根据医院豁免准备的atmp:欧洲血液联盟立场文件。

IF 14.6 2区 医学 Q1 HEMATOLOGY
HemaSphere Pub Date : 2025-09-23 DOI:10.1002/hem3.70215
Dragoslav Domanović, Marc Turner, Christof Jungbauer, Bernardo Rodrigues, Johanna Nystedt, Primož Rožman, Monique Debattista, Tengyu Wang, Einar Klæboe Kristoffersen, Kalinga Perera, Urban Švajger, Lilian Hook, Marjolaine Jacques, Ana Paula Sousa, Marten Hansen, Peter O'Leary, Pierre Tiberghien, European Blood Alliance Ad Hoc ATMPs Group
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However, the ATMP Regulation (EC) No 1394/2007 also allows their production and use within the country under the hospital exemption (HE) clause, provided that specific criteria are met and approved by the National Competent Authorities.<span><sup>1</sup></span></p><p>Since the ATMP Regulation was introduced in 2007, the ATMP field has experienced significant scientific and technological advancements, whereas the regulatory framework remains largely unchanged and appears overly restrictive, potentially hindering the development and availability of these innovative therapies. Although many health conditions may benefit from ATMP therapies, the high development and manufacturing costs, which are also driven by regulatory requirements, often discourage commercial investment, especially for rare diseases or niche applications. In some instances, marketing authorizations have been withdrawn or not renewed, mainly for commercial reasons rather than due to clinical issues.<span><sup>2</sup></span></p><p>In contrast, HE is widely acknowledged as a valuable tool, enabling access to innovative and often life-saving treatments in cases of unmet clinical need. However, the current HE provisions—restricting production to the same Member State, requiring nonroutine preparation within the hospital, and assigning responsibility to a single practitioner—are ill-suited to today's clinical and manufacturing realities. These limitations reduce the scalability and broader applicability of ATMP production, thereby affecting supply. Furthermore, disparities in how Member States interpret and implement HE have resulted in inconsistent quality, safety, and efficacy standards across the EU.<span><sup>3</sup></span> Additionally, the EU lacks a system for monitoring health outcomes in patients treated with ATMPs through HE. 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Recital 18 of the proposal also suggests the potential for an adapted framework for less complex ATMPs manufactured under HE.<span><sup>4</sup></span></p><p>Although industry associations have generally supported tighter restrictions on the use of HE,<span><sup>5</sup></span> the European Blood Alliance (EBA), alongside multiple scientific societies and professional organizations, has expressed strong support for maintaining and strengthening this exemption.<span><sup>6</sup></span> The EBA comprises 29 national blood services that represent the majority of public blood collection in the EU, EFTA, and the United Kingdom.<span><sup>7</sup></span> Besides core activities, EBA members participate in developing and producing cell-based ATMPs. In response to the differing views within the industry, the EBA has intensified its focus on ATMPs by launching a survey among its members regarding their HE-related activities. Based on the survey results, the EBA convened a working group of experts to develop a position aimed at strengthening the HE framework.</p><p>The EBA strongly advocates for expanding, not limiting, the use of HE for ATMPs. Instead of being an exceptional measure, HE should become a harmonized regular approach for producing ATMPs, including those with marketing authorization that are not available nationally. An EU system for monitoring outcomes in treated patients with ATMPs under HE should be established. The EBA also suggests modifying the ATMP framework to include the new elements in the SoHO regulation and reassessing the classification of products as either SoHO products or ATMPs.</p><p>The SoHO regulation establishes more stringent standards for SoHO products intended for human use.<span><sup>8</sup></span> Their regulatory approval necessitates strong evidence of safety, quality, and efficacy, along with outcome monitoring and benefit-risk assessments. These requirements could serve as a basis for reclassifying lower risk cell-based ATMPs as SoHO products under specific conditions. The development and manufacturing of new ATMPs must continue to be subject to strict regulatory oversight.</p><p>The EBA recognizes the essential role of non-profit SoHO establishments and hospitals in the development and production of cell-based ATMPs under HE. According to the EBA 2024 survey (manuscript in preparation), blood establishments in many EU countries are actively engaged in ATMP activities within the HE framework. Their involvement reflects the longstanding synergy between SoHOs and many ATMPs. Blood, tissues, and cells often serve as critical starting materials for ATMPs. Public-sector establishments have played a leading role globally in the development of hematopoietic stem cell transplantation, an affordable and curative treatment for several disorders. 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In some instances, marketing authorizations have been withdrawn or not renewed, mainly for commercial reasons rather than due to clinical issues.<span><sup>2</sup></span></p><p>In contrast, HE is widely acknowledged as a valuable tool, enabling access to innovative and often life-saving treatments in cases of unmet clinical need. However, the current HE provisions—restricting production to the same Member State, requiring nonroutine preparation within the hospital, and assigning responsibility to a single practitioner—are ill-suited to today's clinical and manufacturing realities. These limitations reduce the scalability and broader applicability of ATMP production, thereby affecting supply. Furthermore, disparities in how Member States interpret and implement HE have resulted in inconsistent quality, safety, and efficacy standards across the EU.<span><sup>3</sup></span> Additionally, the EU lacks a system for monitoring health outcomes in patients treated with ATMPs through HE. 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Recital 18 of the proposal also suggests the potential for an adapted framework for less complex ATMPs manufactured under HE.<span><sup>4</sup></span></p><p>Although industry associations have generally supported tighter restrictions on the use of HE,<span><sup>5</sup></span> the European Blood Alliance (EBA), alongside multiple scientific societies and professional organizations, has expressed strong support for maintaining and strengthening this exemption.<span><sup>6</sup></span> The EBA comprises 29 national blood services that represent the majority of public blood collection in the EU, EFTA, and the United Kingdom.<span><sup>7</sup></span> Besides core activities, EBA members participate in developing and producing cell-based ATMPs. In response to the differing views within the industry, the EBA has intensified its focus on ATMPs by launching a survey among its members regarding their HE-related activities. 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引用次数: 0

摘要

在欧盟,先进治疗药物(atmp)——包括体细胞疗法、基因疗法和组织工程产品——通常受到欧洲药品管理局(EMA)的集中营销授权。然而,ATMP法规(EC) No 1394/2007也允许在医院豁免(HE)条款下在国内生产和使用,前提是满足国家主管当局批准的特定标准。自2007年引入ATMP法规以来,ATMP领域经历了重大的科学和技术进步,而监管框架基本保持不变,似乎过于严格。这可能会阻碍这些创新疗法的发展和可用性。虽然许多健康状况可能受益于ATMP疗法,但高昂的开发和制造成本(也受到监管要求的驱动)往往阻碍商业投资,特别是对罕见疾病或利基应用。在某些情况下,上市许可被撤销或不再续期,主要是出于商业原因,而不是由于临床问题。相比之下,高等教育被广泛认为是一种有价值的工具,可以在临床需求未得到满足的情况下获得创新的、往往是挽救生命的治疗方法。然而,目前的HE规定——将生产限制在同一成员国,要求在医院内进行非常规制备,并将责任分配给单个医生——不适合当今的临床和制造现实。这些限制降低了ATMP生产的可扩展性和更广泛的适用性,从而影响了供应。此外,成员国如何解释和实施HE的差异导致整个欧盟的质量、安全性和有效性标准不一致。3此外,欧盟缺乏通过HE监测atmp治疗患者健康结果的系统。开发这样一个系统对于确保质量和安全的透明度、产生科学知识、提高医疗保健效率和提高利益相关者的意识至关重要。进一步的挑战在于atmp和人类来源物质(SoHO)之间模糊的监管分类边界,这导致适用框架的法律不确定性。欧盟委员会2023年修订药品指令的提案包括改进数据收集和根据HE生产的atmp年度审查的规定,并通过ema管理的存储库公开报告。该提案的陈述18也表明了在HE下生产的不太复杂的atmp的适应框架的潜力4 .尽管行业协会通常支持对HE的使用进行更严格的限制5,欧洲血液联盟(EBA)以及多个科学协会和专业组织表示强烈支持维持和加强这一豁免6EBA由29个国家的血液服务机构组成,代表了欧盟、欧洲自由贸易联盟和英国的大部分公共血液采集。7除了核心活动外,EBA成员还参与开发和生产基于细胞的atmp。为了回应业界的不同意见,EBA在其成员中开展了一项关于他们与he相关活动的调查,从而加强了对atmp的关注。根据调查结果,EBA召集了一个专家工作组,制定旨在加强高等教育框架的立场。EBA强烈主张扩大,而不是限制,在atm机上使用HE。HE不应成为一项特殊措施,而应成为生产atmp的统一常规方法,包括那些在全国范围内无法获得上市许可的atmp。应该建立一个欧盟系统来监测在HE下治疗的atmp患者的结果。EBA还建议修改ATMP框架,以包括SoHO监管中的新元素,并重新评估产品的分类,无论是SoHO产品还是ATMP。SoHO条例为人类使用的SoHO产品建立了更严格的标准它们的监管批准需要安全性、质量和有效性的有力证据,以及结果监测和利益风险评估。这些要求可以作为在特定条件下将低风险细胞atmp重新分类为SoHO产品的基础。新atmp的开发和制造必须继续受到严格的监管监督。EBA认识到非营利SoHO机构和医院在HE下基于细胞的atmp的开发和生产中的重要作用。根据EBA 2024调查(准备中的手稿),许多欧盟国家的血液机构在HE框架内积极参与ATMP活动。他们的参与反映了soho和许多atmp之间长期的协同作用。 血液、组织和细胞通常是atmp的关键起始材料。公共部门机构在全球造血干细胞移植发展方面发挥了主导作用,这是一种可负担得起的治疗几种疾病的方法。虽然造血移植物不属于atmp,但它们具有多种特征。值得注意的是,在过去的50年里,干细胞移植的成功依赖于类似于HE基础的原理。此外,SoHO机构通常提供开发和生产atmp所需的训练有素的人员、基础设施、设备和存储容量。所有相关利益相关者,特别是监管机构和政策制定者,都应该承认这些共同特征。EBA坚信,扩大HE的概念,加强公共SoHO机构在开发和生产高质量和安全的atmp方面的作用,将增加制造中心的数量,降低生产成本,最重要的是,增加患者获得负担得起的创新疗法的机会。EBA ATMPs组所有成员:概念化(平等);写作—评审与编辑(同等)。Dragoslav domanoovic:概念化(lead);写作——原稿(主笔);写作—评审与编辑(同等)。作者声明无利益冲突。这项研究没有得到资助。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

ATMPs prepared under hospital exemption: European Blood Alliance position paper

ATMPs prepared under hospital exemption: European Blood Alliance position paper

In the European Union, advanced therapy medicinal products (ATMPs)—including somatic cell therapies, gene therapies, and tissue-engineered products—are generally subject to centralized marketing authorization by the European Medicines Agency (EMA). However, the ATMP Regulation (EC) No 1394/2007 also allows their production and use within the country under the hospital exemption (HE) clause, provided that specific criteria are met and approved by the National Competent Authorities.1

Since the ATMP Regulation was introduced in 2007, the ATMP field has experienced significant scientific and technological advancements, whereas the regulatory framework remains largely unchanged and appears overly restrictive, potentially hindering the development and availability of these innovative therapies. Although many health conditions may benefit from ATMP therapies, the high development and manufacturing costs, which are also driven by regulatory requirements, often discourage commercial investment, especially for rare diseases or niche applications. In some instances, marketing authorizations have been withdrawn or not renewed, mainly for commercial reasons rather than due to clinical issues.2

In contrast, HE is widely acknowledged as a valuable tool, enabling access to innovative and often life-saving treatments in cases of unmet clinical need. However, the current HE provisions—restricting production to the same Member State, requiring nonroutine preparation within the hospital, and assigning responsibility to a single practitioner—are ill-suited to today's clinical and manufacturing realities. These limitations reduce the scalability and broader applicability of ATMP production, thereby affecting supply. Furthermore, disparities in how Member States interpret and implement HE have resulted in inconsistent quality, safety, and efficacy standards across the EU.3 Additionally, the EU lacks a system for monitoring health outcomes in patients treated with ATMPs through HE. Developing such a system is crucial to ensure transparency in quality and safety, generate scientific knowledge, enhance healthcare efficiency, and raise stakeholder awareness.

A further challenge lies in the ambiguous regulatory classification boundary between ATMPs and substances of human origin (SoHO), which results in legal uncertainty over applicable frameworks. The European Commission's 2023 proposal to revise the Medicinal Products Directive includes provisions for improved data collection and annual reviews of ATMPs produced under HE, with public reporting through an EMA-managed repository. Recital 18 of the proposal also suggests the potential for an adapted framework for less complex ATMPs manufactured under HE.4

Although industry associations have generally supported tighter restrictions on the use of HE,5 the European Blood Alliance (EBA), alongside multiple scientific societies and professional organizations, has expressed strong support for maintaining and strengthening this exemption.6 The EBA comprises 29 national blood services that represent the majority of public blood collection in the EU, EFTA, and the United Kingdom.7 Besides core activities, EBA members participate in developing and producing cell-based ATMPs. In response to the differing views within the industry, the EBA has intensified its focus on ATMPs by launching a survey among its members regarding their HE-related activities. Based on the survey results, the EBA convened a working group of experts to develop a position aimed at strengthening the HE framework.

The EBA strongly advocates for expanding, not limiting, the use of HE for ATMPs. Instead of being an exceptional measure, HE should become a harmonized regular approach for producing ATMPs, including those with marketing authorization that are not available nationally. An EU system for monitoring outcomes in treated patients with ATMPs under HE should be established. The EBA also suggests modifying the ATMP framework to include the new elements in the SoHO regulation and reassessing the classification of products as either SoHO products or ATMPs.

The SoHO regulation establishes more stringent standards for SoHO products intended for human use.8 Their regulatory approval necessitates strong evidence of safety, quality, and efficacy, along with outcome monitoring and benefit-risk assessments. These requirements could serve as a basis for reclassifying lower risk cell-based ATMPs as SoHO products under specific conditions. The development and manufacturing of new ATMPs must continue to be subject to strict regulatory oversight.

The EBA recognizes the essential role of non-profit SoHO establishments and hospitals in the development and production of cell-based ATMPs under HE. According to the EBA 2024 survey (manuscript in preparation), blood establishments in many EU countries are actively engaged in ATMP activities within the HE framework. Their involvement reflects the longstanding synergy between SoHOs and many ATMPs. Blood, tissues, and cells often serve as critical starting materials for ATMPs. Public-sector establishments have played a leading role globally in the development of hematopoietic stem cell transplantation, an affordable and curative treatment for several disorders. Although hematopoietic grafts are not classified as ATMPs, they share multiple characteristics with them. Notably, the success of stem cell transplantation over the past five decades has relied on principles analogous to those underpinning HE.

Moreover, SoHO establishments often provide the trained personnel, infrastructure, equipment, and storage capacity required for the development and production of ATMPs.9

These shared features should be acknowledged by all relevant stakeholders, particularly regulators and policymakers.

The EBA strongly believes that expanding the concept of HE and strengthening the role of public SoHO establishments in the development and production of high-quality and safe ATMPs will increase the number of manufacturing centers, reduce production costs, and most importantly, enhance patient access to affordable and innovative therapies.

All members of the EBA ATMPs Group: Conceptualization (equal); writing—review and editing (equal). Dragoslav Domanović: Conceptualization (lead); writing—original draft (lead); writing—review and editing (equal).

The authors declare no conflicts of interest.

This research received no funding.

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来源期刊
HemaSphere
HemaSphere Medicine-Hematology
CiteScore
6.10
自引率
4.50%
发文量
2776
审稿时长
7 weeks
期刊介绍: HemaSphere, as a publication, is dedicated to disseminating the outcomes of profoundly pertinent basic, translational, and clinical research endeavors within the field of hematology. The journal actively seeks robust studies that unveil novel discoveries with significant ramifications for hematology. In addition to original research, HemaSphere features review articles and guideline articles that furnish lucid synopses and discussions of emerging developments, along with recommendations for patient care. Positioned as the foremost resource in hematology, HemaSphere augments its offerings with specialized sections like HemaTopics and HemaPolicy. These segments engender insightful dialogues covering a spectrum of hematology-related topics, including digestible summaries of pivotal articles, updates on new therapies, deliberations on European policy matters, and other noteworthy news items within the field. Steering the course of HemaSphere are Editor in Chief Jan Cools and Deputy Editor in Chief Claire Harrison, alongside the guidance of an esteemed Editorial Board comprising international luminaries in both research and clinical realms, each representing diverse areas of hematologic expertise.
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