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新冠特效药上市在即,“富国囤积穷国难求”现象又重演

新冠特效药上市在即,“富国囤积穷国难求”现象又重演

James Paton, 彭博社 2021年10月15日
很多穷国依然只能重蹈疫苗分配的命运,在“排队”时排在最后面。

日前,美国制药公司默沙东研发出一款很有希望的新冠肺炎特效药的消息让无数人欢欣鼓舞。目前这款新药尚未获批,但是已经有少数富国提前下好了订单。这不禁让人担心,在新冠特效药上,也会跟疫苗一样,出现“富国囤货、穷国难求”的局面。

世卫组织委托起草的一份独立报告显示,世卫组织牵头启动一项新冠特效药分配平台计划,很可能会面临跟全球疫苗分配平台(Covax)相同的命运,即没有明确的机制就采购合同和来源国进行谈判,各国能分到多少特效药全凭运气。

为了获得市场准入,默沙东已经采取了一系列措施,比如向一些非专利药品厂商授权生产这款试验性药品等。不过和当初研发疫苗时一样,令人忧心的一幕再度重演了,包括澳大利亚、新加坡、马来西亚和泰国内的部分发达国家甚至是中等收入国家,已经开始跟随美国的脚步,开始部署谈判采购这款名叫莫努匹韦的药物了。

为了促进新冠药物在全球的公平分配,世卫组织启动了“抗击新冠肺炎工具加速器”计划(ACT-Accelerator)。该计划扩大了据称首款能降低新冠重症死亡率的类固醇药物地塞米松的分配范围,分析了1700临床试验以找到有效的新疗法,并且为多项大规模药物试验提供了资金支持。尽管有了这样一个全球计划,但是在特效药的问题上,很多穷国依然只能重蹈疫苗分配的命运,在“排队”时排在最后面。

结构短板

咨询公司Dalberg Advisors在采访了100多名政府、企业和卫生组织官员后得出结论,称“该 计划尚未就各国的供应和合同谈判问题建立一个明确的采购架构。”

该公司研究发现,世卫组织的“抗击新冠肺炎工具加速器”计划“在向穷国和中等收入国家的充分供应问题上,可能会面临与Covax平台相同的挑战。”特别是美国超前采购莫努匹韦很可能会加剧这种分配不公。

为了避免这种情况,扩大发展中国家获得新冠特效药的机会,各方也做了大量努力,由于口服药具有生产成本低和易用性强等特点,这也为广大发展中国家带来了利好。默沙东公司已经与几家印度仿制药公司签署了授权许可,以便向100多个中低收入国家供应这款药物。与此同时,全球性卫生组织国际药品采购机制(Unitaid)及其合作伙伴也正在就莫努匹韦的供应问题进行讨论。

默沙东的全球制药公共政策常务总监保罗·沙佩尔表示:“我认为大家的担忧是可以理解的。我们已经与志愿授权伙伴出台了一项政策,以满足全球需求,将这款药物送到全世界需要它的病人手里。”

经验教训

很多官员都希望在新冠特效药的问题上不要重蹈Covax的覆辙。Covax是由世卫组织等机构牵头的一个新冠疫苗国际分配平台。但由于各个富国大量囤积疫苗以保护本国人口,导致很多穷国分配到的疫苗杯水车薪,而与此同时,有些富国已经在开始给本国老百姓打加强针了。

“我们是否已经学到教训了?”非盈利机构“被忽视疾病药物倡议”(Drugs for Neglected Diseases Initiative.)的北美地区执行主任瑞秋·科恩质问道。“广大中低收入国家的多数人口迄今尚未接种疫苗,如果他们能早早获得这款特效药,就能极大从中受益。”

科恩表示,莫努匹韦这种新型抗病毒药物的紧急使用无疑是一个好消息,但各地仍应加强对患者的检测工作,因为这种药物在患者感染的早期最有效。另外,这种药卖多少钱,谁能买得到——而且如果供应有限的话,谁将买不到,这些都是重要问题。

美国在6月份已经决定向默沙东支付12亿美元,购买170万个疗程的莫努匹韦,相当于每个疗程700美元。在此之后,多个国家也纷纷跟进洽购。澳大利亚、马来西亚、新加坡和新西兰已经成功下单,泰国也在上周敲定了合同。据伦敦的Airfinity Ltd公司称,目前大约有10个国家已经签订了莫努匹韦的采购合同,或者正在进行洽购。

高期望

人们对莫努匹韦的广泛应用抱有很高的希望。今年4月,默沙东将它授权给了印度西普拉公司、雷迪博士实验室和Hetero实验室等国外药企。默沙东还与药品专利池组织商讨了增加授权的问题,并表示它打算根据世界银行的收入标准,对莫努匹韦实行阶梯定价机制。

沙佩尔表示,目前,默沙东正在申请在美国的紧急使用许可,到年底前,默沙东有望生产出1000万个疗程的莫努匹韦,到明年它的产量将“显著增加”。

去年,世卫组织等机构启动了“抗击新冠肺炎工具加速器”计划,以促进新冠疫苗、检测产品和治疗方法的研发和公平分配。上周五发布的一份报告指出,该计划在疫情中发挥了重要作用,但也有一些内部和外部的挑战阻碍了它的进度。世卫组织在一份声明中称,将在修订的战略中采纳有关意见建议。

国际药品采购机制(Unitaid)也是“抗击新冠肺炎工具加速器”计划的牵头部门之一。该组织正在想方设法确保新药获得世卫组织审批后,相关国际采购工作能够立即准备就绪。不过但该组织的代表埃尔韦·维胡塞尔在一份声明中表示,明年该组织至少还需要30多亿美元的资金来做这项工作。

国际药品采购机制表示:“与疫苗相比,药品的采购和分配更复杂,涉及的实体也更多,这也使得新药的采购要更加复杂。”

考虑到新冠病毒还有进一步变异的风险,加之有些国家的疫苗接种水平仍然很低,新冠特效药对很多国家的价值都是不言而喻的。截止到上周,全球有超过55个国家的人口接种比例尚不足10%。

日内瓦国际与发展研究所全球卫生中心联席主任苏埃利·穆恩指出:“那些难以广泛获得疫苗的国家,恰恰就是那些更迫切需要特效药的国家。”

该报告称,如果像莫努匹韦这样的特效药能很快问世,世卫组织的相关平台就应“迅速采取先发制人的行动”,以避免在特效药的国际分配上重蹈Covax的覆辙。(财富中文网)

译者:朴成奎

日前,美国制药公司默沙东研发出一款很有希望的新冠肺炎特效药的消息让无数人欢欣鼓舞。目前这款新药尚未获批,但是已经有少数富国提前下好了订单。这不禁让人担心,在新冠特效药上,也会跟疫苗一样,出现“富国囤货、穷国难求”的局面。

世卫组织委托起草的一份独立报告显示,世卫组织牵头启动一项新冠特效药分配平台计划,很可能会面临跟全球疫苗分配平台(Covax)相同的命运,即没有明确的机制就采购合同和来源国进行谈判,各国能分到多少特效药全凭运气。

为了获得市场准入,默沙东已经采取了一系列措施,比如向一些非专利药品厂商授权生产这款试验性药品等。不过和当初研发疫苗时一样,令人忧心的一幕再度重演了,包括澳大利亚、新加坡、马来西亚和泰国内的部分发达国家甚至是中等收入国家,已经开始跟随美国的脚步,开始部署谈判采购这款名叫莫努匹韦的药物了。

为了促进新冠药物在全球的公平分配,世卫组织启动了“抗击新冠肺炎工具加速器”计划(ACT-Accelerator)。该计划扩大了据称首款能降低新冠重症死亡率的类固醇药物地塞米松的分配范围,分析了1700临床试验以找到有效的新疗法,并且为多项大规模药物试验提供了资金支持。尽管有了这样一个全球计划,但是在特效药的问题上,很多穷国依然只能重蹈疫苗分配的命运,在“排队”时排在最后面。

结构短板

咨询公司Dalberg Advisors在采访了100多名政府、企业和卫生组织官员后得出结论,称“该 计划尚未就各国的供应和合同谈判问题建立一个明确的采购架构。”

该公司研究发现,世卫组织的“抗击新冠肺炎工具加速器”计划“在向穷国和中等收入国家的充分供应问题上,可能会面临与Covax平台相同的挑战。”特别是美国超前采购莫努匹韦很可能会加剧这种分配不公。

为了避免这种情况,扩大发展中国家获得新冠特效药的机会,各方也做了大量努力,由于口服药具有生产成本低和易用性强等特点,这也为广大发展中国家带来了利好。默沙东公司已经与几家印度仿制药公司签署了授权许可,以便向100多个中低收入国家供应这款药物。与此同时,全球性卫生组织国际药品采购机制(Unitaid)及其合作伙伴也正在就莫努匹韦的供应问题进行讨论。

默沙东的全球制药公共政策常务总监保罗·沙佩尔表示:“我认为大家的担忧是可以理解的。我们已经与志愿授权伙伴出台了一项政策,以满足全球需求,将这款药物送到全世界需要它的病人手里。”

经验教训

很多官员都希望在新冠特效药的问题上不要重蹈Covax的覆辙。Covax是由世卫组织等机构牵头的一个新冠疫苗国际分配平台。但由于各个富国大量囤积疫苗以保护本国人口,导致很多穷国分配到的疫苗杯水车薪,而与此同时,有些富国已经在开始给本国老百姓打加强针了。

“我们是否已经学到教训了?”非盈利机构“被忽视疾病药物倡议”(Drugs for Neglected Diseases Initiative.)的北美地区执行主任瑞秋·科恩质问道。“广大中低收入国家的多数人口迄今尚未接种疫苗,如果他们能早早获得这款特效药,就能极大从中受益。”

科恩表示,莫努匹韦这种新型抗病毒药物的紧急使用无疑是一个好消息,但各地仍应加强对患者的检测工作,因为这种药物在患者感染的早期最有效。另外,这种药卖多少钱,谁能买得到——而且如果供应有限的话,谁将买不到,这些都是重要问题。

美国在6月份已经决定向默沙东支付12亿美元,购买170万个疗程的莫努匹韦,相当于每个疗程700美元。在此之后,多个国家也纷纷跟进洽购。澳大利亚、马来西亚、新加坡和新西兰已经成功下单,泰国也在上周敲定了合同。据伦敦的Airfinity Ltd公司称,目前大约有10个国家已经签订了莫努匹韦的采购合同,或者正在进行洽购。

高期望

人们对莫努匹韦的广泛应用抱有很高的希望。今年4月,默沙东将它授权给了印度西普拉公司、雷迪博士实验室和Hetero实验室等国外药企。默沙东还与药品专利池组织商讨了增加授权的问题,并表示它打算根据世界银行的收入标准,对莫努匹韦实行阶梯定价机制。

沙佩尔表示,目前,默沙东正在申请在美国的紧急使用许可,到年底前,默沙东有望生产出1000万个疗程的莫努匹韦,到明年它的产量将“显著增加”。

去年,世卫组织等机构启动了“抗击新冠肺炎工具加速器”计划,以促进新冠疫苗、检测产品和治疗方法的研发和公平分配。上周五发布的一份报告指出,该计划在疫情中发挥了重要作用,但也有一些内部和外部的挑战阻碍了它的进度。世卫组织在一份声明中称,将在修订的战略中采纳有关意见建议。

国际药品采购机制(Unitaid)也是“抗击新冠肺炎工具加速器”计划的牵头部门之一。该组织正在想方设法确保新药获得世卫组织审批后,相关国际采购工作能够立即准备就绪。不过但该组织的代表埃尔韦·维胡塞尔在一份声明中表示,明年该组织至少还需要30多亿美元的资金来做这项工作。

国际药品采购机制表示:“与疫苗相比,药品的采购和分配更复杂,涉及的实体也更多,这也使得新药的采购要更加复杂。”

考虑到新冠病毒还有进一步变异的风险,加之有些国家的疫苗接种水平仍然很低,新冠特效药对很多国家的价值都是不言而喻的。截止到上周,全球有超过55个国家的人口接种比例尚不足10%。

日内瓦国际与发展研究所全球卫生中心联席主任苏埃利·穆恩指出:“那些难以广泛获得疫苗的国家,恰恰就是那些更迫切需要特效药的国家。”

该报告称,如果像莫努匹韦这样的特效药能很快问世,世卫组织的相关平台就应“迅速采取先发制人的行动”,以避免在特效药的国际分配上重蹈Covax的覆辙。(财富中文网)

译者:朴成奎

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.

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