Mutane da yawa sun yarda cewa idan Dr. Anthony Fauci ko dai yayi murabus ko kuma aka cire shi daga matsayinsa na Daraktan Cibiyar Kula da Allergy da Cututtuka (NIAID), to za a warware duk matsalar COVID-rikicin na yau da kullun, dabaru da dabarun gudanarwa, rashin gaskiya, rashin gudanar da mulki da kuma keta ɗabi'a a cikin Ma'aikatar Lafiya da Ayyukan Jama'a ta Amurka (HHS).
A karkashin wannan ka'idar, Dr. Fauci ne ke da alhakin manufofin da aka ɓullo da su a lokacin cutar kanjamau sannan kuma suka bunƙasa yayin COVIDcrisis, kuma da zarar an cire ƙwayar cutar za ta murmure.
Ban yarda ba. Dokta Fauci yana wakiltar alama, ba dalilin matsalolin da ke faruwa a cikin HHS ba. Dokta Fauci, wanda ya shiga tsarin mulki na HHS a matsayin hanya don guje wa daftarin tsarin VietNam kuma ya keɓance yawancin matsalolin gudanarwa da suka haɓaka tun waccan lokacin, kawai wani Daraktan NIAID zai maye gurbinsa wanda zai iya yin muni. Matsalolin da ke tattare da ita ita ce gurbatattun tsarin gudanar da mulki wanda ya kebe gaba daya daga lura da ayyuka daga zababbun jami'ai.
The"jihar gudanarwa” wata kalma ce ta gama gari da ake amfani da ita wajen bayyana tsarin mulkin da a halin yanzu ke iko da kusan dukkanin masu rike da madafun iko a Amurka, in ban da Kotun Koli ta Amurka (SCOTUS) ba da wuri ba. abokan aikin jarida na kamfanoni hakika yajin aikin riga-kafi ne da gwamnatin jihar ta yi domin mayar da martani ga wani mataki da ke barazana ga ikonta.
Barazanar da ake warwarewa ita ce dabarar tsarin mulki wacce hujjar shari'a ta dogara akansa, cewa kasancewar wannan ikon da ba a ayyana haƙƙoƙin da ba a fayyace ta musamman a Tsarin Mulkin Amurka ba kamar yadda ake ba da rigunan tarayya tare da jihohi ɗaya. An buga shi a ƙarƙashin murfin siyasa na ɗaya daga cikin batutuwan siyasa masu cike da cece-kuce a tarihin Amurka na zamani, wannan wani rikici ne kawai da ke nuna cewa tsarin mulki da abokansa a cikin kafofin watsa labarai na kamfanoni za su ci gaba da yin tsayayya da duk wani takunkumi na tsarin mulki ko na doka kan ikonsa da damarsa.
Juriya ga kowane nau'i na sarrafawa ko sa ido ya kasance daidaitaccen ɗabi'a na tsarin mulki a cikin tarihin gwamnatin Amurka, kuma wannan yanayin ya haɓaka tun ƙarshen yakin duniya na biyu. Kwanan nan, wannan barazanar da ke tattare da tsarin tsarin mulki ga Gwamnatin Gudanarwa an inganta shi a cikin yanayin West Virginia vs Hukumar Kare Muhalli, inda kotu ta yanke hukuncin cewa lokacin da hukumomin tarayya suka ba da ka'idoji tare da tasirin tattalin arziki da siyasa, ƙa'idodin ba su da inganci sai dai idan Majalisa ta ba da izini na musamman. Tare da wannan shawarar, a karon farko a cikin tarihin zamani an fara aiwatar da iyakokin tarihin kan faɗaɗa ikon manyan ma'aikatan da ba zaɓaɓɓu ba a cikin tsarin mulkin Tarayya.
Ƙaddamar da doka don Jihar Gudanarwa.
Koyarwar ba wakilai wata ka'ida ce a cikin dokar gudanarwa wanda Majalisa ba za ta iya ba da ikonta na majalisa ga wasu ƙungiyoyi ba. Wannan haramcin yawanci ya ƙunshi Majalisa tana ba da ikonta ga hukumomin gudanarwa ko ga ƙungiyoyi masu zaman kansu.
In JW Hampton da Amurka, 276 US 394 (1928), Kotun Koli ta fayyace cewa lokacin da Majalisa ta ba wa hukuma ikon yin tsari, dole ne Majalisa ta ba hukumomin "ka'idar fahimta" wacce za ta dogara da dokokinsu. Ana kallon wannan ma'auni a matsayin mai sassaucin ra'ayi, kuma ba a taɓa yin amfani da shi ba, idan har abada, don rushe doka.
In ALA Schechter Poultry Corp. v. Amurka, 295 US 495 (1935), Kotun Koli ta yanke hukuncin cewa "Ba a yarda Majalisa ta yi watsi da ko kuma mika wa wasu muhimman ayyukan majalisa da aka ba ta ba."
"Chevron girmamawa"
Daya daga cikin mahimman ka'idoji a cikin tsarin gudanarwa, "Chevron deference" kalma ce da aka yi bayan wani lamari mai mahimmanci, Chevron USA, Inc. v. Natural Resources Defence Council, Inc., 468 US 837 (1984), yana nufin koyaswar mutunta shari'a da aka bayar ga ayyukan gudanarwa.
Koyarwa ta Chevron ita ce lokacin da wakilan majalisa zuwa hukumar gudanarwa kan wani batu ko tambaya ba ta fito fili ba sai dai a fakaice, kotu na iya ba ta musanya fassarar nata na kundin don ingantaccen fassarar da hukumar gudanarwa ta yi. Wato lokacin da dokar ta yi shiru ko kuma aka samu shubuha dangane da takamaiman batun, abin tambaya a gaban kotu shi ne ko matakin da hukumar ta dauka ya samo asali ne daga halalcin gina dokar?
Gabaɗaya, don a ba da fifikon Chevron, fassarar da hukumar ta yi game da ƙa'idar da ba ta dace ba dole ne ya halatta, wanda kotu ta ayyana da nufin "ma'ana" ko "ma'ana." A cikin ƙayyadaddun dacewa na takamaiman ginin ƙa'ida ta hukumar, shekarun wannan fassarar gudanarwa da kuma aikin majalisa ko rashin aiki don amsa wannan fassarar da ke faruwa na iya zama jagora mai amfani.
Barazanar Shari'a ga Jihar Gudanarwa
Kaɗan kaɗan ne ke jin daɗin cewa waɗannan batutuwan suna ƙarƙashin hukunce-hukuncen kwanan nan game da wanda za su nada a Kotun Koli. Nadin na farko na Trump guda biyu a babbar kotun—Neil Gorsuch da Brett Kavanaugh—sun kasance biyu daga cikin manyan masu tunanin shari’ar kasar kan dokar gudanarwa, kuma mai ba da shawara a fadar White House Don McGahn ya bayyana karara cewa wannan ba kwatsam ba ne. Haka kuma da nadin da Trump ya yi a kananan kotuna, wadanda suka hada da kwararrun masu bin doka da oda kamar su DC Circuit Neomi Rao da Greg Katsas, da Andrew Oldham na yanki na biyar.
COVIDcrisis da Gwamnatin Jihar
Bakin tarihin COVIDcrisis ya ƙunshi tsare-tsare na haɗin gwiwa tsakanin ɗimbin buƙatun kamfanoni, 'yan duniya, da tsarin gudanarwa (Taron 201); na gaba yunƙurin rufe laifin gudanar da ayyukan gwamnati wajen haifar da rikicin; wanda ya biyo bayan mummunan rashin gudanar da manufofin kiwon lafiyar jama'a, yanke shawara, da sadarwa duk suna aiki cikin kulle-kulle tare da zaman tsare-tsare da suka gabata. Wannan haɗin gwiwar ba da amsa maras aiki na tsare-tsare ya bayyana wa kowa don ganin cewa Ma'aikatar Lafiya da Ayyukan Jama'a ta Amurka ta zama babban misali da ke kwatanta sakamako mai amfani na wannan gurɓataccen tsari, gurɓataccen tsari da kuma tsarin gwamnati wanda ba shi da lissafi.
A cikin gwamnatoci biyu da shugabannin da suka yi gwagwarmayar ra'ayoyin duniya daban-daban, manufofin HHS COVID sun ci gaba da ɗan canji ko kaɗan; wata gwamnati da alama tana gudana kai tsaye zuwa na gaba da kyar. Idan wani abu, a ƙarƙashin Biden, hannun HHS na gwamnatin Amurka ya zama mafi iko, mafi rashin lissafi, kuma mafi rarrabuwa daga kowace buƙata don la'akari da sakamakon zamantakewa da tattalin arziƙin ayyukansu. Yayin da wannan ya ci gaba, aikin ofishin na HHS ya ƙara zama mai ban sha'awa kuma mai ban sha'awa ga buƙatun tattalin arziki na masana'antun masana'antu-magunguna.
Wannan ya bayyana a fili a cikin kiyaye yanayin gaggawa na likita, wanda ke ba wa jami'an HHS iko kusan marasa iyaka don ketare hane-hane na tsarin mulki, duk da tabbataccen shaidar cewa babu wani gaggawa na likita. Kula da dabarar gaggawar lafiyar jama'a ya zama dole duka biyu don kiyaye iko da kuma kudaden shiga na kwangilar Gwamnatin Amurka ga kamfanonin da ke cin riba na batsa daga siyar da matakan rigakafin "Izinin Amfani da Gaggawa" na likitanci waɗanda aka ba su izinin ketare ka'idojin da aka dade ana kafa su, tsarin halitta, da ka'idojin abin alhaki na doka. Haɗin gwiwar jama'a da masu zaman kansu kamar babu abin da Amurka ta taɓa gani a baya, wanda ke yin hakan Ribar Yaƙin da Harry Truman ya yi yaƙi da shi kamar wasan yara.
Akwai rikice-rikice na ƙungiya wanda ke ba da damar babban iko ga waɗanda suka tashi zuwa saman ƙungiyoyin kimiyyar farar hula a cikin HHS. Su wadannan ma’aikatun kusan ba a taba ganin irinsu ba, suna da aikin fasaha ne daga bangaren zartaswa, amma kuma kusan gaba daya suna samun kariya daga bin diddigi daga bangaren zartarwa na gwamnati da ke da alhakin gudanar da su – don haka wadannan ma’aikatan ba su da la’akari da wadanda a zahiri suke biyan kudaden ayyukansu (masu biyan haraji). Matukar ana iya ɗaukar waɗannan masu gudanar da aiki, wannan lissafin yana gudana a kaikaice daga majalisa.
Ana iya inganta kasafin kuɗin ƙungiyoyin su ko kuma a yanke su a cikin shekaru masu zuwa, amma in ba haka ba ana kiyaye su da yawa daga matakin gyara ciki har da ƙarewar aikin da ba a samu wasu manyan laifuka ba. A cikin ma'anar Machiavellian, waɗannan manyan jami'an gudanarwa suna aiki a matsayin Yarima, kowace cibiyar kiwon lafiya ta tarayya tana aiki a matsayin birni mai cin gashin kanta, kuma masu gudanar da mulki da sarakunansu suna aiki daidai da haka.
Don kammala wannan kwatanci, majalisa tana aiki iri ɗaya da Vatican a cikin karni na 16, tare da kowane Yarima yana neman tallafi da iko ta hanyar samun tagomashi tare da manyan limaman coci. A matsayin ingantacciyar wannan kwatancin, muna kallon gidan wasan kwaikwayo akan C-SPAN duk lokacin da wani ɗan majalisa ko ɗan majalisar dattijai ya tambayi manajan kimiyya mai fushi, kamar wanda aka yi ta maimaitawa tare da musanyar girman kai na Anthony Fauci yayin shaidar majalisa.
A cikin gwanintarsa "Mafi Kyau kuma Mafi Haskaka: Gudanarwar Kennedy-Johnson", David Halberstam ya buga wata magana daga wakilin jaridar New York Times Neil Sheehan don kwatanta rawar da gwamnatin kasar ke takawa kan jerin matsananciyar matsananciyar yanke shawara wanda ya haifar da daya daga cikin manyan gazawar manufofin jama'a na Amurka a karni na 20 - yakin VietNam. kamanceceniya da waɗanda ke da alaƙa da martanin COVIDcrisis Kuma kamar yadda yake a halin yanzu, hannun ɓoye na ƙungiyar leƙen asirin Amurka galibi yana kan bango, koyaushe yana tura iyakoki na karbuwa daga Halberstam da Sheehan;
"Tunda ayyukan sirri sun kasance wani ɓangare na wasan, a cikin wani lokaci ana samun manyan matakan ofisoshi, musamman yayin da CIA ta zama mafi ƙarfi, sannu a hankali yarda da ayyukan ɓoye da ƙazanta a matsayin wani ɓangare na tsarin diflomasiyya da siyasa; mafi girma da manyan jami'an gwamnati sun zama masu haɗin gwiwa (kamar yadda mataimakin shugaban kasa, McGeorge duka biyu na aikin Budyt, da Johnson zai yi aiki a kan Budyt. hankali, amincewar shugaban kasa). Hakan dai na nuni ne da irin takaicin da jami'an tsaron kasar, masu zaman kansu, duk suka ji, wajen yin daidai da manufofin kasashen waje na al'ummar kama-karya, wanda ya ba wa jami'anta 'yanci da kuma ga dukkan alamu ba a binciki shugabanninta. Kasancewa cikin ciki da adawa ko tambayar ayyukan ɓoye ana ɗaukar alamar rauni. (A cikin 1964, wani jami'in CIA da aka haifa, yana mamakin ko muna da 'yancin gwada wasu ayyukan baƙar fata a Arewa, Desmond FitzGerald, mai lamba-uku a cikin Hukumar ya gaya masa cewa, "Kada ku jika sosai" - tsohuwar tsohuwar makaranta ta wani wanda ya san ainihin ka'idodin wasan ga wani mai laushi, yana tambaya game da yadda ake aiwatar da wannan doka ta Adlai. Stevenson zuwa mafi ƙarancin lokacin aikinsa a lokacin Bay of Pigs, abin kunya na musamman kamar yadda ya tsaya ya yi ƙarya a Majalisar Dinkin Duniya game da abubuwan da bai sani ba, amma wanda, ba shakka, Cubans sun sani. Ayyukan da aka ɓoye sau da yawa sun ci gaba da Gudanarwa da kanta kuma suna jawo Gudanarwa tare da su, kamar yadda Bay of Pigs ya nuna - tun da shirye-shiryen da horarwa sun yi, ba za mu iya gaya wa Cubans masu son 'yanci ba cewa ya ƙare, za mu iya, in ji Allen Dulles. Ya ja hankalin jama'a kamar Shugaban kasa tare da shi cikin wannan bala'i na musamman. A lokacin, Fulbright ya yi jayayya da shi, ba wai kawai ya yi jayayya cewa zai kasa ba, wanda ya kasance mai sauƙi a ce, amma ya wuce wannan, kuma kasancewarsa mutumin jama'a, ya shiga cikin mafi yawan muhawara, jayayya da shi a kan dalilai na ɗabi'a, cewa shi ne ainihin rashin son yin abubuwa irin wannan wanda ya bambanta mu da Tarayyar Soviet kuma ya sanya mu na musamman, ya sa ya cancanci zama dimokuradiyya. "Dole ne a sake yin wani batu game da ko da goyon bayan da aka yi na hambarar da Castro; ya saba wa ruhi da kuma watakila wasikar, na yarjejeniyoyin da Amurka jam'iyya ce da ta Amurka. dokokin gida. . . . Ba da wannan aiki ko da a boye goyon baya ne na wani gunki tare da munafunci da izgili da cewa kullum da Amurka ke yin Allah wadai da Tarayyar Soviet a Majalisar Dinkin Duniya da sauran wurare. Wannan batu ba zai yi hasarar sauran duniya ba—ko kuma a kan lamirinmu game da wannan al’amari,” ya rubuta Kennedy. Amma mahawara irin wannan ba ta samu karbuwa sosai a wancan zamani ba; a maimakon haka gwamnatin Kennedy ta kasance mai tsaurin ra'ayi musamman wajen son daidaita 'yan gurguzu a sabbin ayyukan fafutuka na zamani da na boye, kuma layin da ke tsakanin abin da dimokuradiyya za ta iya yi da abin da ba zai iya yi ba ya fi duhu a wadannan shekarun fiye da sauran.
Wadannan mutane, galibi masu zaman kansu, suna aiki ne a wani mataki daban da manufofin jama'a na Amurka, kuma bayan shekaru da yawa lokacin da wakilin New York Times Neil Sheehan ya karanta dukan tarihin tarihin yakin, cewa tarihin da aka sani da Pentagon Papers, zai zo da wani ra'ayi fiye da kowa, wanda shine cewa gwamnatin Amurka ba ita ce abin da ya yi tsammani ba; kamar dai akwai gwamnatin Amurka ta ciki, abin da ya kira “jahar ce ta tsakiya, wacce ta fi komai karfi. wanda abokan gaba ba 'yan gurguzu ba ne kawai, amma duk wani abu, 'yan jarida nasa, na shari'a, na majalisa, gwamnatocin kasashen waje da abokantaka - duk waɗannan abubuwa ne masu yuwuwar gaba.. Ta ci gaba da wanzuwa kuma ta dawwama, "Sheehan ya ci gaba da cewa, "sau da yawa yana amfani da batun hana gurguzu a matsayin makami ga sauran sassan gwamnati da 'yan jarida, kuma a karshe, ba ya aiki dole ne don amfanin jamhuriya sai dai don biyan bukatunta, dawwamar da kanta; yana da nasa lambobin da suka bambanta da lambobin jama'a. Sirri wata hanya ce ta kare kanta, ba wai barazanar da gwamnatocin kasashen waje suke yi ba, amma daga gano al'ummarta bisa zargin cancanta da hikimarta..” Sheehan ya lura cewa, kowace gwamnatin da ta gaje ta, ta yi taka tsantsan, da zarar ta hau kan karagar mulki, don kada ta fallasa raunin da magabata ke da shi, bayan haka, mutane daya ne ke tafiyar da gwamnatocin, suna da ci gaba da juna, kuma kowace gwamnatin da ta gaji ta samu kanta da kusan makiya iri daya.
Jiha Mai Gudanarwa da Jujjuyawar Tattalin Arziki
Ajalin "karkatar da mulkin kama-karyaMasanin siyasa kuma marubuci Dr. Sheldon Wolin ne ya fara kirkiro shi a cikin 2003, sannan Chris Hedges da Joe Sacco suka kara nazarinsa a cikin littafinsu na 2012.Ranakun Halaka, Kwanakin TawayeWolin ya yi amfani da kalmar “Jumhuriyar Jumhuriyar Jumhuriyar Jumhuriyar Jumhuriyar Jama’a” don haskaka al’amuran tsarin siyasar Amurka, da kuma bayyana ra’ayinsa cewa gwamnatin tarayyar Amurka ta zamani tana da kamanceceniya da gwamnatin Nazi ta Jamus mai tarihi.
Hedges da Sacco sun gina bisa fahimtar Wolin don faɗaɗa ma'anar karkatar da mulkin kama-karya don bayyana tsarin da kamfanoni suka lalata da kuma murƙushe dimokuradiyya, kuma inda tattalin arzikin tattalin arziki ya zama babban ƙarfin da ke jagorantar yanke shawara na siyasa (maimakon ɗa'a, Maslow's matsayi na bukatun, ko vox populi). Karkashin jujjuyawar mulkin kama-karya, kowane albarkatun kasa da mai rai sun zama commodified kuma manyan kamfanoni suka yi amfani da su har ta kai ga rushewar, kamar yadda wuce haddi amfani da kuma abin mamaki lull da magudi da dan kasa su mika ’yancinsu da shigarsu cikin gwamnati.
Juyar da mulkin kama-karya yanzu shine abin da gwamnatin Amurka ta shiga, kamar yadda Wolin ya yi gargadin cewa zai iya faruwa shekaru da yawa da suka gabata a cikin littafinsa "Haɗin DemokraɗiyyaJihar gudanarwa ta mayar da Amurka a matsayin "dimokuradiyya mai sarrafawa" karkashin jagorancin tsarin mulki wanda ba za a iya daukar nauyin wakilan jama'a ba. Wani lokaci ana kiransa 4th estate, wannan dodo kuma ana kiransa "jihar mai zurfi", ma'aikatan gwamnati, jihar tsakiya, ko tsarin gudanarwa.
Tsarukan siyasa da suka rikide zuwa mulkin kama-karya, ba su da shugaba mai kama-karya, sai dai gungun masu gudanar da mulki marasa gaskiya ne ke tafiyar da su. “Shugaba” a zahiri yana biyan bukatun shugabannin gudanarwa na gaskiya. Wato, ba zaɓaɓɓu ba, rukunin masu mulki na masu gudanar da mulki ba tare da gani ba ne ke tafiyar da ƙasar daga ciki.
Ma'aikaci (Fascist) yana haɗin gwiwa tare da Jiha Mai Gudanarwa
Domin kimiyya, likitanci da siyasa zaren guda uku ne da aka saka su a cikin zane iri ɗaya na manufofin jama'a, dole ne mu yi aiki don gyara duka ukun lokaci guda. Lalacewar tsarin siyasa ta ƴan kasuwan duniya sun taɓo har zuwa tsarin kimiyya, likitanci da tsarin kiwon lafiya.
Lalacewar kimiyya da magani ta hanyar buƙatun kamfanoni yana faɗaɗa isarsa; yana da lahani kuma ba zai iya jurewa ba. Kame ka'ida ta hanyar buƙatun kamfanoni yana gudana a cikin siyasarmu, hukumomin gwamnati da cibiyoyi. Kamfanonin sun kutsa kai cikin dukkan bangarorin gwamnati uku.
Haɗin gwiwar kamfanoni da jama'a waɗanda suka zama masu salo suna da wani suna, wannan suna shine Fascism - kalmar kimiyyar siyasa don haɗakar buƙatun kamfanoni da ƙasa. Ainihin, tashin hankali tsakanin sha'awar jamhuriya da 'yan ƙasa (wanda Jefferson ya ji ya kamata ya zama na farko), da kuma buƙatun kuɗi na kasuwanci da kamfanoni (Madaidaicin Hamilton) ya yi nisa sosai ga buƙatun kamfanoni da masu mallakarsu na biliyan biliyan a cikin kuɗin jama'a.
Haɓaka karkatacciyar mulkin kama-karya sau da yawa ana yin ta ne ta hanyar buƙatun kuɗi na mutum ɗaya na ma'aikata, kuma yawancin dimokiradiyya na yamma sun shiga wannan tsari. Bukatun kamfanoni suna samun tasiri cikin sauƙi kuma ana samun karɓuwa daga ma'aikatu saboda la'akarin ayyuka masu ƙarfi bayan aikin tarayya ("ƙofa mai juyawa") da kama ƙungiyoyin majalisu ta hanyar masu fafutuka da ke ba da buƙatun kamfanoni.
A cikin wani labarin bincike da aka buga a cikin Jaridar Likita ta Burtaniya mai suna "Daga FDA zuwa MHRA: su ne masu sarrafa magunguna don haya", 'yar jarida Maryanne Demasi ta rubuta hanyoyin da ke haifar da ci gaban haɗin gwiwar jama'a da masu zaman kansu tsakanin hukumomin gudanarwa da kuma hukumomin da ake biyan su don tsarawa da kulawa. Hanyoyi daban-daban guda biyar da ke tafiyar da tsarin haɗin gwiwar an gano su a kusan dukkanin manyan hukumomin kula da samfurin likita guda shida (Australia, Kanada, Turai, Japan, Birtaniya, da Amurka):
Kudaden masana'antu. Kuɗin masana'antu ya cika manyan masu tsara tsarin duniya. Mafi yawan kasafin kuɗin masu gudanarwa-musamman ɓangaren da aka fi mayar da hankali kan magunguna-an samo su ne daga kuɗin masana'antu. Daga cikin masu gudanarwa shida, Ostiraliya tana da mafi girman kaso na kasafin kuɗi daga kuɗin masana'antu (96%) kuma a cikin 2020-2021 ta amince da fiye da tara na kowane aikace-aikacen kamfanin magunguna 10. Hukumar Kula da Kaya ta Ostiraliya (TGA) ta musanta cewa kusan dogaronta na keɓanta kan tallafin masana'antar harhada magunguna rikici ne na sha'awa (COI).
Wani bincike na shekaru talatin na PDUFA a Amurka ya nuna yadda dogaro da kuɗaɗen masana'antu ke ba da gudummawa ga raguwar ƙa'idodin shaida, a ƙarshe yana cutar da marasa lafiya. A Ostiraliya, masana sun yi kira da a sake fasalin tsarin TGA da ayyukanta, suna masu cewa hukumar ta yi kusa da masana'antu.
Masanin ilimin zamantakewa Donald Light na Jami'ar Rowan da ke New Jersey, Amurka, wanda ya kwashe shekaru da yawa yana nazarin ƙa'idodin miyagun ƙwayoyi, ya ce, "Kamar FDA, an kafa TGA don zama cibiya mai zaman kanta. Duk da haka, yawancin kuɗaɗen kuɗi daga kamfanonin da ake cajin samfuran su don kimantawa shine babban rikici na sha'awa kuma babban misali na cin hanci da rashawa na hukumomi."
Haske ya ce matsalar masu kula da magunguna ta yadu. Ko da FDA-wanda ya fi dacewa mai kula da kuɗi-ya ba da rahoton kashi 65% na kudaden da yake bayarwa don kimanta magunguna ya fito ne daga kudaden masu amfani da masana'antu, kuma a cikin shekarun da suka wuce kudaden masu amfani sun fadada zuwa magungunan ƙwayoyi, biosimilars, da na'urorin likita.
"Ya bambanta da samun amintacciyar kungiya mai zaman kanta kuma tana tantance magunguna. Ba su da tsauri, ba masu zaman kansu ba ne, zaɓaɓɓu ne, kuma suna riƙe bayanai. Likitoci da marasa lafiya dole ne su yaba da yadda ba za a iya amincewa da masu sarrafa magunguna ba muddin aka kama su ta hanyar tallafin masana'antu."
Joel Lexchin, wani mai bincike kan manufofin miyagun ƙwayoyi a Jami’ar York da ke Toronto, ya ce, “Ya kamata mutane su sani game da duk wani COIs na kuɗi da masu ba da shawara suke da shi don su iya tantance ko waɗannan COI sun yi tasiri a kan shawarar da suke ji. Mutane na bukatar su amince da abin da suka ji daga jami’an kiwon lafiyar jama’a kuma rashin fayyace gaskiya yana hana amincewa.”
Daga cikin manyan masu gudanarwa shida, masu kula da magunguna na Kanada kawai ba sa neman shawarwari akai-akai daga kwamiti mai zaman kansa kuma ƙungiyar tantancewarsa ita kaɗai ce gabaɗaya gaba ɗaya ba ta COIs na kuɗi. Masu kula da Turai, Jafananci, da Burtaniya suna buga jerin mambobi tare da cikakkun bayanansu akan layi don samun damar jama'a, yayin da FDA ke yanke hukunci COIs akan tsarin taro-ta-kwaro kuma suna iya ba da izinin barin shiga membobin.
Daga cikin masu tsara tsarin duniya, biyu kawai-FDA da PMDA-suna samun bayanan matakin haƙuri akai-akai. Kuma ba wanda ya buga waɗannan bayanan da hankali. Kwanan nan, ƙungiyar sama da furofesoshi 80 da masu bincike da ake kira Kiwon Lafiyar Jama'a da Ma'aikatan Kiwon Lafiyar Jama'a don Gaskiya sun kai karar FDA don samun damar yin amfani da duk bayanan da hukumar ta yi amfani da su don ba da lasisin rigakafin cutar ta Pfizer. (duba nan) FDA ta yi iƙirarin cewa nauyin da ke kan hukumar ya yi yawa kuma ya bukaci a ba shi izinin sakin takardun da aka gyara daidai a kan adadin shafukan 500 a wata, gudun da zai dauki kimanin shekaru 75 don kammalawa. A cikin nasara ga masu fafutukar tabbatar da gaskiya, wani Alkalin Kotun Tarayya na Amurka ya soke wannan, yana yanke hukuncin cewa FDA za ta bukaci jujjuya duk bayanan da aka gyara daidai cikin watanni takwas. Pfizer ya nemi shiga tsakani don tabbatar da "bayanan da ke keɓe daga bayyanawa a ƙarƙashin dokar FOI ba a bayyana su ta hanyar da ba ta dace ba," amma an ƙi buƙatar ta.
Amincewa da sauri. Bayan rikicin AIDS na shekarun 1980 da 1990, an gabatar da PDUFA “kuɗin mai amfani” a cikin Amurka don ba da ƙarin ma'aikata don taimakawa saurin amincewa da sabbin jiyya. Tun daga wannan lokacin, akwai damuwa game da yadda ya tsara tsarin bita na ka'idoji-alal misali, ta hanyar ƙirƙirar "kwanakin PDUFA," kwanakin ƙarshe don FDA don sake duba aikace-aikacen, da kuma tarin "hanyoyi masu sauri" don saurin magunguna zuwa kasuwa. Al'adar yanzu ta zama ruwan dare gama duniya.
Ƙofar juyawa-masana'antu. Masu sukar suna jayayya cewa kama tsarin ba wai kawai ana gasa shi ta hanyar yadda ake ba da kudade ba, har ma da ma'aikata. "Kofa mai juyawa" ta ga yawancin jami'an hukumar sun ƙare aiki ko tuntuɓar kamfanoni iri ɗaya da suka tsara.
A FDA, gabaɗaya ana ɗaukarsa a matsayin babban mai tsara tsarin duniya, tara cikin 10 na kwamishinonin da suka gabata tsakanin 2006 da 2019 sun ci gaba da tabbatar da ayyukan da ke da alaƙa da kamfanonin harhada magunguna, kuma na 11th kuma na baya-bayan nan, Stephen Hahn, yana aiki da Flagship Pioneering, kamfani wanda ke aiki azaman mai haɓaka sabbin kamfanoni na biopharmaceutical.
A cikin yanayin duka Cibiyoyin Kula da Cututtuka da Cututtuka (CDC) da Cibiyar Kiwon Lafiya ta Kasa (NIH), akwai kuma alaƙar kuɗi kai tsaye waɗanda ke ɗaure kamfanoni, dan jari hujja kungiyoyi masu zaman kansu (kamar Gidauniyar Bill da Melinda Gates), da kuma jihar gudanarwa. Ni da ku irin ku ba za mu iya “bawa” gwamnatin tarayya ba kamar yadda a ƙarƙashin Dokokin Saye na Tarayya ana ɗaukar wannan a matsayin haɗari don yin tasiri mara kyau. Amma CDC ta kafa mara riba "CDC Foundation” A cewar Gidan yanar gizon kansa na CDC,
"Majalissar ta kafa ta a matsayin kungiya mai zaman kanta, mai zaman kanta, Gidauniyar CDC ita ce kadai hanyar da Majalisa ta ba da izini don tattara abokan aikin agaji da albarkatu masu zaman kansu don tallafawa aikin kare lafiyar CDC."
Hakanan, NIH ta kafa "Foundation ga National Cibiyoyin Lafiya", a halin yanzu karkashin jagorancin Shugaba Dr. Julie Gerberding (tsohuwar darektan CDC, sannan Shugaba na Merck Vaccines, sannan Babban Jami'in Kula da Lafiya da Mataimakin Shugaban Kasa, Kiwon Lafiyar Jama'a & Dorewa a Merck and Company - inda ta ke da alhakin biyan buƙatun Merck's ESG) Ayyukan Dr.
Waɗannan ƙungiyoyin sa-kai na majalissar da aka yi hayar su suna ba da abin hawa ta yadda rukunin magunguna-magungunan ke iya shigar da kuɗi cikin NIH da CDC don yin tasiri duka ajandar bincike da manufofin.
Sannan muna da alaƙa mafi ƙarfi wanda ke ɗaure rukunin magunguna-magungunan riba ga CDC da ma'aikatan NIH da masu gudanarwa, dokar Bayh-Dole.
Wikipedia yana ba da taƙaitaccen taƙaitaccen bayani:
Dokar Bayh-Dole ko Dokar Canje-canje na Dokar Patent da Alamar Kasuwanci (mashaya L. 96-517, Disamba 12, 1980) doka ce ta Amurka wacce ke ba da izinin mallaka ta ƴan kwangilar ƙirƙira da suka taso daga binciken da gwamnatin tarayya ke bayarwa. Sanatoci biyu ne suka dauki nauyin. Birch Bay na Indiana da Bob Dole na Kansas, an karɓi dokar a cikin 1980, an tsara shi a 94 Matsayi. 3015, da 35 USC § 200-212, kuma ana aiwatar da shi ta hanyar 37 CFR 401 don yarjejeniyar ba da kuɗaɗen tarayya tare da ƴan kwangila da 37 CFR 404 don lasisin abubuwan ƙirƙira mallakar gwamnatin tarayya.
Babban canji da Bayh–Dole ya yi shine a cikin hanyoyin da ƴan kwangilar tarayya waɗanda suka mallaki abubuwan ƙirƙiro da aka yi tare da tallafin tarayya zasu iya riƙe wannan ikon. Kafin dokar Bayh-Dole, Dokar Siyan Kuɗi ta Tarayya ta buƙaci amfani da wani sashe na haƙƙin mallaka wanda a wasu lokuta yana buƙatar ƴan kwangilar tarayya ko masu ƙirƙira su sanya abubuwan ƙirƙira da aka yi a ƙarƙashin kwangila ga gwamnatin tarayya sai dai idan hukumar ba da kuɗi ta yanke shawarar cewa amfanin jama'a ya fi dacewa ta hanyar kyale ɗan kwangila ko mai ƙirƙira ya riƙe babba ko keɓaɓɓen haƙƙoƙi. Cibiyoyin Kiwon Lafiya na ƙasa, Gidauniyar Kimiyya ta ƙasa, da Sashen Kasuwanci sun aiwatar da shirye-shirye waɗanda ke ba ƙungiyoyin sa-kai damar riƙe haƙƙoƙin ƙirƙira bisa sanarwa ba tare da neman shawarar hukuma ba. Sabanin haka, Bayh–Dole daidai gwargwado yana ba ƙungiyoyin sa-kai da ƙananan ƴan kwangilar kasuwanci damar riƙe mallakar abubuwan ƙirƙira da aka yi a ƙarƙashin kwangila kuma waɗanda suka samu, muddin aka bayyana kowace ƙirƙira akan lokaci kuma ɗan kwangilar ya zaɓi ya riƙe ikon mallaka a cikin wannan ƙirƙirar.
Babban canji na biyu tare da Bayh-Dole shine baiwa hukumomin tarayya izinin ba da lasisi na musamman ga abubuwan ƙirƙira mallakin gwamnatin tarayya.
Duk da yake an yi niyya da farko don ƙirƙirar abubuwan ƙarfafawa ga cibiyoyin ilimi na tarayya, ƙungiyoyi masu zaman kansu, da ƴan kwangila na tarayya don kare ƙirƙira da sauran kaddarorin fasaha ta yadda samfuran fasaha na saka hannun jari na masu biyan haraji za su iya taimakawa haɓaka kasuwancin, sharuɗɗan Bayh-Dole kuma yanzu an yi amfani da su ga ma'aikatan tarayya, wanda ya haifar da biyan kuɗi na sirri ga takamaiman ma'aikata da hukumomi, rassa da sassan da suke aiki.
Wannan yana haifar da ƙwaƙƙwaran ɓarna ga ma'aikatan tarayya don fifita takamaiman kamfanoni da takamaiman fasahar da suka ba da gudummawa dangane da kamfanoni da fasaha masu fafatawa. Wannan tsarin yana da ban sha'awa musamman a cikin yanayin ma'aikatan tarayya wadanda ke da rawa wajen tantance alkiblar rabon kudade na bincike, kamar yadda lamarin yake Dokta Anthony Fauci.
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Robert W. Malone likita ne kuma masanin ilimin halittu. Ayyukansa sun mayar da hankali kan fasahar mRNA, magunguna, da bincike na sake fasalin ƙwayoyi.
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