新冠肺炎疫情下,中国如何帮助非洲国家在疫苗研发竞赛中赢下一席之地?

 In op-ed, 分析

在中国武汉市出现新冠肺炎疫情六个月后,全球仍然在为开发合适的疫苗和总结治疗方法的努力。世界卫生组织报告说,目前正在开发的疫苗中共有125种候选疫苗,其中10种正在进行临床评估。最近几周,是否需要在非洲国家进行疫苗接种和治疗试验一直存在争议。 但是到目前为止,辩论仍未解决这个难题的主要问题—无论哪种药或疫苗通过试验,非洲人是否可以获得其知识产权。

关于这一问题的争议缘于一次电视直播。两位法国医生参加了这次电视直播的讨论,他们在就如何以及在何处进行疫苗接种试验发表自己的意见。在讨论中,他们建议,由于非洲国家的道德限制门槛低,可以在非洲开展试验。许多评论员的强烈抗议并谴责了他们的建议,最终导致世界卫生组织总干事在四月份的网络新闻发布会上提出了谴责。

同时,因这一次电视直播,人们将目光转移到非洲与新冠肺炎的相关研究,并发现在非洲的新冠肺炎相关临床试验数量十分低。不管是试验、治疗还是疫苗,数量都很低。自大声疾呼以来,其他科学家指出,需要在非洲不同背景、情境和种族之间进行伦理临床试验,以研究不同干预措施如何影响不同疾病的治疗。这些科学家认为,这一想法在许多非洲国家遭受重大疾病负担之际尤为重要。 正如《柳叶刀》最近的一篇文章很好地解释道,在当前的大流行中,这一问题的紧迫性越来越高。

然而,在撰写本文时,在WHO的国际临床试验注册平台(ICTRP)上列出的与新冠疫情相关的1556项介入性临床试验中,只有38个试验囊括了非洲国家—这一数据不到总数的2.5%。那些涉及非洲国家的试验仅集中在少数几个国家—仅在埃及就有23个,在南非有8个,在尼日利亚,加纳,突尼斯,肯尼亚和赞比亚也进行了其他试验。这表明,在40多个非洲国家中,目前尚未进行或计划进行与新冠疫情相关的试验。这些数字与中国参与的389项试验和印度的59项试验数量相比差强人意。

令人遗憾的是,以上数据并不是新鲜事—尽管有明确的需求,但在疫情之前,ICTRP列出的临床试验中仅有5%一下涉及非洲国家的参与。非洲科学院的临床试验社区和非洲疫苗监管论坛(AVAREF)等正努力解决和纠正这一问题,与此同时,相关新的COVID-19新倡议也已启动,包括不少非洲大学的响应而发起的世界卫生组织的团结试验(Solidarity Trail),以及新冠肺炎临床研究联盟—他们致力于在资源有限的环境中加快对新冠肺炎的研究。

但是所有这些讨论都遗漏了一个关键问题:知识产权。

对于全球制药业而言,有一项内容至关重要—知识产权。知识产权驱使人们进行试验并寻找可行的治疗方法或疫苗。对于该行业,知识产权可有效地帮助制药公司或科学组织实现短期垄断,成为对临床有效药物的成功创新和生产的奖励(其研发费用可能非常昂贵)。

然而,知识产权制度下也有可能会带来附带效应,这意味着那些依赖药物维持生命和获得基本药物治疗的患者将会付出更高的成本。对于发展中国家患者而言尤其如此,那里的专利持有制造商推动产品进入市场的速度可能会很慢(或者根本不会将药物引进市场)。即使对于进行审判的国家的公民来说,仍然如此仍然公平吗?

近年来,发展中国家获得药物“难”这一问题已经可以通过“强制许可”制度得到解决。 这一制度,从世界贸易组织下的现行国际知识产权保护法的框架,为较贫穷的国家的药物制造提供了额外的灵活性。南非等国家利用这一额外的灵活性用于HIV/AIDS药物制造,甚至在最近新冠疫情流行时也激活了这样的灵活性制度。近期,智利和以色列也同样针对新冠肺炎实行了这一灵活性制度。

但这并不是重点。

为什么包括非洲国家在内的贫穷国家都没有任何与制药相关的知识产权?

尽管中国的制药业在全球范围内的规模要比英国,美国甚至印度等许多其他国家小得多。但非洲岛国科摩罗的经验及其在中国的支持下抗击疟疾的努力是一个有趣的案例研究。

大约十年前,由广东新南方集团和广州中医药大学共同创立的青蒿科技有限公司公司发明了青蒿素哌喹片并申请了专利,青蒿素哌喹片是基于诺贝尔化学奖获得者屠呦呦发现的青蒿素研发的。 青蒿科技有限公司与科摩罗当局一起合作采用大规模药物管理(MDA)的方法,实施了一项宏伟的计划,使用该药从(最初是较小的)科摩罗群岛根除疟疾,这一项目得到了中国政府的支持。 MDA既不治疗疟疾的症状,也不仅仅试图用蚊帐或待乙妥来防蚊从而阻止疟疾传播给人类。不同的是,MDA使整个人类成为疟疾寄生虫的敌对环境,其环境持续时间长于其生命周期。这个过程包括一个月的三个疗程的青蒿素哌喹片疗程。这取得了令人瞩目的积极成果–最初,科摩罗莫爱利岛和恩祖瓦尼岛的疟疾流行率降低了98%。

但是,该项目同样存在争议。有人批评地方团队的参与度很低,项目实施前后都缺乏公开评估,包括副作用方面。至关重要的是,所使用的产品仅处于开发的第4阶段—导致出现“中国在整个非洲国家测试疟疾药物”这样的负面标题。

尽管如此,科摩罗当局和中国的援助伙伴仍继续执行该政策,将其扩大到该国最大的岛屿。世卫组织年度世界疟疾报告显示,科摩罗疟疾病例从2010-2013年每年成千上万急剧下降,到2017年下降到每年不足4000例。然而,在2018年,世卫组织拥有最新数据,科摩罗报告的病例数量大幅增加了587%,从2017年的2274例增加到2018年的15613例。这表明,从短期来看,阿尔特奎克的MDA不足以消灭岛上的疟疾,但潜在的原因是增加包括改善诊断和报告,病媒控制不充分以及气候因素。

但是,考虑到科摩罗当局的参与,更重要的问题是—科摩罗从合作中获得了什么样的长期价值?是的,健康是很好,但是青蒿科技利用在其科摩罗的早期成功在非洲及其他地区销售和出售青蒿素哌喹片。科摩罗人并没有从这些销售中以及从“实验”中获得知识产权或从同样的方式受益。该知识产权由中国公司持有,但从未扩大到科摩罗。

这不是唯一的情况。还有许多其他涉及美国、英国、法国和德国等其他制药巨头公司的例子。现在,富裕国家的制药公司与非洲研究机构之间也开展了许多此类合作,包括提供援助。例如,这家与塞内加尔研究所合作开发新冠肺炎10分钟快速测试的英国公司获得了来自英国的援助。问题在于,即使在这些情况下,也很少有讨论或分享这种研究产生的收益用于治疗,也没用讨论药物或疫苗的任何知识产权是否会扩展到进行试验的国家。

将知识产权扩展到非洲相关组织将为各国政府提供新的更强有力的激励措施,以在本国投资医药和药物研发,从长远来看,这可能是变革性的。

我们怎样才能做到这一点?

多年来,联合国艾滋病规划署一直在鼓励包括非洲在内的许多发展中国家推动本地的医药和医疗设备制造,旨在为非洲创造就业机会,同时降低当地卫生组织的医药成本和耐心。在此之前,我所在的睿纳新咨询公司与联合国艾滋病规划署、中国药品及保健品进出口商会合作。我们合作撰写了一份报告,报告重点介绍了21个非洲国家的此类医药发展机会。

艾滋病规划署、联合援助组织或其他类似组织,最好在中国的支持下,也要采取类似的举措来推动知识产权方面的发展,尤其是在新冠肺炎全球蔓延的情况下。

哥斯达黎加提议的新冠肺炎专利库平台将于本周启动,这是朝着正确方向迈出的一步。中国领导人习近平在线上世界卫生大会上承诺制造新冠肺炎疫苗也是正确的方向(如果由中国组织开发),这会是是“全球公益”。希望(尽管尚未澄清)这意味着它将至少在未来几年内免费提供给世界各国。但是,对于非洲发展的长期解决方案,不管是来自中国还是全球疫苗和免疫联盟(GAVI Alliance)的援助,长期解决方案并不指制造与非洲有关的药品或免费赠予。

长期解决方案是在非洲大陆充分开发这些药物,并让非洲相关组织拥有知识产权。即使这是知识产权收益和利润的一小部分,也将帮助非洲国家实现可持续发展目标。这就是我们需要开始讨论和商议的。

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Edmond is a research analyst who is passionate about sustainable development, innovation, and the environment. Passionate about climate financing, he firmly believe there is a more reliable system to promote equality, growth, and welfare in societies without affecting the ecosystem. Through his skills, knowledge and experienced gained over 7 years, he wants to make an impact in the world of development. Edmond holds a Master’s Degree in Public Policy from Korea Development Institute and a BA Degree (Honors) in Business from University of Derby.

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