--- title: "Vaccine Manufacturing Intellectual property" description: "Vaccine Manufacturing patents serve as an incentivisation to solve problems and to advance the borders of human knowledge." image: https://spoor.com/wp-content/uploads/2021/03/Sector_Life-Science-Chemistry-PHarmaceuticals-and-Agriculture-1.jpg canonical: https://spoor.com/zh/the-trips-waiver-and-the-business-of-vaccine-manufacturing/ url: https://spoor.getmd.ai/zh/the-trips-waiver-and-the-business-of-vaccine-manufacturing/.md last_converted: 2026-09-23T01:02:01.575Z --- ```json { "@context": "https://schema.org", "@graph": [ { "@type": "Article", "@id": "https://spoor.com/the-trips-waiver-and-the-business-of-vaccine-manufacturing/#article", "isPartOf": { "@id": "https://spoor.com/the-trips-waiver-and-the-business-of-vaccine-manufacturing/" }, "author": { "name": "Spoor & Fisher", "@id": "https://spoor.com/#/schema/person/7dad7b9bcdd00617832fbe66d90d9c29" }, "headline": "The TRIPS Waiver and the Business of Vaccine Manufacturing", "datePublished": "2021-09-10T10:23:05+00:00", "dateModified": "2022-09-28T15:25:56+00:00", "mainEntityOfPage": { "@id": "https://spoor.com/the-trips-waiver-and-the-business-of-vaccine-manufacturing/" }, "wordCount": 916, "commentCount": 0, "publisher": { "@id": "https://spoor.com/#organization" }, "image": { "@id": "https://spoor.com/the-trips-waiver-and-the-business-of-vaccine-manufacturing/#primaryimage" }, "thumbnailUrl": "https://spoor.com/wp-content/uploads/2021/03/Sector_Life-Science-Chemistry-PHarmaceuticals-and-Agriculture-1.jpg", "articleSection": [ "News Article" ], "inLanguage": "zh-Hans", "potentialAction": [ { "@type": "CommentAction", "name": "Comment", "target": [ "https://spoor.com/the-trips-waiver-and-the-business-of-vaccine-manufacturing/#respond" ] } ] }, { "@type": "WebPage", "@id": "https://spoor.com/the-trips-waiver-and-the-business-of-vaccine-manufacturing/", "url": "https://spoor.com/the-trips-waiver-and-the-business-of-vaccine-manufacturing/", "name": "Vaccine Manufacturing Intellectual property - 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10 9 月 2021 南非卫生部透露，迄今为止已接种了超过 1220 万种 Covid-19 疫苗，在撰写本文时，已有 580 万人完全接种了疫苗。我们的国家在让公民受到打击方面起步缓慢，这导致许多人将滞后归咎于知识产权 (IP) 法，特别是专利保护。 事实上，南非和印度去年呼吁放弃以下义务： - 第 1 节（版权和相关权）， - 第 4 节（工业设计）， - 第 5 节（专利），以及 - 《与贸易有关的知识产权协议》（TRIPS 协议）第 7 条（保护未公开信息），在一段时间内强制执行与“Covid-19 的预防、遏制或处理”相关的知识产权保护至少三年。 参加了最近在 GIBS/PPS 医疗保健行业洞察 2021 会议上的“疫苗权益与制造”小组讨论，教授 [约翰麦克奈特](https://spoor.com/our-people/prof-john-mcknight/)Spoor & Fisher 的专利律师明确表示：“南非（和非洲）的疫苗接种率相对较低，造成这种情况的原因有很多，但专利法不是其中之一。 “放弃专利和其他知识产权保护不会加速疫苗接种。其他多种因素影响非洲大陆的疫苗分销，尤其是原材料供应、生产能力和复杂的制造工艺。” **质量和安全问题** 马克斯普朗克创新与竞争研究所在其“Covid-19 和知识产权的作用”（2021 年）中警告说，从根本上扩大制造规模可能会以牺牲质量和安全为代价优先考虑数量。 南非的制药行业主要受 1965 年第 101 号药品和相关物质法及其法规的监管。该立法由南非保健品监管局 (SAPHRA) 管理。 根据 SAHPRA 指南，在南非注册 Covid-19 疫苗的申请人： - 必须拥有制造、包装/标签、测试、进口、分销或批发健康产品的企业许可证（或必须申请此类许可证）， - 必须按照良好生产规范 (GMP) 生产疫苗， - 必须提交风险管理计划以解决数据中的不确定性，以及 - 必须考虑南非特有的问题，例如艾滋病毒和结核病。 McKnight 教授指出，就像丛林有其五大动物物种一样，IP 也有五大动物物种。这些知识产权种类是专利、商标、注册设计、版权和“专有技术”（专有和机密信息）。多个国家都呼吁放弃这些权利，但这本身并不能使潜在制造商介入、制造疫苗并将其分发给需要它们的人。 **灵活性已经内置** “因此，对 TRIPS 豁免的广泛呼吁是一种不成比例的反应。 “这是善意的，但不可行，”麦克奈特教授说。 他接着指出，TRIPS 已经具有一定的灵活性，允许成员国在授予知识产权权利方面有一定的回旋余地。例如，南非专利法允许政府使用专利，但须根据第 4 条获得专利权人的批准。第 78 条甚至允许政府征用（获得）——而不仅仅是使用——专利，但须经批准专利权人的。在没有专利权人同意的情况下，高等法院决定什么是合理的。所有这些都已经完成。有很多选项和灵活性可供选择。为什么不利用这些？ 最重要的是，TRIPS 和南非立法允许“强制许可”，根据第 56 条，“任何能够证明专利权被滥用的利益相关者都可以按照规定的方式向专员申请强制许可。专利许可”。这可能适用： - 如果南非对专利物品的需求没有在合理的范围内得到足够的满足；或者 - 如果对专利产品的需求是通过进口满足的，并且专利权人收取的价格与专利权人制造专利产品的国家/地区的价格相比过高。 **其他类型的协议** 世界贸易组织（WTO）最近将其下一次正式讨论 TRIPS 豁免的会议推迟到 9 月，理由是在解决疫苗和其他 Covid-相关产品。 然而，制造商和发展中国家之间的讨论取得了进展，辉瑞和 BioNTech 同意与南非的 Biovac 研究所合作，每年生产 1 亿剂用于非洲。像这样的协议比放弃专利权更有意义，而且确实以知识产权为基础，因为它们涉及合作和资源池。 **我们不能破坏研发** 专利是解决问题和推进人类知识边界的激励措施。它们允许创新者“收获果实”，可以说，他们承担的巨大风险和扩展人类知识平台的成本。 放弃专利会削弱知识产权的重要性，这将对药物创新的激励产生巨大的不利影响——这两者都与 Covid-19 新变种的疫苗开发和其他医学研究领域有关。 McKnight 教授感叹 IP 在大流行时期可能会名誉扫地，而目前情况确实如此。但他最后说：“如果你认为专利对技术进步有限制作用，那么尝试在没有专利的情况下推进技术。” *这篇文章最初发表在 poliity.org.za 上。*