Malamulo padziko lonse ali ndi ulamuliro waukulu pa maindasitale a mankhwala, kukonza, kugwiritsa ntchito mankhwala, ndi kupezeka kwa mankhwala kudzera m'malamulo okonzedwa bwino. Zigamulo zimenezi zingafulumize kukonza ndi kuwongolera njira zoyendera zokhalira ndi wodwalayo kapena ndalama zokwera ndi kuchepetsa kuperekedwa kwa ndalama. Kumvetsa mmene malamulo amapangidwira ndi nyumba za malamulo, mabungwe, ndi kukonzanso zisonkhezero za makompyuta nkofunika kwa opanga malamulo, akatswiri a zaumoyo, ndi odwala mofanana. Nkhaniyi ikupenda njira zazikulu za malamulo zimene zimayambukira kampani ya mankhwala, kutetezera ndi kuyendetsa malamulo apamwamba a za malamulo ndi kubwezera malamulo ndi mpikisano, ndi kupenda kumene kukusinthanso zinthu.

Malo Olamulira Opereka Mathangata Okhala ndi Malamulo

Makampani opanga mankhwala amagwira ntchito m'malamulo ambirimbiri amene amalamulira mbali iliyonse ya mankhwala osokoneza bongo’ njinga za moyo. Malamulo ameneŵa amachokera ku makhoma a boma, mabungwe oyendetsa zinthu, ndi mapangano a malonda a mayiko osiyanasiyana. Chiyambukiro chawo cha kampani chimakhala ndi ndalama zimene ingapereke kaamba ka mankhwala atsopano, kuti angasangalale ndi ntchito ya msika, ndi kaya ngati odwala angakhoze kugula mankhwala amene afuna.

Malamulo Opanda Chilungamo ndi Nthaŵi Zochoka Panyumba

Makampani ozembera malonda ndi opanga mankhwala ali maziko a ntchito zomangamanga. Amapatsa opanga malo apadera kwa kanthaŵi kochepa a ̬ moyenerera zaka 20 kuchokera pa deti la madeti la madeti a kukonzanso ndi kukonzanso ndalama. Komabe, kuwonjezera mankhwala osokoneza bongo kumayang'anizana ndi njira zopangira mankhwala oyenerera (m'jerect , Hatch-Waxman Act mu United States) kapena zikalata zotetezera ku Ulaya. Pamene kuli kwakuti zimenezi zimawonjezera kuwonjezera kuwonjezereka kwa ntchito, zimachedwetsa kuloŵa kwa mankhwala otchuka, kusungitsa mitengo yapamwamba kwa zaka zambiri. Opanga malamulo ayenera kulinganiza kufunika kwa mankhwala atsopano ndi chidwi chaponse.

Malamulo amasiyanasiyana m'mayiko ambiri. Mayiko ena amakhazikitsa malamulo oyenerera kapena amalola kuti anthu azikhala ndi malamulo okakamiza pa zinthu zofunika pa thanzi la anthu. Mwachitsanzo, Doha Declaration on TRIPS and Public Health inatsimikizira kuti mayiko angachotse mphamvu zololeka kupanga mitundu ya mankhwala ofunika kwambiri panthaŵi ya mavuto.

Njira Zovomerezeka

Malamulo amene amakhazikitsa njira zovomerezera mankhwala amayambukira mwachindunji madeti a nthaŵi zoloŵa m'masitolo ndi ndalama. Mabungwe onga ngati FDA ndi European Medicines Agency (EMA) akugwira ntchito pansi pa malamulo amene amalamulira ziyeneretso za kupima, miyezo ya chitetezo, ndi malamulo openda nthaŵi. Njira zoyendera zopimira pa msika zikhoza kuchedwa kuloŵa ndi kukwera kwa ndalama za FDA ’ Accanonfor the EMAPRACTription kapena E’ PRIME Ô adapangidwa ndi lamulo lopanga liŵiro lakufikira kulonjeza chithandizo chamankhwala. Mosiyana ndi zimenezo, ziyenerezo zolemera zingachedwetsa kuloŵa m'makerekezo ndi kukwera mtengo.

Zoyesayesa zaposachedwapa za boma, monga ngati 21 Century Cures Act mu U.S., zimafuna kupanga njira zamakono zoyesera matenda ndi kuphatikizapo umboni weniweni wa dziko kuti zikhululukire popanda kulolera molakwa.

Kufufuza ndi Kupita Patsogolo

Maboma amagwiritsira ntchito ngongole za msonkho, zopereka, ndi ndalama zothandizira kusonkhezera mankhwala R&D. The Orgin Drug Act (1903) mu United States ndi chitsanzo chotchuka: imapereka ngongole za msonkho kaamba ka kupima kwa odwala, nyengo ya zaka zisanu ndi ziŵiri ya kuchotsa kwa msika, ndi olipira ndalama kaamba ka mankhwala opha matenda osapezekapezeka. Malamulo ofananawo alipo ku Japan ndi ku Ulaya. Pamene kuli kwakuti zisonkhezero zimenezi zatsogolera mwachipambano ku mazana ambiri a mankhwala atsopano amasiye, iwo apezanso chitokoso ku ku kupangitsa kudalira kwa ndalama zapamwamba pa kuchiritsa anthu odwala. Kusintha kwa malamulo, monga ngati kulipira mankhwala opangika kapena ndalama zopimira ku matenda. Kuletsa kugwiritsa ntchito molakwa, amakangana nthaŵi zambiri kuti apeŵe kugwiritsa ntchito molakwa.

Malamulo Oletsa Mankhwala Osokoneza Bongo

Malamulo ena amaloŵerera mwachindunji kuti akhazikitse kapena kuchepetsa mitengo ya mankhwala, makamaka m’maiko amene ali ndi njira zosamalira zaumoyo imodzi. Malamulo ameneŵa kaŵirikaŵiri amakonza kuti mankhwala akhale okhoza kugulitsidwa pamene akutsimikizira makampani opanga mankhwala apezeko malipiro abwino.

Njira Zoyendetsera Mitengo ndi Njira Zothandizira Kutenga Mitengo

Maiko onga Canada, France, ndi Germany amagwiritsira ntchito njira zoyendetsera mitengo imene imaika mitengo yokhoza kuloledwa kwa mankhwala atsopano. Mwachitsanzo, Germany ̵ malamulo a AMNOG amalamula kuti opanga apange apange ndalama za dziko ndi bungwe la ndawala ya zaumoyo ya dzikolo mkati mwa chaka chimodzi cha kutsegulidwa, kozikidwa pa phindu lowonjezereka la mankhwala. Maiko ambiri amagwiritsira ntchito kutsegulidwa kwa kunja kwa zilozero, kumene mtengo m'dziko limodzi umasonyezedwa ndi mitengo ya maiko ofanana. Dongosolo limeneli limaletsa opanga inshuwalansi ya zaumoyo kukwera kwambiri msika wina koma lingaletsenso kutumiza pepala lolembedwa.

United States ndi wopambana pakati pa maiko otukuka chifukwa cha kusoŵeka kwake kwa zilamuliro za boma zachindunji, ngakhale kuti maiko ena ayesa kuzidziŵikitsa.

Manda Osonyeza Kuyera

Kusoŵeka kwa kuonekera kwa mankhwala okhoza kugulitsidwa kuli chopinga chosatha. Nyumba za malamulo zingapo zayankha mwa kukhazikitsa malamulo ofuna makampani opanga mankhwala kuvumbula R&D, mtengo wogulitsa, ndi mitengo ya ukonde. Drug Price Transparency Act (mbali ya 2022 bus) imafuna opanga mankhwala ochirikiza mtengo kukwera kwa mtengo. EU̱ imakakamiza mamembala a Transparective kufalitsa chidziŵitso cha mankhwala ndi kukonza. Malamulo a Transparection amalimbikitsa opanga ndi odwala kukambirana ndi kuchititsa makampani kukhala ndi mlandu.

Kutchula Malo a Mitundu Yonse

Malamulo amalingalira mowonjezereka kugwiritsira ntchito market a mitundu yonse kugula mankhwala m'nyumba. Mu 2023, Dipatimenti ya Zaumoyo ndi Mautumiki Aumunthu ya United States inalengeza chitsanzo chimene chingagwirizanitse Medicare Part B pa decta ya mitengo yachilendo. Njira imeneyi, nthaŵi zina imatchedwa kuti “ yoyanjidwa kwambiri ” kutsegulira, yakhala ikulingaliridwa m'mitundu yosiyanasiyana m'mafashoni. Pamene kuli kwakuti zolembera za maiko onse zingachepetse mtengo, ikhozanso kuchepetsa ndalama zimene makampani amapanga m'misika yaing'ono, ngakhale kuti kukhoza kuchepetsa kupezeka kwa odwala padziko lonse.

Mpikisano wa Amalonda ndi Mankhwala Auchiŵanda

Malamulo amathandiza kwambiri kuti mpikisanowu ukhale wogwirizana ndi malamulo ndiponso kuti anthu aziutsatira bwino.

Kuloŵa m’Nthambi ya Hatch-Waxman

Drug Price Consunt and Paten Perduction Act ya 1984 (imene imadziwika kwambiri monga Hatch-Waxman Act) inasintha malonda a mankhwala osokoneza bongo. Inachita njira yatsopano yachidule yogwiritsira ntchito mankhwala (NA), kulola kuti zitsazi zidalire pa chitetezo ndi mphamvu ya mankhwala osokoneza bongo oyambirira. Posinthanitsa, inalola mawu ovomerezeka a kuwonjezera a m'make a makampani a mankhwala. Act inakhazikitsanso nyengo ya 180-tsiku la kufunsira kwa mtundu woyamba kutsutsa kukhazikitsa, kuyambitsa njira ya poyamba ya malonda a msika. Mapangano ofananawo alipo mu Ulaya pansi pa 2001/83 / C. Opanga malamulo nthaŵi ndi nthaŵi zina kukonza malamulo ameneŵa kuti athetse, monga ngati #220; kupenyerera kwa productive proce #1; proces proces proces .

Malamulo a Zinthu Zamoyo Zofanana

Mankhwala a biolognic ndi ovuta kwambiri kuposa maselo amodzi, ndipo kugulitsa zinthu zamoyo kumafuna malamulo oyenerera. Malamulo a Biologics Price Conquentince ndi Innovation Act (BPCII) a 2009 adapanga njira ya nthanga za biomiculans mu U.S., yosonyezedwa ndi Hatch-Waxman Act ya mamolecule. Imapereka nyengo ya zaka 12 ya kudalirana kwa mphamvu za biology ndi ikufuna njira ya kukonza zinthu. Lamulo la ku Ulaya (Directivations 2001/83/EC) lili ndi dongosolo lofanana. Kusinthasintha kwa masinthidwe, kutchula maina, ndi malamulo a m'malo a kuzungulira ndi kuzungulira mayiko ena. Kuphatikiza kwa zikhalidwe ku Germany, malamulo ogwirizana ndi kuzungulira ndi kuzungulira kwa ku Norway, ku Norway ndi kukwera kwa malonda kwa malonda.

Zochita Zoletsa Kulimbana ndi Nkhondo ndi Mabanja

Malamulo amalimbananso ndi khalidwe lolimbana ndi kupikisana limene limalepheretsa kulowa mwapadera. “ Paras- lay-lay ̵ Malomwi ̵ kumene kampani ya kampani ya kampani imalipira mpikisano wapadera kuchedwa kuyambitsa mabaibulo otsika kwambiri a̬ latopetsedwa ndi malamulo oletsa kulowa m'mapangano a U.S. ndi EU. U.S. Khoti lalikulu la U. m'FC v. Aclis (2013) inalamula kuti midzi yotero iyenera kupendedwa pansi pa lamulo. Pambuyo pake, malamulo ena a boma apereka malamulo ofuna kuperekedwa kwa malamulo ameneŵa. Bungwe la Ulaya laika zoko zoko zokongola kwambiri pa makampani ochita zimenezi. Malamulo ogwirizana ndi kuletsa ntchito yopanga malamulo ameneŵa.

Kubwezera ndi Inshuwalansi Zopereka Chigwirizano ndi Ukwati

Ngakhale mankhwalawo atapezeka, odwala sangapindule pokhapokha atagulitsidwa ndi inshuwalansi kapena mapulogalamu a zaumoyo.

Chiletso cha Medicara D ndi Chiletso cha Kutha kwa Magazi

Kwa zaka zambiri, pulogalamu ya ku Medicare ku United States inaletsedwa ndi lamulo kuti isamayendetse mitengo ya mankhwala mwachindunji kwa opanga makampani. Lamulo limeneli linaikidwa mu bungwe la Medicare Modertial Act ya 2003. Chifukwa cha zimenezi, anthu okonza mapulani adachepetsa mphamvu zotsazikira. Lamulo la Infladion Reduction Act la 20222 Act la m'mbiri mwa kupatsa Medicacara mphamvu yoyendera mitengo ya mankhwala ena owonjezera kuyambira 2026. Kusintha kumeneku kumayembekezeredwa kuchepetsa ndalama zowonongedwa za anthu olembetsa ndi kuchepetsa ndalama za dziko ndi madola mabiliyoni chaka chilichonse.

Kupanga Zinthu Mwaluso Ndiponso Njira Yochiritsira

Malamulo amakhudzanso mmene amasuzumira mankhwala. Mayiko ena akhazikitsa malamulo oletsa kugwiritsira ntchito njira zothandizira anthu otsalira, zimene zimafuna odwala kuyesa mankhwala otsika asanapeze mankhwala odula kwambiri. Njira zothandizira zingachititse kuchedwa kupeza chithandizo chabwino, makamaka pamavuto aakulu. Komanso, malamulo amene amalamula kuti mapulogalamu a mitundu yambiri athe kuwonjezera njira zoyendera. Opanga malamulo amafuna kulinganiza bwino mwa kukonza malamulo opindulitsa, monga zifunsitso zaposachedwapa za bungwe la boma kuti aperekere mankhwala osokoneza bongo.

Mapikica Ozikidwa pa Pricing ndi Zotulukapo Zozikidwa pa Maziko

Mapikica obwezeranso ndalama, monga ngati mapulogalamu a mtengo, amagwirizanitsa zopereka zachipatala. Nyumba zambiri za malamulo zalola kapena kuyesa makonzedwe ameneŵa m'maprogramu a boma. Mwachitsanzo, Medicare Sevete Generation Reconfidence Care Organization ndi boma Medicaidrs amalola ziyambukiro za mapangano a ndalama zoikidwiratu za dziko lapansi. Chichirikizo cha Legislative cha zopereka chidziŵitso chenicheni ndi kutetezera ku chinyengo ndi mlandu (madoko otetezeredwa) amalimbikitsa opanga ndi olipira kuti aloŵetse m'panganolo la za kulimba mtima. Malamulo ameneŵa angagwirizanitse zisonkhetso za zija za zifunsizo za ku zifunsizo za kugulitso za kugulitsidwa kwa anthu opirira osati malonda.

Kupita Patsogolo kwa Malamulo Posachedwapa

M’zaka zaposachedwapa, mkangano wa zamankhwala wakula kwambiri, ndipo ukuchititsa kuti boma lizilamulira dziko lonse.

Kuchepetsa Kukwera kwa Mafuta ku United States

Pa August 2022, Act ya Inflateon Reduction (IRA) imaimira kuchuluka kwa mankhwala osokoneza bongo m'zaka makumi ambiri. Malamulo apadera amaphatikizapo Medicare kukambirana kwa 60 kwa mankhwala osokoneza bongo pa 2029, chipewa cha pachaka cha $2,000 cha pa kapepala ka paramende pa Party D, kukwera mtengo kwa mtengo wa mankhwala kumakwera kwambiri kuposa mtengo wa mtengo, ndipo kupendedwa kwa mapindu a mbali ya D kumachepetsa ndalama zowononga. IRA imachedwetsa kuyambika kwa mtengo wa mankhwala ang'onoang'ono a m’onoang'ono mpaka zaka 9 pambuyo pa chivomerezo ndi za kuchepetsa nyengo yachitukuko kwa odwala. Lamuloli likuyembekezeredwa kuchepetsa kugwiritsa ntchito mankhwala kwa anthu mamiliyoni ambiri koma la kuswa lamulo kwa malamulo a boma.

Njira Yopangira Mankhwala ndi Kusintha Zinthu za EU

Bungwe la European Commission linatulutsa Strategy yake ya Phrametics ya ku Ulaya mu 2020, cholinga chofuna kupanga mankhwala osavuta, osavuta kugula, ndi atsopano. Masinthidwe a malamulo akuphatikizapo kuchepetsa nyengo ya chitetezo kuyambira pa zaka 8 mpaka 6, ndi mapindu ena owonjezera osamalira zofunika zamankhwala kapena kuyesa kothandiza. Njirayi imayesanso kuthetsa kupereŵera, kulimbikitsa kupangidwa kwa mankhwala obiriŵira, ndi kukonzanso mankhwala amasiye. Ngati alandira, kusintha kumeneku kungabwezeretsenso malo a zaumoyo kudutsa m'maboma 27 a ziŵalo ndi mitengo ya mankhwala osokoneza bongo.

Kusintha Zinthu pa Ntchito Yogwiritsa Ntchito Mankhwala Osokoneza Bongo Padziko Lonse

Malamulo ku Canada, Japan, ndi maiko olandira motsika ndi pakati akupitirizabe kukonza zinthu. Canada ̱ adasintha malamulo awo kufutukula mitanga yawo ya makompyuta ndi kuwonjezera kuonekera. Japan imakonzanso mitengo ya mankhwala kudzera pa National Health Inshuwalansis kupima mtengo wa mankhwala osokoneza bongo ndipo yayambitsa njira yofufuzira mankhwala owonjezera. Bungwe la World Health Organization laitana kaamba ka kugwiritsira ntchito kowonjezereka kwa ndalama zopezedwa ndi kuonekera kwaufulu kutsika kwa mitengo ya zinthu.

Kumaliza

Malamulo ali ndi mphamvu yapadera yopanga makampani opanga mankhwala kudzera m'malamulo amene amayambukira mbali iliyonse ya moyo wa mankhwala osokoneza bongo. Kutetezera ndi R&D zisonkhezero zolamulira ndalama, kupikisana kwa mtundu wina, ndi malamulo othandizira, malamulo amasankha ngati kusinthasintha zinthu ndi kaya odwala angapereke mankhwala amene amafunikira. Masinthidwe aposachedwapa, monga ngati U.S. Reduction Reduction Act ndi EUPractic System, zimasonyeza kuti ndale yomakula ya zandale idzachepetsa mitengo ya mankhwala osokoneza bongo. Komabe, kukwaniritsa kulinganiza kokhazikika pakati pa kusintha kwa mankhwala ndi kutsimikizira kupezeka kwa mankhwala kopereka chitokoso. Malingaliro, malamulo ozikidwa pa umboni wodalirika ndi malamulo a zamankhwala ofunika kupanga zinthu zimene zikuthandiza kukonza mankhwala pamene zikulimbikitsa njira zamakono.

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