Mitemo inoshandisa chiremera chenyika yose chesimba pamusoro peindasitiri yemishonga, kuumba kukura, kugadzira, uye kuvapo kwemishonga kupfurikidza nemitemo yakagadzirwa nokungwarira. Izvi zvisarudzo zvemitemo zvinogona kukurumidzisa kugadzirwa nokuvandudza kusvika kwomurwere kana kuti kuisa mari yakakwirira ndokuganhurira kugoverwa. Kunzwisisa kuti mitemo inoitwa neparamende, masangano, uye kupesvedzerazve kwemitumbi yemirimo kunokosha kuvagadziri vemiitiro yemirimo, nyanzvi dzezvoutano, uye varwere zvakafanana. Nyaya inonzvera miitiro mikuru yemitemo inotapura kuiswa kwemishonga inotapura murutivi rwachiremba, padziviriro nemitengo yemitengo yemitengo yemitengo yemitengo, uye kunzvera kugadziridzazve mishonga kuri kugadziridza nzvimbo yenzvimbo.

Mavara Anodzora Mitemo Anodzora

Makambani anogadzira mishonga anoshanda mukati memitemo mizhinji inodzora chikamu chiri chose chemirimo ’ chikabhuro. Mitemo iyi inobva kudzimba dzomutemo werudzi, masangano anotungamirira, uye zvibvumirano zvebhizimisi ramarudzi ose. Simba rawo reboka rinogona kuraira kuti kambani inogona kuraira kurapa kutsva kwakadini, kuti inogona kufarikanya nguvai kutengeswa, uye kana varwere vachigona kutenga mushonga wavanoda.

Mitemo Yakaipa Nenhambo Dzokusunungurwa

Mapatent ndiwo mapfundo ezvinogadzirwa nemishonga. Vanopa vagadziri vadzori vechinguvana ̬ nenzira inofananidzirwa makore 20 kubva pamusi wescreen ̬ makambani anobhejera kunyorazve ndyiko huru nokuvandudza. Zvisinei, maruramiro emirimo anowanzotarisana newedzero kupfurikidza namasangano apamutemo akadai sokudzorerwa kwapamutemo (g., Hatch-Waxman Act yechinguvana muUnited States) kana kuti magwaro okuwedzera anodzivirira muEurope. Nepo iwaya anopa mibayiro mitsva, anononotsawo kupinda kwemirimo yakaderera yezvo, anochengeta mitengo yakakwirira kwamakore. Vaiti veMutemo vanofanira kudzikamisa kudikanwa kuwana mirimo mitsva mukuwana puro inokwana.

Mitemo inosiyana - siyana munyika dzakawanda. Dzimwe nyika dzinoisa mipimo yokuzviwanisa yakakwana kana kuti dzinobvumira kumanikidzwa kwemigariro youtano yavose. Doha Declaration on TRIPS and Public Health, somuenzaniso, yakasimbisa kuti nyika dzinogona kukurira kodzero dzokuburitsa zvimiro zvemishonga zvinokosha munguva dzenjodzi.

Nzira Dzinotenderwa Nevatungamiriri

Mitemo inotanga tendero dzetendero dzemirimo inotapura zvakananga nguva dzokupinda mumusika nendyiko. Mitemo yakadai seFood and Drug Administration yeUNITED (FDA) neEuropean Medicines Agency (EMA) inoshanda mugadziriro dzemitemo dzinoraira zvinodikanwa zvokuedza, mipimo yekotsekano, uye hwirudzura nguva. Zviratidzo zvinorema zvinodzorwa nezvinovimbisa kurapa. Zvirango zvinorema zvinorema zvinogona kunonotsa kupinda nokuwedzera musika uye kukwira mari, izvo zvinopfuudzira kuvatengi.

Kuedza kubuda kwemitemo munguva pfupi yapfuura, kwakadai sePureaux Cures Act muU.S., kunovavarira kuita kuti kuedza kwemazuva ano kuve kwemazuva ano uye kunosanganisira uchapupu chaihwo hunoratidza kuti nyika ibvumire nokukurumidza pasina kubvumiranisa zvinhu zvisina ngozi.

Nzvero Neenderero Mberi

Hurumende dzinoshandisa zvikwereti zvemitero, mari, uye mari inobhadharwa kuti dzinyandure mishonga R&D. Breat yeMirimo (1903) muUnited States muenzaniso wakatanhamara: inopa chikwereti chemitero nokuda kwokunzvera kwezvokurapa, nhambo yemari inopfuudzwa yegore rinomwe, uye vabhadharisi vemirimo inoparira zvirwere zvisingawanzowaniki. Mitemo yakafanana iripo muJapan neEurope. Nepo idzi sundo dzakatungamirira nenzira inobudirira kumazana emirimo mitsva mitsva yenherera, dzakawanawo kutsoropo nokuda kwokushandisa mitengo yakakwirira pakurapa kwavagari vemo vaduku vanotambura. Kuchinja pamutemo, zvakadai semipimo yemitengo inopfupi inopfupi kana kuti mibhadharo, inokurukurwa nguva nenguva kuti idzivise kubatwa zvisina kufanira.

Mitemo Yakananga Yemirimo Inotengesa

Mimwe mitemo inopindira zvakananga kuti igadzire kana kuti iganhure mitengo yemirimo, zvikurukuru munyika dzine gadziriro dzokutarisira utano imwe. iyi mitemo inowanzovavarira kuchengeta mishonga ichibvira nepo ichivimbisa kuti makambani anogadzira mishonga anowana bhadharo rine mufungo.

Zvidzorero zvemitengo Negadziriro Dzokudzosera

Nyika dzakafanana neCanada, France, uye Germany dzinoshandisa ganhuriro dzemitengo inoisa mitengo inobvumirwa yemirimo mitsva. Somuenzaniso, Germany ̵ mutemo weAMNOG unoraira kuti vagadziri vataurire mutengo nesangano renyika remari yeinishuwarenzi youtano mukati megore rimwe rokutanga, yakavakirwa pakubetsera kwakawedzerwa. Marudzi mazhinji anoshandisa nongedzero dzokunze, apo mutengo mune imwe nyika unoiswa pamitengo munyika dzakafanana. Iyi tsika ino inodzivisa vagadziri kubatira mari yakakwirira zvikuru mumisika yakati asi inogonawo kudzivisa kuendesa kumhanya.

United States yakatanhamara pakati pamarudzi akabudirira nokuda kwokusavapo kwayo kwedzoreso dzemari yakananga dzehurumende, kunyange zvazvo dzimwe nyika dzakaedza kudzisuma.

Kujeka

Kushaikwa kwokuratidza kunoramba kuri mhinganidzo kumishonga inobhadharwa. Masangano emitemo anoverengeka akagamuchira kupfurikidza nokupfuudza mitemo inoda makambani emishonga kuzivisa R&D ndyiko, ndyiko dzokutengesa, uye mitengo yemitengo yemambure. Drug Price Transparefication Act (chikamu che 20222 eamnibus pastiki) inoda vagadziri vemirimo kuti varuramise mutengo kukwira kumusoro kwemitengo. EU&# 817; inoraira mitezo kubudisa mashoko pamusoro pemishonga uye mipinduro. Transparency reparency inoita kuti vabhadharo uye varwere vadzorerwe mishonga iri nani uye vasarutsive nemakambani.

Kuzivisa Kwamarudzi Ose

Mitemo inorangarira nenzira inowedzera kushandisa market amarudzi ose kupedzisa kushandiswa kwemirimo yomumba. Muna 2023, Department of Health and Human Services yeU.S. yakazivisa muenzaniso uyo ungabatanidza Mitengo yeMirimo yeMedicare kumitengo yemimwe mitengo. Iyi nzira, pane dzimwe nguva inonzi “ nyika inodingwa zvikurusa ” kurongedzerwa, yakakarakadzwa muzvimiro zvakasiyana- siyana mumabhiri emasangano. Nepo nongedzero dzamarudzi ose dzinogona kuderedza ndyiko, inoisawo ngozi mibairo mumisika miduku, inobvira inoderedza kukwanisa kupinda munyika yose.

Makwikwi Okushambadza Nezvinodhaka Zverudzi

Mabhuku anoshandiswa pakudzikamisa mitengo anobatsira chaizvo kuumba mamiriro ezvinhu epamutemo uye okugadzirisa zvinhu anoita kuti makwikwi aya akwanise kuderera.

Muitiro weHatch-Waxman uye Kupinda Kwakasiyana - siyana

Drug Price Concence and Paten Perduction Act ya1948 (inozivikanwa kazhinji kazhinji seHatch-Waxman Act) yakashandura musika wemirimo worudzii. Yakatangawo kupfupikisa kushandisirwa kwemirimo itsva (NA), ichiita kuti zvisavike pakoseiwo pakotsekano uye kugona kubuda mumirimo yeIndasimu yekutanga. Kutsinhano yakabvumira kuwedzerwa kweshoko rapamutemo reinjinira. Act yakatangawo nguva ye180-zuva re180 yeaclus resitus reFin as com, kudenha kunyoresa, kuvamba kupinda kwokutanga kwemisika. Zvimiro zvakafanana zviripo muEurope pasi pePrectal 2001/8E. Vagadziri vemitemo nguva nenguva nenguva iyi mitemo inobvumira mitemo kuva pedyo, se-panyuro, se-5202%; proptuaset procet proces #1

Mashandiro Ezvinhu Zvinorarama Nazvo Akaenzana

Mishonga inogadzirwa naFractal Price Back and Innovation Act ya2009 yakagadzirwa nzira yebiomicus muU.S., yakagadzirwa serate yeHatch-Waxman yemitemoreyimu. Inopa nguva yemakore 12 yezvinonyorwa zvesayenzi uye inoda muitiro wekugadziridza kugadzirwa kwemitengo. Mutemo weEurope (Drectivasplanet in U.S. 2001/83 Ceac) une chigadzirwa chakafanana. Kujeka kwaHatch-Waxman pasting, kunyora mazita, uye mitemo inotsiva zvinhu zvipenyu inovakwa necherekedzwa.

Miitiro Yokurwisa Nenzvimbo Dzokugara

Mitemo inodenhawo mufambiro unodzivisa kubatanidzwa kwakarovedzeka. “ Bheja- reficial ̵ Matura ̵ umo kambani yebhubhurokwa inobhadhara mukwikwidzi wakaenzana kunonozetsa kutanga shanduro yakachipa ̬ yakadenhwa pasi pemitemo inodzivisa kuva nomutezo wetsika muU.S. neEU.S. Dare gurusa reFTC v. Actavis (2012) yakatonga kuti misha yakadaro inofanira kuongororwa pasi pomurayiro. Pamuteveri, mimwe mibatanidzwa yehurumende yakapfuudzati yapfuudza mitemo inoda kuziviswa kunyorwa kweizvi zvibvumirano. Dare reEurope rakaisa zvisakiso zvakaisvonaka pamakambani akadaro. Mitengo inodzivisa kunonotsa mitemo iyi inoshanda panguva yakakodzera.

Kudzorerwa Kwemari Neinishuwarenzi Zvinofukidza Miitiro

Kunyange kana mushonga unowanika pamusika, varwere havagoni kubatsirwa kana vakasauwana neinishuwarenzi kana kuti nepurogiramu dzoutano dzevoruzhinji.

Mimedicare Rutivi D Nechirambidzo Chokuparadzana

Kwamakore, gadziriro yeMedicare yeU.S. yakarambidzwa zvakajeka nomutemo kubva pakukwidza mitengo yemirimo zvakananga navagadziri. Iyi ganhuriro yakasimbiswa muMedicare Modertial Act yeMaterminitial ya2003. Somuuyo, Part D vatsigiri vemitengo yakanga yakaganhurirwa simba rokukwidziridza. Infladiation Reduction Act ya 20222 Act yakaratidzira chinjo yenhau kupfurikidza nokupa Medicaracure chiremera chokuwirira mitengo yemirimo yakakwirira inovamba muna 2026. Iyi transctis transmection inokarirwa kuderedza ndyiko dzemari inodzo yehurumende yemabhiriyoni emadhora ane chitsauko gore negore.

Kugadzira Kwakakodzera uye Kurapa Kwomushure

Kudzikamisa mutemo kunopesvedzerawo nzira iyo vapinyi vanoshandisa nayo nzira dzemirimo. Dzimwe nyika dzakaisa mitemo inoganhurira kushandiswa kwemitemo yokurapa nhanho, inoda kuti varwere vaedze mirimo yakachipa vasati vawana mushonga unodhura wakanyorwa. Kurapa kwokutevera kunogona kunonotsa kusvika pakurapa kwakanakisisa, zvikurukuru nokuda kwemigariro isingaperi. Nenzira yakapesana, mitemo inoraira kufukidzwa kwakafara kunogona kuvandudza kusvika asi kungawedzera mitengo. Vagadziri vemitemo vanotsvaka dzikamo kupfurikidza nomutemo wegadziriro inobetsera, zvakadai sezvinodikanwa zvehurumende zvemisi ichangobva kupfuura iyi nokuda kwokupfuudza puro yeboka remirimo.

Zvikamu Zvinotsamira Paukoshi Nezvinobuda

Mitemo inodzosera kudzorerwazve yemari, yakadai semapringita akavakirwa paukoshi, inobvumira miuyo yezvokurapa. Masangano mazhinji emitemo akabvumira kana kuti kunzvera iyi gadziriro mukati mepurogiramu dzavose. Somuenzaniso, Medicare Eventer Generation Reconfidence Care Organization uye hurumende Médidadrs inobvumira miuyo yakavakirwa pamiuyo. Tsigiro yeLegislilative yemiunganidzwa yezvoruzivo chairwo uye dziviriro mukurwisana nekodzero dzokushatadzira (zviteshi zvapa zvakakotseka) zvinokurudzira vagadziri navabhadhari kupinda zvibvumirano zvakadaro. Mitengo iyi inogona kubatanidza zvikonzero kumiuyo youtano youtera panzvimbo pokutengesa.

Kubudirira Kwomutemo Kwemisi Yazvino Uno Nezviito Zvomunguva Yemberi

Kukakavadzana kwemishonga kwakawedzera mumakore achangopfuura, kuchiparira kugadzwa kwemitemo kunokosha munyika yose.

Kuderedza Kukwira Kwemari Mumutemo weUnited States

Chinoiswa mumutemo muna August 2022, Indaction Reduction Act (IRA) inomirira kukwira kukurusa kwemirimo inochinja mumakumi amakore. Gadziriro dzinokosha dzinobatanidza Medicare res reconfix yemirimo 60 panosvika 2029, $2 000 pagore yemirimo yeparera yeParty D, kukwira kwemitengo kunowedzera kukwira kwemitengo yemirimo, uye kudzo yemari inodzo yeParticlet transvolutions divicess pertures. IRA inononotsawo kutanga mutengo wemirimo miduku yemishonga kusvikira makore 9 pashure petendero uye dzidzo yemiripo kusvikira makore 13 kusvikira kukura nhambo inodzo chaiyo. Mutemo uyu unokanwa kuderedza mishonga nemamiriyoni evarwere asi unotongedzerwawo kudarika pamutemo. Kuputsawo pamutemo kwemitengo yapamutemo yarongerwe muteshipi .

Kugadzira Makemikari uye Kuchinja Zvinhu muEU

European Commission yakabudiswa Strategy yayo yeParmaceutical for Europe muna 2020, ichivavarira kuita kuti mishonga ive inosvikika zvikuru, isingabhadhari, uye itsva. Chinjo dzinokarakadzwa dzomutemo dzinobatanidza kuderedza nhambo yemashandiro emitemo edziviriro kubva pamakore 8 kusvikira ku 6, nemimwe mibayiro yokurapa isina kutsarukana kana kuti kutungamirira muedzo wakaenzana. Nzira yacho inotsvakawo kurwisa kuperevedza, kusimudzira kugadzirwa kwegirini, uye kugadziridza zvishuvo zvemirimo isina pamutemo. Kana zvikagamuchirwa, izvi zvingadzoserazve nzvimbo yezve kurapa mumitengo 27 uye mitengo yemirimo ine mwero.

Kuchinjira Nyika Yose Kwokuchinja Zvinodhaka

Maraiti muCanada, Japan, uye mari yakaderera napakati zviri kufambira mberiwo mukuchinja. Canada ̱ Patentided Medicine Prices Review Board (PMPRB) yakagadziridza mirau yayo yokukudza tswanda yayo yenyika dzinoparira nokuwedzera kujeka. Japan inohwirudzura mitengo yemirimo inodzorwa neNational Inssurance zvinodhaka zvinovakisa uye yakatanga gadziriro yokunzvera kubhadhakisa zvinodhaka zvinoshanda zvikuru. World Health Organization yakadana nokuda kwokushandisa kukuru kwemitengo inoiswa mupeyikedzo nokuzvidira kukwira.

mhedziso

Mitemo ine simba rinoshamisa rokuumba indasitiri yemishonga kupfurikidza nemitemo inobata chikamu chiri chose chemirimo inoshandiswa. Kubva kudziviriro yakarongeka neR&D kurudziro dzokudzora mutengo, makwikwi akafanana, uye kudzorwa kwemitengo yemitemo inosarudzwa, zvisarudzo zvemitemo zvinosarudza kana kuvandudza kunobudirira uye kana varwere vachigona kubhadhara mishonga yavanoda. Kuchinja kwazvino uno, kwakadai seU.S. Reducation Reduction Act neEUNICES, zvinoratidza kuti EUP Phracciatetic Systect ichadzora mitengo yemirimo inokura kuti idzoredze kugadzirwa kwemirimo inopfuta zvakanaka uye kuvimbisa kusvika kwakafara kunoramba kuri mumwe wemibvunzo inodenha zvikurusa yenguva yedu. Mafungiro, anokudzwa noufakazi wezvokugadzirwa kwomutemo zvinokosha kuita kuti pave mishonga inorapa apo inosimudzira utano hwenguva yemberi.

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