药悟
读完需要
速读仅需 22 分钟
👀
Following a two-year negotiation process, the Sixty-first World Health Assembly adopted, in May 2008, resolution WHA61.21 on the global strategy and plan of action on public health, innovation and intellectual property, for the period 2008‒2015. In the following year, the Health Assembly adopted resolution WHA62.16 (2009), in which it finalized the list of stakeholders responsible for the implementation of each element and sub-element, established progress indicators for each element, and proposed time frames in which the specified actions should be accomplished (1).
经过两年的谈判，2008 年 5 月，第六十一届世界卫生大会通过了关于全球公共卫生、创新和知识产权战略与行动计划（2008-2015 年）的 WHA61.21 号决议。次年，卫生大会通过了 WHA62.16 号决议（2009 年），最终确定了负责实施各个要素和子要素的利益相关者名单，建立了各个要素的进度指标，并提出了完成具体行动的时间框架 (1)。
Concerned about the pace of implementation, the Sixty-eighth World Health Assembly in 2015 decided in resolution WHA68.18 to extend the time frame of the plan of action from 2015 until 2022 and to undertake an overall programme review. In 2017, the report of the review panel recommended a way forward, including details of what elements or actions should be added, enhanced or concluded in the next stage of implementation until 2022 (2).
由于对实施进度的担忧，2015 年第六十八届世界卫生大会在 WHA68.18 号决议中决定将行动计划的时间框架从 2015 年延长至 2022 年，并进行全面的项目评估。2017 年，评估小组的报告提出了前进的方向，包括在 2022 年之前实施的下一阶段中应增加、加强或完成的要素或行动的具体细节 (2)。
This summary of progress responds to the request to the WHO Secretariat to draw up a detailed implementation plan and establish a mechanism to support implementation and monitoring of the global strategy and plan of action in line with the recommendations of the review panel (2). Additionally, in 2022, in resolution WHA75.14, the World Health Assembly decided to extend the time frame of the plan of action on public health, innovation and intellectual property from 2022 to 2030 (3). An implementation plan for the GSPA-PHI for the biennium 2024-26, with progress indicators, will be published online.
本进展摘要回应了世卫组织秘书处的请求，拟定了详细的实施计划，并建立了支持实施和监测全球战略与行动计划的机制，以符合评估小组的建议 (2)。此外，2022 年，世界卫生大会在 WHA75.14 号决议中决定将公共卫生、创新和知识产权行动计划的时间框架从 2022 年延长至 2030 年 (3)。2024-26 年两年期的 GSPA-PHI 实施计划及进度指标将在线发布。
👀
2.1 Prioritizing research and development needs 优先考虑研发需求
WHO’s Global Observatory on Health Research and Development (hereinafter the “Observatory”) and Global Malaria Programme have developed and implemented an approach to prioritize research and development for malaria (a Type III disease, namely one that is overwhelmingly or exclusively incident in developing countries). The experience gained and the feedback received on the report related to this prioritization approach informed the development of new initiatives for monitoring and prioritization of research and development by the Global Malaria Programme. An interactive analysis of the malaria vaccines that are in the clinical phase of development was conducted and published by the Global Malaria Programme in 2022 (4). Other reviews of health products in the pipeline and the development of desired product profile characteristics for new products are also underway in several areas of malaria control, including therapeutics and vector control.
世卫组织全球卫生研究与发展观察站（简称“观察站”）和全球疟疾项目开发并实施了一种优先考虑疟疾研究与发展的方法。疟疾是一种主要发生在发展中国家的 III 型疾病。关于这种优先化方法的报告所获得的经验和反馈信息，推动了全球疟疾项目新的研究与发展监测和优先排序举措。全球疟疾项目在 2022 年进行了互动分析，涉及处于临床开发阶段的疟疾疫苗，并发布了相关报告 (4)。其他健康产品的审查和新产品特征的开发也在疟疾控制的多个领域进行中，包括治疗和媒介控制。
The Observatory continues to provide up-to-date information and analyses to support the prioritization of research needs and to identify gaps, and regularly updates its narrative reports on research and development priorities (5). The Emerging Technologies, Research Prioritization and Support (EPS) unit serves as a dedicated Unit for the development of prioritized research agendas across all disease areas. The Observatory has developed guidance for WHO staff on taking a systematic approach to undertaking research priority-setting exercises (6). In 2022, in collaboration with the Antimicrobial Resistance Division, the Observatory published a new analysis of bacterial vaccines in development against drug resistant pathogens (7), in addition to two updated reviews of antibacterial products in the preclinical and clinical phases of development (8,9). In addition, the Observatory continues to add newly developed WHO target product profiles, which are now available for over 30 indications, including for products and diagnostics for Buruli ulcer, COVID-19, HIV/AIDS, human African trypanosomiasis, leishmaniases, mycetoma, onchocerciasis, scabies, and yaws (10). In April 2021, the Director-General established WHO’s Science Council, comprising international experts from a broad range of disciplines to provide guidance on WHO’s science and research strategy and facilitate the adoption of new ideas and opportunities in research and innovation to improve global health. In 2022, the Science Council worked off the workshop held in late 2021, to develop their recommendations to accelerate equitable access to genomics technologies for global health. The Science Council gathered in person in Geneva in July 2022, when the report was officially launched (11). In April 2023, the Science Council published a draft report on mRNA technology for improving global health, for public consultation (12). The Science Council gathered for its second inperson meeting in July 2023. The next Science Council report will focus on information technology and digital health, including components of implementation science and equitable access to emerging technologies (13).
观察站继续提供最新的信息和分析，以支持研究需求的优先排序，并识别研究差距，同时定期更新其研究与发展优先级的叙述报告 (5)。新兴技术、研究优先排序和支持（EPS）部门专门负责制定各疾病领域的优先研究议程。观察站为世卫组织工作人员制定了系统性进行研究优先排序的指导意见 (6)。2022 年，观察站与抗菌素耐药性部门合作，发布了针对耐药病原体的细菌疫苗开发的新分析报告 (7)，并更新了两份关于处于临床前和临床开发阶段的抗菌产品的审查报告 (8,9)。此外，观察站还不断增加新开发的世卫组织目标产品特征，这些特征目前涵盖了 30 多种适应症，包括布鲁里溃疡、COVID-19、HIV/AIDS、非洲人类锥虫病、利什曼病、足菌肿、河盲症、疥疮和雅司病的产品和诊断 (10)。2021 年 4 月，总干事成立了世卫组织科学委员会，该委员会由来自多个学科的国际专家组成，为世卫组织的科学和研究战略提供指导，并促进新理念和机会的采用，以改善全球健康。2022 年，科学委员会在 2021 年底举办的研讨会基础上，制定了加速基因组技术在全球健康中公平获取的建议。科学委员会于 2022 年 7 月在日内瓦召开会议，正式发布了报告 (11)。2023 年 4 月，科学委员会发布了一份关于改进全球健康的 mRNA 技术草案报告，供公众咨询 (12)。科学委员会于 2023 年 7 月举行了第二次现场会议。下一份科学委员会报告将重点关注信息技术和数字健康，包括实施科学和公平获取新兴技术的内容 (13)。
2.2 Promoting research and development 促进研究与开发
The Observatory continues to serve as WHO’s authoritative source of global information and strategic direction on research for health. It does so by serving as a global analytical and information- sharing mechanism to promote and disseminate relevant information and the results of analyses on health research and development, and to help to coordinate efficient and equitable priority-setting for new investments in health research based on public health needs. This activity, supported by the active engagement of groups of diverse stakeholders, including the Science Council, serves to promote evidence-informed decisions on new investments in health research based on public health needs in a coordinated and equitable manner.
全球卫生研究观测站继续作为世界卫生组织权威的信息和战略指导来源。通过全球分析和信息共享机制，观测站促进和传播有关卫生研究与发展的相关信息和分析结果，帮助协调基于公共卫生需求的新卫生研究投资的高效和公平的优先级设定。这项活动得到了包括科学委员会在内的各种利益相关者的积极参与，旨在基于公共卫生需求，促进证据知情的新卫生研究投资决策，以协调和公平的方式进行。
The UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases supports, since 2008, a Clinical Research and Development Fellowship programme (CRDF), with the objective to create a critical mass of clinical research and development leaders in low- and middle-income countries, to tackle neglected tropical diseases. For example, 19 fellows have worked on the different study phases in adults and children, in the development of the RTS,S/AS01 (RTS,S) malaria vaccine, that WHO recently recommended for its widespread use. The CRDF scheme also contributed to responding to epidemics and during the COVID-19 pandemic, the CRDF programme helped building health system resilience with 74% of trained Fellows involved in clinical research, mostly as clinical trial managers (14).
自 2008 年以来，联合国儿童基金会、联合国开发计划署、世界银行和世界卫生组织的热带病研究和培训特别计划（TDR）支持一个临床研究与开发奖学金项目（CRDF），旨在培养低收入和中等收入国家的临床研究和开发领导者，以应对被忽视的热带病。例如，有 19 名学员参与了 RTS,S/AS01 (RTS,S) 疟疾疫苗在成人和儿童不同研究阶段的开发工作，世卫组织最近建议该疫苗广泛使用。CRDF 项目还对应对疫情做出了贡献，在 COVID-19 大流行期间，CRDF 项目帮助建立了卫生系统的韧性，74%的受训学员参与了临床研究，主要担任临床试验经理。
2.3 Building and improving research capacity 建立和提高研究能力
The UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases continues its research capacity strengthening activities in clinical research and implementation research to identify bottlenecks and break through barriers to life-saving interventions. This is achieved through a considerable effort to build in-country capacity and institutional competences to address local research needs through transdisciplinary approaches, including communities, researchers, implementers and policy makers such as regional training centres initiative, the postgraduate programme, with eight universities contributing to build the critical mass, the Structured Operational Research and Training (SORT-IT) programme and the Social Innovation for Health Initiative (SIHI). Recent developments include the opening of a postgraduate training centre in Senegal as a hub for improving support to French speaking African countries.
联合国儿童基金会、联合国开发计划署、世界银行和世界卫生组织的热带病研究与培训特别计划，继续在临床研究和实施研究方面加强研究能力建设，旨在识别并克服生命拯救干预措施的瓶颈和障碍。这通过大量努力来实现，旨在通过跨学科方法，包括社区、研究人员、实施者和政策制定者，来满足地方研究需求。这些努力包括区域培训中心计划、研究生项目（由八所大学参与建设关键人才）、结构化操作研究与培训（SORT-IT）计划以及卫生社会创新计划（SIHI）。最近的进展包括在塞内加尔设立了一个研究生培训中心，作为改善对法语非洲国家支持的枢纽。
The Secretariat provides support to national and regional regulatory networks, such as the African Vaccine Regulatory Forum, in order to strengthen vaccines regulatory functions and systems in Africa. The Forum, an informal capacity-building platform aimed also at improving the regulatory oversight of interventional clinical trials being conducted in Africa, received support from the Secretariat for implementation of its joint reviews guideline including a training manual for inspection of clinical trial sites, and for development of its compassionate use guide. The Secretariat also provided specific support to the Forum for COVID-19 response activities, including the development of training material for the use of its MedNet and DataForm platforms for joint reviews. In December 2019, the Secretariat reactivated the Paediatric Regulatory complementary and integrative medicine in November 2021 and the next annual workshop is planned for November 2022.
秘书处为国家和区域监管网络提供支持，例如非洲疫苗监管论坛，以加强非洲的疫苗监管职能和系统。该论坛是一个非正式的能力建设平台，旨在改进对在非洲进行的干预性临床试验的监管监督。秘书处为其联合审查指南的实施提供了支持，包括制定临床试验场所检查培训手册和同情使用指南。此外，秘书处还为论坛的 COVID-19 应对活动提供了具体支持，包括开发使用其 MedNet 和 DataForm 平台进行联合审查的培训材料。2019 年 12 月，秘书处重新启动了儿科监管补充和整合医学，并计划在 2022 年 11 月举行下一次年度研讨会。
2.4 Promoting transfer of technology 促进技术转让
The Secretariat updated guidelines on the transfer of technology in pharmaceutical manufacturing and will present them for endorsement to the forthcoming meeting of the Expert Committee on Specifications for Pharmaceutical Preparations. WHOUNCTAD joint webinars were organized on investing in high-quality local vaccine production for COVID-19.
秘书处更新了药品生产技术转移指南，并将在即将召开的药品制剂规范专家委员会会议上提交批准。世卫组织与联合国贸易和发展会议（UNCTAD）联合举办了关于投资高质量本地疫苗生产的网络研讨会，重点关注 COVID-19 疫苗的生产。
WHO supported the efforts of the Secretariat of the World Trade Organization (WTO) on more effective implementation of Article 66.2 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) on health-related technology transfer. Discussions took place with least- developed countries on the broader development and policy context of technology transfer with a focus on three specific fields of technology transfer, namely the fields of health, agriculture and the environment.
世卫组织支持世界贸易组织（WTO）秘书处更有效地实施《与贸易有关的知识产权协定》（TRIPS）第 66.2 条关于健康相关技术转移的工作。与最不发达国家讨论了技术转移的更广泛发展和政策背景，重点在健康、农业和环境三个特定领域的技术转移。
In response to the Solidarity Call to Action, the COVID-19 Technology Access Pool (CTAP) was established by WHO and receives support from the United Nations Development Programme (UNDP), Unitaid, the UN Technology Bank and the Medicines Patent Pool. C-TAP was launched to facilitate timely, equitable and affordable access to COVID-19 health products through the sharing of intellectual property, knowledge, and data with quality-assured manufacturers to scale up production around the world.
为响应团结行动呼吁，世卫组织建立了 COVID-19 技术访问池（C-TAP），并得到联合国开发计划署（UNDP）、Unitaid、联合国技术银行和药品专利池的支持。C-TAP 的设立旨在通过与有质量保证的制造商共享知识产权、知识和数据，促进 COVID-19 健康产品的及时、公平和可负担的获取，从而扩大全球生产。
Several technologies have now been licensed to C-TAP. The Spanish National Research Council (CSIC) and the United States National Institutes of Health (NIH) have shared their technologies with C-TAP for the development of COVID-19 diagnostics, vaccines and therapeutics. The technology received from CSIC has been sublicensed to Biotech Africa to promote access in low- and middle-income countries (22). Medigen Vaccine Biologics Corp has shared with C-TAP a worldwide license for a COVID-19 vaccine based on the COVID-19 spike protein sequence that Medigen licensed from the US National Institutes of Health (NIH). This is the first transparent, global, non-exclusive license for a COVID-19 vaccine and the first health technology developed by a private company and included in C-TAP (23). The University of Chile shared with C-TAP a worldwide license for a system for quantification of neutralizing antibodies (NAbs) against SARS-CoV-2. This diagnostic can be used in facilities using heightened control measures similar to Biosafety Level 2 (BSL-2) laboratories (24). All licenses are worldwide, non-exclusive, and transparently available on the C-TAP website (25). C-TAP and its supporting partners continue to negotiate with public and private partners for new licenses and to grant sublicenses to for the technologies already in C-TAP to manufacturers.
目前，已有多项技术授权给 C-TAP。西班牙国家研究委员会（CSIC）和美国国家卫生研究院（NIH）已与 C-TAP 共享其技术，用于开发 COVID-19 诊断、疫苗和治疗方法。CSIC 的技术已再许可给 Biotech Africa，以促进在低收入和中等收入国家的使用。Medigen 疫苗生物技术公司已与 C-TAP 共享了一项基于 COVID-19 刺突蛋白序列的全球性 COVID-19 疫苗许可，该疫苗是从美国国家卫生研究院（NIH）获得的许可。这是首个透明的、全球性的、非独占的 COVID-19 疫苗许可，也是首个由私人公司开发并纳入 C-TAP 的健康技术。智利大学已与 C-TAP 共享了一项用于量化针对 SARS-CoV-2 的中和抗体的全球性系统许可证。这种诊断方法可以在类似生物安全等级 2（BSL-2）实验室的高度控制设施中使用。所有许可证均为全球性、非独占性，并在 C-TAP 网站上透明提供。C-TAP 及其支持合作伙伴继续与公共和私人合作伙伴就新许可证进行谈判，并向制造商授予已在 C-TAP 中的技术再许可。
Since the establishment of the first COVID-19 mRNA vaccine technology transfer hub in South Africa, in June 2021 (26), WHO and its partners have supported the development of such technology, that has concluded the pre-clinical study phase. The 15 partners have all received training at the hub in South Africa on the laboratory scale manufacturing process (27). The medicine Patent Pool, as WHO’s implementing partner, undertakes facility assessments at each receiving partner to define tailored technology transfer strategies and plans, while the hub and the first technology recipient in South Africa are upgrading their facilities to GMP standards.
自 2021 年 6 月在南非建立首个 COVID-19 mRNA 疫苗技术转移中心以来，世卫组织及其合作伙伴一直支持该技术的发展，目前已完成临床前研究阶段。15 个合作伙伴在南非的中心接受了实验室规模制造过程的培训。作为世卫组织的实施合作伙伴，药品专利池对每个接受合作伙伴进行设施评估，以制定量身定制的技术转移策略和计划，而南非的中心和首个技术接受者正在升级其设施以达到 GMP 标准。
2.5 Managing intellectual property to contribute to innovation and public health 管理知识产权以促进创新和公共健康
In September 2023, in their third meeting since the onset of the COVID-19 pandemic, the Directors-General of WHO, WIPO and WTO agreed to shift the focus of trilateral cooperation from the response to the COVID-19 pandemic to increasing and broadening support for more effective and sustainable use of TRIPS flexibilities to increase access to health technologies and to be better prepared for future pandemics (28).
在 2023 年 9 月的第三次会议上，世卫组织、世界知识产权组织（WIPO）和世界贸易组织（WTO）的总干事们同意将三方合作的重点从应对 COVID-19 疫情转移到更有效和可持续地使用 TRIPS 灵活性，以增加对健康技术的获取并更好地为未来的大流行做好准备（28）。
WHO, WIPO and WTO published updated information notes on “Integrated health, trade and IP approach to respond to the COVID-19 pandemic” in October 2021 and May 2023 (29,30). These information notes map the challenges posed by the COVID-19 in relation to the integrated health, trade and intellectual property framework set out in the second edition of the Trilateral Study on “Promoting Access to Medical Technologies and Innovation” (31). The updates contain developments up to May 2023, including on the impact of COVID-19 on health systems and responses at the global level, policy challenges, meeting the demand for health technologies and medical services, international trade, intellectual property aspects, international initiatives to support research and development and equitable access, regulatory responses, transparency and mapping the way forward.
世卫组织、WIPO 和 WTO 分别在 2021 年 10 月和 2023 年 5 月发布了关于“应对 COVID-19 疫情的综合健康、贸易和知识产权方法”的更新信息说明（29,30）。这些信息说明描绘了 COVID-19 在健康、贸易和知识产权框架内的挑战，这些框架在三方研究的第二版中得到了详细阐述，题为“促进获取医疗技术和创新”（31）。更新内容包含截至 2023 年 5 月的发展情况，包括 COVID-19 对健康系统和全球响应的影响、政策挑战、满足健康技术和医疗服务的需求、国际贸易、知识产权方面、支持研发和公平获取的国际倡议、监管响应、透明度以及前进方向的映射。
Within the existing trilateral collaboration framework between WHO, WIPO and WTO, the COVID-19 Technical Assistance Platform website was created as a one-stop shop for the three organizations to make available their expertise in public health, IP and trade matters in a coordinated and systematic manner to help Member States address the COVID-19 pandemic (32). The Platform also facilitates the provision of tripartite technical assistance on the pathways for accessing vaccines, medicines and technologies, including through coordination between members facing similar challenges to facilitate collective responses.
在世卫组织、WIPO 和 WTO 现有的三方合作框架内，创建了 COVID-19 技术援助平台网站，作为三方在公共卫生、知识产权和贸易问题上提供专业知识的“一站式服务”，以协调和系统的方式帮助成员国应对 COVID-19 疫情（32）。该平台还促进了在获取疫苗、药品和技术的路径上的三方技术援助，包括通过协调面临类似挑战的成员之间的合作以促进集体响应。
WHO, WIPO and WTO agreed to organize practical capacity-building workshops at the technical level to enhance the flow of updated information on current developments in the pandemic and responses to achieve equitable access to COVID-19 health technologies (33). The first in the series of workshops, titled “WHO, WIPO, WTO Workshop on Innovation in, and Access to, COVID-19 Technologies”, was held on September 27, 2021 to discuss technology transfer and licensing as specific IP policy options. The workshop, held virtually, conveyed information to enhance knowledge and understanding of how IP, know-how and technology transfer work in practice, not only vis-à-vis medical technologies but also for related products and services. This was aimed at strengthening the capacity of policymakers and experts in member governments to address the pandemic accordingly (34). A second workshop in this series, titled “WHO-WIPO-WTO Workshop: Innovation and Access to diagnostics for COVID-19 and beyond”, was held on October 28, 2022, providing information on practical capacity-building for increasing access to in vitro diagnostics, including a review of the landscape of in vitro diagnostics for COVID-19, understanding relevant regulatory processes, considering relevant intellectual property and trade issues, and providing a forum for the exchange of experiences and views to help the Secretariats of the three organizations to respond to the capacity-building needs of their members (35).
世卫组织、WIPO 和 WTO 同意在技术层面组织实际的能力建设研讨会，以增强关于当前疫情发展和响应的最新信息流动，旨在实现 COVID-19 健康技术的公平获取（33）。2021 年 9 月 27 日举行了题为“世卫组织、WIPO、WTO 创新与获取 COVID-19 技术研讨会”的首场系列研讨会，讨论了技术转让和许可作为具体知识产权政策选项。此次虚拟研讨会传递了有关知识产权、技术诀窍和技术转让在实践中如何运作的信息，不仅针对医疗技术，也包括相关产品和服务，旨在加强成员国政府政策制定者和专家的能力以应对疫情（34）。该系列的第二场研讨会于 2022 年 10 月 28 日举行，题为“世卫组织-WIPO-WTO 研讨会：COVID-19 及以后的诊断创新与获取”，提供了关于增加体外诊断获取的实际能力建设信息，包括 COVID-19 体外诊断的景观回顾、理解相关的监管流程、考虑相关的知识产权和贸易问题，并提供了交流经验和观点的平台，以帮助三方秘书处响应成员的能力建设需求（35）。
On 28 February 2022, WHO, WIPO and WTO jointly organized a workshop focused on access and use of information resources for COVID-19 response (36). The purpose of the workshop was to enhance understanding of the characteristics, potential uses and limitations of particular information sources related to the pandemic. Points raised for future consideration included the connection of various data resources, the importance of coherent information across resources, the utility of expanding resources to include data related to other diseases and how to leverage or improve resources to prepare for future pandemics.
2022 年 2 月 28 日，世卫组织、WIPO 和 WTO 联合组织了一次研讨会，重点讨论获取和使用 COVID-19 应对的信息资源（36）。研讨会的目的是增强对与疫情相关的特定信息源的特点、潜在用途和局限性的理解。未来考虑的要点包括连接各种数据资源、确保资源间信息的一致性、扩展资源以包含其他疾病相关数据的实用性以及如何利用或改进资源为未来的大流行做准备。
The 10th WHO-WIPO-WTO Trilateral Symposium was hosted by WHO on 14 November 2023 (37), as a public event in hybrid format open to government representatives and other interested stakeholders, on the topic of climate change and human health.
2023 年 11 月 14 日，世卫组织主办了第十届世卫组织-WIPO-WTO 三方研讨会，作为一次公开的混合形式活动，面向政府代表和其他感兴趣的利益相关者，讨论气候变化与人类健康的主题（37）。
WHO monitors coverage and use of existing and new user-friendly databases of patent status and licensing information for key health technologies. WHO has launched the Technology Access Pool database as a global one-stop shop for dynamic information on selected therapeutics, diagnostics, vaccines and other health products (38). The database includes information on clinical trials, scientific publications, regulatory status, manufacturers, patent status, licensing agreements, and other publicly available data. WHO continues to promote the development of user-friendly databases. WHO and Unitaid published in April 2023 a technical briefing document explaining some of the legal instruments that Member States may use to promote public health and access to key COVID-19 therapeutics, in the framework of their multilateral trade obligations and rights and according to their national legislations and level of development (39).
世卫组织监测现有和新开发的关键健康技术专利状态和许可信息的用户友好数据库的覆盖和使用情况。世卫组织推出了技术访问池数据库，作为动态信息的全球“一站式服务”，包括选择的治疗方法、诊断、疫苗和其他健康产品的信息（38）。数据库包含关于临床试验、科学出版物、监管状态、制造商、专利状态、许可协议和其他公开可用数据的信息。世卫组织继续推动用户友好数据库的发展。2023 年 4 月，世卫组织和 Unitaid 发布了一份技术简报文件，解释了一些成员国可以在其多边贸易义务和权利框架内使用的法律工具，以促进公共卫生和获取关键 COVID-19 治疗方法，依据其国家立法和发展水平（39）。
2.6 Improving delivery and access 改善供应和可及性
The Secretariat has developed and shared good practices on evidence-based methodology for selection of all major health product types. WHO launched a digital version of the Model List of Essential Medicines and the Model List of Essential in vitro Diagnostics. In March 2020, WHO published a guidance manual on how to update a national essential medicines list (40). It also published, in July 2021, a guidance document for countries on methods for developing and updating national lists of essential in vitro diagnostics. A webinar to help countries to develop national essential diagnostics lists was held in October 2021. WHO has also published a how-to guide on institutionalizing health technology assessment mechanisms. A global survey on health technology assessment processes in Member States has been developed, pilot-tested, and implemented. The survey website, with detailed methods and a database of country results, has been published online (41).
秘书处开发并分享了关于主要健康产品类型选择的循证方法最佳实践。世卫组织推出了数字版《基本药物目录》和《基本体外诊断目录》。2020 年 3 月，世卫组织发布了如何更新国家基本药物目录的指导手册。2021 年 7 月，世卫组织发布了针对各国的指导文件，介绍了制定和更新国家基本体外诊断目录的方法。为了帮助各国制定国家基本诊断目录，世卫组织在 2021 年 10 月举办了一次网络研讨会。世卫组织还发布了一本如何制度化卫生技术评估机制的操作指南。关于成员国卫生技术评估流程的全球调查已经开发、试点并实施。调查网站上发布了详细的方法和国家结果数据库。
In September 2020, WHO published an update of the WHO guideline on country pharmaceutical pricing policies. The guideline includes evidence-informed recommendations for the promotion of price transparency of pharmaceutical products.
2020 年 9 月，世卫组织更新了国家药品定价政策指南。该指南包括促进药品价格透明的循证建议。
In April 2021, WHO convened the third Fair Pricing Forum, with promoting and monitoring transparency in medicine prices being a major theme. To ensure greater adoption of the pricing guideline’s recommendations, WHO also published 10 plainlanguage summaries and a handbook containing 12 country case studies of pricing policies. In addition, WHO has been hosting monthly webinars on various topics in pharmaceutical pricing policies and created an online community of practice for discussion and collaboration. In collaboration with the Noncommunicable Diseases Department of the WHO Regional Office for Europe, MHP conducted three national surveys of the availability and affordability of NCD medicines and started updating the new Country Assessment Platform (CAP) MEDMON tool for surveys and further monitoring. WHO is currently piloting the tool in two countries. WHO has published a report on access to insulin in 2021 entitled: “Keeping the 100-year-old promise: making insulin access universal”, identifying critical barriers to and potential solutions to improve access to insulin. WHO is in process of developing new methodologies to analyze publicly available price information and has updated the database of national price information sources. WHO is developing methodology guidance for tracking pharmaceutical spending at the country level.
2021 年 4 月，世卫组织召开了第三届公平定价论坛，重点讨论促进和监测药品价格透明度。为了确保定价指南建议的更广泛采用，世卫组织还发布了 10 份通俗易懂的摘要和一本包含 12 个国家定价政策案例研究的手册。此外，世卫组织每月举办关于药品定价政策的各种主题的网络研讨会，并创建了一个在线实践社区以便讨论和合作。与世卫组织欧洲区域办事处的非传染性疾病部门合作，MHP 进行了三次关于非传染性疾病药品可获得性和可负担性的国家调查，并开始更新新的国家评估平台（CAP）MEDMON 工具以进行调查和进一步监测。世卫组织目前正在两个国家试点该工具。2021 年，世卫组织发布了一份关于胰岛素可及性的报告，题为《兑现百年承诺：实现胰岛素普及》，指出了改善胰岛素可及性的关键障碍和潜在解决方案。世卫组织正在开发新的方法来分析公开的价格信息，并更新了国家价格信息来源数据库。世卫组织正在制定国家层面药品支出跟踪的指导方法。
The Secretariat provided support to Member States for strengthening national regulatory capacity and regional harmonization activities. Since 2021, nine additional national regulatory authorities have been benchmarked (total of 33 to date) while 38 additional national regulatory authorities completed self-benchmarking (total of 58 to date) using the WHO Global Benchmarking Tool. To date, 57 (29%) of WHO’s 194 Member States are operating at either Maturity Level 3 (stable, well-functioning and integrated regulatory system) or Maturity Level 4 (advanced level of performance and continuous improvement). In accordance with resolution WHA67.20 (2014) on regulatory system strengthening for medical products, the Director-General launched the WHO network for regulatory system strengthening called the Coalition of Interested Parties (CIP) Network, and the CIP web platform. The CIP web platform is a secure, central repository for sharing confidential information related to collaborations between NRAs and CIP members. It is worth mentioning that with strategic support to strengthening regulatory capacity, the NRAs of Nigeria, Egypt, China and South Africa achieved Maturity Level (ML) 3, commensurate with a stable, well-functioning and integrated regulatory system.
秘书处为成员国提供支持，以加强国家监管能力和区域协调活动。自 2021 年以来，又有 9 个国家监管机构进行了基准测试（总数达到 33 个），而 38 个国家监管机构完成了自我基准测试（总数达到 58 个）使用世卫组织全球基准工具。到目前为止，世卫组织 194 个成员国中的 57 个（29%）在运行 3 级（稳定、运作良好和集成的监管系统）或 4 级（高级性能和持续改进）的监管系统。根据第 67.20 号决议（2014）关于医疗产品监管系统加强的内容，世卫组织总干事启动了一个名为“利益相关方联盟（CIP）网络”的世卫组织监管系统加强网络及其网络平台。CIP 网络平台是一个安全的中央储存库，用于共享国家监管机构和 CIP 成员之间合作的机密信息。值得一提的是，随着监管能力的战略支持，尼日利亚、埃及、中国和南非的国家监管机构达到了三级成熟度（ML），相当于一个稳定、运作良好和集成的监管系统。
Since early 2022, the WHO initiated a new advocacy approach to engage new Member States in the Collaborative Registration Procedure (CRP), in view of the relevancy of the programme during the COVID-19 pandemics for Member States to be able to accelerate the assessment and registration of medical products. The CRP is designed by the Secretariat to facilitate assessments and accelerate national registration of products prequalified by WHO (PQ CRP) or approved by SRAs (SRA CRP). Since early 2022, with a more personalized reach out and wider regional coverage twenty-one (21) new Member States initiated engagement in SRA CRP and PQ CRP. In 2022, the secretariat also developed and implemented a 5-step systematic approach when a Member State joins CRP for medicines and vaccines, to support the implementation of facilitated regulatory pathways in the countries, including CRP. Resulting from this activity, a significantly higher number of much-needed medical products have been submitted to and registered by member states using CRP, with the support of the secretariat. For SRA CRP more than 200 submissions for 47 products were made to more than 40 Member States, and 107 products registrations have been granted. For PQ CRP more than 1450 submissions for about 300 medicines were made to more than 40 Member States and 800 registrations have been granted.
自 2022 年初以来，世卫组织启动了一种新的宣传方法，以吸引新的成员国参与协作注册程序（CRP），鉴于该计划在 COVID-19 大流行期间的相关性，成员国能够加速评估和注册世卫组织预认证的产品（PQ CRP）或由严格监管机构批准的产品（SRA CRP）。自 2022 年初以来，通过更个性化的接触和更广泛的区域覆盖，21 个新成员国开始参与 SRA CRP 和 PQ CRP。2022 年，秘书处还制定并实施了一个 5 步系统方法，当成员国加入 CRP 用于药品和疫苗时，支持在国家中实施便捷的监管途径，包括 CRP。由于这项活动的结果，成员国在秘书处的支持下，使用 CRP 提交和注册的急需医疗产品数量显著增加。对于 SRA CRP，超过 40 个成员国提交了 200 多份 47 种产品的申请，并授予了 107 个产品的注册。对于 PQ CRP，超过 40 个成员国提交了 1450 多份 300 种药品的申请，并授予了 800 个注册。
In April 2021, WHO published guidelines on Good Reliance Practices and Good Regulatory Practices following their adoption by WHO’s Expert Committee on Specifications for Pharmaceutical Preparations in October 2020. Both policy documents will help to streamline and support regulatory practices at global, regional and national levels. In June 2021, WHO issued a policy on the evaluation and designation of regulatory authorities as WHO-listed authorities (42). The WHO-listed authorities framework will replace the concept of stringent regulatory authorities.
2021 年 4 月，世卫组织发布了《良好依赖实践》和《良好监管实践》指南，这些指南在 2020 年 10 月被世卫组织药品制备规范专家委员会采纳。这两份政策文件将有助于在全球、区域和国家层面简化和支持监管实践。2021 年 6 月，世卫组织发布了一项关于评估和指定监管机构为世卫组织列名机构的政策。世卫组织列名机构框架将取代严格监管机构的概念。
The Access, Watch and Reserve (AWaRe) classification of antibiotics and the associated database were updated in 2023 (43). This update includes an additional 78 antibiotics not previously classified, bringing the total to 257. The WHO essential medicines list antibiotic book, published in December 2022, provides guidance on antibiotic treatment for more than 30 syndromes (44).
2023 年更新了抗生素的获取、监督和储备（AWaRe）分类及其相关数据库。这次更新包括了 78 种以前未分类的抗生素，总数达到 257 种。世卫组织基本药物清单抗生素书于 2022 年 12 月出版，为 30 多种综合症的抗生素治疗提供了指导。
The Secretariat has provided technical support to nine Member States to integrate the provision of assistive products into their health services, with a focus on training of the primary health care workforce using WHO’s training in priority assistive products, which is due to be formally launched by the WHO Academy in 2022. The Secretariat surveyed the needs and priorities for assistive products within humanitarian response and is developing an essential assistive products list and manual for emergency response. In October 2021, WHO published 30 training videos for medical devices needed for oxygen-delivery systems; they will be uploaded shortly in the OpenWHO platform. The list of priority medical devices and its associated technical specifications as well as technical specifications for personal protective equipment for COVID-19 have been updated and translated into all six official languages of the United Nations.
秘书处已为九个成员国提供了技术支持，将辅助产品的提供纳入其卫生服务中，重点是使用世卫组织优先辅助产品培训，对初级卫生保健工作者进行培训，该培训将于 2022 年由世卫组织学院正式启动。秘书处调查了人道主义响应中辅助产品的需求和优先事项，并正在制定应急响应的基本辅助产品清单和手册。2021 年 10 月，世卫组织发布了 30 个关于氧气输送系统所需医疗设备的培训视频；它们将很快上传到 OpenWHO 平台。优先医疗设备清单及其相关技术规范以及 COVID-19 个人防护设备的技术规范已更新，并翻译成联合国的所有六种官方语言。
2.7 Promoting sustainable financing mechanisms 促进可持续融资机制
G-FINDER tracks and reports global funding for research and development on neglected diseases, and Member States should commit themselves to provide information to G-FINDER (45). G-FINDER tracks public, private and philanthropic funding of basic research and product development for global health priorities. The focus of the project is neglected diseases. G-FINDER reported that the top public funders of research and development in 2020 were high income countries, providing 97% of the public sector total (46). Despite an increase in survey participation by lowand middle-income countries, funding from these countries reduced in 2020 (46). The G-FINDER database also includes data reported by researchers, although this may not represent the full funding of their institution or Member State.
G-FINDER 负责跟踪并报告全球针对被忽视疾病的研究和开发资金，成员国应当承诺向 G-FINDER 提供相关信息。G-FINDER 跟踪公共、私人和慈善机构对全球健康优先事项的基础研究和产品开发的资金情况，重点关注被忽视的疾病。G-FINDER 的报告显示，2020 年，研究和开发的主要公共资金来源是高收入国家，占公共部门总资金的 97%。尽管低收入和中等收入国家的调查参与度有所增加，但这些国家在 2020 年的资金投入有所减少。G-FINDER 数据库还包含由研究人员报告的数据，尽管这些数据可能不完全反映其机构或成员国的全部资金情况。
2.8 Establishing a monitoring and accountability mechanism 建立监测和问责机制
The WHO Executive Board at its 148th session noted the implementation plan 2020‒ 2022 to guide further action on the prioritized recommendations of the review panel addressed to the Secretariat. To assess progress in implementation of the recommendations addressed to Member States, the Secretariat conducted a questionnaire to gather baseline information from Member States. The Secretariat presented preliminary results of the analyses of the responses during an informal consultation with Member States in December 2020 and the analysis has been published (47). A second survey was undertaken to provide further information on Member States’ progress in the implementation of the review panel recommendations. The survey included 33 detailed questions covering the eight Elements of the GSPA-PHI, and responses were received from 36 Member States, covering all six WHO regions and all World Bank income groups. A report of the survey results will be presented to Member States and will soon be available online.
在第 148 届会议上，WHO 执行委员会注意到 2020-2022 年实施计划，以指导进一步落实审查小组向秘书处提出的优先建议。为评估成员国执行这些建议的进展情况，秘书处进行了问卷调查，收集了成员国的基础信息。在 2020 年 12 月与成员国的非正式磋商中，秘书处展示了初步分析结果，且这些分析结果已公布。随后进行的第二次调查进一步收集了成员国在执行审查小组建议方面的进展信息。这次调查包含 33 个详细问题，涵盖 GSPA-PHI 的八个要素，收到了来自 36 个成员国的回复，覆盖了 WHO 的六个区域和所有世界银行收入组别。调查结果报告将提交给成员国，并将很快在线发布。
Responding to the request made in resolution WHA75.14 (2022), WHO undertook in 2023 a review of the indicators included in the overall programme review of the GSPAPHI, in consultation with Member States, as well as WHO regional offices and relevant teams in WHO headquarters, and developed proposed revisions to align indicators with the new term of validity of the plan of action (3), alongside a new implementation plan for GSPA-PHI for the 2024–26 biennium.
为响应第 75 届世界卫生大会决议（2022 年）中的请求，WHO 在 2023 年对 GSPA-PHI 整体计划审查中的指标进行了审查，与成员国、WHO 区域办事处及总部相关团队协商后，提出了修订建议，以使指标与新行动计划的有效期保持一致，并制定了 2024-26 双年度 GSPA-PHI 的实施计划。
👀
（略）
