hkggdotary kr aoalysis io hkgparisko tk tbd igpaht kn tbd PZI]X patdotsrdcigd. Pbd staoàr` kn tdst àta prktdhtiko rdquird` jy tbd PZI]X Acrddgdot ao`tbd igplihatikos nkr ahhdss tk gdìhiods io `dvdlkpioc hkuotrids ard issuds tbat ard ydt

tk jd nully dxagiod` ao` uo`drstkk`.

Pbis artihld dxagiods tbd ldcal nragdwkrf nkr tdst àta prktdhtiko uo`dr tbd PZI]XAcrddgdot ao` tbd kjlicatikos it hrdatds nkr Gdgjdr Xtatds io rdlatiko tk àtadxhlusivity. It iovdsticatds tbd dxtdot tk wbihb tbd PZI]X tdst àta prktdhtikordquirdgdots igpksd ndttdrs ko hkgpulskry lihdosioc ao` tbd qudstiko kn wbdtbdr tbdricbt tk fddp uoìshlksd` ionkrgatiko hkoni`dotial hao jd ìspdosd` witb tbrkucb tbdhkgpulskry lihdosioc gdhbaoisg. Pbd artihld hkosi`drs tbd hkoodhtiko jdtwddo tdstàta prktdhtiko ao` tbd odd` tk sandcuar` pujlih bdaltb, witb partihular nkhus ko tbdigplihatikos nkr ahhdss tk gdìhiods io `dvdlkpioc hkuotrids. It is pksitd` tbat

"#$%&'() * #+),-, ../= 1:8%0%4>3 29%05,963 .,H6'9,9 J4 .%+3


4/28

Ekuroal kn Law, Ionkrgatiko ao` Xhidohd ^kl :8(:) :=10-:=14

DA] :

`dvdlkpioc hkuotrids ard okt lifdly tk `drivd aoy rdal jdodnit nrkg àta dxhlusivity,ktbdr tbao as a pkssijld jkkst tk iovdstgdot io tbd lkhal pbargahdutihal ioùstry.Bkwdvdr, `dvdlkpioc hkuotrids ard still kjlicd` tk hkgply witb tbdir kjlicatikos uo`dr

tbd PZI]X Acrddgdot, iohluìoc iotrkùhioc àta prktdhtiko ldcislatiko, wbihb hkul``dlay tbd availajility kn cdodrih gdìhiods. Pbd artihld arcuds tbat àta dxhlusivitysbkul` okt jd a jarridr tk tbd usd kn hkgpulskry lihdohds ao` tbat it gay jd pkssijld tkrdly ko tbd crkuo`s nkr hkgpulskry lihdosioc uo`dr tbd PZI]X Acrddgdot tk satisnytbd dxhdptikos tk PZI]X àta dxhlusivity rdquirdgdots. It tafds tbd vidw tbat tbdprkgktiko kn nrdd tra`d ao` `dvdlkpgdot kn pbargahdutihal gaounahturioc hapahitywill ck a lkoc way io alldviatioc skgd kn tbd hballdocds rdlatioc tk ahhdss tk gdìhiodstbat gay jd hausd` jy àta dxhlusivity ao` iotdlldhtual prkpdrty (I]) prktdhtiko.

Iotrkùhtiko

Pbd Acrddgdot ko Pra`d Zdlatd` Aspdhts kn Iotdlldhtual ]rkpdrty Zicbts (tbdPZI]X Acrddgdot) is tbd nirst iotdroatikoal acrddgdot tk sdt hdrtaio gioigugstaoàr`s nkr tbd prktdhtiko kn tdst àta sujgittd` tk oatikoal `ruc rdculatkry

autbkritids io kr`dr tk kjtaio garfdtioc apprkval nkr pbargahdutihals.:Pbis

prktdhtiko bas hrdatd` a sui cdodris prkpridtary ricbt io uoìshlksdìonkrgatiko, afio tk a patdot ricbt. Pbd PZI]Xrdcigd nkr tdst àta prktdhtiko

is alsk pkpularly fokwo as àta dxhlusivity, altbkucb tbdrd is skgdhkotrkvdrsy as tk wbdtbdr tbd PZI]X àta prktdhtiko prkvisikos ahtuallydstajlisb a àta dxhlusivity rdcigd kr okt. Pbdrd bas jddo guhb hkohdro as tktbd dnndht tbat tbd PZI]X nragdwkrf nkr tdst àta prktdhtiko gay bavd koahhdss tk gdìhiods, dvdo tbkucb tbis issud bas okt ydt attrahtd` tbd sagdldvdl kn aha`dgih hkggdotary kr aoalysis io hkgparisko tk tbd igpaht kn tbdPZI]X patdots rdcigd. Pbd staoàr` kn tdst àta prktdhtiko rdquird` jy tbdPZI]X Acrddgdot ao` tbd igplihatikos nkr ahhdss tk gdìhiods io `dvdlkpiochkuotrids ard issuds tbat ard ydt tk jd nully dxagiod` ao` uo`drstkk`.

"#$%&'() * #+),-, ../= 1:8%0%4>3 29%05,963 .,H6'9,9 J4 .%+3


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Bugao Zicbts as Dtbihal Jasis nkr Xhidohd 8

DA] 8

Pbis artihld dxagiods tbd ldcal nragdwkrf nkr tdst àta prktdhtiko uo`dr tbdPZI]X Acrddgdot ao` tbd kjlicatikos it hrdatds nkr Gdgjdr Xtatds io rdlatikotk àta dxhlusivity. It iovdsticatds tbd dxtdot tk wbihb tbd PZI]X tdst àta

prktdhtiko rdquirdgdots igpksd ndttdrs ko hkgpulskry lihdosioc ao` tbdqudstiko kn wbdtbdr tbd ricbt tk fddp uoìshlksd` ionkrgatiko hkoni`dotialhao jd ìspdosd` witb tbrkucb tbd hkgpulskry lihdosioc gdhbaoisg. Pbdartihld hkosi`drs tbd hkoodhtiko jdtwddo tdst àta prktdhtiko ao` tbd odd` tksandcuar` pujlih bdaltb, witb partihular nkhus ko tbd igplihatikos nkr ahhdss tkgdìhiods io `dvdlkpioc hkuotrids. It is pksitd` tbat `dvdlkpioc hkuotrids ardokt lifdly tk `drivd aoy rdal jdodnit nrkg àta dxhlusivity, ktbdr tbao as apkssijld jkkst tk iovdstgdot io tbd lkhal pbargahdutihal ioùstry. Bkwdvdr,`dvdlkpioc hkuotrids ard still kjlicd` tk hkgply witb tbdir kjlicatikos uo`drtbd PZI]X Acrddgdot, iohluìoc iotrkùhioc àta prktdhtiko ldcislatiko, wbihbhkul` `dlay tbd availajility kn cdodrih gdìhiods. Pbd artihld arcuds tbat àta

dxhlusivity sbkul` okt jd a jarridr tk tbd usd kn hkgpulskry lihdohds ao` tbatit gay jd pkssijld tk rdly ko tbd crkuo`s nkr hkgpulskry lihdosioc uo`dr tbdPZI]X Acrddgdot tk satisny tbd dxhdptikos tk PZI]X àta dxhlusivityrdquirdgdots. It tafds tbd vidw tbat tbd prkgktiko kn nrdd tra`d ao``dvdlkpgdot kn pbargahdutihal gaounahturioc hapahity will ck a lkoc way ioalldviatioc skgd kn tbd hballdocds rdlatioc tk ahhdss tk gdìhiods tbat gay jdhausd` jy àta dxhlusivity ao` iotdlldhtual prkpdrty (I]) prktdhtiko.

1 Pbd Oaturd kn @ata Dxhlusivity

@ata dxhlusivity bas jddo `dniod` as tbd prktdhtiko kn hlioihal tdst àtardquird` tk jd sujgittd` tk a rdculatkry acdohy tk prkvd sandty ao` dnnihahykn a odw `ruc, ao` prdvdotiko kn cdodrih `ruc gaounahturdrs nrkg rdlyioc kotbis àta io tbdir kwo applihatikos. 8

@ata dxhlusivity bas alsk jddo `dshrijd` as5

a tigd-jkuo` nkrg kn iotdlldhtual prkpdrty prktdhtiko tbat sddfs tkallkw hkgpaoids tk rdhkup tbd hkst kn iovdstgdot io prkùhioc àtardquird` jy tbd rdculatkry autbkrity. Pbd dnndht kn àta dxhlusivity is

tk prdvdot tbd dotry kn cdodrih hkgpdtitkrs, io`dpdo`dot kn tbd patdotstatus kn tbd prkùht io qudstiko.0

82 R RN%4&3 SF69%6,IJH 7%6,46 .JH,4&J4I E)9 7'8$JH


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DA] 0

A àta dxhlusivity rdcigd is tbdrdnkrd hkohdrod` witb tbd dxtdot tk wbihb aoatikoal `ruc rdculatkry jk`y gay jd prkbijitd` nrkg rdlyioc ko tbdkricioatkrs àta io apprkvioc tbd prkùhts kn prkspdhtivd cdodrih

hkgpdtitkrs. Pdst àta okrgally hkotaios ionkrgatiko tbat doajlds tbdckvdrogdot tk assdss tbd risfs ao` dnnihahy kn a `ruc jdnkrd craotioc itgarfdt autbkrizatiko.4 Xuhb ionkrgatiko gay iohlu`d `ruc hkgpksitiko,nahtkrioc gdtbk` ao` pktdotial bdaltb risfs tk pdkpld, wbihb gafds tbd àtakn sicoinihaot hkggdrhial valud.>

Cdodrally, jdnkrd garfdtioc apprkval is craotd` nkr pbargahdutihals io aoyhkuotry, tbd rdldvaot oatikoal `ruc rdculatkry autbkrity gust bavd jddosatisnid` as tk tbd sandty, dnnihahy ao` quality kn tbd `ruc. Pbis is okrgallysatisnid` tbrkucb rdliaohd ko tbd ionkrgatiko tbat hao jd cldaod` nrkg tbd tdstàta sujgittd` jy tbd gaounahturioc hkgpaoy, wbihb wkul`, agkocst ktbdr

tbiocs, iohlu`d tbd hbdgihal hkgpksitiko kn tbd `rucs ao` prd-hlioihal ao`hlioihal `ruc trials, as wdll as tdsts hkoùhtd` io tbd gaounahturioc prkhdss.Xuhb tdst àta gay sujsdqudotly jd rdlid` ko tk rdcistdr cdodrih sujstitutds kotbd crkuo` kn jikdquivaldohd. Pbd igplihatiko kn tbis is tbat cdodrihgaounahturdrs ard ajld tk rdly ko prkpridtary ionkrgatiko cdodratd` athkosi`drajld hkst jy tbd kricioatkr kohd tbd pdrik` kn prktdhtiko prkvi`d` jytbd àta dxhlusivity rdcigd bas dxpird`. Pbis allkws cdodrih gaounahturdrs tkdotdr tbd garfdt witbkut tbd nioaohial jur`do kn cdodratioc tbdir kwo tdstàta. Pbdrd ard alsk dtbihal issuds iovklvd` io allkwioc cdodrih gaounahturdrstk rdly ko tbd kricioatkrs tdst àta. Hlioihal trials cdodrally iovklvd tbd usd knjktb bugao ao` aoigal rdsdarhb sujedhts3 ao` rdquirioc cdodrihgaounahturdrs tk ùplihatd hlioihal rdsults will dotail kodrkus hkosdqudohds

nkr tbd rdsdarhb sujedhts. ]aracrapb 1: kn tbd Skrl` Gdìhal Asskhiatikos@dhlaratiko kn Bdlsiofiis partihularly iostruhtivd io rdlatiko tk tbd dtbihal issudsiovklvd` io hlioihal trials. It prkvi`ds5

Gdìhal rdsdarhb iovklvioc bugao sujedhts gust hkonkrg tk cdodrallyahhdptd` shidotinih priohiplds, jd jasd` ko a tbkrkucb fokwld`cd kn tbdshidotinih litdraturd, ktbdr rdldvaot skurhds kn ionkrgatiko, ao` a`dquatdlajkratkry ao`, as apprkpriatd, aoigal dxpdrigdotatiko. Pbd wdlnard knaoigals usd` nkr rdsdarhb gust jd rdspdhtd`.2

]aracrapb 12 kn tbd Bdlsiofi @dhlaratiko nurtbdr prkvi`ds tbat aoy gdìhal

rdsdarhb iovklvioc tbd usd kn bugao sujedhts gust jd prdhd`d` jy a hardnulassdssgdot kn tbd nkrdsddajld risfs ao` jur`dos tk bugao sujedhts ao`hkgguoitids anndhtd` jy tbd iovdsticatiko. Pbd igplihatiko kn tbdsd prkvisikosis tbat wbdrd tbdrd is alrda`y sunnihidot fokwld`cd io tbd nidl` nrkg prdvikus

4. ;+-,93 S7%6,46 79)6,H6J)4 %40 *HH,&& 6) @,0JHJ4,U M?, 5)$)A8J% %40 7,9'NJ%4 M9%0,

79)A)6J)4 *I9,,A,46&\ 1W__P> OT D"N F E7&1,%&& 2%B1%N 86 -'% )+%#15"&ZWK3 ZQ_/>:8J0/37?


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DA] 4

hlioihal trials, tbdrd hao bar`ly jd a eustinid` jasis nkr rdpdatioc tbd sagdprkhdss.

]rdhluìoc cdodrih gaounahturdrs nrkg usioc prdvikusly sujgittd` tdst àtaio kr`dr tk caio ahhdss tk a civdo garfdt hao pksd a rdal jarridr tk ahhdss tkgdìhiods io `dvdlkpioc hkuotrids.9 It bas tbus jddo arcud` tbat tbdrdculatkry giasga khhasikod` jy tbd àta dxhlusivity rdcigd is a sicoinihaotpart kn tbd clkjal systdg tbat dgjarckds ahhdss tk gdìhiods io `dvdlkpiochkuotrids.1=Pbd rdasko tbd àta dxhlusivity rdcigd is prkjldgatih io tdrgs knahhdss tk gdìhiods is tbat, wbdrd tdst àta is prktdhtd`, cdodrihgaounahturdrs will okt jd ajld tk rdly ko it nkr tbd purpksd kn sddfiocgarfdtioc apprkval uotil tbd dxpiratiko kn tbd prktdhtiko knndrd`. Pbdigplihatiko is tbdrdnkrd tbat tbd rickrkus, tigd hkosugioc ao` dxpdosivdprkhdss kn cdodratioc tdst àta will sdrvd as a sujstaotial ìsiohdotivd tk

garfdt dotry jy tbd cdodrih ioùstry ao`, as a hkosdqudohd, ahhdss tk hbdapdrgdìhiods will jd `dlayd`.

Sbdrd a prkùht is uo`dr patdot, àta dxhlusivity is uolifdly tk jd kn gatdrialdnndht as tbd patdot bas tbd sagd dnndht io prdvdotioc dotry kotk tbd garfdt kncdodrih vdrsikos kn tbd prkùht. Bkwdvdr, wbdrd tbd prkùht is oktpatdotajld kr knn patdot, àta dxhlusivity hao aht io`dpdo`dotly tk prdvdot aoycdodrih hkgpaoids wisbioc tk dotdr tbd garfdt nrkg `kioc sk uotil tbd àtadxhlusivity rdcigd do`s.11@ata dxhlusivity gay hkondr a strkocdr ricbt tbao apatdot as ckvdrogdots bavd a ligitd` ajility tk iotdrndrd witb it. Ackvdrogdot gay iotdrndrd witb tbd dxhlusivd ricbts kn a patdot bkl`drtbrkucb hkgpulskry lihdosioc jut a àta dxhlusivity rdcigd haookt jd sk

dasily truohatd`.1:

Pra`d sdhrdts bavd jddo rdhkcoisd` ao` prktdhtd` uo`dr hkggko law ruldsao` uonair hkgpdtitiko ldcislatiko io a ougjdr kn hkuotrids nkr gaoy ydars,lkoc jdnkrd tbd a`vdot kn PZI]X.18Pbd PZI]X Acrddgdot is, bkwdvdr, tbd nirstiotdroatikoal hkovdotiko tk iotrkùhd ao iotdroatikoal rdcigd nkr tdst àtaprktdhtiko ao` tbis is cdodrally hkosi`drd` kod kn its gkst sicoinihaotndaturds.10]rikr tk PZI]X, Artihld 1=jis kn tbd ]aris Hkovdotiko nkr tbd ]rktdhtiko

kn Ioùstrial ]rkpdrty prkvi`d` nkr prktdhtiko acaiost uonair hkgpdtitiko.14

Ajrka` iotdrprdtatiko kn Artihld 1=jis kn tbd ]aris Hkovdotiko gay bavd tbd

9@ < @)9I%43 S@,0JHJ4,& E)9 6?, ;,N,$)(J4I c)9$0U 79)A)6J4I *HH,&& %40 :44)N%6J)4 J4

6?, 7)&6 b M XQ O,1B%#&1-; 86 48#8,-8 K"57=-; 86 D"N 2%B1%NQK3

XZ/1== [ =%B,93 SR40J4I ;9'I


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DA] >

dnndht kn prktdhtioc tdst àta acaiost uonair hkgpdtitiko jut `kds okt knndraoytbioc afio tk àta dxhlusivity. Bkwdvdr, as will jd sddo jdlkw, tbd PZI]Xtdst àta prktdhtiko nragdwkrf traoshdo`s tbd rdquirdgdot kn prktdhtioc

prkùhts acaiost uonair hkgpdtitiko jy dstajlisbioc a àta dxhlusivitynragdwkrf tbat ahhkr`s tbd status kn ao io`dpdo`dot prkpridtary ricbt ko tbdparty dotitld` tk suhb prktdhtiko.

1.1 Pdst @ata ]rktdhtiko To`dr PZI]X

Pbd PZI]X Acrddgdot igpksds ao kjlicatiko ko all Gdgjdr Xtatds tk knndra`dquatd prktdhtiko nkr hkoni`dotial ionkrgatiko sujgittd` as a prdrdquisitdnkr caioioc garfdt apprkval nkr a odw `ruc. Artihld 89 kn tbd PZI]X

Acrddgdota``rdssds tbis issud io tbd nkllkwioc tdrgs5

1. Io tbd hkursd kn dosurioc dnndhtivd prktdhtiko acaiost uonairhkgpdtitiko as prkvi`d` io Artihld 1=jis kn tbd ]aris Hkovdotiko(19>3), Gdgjdrs sball prktdht uoìshlksd` ionkrgatiko io ahhkràohdwitb paracrapb : ao` àta sujgittd` tk ckvdrogdots krckvdrogdotal acdohids io ahhkràohd witb paracrapb 8.

:. Oatural ao` ldcal pdrskos sball bavd tbd pkssijility kn prdvdotiocionkrgatiko lawnully witbio tbdir hkotrkl nrkg jdioc ìshlksd` tk,ahquird` jy, kr usd` jy ktbdrs witbkut tbdir hkosdot io a gaoodrhkotrary tk bkodst hkggdrhial prahtihds sk lkoc as suhb ionkrgatiko5

a. is sdhrdt io tbd sdosd tbat it is okt, as a jk`y kr io tbd prdhisdhkonicuratiko ao` assdgjly kn its hkgpkodots, cdodrallyfokwo agkoc kr rdaìly ahhdssijld tk pdrskos witbio tbdhirhlds tbat okrgally `dal witb tbd fio` kn ionkrgatiko ioqudstiko6

j. bas hkggdrhial valud jdhausd it is sdhrdt6 ao`

h. bas jddo sujedht tk rdaskoajld stdps uo`dr tbd hirhugstaohds,jy tbd pdrsko lawnully io hkotrkl kn tbd ionkrgatiko, tk fddp it

sdhrdt.

8. Gdgjdrs, wbdo rdquirioc, as a hkoìtiko kn apprkvioc tbd garfdtiockn pbargahdutihal kr kn acrihultural hbdgihal prkùhts wbihb utilizdodw hbdgihal dotitids, tbd sujgissiko kn uoìshlksd` tdst kr ktbdràta, tbd kricioatiko kn wbihb iovklvds a hkosi`drajld dnnkrt, sballprktdht suhb àta acaiost uonair hkggdrhial usd. Io a`ìtiko,Gdgjdrs sball prktdht suhb àta acaiost ìshlksurd, dxhdpt wbdrdodhdssary tk prktdht tbd pujlih, kr uoldss stdps ard tafdo tk dosurdtbat tbd àta ard prktdhtd`.

Ao arcugdot bas jddo ga`d tbat tbd ioitial wkrìoc kn Artihld 89(1),dosurioc dnndhtivd prktdhtiko acaiost uonair hkgpdtitiko, succdsts tbat tbd


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DA] 3

prktdhtiko annkr`d` uo`dr Artihld 89 is nkuo`d` ko tbd rulds rdlatioc tk uonairhkgpdtitiko as kutliod` io Artihld 1=jis kn tbd ]aris Hkovdotiko.1> Xuhbprktdhtiko wkul` tbdrdnkrd knndr a sandcuar` acaiost uonair hkggdrhial

prahtihds witbkut civioc risd tk dxhlusivd ricbts.13

Ko tbis jasis, Artihld 89 `kdsokt hrdatd prkpridtary ricbts jut koly civds `d nahtk hkotrkl tk tbd kwodr kntbd uoìshlksd` ionkrgatiko.12 @aoidl Cdrvais bas tafdo tbd vidw tbat tbdprktdhtiko acaiost uonair hkggdrhial usd is dokucb tk satisny tbd prktdhtikoacaiost oko-ìshlksurd.19Harlks Hkrrda alsk gaiotaios tbd pksitiko tbat tbd tdxtkn Artihld 89 is uousually hldar io sbkwioc tbat tbd kjlicatiko uo`dr tbdprkvisiko `kds okt ck jdyko` tbd rdquirdgdot kn prktdhtiko acaiost uonairhkggdrhial prahtihd rdhkcoisd` io tbd ]aris Hkovdotiko.:= Bd nurtbdr arcudstbat okt koly `kds tbd laocuacd kn Artihld 89 nall sbkrt kn wbat hkul` jdrdhkcoisd` as àta dxhlusivity kr tbd hrdatiko kn ao io`dpdo`dot prkpridtaryricbt, jut alsk tbat aoy iotdrprdtatiko rdquirioc tbd dstajlisbgdot kn dxhlusivd

ricbts,as hkostaotly statd` jy tbd Toitd` Xtatds (TX) ao` tbd pbargahdutihalioùstry, is nuoàgdotally at variaohd witb tbd laocuacd kn PZI]X.:1

Sbild tbd arcugdot tbat Artihld 89 `kds okt ck jdyko` tbd rdquirdgdot tkprktdht acaiost uonair hkggdrhial usd (as prkvi`d` nkr io tbd ]aris Hkovdotiko)`kds skuo` attrahtivd, it is okt odhdssarily hkoviohioc. It is igpkrtaot tk oktdtbat kjlicatikos uo`dr tbd ]aris Hkovdotiko ard alrda`y iohkrpkratd` io tbdPZI]X Acrddgdotjy virtud kn Artihld :, wbihb prkvi`ds5

1. Io rdspdht kn ]arts II, III ao` I^ kn tbis Acrddgdot, Gdgjdrs sballhkgply witb Artihlds 1 tbrkucb 1:, ao` Artihld 19, kn tbd ]arisHkovdotiko (19>3).

:. Oktbioc io ]arts I tk I^ kn tbis Acrddgdot sball `drkcatd nrkgdxistioc kjlicatikos tbat Gdgjdrs gay bavd tk dahb ktbdr uo`dr tbd]aris Hkovdotiko, tbd Jdrod Hkovdotiko, tbd Zkgd Hkovdotiko ao`tbd Prdaty ko Iotdlldhtual ]rkpdrty io Zdspdht kn Iotdcratd` Hirhuits.

Civdo tbd naht tbat kjlicatikos uo`dr tbd ]aris Hkovdotikoard alrda`y jioìocko partids, it wkul` jd supdrnlukus tk rdprkùhd Artihld 1=jis kn tbd ]arisHkovdotiko io tbd tdxt kn tbd PZI]X Acrddgdot. Io a`ìtiko, it is hldar tbatArtihld 89 kn PZI]X hkotaios spdhinih prkvisikos tbat sujstaotially ìnndr nrkgArtihld 1=jis. Io`dd`, tbd kpdoioc wkrìoc kn Artihld 89 says tbat Gdgjdrs, io

tbd hkursd kn dosurioc a`dquatd prktdhtiko acaiost uonair hkgpdtitiko, gustprktdht uoìshlksd` ionkrgatiko io liod witb tbd nurtbdr staoàr`s igpksd` jytbd prkvisiko. It is tbdrdnkrd sujgittd` tbat tbd prktdhtiko rdquird` uo`drArtihld 89 is okt eust hkoniod` tk tbd prktdhtiko acaiost uonair hkggdrhial usd,as a ougjdr kn dgiodot shbklars io tbd nidl` bavd arcud`, jut alsk rdquirds

1>DL5M*;`:5MF;3 %8)N, 4 OW3 KWP/13:8J0/12:8J0/19; 2,9N%J&3 4'% 42


10/28


DA] 2

staoàr`s sicoinihaotly bicbdr tbao tbksd availajld uo`dr tbd ]aris Hkovdotiko.Sritioc io a sigilar vdio, Ouok ]irds `d Harvalbk arcuds5

tbd purpksd kn Artihld 89 is okt tk kjlicd SPK Gdgjdrs tk prkvi`dnkr dnndhtivd prktdhtiko acaiost uonair hkgpdtitiko, jut ratbdr tkhlariny twk issuds rdlatioc tk tbd prktdhtiko kn tra`d sdhrdts tbat tbdldcislatiko kn gaoy hkuotrids ba` naild` tk a``rdss apprkpriatdly::

: Is Artihld 89 Ajkut @ata Dxhlusivity;

Pbd `rantioc bistkry kn PZI]X sbkws tbat tbd TX attdgpt tk iotrkùhd a tdo-ydar àta dxhlusivity staoàr` was wbklly rdedhtd` jy tbd odcktiatkrs.:8Hkrrdabas partihularly arcud` tbat tbd laocuacd kn PZI]X`kds okt succdst tbat tbdgaoàtd` tdst àta prktdhtiko sbkul` jd ahhkr`d` tbrkucb tbd craot kndxhlusivd ricbts.:0 A litdral iotdrprdtatiko kn PZI]X Artihld 89 `kds oktdxplihitly ìshlksd a àta dxhlusivity rdcigd.:4 Bkwdvdr, wbdo iotdrprdtdàcaiost tbd jahf`rkp kn tbd naht tbat Artihld 89(8) is gdaot tk rdstraiohkuotrids nrkg ahtioc io a way iohkosistdot witb tbd tra`d sdhrdt status kn tdstàta, it wkul` sddg tbat tbd rdaskoajld iondrdohd tk jd `rawo is tbat Artihld89(8) is gdaot tk kpdratd as a àta dxhlusivity staoàr`. :>Io`dd`, Lkroa @wydrbas dxprdssd` tbd vidw tbat tdst àta is nast jdhkgioc a odw I] ricbt5

It sbintd` nrkg a gdrd tra`d sdhrdt tk a sdparatd ricbt afio tk a patdotwitb a gioigug prktdhtiko kn nivd ydars. It alsk sbintd` nrkg aprktdhtiko kn uoìshlksd` tdst ionkrgatiko tk a prktdhtiko nkr dvdo

pujlihly availajld ionkrgatiko. Pbd igpaht bas jddo tk prdvdotcdodrih pbargahdutihal gaounahturdrs nrkg dotdrioc tbd garfdt, tbusprdvdotioc pdkpld io `dvdlkpioc hkuotrids nrkg rdhdivioc lindsaviocgdìhiods. Ok hrdìjld eustinihatiko nkr suhb prktdhtiko bas jddoknndrd`. Pbd rdsdarhb ao` `dvdlkpgdot hksts bavd alrda`y jddordhkvdrd` jy tbd patdot bkl`drs, bavioc jddo iohlu`d` io tbd prihd kntbd gdìhatikos nkr kvdr twdoty ydars.:3

Aarko Ndllgdtb bas arcud` tbat tbd pujlih prktdhtiko dxhdptiko io Artihld89(8) hao koly jd eustinid` io hasds kn rdal pujlih dgdrcdohy ao` tbat allkwioca hkgpdtitkr tk usd tbd tdst àta hao bar`ly jd eustiniajld dvdo io ao

dgdrcdohy dxhdpt wbdo it hao jd prkvdo tbat tbd hkgpdtitkr ba` tbd kolyavailajld nahilitids nkr tdstioc tbd `ruc.:2Ko tbd ktbdr bao`, io ùjiis jdoicoikra

::L 7J9,& 0, 5%9N%$?)3 4'% 42


11/28


DA] 9

pradndrdoà suot is a priohipld kn statutkry iotdrprdtatiko tbat says tbdigpksitiko kn kodrkus kjlicatikos sbkul` jd ìshkuracd` wbdrd tbd laocuacdkn a trdaty is hapajld kn ìnndrdot iotdrprdtatikos kr hkotaios hdrtaio

agjicuitids.:9

Bavioc rdcar` tk tbd naht tbat Artihld 89 allkws tbd usd kn tdstàta wbdrd suhb usd is odhdssary tk prktdht tbd pujlih, a litdral iotdrprdtatikokn Artihld 89(8) `kds okt suppkrt tbd vidw tbat suhb usd hao koly jd availajldwbdrd tbdrd is ao dgdrcdohy. It is sujgittd` tbat all tbat is rdquird` tk usd tdstàta uo`dr Artihld 89 is dvi`dohd tbat tbis usd is hldarly io tbd pujlih iotdrdstao` okt nkr hkggdrhial hkosi`dratikos. Zdquirioc a pujlih bdaltb dgdrcdohyjdnkrd allkwioc tbd usd kn tdst àta wkul` uoodhdssarily ndttdr tbd nldxijilitykn tbd PZI]X Acrddgdot.

@ata dxhlusivity bas jddo tbd sujedht kn guhb hritihisg nkr a ougjdr knrdaskos. It is vidwd` as hkondrrioc patdot-lifd prktdhtiko ko tdst àta tbrkucb

tbd hrdatiko kn nioaohial ìsiohdotivds acaiost cdodrih gaounahturdrs wbk gaywaot tk dotdr tbd garfdt jy rdquirioc tbdg ditbdr tk wait nkr tbd àtadxhlusivity tk dxpird kr tk iovdst sicoinihaotly io tbd prkùhtiko kn a odw sdt kntdst àta. It alsk dxtdo`s patdot prktdhtiko wbihb, it is jdlidvd`, wkul` bavdprkvi`d` a`dquatd hkgpdosatiko nkr tbd kricioatkr jrao` hkgpaoy.8= @atadxhlusivity is tbdrdnkrd aoktbdr nahtkr tbat gay bavd vdry sdrikus igplihatikosnkr bdaltb hard systdgs ao` ahhdss tk annkràjld gdìhiods io `dvdlkpiochkuotrids.

Sbilst àta prktdhtiko ligits tbd ajility kn hkuotrids tk `drkcatd nrkg tbddxhlusivd ricbts kn kricioatkrs jy dobaohioc cdodrih prkùhtiko,pbargahdutihal hkgpaoids hkotioud tk pursud crdatdr prktdhtiko nkr patdots

ao` tdst àta ao` tbd rdùhtiko kn prihd hkotrkls.81

Io tbd wkr`s kn Ndllgdtb5

dhkokgihally `dvdlkpd` hkuotrids bavd hkosistdotly pusbd` nkr aoiotdrprdtatiko kn tbd PZI]X Acrddgdot tbat wkul` hkondr ko larcdpbargahdutihal hkgpaoids prihd-ionlatioc gkokpklids kvdr `rucs tbatard oditbdr patdotd` okr patdotajld, tbrkucb cuaraotdds kn dxhlusivdricbts tk hlioihal tdstioc àta odhdssary tk kjtaio garfdtioc apprkval.8:

Aoktbdr sicoinihaot hkosi`dratiko bdrd is tbd dnndht kn tdst àta prktdhtiko kopatdotd` prkùhts tbat ard hkgpulskrily lihdosd`. Civdo tbat tbd àtadxhlusivity rdcigd hkondrs a ricbt io`dpdo`dot kn tbd patdot, tbd craot kn a

hkgpulskry lihdohd io rdlatiko tk a pbargahdutihal prkùht is arcuajlywitbkut prdeuìhd tk tbd tdst àta prktdhtiko. Pbdrdnkrd, tbd ajility kn tbdhkgpulskry lihdosdd tk rdly ko tbd kricioatkrs hlioihal trial rdsults nkr caioioc

:9= * 2%94,9 1,0>3 E="5$A& D"N G15-18,"#;1M?)A&)4


12/28


DA] 1=

garfdtioc apprkval ko tbd jasis kn tbd hkgpulskry lihdohd alkod gay jd`djatajld. Pbis pkiot is dxagiod` nurtbdr jdlkw.

:.1 Dldgdots kn Pdst @ata ]rktdhtiko To`dr tbd PZI]X Acrddgdot

As alrda`y oktd` ajkvd, Artihld 89(8) prkvi`ds nkr tdst àta prktdhtiko ao`dohapsulatds tbd PZI]X tdst àta prktdhtiko rdcigd. Pbis rdcigd hao jdjrkfdo `kwo iotk tbd nkllkwioc dldgdots5

a. tbd prkùht gust utilizd odw hbdgihal dotitids (odwodssrdquirdgdot)6

j. tbd kricioatiko kn tbd uoìshlksd` tdst àta gust iovklvdhkosi`drajld dnnkrt (kricioatiko rdquirdgdot)

h. tbd tdst àta gust jd prktdhtd` acaiost uonair hkggdrhial usd(prktdhtiko acaiost uonair hkgpdtitiko rdquirdgdot)6 ao`

`. tbd tdst àta gust jd uoìshlksd` dxhdpt wbdrd odhdssary tkprktdht tbd pujlih kr wbdrd stdps ard tafdo acaiost uonairhkggdrhial usd (oko-ìshlksurd kjlicatiko ao` tbd dxhdptikos).

Odwodss Zdquirdgdot

Artihld 89(8) prkvi`ds tbat tbd pbargahdutihal kr acrihultural hbdgihalprkùht nkr wbihb prktdhtiko is skucbt gust utilisd odw hbdgihal dotitids. Ithkul` jd arcud` tbat tbd rdquirdgdot tbat tbd hbdgihal dotity is odw is afiotk tbd rdquirdgdot nkr okvdlty io patdot law. In tbis is tbd hasd, tbdo tbd odxtqudstiko is wbat is tbd staoàr` rdquird` tk satisny tbis odwodss rdquirdgdot;Xiohd tbis tdrg is okt `dniod` jy tbd PZI]X Acrddgdot, it is sujgittd` tbathkuotrids ard at lijdrty tk `dhi`d tbd staoàr` kn odwodss nkr tdst àtaprktdhtiko tbat suits tbdir lkhal hirhugstaohds. Pbis pksitiko is nully iohkoskoaohd witb Artihld 1(1) kn tbd PZI]X Acrddgdot wbihb prkvi`ds tbatGdgjdrs ard uo`dr ok kjlicatiko tk prkvi`d gkrd dxtdosivd prktdhtiko tbaotbat rdquird` uo`dr tbd Acrddgdot ao` tbat tbdy sball jd nrdd tk `dtdrgiodtbd suitajld gdtbk` kn donkrhioc tbd prkvisikos kn tbd Acrddgdot witbio tbdirldcal systdg ao` prahtihd.

Io tbd altdroativd, it bas jddo arcud` tbat tbd hkohdpt kn odwodss io rdspdhtkn hbdgihal dotitids `kds okt rdlatd tk tbd okvdlty kr uoìshlksd` oaturd kn tbdàta jut tbd a`gioistrativd aht kn rdcistratiko.88Io ktbdr wkr`s, tbd hkohdpt knodw uo`dr Artihld 89(8) bas oktbioc tk `k witb tbd patdot staoàr` knokvdlty jut rdcistratiko ao` tbd dnndhts kn rdcistratiko kn a hbdgihal dotity nkrpurpksds kn its okvdlty ard jasihally tdrritkrial.80Cdrvais bas `dshrijd` tbis as

88

7J9,& 0, 5%9N%$?)3 %8)N, 4 WO3 T]P/80:8J0 T]P`Z/


13/28


DA] 11

tbd prahtihal apprkahb tk `dnioioc odw uo`dr Artihld 89(8). 84Bd kpiods tbatprkvi`d` tbat a hbdgihal dotity bas okt jddo prdvikusly sujgittd` nkrrdculatkry apprkval io a civdo hkuotry, it sbkul` jd hkosi`drd` odw ao` tbd

àta cdodratd` nrkg it sbkul` jd dlicijld nkr prktdhtiko.8>

Pk àtd, tbdrd basjddo ok knnihial cuiàohd as tk wbihb kn tbdsd ìnndrioc vidws sbkul` jda`kptd` jy Gdgjdrs as nulnillioc tbd odwodss rdquirdgdot io Artihld 89(8).Xdhtiko :=1 kn tbd TX Nkk` @rucs ao` Hksgdtih Aht,nkr iostaohd, `dniods a odw`ruc as5

Aoy `ruc (dxhdpt a odw aoigal `ruc kr ao aoigal ndd` jdarioc kr hkotaioioca odw aoigal `ruc) tbd hkgpksitiko kn wbihb is suhb tbat suhb `ruc, as ardsult kn iovdsticatikos tk `dtdrgiod its sandty ao` dnndhtivdodss nkr usd uo`drsuhb hkoìtikos, bas jdhkgd sk rdhkcoizd`, jut wbihb bas okt, ktbdrwisd tbaoio suhb iovdsticatikos, jddo usd` tk a gatdrial dxtdot kr nkr a gatdrial tigd

uo`dr suhb hkoìtikos.Altbkucb usioc tbd aht kn rdcistratiko as a jdohbgarf nkr odwodss is`dndosijld uo`dr Artihld 89, it is okodtbdldss sujgittd` tbat tbd odwodssrdquirdgdot io Artihld 89 sbkul` okt jd jasd` ko tbd aht kn rdcistratiko.Hbdgihal dotitids sbkul` koly jd hkosi`drd` odw wbdrd tbd hbdgihalhkgpksitiko bas okt jddo nkrgdrly rdhkcoisd` jy pdkpld, qualinid` jyshidotinih traioioc ao` dxpdridohd, as sand ao` dnndhtivd nkr tbd trdatgdot it basjddo nkuo` tk knndr. Pbdrd is alsk suppkrt nkr tbd vidw tbat Artihld 89(8) willokt hkvdr hasds wbdrd apprkval is rdquird` nkr odw `ksacd nkrgs,hkgjioatikos, odw nkrgs kn a`gioistratiko, hrystalliod nkrgs, iskgdrs, dth kndxistioc prkùht,83 as tbdy wkul` okt nall witbio tbd `dnioitiko kn a odw

hbdgihal dotity. Io suggary, it is sujgittd` tbat siohd PZI]X `kds oktprkvi`d a hldar `dnioitiko kn tbd odwodss rdquirdgdot, Gdgjdrs gay rdly koArtihld 1(1) kn tbd PZI]X Acrddgdot tk iotdrprdt tbis rdquirdgdot io a wayhkoùhivd tk tbdir skhik-dhkokgih wdlnard.

Kricioatiko Zdquirdgdot

Artihld 89(8) prkvi`ds tbat tbd kricioatiko kn tdst àta tk jd prktdhtd` gustiovklvd hkosi`drajld dnnkrts. It is cdodrally assugd` tbat nkr pbargahdutihals,tbd cdodratiko kn tdst àta io gkst hasds iovklvds hkosi`drajld dnnkrtdspdhially io hkoùhtioc hlioihal trials.82 It wkul` appdar tbat a rdaskoajld

iondrdohd tk `raw nrkg tbis prkvisiko is tbat tbd dnnkrt iovklvd` sbkul` oktkoly jd sujstaotial dhkokgihally jut alsk io tdhboihal ao` shidotinih tdrgs. 89Kotbd ktbdr bao`, tbis part kn tbd tdst àta prktdhtiko rdcigd bas jddo hritihisdàs dxtdoìoc I] jdyko` its jkuoàrids kn rdwarìoc tbd hrdatkrs kn kricioali`das ao` odw iovdotikos tk tbd prktdhtiko kn iovdstgdot ao` okt iotdlldhtualhkotrijutiko. 0= Pbd prktdhtiko kn iovdstgdot, ahhkrìoc tk Hkrrda, sbkul` jd

842,9N%J&3 %8)N, 4 OZ3 KQQ`K/8>:8J0/835)99,%3 %8)N, 4 OT3TP]H822,9N%J&3 %8)N, 4 OZ3 KQK/89

DL5M*;`:5MF;3 %8)N, 4 OW3 KTO/0=5)99,%3 %8)N, 4 OT3 TZ_/


14/28


DA] 1:

witbio tbd purvidw kn hkgpdtitiko law ao` okt I].01It is, bkwdvdr, `kujtnul init hao jd ricbtly arcud` tbat tbd `dvdlkpgdot kn a odw iovdotiko hao jd nullysdparatd` nrkg tbd iovdstgdot tbat iodvitajly ckds witb it. Pbdrd is alsk ok

caiosayioc tbd naht tbat tdst àta cdodratiko iovklvds sujstaotial dhkokgihrdskurhds ao` shidotinih fokwld`cd. It is tbus sujgittd` tbat tbd hkosi`drajlddnnkrt rdquirdgdot will jd dasily gdt io virtually all hasds kn pbargahdutihaltdst àta cdodratiko.

]rktdhtiko Acaiost Tonair Hkgpdtitiko Zdquirdgdot

Artihld 89(8) rdquirds oatikoal `ruc rdculatkry autbkritids tk prktdhtionkrgatiko sujgittd` tk tbdg acaiost uonair hkggdrhial usd tk tbd dxtdottbat suhb ionkrgatiko rdgaios uoìshlksd`. It sbkul` jd oktd` tbat tbd tdstàta rdcigd uo`dr Artihld 89(8) is dssdotially nkr rdculatkry apprkval nkrgarfdtioc pbargahdutihal kr acrihultural prkùhts. It `kds okt dotail sdlliockr knndrioc àta nkr sald.0: Pk tbat dxtdot, tbd pkiot bas jddo ga`d tbathkggdrhial usd hao koly gdao craotioc garfdtioc apprkval tk hkgpdtiocckk`s witbkut tbd hkosdot kn tbd nirst rdcistraot. 08 As ]irds `d Harvalbkarcuds5

Pbd wbkld i`da kn Artihld 89.8 is tk prkbijit parasitih jdbavikur kr nrddriìoc. Aoy gdasurds, suhb as rdlyioc ko jikdquivaldohd tdsts kr ktbdrajri`cd` prkhdùrds tbat alldviatd tbd sdhko` rdcistraot nrkgkjlicatikos tbat bavd jddo igpksd` tk tbd nirst rdcistraot sbkul` jd`ddgd` as suhb.

Ko tbd ktbdr bao`, Hkrrda bas arcud` tbat tbd hkohdpt kn uonair is rdlativd tktbd valuds kn a partihular hkgguoity ao` varids agkoc Gdgjdrs. 00Bd pksitstbat dvdo tbkucb tbd usd jy ckvdrogdot gay bavd hkggdrhial igplihatikos,it still `kds okt agkuot tk a hkggdrhial ahtivity jut a `dndosijld Xtatdprahtihd.04 Bd tbus bicblicbts tbd nkllkwioc as ahtikos a hkuotry gayuo`drtafd witbkut viklatioc Artihld 89(8)5

a. Zdquird tbd sdhko`-dotraot tk prkùhd its kwo tdstioc àta kr tkkjtaio ao autbkrizatiko kn usd nrkg tbd kricioatkr kn tbd àta6

j. Allkw tbd sdhko`-dotraot tk rdly ko tbd kricioatkrs àta acaiostpaygdot kn hkgpdosatiko6

h. Tsd tbd kricioatkrs àta io kr`dr tk tdhboihally dxagiod sdhko`-dotry applihatikos. Io tbis hasd, tbd autbkrity ìrdhtly rdlids ko tbdkricioatkrs àta6

01:8J0/0:42


15/28


DA] 18

`. Zdquird tbd sdhko`-dotraot tk prkvd tbat bis prkùht is sigilar tkao alrda`y rdcistdrd` prkùht, witbkut bavioc tk dxagiod ao`rdly upko tbd kricioatkrs àta.0>

Birkfk Yagaod alsk tafds a sigilar vidw, pksitioc tbat Artihld 89(8) kolyrdquirds Gdgjdrs tk prdvdot tbd ìshlksurd kn àta sujgittd` tk rdculatkryjkìds tk hkgpdtitkrs ao` `kds okt dotail gkrd tbao tbd prktdhtiko acaiostuonair hkggdrhial usd jy hkgpdtitkrs.03 Io Zuhfdlsbaus v Gksaotk,02 it wasarcud` jdnkrd tbd TX Xuprdgd Hkurt tbat tbd usd jy a sujsdqudot applihaotkn Gksaotks prktdhtd` acrkhbdgihal prkùht àta was uohkostitutikoal, dvdotbkucb Gksaotk was dotitld` tk hkgpdosatiko nkr tbd usd. Pbd TX XuprdgdHkurt rdedhtd` Gksaotks hkgplaiot ao` oktd` tbd hkggko prahtihd kn rdlyiocko kricioatkrs àta io tbd TX. Pbis hasd was `dhi`d` a `dha`d jdnkrd tbddotry iotk nkrhd kn tbd PZI]X Acrddgdot. Pbd Hkurt io tbd Gksaotks hasd ì`

okt rdhkcoisd tbd kricioatkrs ricbt tk dxhlusivd usd jut tbdrd was aokjlicatiko tk hkgpdosatd tbd kricioal kwodr kn tbd àta. Pbd HaoaìaoNd`dral Hkurt kn Appdals `dhisiko io Jaydr Ioh. v Haoaà (Attkrody Cdodral)09isalsk vdry iostruhtivd. Pbd `dhisiko was jasd` ko Okrtb Agdrihao Nrdd Pra`dAcrddgdot (OANPA)4= prkvisikos hkohdroioc tdst àta prktdhtiko tbat ardsigilar tk tbd prkvisikos kn PZI]X Artihld 89. Pbd Hkurt bdl` io Jaydr Ioh. vHaoaà (Attkrody Cdodral) tbat in tbd cdodrih gaounahturdr dxdrhisds tbd kptikokn bavioc tbd Gioistdr dxagiod tbd hkoni`dotial ionkrgatiko nild` jy tbdiookvatkr, it will jd rdlyioc ko tbd tdst àta. Pbd Hkurt bkwdvdr oktd` tbattbis wkul` okt jd tbd hasd in tbd cdodrih gaounahturdr is ajld tk dstajlisb tbdsandty ao` dnndhtivdodss kn its prkùht ko tbd jasis kn jikdquivaldohd krjikavailajility stuìds witbkut tbd Gioistdr bavioc tk rdly ko tbd iookvatkrs

àta.

Altbkucb tbd Haoaìao hkurts bavd rdhkcoisd` usd ko tbd jasis knjikdquivaldohd as okt agkuotioc tk uonair hkggdrhial usd, it is wrkoc tkhkotdo` tbat tbdrd is a cdodral hkosdosus ko tbis pkiot. @aoidl Cdrvais oktd`tbat suhb usd hkul` hkgd uo`dr shrutioy ao` tbat tbd iotdrprdtatiko kn tbdHaoaìao Hkurt is at k``s witb tbd vidw suppkrtd` jy a ougjdr kn SPKGdgjdrs iohluìoc tbd Durkpdao Toiko ao` tbd Toitd` Xtatds. 41Io a sigilarvdio, Ouok ]irds `d Harvalbk `dshrijds aoy rdliaohd jy ckvdrogdot ko tbdiookvatkrs àta as ao uoautbkrisd` nrdd riìoc tbat sbkul` jd ìshkuracd`.4:Edrkgd Zdihbgao ko tbd ktbdr bao` hkotdo`s tbat Artihld 89 kn PZI]X`kds

0>:8J0 TZQ/03m e%A%4,3


16/28


DA] 10

okt prkbijit ckvdrogdots nrkg rdlyioc ko iookvatkrs àta ko tbd jasis knjikdquivaldohd.48

Sbilst tbd Haoaìao hkurts ao` skgd dxpdrts sddg tk navkur tbd vidw tbatusd ko tbd jasis kn jikdquivaldohd `kds okt agkuot tk ao uonair hkggdrhialprahtihd, it is still `kujtnul in tbis vidw hao jd sddo as nully hkosistdot witbkjlicatikos uo`dr tbd PZI]X Acrddgdot. A litdral iotdrprdtatiko kn Artihld 89, itis sujgittd`, hldarly succdsts tbat aoy usd kn prktdhtd` tdst àta witbkut tbdkwodrs hkosdot will jd iohkosistdot witb tbd PZI]X Acrddgdotdxhdpt wbdrd itis usd` tk prktdht pujlih bdaltb kr in it `kds okt agkuot tk uonair hkggdrhialusd. Pbd usd kn suhb àta nkr tbd purpksds kn ashdrtaioioc tbd sandty ao`dnnihahy kn `rucs will okt jd uonair hkggdrhial usd.40

As gdotikod` darlidr, kod uosavkury dnndht kn rdstraioioc `ruc rdculatkryautbkritids nrkg craotioc garfdtioc apprkval ko tbd jasis kn jikdquivaldohdis tbd prkjldg kn bavioc tk sujstaotially rdpdat tkxihklkcihal ao` hlioihaltrials, wbihb will okt koly jd prknlicatd jut alsk dtbihally prkjldgatih. 44Okodtbdldss, it wkul` appdar tbat rdliaohd ko tbd kricioatkrs tdst àta nkr tbdpurpksds kn craotioc garfdtioc apprkval tk a cdodrih hkgpaoy, wbdtbdr statdkwod` kr okt, wkul` ruo ankul kn tbd tdokr kn tbd prkvisiko dxhdpt wbdrdtbdrd ard pujlih bdaltb hkosi`dratikos.

Oko-@ishlksurd Kjlicatiko ao` tbd ]ujlih ]rktdhtiko Dxhdptiko

Sbdrd cdodrih hkgpaoids rdly ko àta tbat is pujlihly availajld, Artihld 89will okt apply, as tbd ionkrgatiko gust jd uoìshlksd` tk qualiny nkr

prktdhtiko. Pbis prkvisiko is, bkwdvdr, sujedht tk tbd pujlih prktdhtikodxhdptiko io Artihld 89(8).4>Pbd igplihatiko kn tbis dxhdptiko is tbat Gdgjdrsgay ìshlksd suhb ionkrgatiko wbdrd odhdssary tk prktdht pujlih bdaltb kriotdrdst kr wbdrd hdrtaio stdps bavd jddo tafdo tk a`dquatdly prktdht tbdìshlksd` àta acaiost uonair hkggdrhial usd kr hkgpdtitiko. Pbd PZI]XAcrddgdot`kds okt prkvi`d cuiàohd ko wbdo it will jd odhdssary tk prktdhttbd pujlih. Hkrrda bas kpiod` tbat tbis prkvisiko is sujedht tk a odhdssity tdst. 43@dndrdohd gay jd civdo tk Gdgjdrs io `dtdrgioioc wbdo suhb odhdssityarisds jut a Gdgjdr iovkfioc tbd prkvisiko gay bavd tk jdar a vdry kodrkusjur`do kn prkkn, sbkul` tbd gdasurd tafdo jd hballdocd`.42

Pbdrd is skgd suppkrt nkr tbd vidw tbat ìshlksurd gay jd allkwd` tk doajld ahkgpulskry lihdosdd tk ahquird garfdtioc apprkval, dspdhially wbdrd tbdlihdohd is issud` tk hkrrdht aoti-hkgpdtitivd prahtihds kr tk gddt tbd `dgao`s

48G m OT !"#T7%--%


17/28


DA] 14

kn pujlih bdaltb.49 Pbis is dxagiod` nurtbdr jdlkw io tbd sdhtiko ko àtadxhlusivity ao` hkgpulskry lihdosioc.>= It is igpkrtaot tk oktd tbat Artihld 89`kds okt prkvi`d nkr a sdt ùratiko kn tdst àta prktdhtiko ao` it wkul` sddg

tbat suhb prktdhtiko gay hkotioud io`dnioitdly uotil tbd àta hao ok lkocdr jdhkosi`drd` uoìshlksd`. Pbd cdodrally ahhdptd` tdrg kn prktdhtiko, nrkg tbdhurrdot prahtihd agkocst Gdgjdrs, is nivd tk tdo ydars. >1It bas jddo succdstd`tbat tdrgs kn prktdhtiko sbkul` jd `dhi`d` ko a hasd-jy-hasd jasis, tafioc iotkahhkuot tbd rdskurhds hkggittd` tk tbd cdodratiko kn tbd tdst àta ao` itsokvdlty, jut sujedht tk a gaxigug prktdhtiko pdrik` tk avki` ajusds. >:

8 @ata Dxhlusivity ao` Hkgpulskry Lihdosioc

A pdrtiodot pkiot tk hkosi`dr bdrd is tbd lifdly igplihatiko kn tdst àtaprktdhtiko ko tbd usd kn hkgpulskry lihdosioc. Artihld 81 kn tbd PZI]XAcrddgdot, wbihb `dals witb usd witbkut autbkrisatiko, prkvi`ds nkrhkgpulskry lihdosioc kn patdotd` prkùhts. Io :==1, tbd SPK Gioistdrsa`kptd` tbd @kba @dhlaratiko ko tbd PZI]X Acrddgdot ao` ]ujlih Bdaltb (@kba@dhlaratiko). ]aracrapb 0 kn tbd @kba @dhlaratikoprkvi`ds tbus5

Sd acrdd tbat tbd PZI]X Acrddgdot `kds okt ao` sbkul` okt prdvdotgdgjdrs nrkg tafioc gdasurds tk prktdht pujlih bdaltb. Ahhkrìocly,wbild rditdratioc kur hkggitgdot tk tbd PZI]X Acrddgdot, wd annirgtbat tbd Acrddgdot hao ao` sbkul` jd iotdrprdtd` ao` igpldgdotdìo a gaoodr suppkrtivd kn SPK gdgjdrs' ricbt tk prktdht pujlihbdaltb ao`, io partihular, tk prkgktd ahhdss tk gdìhiods nkr all. >8

Pbd prkjldg was tbat uo`dr Artihld 81(n) kn PZI]X, ckk`s ga`d pursuaot tk ahkgpulskry lihdohd io aoy civdo hkuotry sbkul` jd prd`kgioaotly nkr tbdsupply kn tbd `kgdstih garfdt. ]aracrapb > kn tbd @kba @dhlaratikogaoàtdstbd Hkuohil nkr PZI]X tk nio` a sklutiko tk tbd prkjldgs tbat hkuotridswitbkut a gaounahturioc hapahity io tbd pbargahdutihal sdhtkr gaydohkuotdr io usioc tbd hkgpulskry lihdosioc systdg. Pbd sklutiko hagd io tbdnkrg kn tbd @kba ]aracrapb-> Igpldgdotatiko @dhisiko>0wbihb bas okw jdhkgdPZI]X Artihld 81jis tbrkucb tbd ]rktkhkl Agdoìoc tbd PZI]X Acrddgdot kn >@dhdgjdr :==4. Pbd agdo`gdot is tk tafd dnndht upko ahhdptaohd jy twktbir`s kn Gdgjdr Xtatds jut tbd ougjdr kn ahhdptaohds tbat bavd sk nar jddo

rdhkr`d` is still jdlkw tbis rdquirdgdot. SPK Gdgjdrs prdsdotly bavd uotil

49DL5M*;`:5FM;3 %8)N, 4 OW3 KTW/>=F,, &,H6J)4 T 8,$)+/>1:h7@*3) 2%B1%N 86 .^1&-1,* G"-" .^5=7&1B1-; D%*1&="-18, 1, M%=%5-%0 L87,-#1%&

1:46,94%6J)4%$ *&&)HJ%6J)4 )E 7?%9A%H,'6JH%$ @%4'E%H6'9,9& *&&)HJ%6J)43 W__W>/>:7J9,& 0, 5%9N%$?)3 %8)N, 4 WO3 T]]/>8G8'" !1,1&-%#1"= G%5="#"-18, 8, -'% 42


18/28


DA] 1>

@dhdgjdr :=14 tk ahhdpt tbd agdo`gdot. >4 Pbd @kba ]aracrapb->Igpldgdotatiko @dhisikois, bkwdvdr, io nkrhd io tbd gdaotigd.>>

A pktdotial prkjldg tbat gay arisd is tbat dvdo wbdrd a hkgpulskry lihdohd isissud`, tbd cdodrih gaounahturdr gay still bavd tk sddf tbd apprkval kn tbdpatdot bkl`dr tk gafd usd kn tbd tdst àta tk kjtaio garfdtioc apprkval.>3 Itbas jddo arcud` tbat wbdrd a hkgpulskry lihdohd is issud` io rdspdht kn a`ruc, àta dxhlusivity gay still prdsdot a sicoinihaot bur`ld jy gafiocgarfdtioc autbkrisatiko nkr tbd `ruc gkrd ìnnihult.>2 Pbis is jdhausd Artihld89(8) dstajlisbds a quasi-prkpridtary, quasi-patdot systdg tbat hkondrs ricbtstbat ard sdparatd ao` ìstioht nrkg a patdot ricbt.>9Io tbd wkr`s kn Ouok ]irds`d Harvalbk5

Pdst àta, ahtually gay suppkrt garfdtioc apprkval kn patdotd`prkùhts, jut tbdy ard iovariajly `dvdlkpd` antdr tbd iovdotiko issujgittd` tk tbd patdot knnihd. Nkr tbdsd rdaskos, tbd tdrgs knprktdhtiko kn tdst àta bavd ok hkoodhtiko witb patdots.

It tbdrdnkrd nkllkws tbat tbd craot kn a hkgpulskry lihdohd tk prkùhd cdodrihs`kds okt, cdodrally, anndht tbd prktdhtiko availajld uo`dr Artihld 89(8).

Pbd qudstiko tbat nkllkws nrkg tbis is wbdtbdr a hkgpulskry lihdosdd gayavki` caioioc tbd àta kwodrs autbkrisatiko nkr garfdtioc apprkval. A hasdhkul` jd ga`d nkr arcuioc tbat usd jy ckvdrogdot, pursuaot tk tbd craot kn ahkgpulskry lihdohd, is okt uonair ao` sbkul` okt jd trdatd` as suhb. Pbis isjdhausd tbd hkgpulskry lihdosioc rdcigd uo`dr Artihld 81 kn tbd PZI]X

Acrddgdot rdquirds tbd paygdot kn a`dquatd rdguodratiko wbdrd ahkgpulskry lihdohd is tk jd issud`. It is tbdrdnkrd prdsugd` tbat tbdhkgpdosatiko pai` tk a patdot bkl`dr nkr tbd hkgpulskry lihdohd wkul` bavdtafdo tbd àta dxhlusivity ricbt iotk ahhkuot ao` suhb usd kn tbd ionkrgatikosbkul`, tbdrdnkrd, ok lkocdr jd hkosi`drd` uonair. Jdsi`ds, suhb usd hao alskhkovdoidotly nall uo`dr tbd pujlih bdaltb dxhdptiko availajld uo`dr Artihld89(8).

Io a sigilar vdio, usd jy a tbir` party pursuaot tk a hkgpulskry lihdohdcraotd` nkr pujlih bdaltb rdaskos will okt, it is sujgittd`, jd iohkosistdot witbArtihld 89(8) prkvi`d` tbat tbd tbir` party is rdquird` tk pay a`dquatd

>4)+%,0+%,- 86 -'% 42


19/28


DA] 13

hkgpdosatiko tk tbd patdot bkl`dr wbk will alsk jd tbd kwodr kn tbd tdst àta.Artihld 81(b) kn tbd PZI]X Acrddgdot prkvi`ds tbat tbd ricbt bkl`dr sball jdpai` a`dquatd hkgpdosatiko io tbd hirhugstaohds kn dahb hasd, tafioc iotk

ahhkuot tbd dhkokgih valud kn tbd autbkrizatiko. It is tbus sujgittd` tbat itwill jd ao kodrkus jur`do io`dd` tk dxpdht a hkgpulskry lihdosdd tk pay asdparatd rdguodratiko nkr tbd patdot ricbt ao` aoktbdr nkr àta dxhlusivity.Xiohd Artihld 81(b) alrda`y rdquirds tbd hkgpdosatiko pai` tk tbd ricbt bkl`drtk tafd hkcoisaohd kn tbd dhkokgih valud kn tbd autbkrisatiko, tbis will jddokucb tk hkgpdosatd nkr tbd usd kn tdst àta as wdll. Io tbd licbt kn tbdnkrdckioc arcugdots ao` tbd prkvisikos kn tbd @kba @dhlaratiko, it issujgittd` tbat kohd a hkgpulskry lihdohd is issud` uo`dr Artihld 81 kn PZI]Xtbd àta dxhlusivity rdcigd sbkul` pksd ok nurtbdr jarridr tk tbd usd kn tbdhkgpulskrily lihdosd` prkùht.

8.1 Hao Pdst @ata jd Hkgpulskrily Lihdosd`;

Aoktbdr issud tbat is odhdssary tk hkosi`dr is wbdtbdr tbd ckvdrogdot haocraot a hkgpulskry lihdohd io rdlatiko tk a tdst àta ricbt, dspdhially io hasdswbdrd tbdrd is ok odd` tk cdt a hkgpulskry patdot lihdohd. A jridndxagioatiko kn tbd odcktiatiko bistkry kn tbd PZI]X Acrddgdot gay jdpdrtiodot bdrd. Pbd Aodll `rant (Hbairgaos `rant) kn :8 Euly 199= prkvi`d` asnkllkws ko tbis pkiot5

:A(a). ]artids sball okt ìshkuracd kr igpd`d vkluotary lihdosioc knuoìshlksd` ionkrgatiko jy igpksioc dxhdssivd kr ìshrigioatkryhkoìtikos ko suhb lihdohds kr hkoìtikos wbihb ìlutd tbd valud knsuhb ionkrgatiko.

:A(j). Pbdrd sball jd ok hkgpulskry lihdosioc kn prkpridtaryionkrgatiko. 3=

Pbd Jrussdls @rant kn @dhdgjdr 199= ì` okt bavd tbd dquivaldot kn Artihld:A(j) io tbd Aodll `rant jut okodtbdldss prkvi`d` tbus5

8A. ]artids sball okt ìshkuracd kr igpd`d vkluotary lihdosioc knuoìshlksd` ionkrgatiko jy igpksioc dxhdssivd kr ìshrigioatkryhkoìtikos ko suhb lihdohds kr hkoìtikos wbihb ìlutd tbd valud kn

suhb ionkrgatiko.31

Pbdsd prkvisikos prkbijitioc kr ìshkuracioc tbd hkgpulskry lihdosioc knprkpridtary ionkrgatiko wdrd okt iohlu`d` io tbd nioal tdxt kn tbd PZI]XAcrddgdot. @kds tbis gdao tbd PZI]X Acrddgdot hao okw jd iotdrprdtd` asallkwioc tbd hkgpulskry lihdosioc kn prkpridtary ionkrgatiko; ]irds `dHarvalbk arcuds tbat tbd naht tbat Artihld 89(8) `kds okt gdotiko hkgpulskry

3=L'"1#+",A& 2%98#- -8 -'% XPX] M-"-7& 86 :8#$ 1, -'% P%*8-1"-1,* X#879] P%*8-1"-1,*

X#879 8, 4#"0%Z2%="-%0 )&9%5-& 86


20/28


DA] 12

lihdosioc `kds okt suppkrt tbd iondrdohd tbat it nkrji`s it, as tbd Acrddgdot`kds dxplihitly nkrji` hkgpulskry lihdosioc wbdrd suhb is `ddgd` odhdssary.Pbis is tbd hasd io rdspdht kn tra`dgarfs uo`dr Artihld :8, wbihb prkvi`ds

tbus5

]artids gay `dtdrgiod hkoìtikos ko tbd lihdosioc ao` assicogdot kntra`dgarfs, it jdioc uo`drstkk` tbat tbd hkgpulskry lihdosioc kntra`dgarfs sball okt jd pdrgittd` ao` tbat tbd kwodr kn a rdcistdrd`tra`dgarf sball bavd tbd ricbt tk assico bis tra`dgarf witb krwitbkut tbd traosndr kn tbd jusiodss tk wbihb tbd tra`dgarf jdlkocs.

Pbd arcugdot, tbdrdnkrd, is tbat PZI]Xbas hldarly ao` uodquivkhally ga`d itfokwo wbdrd hkgpulskry lihdosioc is okt availajld, as io tbd hasd nkrtra`dgarfs, ao` io tbd ajsdohd kn suhb dxprdss prkbijitiko, it sbkul` jdprdsugd` tbat hkgpulskry lihdosioc will jd availajld. Sbild tbis arcugdot isvdry hkgpdllioc io priohipld, it is uolifdly tbat hkgpulskry lihdosioc hao jddnndhtivdly pursud` io prahtihd uo`dr tbd prkvisikos kn Artihld 89(8) dxhdptwbdrd tbd crkuo`s nkr tbd hkgpulskry lihdohd nall witbio tbd dxhdptikosrdhkcoisd` uo`dr Artihld 89(8). Pbus, ok hkgpulskry lihdohd hao jd craotdùo`dr Artihld 89(8) savd tk tbd dxtdot odhdssary tk prktdht tbd pujlih iotdrdstkr uoldss a`dquatd stdps ard tafdo tk prdvdot uonair hkgpdtitiko. It wkul`tbdrdnkrd appdar tbat hkgpulskry lihdosioc gay jd availajld uo`dr Artihld89(8) wbdrd it is usd` as a gdasurd nkr tafioc a`vaotacd kn tbd dxhdptikosrdhkcoisd` uo`dr tbat prkvisiko. Aoy stdps tafdo io dxhdss kn tbd dxhdptikoswill jd ankul kn tbd PZI]X Acrddgdot.

0 Pbd Clkjal Gkvd Pkwar`s a Toivdrsal Xtaoàr` nkr @ataDxhlusivity

Gaoy hkuotrids bavd alrda`y ldcislatd` tk prkvi`d nkr àta dxhlusivityprktdhtiko. Io tbd TX, tbd Nkk` ao` @ruc A`gioistratiko (tbd oatikoal `rucrdculatkry autbkrity) is nkrji``do nrkg ahhdptioc ao applihatiko nkrgarfdtioc apprkval nrkg a hkgpdtitkr nkr tbd nirst nivd ydars kn rdcistratikowitbkut tbd hkosdot kn tbd ioitial rdcistraot.3: Pbd sagd prahtihd bas jddoa`kptd` jy Bdaltb Haoaà.38Io tbd Durkpdao Hkgguoity (DH), Gdgjdrs ardokw rdquird` tk craot six tk tdo ydars kn àta dxhlusivity tk `rucs tbat bavd

jddo civdo garfdtioc apprkval.30

Pbd DH bas tafdo tbd pksitiko tbat tbd jdstway tk prktdht tdst àta acaiost uonair hkggdrhial usd is àta dxhlusivity

3:K880] G#7*& ",0 L8&+%-15 )5-]WO DF5 o TKK1H>1T>1R>1JJ> 1W__O>/38K880 F G#7*& )5-3 53 %A,40,0 8- o 5/_Z/__Q/O3 OW] 5/ 2%Y/ WQ]Q 1O]]K>

15%4/>/30L87,51= G1#%5-1B% YUUV\W_fW__Ol #G . TOOjPK3 %96/ O_g : ;)00&`FAJ6?3 S;%6% 79)6,H6J)4

%40 *89J0I,0 *(($JH%6J)4& E)9 @%9B,6J4I *'6?)9J&%6J)4& J4 6?, 7?%9A%H,'6JH%$ :40'&69-\

J4 ]T3 OOT/


21/28


DA] 19

irrdspdhtivd kn wbdtbdr tbd prkùht is patdotd` kr okt.34Io Australia, tdst àtardcistratiko is pdrnkrgd` jy tbd Pbdrapdutih Ckk`s A`gioistratiko ao`prktdhtiko is availajld nkr a pdrik` kn nivd ydars nrkg tbd àtd kn rdcistratiko. 3>

Pbd eustinihatiko nkr ligitioc tbd dxtdot kn tbd àta dxhlusivity pdrik`, asalrda`y oktd`, is tk avki` a situatiko wbdrd dvdry cdodrih gaounahturdr willbavd tk uo`drtafd tbdir kwo hlioihal trials, wbihb will okt koly dotail asicoinihaot wastd kn rdskurhds as wdll as dtbihal issuds, jut alsk gafd itsujstaotially ìnnihult nkr pdkpld io `dvdlkpioc hkuotrids tk caio ahhdss tkguhb odd`d` `rucs at annkràjld prihds. Pbd hkotrary arcugdot, put nkrwar`jy tbd I] dxpkrtioc hkuotrids, is tbat tbdrd will jd littld iohdotivd tk garfdt`rucs io `dvdlkpioc hkuotrids witbkut a rkjust àta dxhlusivity rdcigd.33Pdstàta prktdhtiko knndrs aoktbdr laydr kn prktdhtiko tk prkùhts tbat ard oktpatdotd` kr wbdrd tbd patdot tdrg bas dxpird` kr is hlksd tk dxpiratiko at tbd

tigd kn rdcistratiko.Xiohd tbd dgdrcdohd kn tbd PZI]X Acrddgdot, tbd TX bas `dvdlkpd` tbdprahtihd kn iohluìoc a nivd ydar àta dxhlusivity rdcigd io its jilatdral tra`dacrddgdots.32 Pbd TX bas alsk jddo usioc gkrd hkdrhivd gdasurds uo`dr its8=1 Sathb List tk donkrhd tbis iotdrprdtatiko kn tbd PZI]X kjlicatikos. Nkriostaohd, io 199> a spdhial 8=1 prkhdùrd was lauohbd` acaiost Australia nkrnailioc tk prkvi`d a`dquatd prktdhtiko tk tdst àta sujgittd` nkr garfdtiocapprkval.39Pbis prkjajly ionludohd` Australias a`kptiko kn its kwo nivd-ydaràta dxhlusivity rdcigd io 1992.2= Ktbdr hkuotrids tbat bavd hkgd uo`dr TXtra`d saohtikos kr prdssurd nkr oko-hkgpliaohd witb àta dxhlusivityrdquirdgdots iohlu`d Arcdotioa, Paiwao ao` Pbailao`.21

0.1 Nrdd Pra`d Acrddgdots ao` @ata ]rktdhtiko

Pbd varikus nrdd tra`d acrddgdots ao` jilatdral tra`d acrddgdots odcktiatd`jy tbd TX hkotaio prkvisikos tbat igpksd a ldvdl kn tdst àta prktdhtiko tbatckds jdyko` tbd rdquirdgdots hkotaiod` io PZI]X. Nkr iostaohd, tbd ]druviao

34L8++7,15"-18, 6#8+ -'% .7#89%", L8++7,1-1%& ",0 4'%1# !%+/%# M-"-%& -8 -'% L87,51=

8, 4#"0%Z2%="-%0 )&9%5-& 86 /33F,, 5 @ 5)99,%3 ?#8-%5-18, >6 G"-" M7/+1--%0 K8# 4'% 2%*1&-#"-18, >6 ?'"#+"5%7-15"=&I


22/28


DA] :=

Pra`d ]rkgktiko Acrddgdot ao` tbd Hklkgjia Pra`d ]rkgktiko Acrddgdot jktbiohlu`d prkvisikos tbat prkbijit tbd usd kn tdst àta ko sandty ao` `rucdnnihahy tk kjtaio ckvdrogdotal apprkval kn cdodrih `rucs.

Io a sigilar vdio, tbd @kgioihao Zdpujlih-Hdotral Agdrihao Nrdd Pra`d Acrddgdot(HANPA) rdquirds sicoatkrids tk prkvi`d tdst àta prktdhtiko nkr nivd ydarsnrkg tbd gkgdot tbd prkùht is craotd` garfdt apprkval io tbdir hkuotry. 2:Pbis bas jddo `dshrijd` as ao dnndhtivd nivd-ydar jar ko hkgpulskry lihdosiocnrkg tbd tigd kn garfdtioc apprkval.28 OANPA alsk prkvi`ds nkr tdst àtaprktdhtiko nkr a gioigug kn nivd ydars nrkg tbd àtd ko wbihb garfdtapprkval is craotd`.20It is arcuajld tbat tbd staoàr` kn prktdhtiko rdquird` jyPZI]Xis tbat tbd tdst àta gust okt jd usd` nkr ao uonair hkggdrhial purpksd,ao` gust okt uoùly rdstriht cdodrih gaounahturdrs sddfioc tk usd it nkrgarfdtioc apprkval. @ata prktdhtiko uo`dr PZI]X is koly applihajld tk àta

rdlatioc tk odw hbdgihal dotitids. Bkwdvdr, uo`dr HANPA, it applids tk odwprkùhts witb a hbdgihal dotity okt nkrgdrly apprkvd` io tbd hkuotryirrdspdhtivd kn wbdtbdr tbd hbdgihal dotity is odw kr okt. 24

0.:. @ata Dxhlusivity ao` tbd Zicbt tk Bdaltb

Pbdrd is ao dgdrcioc ìshkursd ko tbd odd` tk rdhkcoisd ahhdss tk ionkrgatikonrkg hlioihal trials as a jasih hkgpkodot kn tbd ricbt tk bdaltb. 2>It is igpkrtaottk oktd tbat tbd dxpiratiko kn àta dxhlusivity `kds okt gafd tbd tdst àtaavailajld tk tbd pujlih, as suhb ionkrgatiko still rdgaios hkoni`dotial dvdoantdr tbd pdrik` kn àta dxhlusivity bas dxpird`. Bkwdvdr, arcuajly tbdrd ishkosi`drajld pujlih iotdrdst io gafioc hlioihal trial rdsults availajld tk tbdpujlih tk sandcuar` pujlih bdaltb. Ahhdss tk darly hlioihal trials, iohluìocpbasd 1 dxplkratkry trials, hkul` prkvi`d bdlpnul ionkrgatiko ajkut tbd bdaltbao` sandty issuds tbat gay attdo` tbd garfdtioc kn pbargahdutihal prkùhts.23It is arcuajld, tbdrdnkrd, tbat tbdrd dxists tbd odd` tk `dvdlkp apprkpriatdfokwld`cd systdgs ao` rdliajld rdculatkry struhturd arkuo` gdìhalfokwld`cd.22 Bdohd, it is sujgittd` tbat nkllkwioc tbd dxpiratiko kn tbd àtadxhlusivity pdrik`, suhb ionkrgatiko sbkul` jd rdaìly availajld, at ldast nkrtbd purpksds kn gdìhal rdsdarhb ao` tbd a`vaohdgdot kn fokwld`cd.

Pbd hkotrkvdrsy rdcarìoc rdsdarhb rdpkrtioc ao` garfdtioc prahtihds knClaxkXgitbFliod ao` tbd usd kn its `ruc ]raxil nkr tbd trdatgdot kn `dprdssiko

io hbil`rdo illustratds tbd pkiot tbat ahhdss tk hlioihal trial ionkrgatiko is io tbd

2:G8+1,15", 2%97/=15ZL%,-#"= )+%#15", K#%% 4#"0% )*#%%+%,-3 &JI4,0 K *'I'&6 W__Q

1,46,9,0 J46) E)9H, O @%9H? W__X> %96 OK/O_/O18> 1SG8+1,15", 2%97/=15ZL%,-#"= )+%#15",

K#%% 4#"0% )*#%%+%,-\>28R 5)+$,-3 SM?,


23/28

Bugao Zicbts as Dtbihal Jasis nkr Xhidohd :1

DA] :1

pujlih iotdrdst.29 Pbd hkgpaoy was prksdhutd` jy tbd Attkrody Cdodral knOdw Ykrf nkr nailioc tk ìshlksd odcativd àta ao` lkpsi`d` pujlihatikos tkprkgktd knn-lajdl prdshriptikos.9= Aoktbdr dxagpld is tbd hkotrkvdrsy

surrkuoìoc Gdrhf ao` its paio rdlidn gdìhatiko îkxx, wbihb is dstigatd` tkbavd hausd` buo`rd`s kn tbkusao`s kn sdvdrd gykharìal ionarhtikos ao`harìah `datbs.91Pbdsd iohi`dots prkvi`d a skuo` jasis nkr tbd prkpksitiko tbathlioihal trial àta sbkul` jd ahhdssijld wbdrd odhdssary tk ashdrtaio tbd sandtyao` dnnihahy kn pbargahdutihals.

Pbd arcugdot tbat ahhdss tk tdst àta is a nuoàgdotal part kn tbd ricbt tkbdaltb is nkuo`d` ko tbd prdgisd tbat tdst àta is a pujlih ckk` 9: ao` tbdajility tk ahhdss tdst àta ionkrgatiko is sddo as a gaekr dldgdot kn tbd ricbt tktbd bicbdst attaioajld staoàr` kn bdaltb.98 As oktd` darlidr, tbd PZI]XAcrddgdot`kds rdhkcoisd tbd pujlih iotdrdst io tdst àta ao` tbus prkvi`ds ao

dxhdptiko tk tbd ruld acaiost ìshlksurd wbdrd it is odhdssary tk prktdht tbdpujlih.90 Pbd ricbt tk bdaltb dotails tbd ahtualisatiko kn pujlih ckals suhb asavailajility, ahhdssijility ao` quality,94 partihularly io tbd nidl` knpbargahdutihals. Xuhb ckals hao bar`ly jd rdalisd` witbkut nair ahhdss tkgdìhal hard tbat is sujstaotially sbkwo tk jd shidotinihally `dpdoàjld ao`pujlihly ahhdptd` as dnndhtivd. Pbd Durkpdao Hkurt kn Bugao Zicbts(DHtBZ) `dhisiko io Xuoày Pigds v Toitd` Fioc`kgis skgdwbat pdrtiodot tktbd tkpih.9> Ao artihld io Pbd Xuoày Pigds, dxagioioc tbd bistkry kn tbdgaounahturioc ao` rdculatkry apprkval kn tbali`kgi`d, ba` jddo jaood` jyao ioeuohtiko jdhausd its pujlihatiko wkul` agkuot tk hkotdgpt kn hkurt. PbdDHtBZ nkuo` tbat tbd ioeuohtiko wkul` agkuot tk ao uoeustiniajldionriocdgdot kn Artihld 1= kn tbd Durkpdao Hkovdotiko ko Bugao Zicbts, wbihb

cuaraotdds tbd nrdd`kg kn dxprdssiko. Pbd DHtBZ partihularly oktd` tbat ioissuds pdrtaioioc tk pujlih bdaltb, tbd pujlih bas a ricbt tk jd prkpdrlyionkrgd`.93

Pbd bugao ricbts ìgdosiko tk tbd àta prktdhtiko prkvisiko kn tbd PZI]XAcrddgdot gay tbdrdnkrd jd a pkwdrnul wdapko io a``rdssioc tbd pujlih

29; @87#,"= 86 -'% )+%#15", !%015"= )&&851"-18,OTK]3 OTK]g G L G'9,J0J4J3 . =

@Hm,49- %40 7 < @%4&EJ,$03 S5$J4JH%$ M9J%$& %40 ;9'I 79)A)6J)4U F,$,H6JN, /91< m)96)43 SCJ)^^3 6?, :A($)&J)4 )E @,9HB %40 *E6,9&?)HB& %6 6?, h;*\ 1W__Q> TXQ 4'%

D",5%-OK]Kg R G M)()$3 Sh%J$J4I 6?, 7'8$JH m,%$6? ``

TKO P%N .,*=",0 @87#,"= 86 !%0151,%OP_P/9:G m OT !"#T7%--%


24/28


DA] ::

bdaltb igplihatikos kn tbd PZI]X àta prktdhtiko rdcigd. Pbdrd is `dnioitdlytbd pkssijility kn pujlih bdaltb issuds arisioc nrkg àta prktdhtiko ao` tbis isdqually rdhkcoisd` io Artihld 89(8) kn tbd PZI]X Acrddgdot. Gdgjdr Xtatds,

tbdrdnkrd, rdsdrvd tbd ricbt tk usd suhb ionkrgatiko kr allkw ao io`dpdo`dottbir` party tk usd it wbdrd odhdssary tk prktdht pujlih bdaltb tk tbd dxtdot tbattbd prktdhtiko acaiost uonair hkggdrhial usd is okt hkgprkgisd`. Xtatds, ioditbdr usioc kr allkwioc tbd usd kn suhb ionkrgatiko, hao eustiny tbd usd jyrdlyioc ko tbd ricbt tk bdaltb.

Pbd kricioatkr tdst àta hao jd usd` nkr craotioc garfdtioc apprkval tkcdodrih gaounahturdrs, ditbdr pursuaot tk a hkgpulskry lihdohd kr nkllkwioctbd dxpiratiko kn tbd àta dxhlusivity pdrik`. Tsd kr ìshlksurd kn suhbionkrgatiko hao alsk jd eustinid` jktb uo`dr PZI]X ao` iotdroatikoal bugaoricbts law nkr tbd purpksds kn ashdrtaioioc tbd dnnihahy kr sandty kn tbd

prkùht, prkvi`d` a`dquatd stdps ard tafdo tk dosurd tbd ìshlksurd `kds oktrdsult io uonair hkggdrhial usd kn tbd àta.

0.8 Pdst @ata ao` Hlioihal Prial Zdpkrtioc

Io :==0, tbd Clkjal Nkrug ao` Gioistdrial Xuggit ko Bdaltb Zdsdarhb issud`tbd Xtatdgdot ko Bdaltb Zdsdarhbwbihb dgpbasisd` tbd odd` tk prkgktd ahhdsstk rdliajld ao` up-tk-àtd dvi`dohd ko tbd dnndhts kn iotdrvdotikos ao` halld`ko tbd SBK tk hrdatd a platnkrg hkoodhtioc a odtwkrf kn iotdroatikoalhlioihal trials rdcistdrs tk dosurd a siocld pkiot kn ahhdss ao` tbd uoagjicukusi`dotinihatiko kn trials. Pbis was nurtbdr rdionkrhd` jy tbd ninty-dicbtb Skrl`Bdaltb Assdgjly io Zdsklutiko SBA42.80. As a rdsult, tbd IotdroatikoalHlioihal Prial Zdcistry ]latnkrg (IHPZ]) was dstajlisbd` jy tbd SBK io:==4, witb tbd aig kn dobaohioc tbd SBK Prial Zdcistratiko @ata Xdt ko allhlioihal trials ao` prkgktioc pujlih ahhdss tk tbd ionkrgatiko.92 Pbd IHPZ]sdarhb pkrtal prkvi`ds a kod-stkp pkiot kn ahhdss ko ionkrgatiko rdlatioc tkhurrdot kr hkgpldtd` hlioihal trials jy usioc rdhkr`s sujgittd` jy àtaprkvi`drs all kvdr tbd wkrl`. Pbd IHPZ] is larcdly `dpdo`dot ko jktb oatikoalao` rdcikoal rdcigds nkr igpldgdotatiko ao` donkrhdgdot. 99 Sbilst tbdhrdatiko kn tbd IHPZ] is uo`kujtd`ly a sicoinihaot stdp tkwar`s dosurioc tbdahhdssijility kn hlioihal trial àta, a ougjdr kn dxpdrts bavd tafdo tbd vidw tbattbd IHPZ] gioigal àta sdt is skgdwbat ioa`dquatd ao` gkrd ionkrgatikowkul` jd rdquird` nkr aoy gdaoiocnul aoalysis kn hlioihal trials tk jd

pkssijld.1==

Kod gaekr hkohdro kn tbd pbargahdutihal ioùstry is tbat hlioihal trialrdcistratiko gay knndr hkgpdtitkrs ahhdss tk ionkrgatiko tbat is sujstaotiallyprkpridtary. Zdprdsdotativds kn tbd ioùstry bavd partihularly dxprdssd` tbdkjedhtikos kn its gdgjdrs tk tbd ìshlksurd kn nivd àta itdgs io tbd IHPZ]systdg nkr jdioc hkggdrhially sdositivd, tbdsd jdioc5 knnihial shidotinih titld6

92cm#3


25/28


DA] :8

iotdrvdotiko oagd6 tarcdt sagpld sizd6 prigary kuthkgd6 ao` fdy sdhkoàrykuthkgds. Pbd ioùstry bas arcud` tbat tbd ìshlksurd kn suhb ionkrgatikowkul` `dprivd tbd kricioatkr hkgpaoy kn tbd jdodnits kn jdioc tbd nirst tk

dotdr tbd garfdt witb a okvdl prkùht.1=1

It is, bkwdvdr, pdrtiodot tk oktd asstatd` darlidr, tbat tbd kjlicatiko tk prktdht tdst àta uo`dr PZI]X is oktuoqualinid`. @ishlksurd is allkwd` wbdrd odhdssitatd` jy kvdrriìoc pujlihiotdrdst ao` tbd igpldgdotatiko kn rdcistratiko ao` rdsults rdpkrtioc systdgsnall witbio tbis dxhdptiko.1=:

4 @ata Dxhlusivity ao` Ahhdss tk Gdìhiods

Io cdodral, tbd PZI]X Acrddgdot sddgs tk bavd igpksd` uoinkrg staoàr`stbat ard lifdly tk jdodnit gaekr I] bkl`drs, larcdly rdsi`dot io `dvdlkpd`hkuotrids, at tbd dxpdosd kn dgdrcioc ao` ldast `dvdlkpd` dhkokgids, wbihbwill bavd tk pay bdavidr rdots nkr tbd usd kn gk`dro tdhboklkcy. Pbis is alsktbd hasd witb rdcar` tk tbd spdhinih prkvisikos rdlatioc tk àta dxhlusivity.Io`dd`, nkr tbd vast gaekrity kn Anrihao hkuotrids ao` ktbdr `dvdlkpiochkuotrids witbkut aoy sicoinihaot gaounahturioc hapahity io tbdpbargahdutihal ioùstry, àta dxhlusivity knndrs ok rdal jdodnits. Itshkotrijutiko tk jkkstioc tbd iovdstgdot hligatd io suhb hkuotrids is at jdstdquivkhal, civdo tbd naht tbat pklitihal stajility, skhial sdhurity ao` dhkokgihviajility ard alsk igpkrtaot nahtkrs tbat ionkrg iovdstgdot `dhisikos.Okodtbdldss, as suhhiohtly oktd` jy Gihbadl Gkrcao, tbd PZI]X Acrddgdotbas jdhkgd a rdality tbat gust jd tafdo iotk ahhkuot io aoy stratdcy tkrdgd`y tbd caps io ahhdss ao` iookvatiko io `dvdlkpioc wkrl`

pbargahdutihal garfdts.1=8

Pbd dxtdot tk wbihb tbd PZI]X àta prktdhtiko rdquirdgdots hao jd sai` tkprdhlu`d tbd craot kn garfdtioc apprkval ko tbd jasis kn jikdquivaldohd gayhkotioud tk dlihit sicoinihaot hkggdotarids. It is okodtbdldss hldar tbat tbdPZI]Xodcktiatkrs ìrdhtly rdedhtd` prkpksals tk iohlu`d prkvisikos tbat gicbtajsklutdly prkbijit tbd usd kn kricioatkr tdst àta io craotioc garfdtiocapprkval tk cdodrih gaounahturdrs.1=0 Bkwdvdr, as tbd prdhdìoc sdhtiko`dgkostratds, tbd nldxijilitids allkwd` uo`dr PZI]Xard nurtbdr hirhugshrijd`jy tbd PZI]X-plus kjlicatikos hkotaiod` io gaoy nrdd tra`d acrddgdotspursud` jy tbd TX ao` tbd Durkpdao Toiko. Pbis pkiot was oktd` jy tbd

1=1.,66,9 E9)A *$%4 2)$0?%AA,93 *&&)HJ%6, CJH, 79,&J0,46 D4J6,0 F6%6,&


26/28


DA] :0

Anrihao Toiko io tbd :==4 Hairk @dhlaratiko wbdrd tbd Gioistdrs pksitd` asnkllkws5

Sd oktd tbat tbd Anrihao Crkup ioitiatd` tbd ìshussiko ko tbdhlarinihatiko kn nldxijilitids io PZI]X, partihularly io rdlatiko tk patdotsao` pujlih bdaltb as wdll as jikìvdrsity. Sd hall ko Anrihao hkuotridstk tafd apprkpriatd gdasurds at tbd oatikoal ldvdl tk gafd null usd kntbdsd nldxijilitids io liod witb tbd kuthkgd kn tbd AT HkggissikoSkrfsbkp bdl` io Garhb :==4 io A`ìs Ajaja. Sd hall ko tbd DT okttk iotrkùhd io tbd D]A VDhkokgih ]artodrsbip AcrddgdotWodcktiatikos aoy PZI]X plus prkpksals (wbihb ck jdyko` dxistiocPZI]X kjlicatikos) wbihb wkul` hkgprkgisd tbdsd nldxijilitids. Insuhb prkpksals ard a`vaohd`, tbdy sbkul` jd rdedhtd`. 1=4

Nkr Anriha, it sddgs tbd odd` tk juil` iookvativd hapahity is okt io aoy waydobaohd` jy a àta dxhlusivity rdcigd, jut tbd PZI]X Acrddgdot hkotaioshdrtaio sandcuar`s tk dosurd I] prktdhtiko `kds okt jdhkgd ao igpdìgdot tknrdd tra`d ao` `dvdlkpgdot. It is uolifdly tbat Anriha ao` gkst `dvdlkpiochkuotrids stao` tk jdodnit sicoinihaotly nrkg tbd clkjal gkvd tkwar`s auoivdrsal staoàr` nkr àta dxhlusivity ao` I] prktdhtiko.

It is hkotdo`d` tbat it is hritihal nkr `dvdlkpioc hkuotrids tk nkrg a hkggkonrkot io rdsistioc jilatdral kr nrdd tra`d acrddgdots tbat tafd away krhirhugshrijd tbd nldxijilitids allkwd` io PZI]X. Pbd PZI]X staoàr` nkr àtaprktdhtiko is tbat it gust jd prktdhtd` acaiost uonair hkggdrhial usd.Bkwdvdr, tbd kjlicatiko acaiost ìshlksurd `kds okt prdhlu`d hkuotrids nrkg

ahtioc io tbd oatikoal iotdrdst io tbd dvdot kn a pujlih bdaltb dgdrcdohy. It issujgittd` tbat `dvdlkpioc hkuotrids odd` tk dosurd tbat tbdsd ìstiohtikos ardhapturd` io tbdir oatikoal nragdwkrfs nkr àta prktdhtiko.

4.1 Pbd PZI]XNldxijilitids

Pbd PZI]X Acrddgdot bas a ougjdr kn prkvisikos tk prktdht pujlih iotdrdstao` tbd iotdrdst kn `dvdlkpioc hkuotrids. Pbdsd prkvisikos ard hklldhtivdlyfokwo as tbd PZI]X nldxijilitids. Artihlds 3 ao` 2 kn tbd PZI]X Acrddgdot

prkvi`ds tbat tbd Acrddgdot sbkul` jd igpldgdotd` io a way hkoùhivd tktbd skhik-dhkokgih iotdrdsts kn partids ao` tbat Gdgjdrs ard allkwd` tk tafdgdasurds tk prktdht pujlih bdaltb ao` iotdrdst.1=> Hkgpulskry lihdosioc isaoktbdr gaekr nldxijility tbat gay jd usd` tk wbittld `kwo aoy jarridr tbatgay jd hkostitutd` jy tbd PZI]X àta dxhlusivity rdcigd, dspdhially wbdrdsuhb lihdohds ard issud` tk prktdht pujlih bdaltb. Pbis pksitiko is nurtbdr

1=4*E9JH%4 D4J)4 5)4E,9,4H, #E @J4J&6,9& #E M9%0,3)Od& !1,1&-%#1"= G%5="#"-18, 8,

.?) P%*8-1"-18,&3 T90 #90J4%9- F,&&3 *DjM:j@:Lj;R5./ 1:::> 1_] G'4, W__K>

a?66(Ujj+++/J&&%E9JH%/)9Ij'($)%0&jR7*;R5.GDL_K/7;hn/1=>42


27/28


DA] :4

rdionkrhd` jy tbd naht tbat Artihld 89(8) kn tbd PZI]X Acrddgdot dxplihitlyallkws a pujlih iotdrdst dxhdptiko wbdrd pujlih bdaltb is iovklvd`. Ioa`ìtiko, tbd ldast `dvdlkpd` hkuotrids ard civdo uotil 1 Euly :=:1 tk hkgply

witb tbd staoàr`s igpksd` jy tbd PZI]X Acrddgdot.1=3

SPK Gdgjdrs gaytbdrdnkrd rdly ko tbd availajld PZI]X nldxijilitids tk a``rdss aoy sicoinihaotpujlih bdaltb prkjldg anndhtioc tbdg ao` tbis will okt ruo ankul kn tbdirkjlicatikos uo`dr SPK law. It is, bkwdvdr, igpkrtaot tk oktd tbat `dvdlkpiochkuotrids hao `dprivd tbdir pkpulatikos kn tbdsd nldxijilitids in tbdy `k okt puta cuar` acaiost iokrìoatdly bicb staoàr`s kr PZI]X-plus prkvisikos tbatgay jd igpksd` jy jilatdral kr plurilatdral tra`d acrddgdots.

> Hkohlusiko

Pbd igpaht kn tbd PZI]Xàta dxhlusivity rdquirdgdots ko ahhdss tk gdìhiodsis okt witbkut its hkotrkvdrsids. It is iohkotrkvdrtijld tbat patdots, ao`kjlicatikos arisioc nrkg tbdir prktdhtiko, ard okt tbd koly rdasko nkr tbdprkjldgs asskhiatd` witb ahhdss tk gdìhiods. A gyria` kn skhik-dhkokgihnahtkrs ard rdspkosijld nkr tbd ahhdss tk gdìhiods hkouo`rug. Pbat is wbytra`d rulds ao` I] prktdhtiko sbkul` okt jd nasbikod` io a way tbat willdxahdrjatd tbd prkjldg.

It is jdyko` `kujt tbat tbd rdculatkry purpksd nkr `ruc garfdtioc apprkval isgkrd hkoodhtd` witb dnnihahy ao` sandty kn `rucs tbao lkwdrioc tbdir prihds.@ata dxhlusivity alsk knndrs aoktbdr laydr kn prktdhtiko tk patdot bkl`drs io tbdpbargahdutihal ioùstry ao` tbat prktdhtiko is okt `dpdo`dot ko tbd patdot

tdrg. It tbdrdnkrd appdars tbat àta dxhlusivity will koly jd kn rdal jdodnit tk`dvdlkpioc hkuotrids tbat bavd skgd sujstaotial pbargahdutihalgaounahturioc hapahity.

Artihld 89 kn PZI]X sbkul`, bkwdvdr, okt jd hkostrud` as gafioc tbd usd knhkgpulskry patdot lihdosioc gkrd kodrkus as tbd vali` issuaohd kn ahkgpulskry lihdohd uo`dr tbd PZI]X rdcigd sbkul` a`dquatdly satisny tbdrdquirdgdots kn Artihld 89(8). @dvdlkpioc hkuotrids ard jkuo` jy tbdiriotdroatikoal kjlicatikos io rdlatiko tk tbd prktdhtiko kn I] ricbts. Okodtbdldss,tbd kpdratiko kn tbd PZI]X Acrddgdot is lifdly tk gafd ahhdss tk ckk`ssicoinihaotly ìnnihult io rdcikos tbat ard ydt tk nully dgjrahd tbd clkjal gkvd

tkwar`s tbd prkgktiko kn nrdd tra`d. Pbd PZI]X Acrddgdotwas iotrkùhd` tkdosurd tbat tbd nrdd nlkw kn ckk`s ao` sdrvihds io iotdroatikoal tra`d `kds oktionriocd ko I] ricbts. Bavioc a strkoc iotdroatikoal I] nragdwkrf witbkut ahkrrdspkoìoc rdgkval kn jarridrs tk garfdt dotry is lifdly tk gafd ahhdss tkckk`s gkrd ìnnihult ao` dxpdosivd. Ao igpkrtaot way kn a``rdssioc tbdahhdss tk gdìhiods prkjldg io `dvdlkpioc hkuotrids is tbrkucb tbd stratacdgkn nrdd tra`d. Pbd rdgkval kn jarridrs tk traos-jkr`dr gkvdgdot kn ckk`s willnurtbdr nahilitatd ahhdss tk hbdapdr ckk`s ao` dvdo dohkuracd gaounahturdrs

1=3F,, .^-%,&18, 86 -'% 4#",&1-18, ?%#180 7,0%# )#-15=% SSQVJ 68# D%"&- G%B%=89%0 L87,-#;

!%+/%#&3 cM# ;)H :7j5jXQ 1;,HJ&J)4 )E OO G'4, W_OT>a?66(Ujj+++/+6)/)9Ij,4I$J&?j4,+&q,j4,+&OTq,j69J(qOOp'4OTq,/?6Ar0,HJ&J)4/n/


28/28


tk iovdst gkrd io tbd rdcikos tbat ard lifdly tk jd gkrd hkggdrhially viajldùd tk tbd ajsdohd kn garfdt jarridrs.

It is sujgittd` tbat ahhdss tk tdst àta nkr tbd purpksds kn dosurioc `ruc sandtyao` dnnihahy is ao iotdcral part kn tbd ricbt tk bdaltb ao` rdldvaot tkhkosugdrs wdlnard ao` prktdhtiko. Pbd sagd arcugdot applids tk ahhdss tksuhb prkùhts jy garfdt hkgpdtitkrs dspdhially wbdrd odhdssary tk a``rdss apujlih bdaltb situatiko, dvdo in it is okt a rdal ao` iggdìatd dgdrcdohy. @atadxhlusivity, it is sujgittd`, sbkul` okt jd a jarridr tk tbd usd kn hkgpulskrylihdohds uo`dr PZI]X,jut oditbdr àta dxhlusivity okr hkgpulskry lihdosioc iskn rdal sicoinihaohd wbdrd tbdrd is a gioigal pbargahdutihal gaounahturiochapahity. It is tbus nurtbdr sujgittd` tbat tbdrd is a odd` nkr `dvdlkpiochkuotrids tk usd tbd stratacdg kn dhkokgih hkllajkratiko ao` rdcikoal garfdtiotdcratiko tk `dvdlkp strkoc lkhal gaounahturioc hapahity io tbd

pbargahdutihal sdhtkr ao` prkgktd tbd nrdd gkvdgdot kn ckk`s witbiordcikoal garfdts.

data exclusivity and public health under the trips agreement

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