Consultant, Warsaw, Poland.
Parent's Guide to Cord Blood® Foundation, Brookeville, MD, United States.
Front Immunol. 2024 May 13;15:1379134. doi: 10.3389/fimmu.2024.1379134. eCollection 2024.
This article explains the current regulatory system in Poland regarding Advanced Therapy Medicinal Products given under Hospital Exemptions (ATMP-HE).
The relevant sections of Polish legislation are translated into English and their interaction is described.
We analyze the impact of these regulations from the perspective of three stakeholder groups: manufacturers, physicians, and patients. Amendments enacted between 2018 and 2023 have substantially changed Polish implementation of the ATMP-HE pathway. In Poland, most ATMP-HE treatments have been therapies employing Mesenchymal Stromal Cells (MSC).
Comparison to other European countries shows that Poland is within the mainstream of EU practices regarding ATMP-HE implementation. One notable issue is that Poland has relatively low per capita spending on healthcare, and ATMP-HE in Poland must be funded from outside the government healthcare system. Conclusions. The original intention of the legislation that created ATMP-HE was to allow access to experimental therapies for patients with unmet needs. It remains to be seen if that mission can be fulfilled amidst conflicting pressures from various stakeholder groups.
本文介绍了波兰目前针对医院豁免（ATMP-HE）下的高级治疗药物的监管体系。
将波兰立法的相关部分翻译成英文，并描述其相互作用。
我们从制造商、医生和患者三个利益相关者群体的角度分析了这些规定的影响。2018 年至 2023 年期间颁布的修正案极大地改变了波兰对 ATMP-HE 途径的实施。在波兰，大多数 ATMP-HE 治疗都是使用间充质基质细胞（MSC）的疗法。
与其他欧洲国家相比，波兰在实施 ATMP-HE 方面处于欧盟实践的主流。一个值得注意的问题是，波兰的医疗保健人均支出相对较低，波兰的 ATMP-HE 必须由政府医疗保健系统之外的资金提供。结论。制定 ATMP-HE 的立法的初衷是允许有未满足需求的患者获得实验性治疗。在来自各个利益相关者群体的相互冲突的压力下，这项使命是否能够实现还有待观察。
