#本文僅代表作者觀點,不代表IPRdaily立場#
原標題:輝瑞CEO堅決反對放棄疫苗知識產(chǎn)權(quán)!(附中英文版公開信)
美國藥業(yè)巨頭輝瑞的CEO阿爾伯特·伯拉(Albert Bourla)近日給該公司的員工寫了一封公開信,公開與放棄疫苗知識產(chǎn)權(quán)的事情唱起了反調(diào),稱他“堅決”反對此事,并希望“坦率”探討一番他的看法,同時“透明”地介紹一下輝瑞是如何確保疫苗公平分發(fā)的“事實和實情”。
近日,美國總統(tǒng)拜登在國際社會壓力下宣布支持放棄新冠疫苗知識產(chǎn)權(quán),以幫助欠發(fā)達國家,但美國制藥巨頭、主要的新冠疫苗開發(fā)商之一輝瑞公司卻公開唱起了反調(diào)。
5月8日,美國制藥巨頭輝瑞公司CEO阿爾伯特?伯拉(Albert Bourla)向公司員工發(fā)布一封公開信。他在信中稱自己堅決反對放棄疫苗知識產(chǎn)權(quán)的決定,并“透明”地介紹了輝瑞公司“確保疫苗公平分發(fā)的事實”。
伯拉聲稱,輝瑞公司為疫苗開發(fā)投入大量人力物力,放棄知識產(chǎn)權(quán)會讓投資者產(chǎn)生顧慮,且將會“擾亂疫苗原材料供應(yīng)”,因此他反對放棄專利。
伯拉推特截圖
在信的一開頭,伯拉就強調(diào)了他對于“平等”的定義。伯拉稱,“公平合理的疫苗分配,從一開始就是指引我們前進的北極星。為確保每個國家都能獲得我們的新冠疫苗,有兩個條件必須滿足:一個是任何人都能負擔(dān)起疫苗的價格,另一個則是可靠地為所有人生產(chǎn)足夠多的疫苗?!?/p>
他聲稱,第一個條件“很早之前就已得到滿足”,輝瑞去年6月就采用了“價格分級”的方式,富裕國家需要為每劑疫苗承擔(dān)“一頓外賣的價格”并免費分發(fā)給民眾;中等收入國家的價格約為前者的一半,而低收入國家則是成本價。他還強調(diào),他眼中的“公平”意味著給需要幫助的人提供更多疫苗。
但接下來,伯拉卻做出了自相矛盾的發(fā)言。他透露,輝瑞已達成將給116個國家供貨,并與更多國家就27億劑疫苗的供應(yīng)開展深入談判。然而根據(jù)伯拉的預(yù)計,這些疫苗中只有40%,即10多億劑,今年會被提供給中低收入國家。這種分配與他的“公平”定義似乎不太相符。
伯拉公開信截圖
不過伯拉很快就為自己做出了辯解。他聲稱,是因為中低收入國家大多“根本沒向輝瑞下訂單”,疫苗才會更多地流向富裕國家。
“事實上,高收入國家儲備了大量的疫苗。我對此非常擔(dān)心,于是通過信件、電話、短信等方式聯(lián)系了許多中低收入國家領(lǐng)導(dǎo)人,呼吁他們也來儲備供應(yīng)有限的疫苗。但他們中絕大多數(shù)都找了其他疫苗制造商下單,有的是因為當時mRNA疫苗的技術(shù)尚未經(jīng)過測試,有的是有了在本地生產(chǎn)疫苗的其他選項,還有一些并不認可我們的疫苗。”伯拉稱。
接著他又說,由于供貨不足等原因,許多國家又重新轉(zhuǎn)向輝瑞簽署供貨協(xié)議。他據(jù)此認為,到2021年下半年,輝瑞在富裕國家和中低收入國家的疫苗供應(yīng)會“趨于平衡”,到了2022年所有簽署合同的國家就會有“足夠的疫苗”。
但對于伯拉的說法,彭博社援引賓夕法尼亞大學(xué)衛(wèi)生政策教授伊齊基爾?伊曼紐爾(Ezekiel Emanuel)的話指出,輝瑞疫苗所需的超低溫儲存條件實際上才是最大的挑戰(zhàn),對于缺乏強大基礎(chǔ)設(shè)施的國家來說這才是最難處理的問題。
“知識產(chǎn)權(quán)得到保護,投資者才肯給錢”
在大篇幅的“鋪墊”之后。伯拉最終拋出了他的核心觀點,反對放棄新冠疫苗知識產(chǎn)權(quán)。他聲稱,這種做法“只會導(dǎo)致更多問題”。
伯拉先是表示,輝瑞公司為mRNA疫苗研發(fā)投入了大量人力物力,“從零開始努力”,才得以在“極短時間內(nèi)研發(fā)出高效的救命疫苗”,暗示這些投資不能白費。
“我擔(dān)心放棄專利保護會讓人們不敢冒險。在我們成功開發(fā)出疫苗前,就已經(jīng)投入20億美元,因為我們知道其中的利害關(guān)系。最近我又批準在新冠疫苗研發(fā)上再投入6億美元,使我們2021年研發(fā)總支出超過100億美元。”伯拉稱,“最近的言論不影響我們投資科學(xué),但我不確定那些小型生物技術(shù)創(chuàng)新者是否也會如此,他們完全依賴投資者的資金,而投資者投資的前提是知識產(chǎn)權(quán)得到保護?!?/p>
而伯拉給出的另一個理由則是疫苗原材料供應(yīng)問題。他聲稱,生產(chǎn)疫苗需要19個不同國家供應(yīng)商生產(chǎn)的280種不同材料或成分,放棄疫苗知識產(chǎn)權(quán)會“威脅”原材料流通,擾亂疫苗生產(chǎn)。
這封信在社交媒體上引起了一定的爭議。支持伯拉的人認為,輝瑞公司為疫苗研發(fā)投入大量資金,不應(yīng)該放棄疫苗知識產(chǎn)權(quán),并贊同伯拉關(guān)于“風(fēng)險”的說法;批評者則認為,輝瑞是在給自私自利及供貨量不足狡辯。
輝瑞公司CEO阿爾伯特·伯拉,視頻截圖
此前,拜登政府當?shù)貢r間5月5日發(fā)表一項決定,表示美國將放棄新冠肺炎疫苗的知識產(chǎn)權(quán)專利。此舉是為解決新冠疫苗供應(yīng)不足,發(fā)達國家與發(fā)展中國家之間疫苗分配不平衡而采取的措施,目的在于讓發(fā)展中國家可以不擔(dān)心知識產(chǎn)權(quán)問題,特別是專利問題,能夠自己生產(chǎn)新冠疫苗應(yīng)對疫情。
5月6日,哈里梅根夫婦發(fā)起了一項“確保全球公平獲得疫苗”的運動,向輝瑞、莫德納、阿斯利康、強生和Norovax的CEO發(fā)出了一封公開信。這封發(fā)表在《全球公民》上的公開信要求這五家疫苗生產(chǎn)商的CEO“以非凡的目的、責(zé)任和領(lǐng)導(dǎo)力采取行動”,應(yīng)對“公平危機”,并“采取一切可能的措施增加全球供應(yīng)”。
英國目前對此尚未明確表明態(tài)度,德國已經(jīng)明確表示反對。英國政府發(fā)言人表示,英國方面正與世貿(mào)組織成員國合作解決新冠疫苗的專利問題。
附公開信全文:
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.
(中文版)
今天,我寫這封信是為了與我們的同事就COVID-19訪問和可用性的驅(qū)動因素進行坦誠的交談。
親愛的同事們,
最近,美國貿(mào)易代表將討論放棄某些COVID-19疫苗知識產(chǎn)權(quán)(IP)權(quán)利的聲明,給世界造成了一些混亂。輝瑞公司是否做了足夠的工作來確保公平和公正地分發(fā)我們的COVID-19疫苗?提議的豁免是否會帶來解決方案或帶來更多問題?我今天寫信給您討論這些問題。
從第一天起,公平和公正的分配就是我們的北極星。為了確保每個國家都可以使用我們的COVID-19疫苗,必須滿足兩個條件:任何人都能負擔(dān)得起的價格以及為所有人可靠地生產(chǎn)足夠的疫苗。
早期滿足了第一個條件。早在2020年6月,我們就決定通過分級定價來提供我們的疫苗。較富裕的國家將不得不支付大約一頓外賣飯菜的費用,并免費向其公民提供外賣飯菜。向中等收入國家提供的劑量大約是價格的一半,向低收入國家提供的劑量是成本的。許多最貧窮的社區(qū)將通過捐贈來獲得救助。公平并不意味著我們給每個人都一樣。公平意味著我們?yōu)樾枰嗟娜烁冻龈唷?/p>
滿足第二個條件更具挑戰(zhàn)性,但是我們以驚人的速度到達那里。得益于我們科學(xué)家,工程師和熟練工人的獨創(chuàng)性和辛勤工作,以及輝瑞公司數(shù)十億美元的投資,我們宣布,到2021年,我們將向全球提供超過25億劑。事實上,我們的內(nèi)部目標是30億劑,因此我們對自己的承諾感到很滿意。通過推斷,今年達到30億劑意味著2022年達到40億劑。這些劑量不適合富人或窮人,也不適合北方或南方。這些是所有的劑量。我們已經(jīng)達成了為116個國家/地區(qū)提供服務(wù)的協(xié)議,而我們目前正與更多國家/地區(qū)進行深入談判,以期在2021年達成總計約27億劑的協(xié)議。在所有協(xié)議完成后,我們希望其中的40%,即超過10億劑,將于2021年進入中低收入國家。
這顯然提出了另一個問題。到今天為止,我們已經(jīng)運送了大約4.5億劑,其余對高收入國家更有利。這是為什么?在制定分級定價政策時,我們接觸了所有國家,要求他們下訂單,以便為他們分配劑量。實際上,高收入國家保留了大部分劑量。我個人對此感到關(guān)注,并通過信件,電話甚至短信與許多中低收入國家的負責(zé)人聯(lián)系,敦促他們儲備藥品,因為供應(yīng)有限。但是,他們中的大多數(shù)決定與其他疫苗生產(chǎn)商下訂單,因為當時尚未對mRNA技術(shù)進行測試,或者因為它們提供了本地生產(chǎn)選項。有些甚至沒有批準我們的疫苗。不幸的是,其他疫苗生產(chǎn)商由于各種技術(shù)原因無法履行其供應(yīng)承諾。最初沒有選擇我們的大多數(shù)國家/地區(qū)都回來了,由于我們的供應(yīng)激增,我們已經(jīng)開始與它們簽署供應(yīng)協(xié)議。我們預(yù)計供應(yīng)平衡將在2021年下半年對他們有利,并且到2022年幾乎將有足夠的供應(yīng)。
上周,我有機會向美國貿(mào)易代表提供了這些事實,并解釋了為什么建議放棄知識產(chǎn)權(quán)只會使這一進展脫軌。這帶給我第二個問題。提議的豁免是否會改善供應(yīng)狀況或帶來更多問題?我的回答絕對是后者。
當我們創(chuàng)建疫苗時,世界上任何地方都沒有生產(chǎn)任何mRNA疫苗或藥物的生產(chǎn)。我們必須從頭開始創(chuàng)建制造基礎(chǔ)架構(gòu)。憑借172年的高質(zhì)量生產(chǎn)傳統(tǒng),大量的資金投入,更重要的是,由一支由高技能的科學(xué)家,工程師和制造工人組成的軍隊,我們在創(chuàng)紀錄的時間內(nèi)開發(fā)了世界上最高效的救生疫苗生產(chǎn)機見過。當前,基礎(chǔ)設(shè)施并不是我們更快制造的瓶頸。限制是生產(chǎn)我們的疫苗所需的高度專業(yè)化的原材料的匱乏。這280種不同的材料或組件是由19個不同國家的許多供應(yīng)商生產(chǎn)的。他們中的許多人需要我們的大力支持(技術(shù)和資金)才能提高產(chǎn)量。目前,幾乎每生產(chǎn)一克的原材料都會立即運送到我們的生產(chǎn)設(shè)施中,并立即可靠地轉(zhuǎn)換為疫苗,這些疫苗將立即運送到世界各地(迄今已有91個國家/地區(qū))。擬議的COVID-19疫苗豁免將面臨威脅破壞原材料的流動。這將使我們?yōu)樯a(chǎn)安全有效的疫苗而需要的關(guān)鍵投入物展開爭奪。沒有或幾乎沒有疫苗生產(chǎn)經(jīng)驗的實體可能會追逐我們擴大生產(chǎn)所需的原材料,從而使所有人的安全和保障面臨風(fēng)險。
我想說最后一點。我擔(dān)心放棄專利保護會削弱其他人承擔(dān)巨大風(fēng)險的積極性。在我們知道能否成功開發(fā)疫苗之前,我們投入了20億美元。就在最近,我授權(quán)在COVID-19研發(fā)上追加支出6億美元,這將使我們在2021年的研發(fā)總支出超過100億美元。最近的言論并不會阻止我們繼續(xù)投資于科學(xué)。但是我不確定,對于成千上萬的小型生物技術(shù)創(chuàng)新者而言,情況是否完全相同,這些創(chuàng)新者完全依賴于僅在知識產(chǎn)權(quán)受到保護的前提下進行投資的投資者獲取資金。
結(jié)束大流行并為世界接種疫苗是一項艱巨但可實現(xiàn)的任務(wù)。我們始終致力于盡快為世界各地的患者提供高質(zhì)量,安全和有效的疫苗,并結(jié)束這種致命的大流行。再一次,我們不會讓政治阻礙,我們將繼續(xù)做我們最擅長的事–創(chuàng)造改變患者生活的突破。(源自谷歌翻譯)
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