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ORIGINAL RESEARCH article

Front. Immunol.
Sec. Vaccines and Molecular Therapeutics
Volume 15 - 2024 | doi: 10.3389/fimmu.2024.1379134
This article is part of the Research Topic Community Series in Safety, Efficacy and Mechanisms of Action of Mesenchymal Stem Cell Therapies - Volume II View all 8 articles

Polish Regulatory System Regarding ATMP Hospital Exemptions

Provisionally accepted
Jan Pachocki Jan Pachocki 1*Frances Verter Frances Verter 2,3*
  • 1 Jutro Medical, Warsaw, Poland
  • 2 Other, Brookeville, United States
  • 3 Parent’s Guide to Cord Blood® Foundation, Brookeville, United States

The final, formatted version of the article will be published soon.

    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.

    Keywords: Advanced therapy medicinal products (ATMPs), cell and gene therapy (CGT), Hospital Exemptions (HE), Mesenchymal stromal cells (MSC), regulatory affairs, national licensing provisions, risk -benefit, unproven cell and gene interventions

    Received: 30 Jan 2024; Accepted: 16 Apr 2024.

    Copyright: © 2024 Pachocki and Verter. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Jan Pachocki, Jutro Medical, Warsaw, Poland
    Frances Verter, Other, Brookeville, United States

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.