日前,美國制藥公司默沙東研發(fā)出一款很有希望的新冠肺炎特效藥的消息讓無數(shù)人歡欣鼓舞。目前這款新藥尚未獲批,但是已經(jīng)有少數(shù)富國提前下好了訂單。這不禁讓人擔(dān)心,在新冠特效藥上,也會(huì)跟疫苗一樣,出現(xiàn)“富國囤貨、窮國難求”的局面。
世衛(wèi)組織委托起草的一份獨(dú)立報(bào)告顯示,世衛(wèi)組織牽頭啟動(dòng)一項(xiàng)新冠特效藥分配平臺(tái)計(jì)劃,很可能會(huì)面臨跟全球疫苗分配平臺(tái)(Covax)相同的命運(yùn),即沒有明確的機(jī)制就采購合同和來源國進(jìn)行談判,各國能分到多少特效藥全憑運(yùn)氣。
為了獲得市場(chǎng)準(zhǔn)入,默沙東已經(jīng)采取了一系列措施,比如向一些非專利藥品廠商授權(quán)生產(chǎn)這款試驗(yàn)性藥品等。不過和當(dāng)初研發(fā)疫苗時(shí)一樣,令人憂心的一幕再度重演了,包括澳大利亞、新加坡、馬來西亞和泰國內(nèi)的部分發(fā)達(dá)國家甚至是中等收入國家,已經(jīng)開始跟隨美國的腳步,開始部署談判采購這款名叫莫努匹韋的藥物了。
為了促進(jìn)新冠藥物在全球的公平分配,世衛(wèi)組織啟動(dòng)了“抗擊新冠肺炎工具加速器”計(jì)劃(ACT-Accelerator)。該計(jì)劃擴(kuò)大了據(jù)稱首款能降低新冠重癥死亡率的類固醇藥物地塞米松的分配范圍,分析了1700臨床試驗(yàn)以找到有效的新療法,并且為多項(xiàng)大規(guī)模藥物試驗(yàn)提供了資金支持。盡管有了這樣一個(gè)全球計(jì)劃,但是在特效藥的問題上,很多窮國依然只能重蹈疫苗分配的命運(yùn),在“排隊(duì)”時(shí)排在最后面。
結(jié)構(gòu)短板
咨詢公司Dalberg Advisors在采訪了100多名政府、企業(yè)和衛(wèi)生組織官員后得出結(jié)論,稱“該 計(jì)劃尚未就各國的供應(yīng)和合同談判問題建立一個(gè)明確的采購架構(gòu)。”
該公司研究發(fā)現(xiàn),世衛(wèi)組織的“抗擊新冠肺炎工具加速器”計(jì)劃“在向窮國和中等收入國家的充分供應(yīng)問題上,可能會(huì)面臨與Covax平臺(tái)相同的挑戰(zhàn)。”特別是美國超前采購莫努匹韋很可能會(huì)加劇這種分配不公。
為了避免這種情況,擴(kuò)大發(fā)展中國家獲得新冠特效藥的機(jī)會(huì),各方也做了大量努力,由于口服藥具有生產(chǎn)成本低和易用性強(qiáng)等特點(diǎn),這也為廣大發(fā)展中國家?guī)砹死谩D硸|公司已經(jīng)與幾家印度仿制藥公司簽署了授權(quán)許可,以便向100多個(gè)中低收入國家供應(yīng)這款藥物。與此同時(shí),全球性衛(wèi)生組織國際藥品采購機(jī)制(Unitaid)及其合作伙伴也正在就莫努匹韋的供應(yīng)問題進(jìn)行討論。
默沙東的全球制藥公共政策常務(wù)總監(jiān)保羅·沙佩爾表示:“我認(rèn)為大家的擔(dān)憂是可以理解的。我們已經(jīng)與志愿授權(quán)伙伴出臺(tái)了一項(xiàng)政策,以滿足全球需求,將這款藥物送到全世界需要它的病人手里。”
經(jīng)驗(yàn)教訓(xùn)
很多官員都希望在新冠特效藥的問題上不要重蹈Covax的覆轍。Covax是由世衛(wèi)組織等機(jī)構(gòu)牽頭的一個(gè)新冠疫苗國際分配平臺(tái)。但由于各個(gè)富國大量囤積疫苗以保護(hù)本國人口,導(dǎo)致很多窮國分配到的疫苗杯水車薪,而與此同時(shí),有些富國已經(jīng)在開始給本國老百姓打加強(qiáng)針了。
“我們是否已經(jīng)學(xué)到教訓(xùn)了?”非盈利機(jī)構(gòu)“被忽視疾病藥物倡議”(Drugs for Neglected Diseases Initiative.)的北美地區(qū)執(zhí)行主任瑞秋·科恩質(zhì)問道。“廣大中低收入國家的多數(shù)人口迄今尚未接種疫苗,如果他們能早早獲得這款特效藥,就能極大從中受益。”
科恩表示,莫努匹韋這種新型抗病毒藥物的緊急使用無疑是一個(gè)好消息,但各地仍應(yīng)加強(qiáng)對(duì)患者的檢測(cè)工作,因?yàn)檫@種藥物在患者感染的早期最有效。另外,這種藥賣多少錢,誰能買得到——而且如果供應(yīng)有限的話,誰將買不到,這些都是重要問題。
美國在6月份已經(jīng)決定向默沙東支付12億美元,購買170萬個(gè)療程的莫努匹韋,相當(dāng)于每個(gè)療程700美元。在此之后,多個(gè)國家也紛紛跟進(jìn)洽購。澳大利亞、馬來西亞、新加坡和新西蘭已經(jīng)成功下單,泰國也在上周敲定了合同。據(jù)倫敦的Airfinity Ltd公司稱,目前大約有10個(gè)國家已經(jīng)簽訂了莫努匹韋的采購合同,或者正在進(jìn)行洽購。
高期望
人們對(duì)莫努匹韋的廣泛應(yīng)用抱有很高的希望。今年4月,默沙東將它授權(quán)給了印度西普拉公司、雷迪博士實(shí)驗(yàn)室和Hetero實(shí)驗(yàn)室等國外藥企。默沙東還與藥品專利池組織商討了增加授權(quán)的問題,并表示它打算根據(jù)世界銀行的收入標(biāo)準(zhǔn),對(duì)莫努匹韋實(shí)行階梯定價(jià)機(jī)制。
沙佩爾表示,目前,默沙東正在申請(qǐng)?jiān)诿绹木o急使用許可,到年底前,默沙東有望生產(chǎn)出1000萬個(gè)療程的莫努匹韋,到明年它的產(chǎn)量將“顯著增加”。
去年,世衛(wèi)組織等機(jī)構(gòu)啟動(dòng)了“抗擊新冠肺炎工具加速器”計(jì)劃,以促進(jìn)新冠疫苗、檢測(cè)產(chǎn)品和治療方法的研發(fā)和公平分配。上周五發(fā)布的一份報(bào)告指出,該計(jì)劃在疫情中發(fā)揮了重要作用,但也有一些內(nèi)部和外部的挑戰(zhàn)阻礙了它的進(jìn)度。世衛(wèi)組織在一份聲明中稱,將在修訂的戰(zhàn)略中采納有關(guān)意見建議。
國際藥品采購機(jī)制(Unitaid)也是“抗擊新冠肺炎工具加速器”計(jì)劃的牽頭部門之一。該組織正在想方設(shè)法確保新藥獲得世衛(wèi)組織審批后,相關(guān)國際采購工作能夠立即準(zhǔn)備就緒。不過但該組織的代表埃爾韋·維胡塞爾在一份聲明中表示,明年該組織至少還需要30多億美元的資金來做這項(xiàng)工作。
國際藥品采購機(jī)制表示:“與疫苗相比,藥品的采購和分配更復(fù)雜,涉及的實(shí)體也更多,這也使得新藥的采購要更加復(fù)雜。”
考慮到新冠病毒還有進(jìn)一步變異的風(fēng)險(xiǎn),加之有些國家的疫苗接種水平仍然很低,新冠特效藥對(duì)很多國家的價(jià)值都是不言而喻的。截止到上周,全球有超過55個(gè)國家的人口接種比例尚不足10%。
日內(nèi)瓦國際與發(fā)展研究所全球衛(wèi)生中心聯(lián)席主任蘇埃利·穆恩指出:“那些難以廣泛獲得疫苗的國家,恰恰就是那些更迫切需要特效藥的國家。”
該報(bào)告稱,如果像莫努匹韋這樣的特效藥能很快問世,世衛(wèi)組織的相關(guān)平臺(tái)就應(yīng)“迅速采取先發(fā)制人的行動(dòng)”,以避免在特效藥的國際分配上重蹈Covax的覆轍。(財(cái)富中文網(wǎng))
譯者:樸成奎
日前,美國制藥公司默沙東研發(fā)出一款很有希望的新冠肺炎特效藥的消息讓無數(shù)人歡欣鼓舞。目前這款新藥尚未獲批,但是已經(jīng)有少數(shù)富國提前下好了訂單。這不禁讓人擔(dān)心,在新冠特效藥上,也會(huì)跟疫苗一樣,出現(xiàn)“富國囤貨、窮國難求”的局面。
世衛(wèi)組織委托起草的一份獨(dú)立報(bào)告顯示,世衛(wèi)組織牽頭啟動(dòng)一項(xiàng)新冠特效藥分配平臺(tái)計(jì)劃,很可能會(huì)面臨跟全球疫苗分配平臺(tái)(Covax)相同的命運(yùn),即沒有明確的機(jī)制就采購合同和來源國進(jìn)行談判,各國能分到多少特效藥全憑運(yùn)氣。
為了獲得市場(chǎng)準(zhǔn)入,默沙東已經(jīng)采取了一系列措施,比如向一些非專利藥品廠商授權(quán)生產(chǎn)這款試驗(yàn)性藥品等。不過和當(dāng)初研發(fā)疫苗時(shí)一樣,令人憂心的一幕再度重演了,包括澳大利亞、新加坡、馬來西亞和泰國內(nèi)的部分發(fā)達(dá)國家甚至是中等收入國家,已經(jīng)開始跟隨美國的腳步,開始部署談判采購這款名叫莫努匹韋的藥物了。
為了促進(jìn)新冠藥物在全球的公平分配,世衛(wèi)組織啟動(dòng)了“抗擊新冠肺炎工具加速器”計(jì)劃(ACT-Accelerator)。該計(jì)劃擴(kuò)大了據(jù)稱首款能降低新冠重癥死亡率的類固醇藥物地塞米松的分配范圍,分析了1700臨床試驗(yàn)以找到有效的新療法,并且為多項(xiàng)大規(guī)模藥物試驗(yàn)提供了資金支持。盡管有了這樣一個(gè)全球計(jì)劃,但是在特效藥的問題上,很多窮國依然只能重蹈疫苗分配的命運(yùn),在“排隊(duì)”時(shí)排在最后面。
結(jié)構(gòu)短板
咨詢公司Dalberg Advisors在采訪了100多名政府、企業(yè)和衛(wèi)生組織官員后得出結(jié)論,稱“該 計(jì)劃尚未就各國的供應(yīng)和合同談判問題建立一個(gè)明確的采購架構(gòu)。”
該公司研究發(fā)現(xiàn),世衛(wèi)組織的“抗擊新冠肺炎工具加速器”計(jì)劃“在向窮國和中等收入國家的充分供應(yīng)問題上,可能會(huì)面臨與Covax平臺(tái)相同的挑戰(zhàn)。”特別是美國超前采購莫努匹韋很可能會(huì)加劇這種分配不公。
為了避免這種情況,擴(kuò)大發(fā)展中國家獲得新冠特效藥的機(jī)會(huì),各方也做了大量努力,由于口服藥具有生產(chǎn)成本低和易用性強(qiáng)等特點(diǎn),這也為廣大發(fā)展中國家?guī)砹死谩D硸|公司已經(jīng)與幾家印度仿制藥公司簽署了授權(quán)許可,以便向100多個(gè)中低收入國家供應(yīng)這款藥物。與此同時(shí),全球性衛(wèi)生組織國際藥品采購機(jī)制(Unitaid)及其合作伙伴也正在就莫努匹韋的供應(yīng)問題進(jìn)行討論。
默沙東的全球制藥公共政策常務(wù)總監(jiān)保羅·沙佩爾表示:“我認(rèn)為大家的擔(dān)憂是可以理解的。我們已經(jīng)與志愿授權(quán)伙伴出臺(tái)了一項(xiàng)政策,以滿足全球需求,將這款藥物送到全世界需要它的病人手里。”
經(jīng)驗(yàn)教訓(xùn)
很多官員都希望在新冠特效藥的問題上不要重蹈Covax的覆轍。Covax是由世衛(wèi)組織等機(jī)構(gòu)牽頭的一個(gè)新冠疫苗國際分配平臺(tái)。但由于各個(gè)富國大量囤積疫苗以保護(hù)本國人口,導(dǎo)致很多窮國分配到的疫苗杯水車薪,而與此同時(shí),有些富國已經(jīng)在開始給本國老百姓打加強(qiáng)針了。
“我們是否已經(jīng)學(xué)到教訓(xùn)了?”非盈利機(jī)構(gòu)“被忽視疾病藥物倡議”(Drugs for Neglected Diseases Initiative.)的北美地區(qū)執(zhí)行主任瑞秋·科恩質(zhì)問道。“廣大中低收入國家的多數(shù)人口迄今尚未接種疫苗,如果他們能早早獲得這款特效藥,就能極大從中受益。”
科恩表示,莫努匹韋這種新型抗病毒藥物的緊急使用無疑是一個(gè)好消息,但各地仍應(yīng)加強(qiáng)對(duì)患者的檢測(cè)工作,因?yàn)檫@種藥物在患者感染的早期最有效。另外,這種藥賣多少錢,誰能買得到——而且如果供應(yīng)有限的話,誰將買不到,這些都是重要問題。
美國在6月份已經(jīng)決定向默沙東支付12億美元,購買170萬個(gè)療程的莫努匹韋,相當(dāng)于每個(gè)療程700美元。在此之后,多個(gè)國家也紛紛跟進(jìn)洽購。澳大利亞、馬來西亞、新加坡和新西蘭已經(jīng)成功下單,泰國也在上周敲定了合同。據(jù)倫敦的Airfinity Ltd公司稱,目前大約有10個(gè)國家已經(jīng)簽訂了莫努匹韋的采購合同,或者正在進(jìn)行洽購。
高期望
人們對(duì)莫努匹韋的廣泛應(yīng)用抱有很高的希望。今年4月,默沙東將它授權(quán)給了印度西普拉公司、雷迪博士實(shí)驗(yàn)室和Hetero實(shí)驗(yàn)室等國外藥企。默沙東還與藥品專利池組織商討了增加授權(quán)的問題,并表示它打算根據(jù)世界銀行的收入標(biāo)準(zhǔn),對(duì)莫努匹韋實(shí)行階梯定價(jià)機(jī)制。
沙佩爾表示,目前,默沙東正在申請(qǐng)?jiān)诿绹木o急使用許可,到年底前,默沙東有望生產(chǎn)出1000萬個(gè)療程的莫努匹韋,到明年它的產(chǎn)量將“顯著增加”。
去年,世衛(wèi)組織等機(jī)構(gòu)啟動(dòng)了“抗擊新冠肺炎工具加速器”計(jì)劃,以促進(jìn)新冠疫苗、檢測(cè)產(chǎn)品和治療方法的研發(fā)和公平分配。上周五發(fā)布的一份報(bào)告指出,該計(jì)劃在疫情中發(fā)揮了重要作用,但也有一些內(nèi)部和外部的挑戰(zhàn)阻礙了它的進(jìn)度。世衛(wèi)組織在一份聲明中稱,將在修訂的戰(zhàn)略中采納有關(guān)意見建議。
國際藥品采購機(jī)制(Unitaid)也是“抗擊新冠肺炎工具加速器”計(jì)劃的牽頭部門之一。該組織正在想方設(shè)法確保新藥獲得世衛(wèi)組織審批后,相關(guān)國際采購工作能夠立即準(zhǔn)備就緒。不過但該組織的代表埃爾韋·維胡塞爾在一份聲明中表示,明年該組織至少還需要30多億美元的資金來做這項(xiàng)工作。
國際藥品采購機(jī)制表示:“與疫苗相比,藥品的采購和分配更復(fù)雜,涉及的實(shí)體也更多,這也使得新藥的采購要更加復(fù)雜。”
考慮到新冠病毒還有進(jìn)一步變異的風(fēng)險(xiǎn),加之有些國家的疫苗接種水平仍然很低,新冠特效藥對(duì)很多國家的價(jià)值都是不言而喻的。截止到上周,全球有超過55個(gè)國家的人口接種比例尚不足10%。
日內(nèi)瓦國際與發(fā)展研究所全球衛(wèi)生中心聯(lián)席主任蘇埃利·穆恩指出:“那些難以廣泛獲得疫苗的國家,恰恰就是那些更迫切需要特效藥的國家。”
該報(bào)告稱,如果像莫努匹韋這樣的特效藥能很快問世,世衛(wèi)組織的相關(guān)平臺(tái)就應(yīng)“迅速采取先發(fā)制人的行動(dòng)”,以避免在特效藥的國際分配上重蹈Covax的覆轍。(財(cái)富中文網(wǎng))
譯者:樸成奎
Moves by a small group of countries to acquire supplies of Merck & Co.’s promising COVID pill before it’s even approved are raising concerns that some poorer nations could be left behind in a repeat of the slow and inequitable rollout of vaccines.
A global initiative to deploy COVID therapies like Merck’s molnupiravir is at risk of running into the same problems the Covax effort faced and has no clear mechanism to negotiate contracts and supply countries, according to an independent report commissioned by the World Health Organization.
Merck has taken a series of steps, including licensing its experimental medication to generic-drug firms, to ensure access. Yet, in a worrisome echo of the global vaccine situation, some wealthy and middle-income nations, including Australia, Singapore, Malaysia and Thailand, have followed the U.S. and already secured molnupiravir or started talks to obtain it.
The therapies arm of the ACT-Accelerator, which is working to distribute COVID treatments around the world, has expanded access to the steroid dexamethasone, analyzed more than 1,700 clinical trials to identify new treatments and funded large trials. Still, nations that have struggled to vaccinate their populations could end up in the back of the line for brand new therapies like Merck’s pill.
Structure Lacking
The program “does not yet have a clearly articulated procurement structure to supply countries or to negotiate contracts,” according to the report from consulting firm Dalberg Advisors that was based on interviews with more than 100 government, company and health-group officials, among others.
The WHO-backed effort “could face similar challenges to Covax in ensuring sufficient supply” for poor and middle-income countries, the review found, highlighting the advanced purchase of molnupiravir by the U.S. as a risk.
Efforts are underway to avert the scenario seen with vaccines and widen access to the treatment, a potential boon to poorer countries because of its low production cost and ease of use. Merck signed licensing agreements with Indian generic manufacturers aimed at supplying more than 100 lower- and middle-income countries, should the therapy get approved, while global health group Unitaid and its partners are in supply discussions.
“The concerns I think are understandable, but we’ve put in place a strategy with our voluntary license partners that will be able to meet the demand and really bring this medicine to patients worldwide who need it,” said Paul Schaper, executive director of global pharmaceutical public policy at Merck.
Lessons Learned?
Officials are anxious not to replay the disappointments of Covax, the program coordinated by the WHO and other groups to distribute vaccines. The effort has been hobbled by a lack of supplies after rich nations rushed ahead to protect their own populations, with some already beginning to give booster doses.
“Have we learned our lesson?” said Rachel Cohen, North America regional executive director for the nonprofit Drugs for Neglected Diseases Initiative. “The majority of people in low- and middle-income countries haven’t been vaccinated and could potentially benefit tremendously from this treatment if they got it early enough.”
The emergence of novel antivirals like molnupiravir is good news, but testing needs to be ramped up to detect cases in the first days of infection when the drugs may be most effective, Cohen said. How much they will cost -- and who will receive them and who won’t if supplies are limited -- remain key questions.
Countries are already lining up behind the U.S., which agreed in June to pay Merck about $1.2 billion for 1.7 million treatment courses, or about $700 per course. Australia, Malaysia, Singapore and New Zealand have already secured supplies, while Thailand was finalizing its own pact last week. In all, about 10 countries have either signed deals or are in talks to do so, according to London-based Airfinity Ltd.
High Hopes
Hopes are running high that the drug will be widely available. In April, Merck licensed it to Indian companies including Cipla Ltd., Dr. Reddy’s Laboratories Ltd. and Hetero Labs Ltd. The company also has been in discussions with the Medicines Patent Pool to weigh additional licenses and said it plans to implement a tiered pricing approach based on World Bank income criteria.
Merck itself said it expects to produce 10 million courses by the end of the year as it seeks emergency use authorization in the U.S. “Substantially more” should become available next year, Schaper said.
The ACT-Accelerator was launched last year by the WHO and other organizations to spur the development and equitable delivery of COVID vaccines, tests and therapies. The coalition has played an important role, but has grappled with external and internal challenges that have hampered its progress, according to the report published Friday. The WHO said in a statement that recommendations will be incorporated into a revised strategy.
Unitaid, one of the groups overseeing the therapies campaign, is working to ensure new treatments are ready as soon as the WHO or others approve them, but more than $3 billion is needed to fund the effort next year, a representative, Herve Verhoosel, wrote in a statement.
“With therapeutics, the pipeline is more complex and there are more entities involved than with vaccines, which makes procuring new treatments more complicated,” according to Unitaid.
COVID therapies could be critical for many countries due to the risk of further variants and low immunization levels. More than 55 countries had yet to vaccinate 10% of their populations as of last week.
“The countries where we don’t have widespread access to vaccines are the exact same countries where treatment will be more urgently needed,” said Suerie Moon, co-director of the Global Health Centre at the Graduate Institute of International and Development Studies in Geneva.
If new treatments like Merck’s become available soon, “rapid preemptive action” will be needed to make sure the delivery effort doesn’t face similar challenges to Covax, the report said.