Imithetho yehlabathi lonke isebenzisa igunya elibalulekileyo kushishino lwamayeza, ukuphuhlisa, ukuvelisa, nokufumaneka kwamayeza ngemithetho ecwangcisiweyo. Ezi zigqibo zowiso-mthetho zinokunyusa uphuhliso zize ziphucule ukufikelela komguli okanye iindleko eziphezulu zentengiso zekuthintela ukunikezelwa kwemali. Ukuqonda indlela imithetho egqithiswe ngayo ziipalamente, iingqungquthela, kunye nokuphembelela impembelelo yemibutho elawulayo yeziyobisi kubalulekile kubenzi benkqubo yezonyango, iingcali zezonyango, kunye nezigulana. Eli nqaku lihlolisisa iindlela eziphambili zomthetho ezichaphazela icandelo lonyango, kwimiqathango yokukhusela kunye nokulawula intengo yexabiso ukuze kuhlawulelwe imigaqo kunye nokhuphiselwano oluqhelekileyo, kunye nohlalulo olukhoyo oluye luthi guqule imeko yendalo.

Izakhiwo ezilawulayo zoMthetho

Iinkampani zezenkcitho zisebenza kwimithetho eninzi elawula lonke icandelo leziyobisi ezikwi-’ ibhayisekile. Le mithetho ivela kwiindlu zowiso-mthetho zesizwe, kumaqumrhu alawulayo, nakwizivumelwano zorhwebo lwamazwe ngamazwe. Impembelelo yazo ezimanyeneyo imisela ukuba inkampani inokubiza malini ngonyango olutsha, ixesha elingakanani elinokunandipha ukuthengiswa kweziyobisi, nokuba izigulana zinokulithenga na iyeza elifunayo.

Imithetho Engamkelekanga Namaxesha Okugxothwa

I-Patents zilelona lale siseko solwakhiwo olugunyazisa amayeza. Zinika abasunguli i-̬ yexeshana; ngokwemo-yokuqala iminyaka engama-20 ukusuka kwi-'dial date ̬ iinkampani ezingcakaza ukuphinda zinyuse uphando olukhulu kunye nexabiso lophuhliso. Noko ke, imvume yokufumana iziyobisi zisoloko zijongene nolwandiso olufana nokulungisa okusemthethweni (umz., iHatch-Waxman Act eUnited States) okanye isiqinisekiso sokukhusela eYurophu. Ngelixa ezi zandiso zinyusa iprojekthi eziphezulu, zibambe ungeniswa kweziyobisi eziqhelekileyo, zigcina amaxabiso aphezulu kangangeminyaka. Abenzi bomthetho kufuneka balinganisele imfuneko yokufumana iziyobisi ezintsha kunye nomdla ofikelelekayo.

Umthetho uyahluka-hluka kakhulu kuwo onke amazwe. Amanye amazwe amisela imigaqo engqongqo efuna ukugunyaziswa okanye avumele ukunyanzeliswa kweemeko zonyango loluntu. Ngokomzekelo, isindululo seDoha kwiTRIPS neTreculture Health, siqinisekisa ukuba amazwe anokuzikhupha imvume yokuvelisa iintlobo ezithile zamayeza ayimfuneko ngexesha lamanqam.

Iindlela zokulwamkelo lolawulo

Imithetho emisela iinkqubo zokuvunywa kweziyobisi ngokungqalileyo ichaphazela ixesha lokungena kunye namaxabiso. Iinkqubo ezifana ne-FDA yoLawulo loTshayina neziyobisi (FDA) kunye ne-European Medicines Agency (EMA) esebenza phantsi kwemithetho elawula imfuno zovavanyo lwezakhono, imilinganiselo yokhuseleko, kunye nohlaziyo lwexesha. Iindlela ezicwangcisiweyo zokungena kwi-EPH̬ ezifana ne-FDAP & 8817; ukuqhekeza isiqu se-PRIME ̱ isicwangciso se-PRIMES esingumthetho esisungulwe ngesantya sokufikelela kwisiqinisekiso sonyango. Ngokuphikisanayo, iimfuno zomthetho ezinzima zinokulibazisa ukungena nolwando olunzima.

Imigudu yakutshanje yowiso-mthetho, njenge-21 Century Cures Act kwi-U.S., ijolise ekusebenziseni iindlela zovavanyo lwezamayeza zale mihla kwaye ibandakanya ubungqina behlabathi bokwenene ukukhawulezisa imvume ngaphandle kokulalanisa.

Uphando nophuhliso

Oorhulumente basebenzisa iibhonasi zerhafu, izibonelelo, kunye nezibonelelo zokukhuthaza amayeza i-R&D. UMthetho we-Elevant Drug (1903) eUnited States ungumzekelo obalaseleyo: unika ityala lerhafu lokuvavanya i-alphantiumzam, ixesha lokuthenga irhafu leminyaka esixhenxe, kunye nemali yokuhlawula iziyobisi ezijolise kwizifo ezinqabileyo. Imithetho efanayo ikho eJapan nase-Europe. Ngelixesha ezi zihlombele ngokunempumelelo i-glose i-transki, kwakhona ifumene ukugxekwa kwexabiso lokusebenzisa amaxabiso ee-e-e-actrobisticssssssssss, utshintsho lwemiqathangonyaka encinane yabantu abanezigulana.

Imithetho echaza iziyobisi ngokuthe ngqo

Ezinye izikhululo zowiso-mthetho ziyangenelela ngqo ukuze zimisele okanye zimisele amaxabiso eziyobisi, ingakumbi kumazwe anenkqubo yokunyamekela impilo enye. Le mithetho isoloko ijolise ekugcineni amayeza anokufumaneka ngokulinganayo ngoxa iinkampani zamayeza ziqinisekisa ukuba zifumana ingeniso esengqiqweni.

Izilawuli zamaxabiso kunye neenkqubo zokutyhila

Amazwe anjengeKhanada, iFransi, neJamani asebenzisa ulawulo lwamaxabiso olumisela amaxabiso anokuvunyelwa amaxabiso amatsha. Umzekelo, iAmNOG yomthetho igunyazisa ukuba abenzi bale mveliso bathethe ngexabiso lemali ye-inshorensi yempilo yesizwe ne-athoric yesizwe kunyaka omnye wokundululwa, ngokusekelwe kwingenelo eyongezelelekileyo yonyango. Amazwe amaninzi asebenzisa iprojekthi yangaphandle, apho ixabiso kwelinye ilizwe lithengiswe ngamaxabiso kwibhanti yamazwe alinganayo. Le nkqubo ithintela abenzi ukuba bafumane intengo ephezulu kakhulu kumaxabiso entengiso ezithile kodwa anokuthintela ukusetyenziswa kwe-sentengiso.

IUnited States ibalasele phakathi kwamazwe ahambele phambili ngenxa yokungabikho kwawo kolawulo olungqalileyo lwamaxabiso karhulumente, nangona amanye amazwe eye azama ukuwazisa.

Ukudanyazisa okucace gca

Ukungabikho kokuvela kweprojekthi kungumqobo ozingisileyo kumayeza angafikelelekiyo. Izindlu zowiso-mthetho ezininzi ziye zaphendula ngokunika imithetho efuna iinkampani zezonyango ukutyhila i-R&D iindleko, iindleko zorhwebo, kunye namaxabiso omnatha. I-Drug Price Transparency Act (inxalenye yepakethi yama-20222 ye-omnibus) ifuna abenzi beziyobisi ukuba bathethelele amaxabiso aphezulu ngaphezu kokunyuka kokwehla kwamaxabiso. I-EU̱ i-Scengcengceng amalungu akhuthaza amaziko asasaza ulwazi ngokusetyenziswa kweziyobisi kunye nezibonelelo. Umthetho we-Transparedificiotivel unika abahlawule nabaguli ukuba baqhube ulwano lwezintsebenzi olungcono kunye nezimvo ezifuna ukuphendula kwiinkampani.

Ukusetyenziswa kwemiba yehlabathi

Imithetho iqwalasela ngokukhulayo ukusebenzisa amaphawu eebheji kwinkcitho yeziyobisi zasekhaya. Ngo-2023, iSebe lezempilo kunye neeNkonzo zoluntu lase-U.S. lavakalisa imodeli eyakudibanisa amaxabiso eMedicara B kwisalathiso samaxabiso angaphandle. Le ndlela, maxa wambi ibizwa ngokuba yi-̴ eyona ithandwayo yelizwe i& #8221; ukusetyenziswa kweziyobisi, iye yacetyiswa kwiintlobo ezahlukeneyo kwiindleko zeko-mbutho. Ngoxa ukuthelisa ngezizwe ngezizwe ngezizwe kunganciphisa iindleko, ikwabeka engozini ingeniso yabasebenzi bezoshishino kwiimarikethe ezincinane, ezinokubangela ukufikelela kwizigula ezisemhlabeni.

Ukhuphiswano Lwabathengisi Neziyobisi Zobundlobongela

Ukhuphiswano oluvela kwiziyobisi eziqhelekileyo nezifanayo yenye yezona zixhobo zinamandla zokunciphisa amaxabiso. Imithetho idlala indima engqalileyo ekulungiseni imekobume esemthethweni nelungelelanisayo eyenza olu khuphiswano lukwazi ukuhla.

Umthetho we-Hatch-Waxman kunye noNgeno lohlobo oluthile

Umthetho wePatenst Pacce Baccount and Patt Personation Terment Act ka 1984 (owayaziwa ngokuba nguMthetho weHatch-Waxman) waguqula urhwebo lweziyobisi oluqhelekileyo lwase-U.S. Yadala indlela entsha efutshayelelweyo yeziyobisi (NA) indlela, ivumela ukuba ixhomekeke kwi-data ekhuselekileyo nesebenzayo kwi-innovator remonterior. Ngokutshintshisana, ivumela ulwandiso lwegama elisemthethweni lweziko lobugrabhabha. Umthetho wamisa kwakhona ixesha le-180-sclusclues yexesha lokuqala le-octive ukuvavanya ubuchule, ukuvavanyanisa ungeniso lokuqala lwentengiso. Izicwangciso ze-Ebhusayithi zemithetho ekho phantsi kolawulo oluqhelekileyo lwamanyeneyo, njenge-#82222; imijikelo ye-oplue-opt proces.

Umthetho Wezinto Eziphilayo

Iziyobisi ze-biologic zintsonkothe kakhulu kune-molecule encinane, kwaye zizisa i-bioximagnetics emarikeni zifuna imigangatho eyahlukileyo yolawulo. I-Biologics Price Prize kunye noMthetho we-involution ka-2009 (BPCII) wenziwe i-infsureans ye-biomiculares e-U.S., efuziselwe i-Hatch-Waxman Act yoonoleumles encinci. Inika ixesha leminyaka eli-12 lokufumana i-biologiclicss kwaye ifuna inkqubo yokulungisa iprojective. Umthetho waseYurophu (unyaka 2001/83/EC'ocreactived') unohlobo olufanayo olufanayo, ukuchaza amagama, ukubiza kwe-ophaka kwe-protemplate, imigaqo-mthetho ye-ekhoratimeties.

Izenzo zokulwa nokuhlasela

Imithetho ijolise inkcubeko echasene nophicotho-mphicotho oluthintela ukungena okuqhelekileyo. “ Imali- ye-delay ̵ Indawo yokuhlala i̵ apho inkampani yohlobo oluthile ihlawula umbangi ukuba ilibazise ukukhupha uhlobo oluphantsi koguqulelo lwe-̬ iye yacetyiswa phantsi kwemithetho elwa ukulwa nomthetho we-ocerential eU.S. ne-EU.S. Inkundla ephakamileyo yezoshishino kwi-FTC v. Actis (2012) yagqiba kwelokuba izithuba ezinjalo mazihlolwe phantsi komthetho wesizathu. Ngokulandelayo, ezinye izicawano zesizwe zidlulise imithetho efuna ukukhutshelwa kwezi zivumelwano. I-ofisi ze-Europe ifake izihlazo ezinzima kwimibutho esebenzayo kwimisebenzi enjalo. I-U. I-Actisvotivey

Ukubuyiselwa kwe-Intervey kunye nokukhutshelwa kwemithetho

Kwanaxa kukho iziyobisi emarikeni, izigulana azinakungenelwa ngaphandle kokuba zigqunywe zii-inshorensi okanye ziinkqubo zempilo kawonke-wonke.

Icandelo D Nothintelo Lobuhlanga

Kangangeminyaka, inkqubo yeMedicare yase-U.S. yayivalwa ngumthetho ukuba ichaze amaxabiso eziyobisi ngqo nabenzi. Oku kuthintela kwafakwa kuMthetho weMedicare Modertification ka-2003. Ngenxa yoko, abaxhasi becandelo D bemimiselo babebekelwe umda wamandla okuthelekisa. UMthetho we-Infladiation Reduction ka-202222 waphawula utshintsho olungokwembali ngokunika iMedicare ligunya lokudibanisa amaxabiso athile amaxabiso aphezulu amayeza aqala ngo-2026. Lo mngeni-mthetho ulindeleke ukuba ukunciphisa iindleko zobhaliso kwaye unciphise iindleko zemali ezingamawaka ezigidi zeerandi.

Uyilo Oluqhelekileyo Nonyango Lwenyathelo

Umthetho uphembelela indlela abafaki-mali abasebenzisa ngayo amayeza. Amanye amajelo anike imithetho ethintela ukusetyenziswa kwemithetho yokusetyenziswa konyango lwamanyathelo, efuna izigulana zizame amayeza angephiyo ngaphambi kokufumana amayeza abiza imali eninzi. Unyango lwenyathelo lungalibazisela unyango olusemgangathweni, ngokukodwa kwiimeko ezinganyangekiyo. Ngokuchasene noko, imithetho eyalela ukuba ukwenziwa konyango olubanzi lungaphucula ukufikelela kodwa lunganyusa imiyalelo. Abaphathi bomthetho bafuna ukulungelelathatho oluneyo ngomgaqo oluncedo, njengomyalelo wakutshanje wokufumana iklasi yeziyobisi ecacileyo.

Ingeniso esekelwe kwixabiso kunye neengeniso ezisekelwe kwintengiso

Iimodeli zembuyiselo yokubuyiselwa kwemali, njenge-price esekelwe kwixabiso, ibhatala kwiziphumo zezakhono. Izindlu zowiso-mthetho ezininzi ziye zagunyazisa okanye zavavanya ezi zicwangciso zomqhubi wenqwelo-moya kwiinkqubo zikawonke-wonke. Umzekelo, iMedicare Evece Pate Genera Recount Care corence Organization imodelity Organization kwaye inguMedicaidrs ivumela iziphumo ezisekelwe kwizivumelwano. Inkxaso yemithetho yokuqokelela ugcino-data lokwenene kunye nokukhusela ekukhohliseni nokuxhaphaza (amazibuko akhuselekileyo akhuselekileyo) akhuthaza abenzi kunye nabahlawula iimfuno zokungena ezi zivumelwano. Le mithetho iyakwazi ukumisela izikhundla ezinxulumene neziphumo zempilo ezinxulumene norhwebo.

Uphuhliso loMthetho lwakutshanje notyekelo lwexesha elizayo

Le ngxoxo yamayeza iye yanda kwiminyaka yakutshanje, nto leyo ebangela ukuba kubekho uwiso - mthetho oluphawulekayo ehlabathini lonke.

UMthetho wokuKhuthulwa koMgaqo-nkqubo

Ngo-2029, i-$2 000 esayinwe ngomthetho wecandelo D. Ukukhutshwa kweziyobisi, i-Inflation Reduction Act (IRA) imela eyona njongo itshayelelayo yokuhlahlela kweziyobisi kumashumi eminyaka. Imigaqo engundoqo iquka iMedicare amanani afikelela kuma-60 eziyobisi ngo-2029, i-$2 000 e-afly cappestet yePart D, ukunyuka kwexabiso leziyobisi kunyuke kakhulu, ukunyuka kwexabiso lokunyuka kwexabiso lemali, nokuphinda kuncitshiswe kwexabiso lenxalenye D yemali eyingozi. IRA ikwalibazisa ukuqala kwexabiso le-antelligement-mone yeziyobisi ezincinane ze-magenters (iiiiiiiii-magence) kunye nenkqubo yezebhayoloji de kube yiminyaka eli-13, ngokunempumelelo kuncitshiswa kweziyobisi ezithenjiweyo zezigulanamyubhini ezizi ezizingeno-RD.

Iqhinga lonyango lwe-EU noTshintsho

IKomishini yaseYurophu yakhupha iMicimbi yeNkqutyana yeeNkcubeko yeNkcubeko yeYurophu ngowama-2020, inenjongo yokwenza amayeza afikelelekayo, anokufikeleleka kunye notshintsho. Utshintsho olucetyisiweyo lomthetho luquka ukunciphisa ixesha logcino-lwazi lolawulo ukusuka kwiminyaka eyi-8 ukuya kwengama-6, kunye nemivuzo eyongezelelekileyo yokuhlangabezana neemfuno zezamayeza ezingachananga okanye ukuqhuba iimvavanyo ezisebenzayo. Le nkqubo ikwafuna ukulwa nokunqongophalaza, ukukhuthaza ukuveliswa koluhlaza, kunye nokuphuculwa kweentshukumisa zeziyobisi eziyinkenenkene. Ukuba olu tshintsho lunokusetyenziswa, lungabuyisela ulawulo lwendawo oluhlala kumazwe angama-7 kumazwe angamalungu kunye namaxabiso afanelekileyo amayeza alungele ukusetyenziswa ngokulinganayo.

Ukuthuthwa Kweziyobisi Emhlabeni Wonke

Imithetho yamazwe afumana i-Istature eKhanada, eJapan, kunye namazwe aphantsi naphakathi ahamba phambili kuhlolo lwezichazi-ziyobisi. i-Canada ̱ iPaented Medicine Medicine Prices Review Board (PMPRB) iyilungise imithetho yayo yokwandisa ingobozi yayo yamazwe asebenzisa ikhompata kunye nokwandisa ukubonakala. IJapan ihlaziya amaxabiso eziyobisi ngokuqhubekayo kuvavanyo lweNational Inishuwarensialism kwaye ivelise inkqubo yokuhlola iindleko eziphezulu zeziyobisi. IBhunga Lehlabathi Loluntu lezempilo liye labiza ukusetyenziswa kakhulu kokufumana imali efumaneka kwimiqathango yokuzithandela nakwiimimiselo esezantsi yexabiso lovimba.

Isiphelo

Imithetho ilawula izigqibo zomthetho iqinisekisa ukuba ngaba uphuhliso lwezigulana lunamandla angaqhelekanga okubumba ushishino lwamayeza ngemithetho echaphazela lonke iqondo lobomi beziyobisi. Ukusuka kukhuseleko olusemthethweni kunye ne-R&D iintshukumisa zokulawula amaxabiso, ukhuphiswano oluqhelekileyo, kunye nemigaqo-nkqubo yokubuyisela intsebenziswano, izigqibo zomthetho wemithetho-siseko ziqinisekisa ukuba ngaba ukuphucula ukuhambela phambili kwemeko yezonyango zinokuyihlawula na imichiza efunekayo. Utshintsho lwakutshanje, olufana nomthetho osekelwe kumthetho obalulekileyo wokwenza inkqubo ye-EU. Ukhuseleko lwe-Reduction Reduction kunye noMgalelo-opera-mthetho we-yokusetyenziswa kweziyobisi, ukuphawula ukunyuka kwezobupolitika ukuphelisa amaxabiso eziyobisi. Noko ke, ukufikelela ukulungele ukuhambelana kolwazi olunenzuzo kwinkqubela yonyango oluzayo.

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