Frontiers in Immunology (May 2024)

Polish regulatory system regarding ATMP hospital exemptions

  • Jan Pachocki,
  • Frances Verter

DOI
https://doi.org/10.3389/fimmu.2024.1379134
Journal volume & issue
Vol. 15

Abstract

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IntroductionThis article explains the current regulatory system in Poland regarding Advanced Therapy Medicinal Products given under Hospital Exemptions (ATMP-HE).MethodsThe relevant sections of Polish legislation are translated into English and their interaction is described.ResultsWe 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).DiscussionComparison 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.

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