近日,美国总统拜登在国际社会压力下宣布支持放弃新冠疫苗知识产权,以帮助欠发达国家,但美国制药巨头、主要的新冠疫苗开发商之一辉瑞公司却公开唱起了反调。

 

5月8日,美国制药巨头辉瑞公司CEO阿尔伯特•伯拉(Albert Bourla)向公司员工发布一封公开信。他在信中称自己坚决反对放弃疫苗知识产权的决定,并“透明”地介绍了辉瑞公司“确保疫苗公平分发的事实”。

 

伯拉声称,辉瑞公司为疫苗开发投入大量人力物力,放弃知识产权会让投资者产生顾虑,且将会“扰乱疫苗原材料供应”,因此他反对放弃专利。

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伯拉推特截图

 

在信的一开头,伯拉就强调了他对于“平等”的定义。伯拉称,“公平合理的疫苗分配,从一开始就是指引我们前进的北极星。为确保每个国家都能获得我们的新冠疫苗,有两个条件必须满足:一个是任何人都能负担起疫苗的价格,另一个则是可靠地为所有人生产足够多的疫苗。”

 

他声称,第一个条件“很早之前就已得到满足”,辉瑞去年6月就采用了“价格分级”的方式,富裕国家需要为每剂疫苗承担“一顿外卖的价格”并免费分发给民众;中等收入国家的价格约为前者的一半,而低收入国家则是成本价。他还强调,他眼中的“公平”意味着给需要帮助的人提供更多疫苗。

 

但接下来,伯拉却做出了自相矛盾的发言。他透露,辉瑞已达成将给116个国家供货,并与更多国家就27亿剂疫苗的供应开展深入谈判。然而根据伯拉的预计,这些疫苗中只有40%,即10多亿剂,今年会被提供给中低收入国家。这种分配与他的“公平”定义似乎不太相符。

 

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伯拉公开信截图

 

不过伯拉很快就为自己做出了辩解。他声称,是因为中低收入国家大多“根本没向辉瑞下订单”,疫苗才会更多地流向富裕国家。

 

“事实上,高收入国家储备了大量的疫苗。我对此非常担心,于是通过信件、电话、短信等方式联系了许多中低收入国家领导人,呼吁他们也来储备供应有限的疫苗。但他们中绝大多数都找了其他疫苗制造商下单,有的是因为当时mRNA疫苗的技术尚未经过测试,有的是有了在本地生产疫苗的其他选项,还有一些并不认可我们的疫苗。”伯拉称。

 

接着他又说,由于供货不足等原因,许多国家又重新转向辉瑞签署供货协议。他据此认为,到2021年下半年,辉瑞在富裕国家和中低收入国家的疫苗供应会“趋于平衡”,到了2022年所有签署合同的国家就会有“足够的疫苗”。

 

但对于伯拉的说法,彭博社援引宾夕法尼亚大学卫生政策教授伊齐基尔•伊曼纽尔(Ezekiel Emanuel)的话指出,辉瑞疫苗所需的超低温储存条件实际上才是最大的挑战,对于缺乏强大基础设施的国家来说这才是最难处理的问题。


 

“知识产权得到保护,投资者才肯给钱”

 

在大篇幅的“铺垫”之后。伯拉最终抛出了他的核心观点,反对放弃新冠疫苗知识产权。他声称,这种做法“只会导致更多问题”。

 

伯拉先是表示,辉瑞公司为mRNA疫苗研发投入了大量人力物力,“从零开始努力”,才得以在“极短时间内研发出高效的救命疫苗”,暗示这些投资不能白费。

 

“我担心放弃专利保护会让人们不敢冒险。在我们成功开发出疫苗前,就已经投入20亿美元,因为我们知道其中的利害关系。最近我又批准在新冠疫苗研发上再投入6亿美元,使我们2021年研发总支出超过100亿美元。”伯拉称,“最近的言论不影响我们投资科学,但我不确定那些小型生物技术创新者是否也会如此,他们完全依赖投资者的资金,而投资者投资的前提是知识产权得到保护。”

 

而伯拉给出的另一个理由则是疫苗原材料供应问题。他声称,生产疫苗需要19个不同国家供应商生产的280种不同材料或成分,放弃疫苗知识产权会“威胁”原材料流通,扰乱疫苗生产。

 

这封信在社交媒体上引起了一定的争议。支持伯拉的人认为,辉瑞公司为疫苗研发投入大量资金,不应该放弃疫苗知识产权,并赞同伯拉关于“风险”的说法;批评者则认为,辉瑞是在给自私自利及供货量不足狡辩。

 

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辉瑞公司CEO阿尔伯特·伯拉,视频截图

 

此前,拜登政府当地时间5月5日发表一项决定,表示美国将放弃新冠肺炎疫苗的知识产权专利。此举是为解决新冠疫苗供应不足,发达国家与发展中国家之间疫苗分配不平衡而采取的措施,目的在于让发展中国家可以不担心知识产权问题,特别是专利问题,能够自己生产新冠疫苗应对疫情。

 

56日,哈里梅根夫妇发起了一项确保全球公平获得疫苗的运动,向辉瑞、莫德纳、阿斯利康、强生和NorovaxCEO发出了一封公开信。这封发表在《全球公民》上的公开信要求这五家疫苗生产商的CEO“以非凡的目的、责任和领导力采取行动,应对公平危机,并采取一切可能的措施增加全球供应

 

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英国目前对此尚未明确表明态度,德国已经明确表示反对。英国政府发言人表示,英国方面正与世贸组织成员国合作解决新冠疫苗的专利问题。

 


附公开信全文:

 

Today I Sent This Letter To Have a Candid Conversation With Our Colleagues About the Drivers of COVID-19 Access and Availability

 

Dear Colleagues,

 

The recent announcement that the United States Trade Representative will discuss options to waive some COVID-19 vaccine intellectual property (IP) rights has created some confusion to the world. Has Pfizer done enough to ensure fair and equitable distribution of our COVID-19 vaccine? Is the proposed waiver going to bring solutions or create more problems? I am writing to you today to discuss these questions.

 

Fair and equitable distribution was our North Star from day one. In order to ensure that every country can have access to our COVID-19 vaccine two conditions had to be met: a price that anyone can afford and reliable manufacturing of enough vaccine for all.

 

The first condition was met in the early days. Back in June of 2020 we decided to offer our vaccine through tiered pricing. The wealthier nations would have to pay in the range of about the cost of a takeaway meal and would offer it to their citizens for free. The middle-income countries were offered doses at roughly half that price and the low-income countries were offered doses at cost. Many of the poorest communities will receive their doses through donation. Equity doesn’t mean we give everyone the same. Equity means we give more to those that need more.

 

Meeting the second condition was much more challenging but we are getting there with remarkable speed. Thanks to the ingenuity and hard work of our scientists, engineers and skilled workers, and multibillion dollars of Pfizer investment, we announced that we will provide to the world more than 2.5 billion doses in 2021. In fact, our internal target is 3 billion doses, so we feel quite comfortable about our commitment. Achieving 3 billion doses this year means, by extrapolation, 4 billion doses in 2022. These doses are not for the rich or poor, not for the north or south. These are doses for ALL. We have concluded agreements to supply 116 countries and we are currently in advanced negotiations with many more for a total of approximately 2.7 billion doses in 2021. Upon finalization of all agreements, we expect that 40% of them, or more than 1 billion doses, will go to middle- and low-income countries in 2021.

 

This clearly poses another question. Until today, we have shipped approximately 450 million doses and the balance is more favorable to high income countries. Why is that? When we developed our tiered pricing policy, we reached out to all nations asking them to place orders so we could allocate doses for them. In reality, the high-income countries reserved most of the doses. I became personally concerned with that and I reached out to many heads of middle/low-income countries by letter, phone and even text to urge them to reserve doses because the supply was limited. However, most of them decided to place orders with other vaccine makers either because mRNA technology was untested at that time or because they were offered local production options. Some didn’t even approve our vaccine. Unfortunately, other vaccine producers were not able to meet their supply commitments for varying technical reasons. Most of the countries that did not choose us initially, came back and thanks to our phenomenal supply ramp up, we have started signing supply agreements with them. We expect the supply balance to weigh in their favor in the second half of 2021, and to have virtually enough supply for all in 2022.

 

Last week, I had the opportunity to provide these facts to the US Trade Representative and explain why the suggested waiver of IP rights could only derail this progress. Which brings me to the second question. Is the proposed waiver going to improve the supply situation or create more problems? And my answer is categorically the latter.

 

When we created our vaccine there was no manufacturing production of any mRNA vaccine or medicine anywhere in the world. We had to create manufacturing infrastructure from scratch. With 172 years of quality manufacturing tradition, substantial deployment of capital, and more importantly, an army of highly skilled scientists, engineers and manufacturing workers, we developed in record time the most efficient manufacturing machine of a life-saving vaccine that the world has ever seen. Currently, infrastructure is not the bottleneck for us manufacturing faster. The restriction is the scarcity of highly specialized raw materials needed to produce our vaccine. These 280 different materials or components are produced by many suppliers in 19 different countries. Many of them needed our substantial support (technical and financial) to ramp up their production. Right now, virtually every single gram of raw material produced is shipped immediately into our manufacturing facilities and is converted immediately and reliably to vaccines that are shipped immediately around the world (91 countries to date.) The proposed waiver for COVID-19 vaccines, threatens to disrupt the flow of raw materials. It will unleash a scramble for the critical inputs we require in order to make a safe and effective vaccine. Entities with little or no experience in manufacturing vaccines are likely to chase the very raw materials we require to scale our production, putting the safety and security of all at risk. 

 

And I would like to make a final point. I worry that waiving of patent protection will disincentivize anyone else from taking a big risk. We deployed $2 billion before we knew whether we could successfully develop a vaccine because we understood what was at stake. Just recently, I authorized spending an additional $600 million on COVID-19 research and development that will bring our total spend for R&D in 2021 to more than $10 billion . The recent rhetoric will not discourage us from continuing investing in science. But I am not sure if the same is true for the thousands of small biotech innovators that are totally dependent on accessing capital from investors who invest only on the premise that their intellectual property will be protected.

 

Ending the pandemic and vaccinating the world is a massive, but achievable undertaking. We remain fully focused on getting high-quality, safe and effective vaccines to patients all over the world as quickly as possible and to putting an end to this deadly pandemic. Once again, we will not let politics stand in our way and we will continue doing what we do best – creating breakthroughs that change patients’ lives.

 

今天,我写这封信是为了与我们的同事就COVID-19访问和可用性的驱动因素进行坦诚的交谈。

 

亲爱的同事们,

 

最近,美国贸易代表将讨论放弃某些COVID-19疫苗知识产权(IP)权利的声明,给世界造成了一些混乱。辉瑞公司是否做了足够的工作来确保公平和公正地分发我们的COVID-19疫苗?提议的豁免是否会带来解决方案或带来更多问题?我今天写信给您讨论这些问题。

 

从第一天起,公平和公正的分配就是我们的北极星。为了确保每个国家都可以使用我们的COVID-19疫苗,必须满足两个条件:任何人都能负担得起的价格以及为所有人可靠地生产足够的疫苗。

 

早期满足了第一个条件。早在20206月,我们就决定通过分级定价来提供我们的疫苗。较富裕的国家将不得不支付大约一顿外卖饭菜的费用,并免费向其公民提供外卖饭菜。向中等收入国家提供的剂量大约是价格的一半,向低收入国家提供的剂量是成本的。许多最贫穷的社区将通过捐赠来获得救助。公平并不意味着我们给每个人都一样。公平意味着我们为需要更多的人付出更多。

 

满足第二个条件更具挑战性,但是我们以惊人的速度到达那里。得益于我们科学家,工程师和熟练工人的独创性和辛勤工作,以及辉瑞公司数十亿美元的投资,我们宣布,到2021年,我们将向全球提供超过25亿剂。事实上,我们的内部目标是30亿剂,因此我们对自己的承诺感到很满意。通过推断,今年达到30亿剂意味着2022年达到40亿剂。这些剂量不适合富人或穷人,也不适合北方或南方。这些是所有的剂量。我们已经达成了为116个国家/地区提供服务的协议,而我们目前正与更多国家/地区进行深入谈判,以期在2021年达成总计约27亿剂的协议。在所有协议完成后,我们希望其中的40%,即超过10亿剂,将于2021年进入中低收入国家。

 

这显然提出了另一个问题。到今天为止,我们已经运送了大约4.5亿剂,其余对高收入国家更有利。这是为什么?在制定分级定价政策时,我们接触了所有国家,要求他们下订单,以便为他们分配剂量。实际上,高收入国家保留了大部分剂量。我个人对此感到关注,并通过信件,电话甚至短信与许多中低收入国家的负责人联系,敦促他们储备药品,因为供应有限。但是,他们中的大多数决定与其他疫苗生产商下订单,因为当时尚未对mRNA技术进行测试,或者因为它们提供了本地生产选项。有些甚至没有批准我们的疫苗。不幸的是,其他疫苗生产商由于各种技术原因无法履行其供应承诺。最初没有选择我们的大多数国家/地区都回来了,由于我们的供应激增,我们已经开始与它们签署供应协议。我们预计供应平衡将在2021年下半年对他们有利,并且到2022年几乎将有足够的供应。

 

上周,我有机会向美国贸易代表提供了这些事实,并解释了为什么建议放弃知识产权只会使这一进展脱轨。这带给我第二个问题。提议的豁免是否会改善供应状况或带来更多问题?我的回答绝对是后者。

 

当我们创建疫苗时,世界上任何地方都没有生产任何mRNA疫苗或药物的生产。我们必须从头开始创建制造基础架构。凭借172年的高质量生产传统,大量的资金投入,更重要的是,由一支由高技能的科学家,工程师和制造工人组成的军队,我们在创纪录的时间内开发了世界上最高效的救生疫苗生产机见过。当前,基础设施并不是我们更快制造的瓶颈。限制是生产我们的疫苗所需的高度专业化的原材料的匮乏。这280种不同的材料或组件是由19个不同国家的许多供应商生产的。他们中的许多人需要我们的大力支持(技术和资金)才能提高产量。目前,几乎每生产一克的原材料都会立即运送到我们的生产设施中,并立即可靠地转换为疫苗,这些疫苗将立即运送到世界各地(迄今已有91个国家/地区)。拟议的COVID-19疫苗豁免将面临威胁破坏原材料的流动。这将使我们为生产安全有效的疫苗而需要的关键投入物展开争夺。没有或几乎没有疫苗生产经验的实体可能会追逐我们扩大生产所需的原材料,从而使所有人的安全和保障面临风险。

 

我想说最后一点。我担心放弃专利保护会削弱其他人承担巨大风险的积极性。在我们知道能否成功开发疫苗之前,我们投入了20亿美元。就在最近,我授权在COVID-19研发上追加支出6亿美元,这将使我们在2021年的研发总支出超过100亿美元。最近的言论并不会阻止我们继续投资于科学。但是我不确定,对于成千上万的小型生物技术创新者而言,情况是否完全相同,这些创新者完全依赖于仅在知识产权受到保护的前提下进行投资的投资者获取资金。

 

结束大流行并为世界接种疫苗是一项艰巨但可实现的任务。我们始终致力于尽快为世界各地的患者提供高质量,安全和有效的疫苗,并结束这种致命的大流行。再一次,我们不会让政治阻碍,我们将继续做我们最擅长的事创造改变患者生活的突破。